Fervex, 8 pcs.

Fervex® is a combined preparation that contains paracetamol, pheniramine and ascorbic acid. Paracetamol is a non-narcotic analgesic, blocks cyclooxygenase, mainly in the central nervous system, affecting the centers of pain and thermoregulation; it has analgesic and antipyretic effects.

Pheniramine is a blocker of H1-histamine receptors, it reduces rhinorrhea and lacrimation, eliminates spasticity, edema and hyperemia of the nasal cavity mucosa, nasopharynx and sinus cavities. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood coagulation, tissue regeneration, the synthesis of steroid hormones, reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. Improves tolerance of paracetamol and prolongs its action (associated with prolongation of the T1/2.

Pharmacokinetics

Paracetamol:
After oral administration is rapidly absorbed from the gastrointestinal tract. Maximum concentrations of the drug in the blood plasma are reached 10-60 minutes after ingestion. It is rapidly distributed throughout the body tissues and penetrates through the blood-brain barrier. Binding to plasma proteins is insignificant and has no therapeutic value, but increases with increasing dose.

Metabolism occurs in the liver, 80% of the taken dose reacts with glucuronic acid and sulfates to form inactive metabolites; 17% undergoes hydroxylation to form 8 active metabolites, which conjugate with glutathione to form inactive metabolites.

One of the hydroxylated metabolic intermediates is hepatotoxic. This metabolite is neutralized by conjugation with glutathione, but it may cumulate and in case of paracetamol overdose (150 mg paracetamol/kg or 10 g of oral paracetamol) cause hepatocyte necrosis. It is excreted by the kidneys as metabolites, mainly as conjugates. Less than 5% of the administered dose is excreted unchanged. The elimination half-life is 1 to 3 hours.

Pheniramine:
It is well absorbed in the digestive tract. The elimination half-life from blood plasma is one to one and a half hours. It is eliminated from the body mainly through the kidneys.

Ascorbic acid:
Well absorbed in the digestive tract. Time of maximum therapeutic concentration (TCmax) after oral administration – 4 hours. It is metabolized mainly in the liver. It is excreted by the kidneys, through the intestine, with sweat, unchanged and as metabolites.

Indications

Active ingredient

Composition

Each 4.95 g sachet contains:

The active ingredients:

Paracetamol 0.500 g

Pheniramine maleate 0.025 g

Ascorbic acid 0.200 g

Excipients: Mannitol 3.515 g; citric acid 0.050 g; povidone K30 0.010 g; magnesium citrate 0.400 g; aspartame 0.050 g, lemon rum flavoring* 0.200 g

*Content of lemon rum flavoring: maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geranial, dextrose, E551 silicon dioxide, butylhydroxyanisole.

How to take, the dosage

In the mouth, 1 sachet 2-3 times a day. Before use, the contents of the sachet should be dissolved in a glass (200 ml) of warm water. Maximum duration of treatment is 5 days.

The maximum daily dose of paracetamol in case of body weight over 50 kg should not exceed 4 g/day (or 8 sachets of Feverex®); in children or patients with body weight of 40-50 kg the maximum daily dose of paracetamol should not exceed 3 g/day, in case of body weight less than 40 kg – not more than 2 g/day.

The interval between doses of the drug should be at least 4 hours. In patients with impaired renal function (creatinine clearance <10 ml/min) the interval between doses of the drug should be at least 8 hours.

The drug should not be taken for more than 3 days as an antipyretic and for more than 5 days as an analgesic.

In patients with chronic or decompensated liver disease, in patients with liver failure, chronic alcoholism, in emaciated patients and in patients with dehydration the daily dose of paracetamol should not exceed 3g.

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

Interaction

Ethanol increases the sedative effect of antihistamines (pheniramine), therefore its intake during treatment with the drug Feverex® should be avoided. In addition, ethanol in concomitant use with pheniramine promotes acute pancreatitis,

Pheniramine in the preparation Fervex ® enhances the sedative effects: morphine derivatives, barbiturates, benzodiazepine and other tranquilizers, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserine), antihypertensive drugs of central action, sedatives belonging to H1-blockers, and baclofen, which not only increase sedation, but also increase the risk of side effects of the drug (urinary retention, dry mouth, constipation).

The possibility of increased central atropine-like effects when used in combination with other agents with anticholinergic properties (other antihistamines, antidepressants of the imipramine group, phenothiazine-type neuroleptics, m-choline blocking antiparkinsonics, atropine-like antispasmodics, disopyramide) should be considered.

When using the drug together with inducers of microsomal oxidation: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic effects increases significantly (due to the included paracetamol).

Glucocorticosteroids when used concomitantly increase the risk of glaucoma. Concomitant use with salicylates increases the risk of nephrotoxic effects. Concomitant use with levomycetin (chloramphenicol) increases the toxicity of the latter.

Paracetamol contained in the drug increases the effect of indirect anticoagulants and reduces the effectiveness of uricosuric drugs.

Ascorbic acid increases the blood concentration of benzylpenicillin and tetracyclines; at a dose of 1 g / day increases the bioavailability of ethinylestradiol (including those included in oral contraceptives). Improves intestinal absorption of iron preparations (converts trivalent iron to divalent iron); may increase iron excretion in concomitant use with deferoxamine. Reduces the effectiveness of heparin and indirect anticoagulants. Concomitant use with acetylsalicylic acid (ASA) increases urinary excretion of ascorbic acid and decreases excretion of ASA. Asc reduces the absorption of ascorbic acid by about 30%. Increases the risk of crystalluria during treatment with salicylates and short-acting sulfonamides, slows renal excretion of acids, increases excretion of alkaline drugs (including alkaloids), reduces the blood concentration of oral contraceptives. Increases total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. Quinoline drugs, calcium chloride, salicylates, glucocorticosteroids deplete ascorbic acid during long-term use. When concomitant use ascorbic acid reduces chronotropic effect of isoprenaline. With long-term use or use in high doses may interfere with the interaction of disulfiram and ethanol. In high doses increases excretion of mexiletine by the kidneys. Barbiturates and primidone increase urinary excretion of ascorbic acid. Reduces the therapeutic effect of neuroleptics – phenothiazine derivatives, tubal reabsorption of amphetamine and tricyclic antidepressants.

Special Instructions

The drug is sugar-free and can be used by patients with diabetes.

Fervex® should not be used simultaneously with other drugs containing paracetamol. To avoid toxic liver damage, paracetamol should not be combined with the intake of alcoholic beverages and should not be taken by persons prone to chronic alcohol consumption.

The risk of liver damage increases in patients with alcoholic hepatosis. Do not use concomitantly with drugs with hypnotic and anxiolytic effects, and with impaired renal function without consulting a physician. It is necessary to monitor peripheral blood picture, blood and urine glucose levels, bilirubin, uric acid in plasma, activity of “hepatic” transaminases and lactate dehydrogenase) during long-term use.

The drug may become psychologically addictive if the recommended doses are exceeded and prolonged use occurs.

In order to avoid an overdose of paracetamol, make sure that the total daily dose of paracetamol in all the medications taken by the patient does not exceed 4 g.

The product contains mannitol and aspartame (a source of phenylalanine); the flavoring contains dextrose.

Impact on the ability to drive vehicles and machines

With regard to the possibility of side effects such as drowsiness and dizziness, it is recommended to avoid driving vehicles and operating machinery during treatment with the drug.

Contraindications

Side effects

The drug is well tolerated in the recommended doses.

. Dry mouth, nausea, vomiting, abdominal pain, urinary disorders, constipation, allergic reactions (erythema, skin rash, pruritus, urticaria, Quincke’s edema, anaphylactic shock), drowsiness, accommodation disorders, palpitation, orthostatic hypotension, dizziness, poor coordination, tremor, mental confusion, hallucinations, concentration disorders (more often in elderly patients) may occur.
Rarely – anemia, leukopenia, agranulocytosis, thrombocytopenia, agitation, nervousness, insomnia.

In case of adverse reactions stop taking the drug and consult a physician.

Overdose

Promptoms caused by paracetamol.

In overdose intoxication is possible, especially in elderly patients, children, patients with liver disease (caused by chronic alcoholism), in patients with malnutrition, as well as in patients taking microsomal liver enzyme inducers, which may develop fulminant hepatitis, liver failure, cholestatic hepatitis, in the above cases – sometimes with fatal outcome. The threshold of overdose in these categories of patients may be lower. The clinical picture of acute overdose develops within 24 hours after taking paracetamol.

Symptoms: gastrointestinal disorders (nausea, vomiting, decreased appetite, feeling of discomfort in the abdomen and (or) abdominal pain). pale skin. When administered to adults 7.5 g or more or children more than 140 mg/kg at a time, cytolysis of hepatocytes with complete irreversible liver necrosis, development of liver failure, metabolic acidosis and encephalopathy occurs, which may lead to coma and death. 12-48 hours after paracetamol administration there is an increase in the activity of microsomal liver enzymes, lactate dehydrogenase, bilirubin concentration and decrease in prothrombin concentration. Clinical symptoms of liver damage appear 12-48 hours after overdose of the drug and reach their maximum on the 4th-6th day.

Treatment:

Hospitalization immediately. Gastric lavage during the first hours of poisoning, administration of enterosorbents (activated charcoal, lignin hydrolysis). Determination of the quantitative content of paracetamol in blood plasma before treatment as early as possible after overdose. Administration of SH-group donators and precursors of glutathione synthesis – methionine and acetylcysteine – is most effective during the first 8 hours. The need for additional therapeutic measures (further administration of methionine, intravenous administration of acetylcysteine) is determined depending on the concentration of paracetamol in the blood. and the time elapsed after its administration.

Symptomatic treatment. Laboratory studies of the activity of microsomal liver enzymes should be performed at the beginning of treatment and then – every 24 hours. In most cases, microsomal liver enzyme activity normalizes within 1-2 weeks. In very severe cases, a liver transplant may be required.

Pheniramine-related symptoms.

The signs of pheniramine poisoning are seizures, impaired consciousness, coma. If symptoms of poisoning occur, stop using the drug immediately and seek medical attention. Washing of the stomach, intake of enterosorbents (activated carbon, lignin hydrolysis), intravenous or oral administration of antidote acetylcysteine (if possible, during the first 10 hours after overdose), symptomatic treatment are recommended.

Pregnancy use

An adequate and well-controlled study of Fervex® in pregnant women has not been conducted, therefore it is not recommended to use the drug in this group of patients.

It is unknown whether the active ingredients of the drug penetrate into breast milk. The drug should not be used during lactation.

Similarities