Papaverin Bufus (Solution) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

A03AD01 (Papaverine)

Active Substance

Papaverine (BAN)

Dosage Form

Papaverine Bufus

Solution for intravenous and intramuscular administration 20 mg/1 ml: amp. 2 ml 10 or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration in the form of a transparent, slightly colored liquid.

Excipients: disodium edetate (Trilon B) – 0.05 mg, methionine – 0.1 mg, water for injection – up to 1 ml.

2 ml – ampoules (10) – cardboard boxes.
2 ml – ampoules (100) – cardboard boxes.

Clinical-Pharmacological Group

Myotropic antispasmodic

Pharmacotherapeutic Group

Drugs for the treatment of functional gastrointestinal disorders; papaverine and its derivatives

Pharmacological Action

Myotropic antispasmodic. It inhibits phosphodiesterase (PDE), causes the accumulation of cAMP in the cell and reduces the content of intracellular calcium. It reduces the tone of the smooth muscles of internal organs (gastrointestinal tract, respiratory, urinary, reproductive systems) and blood vessels.

It causes dilation of arteries, promotes an increase in blood flow, including cerebral blood flow. It has a hypotensive effect.

In high doses, it reduces the excitability of the heart muscle and slows intracardiac conduction.

When used in average therapeutic doses, the effect on the central nervous system is weakly expressed.

Pharmacokinetics

Bioavailability is 54%. Plasma protein binding is 90%. It is well distributed in the body, penetrates histohematic barriers. It is metabolized in the liver.

Half-life (T_1/2) is 0.5-2 hours. An increase up to 24 hours is possible.

It is excreted by the kidneys in the form of metabolites. It is completely removed from the blood by dialysis.

Indications

Spasms of the smooth muscles of the abdominal organs, bronchi, peripheral vessels, cerebral vessels, kidneys; angina pectoris (as part of combination therapy).

As an auxiliary agent for premedication.

ICD codes

Dosage Regimen

Administer the solution via intramuscular, subcutaneous, or slow intravenous injection.

For adults, the typical single dose is 10-20 mg (0.5-1 ml of the 20 mg/ml solution).

Maintain an interval of at least 4 hours between consecutive administrations.

For elderly patients, initiate therapy with a reduced single dose not exceeding 10 mg (0.5 ml).

For pediatric patients aged 1 to 12 years, calculate the maximum single dose as 200-300 mcg/kg of body weight.

Do not administer to children under 6 months of age.

Perform intravenous injections slowly and under direct medical supervision to minimize cardiovascular risks.

Adjust frequency of administration based on clinical response and tolerability, not exceeding 5 times daily.

Adverse Reactions

Possible nausea, constipation, drowsiness, increased sweating, arterial hypotension, increased activity of hepatic transaminases.

With rapid intravenous administration, as well as with the use of high doses development of AV block, cardiac arrhythmias.

Contraindications

AV block, glaucoma, severe hepatic insufficiency, elderly age (risk of hyperthermia), children under 6 months of age, hypersensitivity to papaverine.

Use in Pregnancy and Lactation

During pregnancy and lactation (breastfeeding), the safety and efficacy of papaverine have not been established.

Use in Hepatic Impairment

Contraindicated in severe hepatic insufficiency.

Pediatric Use

Contraindicated in children under 6 months of age.

Geriatric Use

Contraindicated in elderly age (risk of hyperthermia).

Special Precautions

Use with caution in conditions after traumatic brain injury, in chronic renal failure, adrenal insufficiency, hypothyroidism, prostatic hyperplasia, supraventricular tachycardia, shock conditions.

Intravenous administration should be slow and under medical supervision.

Alcohol consumption should be avoided during treatment.

Drug Interactions

With simultaneous use with anticholinergic agents, an enhancement of anticholinergic effects is possible.

It is believed that with simultaneous use with alprostadil for intracavernosal injection, there is a risk of priapism.

There are reports of a decrease in the effectiveness of levodopa with its simultaneous use.

It reduces the hypotensive effect of methyldopa.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.