Hydralazine Tablets

Pronunciation: hye-DRAL-a-zeen
Generic Name: Hydralazine
Brand Name: Generic only. No brands available.

Hydralazine is used for:

Treating high blood pressure. It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Hydralazine is a vasodilator. It works by relaxing and dilating (opening) the blood vessels in the body, allowing blood to flow through the vessels more easily and at a lower pressure.

Do NOT use Hydralazine if:

• you are allergic to nitrates or to any ingredient in Hydralazine


• you have problems with the blood vessels of your heart (coronary artery disease) or certain heart valve problems (mitral valvular rheumatic heart disease)

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

Before using Hydralazine:

Some medical conditions may interact with Hydralazine. 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 blood problems (eg, porphyria), blood vessel problems, heart problems, low blood pressure, low levels of vitamin B₆ in your blood, kidney problems, or lupus


• if you have a history of stroke

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

• Medicines that may affect your blood vessels, medicines that treat high blood pressure (eg, diazoxide), or other vasodilators (eg, isosorbide, nitroglycerin) they may increase the risk of Hydralazine's side effects. Check with your doctor or pharmacist if you have questions about which medicines may affect your blood vessels.


• Monoamine oxidase (MAO) inhibitors (eg, phenelzine) because the risk of serious side effects may be increased


• Beta-blockers (eg, propranolol) because their risk of side effects may be increased by Hydralazine


• Epinephrine because its effectiveness may be decreased by Hydralazine

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

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

• Take Hydralazine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Hydralazine on a regular schedule to get the most benefit from it. Taking Hydralazine at the same time each day will help you remember to take it.


• Continue to use Hydralazine even if you feel well. Do not miss any doses.


• If you miss a dose of Hydralazine, 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 Hydralazine.

Important safety information:

• Hydralazine may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Hydralazine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Hydralazine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Tell your doctor or dentist that you take Hydralazine before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood counts and antinuclear antibody titers, may be performed while you use Hydralazine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Hydralazine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Hydralazine, contact your doctor. You will need to discuss the benefits and risks of using Hydralazine while pregnant. It is not known if Hydralazine is found in breast milk. If you are or will be breast-feeding while you are using Hydralazine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydralazine:

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; headache; loss of appetite; nausea; 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); chest pain; decreased or difficult urination; depression; fainting; fast or irregular heartbeat; fever, chills, or sore throat; joint pain; mental or mood changes; numbness of an arm or leg; numbness or tingling of the skin; persistent fatigue or weakness; severe or persistent headache or dizziness; unusual bruising or bleeding; vision changes; yellowing of the eyes or skin.

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

See also: Hydralazine 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 chest pain; fast or irregular heartbeat; flushing; severe headache; shock.

Proper storage of Hydralazine:

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

General information:

• If you have any questions about Hydralazine, please talk with your doctor, pharmacist, or other health care provider.


• Hydralazine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hydralazine. 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 Hydralazine resources

• Hydralazine Side Effects (in more detail)
• Hydralazine Dosage
• Hydralazine Use in Pregnancy & Breastfeeding
• Drug Images
• Hydralazine Drug Interactions
• Hydralazine Support Group
• 1 Review for Hydralazine - Add your own review/rating

Compare Hydralazine with other medications

• Heart Failure
• High Blood Pressure
• Hypertensive Emergency

Hydralazine

Generic Name: Hydralazine hydrocloride

Dosage Form: injection, solution
Hydralazine HCL 20mg/mL 1mL single dose vial

Hydralazine Description

Hydralazine Hydrochloride Injection, USP is an antihypertensive available in a 2 mL vial for intravenous and intramuscular administration. Each mL of the sterile, nonpyrogenic colorless solution contains Hydralazine hydrochloride USP, 20 mg; methylparaben NF, 0.65 mg; propylparaben NF, 0.35 mg; propylene glycol USP,  103.6 mg, and Water for Injection USP q.s. The pH of the solution is 3.4-4.4. pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Hydralazine hydrochloride is 1-hydrazinophthalazine monohydrochloride, and its structural formula is:

Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275 degrees C, with decomposition.

Hydralazine - Clinical Pharmacology

Although the precise mechanism of action of Hydralazine is not fully understood, the major effects are on the cardiovascular system. Hydralazine apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. Hydralazine, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state.

The peripheral vasodilating effect of Hydralazine results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance' and an increased heart rate, stroke volume and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. Hydralzine usually increases renin activity in plasma presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. Hydralzine also maintains or increases renal and cerebral blood flow.

The average maximal decrease in blood pressure usually occurs 10-80 minutes after administration of Hydralazine hydrochloride injection. No other pharmacokinetic data on Hydralazine hydrochloride injection are available.

INDICATIONS & USAGE

Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Contraindications

Hypersensitivity to Hydralazine, coronary artery disease, mitral valvular rheumatic heart disease.

Warnings

In a few patients, Hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients, Hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS: Laboratory Tests.)

Precautions

General

Myocardial stimulation produced by Hydralazine can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

The "hyperdynamic" circulation caused by Hydralazine may accentuate specific cardiovascular inadequacies. For example, Hydralazine may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from Hydralazine but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.

In hypertensive patients with normal kidneys who are treated with Hydralazine, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of Hydralazine. However, as with any antihypertensive agent, Hydralazine should be used with caution in patients with advanced renal damage.

Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Publishing evidence suggests an antipyridoxine effect and that pyridoxine should be added to the regimen if symptoms develop.

Laboratory Tests

Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with Hydralazine even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with Hydralazine hydrochloride.

Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.

Drug Interactions

MAO inhibitors should be used with caution in patients receiving Hydralazine.

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with Hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and Hydralazine hydrochloride injection are used concomitantly.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given Hydralazine continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study rats given Hydralazine by gavage at dose levels of 15, 30 and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. Hydralazine was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rats and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for Hydralazine.

The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with Hydralazine use, epidemiologic studies have so far been insufficient to arrive at any conclusions.

Pregnancy: Tetatogenic Effects

Pregnancy Category C

Animal studies indicate that Hydralazine is teratogenic in mice at 20-30 times the maximum daily human dose of 200-300 mg and possibly in rabbits at 10-15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, Hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be excerised when Hydralazine injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established in controlled clinical trial, although there is experience with the use of Hydralazine hydrochloride in pediatric patients. The usual recommended parenteral dosage, administered intramuscularly or intravenously, is 1.7-3.5 mg/kg of body weight daily, divided into four to six doses.

Adverse Reactions

 Adverse reactions with Hydralazine hydrochloride are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug.

The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.

Common: Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris.

Less Frequent: Digestive-constipation, paralytic ileus. Cardivascular-hypotension, paradoxical pressor response, edema

Respiratory-dyspnea.

Neurologic-peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps, psychotic reactions characterized by depression, disorientation, or anxiety.

Genitourinary-difficulty in urination.

Hernatologic-blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly.

Hypersensitive Reactions-rash, urticaria, pruritis, fever, chill, arthralgia, eosinophilia, and, rarely, hepatitis.

Other-nasal congestion, flushing, lacrimation, conjunctivitis.

Overdosage

Acute Toxicity

No deaths due to acute poisoning have been reported.

Highest known dose survived: adults, 10 g orally. Oral LD50 in rats: 173 and 187 mg/kg.

Signs and Symptoms

Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing.

Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.

Treatment

There is no specific antidote.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.  Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required.

No experience has been reported with extracorporeal or peritoneal dialysis.

DOSAGE & ADMINISTRATION

When there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly  or as a rapid intravenous bolus injection directly into the vein. Hydralazine Hydrochloride Injection should be used only when the drug cannot be given orally. The usual dose is 20-40 mg, repeated as necessary.

Certain patients (especially those with marked renal damage) may require a lower dose. Blood pressure should be checked frequently. It may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10-80 minutes, In cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. Most patients can be transferred to oral Hydralazine hydrochloride with 24-48 hours.

The product should be used immediately after the vial is opened. The product should not be added to infusion solutions. Hydralazine Hydrochloride Injection may discolor upon contact with metal; discolored solutions should be discarded.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Hydralazine Supplied

Product No.        NDC No.

601401               63323-614-01

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 2 mL single dose vial, 25 vials per tray.

Vial stoppers do not contain natural rubber latex.

Store at 20 degrees C to 25 degrees C (68 degrees F to 77 degrees F) [see USP Controlled Room Temperature].

APP

APP Pharmaceuticals, LLC

Schaumburg, IL 60173

45854D

Revised: January 2008

PACKAGE LABEL

Hydralazine HYDROCHLORIDE  Hydralazine hydrochloride  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-614 (63323-614) Route of Administration INTRAMUSCULAR, INTRAVASCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydralazine Hydrochloride (Hydralazine) Hydralazine Hydrochloride 20 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52584-614-01 1 VIAL In 1 BAG contains a VIAL 1 1 mL In 1 VIAL This package is contained within the BAG (52584-614-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040388	10/19/2011

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 10/2011General Injectables & Vaccines, Inc

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Hycort

Generic Name: hydrocortisone topical (hye droe KOR ti sone)

Brand Names: Ala-Cort, Ala-Scalp HP, Aquanil HC, Beta HC, Caldecort, Cortaid, Cortaid Intensive Therapy, Cortaid Maximum Strength, Cortaid with Aloe, Cortalo with Aloe, Corticaine, Cortizone for Kids, Cortizone-10, Cortizone-10 Intensive Healing Formula, Cortizone-10 Plus, Cortizone-5, Dermarest Dricort, Dermarest Eczema Medicated, Dermarest Plus Anti-Itch, Dermtex HC, Genasone/Aloe, Gly-Cort, Gynecort Maximum Strength, Hycort, Hydrocortisone 1% In Absorbase, Hydrocortisone with Aloe, Hydrocortisone-Aloe, Hytone, Instacort, Itch-X Lotion, Locoid, Locoid Lipocream, Locoid Lotion, Massengill Medicated Soft Cloth, MD Hydrocortisone, Neutrogena T-Scalp, NuCort with Aloe, NuZon, Pandel, Recort Plus, Rederm, Sarnol-HC, Scalacort, Texacort, U-Cort, Westcort

What is Hycort (hydrocortisone topical)?

Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Hydrocortisone topical is used to treat inflammation of the skin caused by a number of conditions such as allergic reactions, eczema, or psoriasis.

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

What is the most important information I should know about Hycort (hydrocortisone topical)?

There are many brands and forms of hydrocortisone topical available and not all brands are listed on this leaflet.

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

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Hycort (hydrocortisone topical)?

Do not use this medication if you are allergic to hydrocortisone.

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

FDA pregnancy category C. It is not known whether hydrocortisone topical is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether hydrocortisone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of hydrocortisone topical.

How should I use Hycort (hydrocortisone topical)?

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

Hydrocortisone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using hydrocortisone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with hydrocortisone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use hydrocortisone topical regularly to get the most benefit. Store hydrocortisone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of hydrocortisone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Hycort (hydrocortisone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use hydrocortisone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Hycort (hydrocortisone topical) side effects

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

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin;

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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

What other drugs will affect Hycort (hydrocortisone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied hydrocortisone. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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• Hycort Side Effects (in more detail)
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• Hycort Drug Interactions
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• Hytone Prescribing Information (FDA)


• Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Locoid Lipocream Prescribing Information (FDA)


• Locoid Lotion Prescribing Information (FDA)


• Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Pandel Prescribing Information (FDA)


• Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Proctocort Prescribing Information (FDA)


• Texacort Prescribing Information (FDA)


• U-cort Prescribing Information (FDA)


• Westcort Prescribing Information (FDA)

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• Anal Itching
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• Atopic Dermatitis
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• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone topical.

See also: Hycort side effects (in more detail)

Hydralazine Tablets

Generic Name: hydralazine hydrochloride

Dosage Form: tablet
HYDRALAZINE HYDROCHLORIDE TABLETS, USP

Rx only

DESCRIPTION:

HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is:

HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64.

Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.

CLINICAL PHARMACOLOGY:

Although the precise mechanism of action of hydrALAZINE is not fully understood, the major effects are on the cardiovascular system. HydrALAZINE apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. HydrALAZINE, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state.

The peripheral vasodilating effect of hydrALAZINE results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume, and cardiac output. The preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. HydrALAZINE usually increases renin activity in plasma, presumably as a result of increased secretion of renin by the renal juxtaglomerular cells in response to reflex sympathetic discharge. This increase in renin activity leads to the production of angiotensin II, which then causes stimulation of aldosterone and consequent sodium reabsorption. HydrALAZINE also maintains or increases renal and cerebral blood flow.

HydrALAZINE is rapidly absorbed after oral administration, and peak plasma levels are reached at 1 to 2 hours. Plasma levels of apparent hydrALAZINE decline with a half-life of 3 to 7 hours. Binding to human plasma protein is 87%. Plasma levels of hydrALAZINE vary widely among individuals. HydrALAZINE is subject to polymorphic acetylation; slow acetylators generally have higher plasma levels of hydrALAZINE and require lower doses to maintain control of blood pressure. HydrALAZINE undergoes extensive hepatic metabolism; it is excreted mainly in the form of metabolites in the urine.

INDICATIONS AND USAGE:

Essential hypertension, alone or as an adjunct.

CONTRAINDICATIONS:

Hypersensitivity to hydrALAZINE; coronary artery disease; mitral valvular rheumatic heart disease.

WARNINGS:

In a few patients hydrALAZINE may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydrALAZINE should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. Symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary. (See PRECAUTIONS, Laboratory Tests.)

PRECAUTIONS:

General:

Myocardial stimulation produced by hydrALAZINE can cause anginal attacks and ECG changes of myocardial ischemia. The drug has been implicated in the production of myocardial infarction. It must, therefore, be used with caution in patients with suspected coronary artery disease.

The “hyperdynamic” circulation caused by hydrALAZINE may accentuate specific cardiovascular inadequacies. For example, hydrALAZINE may increase pulmonary artery pressure in patients with mitral valvular disease. The drug may reduce the pressor responses to epinephrine. Postural hypotension may result from hydrALAZINE but is less common than with ganglionic blocking agents. It should be used with caution in patients with cerebral vascular accidents.

In hypertensive patients with normal kidneys who are treated with hydrALAZINE, there is evidence of increased renal blood flow and a maintenance of glomerular filtration rate. In some instances where control values were below normal, improved renal function has been noted after administration of hydrALAZINE. However, as with any antihypertensive agent, hydrALAZINE should be used with caution in patients with advanced renal damage.

Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has been observed. Published evidence suggests an antipyridoxine effect, and that pyridoxine should be added to the regimen if symptoms develop.

Information for Patients:

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests:

Complete blood counts and antinuclear antibody titer determinations are indicated before and periodically during prolonged therapy with hydrALAZINE even though the patient is asymptomatic. These studies are also indicated if the patient develops arthralgia, fever, chest pain, continued malaise, or other unexplained signs or symptoms.

A positive antinuclear antibody titer requires that the physician carefully weigh the implications of the test results against the benefits to be derived from antihypertensive therapy with hydrALAZINE.

Blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, and purpura, have been reported. If such abnormalities develop, therapy should be discontinued.

Drug/Drug Interactions:

MAO inhibitors should be used with caution in patients receiving hydrALAZINE.

When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydrALAZINE, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydrALAZINE are used concomitantly.

Drug/Food Interactions:

Administration of hydrALAZINE with food results in higher plasma levels.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

In a lifetime study in Swiss albino mice, there was a statistically significant increase in the incidence of lung tumors (adenomas and adenocarcinomas) of both male and female mice given hydrALAZINE continuously in their drinking water at a dosage of about 250 mg/kg per day (about 80 times the maximum recommended human dose). In a 2-year carcinogenicity study of rats given hydrALAZINE by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately 5 to 20 times the recommended human daily dosage), microscopic examination of the liver revealed a small, but statistically significant, increase in benign neoplastic nodules in male and female rats from the high-dose group and in female rats from the intermediate-dose group. Benign interstitial cell tumors of the testes were also significantly increased in male rats from the high-dose group. The tumors observed are common in aged rats and a significantly increased incidence was not observed until 18 months of treatment. HydrALAZINE was shown to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one of two rat and one rabbit hepatocyte in vitro DNA repair studies. Additional in vivo and in vitro studies using lymphoma cells, germinal cells, and fibroblasts from mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell lines did not demonstrate any mutagenic potential for hydrALAZINE.

The extent to which these findings indicate a risk to man is uncertain. While long-term clinical observation has not suggested that human cancer is associated with hydrALAZINE use, epidemiologic studies have so far been insufficient to arrive at any conclusions.

Pregnancy Category C:

Animal studies indicate that hydrALAZINE is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones.

There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydrALAZINE should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when hydrALAZINE is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established in controlled clinical trials, although there is experience with the use of hydrALAZINE in pediatric patients. The usual recommended oral starting dosage is 0.75 mg/kg of body weight daily in four divided doses. Dosage may be increased gradually over the next 3 to 4 weeks to a maximum of 7.5 mg/kg or 200 mg daily.

ADVERSE REACTIONS:

Adverse reactions with hydrALAZINE are usually reversible when dosage is reduced. However, in some cases it may be necessary to discontinue the drug. The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency.

Common: Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris

Less Frequent:Digestive: constipation, paralytic ileus.

• Cardiovascular: hypotension, paradoxical pressor response, edema.


• Respiratory: dyspnea


• Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety.


• Genitourinary: difficulty in urination


• Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly.


• Hypersensitivity Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis.


• Other: nasal congestion, flushing, lacrimation, conjunctivitis.

OVERDOSAGE:

Acute Toxicity: No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally.

Oral LD50 in rats: 173 and 187 mg/kg.

Signs and Symptoms: Signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing.

Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.

Treatment: There is no specific antidote.

The gastric contents should be evacuated, taking adequate precautions against aspiration and for protection of the airway. An activated charcoal slurry may be instilled if conditions permit. These manipulations may have to be omitted or carried out after cardiovascular status has been stabilized, since they might precipitate cardiac arrhythmias or increase the depth of shock.

Support of the cardiovascular system is of primary importance. Shock should be treated with plasma expanders. If possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia.

Tachycardia responds to beta blockers. Digitalization may be necessary, and renal function should be monitored and supported as required.

No experience has been reported with extracorporeal or peritoneal dialysis.

DOSAGE AND ADMINISTRATION:

Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels.

The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE.

In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.

HOW SUPPLIED:

HydrALAZINE Hydrochloride Tablets, USP:

10 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘38’ on the other side in bottles of 100 (NDC code: 31722-519-01), 500 (NDC code: 31722-519-05, and 1000 (NDC code: 31722-519-10).

25 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘39’ on the other side in bottles of 100 (NDC code: 31722-520-01), 500 (NDC code: 31722-520-05, and 1000 (NDC code: 31722-520-10).

50 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘40’ on the other side in bottles of 100 (NDC code: 31722-521-01), 500 (NDC code: 31722-521-05), and 1000 (NDC code: 31722-521-10).

100 mg - Orange, round, unscored tablets debossed with ‘H’ on one side and ‘41’ on the other side in bottles of 100 (NDC code: 31722-522-01) and 500 (NDC code: 31722-522-05).

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured for:

Camber Pharmaceuticals, Inc.

Piscataway, NJ 08854

By: Hetero Drugs Limited

2005566-00

Jeedimetla, Hyderabad- 500 055, India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-519 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 10 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 5mm Flavor Imprint Code H;38 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-519-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-01) 2 31722-519-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-05) 3 31722-519-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-519-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-520 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 6mm Flavor Imprint Code H;39 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-520-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-01) 2 31722-520-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-05) 3 31722-520-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-520-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-521 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 8mm Flavor Imprint Code H;40 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-521-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-01) 2 31722-521-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-05) 3 31722-521-10 12 BOTTLE In 1 CASE contains a BOTTLE 3 1000 TABLET In 1 BOTTLE This package is contained within the CASE (31722-521-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

HYDRALAZINE HYDROCHLORIDE  hydralazine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 31722-522 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   STEARIC ACID   FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND Size 11mm Flavor Imprint Code H;41 Contains

Packaging # NDC Package Description Multilevel Packaging 1 31722-522-01 12 BOTTLE In 1 CASE contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CASE (31722-522-01) 2 31722-522-05 12 BOTTLE In 1 CASE contains a BOTTLE 2 500 TABLET In 1 BOTTLE This package is contained within the CASE (31722-522-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040901	01/01/2010

Labeler - Camber Pharmaceuticals (826774775)

Establishment
Name	Address	ID/FEI	Operations
Hetero Labs limited		676162024	MANUFACTURE

Revised: 08/2011Camber Pharmaceuticals

More Hydralazine Tablets resources

• Hydralazine Tablets Side Effects (in more detail)
• Hydralazine Tablets Use in Pregnancy & Breastfeeding
• Drug Images
• Hydralazine Tablets Drug Interactions
• Hydralazine Tablets Support Group
• 1 Review for Hydralazines - Add your own review/rating

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• Heart Failure
• High Blood Pressure
• Hypertensive Emergency

Hyaluronate Sodium

Pronunciation: HYE-al-ure-ON-ate SOE-dee-um
Generic Name: Hyaluronate Sodium
Brand Name: Examples include Hyalgan and Supartz

Hyaluronate Sodium is used for:

Treating knee pain in patients with osteoarthritis who have not received relief from other treatments.

Hyaluronate Sodium is a hyaluronic acid derivative. It works by increasing the effectiveness of the fluid within the knee joint to act as a lubricant and shock absorber.

Do NOT use Hyaluronate Sodium if:

• you are allergic to any ingredient in Hyaluronate Sodium


• you have an infection or skin disease near the joint or injection site

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

Before using Hyaluronate Sodium:

Some medical conditions may interact with Hyaluronate Sodium. 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 are allergic to birds or bird products (eg, eggs, feathers, poultry)

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

• Quaternary ammonium salts because side effects may occur

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

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

• Hyaluronate Sodium comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Hyaluronate Sodium refilled.


• Hyaluronate Sodium is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hyaluronate Sodium at home, a health care provider will teach you how to use it. Be sure you understand how to use Hyaluronate Sodium. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Hyaluronate Sodium is usually given as a series of injections 1 week apart for a total of 3 to 5 injections depending upon the particular product you are using. You may not experience relief until you have received several injections.


• Do not use Hyaluronate Sodium if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not use disinfectants containing ammonium salts to prepare the skin for injection because side effects may occur.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Hyaluronate Sodium, contact your doctor to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Hyaluronate Sodium.

Important safety information:

• Hyaluronate Sodium may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Hyaluronate Sodium with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• You may experience a temporary inflammation in your knee after using Hyaluronate Sodium. If the inflammation is severe or continues, contact your doctor.


• Avoid strenuous activity or prolonged (more than 1 hour) weight-bearing activity (eg, running, tennis, heavy lifting) for at least 48 hours after you are injected with Hyaluronate Sodium.


• Hyaluronate Sodium should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Hyaluronate Sodium, contact your doctor. You will need to discuss the benefits and risks of using Hyaluronate Sodium while pregnant. It is not known if Hyaluronate Sodium is found in breast milk. If you are or will be breast-feeding while you are using Hyaluronate Sodium, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hyaluronate Sodium:

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:

Back pain; mild bruising, heat, redness, swelling, or pain at the injection site; temporary achy feeling; temporary knee inflammation.

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

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

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

If OVERDOSE is suspected:

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

Proper storage of Hyaluronate Sodium:

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

General information:

• If you have any questions about Hyaluronate Sodium, please talk with your doctor, pharmacist, or other health care provider.


• Hyaluronate Sodium is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hyaluronate Sodium. 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 Hyaluronate Sodium resources

• Hyaluronate Sodium Use in Pregnancy & Breastfeeding
• Hyaluronate Sodium Drug Interactions
• Hyaluronate Sodium Support Group
• 28 Reviews for Hyaluronate Sodium - Add your own review/rating

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• Osteoarthritis

Hycodan

Generic Name: homatropine and hydrocodone (HOM a TROE peen and HYE dro KOE done)

Brand Names: Hycodan, Hydromet, Tussigon

What is Hycodan (homatropine and hydrocodone)?

Hydrocodone is a narcotic cough medicine.

Homatropine is a drug that works against the narcotic to prevent an overdose of this medication.

The combination of homatropine and hydrocodone combination is used to treat cough.

Homatropine and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hycodan (homatropine and hydrocodone)?

Before using homatropine and hydrocodone, tell your doctor if you have asthma or other breathing problems, liver or kidney disease, stomach problems, a underactive thyroid, Addison's disease, enlarged prostate or urination problems, glaucoma, or a history of drug addiction or alcoholism.

Do not take more of this medication than prescribed. Adults should not take more than 1 tablet every 4 to 6 hours or 1 teaspoon of the liquid medicine every 4 to 6 hours. Children should not take more than one half-tablet every 4 to 6 hours or one half-teaspoon of the liquid medicine every 4 to 6 hours. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Drinking alcohol can increase certain side effects of homatropine and hydrocodone.

Before you take this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by homatropine and hydrocodone.

Homatropine and hydrocodone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my health care provider before taking Hycodan (homatropine and hydrocodone)?

You should not use this medication if you are allergic to homatropine or hydrocodone.

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

• 
  

  asthma or other breathing problems;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  stomach problems;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  Addison's disease;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  a history of drug addiction or alcoholism.

  
  

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using homatropine and hydrocodone. It is not known whether homatropine and hydrocodone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 6 years old. Homatropine and hydrocodone may cause serious breathing problems in a young child. Older adults and people who are debilitated may be more likely to have side effects from this medication.

How should I take Hycodan (homatropine and hydrocodone)?

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

Do not take more of this medication than prescribed. Adults should not take more than 1 tablet every 4 to 6 hours or 1 teaspoon of the liquid medicine every 4 to 6 hours. Children should not take more than one half-tablet every 4 to 6 hours or one half-teaspoon of the liquid medicine every 4 to 6 hours. Take this medicine with a full glass of water. Drink plenty of water to prevent constipation that may be caused by homatropine and hydrocodone.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using homatropine and hydrocodone. Store at room temperature away from heat, moisture, and light. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Hycodan dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, limp muscles, cold or clammy skin, blue lips, slow heart rate, fainting, shallow breathing, or breathing that stops.

What should I avoid while taking Hycodan (homatropine and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of homatropine and hydrocodone.

Hycodan (homatropine and hydrocodone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  painful urination;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  extreme drowsiness or weakness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  weak or shallow breathing, or breathing that stops;

  
  


• 
  

  feeling anxious or fearful; or

  
  


• 
  

  unusual thoughts or behavior.

  
  

Less serious side effects may include:

• 
  

  mild drowsiness, dizziness;

  
  


• 
  

  trouble concentrating;

  
  


• 
  

  nausea, vomiting, constipation; or

  
  


• 
  

  skin itching or rash.

  
  

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

What other drugs will affect Hycodan (homatropine and hydrocodone)?

Before taking homatropine and hydrocodone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by homatropine and hydrocodone.

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

More Hycodan resources

• Hycodan Side Effects (in more detail)
• Hycodan Dosage
• Hycodan Use in Pregnancy & Breastfeeding
• Drug Images
• Hycodan Drug Interactions
• Hycodan Support Group
• 23 Reviews for Hycodan - Add your own review/rating

• Hycodan MedFacts Consumer Leaflet (Wolters Kluwer)


• Hycodan Prescribing Information (FDA)


• Hydromet Syrup MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydromet Prescribing Information (FDA)


• Tussigon Prescribing Information (FDA)

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• Cough

Where can I get more information?

• Your pharmacist can provide more information about homatropine and hydrocodone.

See also: Hycodan side effects (in more detail)