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Papaverine

Last reviewed on RxList: 3/31/2009
Drug Description

Papaverine Hydrochloride
Sustained Release Capsules, 150 mg

DESCRIPTION

Papaverine hydrochloride, C20H21NO4•HCl, is a white, crystalline powder, odorless, with a slight bitter taste and is soluble in water.

Each capsule contains: papaverine hydrochloride USP 150 mg.

Chemically, it is Isoquinoline,1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-, hydrochloride. It has a molecular weight of 375.85. It has the following structural formula:

Papaverine Hydrochloride Structural Formula Illustration

Manufactured in a special base which is designed for prolonged release. Each capsule also contains the following inactive ingredients: FD&C blue No. 1, FD&C red No. 40, gelatin, pharmaceutical glaze, povidone, silicon dioxide, sodium lauryl sulfate, corn starch, sucrose and talc.

For Consumers

What are the possible side effects of papaverine (Papacon, Para-Time S. R., Pavabid Plateau, Pavacot, Pavagen)?

Stop taking papaverine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Stop taking papaverine and contact your doctor if your skin or eyes develop a yellow tint.

Other, less serious side effects may be more likely to occur. Continue to take papaverine and talk to your doctor if you experience

  • nausea, decreased appetite, diarrhea, or constipation;
  • dizziness or...
Indications & Dosage

INDICATIONS

For the relief of cerebral and peripheral ischemia associated with arterial spasm and myocardial ischemia complicated by arrhythmias.

DOSAGE AND ADMINISTRATION

One capsule every 12 hours. In difficult cases administration may be increased to one capsule every 8 hours or two capsules every 12 hours.

HOW SUPPLIED

Papaverine Hydrochloride Sustained Release Capsules are supplied as: 150 mg brown and clear capsules, imprinted E 5156 and are available in bottles of 100, 500 and 1000.

Storage

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

Protect from moisture.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for: Sandoz Inc. Princeton, NJ 08540. Manufactured by: Epic Pharma, LLC. Laurelton, NY 11413. Rev. 11/08.

Side Effects & Drug Interactions

SIDE EFFECTS

Although occurring rarely, the reported side effects of papaverine include nausea, abdominal distress, anorexia, constipation, malaise, drowsiness, vertigo, sweating, headache, diarrhea, skin rash, flushing of face, increase in heart rate and depth of respiration and slight increase in blood pressure.

DRUG INTERACTIONS

No information provided.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Warnings & Precautions

WARNINGS

No information provided.

PRECAUTIONS

Use with caution in patients with glaucoma. Hepatic hypersensitivity has been reported with gastrointestinal symptoms, jaundice, eosinophilia and altered liver function tests. Discontinue drug if these occur.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

Large doses can depress atrioventricular and intraventricular conduction and thereby produce serious arrhythmias.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

The main actions of papaverine are exerted on cardiac and smooth muscle. Like quinidine, papaverine acts directly on the heart muscle to depress conduction and prolong the refractory period. Papaverine relaxes various smooth muscles. This relaxation may be prominent if spasm exists. The muscle cell is not paralyzed by papaverine and still responds to drugs and other stimuli causing contraction. The antispasmodic effect is a direct one and unrelated to muscle innervation. Papaverine is practically devoid of effects on the central nervous system.

Papaverine relaxes the smooth musculature of the large blood vessels, especially coronary, systemic peripheral and pulmonary arteries. Perhaps by its direct vasodilating action on cerebral blood vessels, papaverine increases cerebral blood flow and decreases cerebral vascular resistance in normal subjects; oxygen consumption is unaltered. These effects may explain the benefit reported from the drug in cerebral vascular encephalopathy.

The direct actions of papaverine on the heart to depress conduction and irritability and to prolong the refractory period of the myocardium provide the basis for its clinical trial in abrogating atrial and ventricular premature systoles and ominous ventricular arrhythmias. The coronary vasodilator action could be an additional factor of therapeutic value when such rhythms are secondary to insufficiency or occlusion of the coronary arteries.

In patients with acute coronary thrombosis, the occurrence of ventricular cardiac arrhythmias is serious and requires measures designed to decrease myocardial irritability. Papaverine may have advantages over quinidine used for a similar purpose, in that it may be given in an emergency by the intravenous route, does not depress myocardial contraction or cause cinchonism and produces coronary vasodilation.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the PRECAUTIONS sections.

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