Maksigan

General characteristics. Structure:

Active ingredients: 500 mg of metamizole sodium, 5 mg of a pitofenon hydrochloride, 0,1 mg bromide fenpiveriniya.

Excipients: starch prezhelatinizirovanny, lactoses monohydrate, silicon dioxide colloid, magnesium stearate, talc.

Pharmacological properties:

Pharmacodynamics. Are a part of drug: non-narcotic analgesic metamizole sodium, myotropic antispasmodic питофенон and m-holinoblokiruyushchee means fenpiveriniya bromide.

Metamizol is derivative pyrazyl ketone. Possesses soothing, febrifugal and antiinflammatory action. Pitofenon, like a papaverine, has direct myotropic effect on smooth muscles of internals and causes its relaxation.

Fenpiveriny at the expense of m-holinoblokiruyushchego of action makes the additional weakening impact on smooth muscles. The combination of three components of drug leads to pain relief, relaxation of unstriated muscles, decrease in the increased body temperature.

Pharmacokinetics. Metamizole sodium is well and quickly soaked up in a GIT. In a wall of intestines it is hydrolyzed with formation of an active metabolite - not changed metamizole sodium in blood is absent (only later in/in introductions its insignificant concentration is found in plasma). Communication of an active metabolite with proteins - 50-60%. It is metabolized in a liver, removed by kidneys. In therapeutic doses gets into maternal milk.

After peroral introduction of a pitofenon there is its bystry reabsorption from a gastrointestinal path. The maximum concentration in plasma is reached within 30-60 min. and makes 0,34 - 1 mmol/l. It is removed with urine. The elimination half-life makes 1,8 hours.

Fenpiveriniya bromide is quickly soaked up from a GIT and reaches the maximum concentration in a blood plasma within 1 hour. It is removed by kidneys of 32,4 - 40,4% in not changed look, with bile 2,5 - 5,3% of substance are allocated.

Indications to use:

Poorly or moderately expressed pain syndrome at spasms of smooth muscles of internals - renal and hepatic gripes, pains of spastic character on the intestines course, альгодисменорея. It can be applied to a short-term symptomatic treatment at joint pains, neuralgia, an ischialgia, a mialgiya.

As supportive application can be applied to reduction of pains after surgical and diagnostic interventions. If necessary drug can be used for decrease in the increased body temperature at catarrhal and infectious and inflammatory diseases.

Route of administration and doses:

Adults and children are more senior than 15 years apply inside (better after food) usually on 1-2 tablets 2-3 times a day, without chewing, washing down with a small amount of liquid. The daily dose should not exceed 6 tablets.

Duration of reception is no more than 5 days.

Increase in a daily dose of drug or duration of treatment is possible only according to the recommendation and under observation of the doctor.

Dosages for children. At children drug is used only on doctor's orders. Children of 12-14 years: a single dose - 1 tablet, the maximum daily dose - 6 tablets (1,5 tablets 4 times a day), 8-11 years - 0,5 tablets, the maximum daily dose - 4 tablets (on 1 tablet 4 times a day), 5-7 years - 0,5 tablets, the maximum daily dose - 2 tablets (on 0,5 tablets 4 times a day).

Features of use:

During treatment drug does not recommend to accept ethanol. At long treatment (more than a week) control of a picture of peripheral blood and a functional condition of a liver is necessary. At suspicion on an agranulocytosis or in the presence of thrombocytopenia it is necessary to stop administration of drug.

Use for stopping of acute abdominal pains is inadmissible (before clarification of the reason).

Use for nursing mothers demands the breastfeeding termination.

The intolerance meets very seldom, however the threat of development of an acute anaphylaxis in/in administrations of drug is rather higher later, than after administration of drug inside. Patients with atopic bronchial asthma and pollinoses have an increased risk of development of allergic reactions.

At treatment of the patients receiving cytostatic HP, reception of metamizole sodium has to be carried out only under observation of the doctor. Coloring of urine in red color due to allocation of a metabolite is possible (clinical value has no).

Influence on ability to control of motor transport and other difficult mechanisms: during treatment it is necessary to be careful when driving vehicles and at occupation potentially dangerous types of activity demanding speed of physical and psychomotor reaction.

Side effects:

Frequency. the side reactions given below was defined according to the following (classification of World Health Organization): very often - more than 1/10; often - from more than 1/100 to less than 1/10; infrequently - from more than 1/1000 to less than 1/100; seldom - from more than 1/10000 to less than 1/1000; very seldom - from less than 1/10000, including separate messages.

Allergic reactions: a small tortoiseshell, a Quincke's disease, in rare instances - a malignant exudative erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease), a bronkhospastichesky syndrome, an acute anaphylaxis. From an urinary system: a renal failure, an oliguria, an anury, a proteinuria, intersticial nephrite, coloring of urine in red color.

From cardiovascular system: lowering of arterial pressure.

From bodies of a hemopoiesis: thrombocytopenia, a leukopenia, an agranulocytosis (it can be shown by the following symptoms: unmotivated rise in temperature, fever, pharyngalgia, swallowing difficulty, stomatitis, and also development of the phenomena of a vaginitis or proctitis).

Anticholinergic effects: dryness in a mouth, the lowered sweating, accommodation paresis, tachycardia, the complicated urination.

At emergence of these or those adverse side reactions, as soon as possible see a doctor.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

At joint appointment with H1-gistaminoblokatorami, phenyl propyl ketones, fenotiazina, tricyclic antidepressants, amantadiny and quinidine strengthening of m-holinoblokiruyushchego of action is possible.

Strengthens effects of ethanol: simultaneous use with Chlorpromazinum or other derivatives of a fenotiazin can lead to development of the expressed hyperthermia.

Tricyclic antidepressants, oral contraceptives and Allopyrinolum increase toxicity of drug.

Phenylbutazone, barbiturates, etc. gepatoinduktor at co-administration reduce efficiency of metamizole sodium. Sedative and anxiolytic HP (tranquilizers) strengthen analgeziruyushchy effect of metamizole sodium.

X-ray contrast HP, colloid blood substitutes and penicillin should not be used during treatment by the drugs containing metamizole sodium.

At co-administration of cyclosporine concentration of the last in blood decreases. Metamizole sodium, forcing out peroral hypoglycemic HP, indirect anticoagulants, GKS and indometacin from communication with protein, can increase expressiveness of their action. Thiamazolum and cytostatics increase risk of development of a leukopenia.

The effect is strengthened by codeine, blockers of H2-histamine receptors and propranolol (slows down a metamizole sodium inactivation).

Contraindications:

Hypersensitivity to pyrazyl ketone derivatives, and other components of drug. Oppression of a marrowy hemopoiesis, stable and unstable stenocardia, chronic heart failure in a decompensation stage, a liver and/or renal failure; deficit glyukozo-6-fosfatdegidrogenazy; tachyarrhythmias; closed-angle form of glaucoma; a prostate hyperplasia with a tendency to an ischuria; intestinal impassability and megacolon; the bronchial asthma, a small tortoiseshell or acute rhinitis provoked by reception of acetylsalicylic acid, salicylates and other non-steroidal anti-inflammatory drugs, a granulocytopenia, pregnancy; lactation period.

Максиган® in this dosage form it is not recommended for use for children under 5 years.

With care and under control of the doctor patients should use drug with the broken function of a liver or kidneys, at tendency to arterial hypotension (systolic pressure is lower than 100 mm hg), to a bronchospasm. At disturbance of a hemopoiesis as a result of treatment by cytostatics.

If at you one of the listed diseases, before administration of drug surely consult with the doctor.

Overdose:

At overdose the following symptoms can be observed by drug: vomiting, feeling of dryness in a mouth, sweating change, accommodation disturbance, a lowering of arterial pressure, drowsiness, confusion of consciousness, an abnormal liver function and kidneys, a spasm.

In need of simultaneous use of the specified and other medicines it is necessary to consult with the doctor.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the date specified on packaging.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in the blister from PVC and aluminum foil. On 1, 2 or 10 blisters with the application instruction place in a cardboard pack. On 10 cardboard packs on 1 blister place in a cardboard box.