Fervex

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Available since: 2019-09-19

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Clinical Pharmacology

Fervex® is a combination drug that contains 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; It has an analgesic and antipyretic effect.

Pheniramine - a blocker of H1-histamine receptors, reduces rhinorrhea and lacrimation, eliminates spasticity, swelling and hyperemia of the mucous membrane of the nasal cavity, nasopharynx and paranasal sinuses. Ascorbic acid is involved in the regulation of redox processes, carbohydrate metabolism, blood clotting, tissue regeneration, in the synthesis of steroid hormones; reduces vascular permeability, reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid. It improves the tolerance of paracetamol and prolongs its action (due to the elongation of T1 / 2.

Pharmacokinetics

Paracetamol:
After ingestion is rapidly absorbed from the gastrointestinal tract. The maximum concentration of the drug in the blood plasma is reached 10-60 minutes after administration. It is rapidly distributed through the tissues of the body, penetrates the blood-brain barrier. Communication with plasma proteins is insignificant and has no therapeutic value, but increases with increasing dose. Metabolism occurs in the liver, 80% of the accepted dose reacts conjugation with glucuronic acid and sulfates with the formation of inactive metabolites; 17% undergoes hydroxylation with the formation of 8 active metabolites, which are conjugated with glutathione with the formation of already inactive metabolites. One of the hydroxylated intermediate products of metabolism has a hepatotoxic effect. This metabolite is neutralized by conjugation with
glutathione, however, it can accumulate and, if overdose of paracetamol (150 mg paracetamol / kg or 10 g paracetamol orally), cause necrosis of hepatocytes. Excreted by the kidneys as metabolites, mainly as conjugates. Unchanged, less than 5% of the received dose is displayed. The half-life is from 1 to 3 hours.

Pheniramine:
Well absorbed in the digestive tract. The half-life of blood plasma is from one to one and a half hours. Excreted 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. Metabolized mainly in the liver. Excreted by the kidneys, through the intestines, with sweat, unchanged and in the form of metabolites.

Indications

It is used in acute respiratory diseases, acute respiratory viral infections, rhinopharyngitis to alleviate the following symptoms:

rhinorrhea, nasal congestion;
headache;
increased body temperature;
lacrimation;
sneezing

Composition

Each bag contains:
Active substances:
Paracetamol - 0.500 g
Ascorbic acid - 0,200 g
Pheniramine Maleate - 0.025 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
* Flavor composition: maltodextrin, acacia gum, α-pinene, β-pinene, limonene, γ-terpinene, linalool, neral, α-terpineol, geranial, dextrose, E551 silicon dioxide, butyl hydroxyanisole.

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Dosage and Administration

For oral use. - on 1 bag 2-3 times a day. Before use, the contents of the bag 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 is 4 g (8 sachets of the preparation Ferveks®) with a body weight of more than 50 kg. 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="" drug="" should="" be="" at="" least="" 8="" hours="" br=""> If there is no relief of symptoms within 5 days after the start of taking the drug, the body temperature remains elevated or after the initial decrease, it suddenly rises again, it is necessary to consult a doctor.

Adverse reactions

The drug is well tolerated in the recommended doses.
There are dry mouth, nausea, vomiting, abdominal pain, disturbance of micturition, constipation, allergic reaction (erythema, skin rash, pruritus, urticaria, angioedema, anaphylactic shock), drowsiness, ccomodation, palpitations, orthostatic hypotension, dizziness, impaired coordination, tremor, confusion, hallucinations, impaired concentration (more often in elderly patients).
Rarely - anemia, leukopenia, agranulocytosis, thrombocytopenia, agitation, nervousness, insomnia.

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

Contraindications

Hypersensitivity to paracetamol, ascorbic acid, phenyramine or any other component of the drug.
Erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase).
Liver failure.
Closed angle glaucoma.
Urinary retention associated with prostate diseases and urinary disorders.
Portal hypertension.
Alcoholism.
Phenylketonuria.
Children's age (up to 15 years).
Pregnancy and lactation (safety has not been studied).

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

Drug interactions

Ethanol enhances the sedative effect of antihistamine drugs (pheniramine), so its use should be avoided during the treatment with Fervex®. In addition, ethanol, while used with pheniramine, contributes to the development of acute pancreatitis.
Pheniramine composed Ferveks® preparation intensifies the effect of sedative drugs: morphine derivatives, barbiturates and other benzodiazepine anxiolytics, neuroleptics (meprobamate, phenothiazine derivatives), antidepressants (amitriptyline, mirtazapine, mianserin), centrally acting antihypertensive drugs, sedatives, belonging to the group H1 -blockers, baclofen; this not only increases the sedative effect, but also increases the risk of side effects of the drug (urinary retention, dry mouth, constipation).

Consideration should be given to the possibility of enhancing central atropine-like effects when used in combination with other substances with anticholinergic properties (other antihistamines, imipramine group antidepressants, phenothiazine neuroleptics, m-cholinoblocking anti-parkinsonics, atropine-like antispasmodics, diopyramid).

When using the drug, together with microsomal oxidation inductors: barbiturates, tricyclic antidepressants, anticonvulsants (phenytoin), flumecinol, phenylbutazone, rifampicin and ethanol, the risk of hepatotoxic action (due to paracetamol) is significantly increased.

Glucocorticosteroids, when used simultaneously, increase the risk of developing glaucoma.

Reception simultaneously with salicylates increases the risk of nephrotoxic action.With simultaneous use with chloramphenicol (chloramphenicol), the toxicity of the latter increases.

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

Special instructions

The drug does not contain sugar and can be used by patients with diabetes.
Ferveks® should not be used simultaneously with other drugs containing paracetamol.

In order to avoid toxic damage to the liver, paracetamol should not be combined with the intake of alcoholic beverages, as well as be taken by persons prone to chronic alcohol consumption.

The risk of liver damage increases in patients with alcoholic hepatosis. If you exceed the recommended doses and with prolonged use may appear mental dependence on the drug.

In order to avoid an overdose of paracetamol, it should be ensured that the total daily dose of paracetamol contained in all medicinal preparations taken by the patient does not exceed 4 g.

INFLUENCE ON THE ABILITY TO MANAGE THE MOTOR TRANSPORT AND MECHANISMS
Considering the possibility of the development of such undesirable effects as drowsiness and dizziness, it is recommended to refrain from driving and mechanisms during the period of drug treatment.

Overdosage

Signs of acute paracetamol poisoning are anorexia, nausea, vomiting, epigastric pain, sweating, pallor of the skin, drowsiness. After 1-2 days, there are signs of liver damage. In severe cases, liver failure, hepatonecrosis, encephalopathy, and coma develop, which can be fatal.

Signs of Pheniramine poisoning are seizures, impaired consciousness, coma. If symptoms of poisoning appear, you should immediately stop using the drug and consult a doctor. It is recommended gastric lavage, taking enterosorbents (Activated charcoal, hydrolytic lignin), intravenous or oral administration of the antidote acetylcysteine (if possible, in the first 10 hours after overdose), symptomatic treatment.