Drugs Details

Drugs Info of Papaverine Injection
Drugs Details
  • Drugs Type  : Multum
  • Date : 6th Mar 2015 04:26 am
  • Brand Name : Papaverine Injection
  • Generic Name : papaverine (injection) (Pronunciation: pa PAV er een)
Descriptions

Papaverine hydrochloride 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 is 6,7-dimethoxy-1-veratrylisoquinoline hydrochloride and contains, on the dried basis, not less than 98.5% of C20H21NO4•HCI. The molecular weight is 375.85. The structural formula is as shown:

 

Papaverine hydrochloride Structural Formula Illustration

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 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 papaverine hydrochloride. Each vial also contains edetate disodium, 0.005%. Sodium hydroxide may have been added during manufacture to adjust the pH.

What are the possible side effects of papaverine injection ()?

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.

Tell your doctor at once if you have a serious side effect such as:

  • low fever, nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes);
  • warmth, redness, or tingly feeling in your face;
  • swelling, pain, or irritation around the IV needle;
  • fast heart rate; or
  • skin rash, bruising, severe tingling, numbness,...

Read All Potential Side Effects and See Pictures of Papaverine Injection »


This monograph has been modified to include the generic and brand name in many instances.

Indications

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 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.

How Supplied

Papaverine Hydrochloride Injection, USP (papaverine hydrochloride injection) , is supplied in multiple-dose vials, 30 mg/mL, 10 mL, with 0.5% chlorobutanol (chloroform derivative) NDC 55390-107-10.

Manufactured for: Bedford Laboratories™ Bedford, OH 44146. Manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146. March 1999.


This monograph has been modified to include the generic and brand name in many instances.

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.

Drug Abuse And Dependence

Drug dependence resulting from the abuse of many of the selective depressants, including papaverine hydrochloride, has been reported.

Read the Papaverine Injection (papaverine hydrochloride injection) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

General

Papaverine Hydrochloride Injection, USP (papaverine hydrochloride injection) , 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.
This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 Physicians' 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 levarteranol. 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.

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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

The most characteristic effect of papaverine is relaxation of the tonus of all smooth muscle, especially when it has been spasmodically contracted. Papaverine hydrochloride apparently acts directly on the muscle itself. This relaxation is noted in the vascular system and bronchial musculature and in the gastrointestinal, biliary, and urinary tracts.

The main actions of papaverine are exerted on cardiac and smooth muscle. Papaverine relaxes various smooth muscles, especially those of larger arteries; this relaxation may be prominent if spasm exists. The antispasmodic effect is a direct one and unrelated to muscle innervation, and the muscle still responds to drugs and other stimuli causing contraction. Papaverine has minimal actions on the central nervous system, although very large doses tend to produce some sedation and sleepiness in some patients. In certain circumstances, mild respiratory stimulation can be observed, but this is therapeutically inconsequential. Papaverine stimulates respiration by acting on carotid and aortic body chemoreceptors.

Papaverine relaxes the smooth musculature of the larger blood vessels, including the coronary, cerebral, peripheral, and pulmonary arteries. This action is particularly evident when such vessels are in spasm, induced reflexly or by drugs, and it provides the basis for the clinical use of papaverine in peripheral or pulmonary arterial embolism.

Experimentally in dogs, the alkaloid has been shown to cause fairly marked and long-lasting coronary vasodilatation and an increase in coronary blood flow. However, it also appears to have a direct inotropic effect and, when increased mechanical activity coincides with decreased systemic pressure, increases in coronary blood flow may not be sufficient to prevent brief periods of hypoxic myocardial depression.

Papaverine is effective by all routes of administration. A considerable fraction of the drug localizes in fat depots and in the liver, with the remainder being distributed throughout the body. It is metabolized in the liver. About 90% of the drug is bound to plasma protein. Although estimates of its biologic half-life vary widely, reasonably constant plasma levels can be maintained with oral administration at 6-hour intervals. The drug is excreted in the urine in an inactive form.


This monograph has been modified to include the generic and brand name in many instances.

 

Patient Information

No information provided. Please refer to the PRECAUTIONS section.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names:

Generic Name: papaverine (injection) (Pronunciation: pa PAV er een)

  • What is papaverine injection ?
  • What are the possible side effects of papaverine injection ?
  • What is the most important information I should know about papaverine injection ?
  • What should I discuss with my health care provider before I receive papaverine injection ?
  • How is papaverine injection given ?
  • What happens if I miss a dose ?
  • What happens if I overdose ?
  • What should I avoid while receiving papaverine injection ?
  • What other drugs will affect papaverine injection ?
  • Where can I get more information?

What is papaverine injection ?

Papaverine injection is a vasodilator that works by relaxing smooth muscles in your blood vessels to help them dilate (widen). This lowers blood pressure and allows blood to flow more easily through your veins and arteries.

Papaverine injection is used to treat many conditions that cause spasm of smooth muscle, including heart attack, chest pain, circulation problems, or disorders of the stomach or gallbladder.

Papaverine injection may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of papaverine injection ?

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.

Tell your doctor at once if you have a serious side effect such as:

  • low fever, nausea, stomach pain, loss of appetite;
  • dark urine, clay-colored stools;
  • jaundice (yellowing of the skin or eyes);
  • warmth, redness, or tingly feeling in your face;
  • swelling, pain, or irritation around the IV needle;
  • fast heart rate; or
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • mild nausea or stomach discomfort;
  • constipation, diarrhea;
  • mild skin rash;
  • tired feeling;
  • headache; or
  • increased sweating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Papaverine Injection (papaverine hydrochloride injection) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about papaverine injection ?

You should not receive this medication if you are allergic to papaverine injection, or have a certain heart condition called AV heart block.

If possible, before you receive papaverine injection tell your doctor if you have glaucoma, liver disease, Parkinson's disease, or if you are using levodopa (Larodopa, Atamet, Parcopa, Sinemet).

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to drowsiness caused by papaverine injection.

Serious side effects of papaverine injection include nausea, stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), redness or tingling in your face, fast heart rate, skin rash, bruising, severe tingling, numbness, pain, muscle weakness, or swelling or pain around the IV needle.

Side Effects Centers
  • Papaverine Injection

Patient Detailed How Take

What should I discuss with my health care provider before I receive papaverine injection ?

You should not receive this medication if you are allergic to papaverine injection, or have a certain heart condition called AV heart block.

If possible, before you receive papaverine injection tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma;
  • Parkinson's disease; or
  • liver disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. Papaverine may be harmful to an unborn baby. Tell your doctor if you are pregnant before you receive this medication.

It is not known whether papaverine injection passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.

How is papaverine injection given ?

Papaverine injection is given as an injection into a muscle, or through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

When given as an injection into a vein, papaverine injection must be given slowly (over 1 or 2 minutes) to prevent vein irritation or other side effects.

Side Effects Centers
  • Papaverine Injection

Patient Detailed Avoid Taking

What happens if I miss a dose ?

Since papaverine injection is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose ?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include weakness, nausea, vomiting, drowsiness, blurred vision, sweating, warmth or redness under your skin, fast heart rate, or seizure (convulsions).

What should I avoid while receiving papaverine injection ?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to drowsiness caused by papaverine injection.

What other drugs will affect papaverine injection ?

Before using papaverine injection, tell your doctor if you take levodopa (Larodopa, Atamet, Parcopa, Sinemet).

This list is not complete and there may be other drugs that can interact with papaverine injection. 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.

Where can I get more information?

Your pharmacist can provide more information about papaverine injection.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.05. Revision date: 12/15/2010.

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