Palladone capsules 8mg
 

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Anesthetic Adjunct Medications


Definition of Anesthetic Adjunct: Anesthetic adjuncts are used to augment specific components of anesthesia, permitting lower doses of general anesthetics with fewer side effects.

Drugs associated with Anesthetic Adjunct

The following drugs and medications are in some way related to, or used in the treatment of Anesthetic Adjunct. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Brevital-Sodium Dilaudid-Hp Palladone-Extended-Release-Capsules Pentothal Stadol-Solution Sublimaze
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Palladone SR capsules


1. Name Of The Medicinal Product

PALLADONE®SR capsules 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

2. Qualitative And Quantitative Composition

The capsules contain Hydromorphone Hydrochloride USP 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

For excipients, see 6.1.

3. Pharmaceutical Form

Prolonged release capsule.

Hard gelatin capsule containing spherical prolonged release pellets.

PALLADONE SR capsules 2 mg are yellow/white capsules marked HCR 2.

PALLADONE SR capsules 4 mg are pale blue/clear capsules marked HCR 4.

PALLADONE SR capsules 8 mg are pink/clear capsules marked HCR 8.

PALLADONE SR capsules 16 mg are brown/clear capsules marked HCR 16.

PALLADONE SR capsules 24 mg are dark blue/clear capsules marked HCR 24.

4. Clinical Particulars 4.1 Therapeutic Indications

For the relief of severe pain in cancer.

4.2 Posology And Method Of Administration

Route of administration

The capsules can be swallowed whole or opened and their contents sprinkled on to cold soft food.

Dosage and administration

Adults and children over 12 years

PALLADONE SR capsules should be used at 12-hourly intervals. The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. 4 mg of hydromorphone has an efficacy approximately equivalent to 30 mg of morphine sulphate given orally. A patient presenting with severe pain should normally be started on a dosage of 4 mg PALLADONE SR capsules 12-hourly. Increasing severity of pain will require increased dosage of hydromorphone to achieve the desired relief.

Elderly and patients with renal impairment

The elderly and patients with renal impairment should be dose titrated with PALLADONE SR capsules in order to achieve adequate analgesia. It should be noted, however, that these patients may require a lower dosage to achieve adequate analgesia.

Patients with hepatic impairment

Contra-indicated.

Children under 12 years

Not recommended.

4.3 Contraindications

Hydromorphone is contra-indicated in patients with known hypersensitivity to hydromorphone or other ingredients in the formulation.

It is also contra-indicated in respiratory depression with hypoxia or elevated carbon dioxide levels in the blood, pregnancy, coma, acute abdomen, hepatic impairment, paralytic ileus, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use. Use of PALLADONE SR capsules should be avoided in patients with raised intracranial pressure or head injury, and also in patients with convulsive disorders or acute alcoholism.

Pre-operative administration of PALLADONE SR capsules is not recommended and is not an approved indication.

4.4 Special Warnings And Precautions For Use

The major risk of opioid excess is respiratory depression. As with all narcotics, a reduction in dosage may be advised in the elderly or infirm patients with severely impaired pulmonary function, toxic pyschosis, delirium tremens, pancreatitis, hypothyroidism, hypotension with hypovolaemia, chronic obstructive airways disease, renal or adrenocortical insufficiency, prostatic hypertrophy, shock or reduced respiratory reserve. PALLADONE SR capsules are not recommended in the first 24 hours post-operatively. After this time they should be used with caution, particularly following abdominal surgery.

PALLADONE SR capsules should not be used where there is the possibility of paralytic ileus occurring. Should paralytic ileus be suspected or occur during use, PALLADONE SR capsules should be discontinued.

Patients about to undergo cordotomy or other pain relieving surgical procedures should not receive PALLADONE SR capsules for 24 hours prior to surgery. If further treatment with PALLADONE SR capsules is indicated, then the dosage should be adjusted to the new post-operative requirement.

The patient may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control. The patient may develop physical dependence; an abstinence syndrome may be seen following abrupt cessation.

When a patient no longer requires therapy with hydromorphone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Hydromorphone has a morphine-like abuse profile and may be sought and abused by people with latent or manifest addiction disorders. Hydromorphone should be used with particular care in patients with a history of alcohol and drug abuse.

The prolonged release capsules may be opened and their contents sprinkled on to soft cold food. However the capsule contents should not be chewed or crushed. The administration of chewed or crushed hydromorphone pellets may lead to a rapid release and absorption of a potentially fatal dose of hydromorphone (see section 4.9).

Concomitant use of alcohol and Palladone SR capsules may increase the undesirable effects of Palladone SR capsules; concomitant use should be avoided.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Centrally acting drugs such as major and minor tranquillisers, anaesthetics, barbiturates, antiemetics, antidepressants, neuroleptics, hypnotics, other opioids, monoamine oxidase inhibitors (see section 4.3) and sedatives may interact with hydromorphone, and potentiate the effects of either drug, e.g. sedation, respiratory depression, etc.

Alcohol may enhance the pharmacodynamic effects of Palladone SR capsules; concomitant use should be avoided.

4.6 Pregnancy And Lactation

PALLADONE SR capsules are not recommended in pregnancy or in the breast-feeding mother as there are insufficient animal or human data to justify such use.

4.7 Effects On Ability To Drive And Use Machines

Hydromorphone may cause drowsiness and patients should not drive or operate machinery if affected.

4.8 Undesirable Effects

Hydromorphone may cause constipation, nausea and vomiting. Constipation may be treated with appropriate laxatives. When nausea and vomiting are troublesome, PALLADONE SR capsules can be readily combined with anti-emetics

Common (incidence of

 

Common

Uncommon

Cardiac and vascular disorders

Hypotension

 

Eye disorders

 

Blurred vision

Miosis

Gastrointestinal and hepatobiliary disorders

Constipation

Dry mouth

Nausea

Vomiting

Biliary colic

Paralytic ileus

General disorders

Asthenic conditions

Drug withdrawal syndrome

Drug tolerance

Peripheral oedema

Immune system disorders

 

Hypersensitivity reactions (including oropharyngeal swelling)

Nervous system disorders

Dizziness

Somnolence

Convulsions

Dyskinesia

Headache

Sedation

Tremor

In particular in high doses hyperalgesia that will not respond to a further dose of hydromorphone (possibly dose reduction or change in opioid required).

Psychiatric disorders

Confusion

Drug addiction

Agitation

Dysphoria

Euphoria

Hallucination

Renal and urinary disorders

Urinary retention

 

Respiratory, thoracic and mediastinal disorders

 

Respiratory depression

Skin and subcutaneous tissue disorders

Pruritus

Rash

Sweating

Urticaria

4.9 Overdose

Signs of hydromorphone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, bradycardia and death may occur in more severe cases. Rhabdomylosis progressing to renal failure has been reported in opioid overdosage.

Treatment of overdosage:

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01mg/kg body weight for children), if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response. If repeated doses are required then an infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state.

Intramuscular naloxone is an alternative in the event IV access is not possible. As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on hydromorphone. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

Other supportive measures as indicated by the patient's progress and clinical condition should be considered.

Additional/other considerations:

Consider activated charcoal (50 g for adults, 1g/kg for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations; however there is no evidence to support this.

PALLADONE SR capsules will continue to release and add to the hydromorphone load for up to 12 hours after administration and management of hydromorphone overdosage should be monitored accordingly. Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural opium alkaloid

ATC code: NO2A A03

Like morphine, hydromorphone is an agonist of mu receptors. The pharmacological actions of hydromorphone and morphine do not differ significantly. The oral analgesic potency ratio of hydromorphone to morphine is approximately 5-10:1. Hydromorphone and related opioids produce their major effects on the central nervous system and bowel. The effects are diverse and include analgesia, drowsiness, changes in mood, respiratory depression, decreased gastrointestinal motility, nausea, vomiting and alteration of the endocrine and autonomic nervous system.

5.2 Pharmacokinetic Properties

Hydromorphone is absorbed from the gastrointestinal tract and undergoes pre-systemic elimination resulting in an oral bioavailability of about 50%. It is metabolised and excreted in the urine mainly as conjugated hydromorphone and with smaller amounts of unchanged hydromorphone, dihydroisomorphine and dihydromorphine. PALLADONE SR capsules have been formulated to produce therapeutic plasma levels following 12-hourly dosing.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Microcrystalline cellulose

Hypromellose

Ethylcellulose (N10)

Colloidal anhydrous silica

Dibutyl sebacate

Capsule shells

Gelatin

Sodium dodecylsulphate

Titanium dioxide (E171)

Black Printing ink

Shellac

Propylene glycol

Iron oxide (E172)

The following colours are included in the capsule shells:

2 mg Quinoline yellow (E104);

4 mg Erythrosine (E127), indigo carmine (E132);

8 mg Erythrosine (E127);

16 mg Iron oxide (E172);

24 mg Indigo carmine (E132).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Eighteen months.

6.4 Special Precautions For Storage

Do not store above 25oC. Store in the original package.

6.5 Nature And Contents Of Container

PVdC/PVC blister packs with aluminium backing foil containing 56 capsules.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

8. Marketing Authorisation Number(S)

PL 16950/0051-0055

9. Date Of First Authorisation/Renewal Of The Authorisation

12 February 1997 / 17 January 2006

10. Date Of Revision Of The Text

May 2011


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Group IV antiarrhythmics


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.

See also

Medical conditions associated with group IV antiarrhythmics:

Angina Angina Pectoris Prophylaxis Arrhythmia Atrial Fibrillation Atrial Flutter Bipolar Disorder Cluster Headaches Heart Failure High Blood Pressure Idiopathic Hypertrophic Subaortic Stenosis Migraine Prevention Nocturnal Leg Cramps Raynaud's Syndrome Supraventricular Tachycardia Drug List: Diltia-Xt-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Sr Cartia-Xt-24-Hour-Sustained-Release-Beads-Capsules Calan-Sr-Controlled-Release-Tablets Cardizem Isoptin-Sr-Controlled-Release-Tablets Tiazac Verelan-Pm-Sustained-Release-Capsules-Controlled-Onset Diltiazem-Hydrochloride-Cd Calan Cardizem-La-24-Hour-Extended-Release-Beads-Tablets Isoptin Cardizem-Cd-24-Hour-Sustained-Release-Beads-Capsules Verelan-Sustained-Release-Pellet-Filled-Capsules Taztia-Xt-24-Hour-Extended-Release-Beads-Capsules Covera-Hs-Sustained-Release-Tablets-Controlled-Onset Dilacor-Xr-24-Hour-Sustained-Release-Capsules Dilt-Xr-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Xr Diltiazem-Hydrochloride-Xt Diltzac Matzim-La
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Atrial Fibrillation Medications


Definition of Atrial Fibrillation:

A condition where there is disorganised electrical conduction in the atria, resulting in ineffective pumping of blood into the ventricle.

Acronym: AF

Drugs associated with Atrial Fibrillation

The following drugs and medications are in some way related to, or used in the treatment of Atrial Fibrillation. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Atrial FibrillationPrevention of Thromboembolism in Atrial Fibrillation (24 drugs) Learn more about Atrial Fibrillation

Medical Encyclopedia:

Atrial fibrillation/flutter

Harvard Health Guide:

Symptoms and treatment for Atrial Fibrillation
Drug List:/tags/betapace-af/
/tags/cardizem/
/tags/cardizem-la-24-hour-extended-release-beads-tablets/
/tags/catapres/
/tags/coreg-cr-extended-release-capsules/
/tags/digitek/
/tags/dilt-xr-24-hour-sustained-release-capsules/
/tags/diltiazem-hydrochloride-cd/
/tags/diltiazem-hydrochloride-xr/
/tags/diltzac/
/tags/lanoxin/
/tags/matzim-la/
/tags/multaq/
/tags/rythmol-sr-sustained-release-capsules/
/tags/tambocor/
/tags/toprol/

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Vulvodynia Medications


Definition of Vulvodynia: Vulvodynia is described as chronic vulvar discomfort with complaints of burning and superficial irritation.

Drugs associated with Vulvodynia

The following drugs and medications are in some way related to, or used in the treatment of Vulvodynia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Aventyl Carbatrol-Sustained-Release-Capsules Effexor-Xr-Extended-Release-Capsules Elavil Epitol Fanatrex Gabarone Lexapro Neurontin Norpramin Pamelor Prozac Prozac-Weekly-Delayed-Release-Capsules Rapiflux Tegretol Tegretol-Xr-Sustained-Release-Tablets Topamax Topamax-Sprinkle Topiragen Vanatrip
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Fibromyalgia Medications


Drugs associated with Fibromyalgia

The following drugs and medications are in some way related to, or used in the treatment of Fibromyalgia. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Fibromyalgia Epicondylitis, Tennis Elbow (17 drugs) Learn more about Fibromyalgia

Medical Encyclopedia:

Fibromyalgia

Harvard Health Guide:

Symptoms and treatment for Fibromyalgia

Drugs.com Health Center:

Fibromyalgia
Drug List: 5-Htp Amibid-La Amrix-Extended-Release-Capsules Comfort-Pac-With-Cyclobenzaprine Cymbalta Deltasone Desyrel Desyrel-Dividose Effexor Effexor-Xr-Extended-Release-Capsules Elavil Fanatrex Fexmid Flexeril Gabarone Ganidin-Nr Gg-200-Nr Guaifenesin-La Guaifenex-G Guaifenex-La Lexapro Lyrica Meticorten Mobic Mucinex Muco-Fen-1200 Neurontin Nuvigil Organidin-Nr-Immediate-Release-Capsules Pristiq Prozac Prozac-Weekly-Delayed-Release-Capsules Q-Bid-La Rapiflux Revia Savella Skelaxin Sterapred Sterapred-Ds Strattera Topamax Topamax-Sprinkle Topiragen Vanatrip Xyrem
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Calcium channel blocking 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.

Calcium channel blockers block voltage gated calcium channels and inhibits the influx of calcium ions into cardiac and smooth muscle cells. The decrease in intracellular calcium reduces the strength of heart muscle contraction, reduces conduction of impulses in the heart, and causes vasodilatation.

Decrease in intracellular calcium in the heart decreases cardiac contractility. Decreased calcium in the vascular smooth muscle reduces its contraction and therefore causes vasodilatation.

Decrease in cardiac contractility decreases cardiac output and vasodilatation decreases total peripheral resistance, both of which cause a drop in blood pressure.

Calcium channel blocking agents are used to treat hypertension.

See also

Medical conditions associated with calcium channel blocking agents:

Angina Angina Pectoris Prophylaxis Arrhythmia Atrial Fibrillation Atrial Flutter Bipolar Disorder Cluster Headaches Coronary Artery Disease Heart Failure High Blood Pressure Hypertensive Emergency Hypertrophic Cardiomyopathy Idiopathic Hypertrophic Subaortic Stenosis Ischemic Stroke Migraine Prevention Nocturnal Leg Cramps Premature Labor Raynaud's Syndrome Subarachnoid Hemorrhage Supraventricular Tachycardia Drug List: Afeditab-Cr Diltia-Xt-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Sr Nimotop Adalat Cartia-Xt-24-Hour-Sustained-Release-Beads-Capsules Calan-Sr-Controlled-Release-Tablets Cardizem Isoptin-Sr-Controlled-Release-Tablets Nifediac-Cc Tiazac Verelan-Pm-Sustained-Release-Capsules-Controlled-Onset Diltiazem-Hydrochloride-Cd Procardia Adalat-Cc-Sustained-Release-Tablets Calan Cardizem-La-24-Hour-Extended-Release-Beads-Tablets Procardia-Xl-Sustained-Release-Tablets Isoptin Nifedical-Xl Cardizem-Cd-24-Hour-Sustained-Release-Beads-Capsules Norvasc Plendil Dynacirc-Cr-Extended-Release-Tablets Verelan-Sustained-Release-Pellet-Filled-Capsules Taztia-Xt-24-Hour-Extended-Release-Beads-Capsules Cardene Cardene-Iv Cardene-Sr-Sustained-Release-Capsules Cleviprex Covera-Hs-Sustained-Release-Tablets-Controlled-Onset Dilacor-Xr-24-Hour-Sustained-Release-Capsules Dilt-Xr-24-Hour-Sustained-Release-Capsules Diltiazem-Hydrochloride-Xr Diltiazem-Hydrochloride-Xt Diltzac Dynacirc Matzim-La Sular-Extended-Release-Tablets Vascor
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Migraine Prevention (Migraine Prophylaxis) Medications



Hydrocephalus Medications


Definition of Hydrocephalus: Hydrocephalus is an accumulation of cerebrospinal fluid in the ventricles of the brain, leading to their enlargement and swelling.

Drugs associated with Hydrocephalus

The following drugs and medications are in some way related to, or used in the treatment of Hydrocephalus. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Hydrocephalus

Micromedex Care Notes:

Hydrocephalus Hydrocephalus In Children

Medical Encyclopedia:

Hydrocephalus

Harvard Health Guide:

Symptoms and treatment for Hydrocephalus
Drug List: Diamox Diamox-Sequels-Sustained-Release-Capsules
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Cevi-Bid Controlled-Release Capsules


Pronunciation: a-SKOR-bik AS-id
Generic Name: Ascorbic Acid
Brand Name: Examples include Cemill and Cevi-Bid
Cevi-Bid Controlled-Release Capsules are used for:

Treating and preventing low levels of vitamin C. It may also be used for other conditions as determined by your doctor.

Cevi-Bid Controlled-Release Capsules are a vitamin. It works by supplementing vitamin C, which is used in many functions in the body.

Do NOT use Cevi-Bid Controlled-Release Capsules if: you are allergic to any ingredient in Cevi-Bid Controlled-Release Capsules

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

Before using Cevi-Bid Controlled-Release Capsules:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have diabetes, glucose-6-phosphate dehydrogenase deficiency, a high iron level in the blood, anemia (eg, sickle cell, sideroblastic, thalassemia), or kidney stones

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

Anticoagulants (eg, warfarin) because side effects may be increased by Cevi-Bid Controlled-Release Capsules

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

How to use Cevi-Bid Controlled-Release Capsules:

Use Cevi-Bid Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cevi-Bid Controlled-Release Capsules may be taken with or without food. Swallow Cevi-Bid Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing. Take Cevi-Bid Controlled-Release Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Cevi-Bid Controlled-Release Capsules. If you miss a dose of Cevi-Bid Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cevi-Bid Controlled-Release Capsules.

Important safety information: Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Cevi-Bid Controlled-Release Capsules unless directed to by your doctor. Cevi-Bid Controlled-Release Capsules may cause incorrect results with some in-home cholesterol test kits. Check with your doctor or pharmacist if you are taking Cevi-Bid Controlled-Release Capsules and need to check your cholesterol at home. Diabetes patients - Cevi-Bid Controlled-Release Capsules may cause incorrect test results with some urine glucose tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet. Cevi-Bid Controlled-Release Capsules may cause incorrect test results with kits used to check for blood in the stool. Check with your doctor if you are taking Cevi-Bid Controlled-Release Capsules when using the test kit. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cevi-Bid Controlled-Release Capsules, discuss with your doctor the benefits and risks of using Cevi-Bid Controlled-Release Capsules during pregnancy. Cevi-Bid Controlled-Release Capsules are excreted in breast milk. If you are or will be breast-feeding while you are using Cevi-Bid Controlled-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Cevi-Bid Controlled-Release Capsules:

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

Diarrhea; 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); kidney stones (eg, abdominal pain/back pain, painful urination).

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: Cevi-Bid 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 gout.

Proper storage of Cevi-Bid Controlled-Release Capsules:

Store Cevi-Bid Controlled-Release Capsules 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 Cevi-Bid Controlled-Release Capsules out of the reach of children and away from pets.

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Cevi-Bid resources Cevi-Bid Side Effects (in more detail) Cevi-Bid Use in Pregnancy & Breastfeeding Cevi-Bid Drug Interactions Cevi-Bid Support Group 0 Reviews for Cevi-Bid - Add your own review/rating Compare Cevi-Bid with other medications Dietary Supplementation Scurvy Urinary Acidification
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Palladone


hydromorphone hydrochloride
Dosage Form: Extended-Release Capsules

FOR USE IN OPIOID-TOLERANT PATIENTS ONLY

WARNING:

Palladone™ (hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. PalladoneCapsules should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg of oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. PalladoneCapsules should be administered once every 24 hours.

Appropriate patients for treatment with Palladone Capsules include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations.

Palladone Capsules are contraindicated for use on an as needed basis (i.e., prn).

PalladoneCapsules are NOT intended to be used as the first opioid product prescribed for a patient, or in patients who require opioid analgesia for a short period of time.

PalladoneCapsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to FATAL RESPIRATORY DEPRESSION. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

PalladoneCapsules contain the potent Schedule II opioid agonist, hydromorphone. Schedule II opioid agonists (which include hydromorphone, fentanyl, methadone, morphine, oxycodone, and oxymorphone), have the highest risk of fatal overdoses due to respiratory depression, as well as the highest potential for abuse. Palladone can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Palladone in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Palladone capsules are to be swallowed whole and are not to be broken, chewed, opened, dissolved or crushed. Consuming alcohol while taking Palladonecapsules or taking broken, chewed, dissolved, or crushed Palladonecapsules or its contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone. Overestimating the Palladone dose when converting the patient from another opioid medication can result in fatal overdose with the first dose. With the long half-life of Palladone (18 hours), patients who receive the wrong dose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

Palladone Description

Palladone™ (hydromorphone hydrochloride extended-release) Capsules are an opioid analgesic supplied in 12 mg, 16 mg, 24 mg, and 32 mg capsule strengths for oral administration. The pellet formulation is the same for all capsule strengths. The strength designation of each capsule indicates the amount of hydromorphone hydrochloride salt. The structural formula, molecular description, and molecular weight are shown below:

Hydromorphone, a fine, white (or nearly white), crystalline powder, is a semi-synthetic congener of morphine. The inactive ingredients in the pellets are ammonio methacrylate copolymer type B, ethylcellulose, and stearyl alcohol. The inactive ingredients in the capsules and the inks used to imprint them are FD&C blue #2 (24 mg strength capsule only), gelatin, red iron oxide (12 mg and 16 mg strength capsules only), synthetic black iron oxide, and titanium dioxide.

PalladoneCapsules are based on a controlled-release melt extrusion technology in which pellets containing hydromorphone HCl and co-melted excipients release the active ingredient significantly more slowly and for a longer period than an immediate-release product. PalladoneCapsules are designed to provide controlled delivery of hydromorphone over 24 hours. The 12 mg, 16 mg, 24 mg, and 32 mg capsules are filled with identical pellets using different fill weights to achieve different strengths.

PalladoneCapsules are for use in opioid-tolerant patients only. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

Palladone - Clinical Pharmacology

Hydromorphone is a pure opioid agonist whose principal therapeutic action is analgesia. Other members of the class known as opioid agonists include substances such as morphine, oxycodone, fentanyl, codeine, and hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, cough suppression, and analgesia. Like all pure opioid agonist analgesics, with increasing doses there is increasing analgesia, unlike with mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the analgesic effect with increasing doses. With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

Central Nervous System

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.

Hydromorphone produces respiratory depression by direct action of brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem to increases in carbon dioxide and to electrical stimulation.

Hydromorphone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.

Hydromorphone causes miosis even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in the setting of Palladone™ Capsule overdose (see OVERDOSAGE).

Gastrointestinal System

Hydromorphone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and in the duodenum. Digestion of food is delayed in the small intestine and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid induced-effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of the sphincter of Oddi, and transient elevations in serum amylase.

Cardiovascular System

Hydromorphone may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Endocrine System

Opioid agonists have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol, and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon in humans and other species, rats and dogs. Thyroid stimulating hormone (TSH) has been shown to be both inhibited and stimulated by opioids.

PHARMACOKINETICS Absorption

Administration of a single Palladone™ Capsule dose is characterized by biphasic absorption, a relatively rapid rise to an initial peak concentration, followed by a second broader peak with therapeutic plasma concentrations maintained over the 24-hour dosing interval. The absolute bioavailability of hydromorphone from PalladoneCapsules has not been determined. Under conditions of multiple dosing, the bioavailability of a once-daily dose of PalladoneCapsules is equivalent to the same total daily dose of immediate-release hydromorphone given in divided doses every 6 hours. Hydromorphone absorption from Palladone Capsules is pH independent but can be significantly increased in the presence of alcohol (see PHARMACOKINETICS: Drug Interactions). Dose proportionality has been established in terms of Cmax and AUC for the 12 mg and 24 mg dosage strengths. Dosage form proportionality on a dose-adjusted basis has been demonstrated for three 12 mg capsules to one 32 mg capsule.

In a study comparing 12 mg PalladoneCapsules dosed every 24 hours to 3 mg of immediate-release hydromorphone dosed every 6 hours in healthy human subjects, the two treatments were found to be equivalent in terms of extent of absorption (AUC) (see Figure 1). The extended-release characteristics of PalladoneCapsules resulted in lower steady-state peak levels (Cmax), higher trough levels (Cmin), and an approximately twofold to threefold reduction in the fluctuation seen with the immediate-release hydromorphone tablets.

Steady-state plasma concentrations with PalladoneCapsules were achieved within 2 to 3 days after initiation of dosing. This is consistent with the mean apparent terminal elimination half-life for Palladone™ of approximately 18.6 hours. This supports the ability to titrate every 2 to 3 days, as necessary. Hydromorphone did not accumulate significantly after multiple dosing with once-daily administration.

Food had no significant effect on the peak (Cmax), AUC or the elimination of hydromorphone from PalladoneCapsules (See Figure 2.).

Distribution

Following intravenous admininstration of hydromorphone, the reported volume of distribution is 295 L (4 L/kg). Hydromorphone is approximately 20% bound to human plasma proteins.


Metabolism

Hydromorphone is metabolized by direct conjugation, or by 6-keto reduction followed by conjugation. Following absorption, hydromorphone is metabolized to the major metabolites hydromorphone-3-glucuronide, hydromorphone-3-glucoside and dihydroisomorphine-6-glucuronide. Also observed were the less prevalent metabolites, dihydroisomorphine-6-glucoside, dihydromorphine and dihydroisomorphine.

Hydromorphone metabolites have been found in plasma, urine and in human hepatocyte test systems. However, it is not known whether hydromorphone is metabolized by the cytochrome P450 enzyme system. Hydromorphone is a poor inhibitor of human recombinant CYP isoforms including CYP1A2, 2A6, 2C8, 2D6, and 3A4 with an IC50 > 50 µM. Therefore, hydromorphone is not expected to inhibit the metabolism of other drugs metabolized by these CYP isoforms.

Elimination

Full mass balance and recovery studies have not been reported for extended-release hydromorphone products. However, hydromorphone and its metabolites have been recovered in urine following the use of immediate-release hydromorphone. Following intravenous administration of hydromorphone, terminal half-life is approximately 3 hours and clearance is 1.66 L/hr. The apparent terminal half-life with controlled release hydromorphone is about 18.6 hours.


Drug Interactions

Concomitant administration of H2 receptor blockers (cimetidine, famotidine, ranitidine) or proton pump inhibitors (omeprazole, lansoprazole) showed no significant effect on Palladone™ steady-state pharmacokinetics.

Patients taking Palladone with other opioid analgesics, general anesthetics, phenothiazines, tricyclic antidepressants or other CNS depressants may experience additional CNS depression and therefore, dose adjustments should be considered. Consuming alcohol while taking Palladone Capsules can cause significant increases in peak hydromorphone concentrations.

SPECIAL POPULATIONS Pediatric

The safety and effectiveness of PalladoneCapsules have not been established in patients below the age of 18.

Geriatric

Age-related increases in exposure in clinical studies were observed between geriatric and younger adult subjects. Greater sensitivity of some older individuals cannot be excluded. Dosages should be adjusted according to the clinical situation.

Gender

Pharmacokinetics of hydromorphone from PalladoneCapsules are comparable in men and women.

Renal Impairment

In patients with mild to moderate renal impairment, based on calculated creatinine clearance, the concentrations of hydromorphone in plasma were slightly higher than in subjects with normal renal function.

Hepatic Impairment

PalladoneCapsules were not studied in patients with severe hepatic insufficiency and are not recommended for use in such patients. Care in initial dose selection and careful observation are recommended in patients with evidence of lesser degrees of hepatic impairment.


Race

The pharmacokinetics of hydromorphone in African Americans and Caucasians in the clinical population were comparable.


Clinical Trials

The efficacy of PalladoneCapsules was established in a double-blind, randomized, parallel group, multicenter, placebo-controlled, four-week trial of patients with pain that was present for at least one month. The majority of these patients experienced moderate to severe pain due to musculoskeletal disorders while maintained on one or more opioid analgesics, often in addition to non-opioid analgesics. Two hundred twenty-one patients with chronic moderate to severe pain were randomized to receive once daily 12 mg PalladoneCapsules or placebo after they had demonstrated that they needed approximately 12 mg of immediate-release hydromorphone (in addition to non-opioid medication) around-the-clock to improve their pain control. Patients randomized to PalladoneCapsules maintained adequate analgesia for a significantly longer period of time (P<0.0001) than patients randomized to placebo.

Indications and Usage for Palladone

PalladoneCapsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time generally weeks to months or longer. PalladoneCapsules should only be used in patients who are already receiving opioid therapy, have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Appropriate patients for treatment with Palladone include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control, and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations.

PalladoneCapsules are NOT intended to be used:

as the first opioid product prescribed for a patient. in patients who require opioid analgesia for a short period of time. on an as needed basis (i.e., prn).

An evaluation of the appropriateness and adequacy of immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.

Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Contraindications

PalladoneCapsules are contraindicated:

for use on an as needed basis (i.e. prn). in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipment. in patients who have acute or severe bronchial asthma. in patients who have or are suspected of having paralytic ileus. in patients with known hypersensitivity to any of its components or the active ingredient, hydromorphone. Warnings

Palladone Capsules are to be swallowed WHOLE and are not to be broken, chewed, OPENED, DISSOLVED OR CRUSHED. Consuming alcohol while taking Palladone Capsules or taking broken, chewed, dissolved, or crushed PalladoneCapsules or capsule contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone.

PalladoneCapsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

Misuse, Abuse and Diversion of Opioids

Hydromorphone is an opioid agonist of the morphine type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Like other opioid agonists, legal or illicit, hydromorphone can be abused. This should be considered when prescribing or dispensing PalladoneCapsules in situations where the healthcare professional is concerned about an increased risk of misuse, abuse, or diversion (see WARNINGS: Drug Abuse and Addiction).

Breaking, crushing, chewing, or dissolving the contents of a Palladone™ Capsule or consuming alcohol while taking Palladone Capsules can result in the uncontrolled delivery of the opioid and poses a significant risk of overdose and death (see Boxed WARNING).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

Hydromorphone may be expected to have additive effects, when used in conjunction with alcohol, other opioids, or drugs, whether legal or illicit, which cause central nervous system depression. Additionally, consuming alcohol while taking Palladone Capsules can cause significant increases in peak hydromorphone concentrations.

Drug Abuse and Addiction

PalladoneCapsules contain an opioid agonist (i.e., hydromorphone), that is a Schedule II controlled substance with high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. Hydromorphone can be abused and is subject to criminal diversion. The high drug content in the extended-release formulation may add to the risk of adverse outcomes from abuse.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with, forging or counterfeiting prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since PalladoneCapsules may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

PalladoneCapsules are intended for oral use only. Consumption of alcohol while taking Palladone Capsules or the use of the broken, crushed, chewed, opened, or dissolved capsule contents poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse can reasonably be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. In addition, parenteral abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Respiratory Depression

Respiratory depression is the chief hazard of opioid agonists, including hydromorphone, the active ingredient in PalladoneCapsules. Respiratory depression is more likely to occur in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.

Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous.

Hydromorphone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of hydromorphone may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

Head Injury

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure. Hydromorphone produces effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Hypotensive Effect

PalladoneCapsules may cause severe hypotension. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume or who are concurrently taking drugs such as phenothiazines or other agents which compromise vasomotor tone. Hydromorphone may produce orthostatic hypotension in ambulatory patients. Hydromorphone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Precautions

PalladoneCapsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to fatal respiratory depression (see WARNINGS).

Patients should be instructed that the use of Palladone™ by anyone other than those to whom it is prescribed is unlawful and may have serious medical consequences, including death.

General

Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Use of PalladoneCapsules is associated with increased potential risks and should be used only with caution in the following conditions: alcoholism, alcohol abuse or alcohol intoxication; drug abuse; history of drug or alcohol abuse; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.

The administration of any opioid agonist, including hydromorphone, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Hydromorphone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Use in Pancreatic/Biliary Tract Disease

Hydromorphone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like hydromorphone may cause increases in the serum amylase concentration.

Tolerance

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical Dependence

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Information for Patients/Caregivers

The healthcare professional should explain the points listed below to caregivers and patients.

Patients should be instructed to read the Medication Guide each time Palladone is dispensed because new information may be available. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be aware that PalladoneCapsules contain hydromorphone, which is a strong pain medication similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. PalladoneCapsules are only to be swallowed whole. To prevent fatal overdose, the capsules and the pellets must not be broken, chewed, crushed, opened, or dissolved. Patients should be instructed not to consume alcohol while taking Palladone Capsules. Patients should talk to their doctor if pain persists or worsens while they are taking PalladoneCapsules. Patients who have bothersome side effects should also let their doctors know. The amount of medicine the patient takes may have to be changed. Patients should NEVER change the amount of PalladoneCapsules they take without speaking to their doctor first. PalladoneCapsules can affect a person’s ability to perform activities that require a high level of attention (such as driving or using heavy machinery). Patients taking PalladoneCapsules should be warned of these dangers and counseled accordingly. Patients should NOT combine PalladoneCapsules with alcohol or other pain medications, sleep aids, or tranquilizers except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death. Women who become pregnant, or who plan to become pregnant, should ask their doctor about the effects that PalladoneCapsules (or any medicine) may have on them and their unborn children. Patients should be advised that if they have been receiving treatment with PalladoneCapsules for more than a few weeks and the medicine is no longer needed, they should contact their doctor who will advise them on how to gradually decrease the medication. When PalladoneCapsules are no longer needed, the unused capsules should be flushed down the toilet. The active ingredient in PalladoneCapsules is hydromorphone, which is a drug that some people abuse. PalladoneCapsules should be taken only by the patient it was prescribed for, and it should be protected from theft or misuse in the work or home environment. Patients should be instructed to keep PalladoneCapsules in a secure place out of the reach of children. Children, especially small children, exposed to PalladoneCapsules are at high risk of FATAL RESPIRATORY DEPRESSION. Use in Drug and Alcohol Addiction

PalladoneCapsules are not approved for use in detoxification or maintenance treatment of opioid addiction. However, the history of an addictive disorder does not necessarily preclude the use of this medication for the treatment of chronic pain. These patients will require intensive monitoring for signs of misuse, abuse, or addiction.

DRUG INTERACTIONS
CNS Depressants

Hydromorphone should be dosed with caution in patients who are concurrently taking other central nervous system depressants that may cause respiratory depression, hypotension, profound sedation or potentially result in coma. Such agents include barbiturates, other sedatives or hypnotics, general anesthetics, other opioid analgesics, phenothiazines and other neuroleptics, centrally acting anti-emetics, benzodiazepines or other tranquilizers, and alcohol.

Muscle Relaxants

Hydromorphone may interact with skeletal muscle relaxants to enhance neuromuscular blocking action to increase respiratory depression.

Mixed Agonist-Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as hydromorphone. In this situation, significant doses of mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and/or may precipitate withdrawal symptoms in these patients.

Monoamine Oxidase Inhibitors (MAOIs)

No specific interaction between hydromorphone and monoamine oxidase inhibitors has been observed, but caution in the use of any opioid in patients taking this class of drugs is appropriate. MAOI therapy should be discontinued for at least two weeks prior to the initiation of therapy with PalladoneCapsules.

H2 Antagonists/Proton Pump Inhibitors

In the patients enrolled in the clinical trials, Palladone™ exposure and effects on pain were comparable when administered with or without various H2 antagonists/proton pump inhibitors.

Drug/Laboratory Test Interactions

There is no known interference of this drug with laboratory tests.

Food

The bioavailability of PalladoneCapsules is not significantly affected by food.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted in animals.

Hydromorphone was negative in the in vitro  bacterial reverse mutation assay and in the in vivo  mouse micronucleus assay. Hydromorphone was negative in the mouse lymphoma assay in the absence of metabolic activation, but was positive in the mouse lymphoma assay in the presence of metabolic activation. Morphinone, an impurity, tested as a besylate salt was negative in the in vitro  bacterial reverse mutation assay and negative in the in vivo  mouse micronucleus assay. Morphinone was positive in the Chinese Hamster Ovary Cell Chromosomal Aberration test in the absence and presence of metabolic activation.

Hydromorphone did not affect fertility in rats at oral doses up to 5 mg/kg which is equivalent to a 32 mg human daily oral dose on a body surface area basis.

Pregnancy Pregnancy Category C

Hydromorphone was not teratogenic in female rats given oral doses up to 10 mg/kg or female rabbits given oral doses up to 50 mg/kg during the major period of organ development. Estimated exposures in the female rat and rabbit were approximately 3-fold and 6-fold higher than a 32 mg human daily oral dose based on exposure (AUC0-24h). In a rat pre- and post-natal study, an increase in pup mortality and a decrease in pup body weight which was associated with maternal toxicity was observed at doses of 2 and 5 mg/kg/day. The maternal no effect level for hydromorphone was 0.5 mg/kg/day which is <1-fold lower than a 32 mg human daily oral dose on a body surface area basis. Hydromorphone had no effect on pup development or reproduction when given to female rats during the pre-natal and postnatal periods up to a dose of 5 mg/kg which is equivalent to a 32 mg human daily oral dose on a body surface area basis.

Hydromorphone administration to pregnant Syrian hamsters and CF-1 mice during major organ development revealed teratogenicity likely the result of maternal toxicity associated with sedation and hypoxia. In Syrian hamsters given single subcutaneous doses from 14 to 278 mg/kg during organogenesis (gestation days 8-10), doses ? 19 mg/kg hydromorphone produced skull malformations (exencephaly and cranioschisis). Continuous infusion of hydromorphone (5 mg/kg, s.c.) via implanted osmotic mini pumps during organogenesis (gestation days 7-10) produced soft tissue malformations (cryptorchidism, cleft palate, malformed ventricals and retina), and skeletal variations (supraoccipital, checkerboard and split sternebrae, delayed ossification of the paws and ectopic ossification sites). The malformations and variations observed in the hamsters and mice were at doses approximately 3-fold higher and <1-fold lower, respectively, than a 32 mg human daily oral dose on a body surface area basis.

There are no adequate and well-controlled studies in pregnant women. Hydromorphone crosses the placenta. PalladoneCapsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (see Labor and Delivery).

Labor and Delivery

PalladoneCapsules are not recommended to be initiated prior to or during labor or in the immediate post-partum period. Women who are taking opioids during pregnancy should not be withdrawn abruptly during labor and delivery, but maintained on their current dose of medication since abrupt withdrawal can precipitate delivery. Neonates whose mothers have been taking hydromorphone chronically may exhibit respiratory depression and/or withdrawal symptoms, at birth and/or in the post-delivery period.

Neonatal Withdrawal Syndrome

Chronic use of opioids during pregnancy can affect the fetus with subsequent withdrawal symptoms. Neonatal withdrawal syndrome presents as irritability, hyperactivity and loss of sleep pattern, abnormal crying, tremor, vomiting, diarrhea and subsequent weight loss or failure to gain weight and may result in death. The duration and severity of neonatal withdrawal syndrome varies based on the drug used, duration of use, the time and dose of last maternal use, and rate of elimination by the newborn. Use standard care as medically appropriate.

Nursing Mothers

Low concentrations of opioid analgesics have been detected in breast milk with the potential for withdrawal symptoms when administration of opioid analgesics to the mother is stopped. The distribution of hydromorphone has not been studied. It is prudent to assume that hydromorphone would also distribute into breast milk. Ordinarily, nursing should not be undertaken while a patient is receiving PalladoneCapsules because of the possibility of sedation and/or respiratory depression in the infant.

Pediatric Use

The safety and effectiveness of PalladoneCapsules have not been established in patients below the age of 18 years.

Geriatric Use

Of the total number of subjects in clinical studies of PalladoneCapsules, 22% were 65 and over, and 6% were 75 and over. Dosages should be adjusted according to the clinical situation. As with all opioids, the starting dose should be reduced to 1/3 to 1/2 of the usual dosage in debilitated patients. Respiratory depression is the chief hazard in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

Laboratory Monitoring

Due to the broad range of plasma concentrations that are associated with individual daily dose requirements to achieve adequate pain relief, the varying degrees of pain, and the development of tolerance seen in patient populations, plasma hydromorphone measurements are usually not helpful in clinical management.

Hepatic Impairment

PalladoneCapsules were not studied in patients with severe hepatic impairment and are not recommended for use in such patients. Care in initial dose selection and careful observation are recommended in patients with evidence of mild to moderate hepatic impairment.

Renal Impairment

In patients with mild to moderate renal impairment, based on calculated creatinine clearance, the concentrations of hydromorphone in plasma were slightly higher than in subjects with normal renal function. Dosages should always be adjusted according to the clinical situation.

Gender

There were no male/female differences detected for efficacy, pharmacokinetic metrics or adverse events in clinical trials.

Race

Analgesia and adverse events were similar in the various ethnic groups included in the clinical program.

Adverse Reactions

The safety of PalladoneCapsules was evaluated in double-blind clinical trials involving 612 patients with moderate to severe pain. An open-label extension study involving 143 patients with cancer pain was conducted to evaluate the safety of PalladoneCapsules when used for longer periods of time in higher doses than in the controlled trials. Patients were treated with doses averaging 40 to 50 mg of PalladoneCapsules per day (ranging between 12 and 500 mg/day) for several months (range 1 to ?52 weeks).

Serious adverse reactions which may be associated with PalladoneCapsules therapy in clinical use are similar to those of other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and to a lesser degree, circulatory depression, hypotension, shock or cardiac arrest (see OVERDOSAGE).

Adverse Events Reported in Controlled Trials

Table 3 lists treatment emergent signs and symptoms that were reported in at least 2% of patients in the placebo-controlled trials for which the rate of occurrence was greater for those treated with 12mg PalladoneCapsules than those treated with placebo.drug abuse and dependence (addiction)

TABLE 3. Adverse Events Reported in the Placebo-Controlled Clinical Trials With Incidence ? 2% in Patients Receiving PalladoneCapsules for Nonmalignant Pain Placebo*
(N = 191) Palladone™*
(N = 190) Body System/
COSTART Term Double-blind
% Double-blind
% * Average exposure was 21 days for Palladone? and 15 days for placebo. Total percentage of patients
with AEs 35.1% 49.5% Body as a Whole 15.7% 18.4%     Headache
    Asthenia
    Infection 2.1%
0.5%
5.8% 4.7%
3.2%
5.3%   Digestive 13.1% 27.9%     Constipation
    Nausea
    Vomiting 1.0%
6.3%
1.6% 15.8%
10.5%
3.2%   Nervous 13.1% 11.6%     Somnolence 1.6% 4.7%   Skin 5.2% 4.7%     Pruritus 1.0% 2.6% Adverse Events Observed in Clinical Trials

PalladoneCapsules have been administered to 785 individuals during completed clinical trials. The conditions and duration of exposure to Palladone™ varied greatly, and included open-label and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing.

These categories are used in the listing below. The frequencies represent the proportion of 785 patients from these trials who experienced that event while receiving PalladoneCapsules. All adverse events included in this tabulation occurred in at least one patient. Events are classified by body system and listed using the following definitions: frequent adverse events - those occurring in at least 1/100 patients; adverse events occurring with an incidence less than 1% are considered infrequent. These adverse events are not necessarily related to Palladone™ Capsule treatment and in most cases were observed at a similar frequency in placebo-treated patients in the controlled studies.

Frequent Adverse Events

Body as a Whole: headache, asthenia, pain, abdominal pain, fever, chest pain, infection, chills, malaise, neck pain, carcinoma, accidental injury

Cardiovascular: vasodilatation, tachycardia, migraine

Digestive: nausea, constipation, vomiting, diarrhea, dyspepsia, anorexia, dry mouth, nausea and vomiting, dysphagia, flatulence

Hematologic and Lymphatic: anemia, leukopenia

Metabolic and Nutritional: peripheral edema, dehydration, edema, generalized edema, hypokalemia, weight loss

Musculoskeletal: arthralgia, bone pain, leg cramps, myalgia

Nervous: somnolence, dizziness, nervousness, confusion, insomnia, anxiety, depression, hypertonia, hypesthesia, paresthesia, tremor, thinking abnormal, hallucinations, speech disorder, agitation, amnesia, tinnitus, abnormal gait

Respiratory: dyspnea, cough increased, rhinitis, pharyngitis, pneumonia, epistaxis, hiccup, hypoxia, pleural effusion

Skin and Appendages: pruritus, sweating, rash

Special Senses: amblyopia, taste perversion

Urogenital: dysuria, urinary incontinence Infrequent Adverse Events

Infrequent Adverse Events

Body as a Whole: face edema, ascites, allergic reaction, cellulitis, overdose, hypothermia, neoplasm, photosensitivity reaction, sepsis, flank pain

Cardiovascular: hypertension, hypotension, syncope, deep thrombophlebitis, arrhythmia, postural hypotension, atrial fibrillation, pallor, bradycardia, electrocardiogram abnormal, myocardial infarction, palpitation, angina pectoris, congestive heart failure, QT interval prolonged, supraventricular tachycardia, thrombosis, cardiomegaly, hemorrhage

Digestive: fecal impaction, intestinal obstruction, abnormal stools, fecal incontinence, hepatic failure, increased appetite, cholangitis, cholecystitis, coli


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Proton pump inhibitors


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.

Proton pump inhibitors act by irreversible inhibition of the H+/K+ ATPase, in the parietal cells of the stomach. It markedly inhibits gastric acid secretion and has a long duration of action. They are used for treatment of gastric and duodenal ulcers, gastroesophageal reflux disease and other excessive gastrointestinal acid secretory disorders.

See also

Medical conditions associated with proton pump inhibitors:

Aspiration PneumoniaBarrett's EsophagusDuodenal UlcerDuodenal Ulcer ProphylaxisErosive EsophagitisGastrointestinal HemorrhageGERDHelicobacter Pylori InfectionIndigestionMultiple Endocrine AdenomasNSAID-Induced Gastric UlcerNSAID-Induced Ulcer ProphylaxisPathological Hypersecretory ConditionsPeptic UlcerStomach UlcerStress Ulcer ProphylaxisSystemic MastocytosisZollinger-Ellison Syndrome Drug List:/tags/zegerid/
/tags/nexium_iv/
/tags/prevacid/
/tags/kapidex/
/tags/prilosec/
/tags/prevacid-solutab-orally-disintegrating-tablets/
/tags/prevacid-i-v/
Protonix-I-V
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Bartter Syndrome Medications


Definition of Bartter Syndrome: Bartter syndrome refers to a rare group of conditions that affect the kidneys. People with Bartter syndrome have a loss of potassium (hypokalemic alkalosis) and a rise in the hormone aldosterone.

Drugs associated with Bartter Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Bartter Syndrome. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Bartter Syndrome Gitelman Syndrome (3 drugs) Learn more about Bartter Syndrome

Medical Encyclopedia:

Bartter syndrome
Drug List: Indocin Indocin-Iv Indocin-Sr-Sustained-Release-Capsules
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Nabilone 1mg Capsules


Nabilone 1 mg Capsules

(nabilone)

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 any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effect and this becomes serious, tell your doctor or pharmacist. In this leaflet: 1. What Nabilone is and what it is used for 2. Before you take Nabilone Capsules 3. How to take Nabilone Capsules 4. Possible side effects 5. How to store Nabilone Capsules 6. Further information What Nabilone Is And What It Is Used For

Nabilone is a medicine that helps to reduce nausea and vomiting caused by many anticancer medicines.

Nabilone is often used when other medicines have not helped your nausea or vomiting.

Nabilone is a man-made chemical known as a cannabinoid. It is not made from the Cannabis plant but it is similar to some marijuana extracts and can cause similar effects.

Before You Take Nabilone Capsules Do not take Nabilone If you are allergic (hypersensitive) to any of the other ingredients of Nabilone Capsules (these are listed in section 6, "Further Information"). If your nausea / vomiting is not due to anticancer treatment. If you are under 18 years. Nabilone is not meant for children. Take special care with Nabilone

It is best if you take Nabilone Capsules in hospital, as you may experience side effects.

Tell your doctor before you start treatment if you have any of the following problems or if you develop any of these during treatment:

Any liver problems. High blood pressure or any other heart problem. Any mental illness, for example depression or schizophrenia. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor if you are taking any sleeping pills, pain killers or tranquillisers.

Taking Nabilone with alcohol

Do not drink alcohol while you are taking Nabilone.

Pregnancy and breast-feeding

Tell your doctor before you start treatment

If you are pregnant, if you think that you are pregnant, or if you intend to become pregnant. If you are breast-feeding or planning to breast-feed.

Your doctor will then decide if you can take this medicine.

Driving and using machines

Nabilone Capsules may cause side effects such as sleepiness, confusion, hallucinations, a feeling of dizziness or spinning, poor muscle co-ordination, problems with your sight and problems with concentration. These side effects may occur up to 3 days after taking Nabilone. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects.

How To Take Nabilone Capsules

Always take Nabilone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to take it. Your doctor will usually start you on the lowest possible dose.

It is best if you take Nabilone Capsules in hospital, especially the first time that you take Nabilone. This is because you may experience side effects.

The hospital doctor or nurse may give you your first dose the night before you start chemotherapy and the second dose one to three hours before it begins.

Swallow the capsules with water.

Dose The usual dose is 1 or 2 capsules twice a day. You should never take more than 2 capsules three times a day. You can take Nabilone while you are having chemotherapy treatment and for up to 2 days after your last dose of chemotherapy.

The dosing recommendations for elderly patients are the same as for other adults.

If you take more Nabilone than you should

If you ever take too many capsules, tell your doctor or get someone to take you to the nearest hospital casualty department immediately together with your medicine to show to the doctor.

If you forget to take Nabilone

If you miss a dose, wait until it is time for the next dose, and then continue as before.

Do not take a double dose to make up for a forgotten dose.

Possible Side Effects

Like all medicines, Nabilone can cause side effects, although not everybody gets them.

Side effects that you may experience are: Feeling sleepy, relaxed, or "high". A few patients have had hallucinations, felt confused, depressed, anxious or had other changes in their mood or mental state. A feeling of dizziness or spinning, especially when you stand up. Poor muscle co-ordination. Dry mouth, problems with your sight or concentration, difficulty sleeping, or headaches. Shaking, a faster heart beat than normal, low blood pressure, losing your appetite and stomach pains.

Any changes in your mood, such as feeling depressed, relaxed or "high", may last for 2 or 3 days after you stop taking Nabilone. You may find that you get used to these feelings.

If you have any of these side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Nabilone Capsules Keep Nabilone Capsules out of the reach and sight of children. Do not use Nabilone after the expiry date which is stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month. Keep the container tightly closed. Store your capsules at room temperature (15-25°C) in a dry place. If your doctor tells you to stop taking the capsules, please take them back to the pharmacist. Medicines should not be disposed of via wastewater or household waste. Only keep the capsules if your doctor tells you to. Further Information What Nabilone contains

Active substance: Nabilone. Each capsule contains 1 mg of nabilone.
Other ingredients: Povidone, starch, gelatin and the colourants E132, E172 and E171.

What Nabilone looks like and contents of the pack Nabilone capsules are blue and white and have CL 3101 printed on them. Each bottle or blister pack of Nabilone contains 20 capsules. Marketing Authorisation Holder Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Dales Pharmaceuticals Limited Snaygill Industrial Estate Keighley Road Skipton North Yorkshire BD23 2RW UK

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last approved in July 2009.

F687


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Methylxanthines


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.

Methylxanthines act as bronchodilators by relaxing bronchial smooth muscle and helps the constricted airways to dilate. The exact mechanism of action with regards to methylxanthine causing bronchodilatation is not well understood but it appears that methylxanthines inhibit the enzyme phosphodiesterase, which degrades cyclic AMP, so methylxanthines tend to increase the concentration of cyclic AMP.

Methylxanthines are bronchodilators used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

See also

Medical conditions associated with methylxanthines:

Apnea of Prematurity Asthma Asthma, acute Asthma, Maintenance Bronchitis COPD Drug List: Theo-24-Sustained-Release-Capsules Uniphyl-Sustained-Release-Tablets Theo-Dur Choledyl Choledyl-Sa Dilor Dilor-400 Dylix-Elixir Elixophyllin-Elixir Lufyllin Lufyllin-400 Neothylline Phyllocontin Quibron-T Quibron-T-Sr Theo-Time Theocap-Sustained-Release-Capsules Theochron-Sustained-Release-Tablets Theolair-Tablets Truphylline Truxophyllin
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Carbetapentane/Guaifenesin Sustained-Release Capsules


Pronunciation: car-bay-ta-PEN-tane/gwye-FEN-eh-sin
Generic Name: Carbetapentane/Guaifenesin
Brand Name: Dynex VR
Carbetapentane/Guaifenesin Sustained-Release Capsules are used for:

Relieving unproductive cough and reducing mucus in the chest due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Carbetapentane/Guaifenesin Sustained-Release Capsules are a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex. The expectorant works by thinning mucus (phlegm) in the lungs, making it less sticky and easier to cough up. This makes coughs more productive.

Do NOT use Carbetapentane/Guaifenesin Sustained-Release Capsules if: you are allergic to any ingredient in Carbetapentane/Guaifenesin Sustained-Release Capsules

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

Before using Carbetapentane/Guaifenesin Sustained-Release Capsules:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have chronic cough due to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces large amounts of mucus if you have a history of heart problems, high blood pressure, prostate problems, an overactive thyroid, diabetes, or glaucoma

Some MEDICINES MAY INTERACT with Carbetapentane/Guaifenesin Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Carbetapentane/Guaifenesin Sustained-Release Capsules are known at this time.

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

How to use Carbetapentane/Guaifenesin Sustained-Release Capsules:

Use Carbetapentane/Guaifenesin Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Carbetapentane/Guaifenesin Sustained-Release Capsules may be taken with or without food. Drinking extra fluids while you are taking Carbetapentane/Guaifenesin Sustained-Release Capsules are recommended. Check with your doctor for instructions. Swallow Carbetapentane/Guaifenesin Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing. If you miss a dose of Carbetapentane/Guaifenesin Sustained-Release Capsules and you are taking it regularly, 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 Carbetapentane/Guaifenesin Sustained-Release Capsules.

Important safety information: Carbetapentane/Guaifenesin Sustained-Release Capsules may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Carbetapentane/Guaifenesin Sustained-Release Capsules. Using Carbetapentane/Guaifenesin Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Carbetapentane/Guaifenesin Sustained-Release Capsules. Carbetapentane/Guaifenesin Sustained-Release Capsules will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. If cough persists for more than 1 week or is accompanied by a fever, contact your health care provider. A persistent cough could be a sign of a serious condition. Carbetapentane/Guaifenesin Sustained-Release Capsules are not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Carbetapentane/Guaifenesin Sustained-Release Capsules during pregnancy. It is unknown if Carbetapentane/Guaifenesin Sustained-Release Capsules are excreted in breast milk. If you are or will be breast-feeding while you are using Carbetapentane/Guaifenesin Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Carbetapentane/Guaifenesin Sustained-Release Capsules:

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

Drowsiness; dry mouth, nose, or throat; upset stomach.

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

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

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

See also: Carbetapentane/Guaifenesin 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 restlessness; seizures; severe agitation.

Proper storage of Carbetapentane/Guaifenesin Sustained-Release Capsules:

Store Carbetapentane/Guaifenesin Sustained-Release Capsules 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 Carbetapentane/Guaifenesin Sustained-Release Capsules out of the reach of children and away from pets.

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Carbetapentane/Guaifenesin resources Carbetapentane/Guaifenesin Side Effects (in more detail) Carbetapentane/Guaifenesin Use in Pregnancy & Breastfeeding Carbetapentane/Guaifenesin Drug Interactions Carbetapentane/Guaifenesin Support Group 0 Reviews for Carbetapentane/Guaifenesin - Add your own review/rating Compare Carbetapentane/Guaifenesin with other medications Cough
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Bartonellosis Medications


Definition of Bartonellosis: Cat scratch disease is an infectious illness caused by the bacteria More...

Drugs associated with Bartonellosis

The following drugs and medications are in some way related to, or used in the treatment of Bartonellosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Bartonellosis

Medical Encyclopedia:

Cat scratch disease
Drug List: Azithromycin-3-Day-Dose-Pack Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Ilosone Monodox Ocudox-Convenience-Kit Oraxyl Pce Rifadin Rifadin-Iv Rimactane Vibra-Tabs Vibramycin Zithromax Zmax-Extended-Release-Oral-Suspension
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ADHD (Attention Deficit Hyperactivity Disorder) Medications


Definition of ADHD: An inability to control behaviour due to difficulty in processing neural stimuli. More...

Drugs associated with ADHD

The following drugs and medications are in some way related to, or used in the treatment of ADHD. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under ADHD Oppositional Defiant Disorder (1 drug) Learn more about ADHD (Attention Deficit Hyperactivity Disorder)

Medical Encyclopedia:

Attention deficit hyperactivity disorder (ADHD)

Drugs.com Health Center:

Mental Health Disorders
Drug List: 5-Htp Adderall Adderall-Xr-Extended-Release-Capsules Aminomine Animi-3 Animi-3-With-Vitamin-D Concerta Cylert Daytrana Desoxyn Desoxyn-Gradumet Dexedrine Dextrostat Divista Eldepryl Epa-Fish-Oil Fish_Oil Fish-Oil-Ultra Focalin Focalin-Xr-Extended-Release-Capsules Icar-Prenatal-Essential-Omega-3 Intuniv Kapvay Liquadd-Solution Lovaza Marine-Lipid-Concentrate Maxepa Maxitears-Dry-Eye-Formula Maxivision-Omega-3-Formula Metadate-Cd-Controlled-Release-Capsules Metadate-Er Methylin Methylin-Er-Controlled-Release-Tablets Mi-Omega Mi-Omega-Nf Norpramin Omacor Omega-500 Pristiq Procentra-Solution Proepa Ritalin Ritalin-La-Extended-Release-Capsules Ritalin-Sr-Controlled-Release-Tablets Sea-Omega Sea-Omega-30 Sea-Omega-70 Strattera Theratears-Nutrition Theromega Tofranil Tofranil-Pm Vyvanse Zelapar
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Typhoid Vaccine Delayed-Release Capsules


Pronunciation: TIE-foyd
Generic Name: Typhoid Vaccine Live
Brand Name: Vivotif Berna Vaccine
Typhoid Vaccine Delayed-Release Capsules are used for:

Preventing typhoid fever in persons 6 years old and older who are at increased risk because they are traveling to an area where this infection is more common, have been in contact with infected individuals, or work in an environment that increases their risk (eg, lab work).

Typhoid Vaccine Delayed-Release Capsules are a vaccine. It works by stimulating the body to produce antibodies against typhoid fever.

Do NOT use Typhoid Vaccine Delayed-Release Capsules if: you are allergic to any ingredient in Typhoid Vaccine Delayed-Release Capsules you have a current infection, cancer, fever, persistent vomiting or diarrhea, other stomach illness, or HIV or another condition that weakens the immune system you are taking a sulfonamide (eg, sulfamethoxazole), another antibiotic (eg, penicillin), or a medicine that weakens the immune system (eg, cyclosporine, certain cancer medicines)

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

Before using Typhoid Vaccine Delayed-Release Capsules:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have an infection or fever, chronic diarrhea, an illness affecting the stomach or intestines, undiagnosed rectal hemorrhage, or persistent vomiting, or you are receiving chemotherapy or radiation therapy

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

Antibiotics (eg, penicillin), corticosteroids (eg, prednisone), immunosuppressants (eg, certain cancer medicines, cyclosporine), or sulfonamides (eg, sulfamethoxazole) because they may decrease Typhoid Vaccine Delayed-Release Capsules's effectiveness Proguanil because it may decrease Typhoid Vaccine Delayed-Release Capsules's effectiveness. You should not take proguanil for at least 10 days after your last dose of Typhoid Vaccine Delayed-Release Capsules. Discuss any questions with your doctor

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

How to use Typhoid Vaccine Delayed-Release Capsules:

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

Take Typhoid Vaccine Delayed-Release Capsules with a cold or lukewarm drink 1 hour before or 2 hours after a meal. Swallow Typhoid Vaccine Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. Do not take cracked or broken capsules. Do not drink alcohol within 2 hours of taking Typhoid Vaccine Delayed-Release Capsules. Do not forget to skip a day between capsules. Take a capsule EVERY OTHER DAY as directed by your doctor. For Typhoid Vaccine Delayed-Release Capsules to be effective, you must complete all 4 doses at least 1 week before exposure to typhoid fever. If you miss a dose of Typhoid Vaccine Delayed-Release Capsules, take it as soon as possible. If you do not remember until the next day, take the dose as soon as possible and reschedule your doses from that day.

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

Important safety information: Notify your doctor if you experience diarrhea, vomiting, or flu-like symptoms after taking Typhoid Vaccine Delayed-Release Capsules. This vaccine helps prevent typhoid fever, but does not provide 100% protection. It is important to also avoid infected people, food, and water. It is recommended that you receive another 4 doses of Typhoid Vaccine Delayed-Release Capsules every 5 years if you continue to be exposed to typhoid fever. Typhoid Vaccine Delayed-Release Capsules are not recommended for use in CHILDREN younger than 6 years of age; 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 Typhoid Vaccine Delayed-Release Capsules during pregnancy. It is not known if Typhoid Vaccine Delayed-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Typhoid Vaccine Delayed-Release Capsules, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Typhoid Vaccine Delayed-Release Capsules:

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

Diarrhea; fever; headache; muscle pain; nausea; stomach cramps or pain; vomiting.

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); difficulty swallowing; unusual hoarseness.

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: Typhoid side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Typhoid Vaccine Delayed-Release Capsules:

Store Typhoid Vaccine Delayed-Release Capsules in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), at all times. Do not freeze. Keep Typhoid Vaccine Delayed-Release Capsules out of the reach of children and away from pets.

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

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

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Typhoid Vaccine resources Typhoid Vaccine Side Effects (in more detail) Typhoid Vaccine Dosage Typhoid Vaccine Use in Pregnancy & Breastfeeding Typhoid Vaccine Drug Interactions Typhoid Vaccine Support Group 0 Reviews for Typhoid - Add your own review/rating Compare Typhoid Vaccine with other medications Typhoid Prophylaxis
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Aortic Stenosis Medications


Definition of Aortic Stenosis: The aorta is the large artery that originates in the left ventricle (lower chamber) of the heart. Aortic stenosis is the narrowing or obstruction of the heart??s aortic valve, which prevents it from opening properly and blocks the flow of blood from the left ventricle to the aorta.

Drugs associated with Aortic Stenosis

The following drugs and medications are in some way related to, or used in the treatment of Aortic Stenosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Aortic Stenosis

Micromedex Care Notes:

Aortic Stenosis

Medical Encyclopedia:

Aortic insufficiency Aortic stenosis Congenital heart disease Mitral stenosis
Drug List: Inderal Inderal-La-Sustained-Release-Capsules
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