Fastorik - instructions for use, dose, side effects, contraindications

The solution obtained after dissolving the contents of the sachet in 200 ml of warm water: a cloudy solution of light orange color with orange flavor and superseded particles.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic means + H1-histamine receptor blocker + vitamin)

ATX: & nbsp

N.02.B.E Anilides

N.02.B.E.51 Paracetamol in combination with other drugs, excluding psycholeptics

Pharmacodynamics:Combined drug.

Paracetamol has an analgesic and antipyretic effect.

Phenyramin - blocker H1-gistaminovyh receptors, reduces rhinorrhea and lacrimation, eliminates spastic phenomena.

Ascorbic acid (vitamin C) replenishes the increased demand for vitamin C in acute respiratory viral diseases and influenza.

Pharmacokinetics:

No pharmacokinetics studies have been conducted.

Indications:

- symptomatic therapy of acute respiratory viral diseases, including influenza, accompanied by t.ch. rhinorrhea, lacrimation, rhinopharyngitis, myalgia, headache.

Contraindications:

- hypersensitivity to one of the components of the drug;

- portal hypertension;

- the state of alcoholic or narcotic intoxication;

- kidney failure;

- phenylketonuria;

- deficiency of glucose-b-phosphate dehydrogenase;

- diabetes;

- hemochromatosis, sideroblastic anemia, thalassemia;

- pregnancy;

- lactation period;

- children's age till 15 years.

Carefully:

- congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome);

- angle-closure glaucoma;

- liver failure;

- viral, alcoholic hepatitis;

- elderly age;

- hyperoxaluria, nephrolithiasis;

- hyperplasia of the prostate.

Dosing and Administration:

Inside. The content of 1 sachet is dissolved in a glass of warm water and is consumed regardless of the meal.

A single dose is the contents of 1 sachet. Repeated dose, if necessary, is taken every 4 hours, but no more than 4 times within 24 hours.

In case of impaired renal function, liver, elderly, the interval between doses should be increased to 8 hours.

If within 3 days after the beginning of taking the drug, there is no reduction in the symptoms of the disease, it is necessary to consult a doctor.

Side effects:

Allergic reactions: skin rash, itching, hives, angioedema.

From the digestive system: dry mouth, nausea, vomiting, constipation, pain in the epigastric region, with prolonged use in large doses - hepatotoxic effect, erosive-ulcerative lesions of the gastrointestinal tract, bleeding in the gastrointestinal tract.

From the cardiovascular system: tachycardia, increased

blood pressure.

From the central nervous system: speed reduction

psychomotor-reactions, a feeling of fatigue, drowsiness, dizziness, - sleep disturbance.

From the urinary system: retention of urine, glucosuria, with prolonged use in large doses - nephrotoxic effect.

On the part of the hematopoiesis system: with prolonged use in large doses - thrombocytopenia, anemia, methemoglobinemia.

Overdose:

Symptoms (due to paracetamol): pallor of the skin, decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis due to intoxication directly depends on the degree of overdose). Toxic effect in adults is possible after taking more than 10-15 g of paracetamol: increased prothrombin time (12-48 hours after administration). A detailed clinical picture of liver damage appears after 1-6 days. Rarely, liver failure develops at a lightning speed and can be complicated by renal insufficiency (tubular necrosis).

Treatment: in the first 6 hours after an overdose - gastric lavage, the introduction of donators SH-groups and precursors of glutathione-methionine synthesis for 8-9 hours after an overdose and acetyl cysteine for 8 hours. The need for additional therapeutic (further introduction of methionine, intravenous acetylcysteine) is determined by the concentration of paracetamol in the blood, passed after its reception.

Interaction:

Conditioned by paracetamol:

Reduces the effectiveness of uricosuric medicines (LS). The concomitant use of paracetamol in high doses increases the effect of anticoagulant drugs (a decrease in the synthesis of procoagulant factors in the liver).

Inductors of microsomal oxidation in the liver (phenytoin, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants), ethanol and hepatotoxic drugs increase the production of hydroxylated active metabolites, which allows the development of severe intoxication even with a slight overdose.

Long-term use of barbiturates reduces the effectiveness of paracetamol.

Ethanol promotes the development of acute pancreatitis.

Inhibitors of microsomal oxidation (incl. cimetidine) reduce the risk of hepatotoxic effects.

Long-term combined use of paracetamol and other non-steroidal anti-inflammatory drugs increases the risk of developing analgesic nephropathy and renal papillary necrosis, the onset of the terminal stage of renal failure.Current simultaneous administration of paracetamol in high doses and salicylates increases the risk of developing kidney or bladder cancer.Diflunisal increases plasma concentration paracetamol by 50% - the risk of hepatotoxicity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Due to phenyramine:

Antidepressants, antiparkinsonian and antipsychotic (phenothiazine derivatives) drugs increase the risk of side effects of phenyramine (urinary retention, dry mouth, constipation), glucocorticosteroids (GCS) increase the risk of developing glaucoma.

Due to ascorbic acid:

Increases the concentration in the blood of benzylpenicillin and tetracyclines; in a dose of 1 g / day increases the bioavailability of ethinyl estradiol (including those included in oral contraceptives).

Improves absorption in the intestine of iron preparations (converts trivalent iron into bivalent iron.

Reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid (ASA), oral contraceptives, fresh juices and alkaline drink reduce absorption and absorption.

With simultaneous application with ASA, urinary excretion of ascorbic acid increases and the excretion of ASA decreases.

Increases the risk of development of crystallopuria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body.

Quinoline drugs, calcium chloride, salicylates, GCS with long-term use deplete the stores of ascorbic acid.

With prolonged use or use in high doses, it can interfere with the interaction of disulfiram and ethanol.

In high doses increases the excretion of mexiletine by the kidneys.

Barbiturates and primidon increase the excretion of ascorbic acid in the urine.

Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

Special instructions:

The drug should not be taken concurrently with other drugs containing paracetamol and ascorbic acid.

High doses of ascorbic acid increase the excretion of oxalates, promoting the formation of kidney stones.

In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function adrenal and blood pressure.

Ascorbic acid as a reducing agent can distort the results of various laboratory tests (blood and urine glucose content, blood plasma - bilirubin, activity of "liver" transaminases and lactate dehydrogenase, uric acid).

During the treatment it is necessary to refrain from using ethanol (it is possible to develop hepatotoxic action), driving motor vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Granules for solution for oral administration

Packaging:

Aluminum sachets, containing 5 g of granules for the preparation of a solution for oral administration. For 8 sachets in a cardboard box with instructions for use.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-001887/10

Date of registration:12.03.2010

The owner of the registration certificate:Plethiko Pharmaceuticals Co., Ltd. Plethiko Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

PLETHICO PHARMACEUTICALS, Ltd. India

Representation: & nbspREZLOV ZAO REZLOV ZAO Kazakhstan

Information update date: & nbsp10.09.2015

Illustrated instructions

Instructions

Fastoric (Fastorik)