Maxigan^® (Solution) Instructions for Use

Marketing Authorization Holder

Unichem Laboratories, Ltd. (India)

Contact Information

Unichem Laboratories Ltd. (India)

ATC Code

N02BB52 (Metamizole sodium in combination with other drugs, except psycholeptics)

Active Substances

Metamizole sodium (Rec.INN registered by WHO)

Pitofenone (Rec.INN registered by WHO)

Fenpiverinium bromide (Rec.INN registered by WHO)

Dosage Forms

Maxigan®		Solution for intravenous and intramuscular administration 500 mg+10 mg+0.02 mg/1 ml: amp. 5 ml 5 pcs.
		Tablets 500 mg+5 mg+0.1 mg: 10, 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, flat, with a bevel and a score.

Excipients: lactose, starch, silicon dioxide, talc, magnesium stearate.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
Solution for injection transparent, light yellow.

Excipients: hydrochloric acid, water for injections.
5 ml – ampoules of dark glass (5) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Non-narcotic analgesic agent (non-narcotic analgesic + spasmolytic)

Pharmacological Action

A combined preparation with analgesic and spasmolytic action.

Metamizole sodium is an analgesic-antipyretic, a pyrazolone derivative. It has analgesic, antipyretic and anti-inflammatory effects.

Pitofenone hydrochloride has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Fenpiverinium bromide, due to its m-cholinolytic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the preparation leads to a mutual enhancement of their pharmacological action, expressed in pain relief, relaxation of smooth muscles and reduction of elevated temperature.

Pharmacokinetics

Data on the pharmacokinetics of Maxigan^® are not provided.

Indications

• Moderately severe pain syndrome with spasms of smooth muscles of internal organs (including renal colic, hepatic colic, biliary colic, intestinal colic, algodysmenorrhea, biliary dyskinesia);
• For short-term symptomatic treatment of neuralgia, arthralgia, sciatica, myalgia;
• As an auxiliary preparation to reduce pain after surgical interventions and diagnostic procedures;
• To reduce elevated body temperature in colds and infectious-inflammatory diseases (for tablets).

ICD codes

Dosage Regimen

Maxigan^® in the form of tablets for oral administration is prescribed to adults and adolescents over 15 years 1-2 tablets 2-3 times/day. The maximum daily dose is 6 tablets. The duration of administration is no more than 5 days.

Children aged 6-8 years are prescribed 1/2 tablet, children aged 9-12 years – 3/4 tablet, children aged 13-15 years – 1 tablet. The frequency of administration is 2-3 times/day.

Tablets are preferably taken after meals.

Maxigan^® in the form of a solution for injection is administered intramuscularly or intravenously. Adults and adolescents over 15 years with severe acute colic the drug is administered intravenously slowly (1 ml over 1 min) 2 ml. If necessary, the drug is administered again after 6-8 hours.

Intramuscularly, the drug is administered 2 ml 2 times/day. The maximum daily dose is 4 ml. The duration of treatment is no more than 5 days.

Children the drug is administered intramuscularly or intravenously depending on age and body weight.

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

Before administration, the solution should be warmed in the hands.

Adverse Reactions

Allergic reactions skin rash, itching; rarely – anaphylactic shock, urticaria, angioedema; in isolated cases – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

From the digestive system in isolated cases – burning sensation in the epigastric region, dry mouth.

From the CNS in isolated cases – headache, dizziness, accommodation paresis.

From the hematopoietic system thrombocytopenia, leukopenia, agranulocytosis (may manifest as fever, chills, sore throat, difficulty swallowing, stomatitis, vaginitis, proctitis).

From the respiratory system bronchospasm (especially in predisposed patients).

From the cardiovascular system tachycardia, decreased blood pressure.

From the urinary system rarely (usually with long-term use or administration in high doses) – oliguria, anuria, proteinuria, interstitial nephritis, red coloration of urine (due to metamizole metabolites); in isolated cases – difficulty urinating.

Local reactions with intramuscular administration, infiltrates at the injection site are possible.

Other in isolated cases – decreased sweating.

Contraindications

• Severe liver dysfunction;
• Severe renal dysfunction;
• Genetic deficiency of glucose-6-phosphate dehydrogenase;
• Tachyarrhythmia;
• Closed-angle glaucoma;
• Prostatic hyperplasia (with clinical manifestations);
• Inhibition of bone marrow hematopoiesis;
• Intestinal obstruction;
• Megacolon;
• Collapse;
• Acute porphyria;
• Granulocytopenia;
• Chronic heart failure in the stage of decompensation;
• Stable and unstable angina;
• Pregnancy (first trimester and last 6 weeks);
• Lactation period (breastfeeding);
• Hypersensitivity to pyrazolone derivatives and other components of the drug.

Maxigan^® in the form of tablets is not prescribed to children under 5 years of age.

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

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

Use in Pregnancy and Lactation

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

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction. With caution and under medical supervision, the drug should be prescribed for impaired liver function.

Use in Renal Impairment

Contraindicated in severe renal dysfunction. With caution and under medical supervision, the drug should be prescribed for impaired renal function.

Pediatric Use

The solution for injection is not prescribed to 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 to adolescents over 15 years 1-2 tablets 2-3 times/day. The maximum daily dose is 6 tablets. The duration of administration is no more than 5 days.

Children aged 6-8 years are prescribed 1/2 tablet, children aged 9-12 years – 3/4 tablet, children aged 13-15 years – 1 tablet. The frequency of administration is 2-3 times/day.

Children the drug is administered intramuscularly or intravenously depending on age and body weight.

Special Precautions

With long-term (more than 1 week) use of the drug, it is necessary to monitor the peripheral blood picture (number of leukocytes and platelets) and the functional state of the liver. If agranulocytosis or thrombocytopenia is suspected, the use of Maxigan^® should be discontinued.

The solution for injection is not used to relieve acute abdominal pain until the cause is clarified.

Parenteral administration of the drug is used in emergency cases (for example, renal or hepatic colic) and in cases where oral administration of the drug is impossible. Intravenous administration of the drug should be carried out with caution (because there is a risk of developing arterial hypotension). Intravenous administration should be carried out slowly, the patient should be in a lying position, it is necessary to monitor blood pressure, heart rate and respiratory rate.

When using Maxigan^®, alcohol consumption should be avoided.

X-ray contrast agents and colloidal blood substitutes should not be used during treatment with preparations containing metamizole sodium.

Influence on the ability to drive vehicles and mechanisms

During the period of taking the drug, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require speed 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, administration of activated charcoal, if necessary, symptomatic therapy is carried out.

Drug Interactions

With simultaneous use of Maxigan^® with other non-opioid analgesics, a mutual enhancement of toxic effects is noted.

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

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

With simultaneous use of Maxigan^® with cyclosporine, the level of the latter in the blood decreases.

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

With simultaneous administration of Maxigan^® with histamine H₁ -receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine, an enhancement of the m-cholinolytic action is possible.

With simultaneous use with ethanol, a mutual enhancement of effects is noted.

With simultaneous use of Maxigan^® with chlorpromazine or other phenothiazine derivatives, the development of severe hyperthermia is possible.

Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin from protein binding, may enhance their clinical effects.

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

With simultaneous use, codeine, histamine H₂ -receptor blockers, propranolol slow down the inactivation of metamizole sodium and enhance its effect.

Pharmaceutical interaction

The solution for injection is pharmaceutically incompatible in the same syringe with solutions of other drugs.

Storage Conditions

The drug should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Pharmacy supply conditions

The drug in the form of tablets is approved for use as an over-the-counter product.

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

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.