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  • Papaverine Teva Injection
    / Teva


    Active Ingredient
    Papaverine (HCl) 40 mg / 2 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    10 X 2 ml

    not in the basket chart 6946 16194

    Dosage

    Method of administration: Intramuscular or intravenous route.
    Papaverine should be administered by or under the immediate supervision of a physician.
    Papaverine administration should be discontinued if any sign or symptom of liver tenderness occurs in the treated patient.
    ECG monitoring should be performed before and during parenteral treatment.
    Adults: From 30 to 120 mg.
    Administration should be slow (1-2 minutes).
    Intravenous use should be reserved for cases where an immediate effect is desired.


    Indications

    As an antispasmodic in the following conditions:
    – Visceral spasm, e.g., gastrointestinal colic, biliary and urinary tract spasms.
    – Peripheral vascular disease in which there is a vasospastic element.
    – Vascular spasm associated with acute myocardial infarction, angina pectoris, peripheral and pulmonary embolism.


    Contra-Indications

    Hypersensitivity to papaverine or any of the other ingredients.
    Intravenous injection: contraindicated in patients with complete atrioventricular block.
    Severe heart failure.
    Recent myocardial infarction.
    Recent heart attack.
    Heart rhythm disorders (bradycardia).
    In case of intracranial hypertension.
    Hepatic disease.


    Special Precautions

    – A too rapid intravenous injection may lead to arrhythmias and fatal apnea.
    – Due to the risk of heart rhythm disorders, caution should be exercised in cases of cardiac conduction disorders or unstable cardiovascular diseases.
    – Administration of papaverine should be discontinued if symptoms of hepatotoxicity occur.
    – Liver and blood tests should be regularly monitored in patients on chronic papaverine treatment.
    – Papaverine should be administered with caution to patients with decreased gastrointestinal motility as they are more exposed to digestive disorders.
    – Intravenous injection is not recommended for children under 15 years of age.
    This medicine contains less than 1 mmol sodium (23 mg) per ampule, that is to say essentially ‘sodium-free’.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    Papaverine reduces the therapeutic effect of levodopa (antiparkinsonian agent).
    If papaverine is given while being treated with calcium antagonists, it is possible that they may increase the effect of papaverine.
    Due to its weak antiarrhythmic properties, papaverine may increase the effects of similar medicinal products such as hypotensive agents.
    Nicotine can reduce or even abolish the vasodilator effects of papaverine.
    The effects of papaverine may be slightly potentiated by concomitant use of central nervous system depressants and a synergistic effect may be expected when combined with morphine.


    Pregnancy and Lactation

    Pregnancy: There are no data on the use of papaverine in pregnant women. Animal studies are not sufficient to assess the reproductive toxicity .
    Papaverine is not recommended during pregnancy or for women who may be pregnant and do not use contraception.
    Lactation: It is not known whether papaverine or its metabolites pass into breast milk. A risk to the breastfed infant cannot be excluded.
    A decision must be made whether or not to discontinue breastfeeding or to discontinue treatment with papaverine, taking into account the benefit of breastfeeding for the infant with regard to the benefit of treatment for the woman.


    Overdose

    Symptoms: Overdose may cause vasomotor instability with nausea, vomiting, weakness, central nervous system depression, flushing, lightheadedness, stroke, heart rhythm disorders and tachycardia.
    Acute overdose is expressed in hypotension and cardiorespiratory depression.
    Treatment: At the first signs of overdose, treatment should be discontinued and the treating physician should be notified who will decide whether hospitalization is required.
    In case of overdose, symptomatic treatment consists of supporting patient ventilation and blood circulation.
    Vital signs (blood gas and cardiac conduction) should be monitored.
    In case of seizures, parenteral administration of diazepam, phenytoin or phenobarbital will be started.
    In case of refractory seizures, thiopental and halothane may be used to induce general anesthesia and a neuromuscular blocking agent may be used to cause paralysis.
    To treat hypotension, administer intravenous fluids and, if necessary, sympathomimetic agents (norepinephrine).
    For the treatment of heart disorders, intravenous administration of calcium gluconate together
    with ECG monitoring may be helpful.


    Important notes

    Incompatibilities: Do not add the papaverine solution to a lactated Ringer’s solution as it may form a precipitate.
    Storage: Store below 25°C. Do not freeze.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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