RiteMED Acetylcysteine

RiteMED Acetylcysteine 600 mg Granules for Solution, contains a characteristic orange and slightly sulfur odored, yellow granules white to off-white granules with orange inclusions.
Each sachet contains: Acetylcysteine 600 mg.

Mucolytic.
Pharmacology: Pharmacodynamics: Acetylcysteine, the N-acetyl derivative of the naturally occurring amino acid, L-cysteine, is a mucolytic agent, an antidote for paracetamol poisoning and a sulfhydryl donor. Acetylcysteine has an intense mucolytic action on mucoid and mucopurulent secretions due to its ability to split disulfide bonds in mucous glycoprotein altering their configuration to improve flow characteristics thus reducing the viscosity of mucus.
Acetylcysteine has antioxidant action because of its nucleophilic free thiol (-SH) group that directly interacts with electrophilic groups of the oxidative radicals. Acetylcysteine protects α₁-antitrypsin (an enzyme that inhibits elastase) from inactivation by hypochlorous acid. Hypochlorous acid (HOCl) is a potent oxidative agent produced by the myeloperoxidase enzyme of activated phagocytes. These activities make acetylcysteine particularly appropriate for the treatment of acute and chronic conditions of the respiratory system characterized by mucoid and mucopurulent dense and viscous secretions.
Pharmacokinetics: Acetylcysteine is rapidly absorbed from the gastrointestinal tract and transported to the liver via the portal circulation, where it undergoes extensive first-pass metabolism. The oral bioavailability of acetylcysteine varies between 6 and 10%. Peak plasma concentrations are observed approximately 0.5 to 1 hour after oral doses of 200 to 600 mg.
Acetylcysteine may be present in plasma as the parent compound or as various oxidized metabolites such as N-acetylcysteine, N,N-diacetylcysteine and L-cysteine. L-cysteine itself is metabolized to glutathione, protein, taurine and sulfate. Renal clearance may account for about 30% of total body clearance. The terminal half-life of total acetylcysteine is 6.25 hours after oral dosing.

Acetylcysteine is used for its mucolytic activity in respiratory disorders associated with productive cough and thick viscous hypersecretion such as acute bronchitis, chronic bronchitis and its exacerbation, pulmonary emphysema, cystic fibrosis, and bronchiectasis.

Adults and Children over 14 Years Old: Orally, contents of 1 sachet once a day, or, as prescribed by a physician.
Duration of treatment: Acute Disorders: 5 to 10 days.
Chronic Disorders: May be continued for several months, according to the advise of a physician.
Directions for use: Empty contents of one (1) sachet into a mug.
Dissolve the granules in about ½ glass (100 mL) of water.
Stir until the solution clears.
Consume entire drink.
Acetylcysteine solution should not be mixed with other medicines to avoid interaction.

Overdosage and Treatment: When orally administered, no particular signs and symptoms have been observed with high dose of acetylcysteine.
In case of overdosage, discontinue acetylcysteine and institute appropriate symptomatic and supportive therapy (e.g., postural drainage and bronchoaspiration).

Hypersensitivity to any ingredient of the product.

Carefully observe asthmatics under treatment with acetylcysteine. If bronchospasm occurs, discontinue acetylcysteine immediately.
Use with caution in patients with a history of peptic ulcer disease because drug-induced nausea and vomiting may increase the risk of gastrointestinal hemorrhage in patients predisposed to the condition and because of a theoretical risk that mucolytics may disrupt the gastric mucosal barrier.
The presence of a sulfur-like odor does not indicate an alteration of the product but is a characteristic of the drug substance contained in the preparation.

Pregnancy: Pregnancy Category B. The safe use of acetylcysteine during pregnancy has not been established. Acetylcysteine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether acetylcysteine is excreted in human milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefit of the product justifies the possible risk.

Hypersensitivity reactions have been reported in patients receiving acetylcysteine, including bronchospasm, angioedema, rashes and pruritus; hypotension, or occasionally hypertension, may occur. Other adverse effects reported include flushing, nausea and vomiting, fever, syncope, sweating, arthralgia, blurred vision, disturbances of liver function, acidosis, convulsions, and cardiac or respiratory arrest.

Based on acetylcysteine's mechanism of action, the concomitant administration of acetylcysteine and other drugs that may interact with this group is not recommended.

Store at temperatures not exceeding 30°C.
Protect from light.

Cough & Cold Preparations

R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

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