Efferalgan (paracetamol) oral solution 3% 90 ml. vial

Description

Efferalgan oral solution Composition
active substance: paracetamol;

1 ml of oral solution contains 30 mg of paracetamol;

Efferalgan oral excipients: macrogol 6000, sucrose solution, sodium saccharin, potassium sorbate, citric acid, caramel-vanilla flavor, purified water.

Efferalgan oral Dosage form
Oral solution.

Basic physical and chemical properties: slightly viscous brown solution with caramel-vanilla smell.

Pharmacotherapeutic group
Analgesics and antipyretics. Paracetamol. ATX code N02B E01.

Pharmacodynamics
It has analgesic, antipyretic and mild anti-inflammatory effects. The mechanism of action is due to the inhibition of the synthesis of prostaglandins and the predominant effect on the center of thermoregulation in the hypothalamus.

Pharmacokinetics
Paracetamol after oral administration is rapidly and completely absorbed in the digestive tract. The maximum concentration of paracetamol in blood plasma is reached within 30-60 minutes after ingestion. Paracetamol is metabolized in the liver to form inactive compounds with glucuronic acid and sulfates.

It is excreted mainly in the urine. 90% of the taken dose of paracetamol is excreted by the kidneys within 24 hours, mainly in the form of glucuronic and sulfate conjugates. Less than 5% is displayed unchanged. The half-life is approximately 2 hours.

Indications
Symptomatic treatment of diseases accompanied by mild to moderate pain and / or fever.

Contraindications
Hypersensitivity to paracetamol or other components of the drug.

Severe renal and / or liver dysfunction, congenital hyperbilirubinemia, glucose-6-phosphate dehydrogenase deficiency, alcoholism, blood diseases, severe anemia, leukopenia.

Interaction with other medicinal products and other forms of interaction
When taking the maximum doses of paracetamol (4 g / day) for at least 4 days, there is a risk of an increase in the effect of an oral anticoagulant and an increased risk of bleeding. The INR (International Normalized Ratio) should be monitored at regular intervals. If necessary, the dose of anticoagulant administration should be adjusted during treatment with paracetamol.

The absorption rate of paracetamol may increase when interacting with metoclopramide and domperidone and decrease with cholestyramine. Barbiturates reduce the antipyretic effect of paracetamol. Anticonvulsants (including phenytoin, barbiturates, carbamazepine), which stimulate the activity of liver microsomal enzymes, can increase the toxic effect of paracetamol on the liver due to an increase in the conversion of the drug to hepatotoxic metabolites. With the simultaneous use of paracetamol with hepatotoxic agents, the hepatotoxic effect of the drug on the liver increases. The simultaneous use of high doses of paracetamol with isoniazid, rifampicin increases the risk of developing hepatotoxic syndrome. Paracetamol reduces the effectiveness of diuretics. Do not use simultaneously with alcohol.

High concentrations of paracetamol can affect laboratory results for the determination of blood glucose by the oxidase-peroxidase method, uric acid when using the phosphotungstic acid method.

Application features
Patients with severe infections, such as sepsis, that are accompanied by a decrease in glutathione levels while taking paracetamol, have an increased risk of metabolic acidosis.

The symptoms of metabolic acidosis are deep, rapid or labored breathing, nausea, vomiting, and loss of appetite. You should immediately consult a doctor if these symptoms appear.

Use with caution with a body weight of up to 50 kg, with chronic malnutrition (low reserves of glutathione in the liver), dehydration, mild to moderate liver failure.

Treatment should be discontinued if acute viral hepatitis is detected.