Papaverine

Papaverine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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Overview

Papaverine is a phosphodiesterase inhibitor that is FDA approved for the treatment of vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral vascular disease,peripheral and pulmonary embolism. Common adverse reactions include general discomfort, nausea, abdominal discomfort, anorexia, skin rash, malaise, vertigo and headache..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Papaverine is recommended in various conditions accompanied by spasm of smooth muscle, such as vascular spasm associated with acute myocardial infarction (coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral vascular disease in which there is a vasospastic element, or certain cerebral angiospastic states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.
• Dosage

• Papaverine Hydrochloride may be administered intravenously or intramuscularly. The intravenous route is recommended when an immediate effect is desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid uncomfortable or alarming side effects.

• Parenteral administration of papaverine hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment of cardiac extrasystoles, 2 doses may be given 10 minutes apart.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Papaverine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in children have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Papaverine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Papaverine in pediatric patients.

Contraindications

• complete atrioventricular heart block

• Intravenous injection of papaverine is contraindicated in the presence of complete atrioventricular heart block. When conduction is depressed, the drug may produce transient ectopic rhythms of ventricular origin, either premature beats or paroxysmal tachycardia.

• Papaverine Hydrochloride is not indicated for the treatment of impotence by intracorporeal injection. The intracorporeal injection of papaverine hydrochloride has been reported to have resulted in persistent priapism requiring medical and surgical intervention.

Warnings

Precautions

• Papaverine Hydrochloride Injection, USP, should not be added to Lactated Ringer’s Injection, because precipitation would result.

• Papaverine Hydrochloride should be used with caution in patients with glaucoma. The medication should be discontinued if hepatic hypersensitivity with gastrointestinal symptoms, jaundice, or eosinophilia becomes evident or if liver function test values become altered.

Adverse Reactions

Clinical Trials Experience

• The following side effects have been reported: general discomfort, nausea, abdominal discomfort, anorexia, constipation or diarrhea, skin rash, malaise, vertigo, headache, intensive flushing of the face, perspiration, increase in the depth of respiration, increase in heart rate, a slight rise in blood pressure, and excessive sedation.

• Hepatitis, probably related to an immune mechanism, has been reported infrequently. Rarely, this has progressed to cirrhosis.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Papaverine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Papaverine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Papaverine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Papaverine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Papaverine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Papaverine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Papaverine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Papaverine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Papaverine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Papaverine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Papaverine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Papaverine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Papaverine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Papaverine in the drug label.

Overdosage

Signs and Symptoms

• The symptoms of toxicity from papaverine hydrochloride often result from vasomotor instability and include nausea, vomiting, weakness, central nervous system depression, nystagmus, diplopia, diaphoresis, flushing, dizziness, and sinus tachycardia.
• In large overdoses, papaverine is a potent inhibitor of cellular respiration and a weak calcium antagonist.
• Following an oral overdose of 15 g, metabolic acidosis with hyperventilation, hyperglycemia, and hypokalemia have been reported. No information on toxic serum concentrations is available.
• Following intravenous overdosing in animals, seizures, tachyarrhythmias, and ventricular fibrillation have been reported. The oral median lethal dose in rats is 360 mg/kg.

Management

• To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
• No specific antidote is known.
• Treatment should be symptomatic and supportive.
• Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor vital signs, blood gases, blood chemistry values, and other variables.

• If convulsions occur, consider diazepam, phenytoin, or phenobarbital. If the seizures are refractory, general anesthesia with thiopental or halothane and paralysis with a neuromuscular blocking agent may be necessary.

• For hypotension, consider intravenous fluids, elevation of the legs, and an inotropic vasopressor, such as dopamine or norepinephrine (levarterenol). Theoretically, calcium gluconate may be helpful in treating some of the toxic cardiovascular effects of papaverine; monitor the ECG and plasma calcium concentrations.

• Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of papaverine hydrochloride.

Pharmacology

There is limited information regarding Papaverine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Papaverine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Papaverine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Papaverine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Papaverine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Papaverine in the drug label.

How Supplied

Storage

There is limited information regarding Papaverine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Papaverine in the drug label.

Precautions with Alcohol

• Alcohol-Papaverine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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