Papaverine Hydrochloride
Injection, Solution · Intravenous, Intramuscular, Parenteral
Uses
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 and administration
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.
Contraindications
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.
Precautions
General 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. Usage In Pregnancy - Pregnancy Category C No teratogenic effects were observed in rats when papaverine hydrochloride was administered subcutaneously as a single agent. It is not known whether papaverine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Papaverine Hydrochloride should be given to a pregnant woman only if clearly needed. 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 papaverine hydrochloride is administered to a nursing woman. Usage in Children Safety and effectiveness in children have not been established.
Side effects
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.
Pregnancy
Usage In Pregnancy - Pregnancy Category C No teratogenic effects were observed in rats when papaverine hydrochloride was administered subcutaneously as a single agent. It is not known whether papaverine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Papaverine Hydrochloride should be given to a pregnant woman only if clearly needed.
Pediatric use
Usage in Children Safety and effectiveness in children have not been established.
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. Treatment – To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physician’s Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient. 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.
Description
Papaverine Hydrochloride, USP, is the hydrochloride of an alkaloid obtained from opium or prepared synthetically. It belongs to the benzylisoquinoline group of alkaloids. It does not contain a phenanthrene group as do morphine and codeine. Papaverine Hydrochloride, USP, is 6,7-dimethoxy-1- veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C 20 H 21 NO 4
• HCI. The molecular weight is 375.85. The structural formula is as shown. Papaverine Hydrochloride occurs as white crystals or white crystalline powder. One gram dissolves in about 30 mL of water and in 120 mL of alcohol. It is soluble in chloroform and practically insoluble in ether. Papaverine Hydrochloride Injection, USP, is a clear, colorless to pale-yellow solution. Papaverine Hydrochloride, for parenteral administration, is a smooth-muscle relaxant that is available in vials containing 30 mg/mL. Each vial also contains edetate disodium 0.005%. The 10 mL vials also contain chlorobutanol 0.5% as a preservative. pH may be adjusted with sodium citrate and/or citric acid. Adobe Systems
How supplied
Papaverine Hydrochloride Injection, USP, 30 mg/mL 0517-4002-25 2 mL Vial packaged in boxes of 25 0517-4010-01 10 mL Multiple Dose Vial* packaged individually *The 10 mL Multiple Dose Vial contains chlorobutanol 0.5% as a preservative. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN4002 Rev. 1/09
Label text from the FDA structured product label by American Regent, Inc. (revised Jul 27, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Papaverine Hydrochloride in 4 products
Papaverine Hydrochloride NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0517-4002 | Papaverine Hydrochloride 30 mg/mL Injection, Solution | American Regent, Inc. | UNAPPROVED DRUG OTHER |
| 54288-142 | Papaverine Hydrochloride 30 mg/mL Injection, Solution | BPI Labs LLC | UNAPPROVED DRUG OTHER |
| 14789-121 | Papaverine Hydrochloride 30 mg/mL Injection | Nexus Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
| 72516-024 | Papaverine Hydrochloride 30 mg/mL Injection, Solution | Oryza Pharmaceuticals Inc. | UNAPPROVED DRUG OTHER |
Papaverine Hydrochloride recalls
- D-0800-2026 Aug 26, 2026 · Class I · Ongoing
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde - D-0742-2022 Apr 13, 2022 · Class II · Terminated
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Frequently asked questions
What is Papaverine Hydrochloride used for?
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…
What are the side effects of Papaverine Hydrochloride?
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… See the full label for the complete list.
Who makes Papaverine Hydrochloride?
Papaverine Hydrochloride is listed by 4 labelers in the FDA NDC directory, including American Regent, Inc., BPI Labs LLC, Nexus Pharmaceuticals, LLC, Oryza Pharmaceuticals Inc..
Has Papaverine Hydrochloride been recalled?
The FDA enforcement database lists 2 recalls for Papaverine Hydrochloride, most recently D-0800-2026 (class i): Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde