Kombispazm

General characteristics. Structure:

Active ingredients: 500 mg of paracetamol, 20 mg of dicyclomine of a hydrochloride.

Vvspomagatelny substances: starch corn, methylhydroxybenzoate, пропилгидроксибензоат, povidone, magnesium stearate, talc, silicon dioxide colloid, sodium krokhmalglikolit, the water purified.

The combined drug containing in structure paracetamol and dicyclomine a hydrochloride. Possesses the febrifugal, anesthetizing, spasmolytic, cholinolytic and myotropic action.

Pharmacological properties:

Pharmacodynamics. Paracetamol as the representative of the NPVP group, has the antipyretic and analgeziruyushchy effect connected with its influence on the centers of thermal control located in a hypothalamus and with ability to inhibit its prostaglandinovy synthesis.
Dicyclomine the hydrochloride is characterized by myotropic, cholinolytic and spasmolytic action. It is capable to eliminate spasms of smooth muscles of a digestive tract, to reduce or stop the pain syndrome caused by spasms, to provide decrease in secretion of sweat, salivary, gastric and bronchial glands.
Effect of dicyclomine is caused by its specific anticholinergic influence on atsetilkholinovy receptors similar to effect of atropine (so-called antimuskarinovy activity of dicyclomine), and also, thanks to blocking a histamine - and bradikinin - the induced spasms, its direct impact on smooth muscles.

Pharmacokinetics. After oral administration paracetamol is quickly and almost completely soaked up in a digestive tract, reaching the maximum concentration in 15-60 minutes after reception. Ability to contact proteins of plasma – about 10%. Paracetamol mostly in the form of inactive metabolites (sulfate of paracetamol and a glucuronide) is metabolized in a liver. A smaller part it with the participation of P450 cytochrome is oxidized with formation of merkaptopurovy acid and cysteine. The elimination half-life of paracetamol makes about 2 hours. Paracetamol in the form of metabolites with urine is preferential removed, only 5 its % are excreted in not changed look. At purpose of drug the patient with a liver failure metabolism of paracetamol does not change.
The dicyclomine hydrochloride after oral administration is quickly distributed in fabrics and in a blood plasma reaches the maximum concentration 60-90 minutes later. According to researches the elimination half-life makes 1,8 hours. Concentration of dicyclomine remain in plasma within a day after a single dose of a dose. The elimination half-life in the second phase of elimination slightly increases. About 80% of drug are excreted with urine, and the rest – with a stake.

Indications to use:

Kombispazm is used for stopping or reduction of a pain syndrome of various etiology: at a headache, a dentagra, neuralgia, mialgiya, radiculitises, rheumatic pains, renal colic, an algomenorrhea.

Route of administration and doses:

Kombispazm it is necessary to accept inside and to wash down with a small amount of water (200 ml)

To adults and children of 15 years Kombispazm is appointed from 1 to 4 times a day (the mode of reception depends on intensity and the nature of pain) on 1-2 tablet.
To children from 7 to 13 years – once or twice a day on ½ tablets.
To children from 13 to 15 years – from 1 to 3 times a day on 1 tablet.
The most admissible daily dosage of Kombispazm for children makes 150 mg on kg of body weight of the child, for adults – 12 tablets (6 g).
The minimum recommended interval between repeated administration of drug makes 4 hours.

Adult patients are recommended to begin therapy by Kombispazm with reception of four tablets in day. The daily dosage can be increased if necessary and lack of side effects to 8 tablets. In the absence of effect during two-week administration of drug or at emergence of side effects when using small dosages, it is reasonable to stop therapy by Kombispazm.

Features of use:

It is necessary to be careful at Kombispazm's appointment to patients with the increased prostate, urination disturbance, heart failure, tachycardia, intestinal impassability, ulcer colitis, disturbances of functions of a liver and kidneys, a stenosis of peloric department, a high-quality hyperbilirubinemia.

Kombispazm can strengthen a gastroezofagalny reflux.
Drug is capable to slow down physical and mental reactions that should be considered during the work with moving mechanisms and management of transport.

Side effects:

When using Kombispazm's emergence of allergic reactions (a small tortoiseshell, skin rashes with an erythema), dryness in a mouth, thirst, the complicated swallowing, disturbance of accommodation, expansion of pupils, increase in intraocular pressure, a hyperemia and a xeroderma, arrhythmia, tachycardia, bradycardia, the complicated urination, locks is possible. Confusion, fever, a leukopenia, thrombocytopenia, an agranulocytosis, a neutropenia is seldom noted. Prolonged use of Kombispazm in high doses can provoke a hepatotoxic action of drug. Emergence of rashes demands drug withdrawal.

Interaction with other medicines:

Kombispazm in a combination with the medicines exerting impact on motility of a digestive tract (Metoclopramidum) is capable to render converse effect.

At a concomitant use with Kombispazm antihistaminic drugs, амантадин, antipsychotic means (Meperidinum), nitrites and nitrates, antiaritmik І a class, benzodiazepines, narcotic analgetics, MAO inhibitors, tricyclic antidepressants, sympathomimetics can strengthen anticholinergic effect of drug.

The concomitant use of drug with barbiturates, rifampicin, alcohol, anticonvulsants increases hepatotoxic effect of paracetamol. Kombispazm is capable to render converse effect to the means used at treatment of glaucoma. Its concomitant use with glucocorticosteroids against the background of the increased intraocular pressure can constitute danger.

It is necessary to avoid a concomitant use of Kombispazm and antacids because of ability of the last to worsen absorption of anticholinergic drugs. When carrying out analyses of secretion of a stomach and at therapy of an achlorhydria it is necessary to consider that anticholinergics have the oppressing effect on secretion of acid in a stomach.

Contraindications:

Kombispazm is contraindicated to patients with glaucoma, tachycardia, a myasthenia, disturbance of passability of urinary tract, hypersensitivity to drug components, heavy disturbances of functions of kidneys and a liver, the children who did not reach seven-year age and women in the lactic period. There are no sufficient data about efficiency and safety of reception of Kombispazm at pregnant women.

Overdose:

High doses of paracetamol have cytolytic effect on hepatic fabric. 12-24 hours later signs (biochemical and clinical) hepatic defeat are shown: activity of a dehydrogenase, hepatic transaminases increases, the level of a prothrombin decreases and concentration of bilirubin increases.

At overdose of drug are noted: pallor of skin, vomiting, nausea, anorexia, abdominal pains.

Overdose treatment: obligatory gastric lavage, N-Acetylcysteinum, performing symptomatic therapy.

Storage conditions:

To store in the unavailable to children, dry, protected from light place at a temperature of 15-25 degrees Celsius.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in planimetric packaging. On 1 planimetric packaging in a cardboard pack. On 10 planimetric packagings at cardboard to a pack.