Maksigan

General characteristics. Structure:

Active ingredients: 2,5 g of metamizole sodium, 10 mg of a pitefenon of a hydrochloride, 100 mkg a bromide fenpiviriniya in 1 ampoule.

Excipients: water for injections, chlorohydrogen acid.

Pharmacological properties:

Pharmacodynamics. The combined drug with analgeziruyushchy and spasmolytic action.

Metamizole sodium – an analgetic antipyretic, is derivative pyrazyl ketone. Has analgeziruyushchy, febrifugal and antiinflammatory effect.

Pitofenona a hydrochloride has direct myotropic effect on smooth muscles of internals and causes its relaxation.

Fenpiveriniya bromide 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 mutual strengthening of their pharmacological action, expressed in pain relief, relaxation of unstriated muscles and decrease in the increased temperature.

Pharmacokinetics. Data on drug pharmacokinetics Maksigan are not provided.

Indications to use:

— moderately expressed pain syndrome at spasms of smooth muscles of internals (including renal colic, hepatic colic, bilious colic, intestinal colic, альгодисменорея, dyskinesia of biliary tract);

— for a short-term symptomatic treatment at neuralgia, an arthralgia, an ischialgia, a mialgiya;

— as auxiliary drug for reduction of pains after surgical interventions and diagnostic procedures;

— for decrease in the increased body temperature at catarrhal and infectious and inflammatory diseases (for tablets).

Route of administration and doses:

Maksigan in the form of tablets for intake appoint to adults and teenagers 15 years on 1-2 таб are more senior. 2-3 times/days. The maximum daily dose – 6 таб. Reception duration – no more than 5 days.

To children at the age of 6-8 years appoint 1/2 таб., to children at the age of 9-12 years - 3/4 таб., to children at the age of 13-15 years - on 1 таб. Frequency rate of reception – 2-3 times/days.

It is more preferable to take a pill after meal.

Maksigan in the form of solution for injections appoint in oil or in / century. To adults and teenagers 15 years at heavy acute gripes are more senior administer the drug in/in slowly (on 1 ml within 1 min.) on 2 ml. If necessary the drug is administered repeatedly in 6-8 h.

The drug in oil is administered on 2 ml of 2 times/days. The maximum daily dose – 4 ml. Treatment duration – no more than 5 days.

To children the drug is administered in oil or in/in depending on age and body weight.

Age	Body weight	In/in introduction	Introduction in oil
3-11 months	5-8 kg	it is 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	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 perhaps repeated administration of drug in the same doses. Before administration of solution it should be warmed in hands.

Features of use:

Use at pregnancy and feeding by a breast. Drug is contraindicated to use at pregnancy (the I trimester and the last 6 weeks) and in the period of a lactation (breastfeeding).

Use at abnormal liver functions. It is contraindicated at the expressed abnormal liver functions. With care and under control of the doctor it is necessary to appoint drug at abnormal liver functions.

Use at renal failures. It is contraindicated at the expressed renal failures. With care and under control of the doctor it is necessary to appoint drug at renal failures.

At long (more than 1 week) use of drug it is necessary to control a pattern of peripheral blood (quantity of leukocytes and thrombocytes) and a functional condition of a liver. At suspicion on an agranulocytosis or thrombocytopenia Maksigan's use should be stopped.

Solution for injections is not used for stopping of acute abdominal pains before clarification of the reason.

Parenteral administration of drug is used in case of emergency (for example, renal or hepatic colic) and when administration of drug is inside impossible. With care it is necessary to carry out to administration of drug (since there is a risk of development of arterial hypotension). It is necessary to carry out to introduction slowly, the patient has to be in a prone position, it is necessary to control the ABP, ChSS and a respiration rate.

At drug use Maksigan it is necessary to avoid alcohol intake.

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

Influence on ability to driving of motor transport and to control of mechanisms. During administration of drug it is not recommended to manage vehicles and to be engaged in other potentially dangerous types of activity demanding speed of psychomotor reactions

Side effects:

Allergic reactions: skin rash, itch; seldom – an acute anaphylaxis, a small tortoiseshell, a Quincke's disease; in isolated cases – a malignant exudative erythema (Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease).

From the alimentary system: in isolated cases - burning sensation in epigastric area, dryness in a mouth.

From TsNS: in isolated cases – a headache, dizziness, accommodation paresis.

From system of a hemopoiesis: thrombocytopenia, a leukopenia, an agranulocytosis (it can be shown by temperature increase, a fever, a pharyngalgia, swallowing difficulty, stomatitis, a vaginitis, a proctitis).

From respiratory system: a bronchospasm (especially at predisposed patients).

From cardiovascular system: tachycardia, decrease in the ABP.

From an urinary system: seldom (usually at long reception or appointment in high doses) – an oliguria, an anury, a proteinuria, intersticial nephrite, coloring of urine in red color (it is caused by metamizol metabolites); in isolated cases – the complicated urination.

Local reactions: at introduction in oil infiltrates in an injection site are possible.

Others: in isolated cases – decrease in sweating.

Interaction with other medicines:

At simultaneous use of Maksigan with other not opioid analgetics mutual strengthening of toxic effects is noted.

Tricyclic antidepressants, oral contraceptives, Allopyrinolum break metabolism of metamizole sodium and increase its toxicity.

Barbiturates, phenylbutazone and other inductors of microsomal enzymes of a liver weaken effect of metamizole sodium.

At simultaneous use of Maksigan with cyclosporine the level of the last in blood decreases.

Sedative drugs and tranquilizers strengthen analgeziruyushchy effect of metamizole sodium.

At co-administration of Maksigan with blockers of histamine H1 - receptors, phenyl propyl ketones, fenotiazina, amantadiny and quinidine strengthening of m-holinoblokiruyushchego of action is possible.

At simultaneous use with ethanol mutual strengthening of effects is noted.

At simultaneous use of Maksigan with Chlorpromazinum or other derivatives of a fenotiazin development of the expressed hyperthermia is possible.

Metamizole sodium, forcing out peroral hypoglycemic drugs, indirect anticoagulants from communication with protein, GKS and indometacin can strengthen their clinical effects.

At simultaneous use of Maksigan with Thiamazolum and cytostatics the risk of development of a leukopenia increases.

At simultaneous use codeine, blockers of histamine H2 - receptors, propranolol slow down an inactivation of metamizole sodium and strengthen its action.

Pharmaceutical interaction. Solution for injections pharmaceutical is incompatible in one syringe with solutions of other medicines.

Contraindications:

— the expressed abnormal liver functions;

— the expressed renal failures;

— genetic deficit glyukozo-6-fosfatdegidrogenazy;

— tachyarrhythmia;

— closed-angle glaucoma;

— a prostate hyperplasia (with clinical manifestations);

— oppression of a marrowy hemopoiesis;

— intestinal impassability;

— megacolon;

— collapse;

— acute porphyria;

— granulocytopenia;

— chronic heart failure in a decompensation stage;

— stable and unstable stenocardia;

— pregnancy (I trimester and last 6 weeks);

— period of a lactation (breastfeeding);

— hypersensitivity to derivatives of pyrazyl ketone and other components of drug.

Maksigan in the form of tablets do not appoint to children 5 years are younger. Solution for injections is not appointed to children aged up to 3 months or with body weight by less than 5 kg.

With care and under control of the doctor it is necessary to appoint drug at abnormal liver functions or kidneys, at predisposition to arterial hypotension (systolic pressure less than 100 mm hg), to a bronchospasm, at hypersensitivity to NPVP or not opioid analgetics (including at instructions in the anamnesis to "an aspirinovy triad").

Overdose:

Symptoms: vomiting, decrease in the ABP, drowsiness, confusion of consciousness, nausea, dryness in a mouth, pain in epigastric area, sweating change, an abnormal liver function and kidneys, a spasm.

Treatment: the gastric lavage, purpose of absorbent carbon, if necessary carry out symptomatic therapy.

Storage conditions:

Drug should be stored in the place, dry, dark, unavailable to children, at a temperature not above 25 °C. A period of validity – 3 years.

Issue conditions:

According to the recipe

Packaging:

On 5 ml in ampoules from dark glass, on 5 ampoules in a strip packaging and a cardboard pack.