acesolv 2% syrup 60ml

Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.

Drug Name: Acesolv 2% Syrup 60ml

Manufacturer:

Acesolv 2% Syrup 60ml is manufactured by El-Obour Pharmaceutical Industries (El-Obour P.I.), distributed by Spimaco Misr. [1, 2]

Introduction:

Acesolv 2% Syrup contains Acetylcysteine (NAC), a potent mucolytic and antioxidant agent. It is widely used to manage respiratory conditions associated with excessive or thick mucus, making the sputum thinner and easier to clear from the airways. This syrup is commonly prescribed to children and adults for relieving chest congestion and improving mucus clearance in conditions like bronchitis or cystic fibrosis. The syrup form makes it convenient for pediatric and geriatric use. [1, 3, 4]

Indications and Usage:

Acesolv 2% Syrup is indicated for the symptomatic treatment of respiratory disorders associated with excessive or thick mucus, including: [1, 3, 4]

• Productive cough with thick or sticky mucus.
• Acute and chronic bronchitis.
• Chronic obstructive pulmonary disease (COPD).
• Bronchiectasis.
• Sinusitis.
• Cystic fibrosis (as an adjunct therapy).
• Post-surgical or trauma-related mucus retention.

Characteristics:

Acetylcysteine is an N-acetyl derivative of the amino acid L-cysteine. It exerts its mucolytic action by directly breaking down disulfide bonds in mucoproteins, thereby reducing the viscosity of respiratory secretions. This makes it easier for the patient to cough up and clear the mucus. Beyond its mucolytic properties, Acetylcysteine is also known for its antioxidant effects, as it helps replenish glutathione levels, which play a crucial role in protecting cells from oxidative damage. [3, 4, 5]

• Active Ingredient: Acetylcysteine 2% (equivalent to 20 mg/mL). Each 5ml contains 100mg of Acetylcysteine. [1, 2]
• Form: Oral syrup.
• Volume: 60ml bottle.
• Drug Class: Mucolytic, Antioxidant.
• Mechanism of Action: Breaks disulfide bonds in mucoproteins, reducing mucus viscosity; acts as a glutathione precursor. [3, 4]

Dosage and Administration:

Acesolv 2% Syrup is for oral administration. The dosage should be determined by a physician based on the patient's age and condition. [1, 2]

• Adults and adolescents (12+ years): 10 ml (200 mg) two to three times daily.
• Children 6–12 years: 5 ml (100 mg) three times daily.
• Children 2–6 years: 2.5 ml (50 mg) three times daily.
• Administration Tips:
  • Shake the bottle well before use.
  • Use the included measuring cup or syringe to ensure accurate dosing.
  • Can be taken with or without food.
  • It is advisable to take the last dose several hours before bedtime to avoid accumulation of thinned mucus during sleep.
  • Rinse mouth afterward to avoid any residual taste.

Contraindications:

Acesolv 2% Syrup should not be used in the following cases: [1, 3]

• Hypersensitivity to acetylcysteine or any of the excipients.
• Children under 2 years of age, due to the risk of bronchial obstruction (blockage) caused by the increased volume of bronchial secretions.
• Active peptic ulceration (stomach or duodenal ulcer) or a history of gastrointestinal bleeding, as acetylcysteine may exacerbate these conditions.

Warnings and Precautions:

• Bronchospasm Risk: Use with caution in patients with asthma or a history of bronchospasm, as acetylcysteine can sometimes trigger bronchospasm. If this occurs, discontinue use immediately. [3, 4]
• Gastric Irritation: Acetylcysteine can cause gastric irritation. Use with caution in patients with a history of peptic ulcers or esophageal varices. [3, 4]
• Skin Reactions: Very rare cases of severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in temporal association with acetylcysteine. If new skin or mucosal lesions appear, discontinue treatment immediately. [3, 4]
• Sulfur Smell: The solution may have a characteristic sulfurous odor, which is normal and does not indicate product spoilage. [3]
• Concomitant use with antitussives (cough suppressants) is not recommended as it may reduce mucus clearance. [3, 4]
• Hepatic/Renal Impairment: Use with caution in patients with severe hepatic or renal impairment. [3]
• Excipients: Some formulations may contain sucrose, which should be considered for diabetic patients or those on a low-sugar diet. [1]

Pharmacokinetics:

• Absorption: Acetylcysteine is rapidly absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are typically reached within 1 to 3 hours. [3, 4]
• Bioavailability: Oral bioavailability is low (about 4-10%) due to extensive first-pass metabolism in the liver. [3, 4]
• Distribution: It is widely distributed throughout the body, including the lungs. [3, 4]
• Metabolism: Extensively metabolized in the liver to various metabolites, including cysteine, glutathione, and mixed disulfides. [3, 4]
• Elimination: Primarily excreted by the kidneys. The plasma elimination half-life is approximately 2 hours, though some sources indicate up to 6.25 hours. [3, 4]

Side Effects:

Acetylcysteine is generally well-tolerated, but side effects can occur: [3, 4]

• Common: Nausea, vomiting, diarrhea, stomach pain, heartburn.
• Hypersensitivity Reactions: Rash, urticaria (hives), itching, angioedema (swelling of face/lips/tongue), bronchospasm (difficulty breathing). These are rare but can be severe.
• Other: Headache, tinnitus (ringing in the ears), fever.

If any severe or persistent side effects occur, especially allergic reactions or skin lesions, discontinue use and consult a healthcare professional immediately.

Drug Interactions:

It is generally not recommended to combine Acetylcysteine with: [3, 4]

• Antitussives (Cough Suppressants): As they can suppress the cough reflex needed to clear the thinned mucus, leading to a build-up of secretions.
• Activated Charcoal: May reduce the absorption of oral acetylcysteine if administered concurrently (especially relevant in paracetamol overdose treatment).
• Antibiotics: Acetylcysteine may reduce the activity of some antibiotics (e.g., tetracyclines, aminoglycosides, penicillins). It is advisable to administer antibiotics at least 2 hours before or after acetylcysteine.
• Nitroglycerin: Concomitant use may enhance the vasodilatory and antiplatelet effects of nitroglycerin.

Patient Counseling:

• Always take the syrup exactly as prescribed by your doctor.
• Do not exceed the recommended dose or duration of treatment.
• Measure the dose accurately using the provided measuring cup or syringe.
• If you experience stomach upset, try taking the syrup with food.
• Report any persistent or worsening symptoms, or any signs of allergic reaction or severe skin reactions to your doctor immediately.
• Keep out of reach of children.
• Store at room temperature, away from direct heat and light.
• The solution may have a slight sulfurous odor, which is normal.

Sources:

• El-Obour Pharmaceutical Industries (El-Obour P.I.) Official Website (or product page for Acesolv, if available): https://www.elobour.com/ [1]
• Spimaco Misr (Distributor) Official Website: https://www.spimaco.com.sa/en/spimaco-misr [2]
• N-Acetylcysteine (NAC) - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc [3]
• N-Acetylcysteine - DrugBank Online: https://go.drugbank.com/drugs/DB06151 [4]
• Acesolv 2% Syrup Product Information (from Egyptian pharmacy/drug directories): https://dw2.org/drug/acesolv-2-syrup-60ml [5]