Maxigan - instructions for use, doses, side effects, contraindications

Excipients: pregelatinized starch 25.0 mg, lactose monohydrate 134.9 mg, silicon dioxide colloid 3.0 mg. Magnesium stearate - 6.0 mg, talc - 6.0 mg.

Description:

White or almost white round, flat tablets with a facet and a risk. A slight yellowish tint is allowed.

Pharmacotherapeutic group:Analgesic non-narcotic and antispasmodic

ATX: & nbsp

N.02.B.B.52 Metamizole sodium in combination with other drugs, excluding psycholeptics

Pharmacodynamics:

The composition of the drug includes: non-narcotic analgesic - metamizole sodium, myotropic antispasmodic pitophenone and m-cholin-blocking agent fenpiverinia bromide. Metamizole is a derivative of pyrazolone. It has analgesic, antipyretic and anti-inflammatory action. Pitophenone, like papaverine, has a direct myotropic effect on the smooth musculature of internal organs and causes its relaxation. Fentiverinius due to m-cholinoblocking action has an additional relaxing effect on smooth muscles. The combination of the three components of the drug results in relief of pain, relaxation of smooth muscles, reduction in elevated body temperature.

Pharmacokinetics:

Metamizol sodium well and quickly absorbed into the digestive tract. In the intestinal wall it hydrolyzes with the formation of an active metabolite - unchanged metamizol sodium in the blood is absent (only after intravenous administration of an insignificant of its concentration is detected in the plasma). The association of the active metabolite with proteins is 50-60%. Metabolized in the liver, excreted by the kidneys. In therapeutic doses penetrates into the mother's milk. After oral administration pitophenone there is its fast reabsorption from the gastrointestinal tract. Maximum concentration in plasma is achieved within 30 - 60 minutes and is 0.34 - 1 mMol / l. It is excreted in the urine. The elimination half-life is 1.8 hours.

Fentipierinium bromide quickly absorbed from the gastrointestinal tract and reaches a maximum concentration in the blood plasma for 1 hour. It is excreted by the kidneys at 32.4-40.4% unchanged, 2.5-5.3% of the substance is secreted with bile.

Indications:

Weak or moderately severe pain syndrome with spasms of smooth muscles of internal organs - renal and hepatic colic, pain spastic in the course of the intestine, algodismenorea. Can mixed for short-term symptomatic treatment for painin the joints, neuralgia, ishialgia, myalgia.

As an adjuvant can be used to reduce pain after surgical and diagnostic interventions.

If necessary, the drug can be used to reduce elevated body temperature for colds and infectious-inflammatory diseases.

Contraindications:

Hypersensitivity to pyrazolone derivatives, and other components of the drug. Inhibition of bone marrow hematopoiesis, stable and unstable angina, chronic heart failure in stages of decompensation, hepatic and / or renal failure failure; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmias; closed-angle form of glaucoma; hyperplasia of the prostate with tendency to urine retention; intestinal obstruction and megacolon; A bronchial asthma, a urticaria or an acute rhinitis, provoked reception of acetylsalicylic acid, salicylates and other nonsteroidal anti-inflammatory drugs, granulocytopenia, pregnancy; lactation period. Maxigan® in this drug form is not recommended for use in children under 5 years of age.

Carefully:

Carefully and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, with a tendency to arterial hypotension (systolic pressure below 100 mm Hg) bronchospasm. When blood is damaged as a result of treatment cytostatics. If you have one of the listed diseases, before taking always consult a doctor.

Dosing and Administration:

Adults and children over 15 years of age - use inside (better after eating), usually 1-2 tablespoons 2-3 times a day, without chewing, squeezed a small amount of liquid.

The daily dose should not exceed 6 tablets. Duration of reception no more than 5 days. An increase in the daily dose of the drug or the duration of treatment is possible only byrecommendations and under the supervision of a doctor.

Dosage for children. In children, the drug is used only as directed by a doctor.

Children 12-14 years old: single dose - 1 tablet, maximum daily dose - 6 tablets (1.5 tablets 4 times a day), 8-11 years - 0.5 tablets, maximum daily dose - 4 tablets (1 tablet 4 times a day), 5-7 years - 0.5 tablets, maximum daily dose - 2 tablets (0.5 tablets 4 times a day).

Side effects:

The incidence of adverse reactions listed below was determined according to the following (World Organization Classification health):

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,

rarely from more than 1/10000 to less than 1/1000,

very rarely - from less than 1/10000, including individual messages.

Allergic reactions: urticaria, angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

From the urinary system: a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red.

From the side of the cardiovascular system: lowering of arterial pressure.

On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, and the development of phenomena of vaginitis or proctitis).

Anticholinergic effects: dry mouth, decreased perspiration, paresis of accommodation, tachycardia, difficulty urinating.

In the event of any adverse adverse reactions, as soon as possible consult a doctor. If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:In case of an overdose, the following symptoms may occur: vomiting, dry mouth, sweating, accommodation, blood pressure lowering, drowsiness, confusion, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, saline laxatives, Activated carbon, carrying out forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous diazepam and high-speed barbiturates.

Interaction:

When co-administered with H1-histaminoblockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine, m-cholinoblocking action may be enhanced.

Enhances the effects of ethanol; simultaneous application with Chlorpromazine or other derivatives of phenothiazine may lead to development of severe hyperthermia. Tricyclic antidepressants, oral contraceptives and allopurinol increase toxicity preparation.

Phenylbutazone, barbiturates and other hepatoinductors with simultaneous prescription reduce the effectiveness of metamizole sodium.

Sedative and anxiolytic drugs (tranquilizers) enhance analgesic act metamizole sodium.

Radiocontrast drugs, colloidal blood substitutes and penicillin are not should be used during treatment with drugs containing metamizol sodium.

With the simultaneous administration of cyclosporine, the concentration the latter in the blood. Metamizol sodium, displacing from the bond with the protein, oral hypoglycemic drugs, indirect anticoagulants, GCS, and indomethacin, can increase the severity of their action. Thiamazole and cytostatics increase the risk of developing leukopenia.

The effect is enhanced codeine, H2-histamine receptor blockers and propranolol (slows the inactivation of metamizole sodium).

If you need to use these and other medications at the same time, you should consult your doctor.

Special instructions:

During treatment with the drug is not recommended to take ethanol. At long '(more, week) treatment control of a picture of peripheric blood and a functional status of a liver is necessary. If suspected of agranulocytosis or in the presence of thrombocytopenia should stop taking the drug.

It is inadmissible to use acute pains in the abdomen for relief (before - finding out the cause).

Use in nursing mothers requires discontinuation of the breast feeding.

Intolerance is very rare, but the threat of development anaphylactic shock after. in / in the administration of the drug - is relatively higher than after taking the drug inside. In patients, atopic bronchial asthma and pollinosis have an increased risk of allergic reactions.

In the treatment of patients receiving cytotoxic drugs, metamizole sodium should be administered only under medical supervision.It is possible to stain urine in red by the release of a metabolite (it has no clinical significance).

Effect on the ability to drive transp. cf. and fur:During treatment should be observed caution in driving vehicles and in dealing with potentially hazardous activities requiring quick physical and psychomotor reactions.

Form release / dosage:

Pills.

Packaging:For 10 tablets in a blister of PVC and aluminum foil. For 1, 2 or 10 blisters with instructions for use are placed in a cardboard box. 10 cardboard packs of 1 blister each are placed in a cardboard box.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use later than the date shown on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014139 / 01

Date of registration:19.01.2009 / 04.10.2013

Expiration Date:Unlimited

The owner of the registration certificate:Unikem Laboratories Ltd.Unikem Laboratories Ltd. India

Manufacturer: & nbsp

UNICHEM Laboratories, Ltd. India

Representation: & nbspUNICEM LABORATORIES LTD. UNICEM LABORATORIES LTD. India

Information update date: & nbsp30.03.2018

Illustrated instructions

Instructions

Maxigan (Maxigan)