EXFLEM Acetylcysteine 600mg Granules for Solution 1's
RXDRUG-DRP-8774-1pc
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Features
Brand
Exflem
Full Details
Dosage Strength
600mg
Drug Ingredients
- Acetylcysteine
Drug Packaging
Granule for Solution 1's
Generic Name
Acetylcysteine
Dosage Form
Granule for Solution
Registration Number
DRP-8774
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Tablet: For the treatment of respiratory conditions characterized by thick and viscous hypersecretion such as acute bronchitis, chronic bronchitis and its exacerbation, pulmonary emphysema, cystic fibrosis, and bronchiectasis.
Granules: 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.
Granules: 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.
Dosage/Direction for Use
Tablet: Adult Dose: 1 effervescent tablet once a day, preferably in the evening.
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.
Direction for use: Dissolve 1 effervescent tablet in a glass (250 mL) of water.
Acetylcysteine solution should not be mixed with other drugs to avoid interaction.
Granules: 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 advice 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.
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.
Direction for use: Dissolve 1 effervescent tablet in a glass (250 mL) of water.
Acetylcysteine solution should not be mixed with other drugs to avoid interaction.
Granules: 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 advice 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.
Administration
Should be taken with food: Dissolve tab/granules in ½ glass of water (250 mL for tab/100 mL for granules). Stir until soln clears. Consume entire drink.
Special Precautions
After proper administration of acetylcysteine, an increased volume of liquefied bronchial secretions may occur. If the patient cannot expectorate efficiently, postural drainage and bronchoaspiration must be used to avoid retention of secretions.
Carefully observe asthmatics under treatment with acetylcysteine. If bronchospasm occurs, discontinue acetylcysteine immediately.
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.
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.
Phenylketonurics: This product contains phenylalanine as one of the metabolites of aspartame.
Carefully observe asthmatics under treatment with acetylcysteine. If bronchospasm occurs, discontinue acetylcysteine immediately.
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.
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.
Phenylketonurics: This product contains phenylalanine as one of the metabolites of aspartame.
Adverse Reactions
Generally, acetylcysteine is well tolerated. Hypersensitivity reactions including urticaria, pruritus, angioedema, bronchospasm, hypotension or hypertension may occasionally occur. Other adverse effects reported include headache, flushing, nausea, vomiting, fever, syncope, drowsiness, tinnitus, chills, sweating/clamminess, chest tightness, arthralgia, blurred vision, disturbances of liver function, acidosis, convulsions, bronchoconstriction, irritation to the trachea and bronchial tracts, and cardiac or respiratory arrest. Hemoptysis, rhinorrhea, and stomatitis have also been reported.
Drug Interactions
Do not mix w/ other medicines.
Action
Pharmacologic Classification: Mucolytic.
Pharmacology: Mechanism of Action: 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 (HOCl) 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: Bioavailability: 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.
Pharmacology: Mechanism of Action: 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 (HOCl) 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: Bioavailability: 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.
MedsGo Class
Cough & Cold Preparations
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