what are side effects of tapazole do it hurt teeth
 

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Antithyroid agents


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.

Antithyroid agents prevent or suppress the biosynthesis of thyroid hormones. Antithyroid agents are used to treat hyperthyroidism by inhibiting the excessive production of thyroid hormones or by decreasing thyroid hormone activity.

See also

Medical conditions associated with antithyroid agents:

Alcoholic Liver Damage Cough Cutaneous Sporotrichosis Diagnosis and Investigation Hyperthyroidism Radiation Emergency Thyroid Cancer Thyroid Storm Drug List: Pima-Syrup Iodotope Iosat Northyx Sski-Drops Tapazole Thyroshield-Solution Yodefan-Liquid
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PreviDent Rinse


Pronunciation: SO-dee-um FLOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Listermint and PreviDent
PreviDent Rinse is used for:

Preventing dental caries.

PreviDent Rinse is a fluoride rinse. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use PreviDent Rinse if: you are allergic to any ingredient in PreviDent Rinse

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

Before using PreviDent Rinse:

Some medical conditions may interact with PreviDent Rinse. 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

Some MEDICINES MAY INTERACT with PreviDent Rinse. However, no specific interactions with PreviDent Rinse are known at this time.

Ask your health care provider if PreviDent Rinse 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 PreviDent Rinse:

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

Use PreviDent Rinse at bedtime after brushing your teeth. Measure the prescribed dose and swish between your teeth for 1 minute, then spit out, unless directed otherwise by your doctor. Do not eat, drink, or rinse your mouth for 30 minutes after using PreviDent Rinse. If you miss a dose of PreviDent Rinse, 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 PreviDent Rinse.

Important safety information: Do not exceed the dose recommended by your doctor or dentist. Notify your dentist if your teeth become spotted or stained. PreviDent Rinse is not recommended for use in CHILDREN younger than 6 years old; safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking PreviDent Rinse, contact your doctor. You will need to discuss the benefits and risks of using PreviDent Rinse while pregnant. It is not known if PreviDent Rinse is found in breast milk. If you are or will be breast-feeding while you are using PreviDent Rinse, check with your doctor. Discuss the risks to your baby. Possible side effects of PreviDent Rinse:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with PreviDent Rinse. 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).

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: PreviDent 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 diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Proper storage of PreviDent Rinse:

Store PreviDent Rinse at room temperature, between 68 and 77 degrees F (20 and 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. Keep PreviDent Rinse out of the reach of children and away from pets.

General information: If you have any questions about PreviDent Rinse, please talk with your doctor, pharmacist, or other health care provider. PreviDent Rinse 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 PreviDent Rinse. 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 PreviDent resources PreviDent Side Effects (in more detail) PreviDent Use in Pregnancy & Breastfeeding PreviDent Support Group 0 Reviews for PreviDent - Add your own review/rating Compare PreviDent with other medications Prevention of Dental Caries
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Fluoritab Fluoride Drops


Generic Name: sodium fluoride
Dosage Form: oral drops
Fluoritab Fluoride Drops 1 fluid ounce size

CONTAINS: SODIUM FLUORIDE IN AN AQUEOUS VEHICLE WITH PRESERVATIVE.

EACH 8 DROPS EQUIVALENT TO 1 MG. F. (FROM 2.2 MG SODIUM FLUORIDE)

PPM FLUORIDE ION                                                        DAILY DOSAGE

IN DRINKING WATER      AGE 6 MO. – 3 YRS.         AGE 3-6 YRS.      AGE 6-16 YRS.

LESS THAN 0.3 PPM         2 DROPS                               4 DROPS               8 DROPS

0.3 TO 0.6 PPM                  NONE                                    2 DROPS               4 DROPS

OVER 0.6 PPM                   NONE                                    NONE                    NONE

KEEP OUT OF REACH OF CHILDREN.
CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.

PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL)

ACTIONS AND INDICATIONS: FLUORITAB DROPS CONTAINING SODIUM FLUORIDE (SYSTEMIC) IS INDICATED AS A DIETARY SUPPLEMENT FOR PREVENTION OF DENTAL CARIES IN CHILDREN IN THE AREAS WHERE THE LEVEL OF FLUORIDE IN DRINKING WATER IS INADEQUATE.

INACTIVE INGREDIENTS: WATER, PRESERVATIVE.
EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS. Fluoritab Fluoride Drops
DISTRIBUTED BY:
FLUORITAB CORPORATION
"BETTER TEETH - BETTER HEALTH"
MUSKEGON, MI 49441
MADE IN U.S.A.
FLUORIDE DROPS  
sodium fluoride  liquid Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0288-5523 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 2.5 g  in 100 mL Inactive Ingredients Ingredient Name Strength WATER   METHYLPARABEN   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0288-5523-01 30 mL In 1 BOTTLE, DROPPER None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/09/2011
Labeler - Fluoritab Corporation (005376702) Registrant - Fluoritab Corporation (005376702) Establishment Name Address ID/FEI Operations Medical Products Laboratories 002290302 manufacture, analysis Establishment Name Address ID/FEI Operations Fluoritab Corporation 005376702 label Revised: 05/2011Fluoritab Corporation
More Fluoritab Fluoride Drops resources Fluoritab Fluoride Drops Use in Pregnancy & BreastfeedingDrug ImagesFluoritab Fluoride Drops Support Group0 Reviews for Fluoritab Fluoride - Add your own review/rating Compare Fluoritab Fluoride Drops with other medications Prevention of Dental Caries
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Sodium Fluoride Cream


Pronunciation: SO-dee-um FLOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Phos-Flur and PreviDent
Sodium Fluoride Cream is used for:

Preventing dental caries.

Sodium Fluoride Cream is a fluoride-containing toothpaste. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Sodium Fluoride Cream if: you are allergic to any ingredient in Sodium Fluoride Cream you have trouble swallowing

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

Before using Sodium Fluoride Cream:

Some medical conditions may interact with Sodium Fluoride Cream. 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

Some MEDICINES MAY INTERACT with Sodium Fluoride Cream. However, no specific interactions with Sodium Fluoride Cream are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sodium Fluoride Cream 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 Sodium Fluoride Cream:

Use Sodium Fluoride Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Brush your teeth with a small amount of Sodium Fluoride Cream. Swish it around your mouth for about 1 minute and then spit it out. Do not swallow it. Do not eat, drink, or rinse your mouth for 30 minutes after using Sodium Fluoride Cream. If you miss a dose of Sodium Fluoride Cream, 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 Sodium Fluoride Cream.

Important safety information: Do not exceed the dose recommended by your doctor or dentist. Notify your dentist if your teeth become spotted or stained. Caution is advised when using Sodium Fluoride Cream in CHILDREN; they may be more sensitive to its effects PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Sodium Fluoride Cream, discuss with your doctor the benefits and risks of using Sodium Fluoride Cream during pregnancy. It is not known if Sodium Fluoride Cream is found in breast milk. If you are or will be breast-feeding while you are using Sodium Fluoride Cream, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Sodium Fluoride Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Sodium Fluoride Cream. 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).

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.

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 diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Proper storage of Sodium Fluoride Cream:

Store Sodium Fluoride Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. 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 Sodium Fluoride Cream out of the reach of children and away from pets.

General information: If you have any questions about Sodium Fluoride Cream, please talk with your doctor, pharmacist, or other health care provider. Sodium Fluoride Cream 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 Sodium Fluoride Cream. 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 Sodium Fluoride resources Sodium Fluoride Use in Pregnancy & Breastfeeding Sodium Fluoride Support Group 3 Reviews for Sodium Fluoride - Add your own review/rating Compare Sodium Fluoride with other medications Prevention of Dental Caries
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Neutra Maxx



Dosage Form: oral gel
ACTIVE INGREDIENTS

ACTIVE INGREDIENT                                      PURPOSE
SODIUM FLUORIDE (NaF) 1.1% (w/v)               ANTICAVITY
INACTIVE INGREDIENTS
DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .

USE

USE: AIDS IN THE PREVENTION OF DENTAL DECAY IN PEDIATRIC PATIENTS AND ADULTS

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.  IF MORE SOLUTION IS ACCIDENTALLY SWALLOWED THAN USED FOR BRUSHING, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

DIRECTIONS:  (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL)   
ADULTS AND CHILDREN 6 YEARS AND OLDER:  USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE.  AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE.  BEFORE BEDTIME IS BEST.  ADULTS SHOULD EXPECTORATE AFTER USE.  CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY.  DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Warnings

WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

PACKAGE LABEL

Neutra Maxx 5000PPM GEL  REFRESHING MINT FLAVOR
THE MAXIMUM AMOUNT OF FLUORIDE AVAILABLE  1.1% SODIUM FLUORIDE 5% POTASSIUM  NITRATE XYLITOL SLS FREE Rx ONLY.  NET WT 4.3 oz  (120 g)
MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS  GRAVETTE, AR 72736  THE MEDICINE AVAILABLE EXCLUSIVELY THROUGH YOUR DENTAL OFFICE. 

OTHER INFORMATION: STORE AT ROOM TEMPERATURE   QUESTION? COMMENTS? CALL 1-479-787-5168 M-F 9AM TO 5PM CST


Neutra Maxx 5000 
sodium fluoride  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-504 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.428 g  in 120 g Inactive Ingredients Ingredient Name Strength WATER   XYLITOL   POTASSIUM NITRATE   CARBOXYMETHYLCELLULOSE SODIUM   GLYCERIN   SODIUM PHOSPHATE   SACCHARIN SODIUM DIHYDRATE   Product Characteristics Color      Score      Shape Size Flavor MINT (Mint) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-504-06 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals

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methimazole


meth-IM-a-zole

Commonly used brand name(s)

In the U.S.

Tapazole

Available Dosage Forms:

Tablet

Therapeutic Class: Antithyroid Agent

Chemical Class: Thionamide

Uses For methimazole

Methimazole is used to treat hyperthyroidism, a condition where the thyroid gland produces too much thyroid hormone. It is also used before thyroid surgery or radioactive iodine treatment.

Methimazole is an antithyroid medicine. It works by making it harder for the body to use iodine to make thyroid hormone. It does not block the effects of a thyroid hormone that was made by the body before its use was begun.

methimazole is available only with your doctor's prescription.

Before Using methimazole

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 methimazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methimazole 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 methimazole in children.

Geriatric

No information is available on the relationship of age to the effects of methimazole in geriatric patients.

Pregnancy Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 methimazole, 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 methimazole 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.

Acenocoumarol Anisindione Dicumarol Phenindione Phenprocoumon 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 methimazole. Make sure you tell your doctor if you have any other medical problems, especially:

Blood or bone marrow problems (e.g., agranulocytosis, aplastic anemia, thrombocytopenia)—Use with caution. May make these conditions worse. Liver disease—Effects may be increased because of slower removal of the medicine from the body. Proper Use of methimazole

Take methimazole only as directed by your doctor to benefit your condition as much as possible. 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.

methimazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, if you are taking more than one dose a day, it is best to take the doses at evenly spaced times day and night. For example, if you are to take 3 doses a day, the doses should be spaced about 8 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your doctor.

Food in your stomach may change the amount of methimazole that is able to enter the bloodstream. To make sure that you always get the same effects, try to take methimazole at the same time in relation to meals every day. That is, always take it with meals or always take it on an empty stomach.

Dosing

The dose of methimazole 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 methimazole. 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 form (tablets): For treatment of hyperthyroidism (overactive thyroid): Adults—At first, 15 to 60 milligrams (mg) daily, divided into 3 equal doses and given every 8 hours. The maintenance dose is 5 to 15 mg daily. Children—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.4 mg per kilogram (kg) of body weight per day, divided into 3 equal doses and given every 8 hours. The maintenance dose is 0.2 mg/kg of body weight per day. Missed Dose

If you miss a dose of methimazole, 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.

Precautions While Using methimazole

It is very important that your doctor check your progress at regular visits to make sure that methimazole is working properly. Blood tests may be needed to check for unwanted effects.

Using methimazole while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking methimazole. If you think you have become pregnant while using the medicine, tell your doctor right away.

Methimazole can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime. Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

Liver problems may occur while you are using methimazole. Stop using methimazole and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

While you are being treated with methimazole, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methimazole may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Before having any kind of surgery, tell the medical doctor in charge that you are using methimazole. Taking methimazole together with medicines used during surgery may increase the risk of side effects.

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

methimazole 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:

More common Black, tarry stools chest pain chills cough fever painful or difficult urination 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 Rare Backache increase or decrease in urination swelling of the feet or lower legs Incidence not known Abdominal or stomach pain bleeding gums bleeding under the skin blood in the urine or stools burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cough or hoarseness dark urine difficulty with moving fever with or without chills general feeling of discomfort, illness, or weakness general feeling of tiredness or weakness headache joint pain light-colored stools loss of appetite and weight lower back or side pain muscle aching or cramping muscle pain or stiffness nausea and vomiting numbness or tingling of the hands, feet, or face pinpoint red spots on the skin soreness of the muscles sores, ulcers, or white spots on the lips or in the mouth swollen joints swollen salivary glands swollen, painful, or tender lymph glands in the neck, armpit, or groin tightness in the chest upper right abdominal pain wheezing yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Cloudy or bloody urine cracks in the skin high blood pressure loss of heat from the body red, swollen skin scaly skin sensation of pins and needles stabbing pain

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:

Incidence not known Abnormal loss of hair dizziness or lightheadedness feeling of constant movement of self or surroundings heartburn hives or welts itching loss of taste pain or discomfort in the chest, upper stomach, or throat redness of the skin sensation of spinning skin rash sleepiness vomiting

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: methimazole 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.

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More methimazole resources Methimazole Side Effects (in more detail)Methimazole DosageMethimazole Use in Pregnancy & BreastfeedingDrug ImagesMethimazole Drug InteractionsMethimazole Support Group0 Reviews for Methimazole - Add your own review/rating methimazole Concise Consumer Information (Cerner Multum) Methimazole Prescribing Information (FDA) Methimazole Monograph (AHFS DI) Methimazole Professional Patient Advice (Wolters Kluwer) Methimazole MedFacts Consumer Leaflet (Wolters Kluwer) Tapazole Prescribing Information (FDA) Compare methimazole with other medications Hyperthyroidism
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CaviRinse Sodium Fluoride Oral Rinse



Dosage Form: oral mouthwash
CaviRinse™
0.2% Sodium Fluoride Oral Rinse DESCRIPTION:

CaviRinse oral rinse is a prescription formulation for use in the prevention of dental caries. This formulation contains 0.2% sodium fluoride in a neutral pH base to help prevent caries and enhance remineralization.

ACTIVE INGREDIENT: Sodium Fluoride 0.2% w/v.

INACTIVE INGREDIENTS: Water, Glycerine, Microdent® (Ultramulsion® of dimethicone and poloxamer), sodium saccharin, flavoring, cetylpyridinum chloride.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. CaviRinse oral rinse provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges.

INDICATIONS AND USAGE:

CaviRinse oral rinse is indicated for use as part of a professional program for the prevention and control of dental caries. CaviRinse oral rinse should be swished vigorously between your teeth once weekly after brushing with conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

DO NOT SWALLOW. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a standard dose is accidentally swallowed. A single 10ml application of CaviRinse oral rinse contains approximately 9mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once weekly after brushing your teeth with a toothpaste. Pour 10ml of CaviRinse oral rinse into the dosage cup, vigorously swish between your teeth for one minute and then spit out. Children 6 to 16 years of age should thoroughly rinse mouth with water.

HOW SUPPLIED:

8oz (236.59ml) of rinse in a plastic bottle with dosage cup.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Vanilla Mint Flavor – NDC 48878-3223-8

Made in U.S.A. by
3M ESPE
Dental Products
St. Paul, MN 55144-1000 U.S.A.
1-800-634-2249

CaviRinse is a trademark of 3M or 3M ESPE AG. MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

© 3M 2010. All rights reserved.

Principal Display Panel – Carton Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)

Principal Display Panel – Bottle Label

NDC 48878-3223-8

Mint

3M ESPE

CaviRinse™

0.2 % Sodium Fluoride

Oral Rinse

Rx Only

Keep out of reach of children.

IMPORTANT: Read

directions thoroughly.

OMNI™

Contents:

8 fl oz

(236.59ml)


CAVIRINSE 
sodium fluoride  mouthwash Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3223 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 2 mg  in 1 mL Inactive Ingredients Ingredient Name Strength water   glycerin   saccharin sodium   cetylpyridinium chloride anhydrous   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 48878-3223-8 1 BOTTLE In 1 BOX contains a BOTTLE 1 236.59 mL In 1 BOTTLE This package is contained within the BOX (48878-3223-8)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Establishment Name Address ID/FEI Operations 3M ESPE Dental Products 799975909 MANUFACTURE Revised: 08/20093M ESPE Dental Products
More CaviRinse Sodium Fluoride Oral Rinse resources CaviRinse Sodium Fluoride Oral Rinse Use in Pregnancy & Breastfeeding CaviRinse Sodium Fluoride Oral Rinse Support Group 3 Reviews for CaviRinse Sodium Fluoride Oral - Add your own review/rating Compare CaviRinse Sodium Fluoride Oral Rinse with other medications Prevention of Dental Caries
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Sodium Fluoride/Potassium Nitrate


Pronunciation: SOE-dee-um FLUR-ide/po-TAS-ee-um NYE-trate
Generic Name: Sodium Fluoride/Potassium Nitrate
Brand Name: PreviDent 5000 Sensitive
Sodium Fluoride/Potassium Nitrate is used for:

Preventing tooth decay. It is also used to help reduce painful sensitivity of the teeth to touch; sweets; or hot, cold, or acidic substances.

Sodium Fluoride/Potassium Nitrate is a topical fluoride toothpaste. It works by strengthening the tooth enamel.

Do NOT use Sodium Fluoride/Potassium Nitrate if: you are allergic to any ingredient in Sodium Fluoride/Potassium Nitrate

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

Before using Sodium Fluoride/Potassium Nitrate:

Some medical conditions may interact with Sodium Fluoride/Potassium Nitrate. 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 problems

Some MEDICINES MAY INTERACT with Sodium Fluoride/Potassium Nitrate. However, no specific interactions with Sodium Fluoride/Potassium Nitrate are known at this time.

Ask your health care provider if Sodium Fluoride/Potassium Nitrate 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 Sodium Fluoride/Potassium Nitrate:

Use Sodium Fluoride/Potassium Nitrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Use Sodium Fluoride/Potassium Nitrate in place of your regular toothpaste unless your doctor tells you otherwise. Place at least a 1-inch strip of the paste onto a soft bristle toothbrush. Brush the teeth thoroughly for at least 1 minute, then spit out the paste. Do NOT swallow. Rinse the mouth well. Spit out the rinse water. Be sure to brush all sensitive areas of the teeth. Use Sodium Fluoride/Potassium Nitrate on a regular schedule to get the most benefit from it. Using Sodium Fluoride/Potassium Nitrate at the same time each day will help you remember to use it. If you miss a dose of Sodium Fluoride/Potassium Nitrate, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Sodium Fluoride/Potassium Nitrate.

Important safety information: Do NOT use more than the recommended dose or use for longer than 4 weeks without checking with your doctor. If your symptoms do not get better or if they get worse, check with your doctor. Sodium Fluoride/Potassium Nitrate may cause harm if a large amount is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Sodium Fluoride/Potassium Nitrate should not be used in CHILDREN younger than 12 years old without checking with your doctor or dentist; 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 Sodium Fluoride/Potassium Nitrate while you are pregnant. It is not known if Sodium Fluoride/Potassium Nitrate is found in breast milk after topical use. If you are or will be breast-feeding while you use Sodium Fluoride/Potassium Nitrate, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Sodium Fluoride/Potassium Nitrate:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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).

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.

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 bloody vomit; burning in the mouth; diarrhea; drooling; nausea; sore tongue; stomach pain or cramping; or vomiting.

Proper storage of Sodium Fluoride/Potassium Nitrate:

Store Sodium Fluoride/Potassium Nitrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Fluoride/Potassium Nitrate out of the reach of children and away from pets.

General information: If you have any questions about Sodium Fluoride/Potassium Nitrate, please talk with your doctor, pharmacist, or other health care provider. Sodium Fluoride/Potassium Nitrate 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 Sodium Fluoride/Potassium Nitrate. 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 Sodium Fluoride/Potassium Nitrate resources Sodium Fluoride/Potassium Nitrate Use in Pregnancy & Breastfeeding Sodium Fluoride/Potassium Nitrate Support Group 3 Reviews for Sodium Fluoride/Potassium Nitrate - Add your own review/rating Compare Sodium Fluoride/Potassium Nitrate with other medications Prevention of Dental Caries
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Fluorishield



Dosage Form: dental gel
UNFLAVORED Fluorishield BRAND OF 1.1% Sodium Fluoride Dental Gel

Your dentist has selected for you Fluorishield, a 1.1% Sodium Fluoride product that was specially developed to prevent tooth decay which can occur from xerostomia (dry mouth). Dry mouth can result from radiation therapy, systemic diseases, medications which affect the salivary glands and mouth breathing. Clinical trials have shown that application of topical fluoride gel in the presence of good oral hygiene can prevent or significantly reduce tooth decay which is related to dry mouth.  Fluorishield topical fluoride gel can be applied with a custom carrier or tray, directly brushed on, or used with an over denture. Your dentist will prescribe the method that is best suited for your individual needs. The gel is easily dispensed when the bottle is inverted for storing.

STORE INVERTED FOR EASY REMOVAL OF CONTENTS.

Description:

Topical neutral 1.1% sodium fluoride for use as a dental caries preventative in children and adults. This prescription product is not a dentifrice.

Warnings:

DO NOT SWALLOW. As with all medications, this product should be kept out of reach of children.

Overdose:

Accidental ingestion of a usual treatment dose (1-2mgF) is not harmful.

Store at temperature between 68?-77?F (20?-25?C).

CAUTION:

Federal (U.S.A.) law prohibits dispensing without a prescription.

INSTRUCTIONS Custom Carriers or Trays

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Add one drop of Fluorishield into each tooth area in the custom carrier and spread evenly with the applicator tip of the fluoride bottle. Place carriers over the teeth and let it remain in place for one (1) minute or longer (as directed by your doctor). Expectorate the excess gel.  Clean carriers with cold water. Spit out the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

Brush On

Brush and floss your teeth to remove plaque. Adults and children 6 years of age or older: Apply a thin ribbon of gel to the toothbrush and spread evenly with the applicator tip of the fluoride bottle. Brush all tooth surfaces and allow fluoride to remain in place for one (1) minute or longer (as directed by your doctor). Clean carriers with cold water. Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

Overdentures

Brush all tooth surfaces.  Clean your dentures. Adults and children 6 years of age or older: Apply one (1) or two (2)drops of Fluorishield to each tooth area in your denture and place the dentures in your mouth. Leave in place for one (1) minute or longer (as directed by your doctor).Expectorate the excess gel in the mouth and do not rinse, eat, or drink for thirty (30) minutes.

MEDICAL PRODUCTS LABORATORIES, INC.

9990 Global Road • Phila., PA 19115-1083 800-523-0191 fax 215-677-7736 www.mplusa.com


Fluorishield 
sodium fluoride  gel Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10733-130 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 11 mg  in 1 g Inactive Ingredients Ingredient Name Strength WATER   SACCHARIN SODIUM   HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 10733-130-04 66 BOTTLE In 1 CARTON contains a BOTTLE 1 114 g In 1 BOTTLE This package is contained within the CARTON (10733-130-04)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/29/2009
Labeler - Medical Products Laboratories, Inc. (002290302) Revised: 02/2011Medical Products Laboratories, Inc.
More Fluorishield resources Fluorishield Use in Pregnancy & Breastfeeding Fluorishield Support Group 3 Reviews for Fluorishield - Add your own review/rating Compare Fluorishield with other medications Prevention of Dental Caries
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sodium iodide


Generic Name: sodium iodide (SOE dee um EYE oh dide)
Brand names: Iodopen, Iodides

What is sodium iodide?

Sodium iodide is a salt that is formed into an injectable medicine.

Sodium iodide is used to treat or prevent iodine deficiency caused by poor nutrition or poor absorption by the body.

Sodium iodide may also be used to treat a thyroid disorder.

Sodium iodide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about sodium iodide? You should not use this medication if you are allergic to sodium iodide.

Before using sodium iodide, tell your doctor if you have kidney disease, tuberculosis, a blood vessel disorder, a goiter, or a thyroid disorder that is not being treated with sodium iodide.

This medication may cause thyroid problems in an unborn baby, but the medication may sometimes be used during pregnancy. Your doctor should determine whether or not this medication is safe or if it will harm the unborn baby. Before you use sodium iodide, tell your doctor if you are pregnant or plan to become pregnant during treatment. Serious side effects include swollen glands or swelling in your throat, severe headache, fast or pounding heart rate, feeling short of breath, or numbness or tingly feeling in your hands or feet. Sodium iodide may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat to help control your condition. What should I discuss with my health care provider before using sodium iodide? You should not use this medication if you are allergic to sodium iodide.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using sodium iodide, tell your doctor if you have:

kidney disease;

tuberculosis;

a blood vessel disorder such as vasculitis (swelling of your blood vessels);

a goiter; or

a thyroid disorder (unless you are being treated for thyroid disorder with sodium iodide).

This medication may cause thyroid problems in an unborn baby, but the medication may sometimes be used during pregnancy. Your doctor should determine whether or not this medication is safe or if it will harm the unborn baby. Before you use sodium iodide, tell your doctor if you are pregnant or plan to become pregnant during treatment. Sodium iodide 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 use sodium iodide?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Sodium iodide injection is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Sodium iodide may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat to help control your condition. Store sodium iodide at room temperature away from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include extreme weakness, burning or metallic taste in your mouth, or fast heart rate.

What should I avoid while using sodium iodide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using sodium iodide.

Sodium iodide 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 a serious side effect such as:

swollen glands or swelling in your throat;

severe headache;

fast, pounding, or uneven heart rate;

feeling short of breath; or

numbness, burning, pain, or tingly feeling in your hands or feet.

Less serious side effects may include:

unusual or unpleasant taste or burning in your mouth or throat;

heartburn;

mild skin rash or itching;

tender gums, tooth pain, mouth soreness;

weakness; or

changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sodium iodide?

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

medicines that contain iodine such as Betadine;

lithium (Eskalith, Lithobid);

sodium iodide I-131 (Iodotope); or

medications to treat overactive thyroid, such as methimazole (Tapazole), propylthiouracil ("PTU"), and others.

This list is not complete and there may be other drugs that can interact with sodium iodide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More sodium iodide resources Sodium iodide Drug Interactions Sodium iodide Support Group 0 Reviews · Be the first to review/rate this drug sodium iodide Oral, Injection, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information Where can I get more information? Your doctor or pharmacist can provide more information about sodium iodide.
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Sodium Fluoride Chewable Tablets



Fluoride Chewable Tablets 1 mg

Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, Magnesium Stearate.

DOSAGE AND ADMINISTRATION:

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

STORAGE:

Store at a Controlled Room Temperature 20?-25?C (68?-77?F)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.


FLUORIDE 
fluoride  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-172 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY   LACTOSE   SACCHARIN   D&C RED NO. 7   MAGNESIUM STEARATE   Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor CHERRY Imprint Code 172 Contains          Packaging # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943) Revised: 05/2011Libertas Pharma, Inc.

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ControlRx Toothpaste



Dosage Form: oral paste, dentifrice
ControlRx™
1.1% Sodium Fluoride Prescription Toothpaste DESCRIPTION:

ControlRx dentifrice is a prescription formulation for use in the prevention of dental caries. This formulation contains 1.1% sodium fluoride in a neutral pH base and a mild abrasive to help remove dental plaque, debris and stain.

ACTIVE INGREDIENT: Sodium Fluoride 1.1% w/w.

INACTIVE INGREDIENTS: Water, Sorbitol, Hydrated Silica, Glycerin, MICRODENT® 2.0% w/w - a patented ULTRAMULSION® of Dimethicone and Poloxamer 407, PEG 12, Flavor, Cellulose Gum, Sodium Lauryl Sulfate, Titanium Dioxide, Sodium Saccharin.

CLINICAL PHARMACOLOGY:

The use of higher-concentration fluoride products results in greater reductions in the incidence of dental caries. ControlRx dentifrice provides enhanced remineralization of demineralized enamel and enhanced protection against subsequent acid challenges, relative to over the counter fluoride products.

INDICATIONS AND USAGE:

ControlRx dentifrice is indicated for use as part of a professional program for the prevention and control of dental caries. ControlRx dentifrice is applied to the teeth using a toothbrush. ControlRx dentifrice should be used once daily in place of a conventional toothpaste, unless otherwise instructed by a dental professional.

CONTRAINDICATIONS:

Do not use in children less than 6 years of age unless recommended by a dental professional.

WARNINGS:

Do not swallow. Keep out of reach of children. Frequent ingestion may result in dental fluorosis in children less than 6 years of age, especially if community water fluoridation exceeds 0.6 ppm fluoride ion. Use in children less than 6 years of age requires special supervision to prevent swallowing. Carefully read all instructions before using this product.

ADVERSE REACTIONS:

Allergic reactions and other idiosyncrasies have been rarely reported.

OVERDOSAGE:

Medical attention should be sought if more than a thin ribbon or pea-sized amount is accidentally swallowed. A thin ribbon or pea-sized amount of ControlRx dentifrice weighs approximately 0.3g and contains approximately 1.5mg of fluoride ion. A 2 oz tube contains 282mg of fluoride ion.

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by a dental professional. Use once daily.

Apply a thin ribbon or pea-sized amount of ControlRx dentifrice to a soft-bristled toothbrush, and brush teeth for two minutes. After brushing, adults should expectorate. Children 6 to 16 years of age should expectorate and thoroughly rinse mouth with water.

HOW SUPPLIED:

2 oz (57g) net wt. of paste in laminate tubes.

STORAGE: Do not freeze or expose to extreme heat.

Rx Only

Refreshing Berry Flavor: 2 oz tube - NDC 48878-3101-6.

MICRODENT and ULTRAMULSION are registered trademarks of Whitehill Oral Technologies, Inc.

Principal Display Panel – Box Label

3M ESPE

NDC 48878-3101-6

ControlRx™

Berry

1.1% Sodium Fluoride

5000 ppm F- Prescription ToothpasteOMNI™

Rx Only

Contents: 1 Tube

NET WT 2oz (57g)

Principal Display Panel – Tube Label

3M ESPE

NDC 48878-3101-6

ControlRx™

Berry

1.1% Sodium Fluoride

5000 ppm F- Prescription Toothpaste

Rx Only

OMNI™

NET WT

2oz (57g)


CONTROLRX 
sodium fluoride  paste, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48878-3101 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) sodium fluoride 11 mg  in 1 g Inactive Ingredients Ingredient Name Strength Water   Sorbitol   Silicon Dioxide   Glycerin   Dimethicone   Poloxamer 407   Polyethylene Glycol   Carboxymethylcellulose Sodium   Sodium Lauryl Sulfate   Titanium Dioxide   Saccharin Sodium   Product Characteristics Color      Score      Shape Size Flavor BERRY (BERRY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 48878-3101-6 1 TUBE In 1 BOX contains a TUBE 1 57 g In 1 TUBE This package is contained within the BOX (48878-3101-6)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/01/2005
Labeler - 3M ESPE Dental Products (799975909) Revised: 05/20103M ESPE Dental Products
More ControlRx Toothpaste resources ControlRx Toothpaste Use in Pregnancy & BreastfeedingControlRx Toothpaste Support Group3 Reviews for ControlRx Toothpaste - Add your own review/rating Compare ControlRx Toothpaste with other medications Prevention of Dental Caries
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Prevident 5000 Sensitive


sodium fluoride and potassium nitrate gel
Dosage Form: gel, dentifrice
Colgate®
PreviDent®5000 ppm

SENSITIVE

Rx ONLY

1.1% Sodium Fluoride, 5% Potassium Nitrate

Prescription Strength Toothpaste for Sensitive Teeth

Prevident 5000 Sensitive Description

Self-topical neutral fluoride toothpaste containing 1.1% (w/w) sodium fluoride and 5% potassium nitrate.

Active Ingredients

Sodium fluoride 1.1% (w/w), Potassium nitrate 5%

Inactive Ingredients

water, hydrated silica, sorbitol, PEG-12, carrageenan, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, sodium saccharin, mica, sodium hydroxide, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

Prevident 5000 Sensitive - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Prevident 5000 Sensitive

A dental caries preventive and sensitive teeth toothpaste; for twice daily self-applied topical use, followed by rinsing. Helps reduce the painful sensitivity of the teeth to cold, heat, acids, sweets or contact in adult patients and children 12 years of age and older. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® 5000 Sensitive brand of 1.1% sodium fluoride toothpaste with 5% potassium nitrate in a squeeze bottle is easily applied onto a toothbrush. This prescription toothpaste should be used twice daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Contraindications

Do not use in pediatric patients under age 12 years unless recommended by a dentist or physician.

Warnings

Not for systemic treatment - DO NOT SWALLOW. Keep out of reach of infants and children. Children under 12 years of age, consult a dentist or physician.

Note: Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.

Precautions General

Not for systemic treatment. DO NOT SWALLOW.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.

Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. In vivo data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.

Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.

Pregnancy Teratogenic Effects Pregnancy Category B

It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate and well-controlled studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.

Nursing Mothers

It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Please refer to the CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use

Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.5

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Overdosage

Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

A treatment dose (a thin ribbon) of PreviDent® 5000 Sensitive contains approximately 2.5 mg fluoride. A 3.4 FL OZ (100 mL) bottle contains approximately 575 mg fluoride.

Prevident 5000 Sensitive Dosage and Administration

Follow these instructions unless otherwise instructed by your dental professional:

Adults and children 12 years of age and older: Apply at least 1 inch strip of PreviDent® 5000 Sensitive onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate, and rinse mouth thoroughly. Use twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or physician. How is Prevident 5000 Sensitive Supplied

3.4 FL OZ (100 mL) in plastic bottles. Mild Mint: NDC 0126-0070-61

STORAGE

Store at Controlled Room Temperature, 68-77°F (20-25°C)

REFERENCES American Dental Association, Accepted Dental Therapeutics Ed. 40 (Chicago, 1984): 405-407. H.R. Englander et al., JADA 75 (1967): 638-644. H.R. Englander et al., JADA 78 (1969): 783-787. H.R. Englander et al., JADA 83 (1971): 354-358. Data on file, Colgate Oral Pharmaceuticals.

Questions? Comments? Please Call 1-800-962-2345
www.colgateprofessional.com

PRINCIPAL DISPLAY PANEL 100 mL Bottle

NDC 0126-0070-61

Colgate®

PreviDent®
5000ppm

SENSITIVE
1.1% Sodium Fluoride
5% Potassium Nitrate

PRESCRIPTION STRENGTH
TOOTHPASTE FOR SENSITIVE TEETH

MILD MINT

3.4 FL OZ (100 mL)

Rx ONLY

P10000587


PREVIDENT  5000 SENSITIVE
sodium fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0126-0070 Route of Administration DENTAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (fluoride ion) Sodium fluoride 12.7 mg  in 1 mL Potassium nitrate (Potassium cation) Potassium nitrate 57.5 mg  in 1 mL Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color GREEN Score      Shape Size Flavor PEPPERMINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0126-0070-61 100 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 07/06/2009
Labeler - Colgate-Palmolive Company (055002195) Revised: 07/2009Colgate-Palmolive Company More Prevident 5000 Sensitive resources Prevident 5000 Sensitive Side Effects (in more detail) Prevident 5000 Sensitive Use in Pregnancy & Breastfeeding 0 Reviews for Prevident 5000 Sensitive - Add your own review/rating Prevident 5000 Sensitive Concise Consumer Information (Cerner Multum) APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information EtheDent Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Gel-Kam Rinse MedFacts Consumer Leaflet (Wolters Kluwer) Phos-Flur Cream MedFacts Consumer Leaflet (Wolters Kluwer) PreviDent 5000 Sensitive MedFacts Consumer Leaflet (Wolters Kluwer) Compare Prevident 5000 Sensitive with other medications Prevention of Dental Caries
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Kids Choice



Dosage Form: gel, dentifrice
ACTIVE INGREDIENT

Active Ingredient: Stannous Fluoride

INACTIVE INGREDIENTS

Glycerine, Hydroxy Ethyl Celluulose, Xylitol

USE

Aids in the prevention of dental decay.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.
Children 6-11 Years:  See directions above.  Adult supervision required.
Children Under 6: Consult a Dentist or Physician.

OTHER INFORMATION

This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.

QUESTIONS ? COMMENTS ?

Questions?? Comments??
Call 1-479-787-5168 M-F 9am to 5pm CST

Warnings

If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.

PACKAGE LABEL

Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel
Manufactured by Massco Dental







Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-005 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .45103 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM (BUBBLE GUM) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-005-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-006 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CREME DE MENTHE (HINT OF MINT) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-006-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-007 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor LIME (LIMEAIDE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-007-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-008 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor GRAPE (GRAPE) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-008-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-009 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-009-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Kids Choice 
stannous fluoride  gel, dentifrice Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63783-015 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE .4510 g  in 120 g Inactive Ingredients Ingredient Name Strength GLYCERIN   HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)   XYLITOL   Product Characteristics Color      Score      Shape Size Flavor COTTON CANDY (COTTON CANDY) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 63783-015-04 120 g In 1 BOTTLE, DISPENSING None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 01/01/1989
Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858) Establishment Name Address ID/FEI Operations Massco Dental A Division of Dunacin Pharmaceuticals 008081858 manufacture Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals
More Kids Choice resources Kids Choice Use in Pregnancy & Breastfeeding Kids Choice Support Group 3 Reviews for Kids Choice - Add your own review/rating Compare Kids Choice with other medications Prevention of Dental Caries
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SSKI Drops


Pronunciation: poe-TASS-ee-uhm EYE-oh-dide
Generic Name: Potassium Iodide
Brand Name: SSKI
SSKI Drops are used for:

Treating lung conditions or disease in which mucus complicates the condition (eg, emphysema, bronchial asthma, bronchitis). It may also be used for other conditions as determined by your doctor.

SSKI Drops are an expectorant. It works by thinning mucous secretions (phlegm) in the lungs and making it less sticky. The mucus is easier to cough up. This reduces chest congestion, which helps make your coughs more productive.

Do NOT use SSKI Drops if: you are allergic to any ingredient in SSKI Drops you have iodine poisoning, Addison disease, kidney disease, lung disease, a skin disorder, stomach disorders, tuberculosis, or a history of preexisting thyroid disease you are taking potassium sparing diuretics (eg, spironolactone) or potassium supplements

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

Before using SSKI Drops:

Some medical conditions may interact with SSKI Drops. 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 an overactive thyroid

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

Lithium because side effects of SSKI Drops may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), aldosterone blockers (eg, eplerenone), or potassium sparing diuretics (eg, spironolactone) because serious side effects, including high blood potassium and irregular heartbeat, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if SSKI Drops 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 SSKI Drops:

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

SSKI Drops may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Dilute each dose in a glass (8 oz/240 mL) of water or fruit juice before taking. Use the dropper that comes with SSKI Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of SSKI Drops, 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 SSKI Drops.

Important safety information: Do not use a salt substitute or a potassium supplement without checking with your doctor. Stop taking SSKI Drops and contact your health care provider if any of the following signs of iodine poisoning occur: burning of the mouth or throat; severe headache; metallic taste in mouth; soreness of the teeth and gums; irritation of the eyes with swelling of the eyelids; increased salivation. Caution is advised when using SSKI Drops in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: SSKI Drops may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using SSKI Drops during pregnancy. SSKI Drops are excreted in breast milk. Do not breast-feed while taking SSKI Drops. Possible side effects of SSKI Drops:

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:

Acne; diarrhea; loss of appetite; nausea; upset stomach; vomiting.

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); black, tarry stools; confusion; fever; irregular heartbeat; metallic taste in the mouth; mouth sores; numbness or tingling of the hands or feet; skin rash; stomach pains; swelling in the neck or throat; unusual tiredness; weakness.

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: SSKI 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 burning of the mouth or throat; muscle weakness; severe headache; soreness of teeth or gums; swelling; irregular heartbeat.

Proper storage of SSKI Drops:

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

General information: If you have any questions about SSKI Drops, please talk with your doctor, pharmacist, or other health care provider. SSKI Drops 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 SSKI Drops. 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 SSKI resources SSKI Side Effects (in more detail) SSKI Use in Pregnancy & Breastfeeding SSKI Drug Interactions SSKI Support Group 0 Reviews for SSKI - Add your own review/rating Compare SSKI with other medications Cough Cutaneous Sporotrichosis Hyperthyroidism Radiation Emergency
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Yodefan Liquid


Pronunciation: poe-TASS-ee-uhm EYE-oh-dide
Generic Name: Potassium Iodide
Brand Name: Yodefan
Yodefan Liquid is used for:

Treating lung conditions or disease in which mucus complicates the condition (eg, emphysema, bronchial asthma, bronchitis). It may also be used for other conditions as determined by your doctor.

Yodefan Liquid is an expectorant. It works by thinning mucous secretions (phlegm) in the lungs and making it less sticky. The mucus is easier to cough up. This reduces chest congestion, which helps make your coughs more productive.

Do NOT use Yodefan Liquid if: you are allergic to any ingredient in Yodefan Liquid you have iodine poisoning, Addison disease, kidney disease, lung disease, a skin disorder, stomach disorders, tuberculosis, or a history of preexisting thyroid disease you are taking potassium sparing diuretics (eg, spironolactone) or potassium supplements

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

Before using Yodefan Liquid:

Some medical conditions may interact with Yodefan Liquid. 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 an overactive thyroid

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

Lithium because side effects of Yodefan Liquid may be increased Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), aldosterone blockers (eg, eplerenone), or potassium sparing diuretics (eg, spironolactone) because serious side effects, including high blood potassium and irregular heartbeat, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Yodefan Liquid 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 Yodefan Liquid:

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

Yodefan Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Dilute each dose in a glass (8 oz/240 mL) of water or fruit juice before taking. Follow each dose with another glass of water. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. If you miss a dose of Yodefan Liquid, 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 Yodefan Liquid.

Important safety information: Do not use a salt substitute or a potassium supplement without checking with your doctor. Stop taking Yodefan Liquid and contact your health care provider if any of the following signs of iodine poisoning occur: burning of the mouth or throat; severe headache; metallic taste in mouth; soreness of the teeth and gums; irritation of the eyes with swelling of the eyelids; increased salivation. Caution is advised when using Yodefan Liquid in CHILDREN because they may be more sensitive to its effects. PREGNANCY and BREAST-FEEDING: Yodefan Liquid may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Yodefan Liquid during pregnancy. Yodefan Liquid is excreted in breast milk. Do not breast-feed while taking Yodefan Liquid. Possible side effects of Yodefan Liquid:

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:

Acne; diarrhea; loss of appetite; nausea; upset stomach; vomiting.

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); black, tarry stools; confusion; fever; irregular heartbeat; metallic taste in the mouth; mouth sores; numbness or tingling of the hands or feet; skin rash; stomach pains; swelling in the neck or throat; unusual tiredness; weakness.

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: Yodefan 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 burning of the mouth or throat; muscle weakness; severe headache; soreness of teeth or gums; swelling; irregular heartbeat.

Proper storage of Yodefan Liquid:

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

General information: If you have any questions about Yodefan Liquid, please talk with your doctor, pharmacist, or other health care provider. Yodefan Liquid 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 Yodefan Liquid. 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 Yodefan resources Yodefan Side Effects (in more detail) Yodefan Use in Pregnancy & Breastfeeding Yodefan Drug Interactions Yodefan Support Group 0 Reviews for Yodefan - Add your own review/rating Compare Yodefan with other medications Cough Cutaneous Sporotrichosis Hyperthyroidism Radiation Emergency
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Eludril Mouthwash


1. Name Of The Medicinal Product

ELUDRIL mouthwash

2. Qualitative And Quantitative Composition

Actives :

Quantity :

Unit :

Chlorhexidine digluconate

0.100

% W/V

Chlorobutanol

0.500

% W/V

Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate).

The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22 mg/ml – 0.33 mg/ml.

Each ml contains 5 mg of chlorobutanol.

The content of chlorobutanol per ml when diluted as recommended is 1.11 mg/ml – 1.66 mg/ml.

Excipients:Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Mouthwash.

Clear colourless Oromucosal solution.

4. Clinical Particulars 4.1 Therapeutic Indications

Eludril mouthwash is an antibacterial solution which inhibits dental plaque formation. It is indicated as an aid in the treatment and prevention of gingivitis, and in maintaining oral hygiene, particularly in situations where toothbrushing is difficult to carry out (eg following oral surgery or in physically or mentally-handicapped patients). It is valuable in the management of aphtous ulceration and oral candidal infections (eg denture stomatitis and thrush) and can be used as an adjuvant treatment for minor infections of the throat.

As a disinfectant solution for the cleansing of removable dentures.

4.2 Posology And Method Of Administration

Eludril is contraindicated in infants and children under six years of age: see section 4.3.

1. As a mouthwash, dilute 10 to 15 ml in the measuring-cup provided for this purpose and fill with lukewarm water to the upper line and use as a mouthwash or a gargle two or three times a day.

2. As a disinfectant for removable dentures, prepare a 1 in 3 dilution of Eludril with water. The dentures previously cleansed should be soaked in the solution for one hour.

Route of administration

Oromucosal use. (This product is not intended to be swallowed)

4.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients.

- Use in infants and children less than 6 years of age.

- Use with anionic agents (see section 4.5).

4.4 Special Warnings And Precautions For Use

Warnings

For oral use only

Do not swallow

Keep out of the eyes and ears. If the mouthwash comes into contact with the eyes or ears, wash out promptly and thoroughly with water.

Discoloration of the tongue, teeth and silicate or composite restorations may occur. This stain is not permanent and can largely be prevented by brushing with a conventional toothpaste daily before using the mouthwash or, in the case of dentures cleansing with a conventional cleanser: see sections 4.5, 4.8.

In case of soreness, swelling or irritation of the mouth, stop using the product and consult a healthcare professional: see section 4.8

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E218) which may cause allergic reactions.

Precautions for use

Chlorhexidine is an irritant and should be used with caution. If there is evidence of irritation or aggravation of the condition, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine is incompatible with anionic agents which are usually present in conventional toothpastes. Therefore, thorough rinsing of the mouth with water, after toothbrushing with toothpaste, should be done before using this medicine: see section 4.3. A short time should elapse between using the two products.

4.6 Pregnancy And Lactation

There is no evidence of any adverse effects in infants arising from the use of Eludril mouthwash during pregnancy or lactation.

Therefore no special precautions are recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

Body System

Adverse Reactions (frequency not known)

Immune system disorders

Anaphylactic shock, anaphylactic reaction, hypersensitivity

Nervous system disorders

-Dysgeusia: transient disturbance of taste sensation

-Mucosal burning sensation: burning sensation of the tongue.

These effects may occur on initial use of the product and usually diminish with continued use.

Gastrointestinal disorders

-Tongue discoloration: Superficial discoloration of the dorsum of the tongue, reversible after discontinuing treatment: see section 4.4.

-Teeth discoloration: Discoloration of the teeth and silicate or composite restorations: see section 4.4.

-Parotid gland enlargement: swelling of the parotid glands reversible after discontinuing treatment.

- Oral desquamation: In cases where oral desquamation occurs dilution of 10ml of the mouthwash with water to the upper line of the measuring cup will often allow continued use of the mouthwash

4.9 Overdose

Overdose is not expected under normal conditions of use of this solution as a mouthwash (normal dilution conditions for 10 ml is 7.4 %v/v and for 15 ml is 11.1 %v/v.). However, due to the undiluted product alcohol content (33.25 % v/v) accidental ingestion of large amounts by children requires prompt medical attention for appropriate action.

Symptoms

Chlorhexidine when taken orally is poorly absorbed. Most patients will develop very few symptoms. Local effects like burning sensation in the mouth and throat may occur. Systemic effects are unlikely if large volumes are ingested. However, large amounts may cause digestive disorders (epigastric pain, diarrhoea) and if chlorhexidine passes into the general system, signs of neurological toxicity may develop.

Emergency procedures

- Do not attempt to empty the stomach

- Administration of milk, water to drink, raw egg, gelatin or mild soap may be advisable provided the airway can be protected.

- General supportive measures should be instituted as deemed necessary by the physician.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives and antiseptics for local oral treatment.

ATC code: A01AB03.

CHLORHEXIDINE : broad-spectrum antibacterial (gram + and gram -) and anti-fungal product with extended bactericidal activity on buccal mucosa.

CHLOROBUTANOL: local anaesthetic providing a quick relief from pain, bacteriostatic reinforcing the activity of chlorhexidine.

5.2 Pharmacokinetic Properties

CHLORHEXIDINE:

Oral:Very weak systemic absorption, distribution mainly via liver and kidneys; little metabolism (no degradation of the molecule). Elimination mainly in faeces (99.5 % of the ingested dose).

Permucosal absorption: negligible. Distribution, metabolism and elimination same as oral route

CHLOROBUTANOL:

Systemic absorption after oral administration. Half-life of 9 to 10 days.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Poloxamer

Alcohol

Sorbitol solution 70 % (crystallising)

Menthol

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Peppermint spirit

Purified Water

6.2 Incompatibilities

See section 4.5

6.3 Shelf Life

Unopened: 3 years

6.4 Special Precautions For Storage

Store away from light,

Store at a temperature of 25°C maximum.

6.5 Nature And Contents Of Container

Clear glass bottle with aluminium cap and a measuring cup.

Pack sizes: 90ml, 250ml and 500ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

PIERRE FABRE LIMITED

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 00603/0012R

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 9th August 1973

Date of last renewal: 16th April 2007

10. Date Of Revision Of The Text

27/01/2011


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Doxazosin 1mg, 2mg, 4mg Tablets


DOXAZOSIN 1 MG TABLETS

DOXAZOSIN 2 MG TABLETS

DOXAZOSIN 4 MG TABLETS

(as mesilate)

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it onto others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What DOXAZOSIN is and what it is used for 2. Before you take DOXAZOSIN 3. How to take DOXAZOSIN 4. Possible side effects 5. Storing DOXAZOSIN 6. Further information

The name of your medicine is DOXAZOSIN 1 mg Tablets, DOXAZOSIN 2 mg Tablets, DOXAZOSIN 4 mg Tablets (referred to as DOXAZOSIN throughout this leaflet).

What Doxazosin Is And What It Is Used For

Doxazosin is one of a group of medicines called alpha-blockers.

DOXAZOSIN tablets are used to treat high blood pressure (hypertension) or the symptoms caused by enlargement of the prostate gland in men.

In patients taking DOXAZOSIN to treat high blood pressure (hypertension) DOXAZOSIN works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with enlargement of the prostate gland, DOXAZOSIN is taken to treat frequent and/or poor passing of urine. This is common in patients with enlargement of the prostate gland. DOXAZOSIN works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.

Before You Take Doxazosin Do not take DOXAZOSIN if you: have ever had an allergic reaction (hypersensitivity) to doxazosin or any of the other ingredients of DOXAZOSIN tablets.

This may have been itching, reddening of the skin or difficulty in breathing.

are breastfeeding. are aged under 16 years of age Take special care with DOXAZOSIN: If you have liver disease tell your doctor before you start taking your tablets. If you are pregnant or trying to become pregnant tell your doctor before you start taking your tablets.

If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used DOXAZOSIN. This is because DOXAZOSIN may cause complications during the surgery which can be managed if your specialist is prepared in advance.

When you start to take DOXAZOSIN you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself.

Taking other medicines:

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers. In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start drugs for erectile dysfunction.

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Driving and using machines:

Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If affected, do not drive or operate machinery and contact your doctor immediately.

Important information about some of the ingredients of DOXAZOSIN:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How To Take Doxazosin Adults and Elderly:

Always take DOXAZOSIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

DOXAZOSIN is usually taken once daily. DOXAZOSIN may be taken in the morning or the evening.

You can take your tablets before or after food.

You should take your tablets at the same time each day with a small amount of water.

The initial dose of DOXAZOSIN is 1mg once daily. Thereafter the dose may be gradually increased (within 1-2 weeks interval) to the usual dose (2mg or 4mg daily).

In some circumstances the dose may be increased to a maximum of 8mg daily if you are being treated for prostate enlargement, or to a maximum of 16mg if you are being treated for high blood pressure.

Children:

This medicine is not recommended for children.

You have been given a calendar pack that will help you remember to take your tablets. If you are taking more than one tablet a day, you must ignore the marking for the day, printed on the back of the blister.

Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking DOXAZOSIN. Even if this is so and you feel well, you should not stop taking your blood pressure medication unless instructed to by your doctor.

Don't change the dose or stop taking the tablets without first checking with your doctor.

Don't wait until your tablets are finished before seeing your doctor.

If you have impression that the effect of DOXAZOSIN is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take DOXAZOSIN:

If you miss a dose just carry on with the next one as normal. Do not take a double dose to make up for the missed one.

If you take more DOXAZOSIN than you should:

Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous.

Tell your doctor immediately or go to your nearest hospital casualty department.

Possible Side Effects

Like all medicines, DOXAZOSIN can have side effects but not everybody gets them.

Most undesirable effects are usually mild and tend to wear off as treatment goes on. It is important to tell your doctor if any unwanted effect causes you concern, including those which may not be listed below.

Problems DOXAZOSIN may cause are:

allergic reaction, with symptoms such as skin rash, itching, which may be accompanied by shortness of breath, difficulty breathing, swelling of the face, tongue and throat. If any of these symptoms occur, STOP taking DOXAZOSIN and seek medical attention immediately. The following events have been reported in patients with high blood pressure being treated with doxazosin, but these may be due to the underlying disease rather than the medicine: chest pain, angina, a feeling of increased, decreased or irregular heart beat, palpitations, heart attack or stroke. Contact your doctor immediately if any of these occur. low white blood cells (which may result in increasing frequency of infection, sore throat, mouth ulcer, high temperature or stomach upset); low blood platelets [which may result in bruising or bleeding easily, nose bleeds (epistaxis)].

If any of these occur contact your doctor.

Other side effects

generally feeling unwell, weakness, tirednesssleepiness, swelling of feet or lower legs (oedema), weight gain

headache , dizziness or faintness, especially on getting up from a sitting or lying position, tremor, tingling or altered sensitivity of the hands and feet vertigo, ringing in the ears (tinnitus) digestive system complaints, including stomach/abdominal pains, constipation, diarrhoea, feeling/being sick, heartburn and wind, dry mouth nasal stuffiness, runny nose and/or sneezing (rhinitis), wheeze, cough painful persistent erection of the penis, erection difficulties (when a man cannot get, or keep a hard, erect penis suitable for sexual activity), discomfort or enlargement of the breasts in men (gynaecomastia), cloudy urine following sexual climax, little or no semen ejaculated at sexual climax painful joints, painful muscles, muscle cramps, muscle weakness, back pain or general pain low blood pressure, hot flushes agitation, anxiety, depression or nervousness, sleeplessness hair loss loss of appetite liver enzyme increases, jaundice (yellowing of the skin or whites of the eyes), hepatitis or bile disorder blurred vision urinary incontinence, urinary disorder or blood in urine

If any of the side - effects become serious, or you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Storing Doxazosin

There are no special precautions for storage. Keep out of the reach and sight of children.

Check the expiry date on the label. Do not use the tablets if the expiry date has passed.

Further Information What DOXAZOSIN contains

The active substance is: doxazosin. Each tablet contains 1mg, 2mg, or 4mg of doxazosin (as mesilate).

The other ingredients are: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) and colloidal anhydrous silica.

What DOXAZOSIN looks like and contents of the pack

DOXAZOSIN comes in three different strengths:

Doxazosin 1 mg tablet is a round white to off-white tablet scored on one side.

Doxazosin 2 mg tablet is a white to off-white capsule shaped tablet scored on one side.

Doxazosin 4 mg tablet is a white to off-white capsule shaped tablet, scored on both sides, with embossement "D4" on one side.

Doxazosin 1 mg, 2 mg and 4 mg tablets are available in calendar packs of 28 tablets in foil blister strips.

The manufacturer / holder of the marketing authorization is: Dexcel-Pharma Ltd. 1 Cottesbrooke Park Heartlands Business Park Daventry Northamptonshire NN11 8YL England

This leaflet was last approved in October 2009.

1217420114-E


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Soltamox


Generic Name: tamoxifen (ta MOX i fen)
Brand Names: Soltamox

What is Soltamox (tamoxifen)?

Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Tamoxifen is used to treat some types of breast cancer in men and women. Tamoxifen is also used to lower a woman's chance of developing breast cancer if she has a high risk (such as a family history of breast cancer).

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

What is the most important information I should know about Soltamox (tamoxifen)? Do not use tamoxifen if you are pregnant. It could harm the unborn baby. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 2 months after your treatment ends. You should not use tamoxifen if you are allergic to it, or if you have a history of blood clots in your veins or your lungs, or if you are also taking a blood thinner such as warfarin (Coumadin).

Before using tamoxifen, tell your doctor if you have liver disease, high triglycerides (a type of fat in the blood), a history of cataract, or a history of stroke or blood clot. Also tell your doctor if you if you are receiving chemotherapy or radiation treatment.

If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication.

To make sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self exams on a regular basis. Your liver function may also need to be tested. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking Soltamox (tamoxifen)? You should not use tamoxifen if you are allergic to it, or if you have:

a history of blood clots in your veins or your lungs; or

if you are also taking a blood thinner such as warfarin (Coumadin).

To make sure you can safely take tamoxifen, tell your doctor if you have any of these other conditions:

liver disease;

high cholesterol or triglycerides (a type of fat in the blood);

a history of stroke or blood clot;

a history of cataract; or

if you are receiving chemotherapy or radiation.

Taking tamoxifen may increase your risk of uterine cancer, stroke, or a blood clot in the lung, which can be fatal. Talk with your doctor about your specific risks in taking this medication. FDA pregnancy category D. Do not use tamoxifen if you are pregnant. It could harm the unborn baby. Use a barrier form of birth control (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 2 months after your treatment ends.

Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether tamoxifen passes into breast milk or if it could harm a nursing baby. However, this medication may slow breast milk production. You should not breast-feed while taking tamoxifen. How should I take Soltamox (tamoxifen)?

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 medication with a full glass (8 ounces) of water.

Tamoxifen can be taken with or without food.

If you are taking tamoxifen to reduce your risk of breast cancer, you may need to take your first dose while you are having a menstrual period. You may also need to have a pregnancy test before you start taking tamoxifen, to make sure you are not pregnant. Follow your doctor's instructions.

Use tamoxifen regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep using this medication for up to 5 years.

To make sure this medication is not causing harmful effects, your doctor may want you to have mammograms and to perform routine breast self exams on a regular basis. Your liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture, heat, or cold. Do not freeze. 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. What should I avoid while taking Soltamox (tamoxifen)?

Avoid eating soy or soy products without first asking your doctor.

Soltamox (tamoxifen) 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 tamoxifen and call your doctor at once if you have a serious side effect such as:

sudden numbness or weakness, especially on one side of the body;

sudden severe headache, confusion, problems with vision, speech, or balance;

chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;

pain, swelling, warmth, or redness in one or both legs;

nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;

unusual vaginal bleeding or discharge;

irregular menstrual periods;

pain or pressure in your pelvic area;

blurred vision, eye pain, or seeing halos around lights;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

fever, chills, body aches, flu symptoms;

new breast lump; or

upper stomach pain, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

hot flashes;

bone pain, joint pain, or tumor pain;

swelling in your hands or feet;

vaginal itching or dryness;

decreased sex drive, impotence, or difficulty having an orgasm;

headache, dizziness, depression; or

thinning hair.

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 Soltamox (tamoxifen)?

Many drugs can interact with tamoxifen. Below is just partial list. Tell your doctor if you are using any of these medications:

bromocriptine (Parlodel);

cimetidine (Tagamet);

clozapine (Clozaril, FazaClo);

cyclophosphamide (Cytoxan, Neosar);

isoniazid (for treating tuberculosis);

letrozole (Femara);

methimazole (Tapazole);

nicardipine (Cardene);

pioglitazone (Actos);

rifampin (Rifadin, Rifater, Rifamate, Rimactane);

ropinirole (Requip);

ticlopidine (Ticlid);

tranylcypromine (Parnate);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

an antibiotic such as terbinafine (Lamisil);

an antidepressant such as bupropion (Wellbutrin, Zyban), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), imipramine (Tofranil), paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and other drugs may interact with tamoxifen. 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 Soltamox resources Soltamox Side Effects (in more detail) Soltamox Use in Pregnancy & Breastfeeding Soltamox Drug Interactions Soltamox Support Group 0 Reviews for Soltamox - Add your own review/rating Soltamox Advanced Consumer (Micromedex) - Includes Dosage Information Soltamox Solution MedFacts Consumer Leaflet (Wolters Kluwer) Soltamox Prescribing Information (FDA) Tamoxifen Prescribing Information (FDA) Nolvadex Monograph (AHFS DI) Nolvadex MedFacts Consumer Leaflet (Wolters Kluwer) Nolvadex Prescribing Information (FDA) Compare Soltamox with other medications Breast Cancer Breast Cancer, Adjuvant Breast Cancer, Male Breast Cancer, Metastatic Breast Cancer, Palliative McCune-Albright Syndrome Precocious Puberty Where can I get more information? Your pharmacist can provide more information about tamoxifen.

See also: Soltamox side effects (in more detail)


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tamsulosin


Generic Name: tamsulosin (tam soo LOE sin)
Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

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

What is the most important information I should know about tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. What should I discuss with my healthcare provider before taking tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children. How should I take tamsulosin?

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.

Your doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

See also: Tamsulosin dosage (in more detail)

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.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower 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 extreme dizziness or fainting.

What should I avoid while taking tamsulosin? Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin. Tamsulosin 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 tamsulosin and call your doctor at once if you have any of these serious side effects:

feeling like you might pass out;

chest pain;

fever, chills, body aches, or flu symptoms; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

weakness, drowsiness;

headache;

nausea, diarrhea;

back pain;

blurred vision;

dental problems;

sleep problems (insomnia);

abnormal ejaculation, decreased sex drive; or

runny nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

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

cimetidine (Tagamet);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

methimazole (Tapazole);

pioglitazone (Actos);

ropinirole (Requip);

ticlopidine (Ticlid);

warfarin (Coumadin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with tamsulosin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you. More tamsulosin resources Tamsulosin Side Effects (in more detail)Tamsulosin DosageTamsulosin Use in Pregnancy & BreastfeedingDrug ImagesTamsulosin Drug InteractionsTamsulosin Support Group65 Reviews for Tamsulosin - Add your own review/rating tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer) Tamsulosin Prescribing Information (FDA) Flomax Prescribing Information (FDA) Flomax Monograph (AHFS DI) Flomax Consumer Overview Compare tamsulosin with other medications Benign Prostatic HyperplasiaOveractive BladderUrinary Tract Stones Where can I get more information? Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)


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