Tradename

International non-proprietary name

Acetylcysteine

Compound

Each effervescent tablet contains:

active substance: Acetylcysteine USP 600 mg excipients: Q . S. _

Dosage form

Effervescent tablets.

Pharmacological properties

Acetylcysteine reduces the viscosity of mucus and other secretions in vitro . It is believed to act by decrease disulfide connections in proteins and changing their configuration to improve performance fluidity. He easily is turning to cysteine in vivo ; and by stimulating the synthesis of glutathione in the liver, it effectively prevents acetaminophen-induced acute hepatotoxicity . Due to its free thiol group , acetylcysteine can form stable thiolates with heavy metals and is of limited use in the treatment of poisonings with these agents. As a nucleophile, it can protect against exposure ionizing radiation and toxicity agents, such how alkylating cytotoxic drugs and some halogenated hydrocarbons. Inorganic nitrates deplete vascular   thiols, what, probably, explains development tolerance to them hemodynamic effect there. Acetylcysteine enhances the vasodilating effect of nitroglycerin and may reverse tolerance to nitrates.

Pharmacokinetics

Acetylcysteine is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 0.5 to 1 hour after oral administration of 200 to 600 mg. Some research indicate on the dose- dependent pharmacokinetics with peak concentrations, the time taken to reach peak concentrations, and bioavailability, increasing _ With increase doses. Acetylcysteine can be present in plasma in form the parent compound or as various oxidized metabolites, such how N -acetylcysteine, N , N -diacetylcysteine and cysteine, or in free form, or bound to plasma proteins labile disulfide bonds, or in the form of a fraction included in protein peptide chains. AT in the study, about 50% were in the form covalently bound to the protein after 4 hours after taking a dose. Oral bioavailability is low and mean values range from 4 to 10% in dependencies from Togo, measured whether general acetylcysteine or reduced forms only. It has been suggested that low bioavailability acetylcysteine at oral _ admission maybe to be tied With metabolism in the intestinal wall and metabolism during the first passage through the liver. Renal clearance may account for about 30% of total clearance organism. At intravenous administered middle final periods half-life constitute 1.95 and 5.58 hours for restored and general acetylcysteine respectively; finite period life general acetylcysteine made up 6.25 hours after oral reception.

Indications for use

one.   For respiratory infections ways, characterized by thick and viscous discharge, such as acute bronchitis, chronic bronchitis and his exacerbation, emphysema lung, cystic fibrosis and bronchiectasis   disease.

2.        To prevent or reduce liver damage that may occur after ingestion of a potentially hepatotoxic amount acetaminophen.   Important to begin treatment as can quicker after overdose and, in in any case, within 24 hours after ingestion.

Contraindications

MUKOTIL contraindicated patients With increased sensitivity or previous anaphylactoid reactions to acetylcysteine or any Components drug.

Dosage and administration

Acetylcysteine is given orally as effervescent tablets dissolved in water at the usual dose of 600 mg daily as a single dose. doses or in 3 reception.

Special instructions and precautions Acetylcysteine should be used with caution in patients with asthma. It should also be used with caution in patients with a history of peptic ulcer disease, because drug-induced nausea and vomiting may increase the risk of gastrointestinal bleeding in patients predisposed to this disease, and also because of the theoretical risk that mucolytics may impair work of the gastrointestinal tract. Gastric mucosal barrier .

Use during pregnancy and during breastfeeding

Pregnancy. Category B. _ No evidence of impaired fertility or harm to the fetus due to acetylcysteine. However, adequate and well-controlled studies in pregnant women have not been conducted. Because animal reproduction research cannot always predict reaction human, this a drug should use in time pregnancy only in case extreme need.

Lactation. unknown stands out whether this a drug With chest milk. Because the many drugs are excreted in breast milk, should be observed caution at appointment acetylcysteine lactating woman.

Interaction with other drugs means

The drug stability and safety of acetylcysteine when mixed with other drugs have not been established.

Side effect

Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including bronchospasm, angioedema, rash and itching, edema, urticaria; maybe arise hypotension or sometimes hypertension. Other side effects reported with acetylcysteine include hot flashes, nausea and vomiting, fever, fainting, sweating, arthralgia, blurred vision, abnormal liver function, acidosis, seizures, and cardiac arrest. or breathing. Hemoptysis, rhinorrhea and stomatitis were connected With by inhalation acetylcysteine.

Overdose

In case of overdose, treatment should be symptomatic.

As an antidote for acetaminophen overdose:

The standard protocol is loading dose 140 mg/kg orally With subsequent 70 mg/kg orally every 4 hours for 17 additional   doses.

Storage conditions

Store at a temperature not exceeding 30°C. Keep away from the world.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions It is dispensed by prescription.

Release form

10 tablets in a tube. This tube is packed in a cardboard box. box together with leaflet.