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

Excipients: sodium citrate pentagemidihydrate (sodium citrate 5,5-aqueous), citric acid, sodium saccharinate (sodium saccharin), currant flavor (flavoring food powder "black currant"), sugar - up to 5 g.

Description:Powder from white to almost white with the smell of black currant.

Pharmacotherapeutic group:ARI and "colds" of symptoms remedy (analgesic non-narcotic agent + alpha-adrenomimetic + vitamin)

ATX: & nbsp

N.02.B.E Anilides

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

Pharmacodynamics:

Combined drug, the effect of which is due to its constituent components; has antipyretic, analgesic, vasoconstrictive effect, eliminates the symptoms of "colds". Narrows the vessels of the nose, eliminates the swelling of the mucous membrane of the nasal cavity and nasopharynx, replenishes the deficiency of vitamin C with "cold" diseases.

The onset of action is 20-30 minutes after administration, and the duration is 4-4.5 hours.

Indications:Prostudox® provides effective relief of cold and flu symptoms such as fever, headache, chills, nasal congestion, sore throat when swallowing.

Contraindications:

The drug should not be taken simultaneously with other paracetamol-containing drugs, with increased sensitivity to the ingredients included in the drug.

Hypersensitivity, thyrotoxicosis, diseases of the cardiovascular system (severe aortic stenosis, acute myocardial infarction, tachyarrhythmia), arterial hypertension, diabetes mellitus, pheochromocytoma, prostatic hyperplasia, angle-closure glaucoma, simultaneous administration of tricyclic antidepressants, beta adrenoblockers, monoamine oxidase inhibitors within 14 days after their cancellation), children's age (up to 14 years), pregnancy, lactation.

Carefully:Renal / hepatic insufficiency, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome); chronic obstructive pulmonary disease, elderly age, deficiency of glucose-6-phosphate dehydrogenase; blood diseases.

Dosing and Administration:

The contents of one package pour into a glass and fill it with hot water, stir until completely dissolved and, if desired, add sugar or honey to taste.

Adults and children over 14 years of age: take one packet every 4-6 hours, but not more than 4 packs within 24 hours.

The drug is not recommended for more than five days without consulting a doctor. If symptoms persist, consult a physician.

Side effects:

Sometimes allergic reactions are possible: skin rash, itching, urticaria, angioedema.

Rarely - from the side of the blood (thrombocytopenia, leukopenia, agranulocytosis); increased intraocular pressure, nausea, vomiting, epigastric pain, urinary retention.

With prolonged use, exceeding the recommended dose, hepatotoxic and nephrotoxic effects may be observed.

Phenylephrine hydrochloride can cause nausea, headache, high blood pressure and, in rare cases, heartbeat that pass after drug withdrawal.

Overdose:

Overdose of paracetamol is manifested after taking 10-15 g: symptoms - discomfort in the epigastric region, nausea, vomiting, pallor of the skin,decreased appetite, nausea, vomiting; hepatonecrosis (the severity of necrosis directly depends on the degree of overdose); increased activity of "hepatic" transaminases, an increase in prothrombin time (12-48 hours after administration); a detailed clinical picture of liver damage manifests itself after 1-6 days. Rarely, a violation of liver function develops at a lightning speed and can be complicated by renal failure (renal tubular necrosis).

Treatment: symptomatic, gastric lavage, administration of donators SH-groups and precursors of glutathione-methionine synthesis 8-9 hours after an overdose and N- acetylcysteine after 12 h. The need for additional therapeutic measures (further introduction of methionine, iv administration N-acetylcysteine) is determined depending on the concentration of paracetamol in the blood, as well as on the time elapsed after its administration.

Interaction:Stimulants of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase production hydroxylated active metabolites of paracetamol,which causes the possibility of the development of severe intoxication with small overdoses. Micro InhibitorsSomal oxidation (cimetidine) reduce riskpathotoxic action of the drug.

Paracetamol increases the effects of monoamine oxidase inhibitors, sedatives, ethanol.

Ethanol promotes the development of acute pancreatitis.

Antidepressants, antiparkinsonian, antipsychotic drugs, phenothiazine derivatives - risk of urinary retention, dry mouth, constipation. Glucocorticosteroids - the risk of glaucoma.

Phenylephrine reduces the hypotensive effect of guanethidine.

Guanethidine enhances the alpha-adrenostimulating effect, and tricyclic antidepressants are the sympathomimetic effects of phenylephrine.

Reduces the effectiveness of uricosuric medicines.

When slowing down the emptying of the stomach (propantheline) there may be a delayed offensive action of the drug. When accelerating the emptying of the stomach (metoclopramide) the drug starts to act faster.

May enhance the effect of indirect anticoagulants.

Special instructions:

Do not use other medicines containing paracetamol, as well as other non-narcotic analgesics, non-steroidal anti-inflammatory drugs (metamizol, acetylsalicylic acid, ibuprofen and the like), barbiturates, antiepileptic drugs, rifampicin, chloramphenicol.

Simultaneous use of other medicines should be agreed with the doctor.

Distorts the results of laboratory tests evaluating the concentration of glucose and uric acid in the plasma.

Form release / dosage:

Powder for solution for oral administration.

Packaging:

5 g in heat-sealable single-dose bags of boufflen, or a combined multilayered material based on foil, or paper with a polyethylene coating.

5 or 10 bags with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, protected from light 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-004194/08

Date of registration:30.05.2008

The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp27.09.2015

Illustrated instructions

Instructions

Prostudox® (Prostudox® )