Universal reference book for medicines
Product name: MAXIGAN (MAXIGAN)

Active substance: fenpiverinium bromide, metamizole sodium, pitofenone

Type: Spasmoanalgesic

Manufacturer: UNICHEM Laboratories (India)
Composition, form of production and packaging
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Tablets are white, round, flat, with a facet and a risk.
1 tab.

metamizole sodium 500 mg

pituophenone hydrochloride 5 mg

fenpiverinia bromide 100 μg

Excipients: lactose, starch, silicon dioxide, talc, magnesium stearate.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
The injection solution is clear, light yellow in color.

1 ml of 1 amp.

metamizole sodium 500 mg 2.5 g

pituophenone hydrochloride 2 mg 10 mg

fenpiverinia bromide 20 μg 100 μg

Auxiliary substances: hydrochloric acid, water d / u.

5 ml - dark glass ampoules (5) - packings of cellular contour (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2005.

PHARMACHOLOGIC EFFECT

Combined drug with analgesic and antispasmodic effect.

Metamizole sodium - an analgesic-antipyretic, is a derivative of pyrazolone.
Has analgesic, antipyretic and anti-inflammatory effect.
Pitofenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax.

Fentiverinia bromide due to m-cholinoblocking action has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action, expressed in relieving pain, relaxing smooth muscles and reducing the elevated temperature.

PHARMACOKINETICS

Data on the pharmacokinetics of Maxigan are not available.

INDICATIONS

- Moderately expressed pain syndrome with spasms of smooth muscles of internal organs (including renal colic, hepatic colic, biliary colic, intestinal colic, algodismenorea, dyskinesia of bile ducts);

-for short-term symptomatic treatment for neuralgia, arthralgia, ischialgia, myalgia;

- as an auxiliary preparation for pain reduction after surgical interventions and diagnostic procedures;

-to reduce the elevated body temperature for colds and infectious-inflammatory diseases (for tablets).

DOSING MODE

Maxigan in the form of tablets for oral administration is prescribed for adults and adolescents over 15 years of age for 1-2 tablets.
2-3 times / day. The maximum daily dose is 6 tablets. Duration of reception - no more than 5 days.
Children aged 6-8 years are prescribed 1/2 tablets, children aged 9-12 years - 3/4 tablets, children aged 13-15 years - 1 tab.
Multiplicity of admission - 2-3 times / day.
Tablets are preferable to take after meals.

Maxigan in the form of a solution for injection is prescribed in / m or / in.
Adults and adolescents over 15 years of age with severe acute colic are injected iv slowly (1 ml for 1 min) 2 ml each. If necessary, the drug is administered again after 6-8 hours.
In / m the drug is administered 2 ml 2 times / day.
The maximum daily dose is 4 ml. Duration of treatment - no more than 5 days.
For children, the drug is given in / m or / in depending on age and body weight.

Age Body mass I / O administration V / m administration

3-11 months 5-8 kg not shown 0.1-0.2 ml

1-2 years 9-15 kg 0.1-0.2 ml 0.2-0.3 ml

3-4 years 16-23 kg 0.2-0.3 ml 0.3-0.4 ml

5-7 years 24-30 kg 0.3-0.4 ml 0.4-0.5 ml

8-12 years old 31-45 kg 0.5-0.6 ml 0.6-0.7 ml

12-15 years 46-53 kg 0.8-1 ml 0.8-1 ml

If necessary, repeated administration of the drug in the same doses is possible.

Before the introduction of the solution, it should be warmed in the hands.

SIDE EFFECT

Allergic reactions: skin rash, itching;
rarely - anaphylactic shock, hives, angioedema; in isolated cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).
On the part of the digestive system: in a few cases - a burning sensation in the epigastric region, dry mouth.

From the side of the central nervous system: in isolated cases - headache, dizziness, paresis of accommodation.

On the part of the hematopoiesis system: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by fever, chills, sore throat, difficulty swallowing, stomatitis, vaginitis, proctitis).

On the part of the respiratory system: bronchospasm (especially in predisposed patients).

From the cardiovascular system: tachycardia, lowering blood pressure.

On the part of the urinary system: rarely (usually with prolonged admission or administration in high doses) - oliguria, anuria, proteinuria, interstitial nephritis, urine staining red (due to Metamizol metabolites);
in isolated cases - difficulty urinating.
Local reactions: with the / m introduction, infiltrates are possible at the injection site.

Other: in single cases - decreased sweating.

CONTRAINDICATIONS

- pronounced violations of the liver function;

- severe renal dysfunction;

- genetic deficiency of glucose-6-phosphate dehydrogenase;

- Tachyarrhythmia;

- an angle-closure glaucoma;

- hyperplasia of the prostate (with clinical manifestations);

- oppression of bone marrow hematopoiesis;

- intestinal obstruction;

- megacolon;

- collapse;

- acute porphyria;

- granulocytopenia;

- chronic heart failure in the stage of decompensation;

- stable and unstable angina;

- Pregnancy (I trimester and the last 6 weeks);

- the period of lactation (breastfeeding);

- Hypersensitivity to pyrazolone derivatives and other components of the drug.

Maxigan in the form of tablets is not prescribed for children under 5 years of age.

Solution for injection is not prescribed for children under 3 months of age or with a body weight of less than 5 kg.

With caution and under the supervision of a doctor, the drug should be prescribed for violations of the liver or kidney function, with a predisposition to arterial hypotension (systolic pressure less than 100 mm Hg), bronchospasm, with increased sensitivity to NSAIDs or non-opioid analgesics (including instructions in the anamnesis for the "aspirin triad").

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy (I trimester and the last 6 weeks) and during lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe impairment of kidney function.
With caution and under the supervision of a doctor should prescribe the drug for violations of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe violations of liver function.
With caution and under the supervision of a doctor, a drug should be prescribed for violations of liver function.
APPLICATION FOR CHILDREN

Solution for injection is not prescribed for children under 3 months of age or with a body weight of less than 5 kg.

Maxigan in the form of tablets for oral administration is prescribed for adolescents over 15 years of age to 1-2 tab.
2-3 times / day. The maximum daily dose is 6 tablets. Duration of reception - no more than 5 days.
Children aged 6-8 years are prescribed 1/2 tablets, children aged 9-12 years - 3/4 tablets, children aged 13-15 years - 1 tab.
Multiplicity of admission - 2-3 times / day.
For children, the drug is given in / m or / in depending on age and body weight.

Age Body mass I / O administration V / m administration

3-11 months 5-8 kg not shown 0.1-0.2 ml

1-2 years 9-15 kg 0.1-0.2 ml 0.2-0.3 ml

3-4 years 16-23 kg 0.2-0.3 ml 0.3-0.4 ml

5-7 years 24-30 kg 0.3-0.4 ml 0.4-0.5 ml

8-12 years old 31-45 kg 0.5-0.6 ml 0.6-0.7 ml

12-15 years 46-53 kg 0.8-1 ml 0.8-1 ml

SPECIAL INSTRUCTIONS

With prolonged (more than 1 week) use of the drug, it is necessary to control the picture of peripheral blood (the number of leukocytes and platelets) and the functional state of the liver.
If suspicion of agranulocytosis or thrombocytopenia, the use of Maxigan should be discontinued.
Solution for injection is not used to stop acute abdominal pains until the cause is clarified.

Parenteral administration of the drug is used in emergency cases (for example, renal or hepatic colic) and in those cases when taking the drug inside is not possible.With caution should be carried out in / in the introduction of the drug (because there is a risk of developing arterial hypotension).
I / O administration should be slow, the patient should be in a prone position, it is necessary to monitor blood pressure, heart rate and respiratory rate.
When using Maxigan, avoid drinking alcohol.

Radiocontrast agents and colloidal blood substitutes should not be used during treatment with drugs containing metamizole sodium.

Impact on the ability to drive vehicles and manage mechanisms

During the period of taking the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring rapidity of psychomotor reactions.

OVERDOSE

Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, dry mouth, pain in the epigastric region, changes in sweating, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, the appointment of activated charcoal, if necessary, conduct symptomatic therapy.

DRUG INTERACTION

With the simultaneous use of Maxigan with other non-opioid analgesics, there is a mutual increase in toxic effects.

Tricyclic antidepressants, oral contraceptives, allopurinol disrupt metamizole sodium metabolism and increase its toxicity.

Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

With simultaneous application of Maxigan with cyclosporine, the level of the latter in the blood decreases.

Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

With the simultaneous appointment of Maxigan with blockers of histamine H 1 -receptors, butyrophenones, phenothiazines, amantadine and quinidine, m-cholinoblocking action may be enhanced.

When applied simultaneously with ethanol, there is a mutual enhancement of the effects.

With the simultaneous use of Maxigan with chlorpromazine or other phenothiazine derivatives, it is possible to develop pronounced hyperthermia.

Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, GCS and indomethacin can enhance their clinical effects.

With the simultaneous use of Maxigan with thiamazole and cytostatics, the risk of developing leukopenia increases.

With simultaneous use of codeine, blockers of histamine H 2 receptors, propranolol slows the inactivation of metamizole sodium and enhances its effect.

Pharmaceutical interaction

Solution for injection is not pharmaceutically compatible in one syringe with solutions of other medications.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, dark place inaccessible to children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
Conditions of leave from pharmacies

The drug in the form of tablets is allowed for use as an OTC product.

The drug in the form of a solution for injection is dispensed by prescription.

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