Quatrox (Tablets) Instructions for Use

Marketing Authorization Holder

Khimpharm, JSC (Kazakhstan)

ATC Code

N02BB72 (Metamizole sodium in combination with psycholeptics)

Dosage Form

Quatrox

Tablets: 10 pcs.

Dosage Form, Packaging, and Composition

Tablets are white or white with a yellowish tint, flat-cylindrical in shape; one side has a bevel and a score line, the other side has a bevel and a corporate logo in the form of a cross.

Excipients: calcium stearate, starch, talc.

10 pcs. – blister packs (1) – cardboard packs.

Clinical-Pharmacological Group

Combination analgesic-antipyretic

Pharmacotherapeutic Group

Combined analgesic agent (opioid analgesic agent + NSAID + psychostimulant agent + barbiturate)

Pharmacological Action

A combined medicinal product that has analgesic, antipyretic, vasodilating, and antimigraine effects. It relieves symptoms of the common cold and influenza.

Metamizole is an analgesic-antipyretic, a pyrazolone derivative, and has analgesic, antipyretic, and antispasmodic effects on the smooth muscles of the urinary and biliary tracts.

Codeine has a central antitussive effect (by suppressing the excitability of the cough center), as well as an analgesic effect due to the excitation of opiate receptors in various parts of the CNS, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain. It depresses respiration to a lesser extent than morphine and less frequently causes miosis, nausea, vomiting, and constipation (activation of opioid receptors in the intestine causes relaxation of smooth muscles, decreased peristalsis, and spasm of all sphincters). It enhances the effect of analgesics.

Caffeine stimulates the psychomotor centers of the brain, has an analeptic effect, enhances the effect of analgesics, eliminates drowsiness and fatigue, and increases physical and mental performance.

Phenobarbital is an antiepileptic agent that has sedative, hypnotic, antispasmodic, and muscle relaxant effects.

Pharmacokinetics

The components of the drug are well absorbed in the gastrointestinal tract.

Codeine: binds slightly to plasma proteins. It undergoes biotransformation in the liver (10% is converted to morphine via demethylation). It is excreted by the kidneys (5-15% unchanged).

Caffeine: is well absorbed in the intestine, T_1/2 is 5 hours (sometimes up to 10 hours). It is excreted mainly by the kidneys as metabolites, about 10% unchanged.

Sodium metamizole: is hydrolyzed in the intestinal wall to form an active metabolite, 4-methyl-amino-antipyrine, which in turn is metabolized to 4-formyl-amino-antipyrine and other metabolites. The binding level of the active metabolite to proteins is 50-60%. Excretion of metabolites occurs through the kidneys. In addition, they are excreted in breast milk.

Phenobarbital: bioavailability is 80%. It is 50% bound to proteins in plasma and penetrates the placenta well. It is biotransformed in the liver. The main metabolite has no pharmacological activity. It is excreted by the kidneys, including 20-25% unchanged.

Indications

Headache; toothache; myalgia; arthralgia; neuralgia; algodysmenorrhea; symptomatic therapy of influenza and acute respiratory viral infections (ARVI).

ICD codes

Dosage Regimen

Administer orally.

For adults and children over 12 years of age, take one tablet.

If pain or fever persists, repeat the dose after 4-6 hours.

The maximum single dose is one tablet.

The maximum daily dose is three tablets.

Do not use for more than 3 days as an antipyretic.

Do not use for more than 5 days as an analgesic.

If symptoms persist beyond these durations, consult a physician.

Do not exceed the stated maximum doses.

Use the lowest effective dose for the shortest duration necessary.

Adverse Reactions

From the digestive system: nausea, vomiting, constipation.

From the CNS: dizziness, drowsiness.

From the hematopoietic system: leukopenia, granulocytopenia, agranulocytosis.

From the cardiovascular system: tachycardia.

Allergic reactions: rash, itching, urticaria.

With long-term uncontrolled use of the drug in high doses, a weakening of the analgesic effect, development of drug dependence due to the presence of codeine, and hepatic and/or renal failure are possible.

Contraindications

Hepatic and/or renal failure; hypersensitivity to the components of the drug; bronchospasm; glucose-6-phosphate dehydrogenase deficiency; anemia, leukopenia; conditions accompanied by respiratory depression; intracranial hypertension; traumatic brain injury; arrhythmias; arterial hypotension; alcohol intoxication; pregnancy, breastfeeding period, children under 12 years of age.

With caution: elderly age.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Contraindication: children under 12 years of age.

Geriatric Use

With caution, the drug should be prescribed to elderly patients.

Special Precautions

With long-term (more than 1 week) treatment, monitoring of the peripheral blood picture and functional state of the liver is necessary.

The results of doping control in athletes may change when taking the drug.

Patients with atopic bronchial asthma and hay fever have an increased risk of developing allergic reactions.

Effect on the ability to drive vehicles and mechanisms

It is necessary to refrain from potentially hazardous activities requiring increased attention, as it slows down the speed of reactions and causes drowsiness.

Drug Interactions

With simultaneous use of medicinal products that depress the CNS, an enhancement of the sedative effect and depressant effect on the respiratory center is possible.

It enhances the effect of ethanol on the psychomotor reaction.

Concomitant use with phenothiazine derivatives may lead to the development of severe hyperthermia.

With simultaneous administration of cyclosporine, its concentration in the blood decreases.

Sodium metamizole, displacing oral hypoglycemic agents, indirect anticoagulants, corticosteroids, and indomethacin from protein binding, increases their activity.

Phenylbutazone, barbiturates, and other inducers of liver microsomal enzymes when administered simultaneously reduce the effectiveness of sodium metamizole.

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

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.