Fervex powder, raspberry flavor, No. 8

As symptomatic therapy for acute respiratory viral infections to relieve the following symptoms:

rhinorrhea, nasal congestion;

headache;

increased body temperature;

lacrimation;

sneeze.

Inside, 1 sachet 2-3 times / day. Before use, the contents of the sachet must be dissolved in a glass (200 ml) of warm water. The maximum duration of treatment is 5 days.

The maximum daily dose of paracetamol with a body weight of more than 50 kg should not exceed 4 g (or 8 sachets of FervexЃ); in children or patients weighing 40-50 kg, the maximum daily dose of paracetamol should not exceed 3 g, with a body weight of less than 40 kg - no more than 2 g.

The interval between doses of the drug should be at least 4 hours.

In patients with impaired renal function (creatinine clearance (CC) <10 ml / min), the interval between doses of the drug should be at least 8 hours.

In patients with chronic or decompensated liver diseases, in patients with hepatic insufficiency, chronic alcoholism, in malnourished patients and with dehydration, the daily dose of paracetamol should not exceed 3 g.

You should not take the drug for more than 3 days as an antipyretic agent and for more than 5 days as a pain reliever.

If there is no relief of symptoms within 5 days after starting the drug, the body temperature remains elevated or after an initial decrease it suddenly rises again, the patient should see a doctor.

Powder for preparation of oral solution (raspberry with sugar) from light pink to light beige; blotches of dark pink color are allowed; the prepared solution is pink, slightly opalescent.

1 pack. paracetamol 500 mg pheniramine maleate 25 mg ascorbic acid 200 mg

Excipients: sucrose - 11.555 g, citric acid - 0.2 g, acacia gum - 0.1 g, sodium saccharinate dihydrate - 0.02 g, raspberry flavor ** - 0.15 g.

• erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase);

• liver failure;

• angle-closure glaucoma;

• urinary retention associated with diseases of the prostate gland and urinary disorders;

• portal hypertension;

• alcoholism;

• phenylketonuria;

• glucose-galactose malabsorption, sucrase / isomaltase deficiency, fructose intolerance;

• children's age (up to 15 years old);

• pregnancy (safety has not been studied);

• lactation period (safety has not been studied);

• hypersensitivity to paracetamol, ascorbic acid, feniramine or any other component of the drug.

• With care: renal failure, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), viral hepatitis, alcoholic hepatitis, old age, diabetes mellitus.

pharmachologic effect

FervexЃ is a combined preparation containing paracetamol, pheniramine and ascorbic acid.

Paracetamol is a non-narcotic analgesic that blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; has an analgesic and antipyretic effect.

Pheniramine - a blocker of histamine H1 receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena, swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses.

Ascorbic acid is a cofactor in some hydroxylation and amidation reactions - it transfers electrons to enzymes, supplying them with a reducing equivalent. Participates in the reactions of hydroxylation of proline and lysine residues of procollagen with the formation of hydroxyproline and hydroxylysine (post-translational modification of collagen), oxidation of lysine side chains in proteins with the formation of hydroxytrimethyllysine (in the process of carnitine synthesis), oxidation of folic acid to folinic acid, metabolism and hydroxomes of the liver dopamine with the formation of norepinephrine. Increases the activity of amidating enzymes involved in the synthesis of oxytocin, adrenocorticotropic hormone and cholecystokinin. Participates in steroidogenesis in the adrenal glands.

Pharmacokinetics

Paracetamol

Absorption is high. The time required to reach the maximum concentration (TCmax) - 30-60 minutes; maximum concentration (Cmax) - 5-20 ?g / ml. Plasma protein binding - 15%. Penetrates the blood-brain barrier (BBB).

It is metabolized in the liver by three main pathways: conjugation with glucuronides, conjugation with sulfates, oxidation by microsomal liver enzymes. In the latter case, toxic intermediate metabolites are formed, which are subsequently conjugated with glutathione, and then with cysteine ??and mercapturic acid. The main isoenzymes of cytochrome P450 for this metabolic pathway are the isoenzyme CYP2E1 (predominantly), CYP1A2 and CYP3A4 (minor role). When glutathione is deficient, these metabolites can cause damage and necrosis of hepatocytes.

Additional metabolic pathways are hydroxylation to 3-hydroxyparacetamol and methoxylation to 3-methoxyparacetamol, which are subsequently conjugated with glucuronides or sulfates.

Conjugated paracetamol metabolites (glucuronides, sulfates and conjugates with glutathione) have low pharmacological (including toxic) activity. T1 / 2 - 1-4 hours. It is excreted by the kidneys in the form of metabolites, mainly conjugates, only 3% unchanged.

In elderly patients, the clearance of the drug decreases and T1 / 2 increases.

Pheniramine

Well absorbed in the digestive tract. T1 / 2 from blood plasma ranges from 1 to 1.5 hours. It is excreted from the body mainly through the kidneys.

Vitamin C

Well absorbed in the digestive tract. The time to create the maximum therapeutic concentration (TCmax) after oral administration is 4 hours. It is metabolized mainly in the liver. It is excreted by the kidneys, through the intestines, with sweat, unchanged and in the form of metabolites.

Plasma protein binding - 25%. Easily penetrates into leukocytes, platelets, and then into all tissues; the highest concentration is achieved in the glandular organs, leukocytes, liver and lens of the eye; penetrates the placental barrier. The concentration of ascorbic acid in leukocytes and platelets is higher than in erythrocytes and plasma. In deficient conditions, the concentration in leukocytes decreases later and more slowly and is considered as a better criterion for assessing deficiency than plasma concentration.

It is metabolized mainly in the liver to deoxyascorbic acid and then to oxaloacetic acid and ascorbate-2-sulfate.

It is excreted by the kidneys, through the intestines, with sweat, breast milk in unchanged form and in the form of metabolites. It is excreted during hemodialysis.

Side effect

The drug is well tolerated in the recommended doses. When using the drug, the following side effects were noted (frequency not established).

From the hematopoietic system: anemia, leukopenia, agranulocytosis, thrombocytopenia.

From the immune system: allergic reactions (erythema, skin rash, itching, Quincke's edema, anaphylactic shock).

From the nervous system: drowsiness, confusion, hallucinations, impaired concentration (more often in elderly patients), agitation, nervousness, insomnia, coordination dysfunction, tremor.

From the side of the organ of vision: violation of accommodation.

From the side of the cardiovascular system: palpitations, orthostatic hypotension, dizziness.

From the digestive system: dry mouth, nausea, vomiting, abdominal pain, constipation.

From the urinary system: urination disorder.

If any adverse reactions occur, the patient should stop taking the drug and consult a doctor.