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Laxido Orange, powder for oral solution, sugar-free


1. Name Of The Medicinal Product

Laxido Orange, powder for oral solution.

2. Qualitative And Quantitative Composition

Each sachet contains the following quantitative composition of active ingredients:

Macrogol 3350 13.125g

Sodium Chloride 350.7mg

Sodium Hydrogen Carbonate 178.5mg

Potassium Chloride 46.6mg

The content of electrolyte ions per sachet following reconstitution in 125ml of water is equivalent to:

Sodium 65mmol/l

Chloride 53mmol/l

Hydrogen Carbonate (Bicarbonate) 17mmol/l

Potassium 5.4mmol/l

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for oral solution. Single-dose sachet containing a free flowing white powder.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of chronic constipation. Laxido Orange is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon.

4.2 Posology And Method Of Administration

Laxido Orange is for oral use.

Chronic Constipation:

A course of treatment for chronic constipation with Laxido Orange does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's Disease, or induced by regular constipating medication in particular opioids and antimuscarinics.

Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily.

Children below 12 years old: Not recommended.

Faecal Impaction:

A course of treatment for faecal impaction with Laxido Orange does not normally exceed 3 days.

Adults, adolescents and the elderly: 8 sachets daily, all of which should be consumed within a 6 hour period.

Children below 12 years old: Not recommended.

Patients with impaired cardiovascular function: For the treatment of faecal impaction the dose should be divided so that no more than 2 sachets are taken in any one hour.

Patients with renal insufficiency: No dosage change is necessary for the treatment of constipation or faecal impaction.

Administration:

Each sachet should be dissolved in 125 ml water. For use in faecal impaction, 8 sachets may be dissolved in 1 litre of water.

4.3 Contraindications

Laxido Orange is contraindicated in intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract (e.g. ulcerative colitis, Crohn's disease and toxic megacolon).

Hypersensitivity to the active substances or any of the excipients.

4.4 Special Warnings And Precautions For Use

The faecal impaction diagnosis should be confirmed by appropriate physical or radiological examination of the rectum and abdomen.

Mild adverse drug reactions are possible as indicated in Section 4.8. If patients develop any symptoms indicating shifts of fluids/electrolytes (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Laxido Orange should be stopped immediately and electrolytes measured and any abnormality should be treated appropriately.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions of Laxido Orange with other medicinal products. However, macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and mainly insoluble in water. It is a theoretical possibility that absorption of these drugs could be reduced transiently. Therefore, other medicines should not be taken orally for one hour before and for one hour after taking Laxido Orange.

4.6 Pregnancy And Lactation

There is no experience with the use of Laxido Orange during pregnancy and lactation and it should not be used during pregnancy and lactation unless clearly necessary.

4.7 Effects On Ability To Drive And Use Machines

Laxido Orange has no influence on the ability to drive and use machines.

4.8 Undesirable Effects

Immune System Disorders:

Allergic reactions are possible.

Gastro-intestinal Disorders:

Potential gastro-intestinal effects that may occur include abdominal distension and pain, borborygmi and nausea. Mild diarrhoea may also occur, but normally resolves after dose reduction.

4.9 Overdose

Severe distension or pain can be treated using nasogastric aspiration. Vomiting or diarrhoea may induce extensive fluid loss, possibly leading to electrolyte disturbances that should be treated appropriately.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Osmotically acting laxatives.

ATC code: A06A D65

Macrogol 3350 induces a laxative effect through its osmotic action in the gut. This product also contains electrolytes to ensure that there is no overall gain or loss of water, potassium or sodium.

Clinical studies using the listed active substances for the treatment of chronic constipation have shown that the dose required to produce normally formed stools tends to decrease over time. For most patients, the maintenance dose will be one to two sachets per day (adjusted according to individual response).

Comparative studies in faecal impaction using active controls (e.g. enemas) have not been performed. However, results from a non-comparative study have shown that, from a population of 27 adult patients, the listed combination of active substances cleared faecal impaction in 12/27 (44%) patients after one day's treatment, increasing to 23/27 (85%) following two days' treatment and 24/27 (89%) recovered at the end of three days.

5.2 Pharmacokinetic Properties

Macrogol 3350 is virtually unabsorbed from the gastro-intestinal tract and is excreted, unaltered, in faeces. Any macrogol 3350 that enters the systemic circulation is excreted in urine.

5.3 Preclinical Safety Data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential, although no tests of its effects on reproduction or genotoxicity have been conducted.

There are no long-term animal toxicity or carcinogenicity studies involving macrogol 3350, although there are toxicity studies using high levels of orally administered high-molecular weight macrogols that provide evidence of safety at the recommended therapeutic dose.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acesulfame Potassium (E950)

Orange Flavour

(Orange flavour contains the following constituents: natural flavouring substances and preparations, maltodextrin and propylene glycol [E1520])

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Sachet: Two years.

Reconstituted solution: Six hours.

6.4 Special Precautions For Storage

Sachet: Store below 25°C.

Reconstituted solution: Store covered in a refrigerator (2°C to 8°C).

6.5 Nature And Contents Of Container

The sachet is composed of paper, low density polyethylene and aluminium.

Sachets are packed in cartons of 2, 8, 10, 20, 30, 50 and 100.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Galen Limited

Seagoe Industrial Estate

Craigavon

BT63 5UA

UK

8. Marketing Authorisation Number(S)

PL 21590/0087.

9. Date Of First Authorisation/Renewal Of The Authorisation

01 May 2008.

10. Date Of Revision Of The Text

10 February 2010


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Urinary pH modifiers


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Urinary pH modifiers are agents that increase the pH of urine. They make the urine more alkaline and prevent the formation of kidney stones. Making the urine more alkaline also helps the kidneys to remove toxic substances.

See also

Medical conditions associated with urinary pH modifiers:

Alkalosis Asystole Diabetic Ketoacidosis GERD Hyperkalemia Hyperuricemia Secondary to Chemotherapy Hyponatremia Indigestion Metabolic Acidosis Nephrolithiasis Renal Tubular Acidosis Urinary Alkalinization Drug List: Urocit-K Neut
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ferumoxsil


Generic Name: ferumoxsil (fer yoo MOX il)
Brand Names: GastroMARK

What is ferumoxsil?

Ferumoxsil is in a group of drugs called imaging contrast agents. Ferumoxsil contains iron, a substance that is magnetic. Contrast agents are used to allow certain internal organs to be seen clearly on an MRI (magnetic resonance imaging).

Ferumoxsil is used to help diagnose certain disorders of the stomach or intestines.

Ferumoxsil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ferumoxsil? Do not receive this medication if you are allergic to ferumoxsil, or if you have a blocked or perforated intestine.

Before receiving this medication, tell your doctor if you are allergic to any drugs, if you have an iron overload disorder (such as chronic hemolytic anemia) or if you have received frequent blood transfusions. Also tell your doctor if you have a history of hiatal hernia, gastroesophageal reflux disease (GERD), inflammatory bowel disease, or if you have recently had any nausea, vomiting or diarrhea.

After receiving ferumoxsil, call your doctor at once if you have severe stomach pain or cramping, or a skin rash with bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects are more likely to occur, such as mild stomach pain, nausea, vomiting, diarrhea, headache, or numbness and tingling of your mouth.

What should I discuss with my health care provider before receiving ferumoxsil? Do not receive this medication if you are allergic to ferumoxsil, or if you have a blocked or perforated intestine.

Before receiving this medication, tell your doctor if you are allergic to any drugs, or if you have:

an iron overload disorder such as chronic hemolytic anemia;

a history of frequent blood transfusions;

a history of hiatal hernia;

gastroesophageal reflux disease (GERD);

inflammatory bowel disease;

if you tend to burp up food, especially when lying down after a meal; or

if you have recently had any nausea, vomiting, or diarrhea.

If you have any of these conditions, you may not be able to receive ferumoxsil.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ferumoxsil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How is ferumoxsil used?

Ferumoxsil is a liquid that you will be asked to drink before your MRI is performed.

Ferumoxsil must be taken on an empty stomach. You will need to fast (not eat or drink anything) for at least 4 hours before you take this medicine.

In some cases, the MRI will be done within 30 minutes after you drink the ferumoxsil. However, you may be asked to drink the liquid several hours before your MRI. Follow your doctor's instructions.

What happens if I miss a dose?

Since ferumoxsil is used only for the purposes of your MRI, you will not be on a dosing schedule.

What happens if I overdose?

Contact your doctor if you think you have received too much of this medication. Symptoms of a ferumoxsil overdose are not known.

What should I avoid while taking ferumoxsil?

On the day of your MRI, avoid foods or beverages that upset your stomach. Ferumoxsil can cause mild to severe stomach discomfort.

Ferumoxsil side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

severe stomach pain or cramping; or

skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects are more likely to occur, such as:

mild stomach pain, nausea, vomiting, diarrhea;

upset stomach;

skin rash or itching;

headache; or

numbness or tingling in or around your mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ferumoxsil?

Before receiving this medication, tell your doctor if you are using iron supplements.

There may be other drugs that can affect ferumoxsil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ferumoxsil resources Ferumoxsil Drug Interactions Ferumoxsil Support Group 0 Reviews for Ferumoxsil - Add your own review/rating Gastromark Prescribing Information (FDA) Compare ferumoxsil with other medications Diagnosis and Investigation Where can I get more information? Your doctor has information about ferumoxsil written for health professionals that you may read.
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Axid Solution


Pronunciation: ni-ZA-ti-dine
Generic Name: Nizatidine
Brand Name: Axid
Axid Solution is used for:

Treating and preventing ulcers. It is also used to treat gastroesophageal reflux disease (GERD) and to treat and maintain healing of erosive esophagitis. It may also be used for other conditions as determined by your health care provider.

Axid Solution is a histamine H2antagonist. It works by reducing acid in the stomach by blocking one of the chemicals (histamine) that stimulates the production of stomach acid.

Do NOT use Axid Solution if: you are allergic to any ingredient in Axid Solution or other H2 antagonists (eg, famotidine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Axid Solution:

Some medical conditions may interact with Axid Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines or other substances if you have kidney or liver problems if you have a history of the blood disease porphyria

Some MEDICINES MAY INTERACT with Axid Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Ketoconazole because effectiveness may be decreased by Axid Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Axid Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Axid Solution:

Use Axid Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Axid Solution maybe taken with or without food. Use a measuring device marked for medicine dosing. Ask your health care provider or pharmacist if you are unsure of how to measure the dose. Continue to use Axid Solution even if you feel well. Do not miss any doses. Antacids may be taken as needed to help relieve stomach pain, unless your health care provider instructed otherwise. If you miss a dose of Axid Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Axid Solution.

Important safety information: Axid Solution may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Axid Solution. Using Axid Solution alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Use Axid Solution with extreme caution in the ELDERLY because they may be more sensitive to its effects. Use Axid Solution with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Axid Solution, discuss with your doctor the benefits and risks of using Axid Solution during pregnancy. Axid Solution is excreted in breast milk. Do not breast-feed while taking Axid Solution. Possible side effects of Axid Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Axid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include difficulty breathing; fast heartbeat; restlessness; tremor; vomiting.

Proper storage of Axid Solution:

Store Axid Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Axid Solution out of the reach of children and away from pets.

General information: If you have any questions about Axid Solution, please talk with your doctor, pharmacist, or other health care provider. Axid Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Axid Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Axid resources Axid Side Effects (in more detail) Axid Use in Pregnancy & Breastfeeding Axid Drug Interactions Axid Support Group 0 Reviews for Axid - Add your own review/rating Compare Axid with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Stomach Ulcer
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Gaviscon Extra Strength


Generic Name: alginic acid, aluminum hydroxide, and magnesium carbonate (al JIN ik AS id, a LOO mi num hye DROX ide, mg NEE see um KAR boe nate)
Brand Names: Acid Gone, Acid Gone Extra Strength, Alenic Alka, Gaviscon Extra Strength, Gaviscon Extra Strength Liquid, Gaviscon Regular Strength Liquid, Genaton, Heartburn Antacid Extra Strength

What is Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Alginic acid is a natural carbohydrate that comes from algae in seaweed (kelp) and is used in many processed foods. It helps this medication create a foam barrier to coat the stomach.

Aluminum and magnesium are minerals that occur naturally and are used as antacids.

The combination of alginic acid, aluminum hydroxide, and magnesium carbonate is used to treat symptoms of stomach ulcers, gastroesophageal reflux disease (GERD), and other conditions caused by excess stomach acid. This medicine is also used to treat heartburn, upset stomach, sour stomach, or acid indigestion.

This medication may be used for other purposes not listed in this medication guide.

What is the most important information I should know about Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Ask a doctor or pharmacist before taking this medication if you have kidney disease, kidney stones, severe constipation, or if you are dehydrated.

Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug. Call your doctor if your symptoms do not improve, or if they get worse while using this medication.

Stop taking this medication and call your doctor at once if you have severe stomach pain, severe constipation, swelling in your ankles or feet, blood in your stools, or if you cough up blood. Some of these may be symptoms of your condition and not side effects of the medication.

What should I discuss with my healthcare provider before taking Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

kidney disease, a history of kidney stones;

severe constipation; or

if you are dehydrated.

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if your symptoms do not improve, or if they get worse while using this medication. Store this medication at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Since antacids are taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe diarrhea.

What should I avoid while taking Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)? Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug. Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking the medication and call your doctor at once if you have any of the following side effects. Some of these may be symptoms of your condition and not side effects of the medication.

severe stomach pain or constipation;

bloody or tarry stools, coughing up blood ;

swelling in your ankles or feet; or

worsening of your stomach condition.

Less serious side effects may include:

mild constipation or diarrhea;

nausea, mild stomach cramps; or

altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gaviscon Extra Strength (alginic acid, aluminum hydroxide, and magnesium carbonate)?

There may be other drugs that can interact with this medication. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gaviscon Extra Strength resources Gaviscon Extra Strength Side Effects (in more detail) Gaviscon Extra Strength Use in Pregnancy & Breastfeeding Gaviscon Extra Strength Drug Interactions Gaviscon Extra Strength Support Group 0 Reviews for Gaviscon Extra Strength - Add your own review/rating Acid Gone Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Genaton MedFacts Consumer Leaflet (Wolters Kluwer) Compare Gaviscon Extra Strength with other medications GERD Indigestion Where can I get more information? Your pharmacist can provide more information about alginic acid, aluminum hydroxide, and magnesium carbonate.

See also: Gaviscon Extra Strength side effects (in more detail)


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Gaviscon Extra Strength Liquid


Generic Name: alginic acid, aluminum hydroxide, and magnesium carbonate (al JIN ik AS id, a LOO mi num hye DROX ide, mg NEE see um KAR boe nate)
Brand Names: Acid Gone, Acid Gone Extra Strength, Alenic Alka, Gaviscon Extra Strength, Gaviscon Extra Strength Liquid, Gaviscon Regular Strength Liquid, Genaton, Heartburn Antacid Extra Strength

What is Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Alginic acid is a natural carbohydrate that comes from algae in seaweed (kelp) and is used in many processed foods. It helps this medication create a foam barrier to coat the stomach.

Aluminum and magnesium are minerals that occur naturally and are used as antacids.

The combination of alginic acid, aluminum hydroxide, and magnesium carbonate is used to treat symptoms of stomach ulcers, gastroesophageal reflux disease (GERD), and other conditions caused by excess stomach acid. This medicine is also used to treat heartburn, upset stomach, sour stomach, or acid indigestion.

This medication may be used for other purposes not listed in this medication guide.

What is the most important information I should know about Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Ask a doctor or pharmacist before taking this medication if you have kidney disease, kidney stones, severe constipation, or if you are dehydrated.

Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug. Call your doctor if your symptoms do not improve, or if they get worse while using this medication.

Stop taking this medication and call your doctor at once if you have severe stomach pain, severe constipation, swelling in your ankles or feet, blood in your stools, or if you cough up blood. Some of these may be symptoms of your condition and not side effects of the medication.

What should I discuss with my healthcare provider before taking Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

kidney disease, a history of kidney stones;

severe constipation; or

if you are dehydrated.

It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if your symptoms do not improve, or if they get worse while using this medication. Store this medication at room temperature away from moisture, heat, and light. What happens if I miss a dose?

Since antacids are taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause severe diarrhea.

What should I avoid while taking Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)? Avoid taking multivitamins, mineral supplements, or other medications (especially antacids) at the same time you take this medication. Antacids can make it harder for your body to absorb certain other drugs. Taking too many antacids together may cause you to take too much of a certain drug. Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop taking the medication and call your doctor at once if you have any of the following side effects. Some of these may be symptoms of your condition and not side effects of the medication.

severe stomach pain or constipation;

bloody or tarry stools, coughing up blood ;

swelling in your ankles or feet; or

worsening of your stomach condition.

Less serious side effects may include:

mild constipation or diarrhea;

nausea, mild stomach cramps; or

altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gaviscon Extra Strength Liquid (alginic acid, aluminum hydroxide, and magnesium carbonate)?

There may be other drugs that can interact with this medication. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gaviscon Extra Strength Liquid resources Gaviscon Extra Strength Liquid Side Effects (in more detail) Gaviscon Extra Strength Liquid Use in Pregnancy & Breastfeeding Gaviscon Extra Strength Liquid Drug Interactions 0 Reviews for Gaviscon Extra Strength - Add your own review/rating Acid Gone Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Genaton MedFacts Consumer Leaflet (Wolters Kluwer) Compare Gaviscon Extra Strength Liquid with other medications GERD Indigestion Where can I get more information? Your pharmacist can provide more information about alginic acid, aluminum hydroxide, and magnesium carbonate.

See also: Gaviscon Extra Strength side effects (in more detail)


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Famotidine Suspension


Pronunciation: fa-MOE-tih-deen
Generic Name: Famotidine
Brand Name: Pepcid Oral Suspension
Famotidine Suspension is used for:

Treating and preventing ulcers. It is also used to treat conditions that cause increased acid secretion (eg, Zollinger-Ellison syndrome), gastroesophageal reflux disease (GERD), and esophagitis. It may also be used for other conditions as determined by your doctor.

Famotidine Suspension is an H2 (histamine) blocker. It works by reducing stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.

Do NOT use Famotidine Suspension if: you are allergic to any ingredient in Famotidine Suspension or to other H2 blockers (eg, ranitidine) you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Famotidine Suspension:

Some medical conditions may interact with Famotidine Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney or liver problems.

Some MEDICINES MAY INTERACT with Famotidine Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Dasatinib because its effectiveness may be decreased by Famotidine Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Famotidine Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Famotidine Suspension:

Use Famotidine Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Famotidine Suspension by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose. If you take atazanavir, erlotinib, itraconazole, ketoconazole, or rilpivirine, ask your doctor or pharmacist how to take it with Famotidine Suspension. Ask your doctor before taking antacids or other acid reducers with Famotidine Suspension. If you miss a dose of Famotidine Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Famotidine Suspension.

Important safety information: Famotidine Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Famotidine Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Notify your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools, or vomit that looks like coffee grounds. You may need to make significant diet and lifestyle changes to help treat and prevent ulcers and other digestive problems, including stress-reduction programs, exercise, and diet changes. Use Famotidine Suspension with caution in the ELDERLY; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Famotidine Suspension while you are pregnant. Famotidine Suspension is found in breast milk. Do not breast-feed while taking Famotidine Suspension. Possible side effects of Famotidine Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Famotidine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Famotidine Suspension:

Store mixed suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Keep Famotidine Suspension in original container. Do not store in the bathroom. Throw away unused suspension after 30 days. Keep Famotidine Suspension out of the reach of children and away from pets.

General information: If you have any questions about Famotidine Suspension, please talk with your doctor, pharmacist, or other health care provider. Famotidine Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Famotidine Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Famotidine resources Famotidine Side Effects (in more detail) Famotidine Use in Pregnancy & Breastfeeding Drug Images Famotidine Drug Interactions Famotidine Support Group 10 Reviews for Famotidine - Add your own review/rating Compare Famotidine with other medications Allergic Urticaria Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome
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Pepcid Oral Suspension


Pronunciation: fa-MOE-tih-deen
Generic Name: Famotidine
Brand Name: Pepcid Oral Suspension
Pepcid Oral Suspension is used for:

Treating and preventing ulcers. It is also used to treat conditions that cause increased acid secretion (eg, Zollinger-Ellison syndrome), gastroesophageal reflux disease (GERD), and esophagitis. It may also be used for other conditions as determined by your doctor.

Pepcid Oral Suspension is an H2 (histamine) blocker. It works by reducing stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.

Do NOT use Pepcid Oral Suspension if: you are allergic to any ingredient in Pepcid Oral Suspension or to other H2 blockers (eg, ranitidine) you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pepcid Oral Suspension:

Some medical conditions may interact with Pepcid Oral Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney or liver problems.

Some MEDICINES MAY INTERACT with Pepcid Oral Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

Dasatinib because its effectiveness may be decreased by Pepcid Oral Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pepcid Oral Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pepcid Oral Suspension:

Use Pepcid Oral Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Pepcid Oral Suspension by mouth with or without food. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose. If you take atazanavir, erlotinib, itraconazole, ketoconazole, or rilpivirine, ask your doctor or pharmacist how to take it with Pepcid Oral Suspension. Ask your doctor before taking antacids or other acid reducers with Pepcid Oral Suspension. If you miss a dose of Pepcid Oral Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pepcid Oral Suspension.

Important safety information: Pepcid Oral Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pepcid Oral Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Notify your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools, or vomit that looks like coffee grounds. You may need to make significant diet and lifestyle changes to help treat and prevent ulcers and other digestive problems, including stress-reduction programs, exercise, and diet changes. Use Pepcid Oral Suspension with caution in the ELDERLY; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pepcid Oral Suspension while you are pregnant. Pepcid Oral Suspension is found in breast milk. Do not breast-feed while taking Pepcid Oral Suspension. Possible side effects of Pepcid Oral Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pepcid Oral side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pepcid Oral Suspension:

Store mixed suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not freeze. Keep Pepcid Oral Suspension in original container. Do not store in the bathroom. Throw away unused suspension after 30 days. Keep Pepcid Oral Suspension out of the reach of children and away from pets.

General information: If you have any questions about Pepcid Oral Suspension, please talk with your doctor, pharmacist, or other health care provider. Pepcid Oral Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pepcid Oral Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Pepcid Oral resources Pepcid Oral Side Effects (in more detail) Pepcid Oral Use in Pregnancy & Breastfeeding Pepcid Oral Drug Interactions Pepcid Oral Support Group 0 Reviews for Pepcid Oral - Add your own review/rating Compare Pepcid Oral with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome
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Pepcid Solution


Pronunciation: fa-MOE-tih-deen
Generic Name: Famotidine
Brand Name: Generic only. No brands available.
Pepcid Solution is used for:

Treating and preventing ulcers. It is also used to treat conditions that cause increased acid secretion (eg, Zollinger-Ellison syndrome), gastroesophageal reflux disease (GERD), and esophagitis. It may also be used for other conditions as determined by your doctor.

Pepcid Solution is an H2 (histamine) blocker. It works by reducing stomach acid by blocking one of the chemicals (histamine) that stimulates the release of acid into the stomach.

Do NOT use Pepcid Solution if: you are allergic to any ingredient in Pepcid Solution or to other H2 blockers (eg, ranitidine) you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pepcid Solution:

Some medical conditions may interact with Pepcid Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have kidney or liver disease

Some MEDICINES MAY INTERACT with Pepcid Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Dasatinib because its effectiveness may be decreased by Pepcid Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pepcid Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pepcid Solution:

Use Pepcid Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pepcid Solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Pepcid Solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Pepcid Solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Pepcid Solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. If you take atazanavir, erlotinib, itraconazole, ketoconazole, or rilpivirine, ask your doctor or pharmacist how to take it with Pepcid Solution. Ask your doctor before taking antacids or other acid reducers with Pepcid Solution. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. If you miss a dose of Pepcid Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pepcid Solution.

Important safety information: Pepcid Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pepcid Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Notify your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds. You may need to make significant diet and lifestyle changes to help treat and prevent ulcers and other digestive problems, including stress-reduction programs, exercise, and diet changes. Use Pepcid Solution with caution in the ELDERLY; they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pepcid Solution while you are pregnant. Pepcid Solution is found in breast milk. Do not breast-feed while using Pepcid Solution. Possible side effects of Pepcid Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); irregular heartbeat; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pepcid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pepcid Solution:

Pepcid Solution is usually handled and stored by a health care provider. If you are using Pepcid Solution at home, store Pepcid Solution as directed by your pharmacist or health care provider. Keep Pepcid Solution out of the reach of children and away from pets.

General information: If you have any questions about Pepcid Solution, please talk with your doctor, pharmacist, or other health care provider. Pepcid Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pepcid Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Pepcid resources Pepcid Side Effects (in more detail) Pepcid Use in Pregnancy & Breastfeeding Drug Images Pepcid Drug Interactions Pepcid Support Group 3 Reviews for Pepcid - Add your own review/rating Compare Pepcid with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome
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Zantac 150 EFFERdose Effervescent Tablets


Pronunciation: ra-NI-ti-deen
Generic Name: Ranitidine
Brand Name: Zantac 150 EFFERdose
Zantac 150 EFFERdose Effervescent Tablets are used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may be used to treat severe irritation of the esophagus (erosive esophagitis) and to maintain healing of erosive esophagitis. It may be used for short-term treatment of stomach or small intestinal ulcers. It may be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Zantac 150 EFFERdose Effervescent Tablets are an H2-receptor blocker. It works by blocking the action of histamine in the stomach. This reduces the amount of acid the stomach makes. Reducing stomach acid helps to reduce heartburn, heal irritation of the esophagus, and heal ulcers of the stomach or intestines.

Do NOT use Zantac 150 EFFERdose Effervescent Tablets if: you are allergic to any ingredient in Zantac 150 EFFERdose Effervescent Tablets you have a history of the blood disease porphyria you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zantac 150 EFFERdose Effervescent Tablets:

Some medical conditions may interact with Zantac 150 EFFERdose Effervescent Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of kidney or liver problems if you have phenylketonuria

Some MEDICINES MAY INTERACT with Zantac 150 EFFERdose Effervescent Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain benzodiazepines (eg, midazolam, triazolam), glipizide, procainamide, or warfarin because the risk of their side effects may be increased by Zantac 150 EFFERdose Effervescent Tablets Dasatinib, delavirdine, gefitinib, certain HIV protease inhibitors (eg, atazanavir), itraconazole, or ketoconazole because their effectiveness may be decreased by Zantac 150 EFFERdose Effervescent Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zantac 150 EFFERdose Effervescent Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zantac 150 EFFERdose Effervescent Tablets:

Use Zantac 150 EFFERdose Effervescent Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Zantac 150 EFFERdose Effervescent Tablets by mouth with or without food. Do not chew or swallow the tablet or dissolve it on the tongue. Place the tablet in a glass and add 6 to 8 oz (180 to 240 mL) of water, as directed by your doctor. Allow the tablet to dissolve completely, then drink all of the liquid. Rinse the container with an additional small amount of water and drink the contents to ensure the entire dose is taken. If you also take itraconazole or ketoconazole, ask your doctor or pharmacist how to take it with Zantac 150 EFFERdose Effervescent Tablets. You may take antacids while you are using Zantac 150 EFFERdose Effervescent Tablets if you are directed to do so by your doctor. Continue to take Zantac 150 EFFERdose Effervescent Tablets even if you feel well. Do not miss any doses. If you miss a dose of Zantac 150 EFFERdose Effervescent Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zantac 150 EFFERdose Effervescent Tablets.

Important safety information: Zantac 150 EFFERdose Effervescent Tablets may rarely cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zantac 150 EFFERdose Effervescent Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product. Zantac 150 EFFERdose Effervescent Tablets may interfere with certain lab tests, including urine protein tests. Be sure your doctor and lab personnel know you are taking Zantac 150 EFFERdose Effervescent Tablets. Zantac 150 EFFERdose Effervescent Tablets should not be used in CHILDREN younger than 1 month old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zantac 150 EFFERdose Effervescent Tablets while you are pregnant. Zantac 150 EFFERdose Effervescent Tablets are found in breast milk. If you are or will be breast-feeding while you use Zantac 150 EFFERdose Effervescent Tablets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Zantac 150 EFFERdose Effervescent Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zantac50 EFFERdose side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; trouble walking.

Proper storage of Zantac 150 EFFERdose Effervescent Tablets:

Store Zantac 150 EFFERdose Effervescent Tablets between 36 and 86 degrees F (2 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zantac 150 EFFERdose Effervescent Tablets out of the reach of children and away from pets.

General information: If you have any questions about Zantac 150 EFFERdose Effervescent Tablets, please talk with your doctor, pharmacist, or other health care provider. Zantac 150 EFFERdose Effervescent Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zantac 150 EFFERdose Effervescent Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Zantac 150 EFFERdose resources Zantac 150 EFFERdose Side Effects (in more detail) Zantac 150 EFFERdose Use in Pregnancy & Breastfeeding Drug Images Zantac 150 EFFERdose Drug Interactions Zantac 150 EFFERdose Support Group 0 Reviews for Zantac50 EFFERdose - Add your own review/rating Compare Zantac 150 EFFERdose with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis Gastric Ulcer Maintenance Treatment Gastrointestinal Hemorrhage GERD Indigestion Pathological Hypersecretory Conditions Stomach Ulcer Stress Ulcer Prophylaxis Surgical Prophylaxis Zollinger-Ellison Syndrome
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Zantac 25 mg EFFERdose Effervescent Tablets


Pronunciation: ra-NI-ti-deen
Generic Name: Ranitidine
Brand Name: Zantac 25 mg EFFERdose
Zantac 25 mg EFFERdose Effervescent Tablets are used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may be used to treat severe irritation of the esophagus (erosive esophagitis) and to maintain healing of erosive esophagitis. It may be used for short-term treatment of stomach or small intestinal ulcers. It may be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Zantac 25 mg EFFERdose Effervescent Tablets are an H2-receptor blocker. It works by blocking the action of histamine in the stomach. This reduces the amount of acid the stomach makes. Reducing stomach acid helps to reduce heartburn, heal irritation of the esophagus, and heal ulcers of the stomach or intestines.

Do NOT use Zantac 25 mg EFFERdose Effervescent Tablets if: you are allergic to any ingredient in Zantac 25 mg EFFERdose Effervescent Tablets you have a history of the blood disease porphyria you are taking dasatinib

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zantac 25 mg EFFERdose Effervescent Tablets:

Some medical conditions may interact with Zantac 25 mg EFFERdose Effervescent Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of kidney or liver problems if you have phenylketonuria

Some MEDICINES MAY INTERACT with Zantac 25 mg EFFERdose Effervescent Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Certain benzodiazepines (eg, midazolam, triazolam), glipizide, procainamide, or warfarin because the risk of their side effects may be increased by Zantac 25 mg EFFERdose Effervescent Tablets Anticoagulants (eg, warfarin) because the risk of their side effects may be increased or their effectiveness may be decreased by Zantac 25 mg EFFERdose Effervescent Tablets Dasatinib, delavirdine, gefitinib, certain HIV protease inhibitors (eg, atazanavir), itraconazole, or ketoconazole because their effectiveness may be decreased by Zantac 25 mg EFFERdose Effervescent Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zantac 25 mg EFFERdose Effervescent Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zantac 25 mg EFFERdose Effervescent Tablets:

Use Zantac 25 mg EFFERdose Effervescent Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Zantac 25 mg EFFERdose Effervescent Tablets by mouth with or without food. Do not chew or swallow the tablet or dissolve it on the tongue. Place the tablet in a glass and add at least 5 mL (1 teaspoonful) of water, as directed by your doctor. Allow the tablet to dissolve completely, then drink all of the liquid. Rinse the container with an additional small amount of water and drink the contents to ensure the entire dose is taken. You may use a dropper or oral syringe to give Zantac 25 mg EFFERdose Effervescent Tablets. Ask your pharmacist for help if you are unsure of how to prepare or use Zantac 25 mg EFFERdose Effervescent Tablets. If you also take itraconazole or ketoconazole, ask your doctor or pharmacist how to take it with Zantac 25 mg EFFERdose Effervescent Tablets. You may take antacids while you are using Zantac 25 mg EFFERdose Effervescent Tablets if you are directed to do so by your doctor. Continue to take Zantac 25 mg EFFERdose Effervescent Tablets even if you feel well. Do not miss any doses. If you miss a dose of Zantac 25 mg EFFERdose Effervescent Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Zantac 25 mg EFFERdose Effervescent Tablets.

Important safety information: Zantac 25 mg EFFERdose Effervescent Tablets may rarely cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zantac 25 mg EFFERdose Effervescent Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product. Zantac 25 mg EFFERdose Effervescent Tablets may interfere with certain lab tests, including urine protein tests. Be sure your doctor and lab personnel know you are taking Zantac 25 mg EFFERdose Effervescent Tablets. Zantac 25 mg EFFERdose Effervescent Tablets should not be used in CHILDREN younger than 1 month old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zantac 25 mg EFFERdose Effervescent Tablets while you are pregnant. Zantac 25 mg EFFERdose Effervescent Tablets are found in breast milk. If you are or will be breast-feeding while you use Zantac 25 mg EFFERdose Effervescent Tablets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Zantac 25 mg EFFERdose Effervescent Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); change in the amount of urine produced; confusion; dark urine; depression; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; severe or persistent headache or stomach pain; unusual bruising or bleeding; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Zantac 25 mg EFFERdose side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; trouble walking.

Proper storage of Zantac 25 mg EFFERdose Effervescent Tablets:

Store Zantac 25 mg EFFERdose Effervescent Tablets between 36 and 86 degrees F (2 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zantac 25 mg EFFERdose Effervescent Tablets out of the reach of children and away from pets.

General information: If you have any questions about Zantac 25 mg EFFERdose Effervescent Tablets, please talk with your doctor, pharmacist, or other health care provider. Zantac 25 mg EFFERdose Effervescent Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Zantac 25 mg EFFERdose Effervescent Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Zantac 25 mg EFFERdose resources Zantac 25 mg EFFERdose Side Effects (in more detail) Zantac 25 mg EFFERdose Use in Pregnancy & Breastfeeding Zantac 25 mg EFFERdose Drug Interactions Zantac 25 mg EFFERdose Support Group 0 Reviews for Zantac 25 mg EFFERdose - Add your own review/rating Compare Zantac 25 mg EFFERdose with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis Gastric Ulcer Maintenance Treatment Gastrointestinal Hemorrhage GERD Indigestion Pathological Hypersecretory Conditions Stomach Ulcer Stress Ulcer Prophylaxis Surgical Prophylaxis Zollinger-Ellison Syndrome
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Heartburn Relief


Generic Name: famotidine (fam OH ti deen)
Brand Names: Heartburn Relief, Leader Acid Reducer, Pepcid, Pepcid AC, Pepcid AC Maximum Strength

What is Heartburn Relief (famotidine)?

Famotidine a histamine-2 blockers. Famotidine works by decreasing the amount of acid the stomach produces.

Famotidine is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Famotidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Famotidine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Heartburn Relief (famotidine)? You should not use this medication if you are allergic to famotidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Before taking famotidine, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or nizatidine (Axid) while you are taking famotidine, unless your doctor has told you to.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Famotidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

What should I discuss with my healthcare provider before taking Heartburn Relief (famotidine)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medication if you are allergic to famotidine or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Ask a doctor or pharmacist if it is safe for you to take famotidine if you have:

kidney disease; liver disease;

a personal or family history of Long QT syndrome;

stomach cancer or other problems; or

asthma, chronic obstructive pulmonary disease (COPD), or other breathing problems.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Famotidine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Heartburn Relief (famotidine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

The chewable tablet must be chewed thoroughly before swallowing.

Shake the oral suspension (liquid) for 5 to 10 seconds before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Although most ulcers heal within 4 weeks of famotidine treatment, it may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Famotidine may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Store at room temperature away from moisture, heat, and light.

Throw away any unused famotidine liquid that is older than 30 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, fast heart rate, or fainting.

What should I avoid while taking Heartburn Relief (famotidine)? Avoid drinking alcohol. It can increase the risk of damage to your stomach.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or nizatidine (Axid) while you are taking famotidine, unless your doctor has told you to.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Heartburn Relief (famotidine) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using famotidine and call your doctor at once if you have a serious side effect such as:

easy bruising or bleeding;

fast or pounding heartbeat;

confusion, hallucinations, seizure;

numbness or tingly feeling; or

jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

nausea, vomiting, diarrhea, constipation;

dry mouth;

dizziness, weakness, mood changes;

headache; or

muscle cramps, joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Heartburn Relief (famotidine)?

Tell your doctor about all other medications you use, especially:

atazanavir (Reyataz);

itraconazole (Sporanox);

ketoconazole (Nizoral); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with famotidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Heartburn Relief resources Heartburn Relief Side Effects (in more detail) Heartburn Relief Use in Pregnancy & Breastfeeding Heartburn Relief Drug Interactions Heartburn Relief Support Group 0 Reviews for Heartburn Relief - Add your own review/rating Heartburn Relief Advanced Consumer (Micromedex) - Includes Dosage Information Famotidine Professional Patient Advice (Wolters Kluwer) Famotidine Monograph (AHFS DI) Famotidine MedFacts Consumer Leaflet (Wolters Kluwer) Pepcid Consumer Overview Pepcid Prescribing Information (FDA) Pepcid Injection Prescribing Information (FDA) Compare Heartburn Relief with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome Where can I get more information? Your pharmacist can provide more information about famotidine.

See also: Heartburn Relief side effects (in more detail)


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Zegerid


Generic Name: omeprazole and sodium bicarbonate (oh ME pray zol and SO dee um by KAR bon ate)
Brand Names: Zegerid

What is omeprazole and sodium bicarbonate?

Omeprazole is a proton pump inhibitor that decreases the amount of acid your stomach produces. Sodium bicarbonate is an antacid that raises the pH in your stomach to keep the omeprazole from breaking down in stomach acid.

Omeprazole and sodium bicarbonate is used to treat ulcers, gastroesophageal reflux disease (GERD), and other conditions involving excessive stomach acid production.

Omeprazole and sodium bicarbonate is not for immediate relief of heartburn symptoms.

Omeprazole and sodium bicarbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about omeprazole and sodium bicarbonate?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Omeprazole and sodium bicarbonate is not for immediate relief of heartburn symptoms.

Omeprazole and sodium bicarbonate can change the way your body absorbs or eliminates certain other drugs. Tell your doctor about all the prescription and over-the-counter medications you use.

This medication contains sodium bicarbonate, a form of salt. If you are on a low-salt or low-sodium diet, you may not be able to use omeprazole and sodium bicarbonate. Talk with your doctor.

Take this medicine on an empty stomach, at least 1 hour before eating a meal. If this medicine is given to a person who is fed through a nasogastric (NG) tube, the feeding should be stopped at least 3 hours before giving the medicine. Do not restart nasogastric feeding for at least 1 hour after giving omeprazole and sodium bicarbonate.

Take the capsule or powder for oral suspension only with water. Do not use any other type of liquid or food.

The 20-mg and the 40-mg forms of this medicine contain the same strength of sodium bicarbonate. Do not use two 20-mg capsules to equal one 40-mg capsule. Do not use two 20-mg powder packets to equal one 40-mg powder packet. If you do not use the exact capsule or powder packet your doctor has prescribed, you may receive too much sodium bicarbonate. What should I discuss with my health care provider before taking omeprazole and sodium bicarbonate?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

This medication contains sodium bicarbonate, a form of salt. Each capsule contains the equivalent of 300 mg of sodium. Each packet of powder contains the equivalent of 460 mg of sodium. If you are on a low-salt or low-sodium diet, you may not be able to use omeprazole and sodium bicarbonate. Talk with your doctor.

To make sure you can safely take omeprazole and sodium bicarbonate, tell your doctor if you have any of these other conditions:

metabolic or respiratory alkalosis (usually after prolonged illness); or

low levels of calcium, magnesium, or potassium levels in your blood.

Taking a proton pump inhibitor such as omeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medication long term or at high doses, and in those who are age 50 and older. It is not clear whether omeprazole is the actual cause of an increased risk of fracture. Before you take this medication, tell your doctor if you have osteoporosis or osteopenia (low bone mineral density). FDA pregnancy category C. It is not known whether omeprazole and sodium bicarbonate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Omeprazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take omeprazole and sodium bicarbonate?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine on an empty stomach, at least 1 hour before eating a meal. If this medicine is given to a person who is fed through a nasogastric (NG) tube, the feeding should be stopped at least 3 hours before giving the medicine. Do not restart nasogastric feeding for at least 1 hour after giving omeprazole and sodium bicarbonate. Take the omeprazole and sodium bicarbonate capsule with a full glass of water. Do not use any other type of liquid or food. Do not open the capsule or empty the medicine powder from it. Swallow the capsule whole.

To use the powder form of this medicine, open a packet and pour all of the powder into a small cup with 1 or 2 tablespoons of water. Do not use any other type of liquid. Stir the mixture and drink it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

The 20-mg and the 40-mg forms of this medicine contain the same strength of sodium bicarbonate. Do not use two 20-mg capsules to equal one 40-mg capsule. Do not use two 20-mg powder packets to equal one 40-mg powder packet. If you do not use the exact capsule or powder packet your doctor has prescribed, you may receive too much sodium bicarbonate. Store at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include confusion, drowsiness, blurred vision, fast heartbeat, sweating, dry mouth, nausea or vomiting.

What should I avoid while taking omeprazole and sodium bicarbonate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Omeprazole and sodium bicarbonate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

easy bruising or bleeding, unusual weakness;

fast or slow heartbeats; or

low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure).

Less serious side effects may include:

headache;

nausea, stomach pain;

diarrhea or constipation;

white patches or sores inside your mouth or on your lips; or

mild fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect omeprazole and sodium bicarbonate?

Tell your doctor about all other medicines you use, especially:

ampicillin (Principen, Unasyn);

atazanavir (Reyataz);

cilostazol (Pletal);

clarithromycin (Biaxin);

clopidogrel (Plavix);

cyclosporine (Neoral, Sandimmune, Gengraf);

diazepam (Valium) or similar sedatives;

digoxin (Lanoxin, Lanoxicaps);

disulfiram (Antabuse);

a diuretic (water pill);

iron supplements;

ketoconazole (Nizoral);

phenytoin (Dilantin);

tacrolimus (Prograf); or

warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with omeprazole and sodium bicarbonate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zegerid resources Zegerid Side Effects (in more detail) Zegerid Use in Pregnancy & Breastfeeding Drug Images Zegerid Drug Interactions Zegerid Support Group 13 Reviews for Zegerid - Add your own review/rating Zegerid Prescribing Information (FDA) Zegerid Advanced Consumer (Micromedex) - Includes Dosage Information Zegerid MedFacts Consumer Leaflet (Wolters Kluwer) Zegerid Consumer Overview Zegerid OTC Consumer Overview Zegerid OTC MedFacts Consumer Leaflet (Wolters Kluwer) Compare Zegerid with other medications Duodenal Ulcer Erosive Esophagitis Gastrointestinal Hemorrhage GERD Stomach Ulcer Where can I get more information? Your pharmacist can provide more information about omeprazole and sodium bicarbonate.

See also: Zegerid side effects (in more detail)


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Herbal products


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Herbal products are medicines derived from plants. They are used as supplements to improve health and well being, and may be used for other therapeutic purposes. Herbal products are available as tablets, capsules, powders, extracts, teas and so on.

Herbal medicines are thought to be safe as it is natural, but in fact it can cause serious adverse effects and interaction with other drugs and supplements.

See also

Medical conditions associated with herbal products:

Acne ADHD Allergies Anemia Anorexia Anxiety Anxiety and Stress Aphthous Ulcer Asthma Atopic Dermatitis Bacterial Infection Bacterial Skin Infection Benign Prostatic Hyperplasia Bronchitis Burns, External Cancer Chronic Fatigue Syndrome Cold Sores Cold Symptoms Condylomata Acuminata Constipation Constipation, Chronic Coronary Artery Disease Cough Depression Dermatitis Diabetes, Type 1 Diabetes, Type 2 Diabetic Nerve Damage Diarrhea Diarrhea, Acute Diarrhea, Chronic Dry Skin Eczema Enuresis Epicondylitis, Tennis Elbow Epilepsy Erectile Dysfunction Eye Dryness/Redness Eye Redness/Itching Fever Fibromyalgia Gallbladder Disease Gas GERD Gingivitis Gout Headache Heart Disease Hemorrhoids Herbal Supplementation High Blood Pressure High Cholesterol Hot Flashes Human Papilloma Virus Indigestion Infectious Gastroenteritis Inflammatory Conditions Influenza Insomnia Labor Induction Labor Pain Liver Cirrhosis Menopausal Disorders Menstrual Disorders Migraine Migraine Prevention Mild Cognitive Impairment Motion Sickness Muscle Pain Muscle Spasm Nasal Congestion Nausea/Vomiting Neuralgia Night Terrors Nocturnal Leg Cramps Nonalcoholic Fatty Liver Disease Obesity Oral and Dental Conditions Osteoarthritis Otitis Externa Overactive Bladder Peripheral Neuropathy Photoaging of the Skin Postmenopausal Symptoms Premenstrual Dysphoric Disorder Prostate Cancer Psoriasis Rheumatoid Arthritis Rhinorrhea Sciatica Sedation Sinus Symptoms Sinusitis Sjogren's Syndrome Skin and Structure Infection Skin Infection Skin Rash Smallpox Prophylaxis Stomach Ulcer Strep Throat Sunburn Systemic Lupus Erythematosus Tonsillitis/Pharyngitis Upper Respiratory Tract Infection Urinary Incontinence Urinary Tract Infection Urticaria Varicose Veins Vomiting Weight Loss Drug List: Azo-Cranberry Evening-Primrose-Oil 5-Htp Carrington-Oral-Wound-Rinse Ginkgo-Biloba Menopause-Support Oramagic-Rx Primrose-Oil Venastat
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pantoprazole Intravenous


pan-TOE-pra-zole

Commonly used brand name(s)

In the U.S.

Protonix Protonix IV

Available Dosage Forms:

Powder for Solution

Pharmacologic Class: Proton Pump Inhibitor

Uses For pantoprazole

Pantoprazole injection is used to treat certain conditions in which there is too much acid in the stomach. It is used for short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) with a history of erosive esophagitis. GERD is a condition in which the acid in the stomach washes back up into the esophagus. pantoprazole may also be used to treat Zollinger-Ellison syndrome or other conditions (e.g., cancer) in which the stomach produces too much acid.

Pantoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

pantoprazole is available only with your doctor's prescription.

Before Using pantoprazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pantoprazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pantoprazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pantoprazole injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole injection in the elderly.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving pantoprazole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using pantoprazole with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rilpivirine

Using pantoprazole with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atazanavir Citalopram Dasatinib Erlotinib Methotrexate Mycophenolate Mofetil Nelfinavir Nilotinib

Using pantoprazole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cranberry Itraconazole Warfarin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pantoprazole. Make sure you tell your doctor if you have any other medical problems, especially:

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Osteoporosis (bone problem) or Zinc deficiency—Use with caution. May make these conditions worse. Proper Use of pantoprazole

A nurse or other trained health professional will give you pantoprazole in a clinic or hospital. pantoprazole is given through a needle placed in one of your veins.

It may take several days before pantoprazole begins to relieve stomach pain. To help relieve this pain, antacids may be taken with pantoprazole, unless your doctor has told you not to use them.

Tell your doctor if you have had problems with a lack of zinc in your body. Your doctor may want you to take zinc supplements.

Your doctor will give you a few doses of pantoprazole until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using pantoprazole

It is important that your doctor check your progress at regular visits. If your condition does not improve, or if it becomes worse, check with your doctor.

pantoprazole may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.

pantoprazole may cause thrombophlebitis. Check with your doctor right away if you notice any of these side effects at the injection site: changes in skin color, pain, tenderness, or swelling of the foot or leg.

Pantoprazole injection may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of pantoprazole, or use it for one year or more.

Do not stop using pantoprazole without first checking with your doctor, or unless told to do so by your doctor.

Make sure any doctor or dentist who treats you knows that you are using pantoprazole. pantoprazole may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (e.g., atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

pantoprazole Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common Accumulation of pus bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site changes in skin color, pain, tenderness, or swelling of the foot or leg fever stomach pain swollen, red, tender area of infection Incidence not known Abdominal or stomach pain absence of or decrease in body movement blindness blistering, peeling, or loosening of the skin bloating of abdomen or stomach bloody or cloudy urine bloody, black, or tarry stools blurred vision chills constipation continuing ringing or buzzing or other unexplained noise in the ears cough dark-colored urine decreased vision diarrhea difficulty with speaking difficulty with swallowing dizziness or lightheadedness fast heartbeat feeling of constant movement of self or surroundings greatly decreased frequency of urination or amount of urine hearing loss hives increased watering of the mouth indigestion itching joint or muscle pain large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs light-colored stools loss of appetite mood or mental changes muscle cramps or spasms muscle pain or stiffness nausea or vomiting pains in the stomach, side, or abdomen, possibly radiating to the back pale skin puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue red skin lesions, often with a purple center red, irritated eyes sensation of spinning shortness of breath skin rash sore throat sores, ulcers, or white spots on the lips or in the mouth swelling of the feet or lower legs swollen glands tightness in the chest unexplained bleeding or bruising unusual tiredness or weakness vomiting wheezing yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Acid or sour stomach belching dizziness headache heartburn indigestion runny nose sleeplessness sneezing stomach discomfort, upset, or pain stuffy nose trouble sleeping unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pantoprazole Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pantoprazole Intravenous resources Pantoprazole Intravenous Side Effects (in more detail) Pantoprazole Intravenous Use in Pregnancy & Breastfeeding Drug Images Pantoprazole Intravenous Drug Interactions Pantoprazole Intravenous Support Group 35 Reviews for Pantoprazole Intravenous - Add your own review/rating Compare pantoprazole Intravenous with other medications Barrett's Esophagus Duodenal Ulcer Erosive Esophagitis GERD Helicobacter Pylori Infection Peptic Ulcer Stomach Ulcer Stress Ulcer Prophylaxis Zollinger-Ellison Syndrome
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famotidine


fam-OH-ti-deen

Commonly used brand name(s)

In the U.S.

Heartburn Relief Pepcid Pepcid AC

Available Dosage Forms:

Tablet Powder for Suspension Tablet, Chewable Tablet, Disintegrating

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Histamine H2 Antagonist

Uses For famotidine

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. It is also used to treat certain conditions where there is too much acid in the stomach (e.g., Zollinger-Ellison syndrome, endocrine tumors).

Famotidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.

famotidine is available with your doctor's prescription and also without a prescription. For the prescription form, there is more medicine in each tablet. Your doctor will have special instructions on the proper use and dose for your medical problem.

Before Using famotidine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For famotidine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to famotidine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of famotidine in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of famotidine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving famotidine.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking famotidine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using famotidine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atazanavir Dasatinib Delavirdine Rilpivirine Tizanidine Tolazoline

Using famotidine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cefditoren Pivoxil Cefpodoxime Proxetil Cyclosporine Itraconazole Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of famotidine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of famotidine

Take famotidine exactly as directed by your doctor or as directed on the package. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Keep using famotidine for the full time of treatment, even if you begin to feel better.

Measure the oral liquid with a marked measuring spoon or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of famotidine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of famotidine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (suspension, tablets): To treat stomach ulcers: Adults—20 milligrams (mg) one or two times per day or 40 mg once a day at bedtime. Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose at bedtime or divided in two doses. The total dose is usually not more than 40 mg per day. To treat gastroesophageal reflux disease (GERD): Adults—20 milligrams (mg) two times per day. Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day. Infants 3 months to 1 year of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose once a day. To treat erosive esophagitis (heartburn): Adults—10, 20, or 40 milligrams (mg) two times per day. Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day. To treat too much stomach acid (Zollinger-Ellison syndrome): Adults—20 milligrams (mg) every 6 hours. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of famotidine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused oral liquid after 30 days.

Precautions While Using famotidine

It is very important that your doctor check your progress at regular visits to make sure famotidine is working properly and to check for unwanted effects.

If your condition does not improve, or if it become worse, check with your doctor.

famotidine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare Bleeding gums blistering, peeling, or loosening of the skin blood in the urine or stools bloody, black, or tarry stools chest pain chills cough or hoarseness diarrhea fever fever with or without chills general feeling of tiredness or weakness high fever itching joint or muscle pain lower back or side pain painful or difficult urination pale skin pinpoint red spots on the skin red, irritated eyes red skin lesions, often with a purple center shortness of breath sore throat sores, ulcers, or white spots on the lips or in the mouth swollen glands unusual bleeding or bruising unusual tiredness or weakness Incidence not known Abdominal or stomach pain anxiety burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings clay-colored stools dark urine depression difficulty with breathing difficulty with swallowing dizziness dry mouth fainting false sense of well-being fast, irregular, pounding, or racing heartbeat or pulse headache hives hyperventilation irritability large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs loss of appetite loss of bladder control loss of consciousness mood swings nausea nervousness noisy breathing personality changes puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue rash restlessness seizures shaking skin rash swelling around the eyes tightness in the chest total body jerking trouble with sleeping troubled with breathing unpleasant breath odor vision changes vomiting of blood wheezing yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Difficulty having a bowel movement (stool) Rare Swelling of the breasts or breast soreness in both females and males Incidence not known Abdominal or stomach discomfort blemishes on the skin change in taste or bad, unusual or unpleasant (after) taste continuing ringing or buzzing or other unexplained noise in the ears decreased interest in sexual intercourse difficulty with moving dry skin fear hair loss or thinning of the hair hearing loss hives or welts inability to have or keep an erection loss in sexual ability, desire, drive, or performance mood or mental changes muscle cramps muscle stiffness pimples redness of the skin redness of the white part of the eyes seeing, hearing, or feeling things that are not there sleeplessness unable to sleep weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: famotidine side effects (in more detail)

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More famotidine resources Famotidine Side Effects (in more detail) Famotidine Use in Pregnancy & Breastfeeding Drug Images Famotidine Drug Interactions Famotidine Support Group 10 Reviews for Famotidine - Add your own review/rating Famotidine Professional Patient Advice (Wolters Kluwer) Famotidine Monograph (AHFS DI) Famotidine MedFacts Consumer Leaflet (Wolters Kluwer) Pepcid Consumer Overview Pepcid Prescribing Information (FDA) Pepcid Injection Prescribing Information (FDA) Compare famotidine with other medications Allergic Urticaria Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Indigestion Pathological Hypersecretory Conditions Peptic Ulcer Stomach Ulcer Upper GI Hemorrhage Urticaria Zollinger-Ellison Syndrome
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Anticholinergics/antispasmodics


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Anticholinergic/antispasmodic agents inhibit the action of acetylcholine. They stop the transmission of parasympathetic nerve impulses therefore lessen the spasms of smooth muscle, such as in the gastrointestinal tract and in the bladder. They are used to treat spasms or conditions with disturbances in the bladder or gastrointestinal motility.

See also

Medical conditions associated with anticholinergics/antispasmodics:

Anesthesia Anticholinesterase Poisoning AV Heart Block Bradyarrhythmia Colitis Crohn's Disease Duodenal Ulcer Endoscopy or Radiology Premedication Enterocolitis Enuresis Excessive Salivation Gas GERD Hot Flashes Irritable Bowel Syndrome Menopausal Disorders Motion Sickness Nausea/Vomiting Organophosphate Poisoning Overactive Bladder Parkinson's Disease Parkinsonian Tremor Peptic Ulcer Perimenopausal Symptoms Postmenopausal Symptoms Urinary Incontinence Drug List: Levsin-Sl Pamine Donnatal Belladonna-Tincture Donnatal-Extentabs-Controlled-Release-Tablets Hyomax-Sl Levbid-Extended-Release-Tablets Levsin Scopace Bentyl Librax Symax-Duotab-Controlled-Release-Tablets Hyomax Hyomax-Sr Robinul Transderm-Scop-Patch Hyosyne-Drops Pamine-Forte A-Spaz Alkabel-Sr-Controlled-Release-Tablets Anaspaz Antispasmodic Atreza Atropen Bel-Phen-Ergot Bellamine Bellamine-S Bellamor Bellaphen-S Bellaspas Bellatal Bellergal-S Cantil Colidrops-Drops Cuvposa Cystospaz D-Tal Digex-Nf Duragal-S Ed-Spaz Eperbel-S Hyomax-Dt Hyomax-Ft Hyosophen Hyospaz Ib-Stat-Spray Levsinex-Extended-Release-Capsules Levsinex-Sr Maldemar Nulev-Orally-Disintegrating-Tablets Pb-Hyos-Elixir Pro-Banthine Quadrapax-Elixir Quarzan Re-Pb-Hyos-Elixir Robinul-Forte Sal-Tropine Servira Spasdel-Drops Spasmolin Spastrin Symax-Fastabs-Orally-Disintegrating-Tablets Symax-Sl Symax-Sr-Extended-Release-Tablets
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Prevacid


Generic Name: lansoprazole
Dosage Form: capsule, delayed release, tablet, orally disintegrating, delayed release
FULL PRESCRIBING INFORMATION Indications and Usage for Prevacid Short-Term Treatment of Active Duodenal Ulcer

Prevacid is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Prevacid/amoxicillin/clarithromycin

Prevacid in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: Prevacid/amoxicillin

Prevacid in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin.

Maintenance of Healed Duodenal Ulcers

Prevacid is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].

Short-Term Treatment of Active Benign Gastric Ulcer

Prevacid is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14)].

Healing of NSAID-Associated Gastric Ulcer

Prevacid is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].

Risk Reduction of NSAID-Associated Gastric Ulcer

Prevacid is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

Prevacid is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].

Short-Term Treatment of Erosive Esophagitis

Prevacid is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Prevacid for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of Prevacid may be considered [see Clinical Studies (14)].

Maintenance of Healing of Erosive Esophagitis (EE)

Prevacid is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14)].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

Prevacid is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].

Prevacid Dosage and Administration

Prevacid is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. Prevacid should be taken before eating. Prevacid products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with Prevacid.

Recommended Dose Indication Recommended Dose Frequency * Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with Prevacid for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of Prevacid may be considered. § The Prevacid dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with Prevacid for more than 4 years. Duodenal Ulcers   Short-Term Treatment 15 mg Once daily for 4 weeks   Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*   Triple Therapy:     Prevacid 30 mg Twice daily (q12h) for 10 or 14 days     Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days     Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days   Dual Therapy:     Prevacid 30 mg Three times daily (q8h) for 14 days     Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer   Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer   Healing 30 mg Once daily for 8 weeks†   Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD)   Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks   Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis   ? 30 kg 15 mg Once daily for up to 12 weeks§   > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD   Nonerosive GERD 15 mg Once daily for up to 8 weeks   Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶

Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)].

Important Administration Information

Administration Options

Prevacid Delayed-Release Capsules – Oral Administration

Prevacid Delayed-Release Capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, Prevacid Delayed-Release Capsules can be opened and administered as follows: Open capsule. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Swallow immediately. Prevacid Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: Open capsule. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces). Mix briefly. Swallow immediately. To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Prevacid Delayed-Release Capsules – Nasogastric Tube (?16 French) Administration

For patients who have a nasogastric tube in place, Prevacid Delayed-Release Capsules can be administered as follows: Open capsule. Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. Inject through the nasogastric tube into the stomach. Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets

Prevacid SoluTab should not be broken or cut. Prevacid SoluTab should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute. Alternatively, for children or other patients who have difficulty swallowing tablets, Prevacid SoluTab can be delivered in two different ways.   Prevacid SoluTab – Oral Syringe   For administration via oral syringe, Prevacid SoluTab can be administered as follows: Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, administer the contents within 15 minutes. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.   Prevacid SoluTab – Nasogastric Tube (?8 French) Administration   For administration via a nasogastric tube, Prevacid SoluTab can be administered as follows: Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water. Shake gently to allow for a quick dispersal. After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes. Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube. Dosage Forms and Strengths 15 mg capsules are opaque, hard gelatin, colored pink and green with the TAP logo and "Prevacid 15" imprinted on the capsule. 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and "Prevacid 30" imprinted on the capsule. 15 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "15" debossed on one side of the tablet. 30 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with "30" debossed on one side of the tablet. Contraindications

Prevacid is contraindicated in patients with known severe hypersensitivity to any component of the formulation of Prevacid. For information on contraindications for amoxicillin or clarithromycin, refer to their full prescribing information, CONTRAINDICATIONS sections.

Warnings and Precautions Gastric Malignancy

Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

Bone Fracture

 Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2) and Adverse Reactions (6.2)].

For information on warnings and precautions for amoxicillin or clarithromycin, refer to their full prescribing information, WARNINGS and PRECAUTIONS sections.

Hypomagnesemia

 Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

 For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].

Adverse Reactions Clinical

Worldwide, over 10,000 patients have been treated with Prevacid in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, Prevacid treatment has been well-tolerated in both short-term and long-term trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Prevacid-treated patients and occurred at a greater rate in Prevacid-treated patients than placebo-treated patients in Table 1.

Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Prevacid Studies Body System/Adverse Event Prevacid
(N= 2768)
% Placebo
(N= 1023)
% Body as a Whole   Abdominal Pain 2.1 1.2 Digestive System   Constipation 1.0 0.4   Diarrhea 3.8 2.3   Nausea 1.3 1.2

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of Prevacid, but higher in the patients who received 60 mg of Prevacid (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Prevacid for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Prevacid, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with Prevacid included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received Prevacid in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System – diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy

Metabolism and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing Experience

Additional adverse experiences have been reported since Prevacid has been marketed. The majority of these cases are foreign-sourced and a relationship to Prevacid has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole – anaphylactic/anaphylactoid reactions; Digestive System – hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Metabolism and Nutritional Disorders – hypomagnesemia; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses – speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with Prevacid plus amoxicillin and clarithromycin, and Prevacid plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Prevacid, amoxicillin, or clarithromycin.

Triple Therapy: Prevacid/amoxicillin/clarithromycin

The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Prevacid/amoxicillin

The most frequently reported adverse reactions for patients who received Prevacid three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with Prevacid three times daily plus amoxicillin three times daily dual therapy than with Prevacid alone.

For information on adverse reactions with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Laboratory Values

The following changes in laboratory parameters in patients who received Prevacid were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and Prevacid, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received Prevacid reported jaundice at any time during the study.

In clinical trials using combination therapy with Prevacid plus amoxicillin and clarithromycin, and Prevacid plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For information on laboratory value changes with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Drug Interactions Drugs with pH-Dependent Absorption Kinetics

Prevacid causes long-lasting inhibition of gastric acid secretion. Prevacid and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, Prevacid and other PPIs should not be co-administered with atazanavir [see Clinical Pharmacology (12.3)].

Prevacid and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) [see Clinical Pharmacology (12.3)].

Warfarin

In a study of healthy subjects, co-administration of single or multiple 60 mg doses of Prevacid and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time [see Clinical Pharmacology (12.3)]. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see Clinical Pharmacology (12.3)].

Tacrolimus

Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Theophylline

A minor increase (10%) in the clearance of theophylline was observed following the administration of Prevacid concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when Prevacid is started or stopped to ensure clinically effective blood levels [see Clinical Pharmacology (12.3)].

Clopidogrel

Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [see Clinical Pharmacology (12.3)]. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Prevacid.

For information on drug interactions for amoxicillin or clarithromycin, refer to their full prescribing information, DRUG INTERACTIONS sections.

USE IN SPECIFIC POPULATIONS Pregnancy

Teratogenic effects

Pregnancy Category B. Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)].

See full prescribing information for clarithromycin before using in pregnant women.

Nursing Mothers

Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue lansoprazole, taking into account the importance of lansoprazole to the mother.

Pediatric Use

The safety and effectiveness of Prevacid have been established in pediatric patients 1 to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, Prevacid was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter, double-blind, placebo controlled study.

Neonate to less than 1 year of age

The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and 1 to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized AUC values 2.04- and 1.88-fold higher at doses of 0.5 mg/kg/day and 1 mg/kg/day, respectively). Infants aged ?10 weeks had clearance and exposure values that were similar to neonates. Infants aged greater than 10 weeks who received 1 mg/kg/day had mean AUC values that were similar to adults who received a 30 mg dose.

Lansoprazole was not found to be effective in a U.S. and Polish 4 week multicenter, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic GERD based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative GERD management (i.e., non-pharmacologic intervention) for 7 to 14 days. Patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ?10 weeks of age or 1.0 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to 4 weeks of double-blind treatment.

The primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding.

There was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups).

There were no adverse events reported in pediatric clinical studies (1 month to less than 12 months of age) that were not previously observed in adults.

Based on the results of the Phase 3 efficacy study, lansoprazole was not shown to be effective. Therefore, these results do not support the use of lansoprazole in treating symptomatic GERD in infants.

One to 11 years of age

In an uncontrolled, open-label, U.S. multicenter study, 66 pediatric patients (1 to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either Prevacid 15 mg daily if ?30 kg or Prevacid 30 mg daily if greater than 30 kg administered for 8 to 12 weeks. The Prevacid dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after 2 or more weeks of treatment if they remained symptomatic. At baseline 85% of patients had mild to moderate overall GERD symptoms (assessed by investigator interview), 58% had non-erosive GERD and 42% had erosive esophagitis (assessed by endoscopy).

After 8 to 12 weeks of Prevacid treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of GERD symptoms.

Twenty-one of 27 erosive esophagitis patients were healed at 8 weeks and 100% of patients were healed at 12 weeks by endoscopy (Table 2).

Table 2: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 1 to 11 GERD Final Visit* % (n/N) * At Week 8 or Week 12 † Symptoms assessed by patients diary kept by caregiver. ‡ No data were available for 4 pediatric patients. Symptomatic GERD   Improvement in Overall GERD Symptoms† 76% (47/62‡) Erosive Esophagitis   Improvement in Overall GERD Symptoms† 81% (22/27)   Healing Rate 100% (27/27)

In a study of 66 pediatric patients in the age group 1 year to 11 years old after treatment with Prevacid given orally in doses of 15 mg daily to 30 mg twice daily, increases in serum gastrin levels were similar to those observed in adult studies. Median fasting serum gastrin levels increased 89% from 51 pg/mL at baseline to 97 pg/mL [interquartile range (25th to 75th percentile) of 71 to 130 pg/mL] at the final visit.

The pediatric safety of Prevacid Delayed-Release Capsules has been assessed in 66 pediatric patients aged 1 to 11 years of age. Of the 66 patients with GERD 85% (56/66) took Prevacid for 8 weeks and 15% (10/66) took it for 12 weeks.

The most frequently reported (2 or more patients) treatment-related adverse reactions in patients 1 to 11 years of age (N=66) were constipation (5%) and headache (3%).

Twelve to 17 years of age

In an uncontrolled, open-label, U.S. multicenter study, 87 adolescent patients (12 to 17 years of age) with symptomatic GERD were treated with Prevacid for 8 to 12 weeks. Baseline upper endoscopies classified these patients into two groups: 64 (74%) nonerosive GERD and 23 (26%) erosive esophagitis (EE). The nonerosive GERD patients received Prevacid 15 mg daily for 8 weeks and the EE patients received Prevacid 30 mg daily for 8 to 12 weeks. At baseline, 89% of these patients had mild to moderate overall GERD symptoms (assessed by investigator interviews). During 8 weeks of Prevacid treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of GERD symptoms based on diary results.

Twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after 8 weeks of Prevacid treatment. One patient remained unhealed after 12 weeks of treatment (Table 3).

Table 3: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 12 to 17 GERD Final Visit % (n/N) * Symptoms assessed by patient diary (parents/caregivers as necessary). † No data available for 5 patients. ‡ Data from one healed patient was excluded from this analysis due to timing of final endoscopy. Symptomatic GERD (All Patients)   Improvement in Overall GERD Symptoms* 73.2% (60/82)† Nonerosive GERD   Improvement in Overall GERD Symptoms* 71.2% (42/59)† Erosive Esophagitis   Improvement in Overall GERD Symptoms* 78.3% (18/23)     Healing Rate‡ 95.5% (21/22)‡

In these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45 pg/mL at baseline to 64 pg/mL [interquartile range (25th to 75th percentile) of 44 to 88 pg/mL] at the final visit. (Normal serum gastrin levels are 25 to 111 pg/mL.)

The safety of Prevacid Delayed-Release Capsules has been assessed in these 87 adolescent patients. Of the 87 adolescent patients with GERD, 6% (5/87) took Prevacid for less than 6 weeks, 93% (81/87) for 6 to 10 weeks, and 1% (1/87) for greater than 10 weeks.

The most frequently reported (at least 3%) treatment-related adverse reactions in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). Treatment-related dizziness, reported in this package insert as occurring in less than 1% of adult patients, was reported in this study by 3 adolescent patients with nonerosive GERD, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting).

Geriatric Use

No dosage adjustment of Prevacid is necessary in geriatric patients. The incidence rates of Prevacid-associated adverse reactions and laboratory test abnormalities are similar to those seen in younger patients [see Clinical Pharmacology (12.3)].

Renal Impairment

No dosage adjustment of Prevacid is necessary in patients with renal impairment. The pharmacokinetics of lansoprazole in patients with various degrees of renal impairment were not substantially different compared to those in subjects with normal renal function [see Clinical Pharmacology (12.3)].

Hepatic Impairment

In patients with various degrees of chronic hepatic impairment, an increase in the mean AUC of up to 500% was observed at steady state compared to healthy subjects. Consider dose reduction in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

Gender

Over 4,000 women were treated with Prevacid. Ulcer healing rates in females were similar to those in males. The incidence rates of adverse reactions in females were similar to those seen in males [see Clinical Pharmacology (12.3)].

Race

The pooled mean pharmacokinetic parameters of Prevacid from twelve U.S. Phase 1 studies (N=513) were compared to the mean pharmacokinetic parameters from two Asian studies (N=20). The mean AUCs of Prevacid in Asian subjects were approximately twice those seen in pooled U.S. data; however, the inter-individual variability was high. The Cmax values were comparable.

Overdosage

Prevacid is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of Prevacid with no adverse reaction. Oral Prevacid doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.

Prevacid Description

The active ingredient in Prevacid Delayed-Release Capsules and Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Prevacid has the following structure:

Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.

Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0.

Prevacid is supplied in delayed-release capsules and in delayed-release orally disintegrating tablets for oral administration.

The delayed-release capsules are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 31, and FD&C Red No. 40.

Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) a


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Prevacid Delayed-Release Capsules


Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid
Prevacid Delayed-Release Capsules are used for:

Preventing or treating certain types of ulcers. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn) and irritation of the esophagus. It is also used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Prevacid Delayed-Release Capsules are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Prevacid Delayed-Release Capsules if: you are allergic to any ingredient in Prevacid Delayed-Release Capsules you are taking an HIV protease inhibitor (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prevacid Delayed-Release Capsules:

Some medical conditions may interact with Prevacid Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Prevacid Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased Clarithromycin or voriconazole because they may increase the risk of Prevacid Delayed-Release Capsules's side effects Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Prevacid Delayed-Release Capsules Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Prevacid Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevacid Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prevacid Delayed-Release Capsules:

Use Prevacid Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prevacid Delayed-Release Capsules by mouth on an empty stomach before eating. Swallow Prevacid Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. You may also open the capsule and sprinkle the contents into 2 oz (60 mL) apple juice, orange juice, or tomato juice. Mix briefly, then swallow at once. Do not chew or crush the granules. Do not store the mixture for use at a later time. After you take your dose, rinse the glass with at least 4 oz (120 mL) of juice and swallow to be sure you have received all of the medicine. Do NOT mix Prevacid Delayed-Release Capsules with other foods or liquids. You may take antacids while you are using Prevacid Delayed-Release Capsules if you are directed to do so by your doctor. If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prevacid Delayed-Release Capsules. If you also take sucralfate, take Prevacid Delayed-Release Capsules at least 30 minutes before taking sucralfate. Continue to take Prevacid Delayed-Release Capsules even if you feel well. Do not miss any doses. If you miss a dose of Prevacid Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prevacid Delayed-Release Capsules.

Important safety information: Prevacid Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prevacid Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. Prevacid Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevacid Delayed-Release Capsules in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevacid Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients. Use Prevacid Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures. Prevacid Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prevacid Delayed-Release Capsules while you are pregnant. It is not known if Prevacid Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Prevacid Delayed-Release Capsules. Possible side effects of Prevacid Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prevacid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prevacid Delayed-Release Capsules:

Store Prevacid Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prevacid Delayed-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Prevacid Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Prevacid Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prevacid Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prevacid resources Prevacid Side Effects (in more detail) Prevacid Dosage Prevacid Use in Pregnancy & Breastfeeding Drug Images Prevacid Drug Interactions Prevacid Support Group 26 Reviews for Prevacid - Add your own review/rating Compare Prevacid with other medications Aspiration Pneumonia Barrett's Esophagus Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Helicobacter Pylori Infection Multiple Endocrine Adenomas NSAID-Induced Gastric Ulcer NSAID-Induced Ulcer Prophylaxis Stomach Ulcer Systemic Mastocytosis Zollinger-Ellison Syndrome
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Nexium Delayed-Release Capsules


Pronunciation: ES-oh-MEP-ra-zole
Generic Name: Esomeprazole
Brand Name: Nexium
Nexium Delayed-Release Capsules are used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may also be used to prevent stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It may also be used with certain antibiotics to treat ulcers of the small intestines and to prevent them from coming back. It may also be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Nexium Delayed-Release Capsules are a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.

Do NOT use Nexium Delayed-Release Capsules if: you are allergic to any ingredient in Nexium Delayed-Release Capsules or to any similar medicine (eg, omeprazole) you are taking dasatinib, certain HIV protease inhibitors (eg, atazanavir, nelfinavir), rifampin, or St. John's wort.

Contact your doctor or health care provider right away if any of these apply to you.

Before using Nexium Delayed-Release Capsules:

Some medical conditions may interact with Nexium Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood potassium or magnesium levels, liver problems or stomach or bowel cancer if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Nexium Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased Voriconazole because it may increase the risk of Nexium Delayed-Release Capsules's side effects Ginkgo biloba, rifampin, or St. John's wort because they may decrease Nexium Delayed-Release Capsules's effectiveness Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, or saquinavir because the risk of their side effects may be increased by Nexium Delayed-Release Capsules Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir, nelfinavir), iron, mycophenolate, or tyrosine kinase inhibitors (eg, dasatinib, erlotinib) because their effectiveness may be decreased by Nexium Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexium Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nexium Delayed-Release Capsules:

Use Nexium Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Nexium Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information. Take Nexium Delayed-Release Capsules by mouth on an empty stomach at least 1 hour before eating. Swallow Nexium Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you have difficulty swallowing the capsule, you may add 1 tablespoon of applesauce to an empty bowl. Open the capsule and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the mixture right away. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets. Do not store the mixture for future use. You may take antacids while you are using Nexium Delayed-Release Capsules if you are directed to do so by your doctor. Continue to take Nexium Delayed-Release Capsules even if you feel well. Do not miss any doses. If you miss a dose of Nexium Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nexium Delayed-Release Capsules.

Important safety information: Nexium Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nexium Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. Nexium Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Nexium Delayed-Release Capsules in high doses, for longer than a year, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Nexium Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Nexium Delayed-Release Capsules. Nexium Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Nexium Delayed-Release Capsules. Use Nexium Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures. Caution is advised when using Nexium Delayed-Release Capsules in CHILDREN; they may be more likely to experience drowsiness from Nexium Delayed-Release Capsules. Nexium Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nexium Delayed-Release Capsules while you are pregnant. It is not known if Nexium Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Nexium Delayed-Release Capsules. Possible side effects of Nexium Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever or chills; persistent sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Nexium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; fast heartbeat; flushing; increased sweating; severe headache, drowsiness, or nausea.

Proper storage of Nexium Delayed-Release Capsules:

Store Nexium Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nexium Delayed-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Nexium Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Nexium Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Nexium Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Nexium resources Nexium Side Effects (in more detail) Nexium Use in Pregnancy & Breastfeeding Drug Images Nexium Drug Interactions Nexium Support Group 52 Reviews for Nexium - Add your own review/rating Compare Nexium with other medications Barrett's Esophagus Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Helicobacter Pylori Infection NSAID-Induced Gastric Ulcer Pathological Hypersecretory Conditions Zollinger-Ellison Syndrome
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