Pharmacotherapeutic group: analgesic (analgesic non-narcotic spasmolytic barbiturate).
ATC code: M02BB52.
Combination drug. The combination of the drug components leads to mutual enhancement of their pharmacological action. Metamizole sodium is a pyrazolone derivative with analgesic and antipyretic effect. Bendazole (dibazole) is a vasodilator; it has a vasodilator effect, stimulates spinal cord function.
It has a direct antispasmodic effect on smooth muscles of blood vessels and internal organs. Facilitates synaptic transmission in the spinal cord. Papaverine hydrochloride is an antispasmodic agent, has a hypotensive effect, reduces tone and relaxes smooth muscles of internal organs and blood vessels. Phenobarbital in small doses has a sedative effect and enhances the effect of other components.
Pain syndrome (mild to moderately pronounced) in spasms of smooth muscles of internal organs:
- renal colic, biliary colic, intestinal colic;
- biliary dyskinesia, postcholecystectomy syndrome;
- spasm of the ureters and bladder;
Spasm of cerebral vessels, migraine.
As an adjunctive medicine: pain syndrome after surgery and diagnostic procedures.
Bendazol, Sodium Metamizole, Papaverine, Phenobarbital
Sodium metamizole (analgin) – 250 mg,
phenobarbital – 20 mg,
bendazole (dibazole) – 20 mg,
papaverine hydrochloride – 20 mg.
potato starch – 46 mg,
talc – 7 mg,
stearic acid – 3 mg,
calcium stearate – 4 mg.
How to take, the dosage
Orally, adults and children over 8 years old take 1 tablet 2-3 times a day. Duration of use without physician’s consultation should not exceed 7 days.
Combination with nitrates (nitroglycerin, nitrosorbide, Sustac etc.), calcium channel blockers (nifedipine, corinfar etc.), beta-adrenoblockers (anapriline, metoprolol, thalinolol etc.), ganglioblockers (pentamine etc.), diuretics (furosemide, hypothiazide etc.), myotropic antispasmodics (dipyridamole, eufylline etc.) increases the hypotensive effect of these drugs.
Simultaneous use with other non-narcotic analgesics may lead to mutual enhancement of toxic effects. Concomitant use with adsorbents, astringents and coating agents reduces absorption of the drug in the gastrointestinal tract.
In case of long-term (more than 7 days) use the peripheral blood picture and functional state of the liver should be controlled.
In the absence of the effect within 3 days the drug administration should be stopped and the patient should consult a physician.
During the treatment it is necessary to refrain from potentially hazardous activities that require high concentration and quick psychomotor reactions.
The drug should be used by children and adolescents under 18 years old only by prescription.
- Hypersensitivity (including. Hypersensitivity (including to pyrazolone derivatives);
- inhibition of medullary hematopoiesis;
- expressed hepatic and/or renal insufficiency;
- deficiency of glucose-6-phosphate dehydrogenase;
- under 8 years of age, pregnancy, period of tachyarrhythmia, severe angina pectoris.Children under 8 years of age, pregnancy, lactation, tachyarrhythmias, severe angina pectoris, collapse, decompensated chronic heart failure;
- closed angle glaucoma;
- prostate hyperplasia;
- intestinal obstruction, megacolon.
Central nervous system: drowsiness, decreased rate of psychomotor reactions.
Gastrointestinal tract: nausea, constipation.
Cardiovascular system: arterial hypotension.
In long-term use: leukopenia, agranulocytosis, liver and kidney function disorders.
Symptoms of overdose: overdose of the drug is caused by the properties of its constituents. In overdose there is pronounced drowsiness dizziness collaptoid state.
Treatment: first aid – gastric lavage administration of activated charcoal. Symptomatic therapy aimed at maintaining vital functions. Treatment of intoxication as well as prevention of serious complications requires intensive medical supervision and treatment.
Symptoms of overdose: acute overdose is manifested by nausea vomiting abdominal pain impaired renal function/acute renal failure (for example as a manifestation of interstitial nephritis) and rarely CNS symptoms (coma seizures) and decreased blood pressure leading to tachycardia and shock. In high overdose, excretion of rubazonic acid may stain the urine red.
Treatment: no specific antidote is known. In recent overdose, primary detoxification (e.g., gastric lavage) or sorption therapy (e.g., activated charcoal) is used to limit drug intake. The main metabolite (4N-methylaminoantipyrine) is removed by hemodialysis hemoperfusion and plasmafiltration. Treatment of overdose as well as prevention of serious complications may require general and special intensive medical supervision and treatment.
Symptoms of overdose: nystagmus ataxia headache congestion blurred speech pronounced weakness decrease or loss of reflexes agitation increase or decrease in body temperature depression of respiration shortness of breath decrease of blood pressure constriction of pupils (replaced by paralytic dilation) oliguria tachy or bradycardia cyanosis confusion consciousness cessation of electrical activity of brain edema coma later – pneumonia arrhythmia heart failure; at 2-10 g – lethal; with chronic toxicity – irritability impaired ability to critically appraise sleep disturbance confusion.
Treatment: no specific antidote. Gastric lavage administration of activated charcoal detoxification therapy symptomatic treatment maintenance of vital body functions.
Symptoms of overdose: There are no known cases of overdose. The most likely adverse event may be a marked decrease in blood pressure.
Treatment: If there is a pronounced decrease in blood pressure, put the patient in the supine position with the lower extremities elevated and apply symptomatic therapy.
Symptoms of overdose: diplopia (double vision) weakness decrease in blood pressure.
Treatment: symptomatic (maintenance of blood pressure).
The drug is contraindicated in pregnancy and during breastfeeding.
The data on the use of the combined drug Andipal during pregnancy are limited. Sodium metamizole as a component of the drug penetrates the placenta. According to the results of preclinical studies the teratogenic effect of sodium metamizole was not detected. In spite of the fact that sodium metamizole weakly inhibits the synthesis of prostaglandins one cannot exclude premature (intrauterine) closure of the arterial duct as well as perinatal complications caused by disorder of platelet aggregation in mother or newborn.
Sodium metabolites of methamisole penetrate into breast milk; therefore, no breast-feeding should be done when using Andipal and also within 48 hours after the last dose.
2 years 6 months. The drug must not be used after the expiration date.
|Conditions of storage|
In a dry place, protected from light and out of the reach of children.
Update PFC AO, Russia
Update PFC AO
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