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: Acenewrax 200 & 600 mg 10 sachets
Manufacturer:
Acenewrax 200 & 600 mg 10 sachets is manufactured by **Arax Pharmaceutical Industries**, Egypt. [1]
Introduction:
Acenewrax contains **acetylcysteine (N-Acetylcysteine)**, a well-known mucolytic and antioxidant. It is available in two strengths: 200 mg and 600 mg. Acetylcysteine acts by cleaving disulfide bonds in mucus, reducing its viscosity to facilitate clearance. It also serves as a precursor to glutathione, a powerful antioxidant, giving it detoxifying properties, particularly in cases of paracetamol overdose. [2, 3]
Indications and Usage:
Acenewrax is indicated for the symptomatic relief and management of:
* **200 mg sachets:** Adjunct therapy for chronic airway diseases (e.g., COPD, chronic bronchitis, cystic fibrosis, emphysema, bronchiectasis), and in acute respiratory conditions like pneumonia, tuberculosis, post-tracheostomy care, and post-thoracic surgery. [2]
* **600 mg sachets:**
* Treatment of paracetamol (acetaminophen) overdose, as an antidote to prevent or reduce hepatic (liver) damage. [2, 3]
* Prevention of contrast-induced nephropathy during diagnostic imaging procedures. [2]
Characteristics:
* **Dosage Form:** Oral powder in sachet (dissolve in water). [1]
* **Strengths:** 200 mg or 600 mg acetylcysteine per sachet. [1]
* **Drug Class:** Mucolytic agent, Antioxidant, Antidote. [2, 3]
* **Mechanism of Action:**
* **Mucolytic:** Acetylcysteine's free sulfhydryl group disrupts disulfide bonds in mucoproteins, which reduces the viscosity of mucus, making it less sticky and easier to expectorate. [2, 3]
* **Antioxidant/Detoxifying:** As a precursor to glutathione (GSH), NAC replenishes depleted GSH stores, crucial for detoxifying harmful metabolites (e.g., NAPQI in paracetamol overdose) and scavenging reactive oxygen species (ROS). [2, 3]
Dosage and Administration:
Acenewrax is administered orally after dissolving the contents of the sachet in water.
* **200 mg solution (Adults and Adolescents > 14 years):** 1 sachet dissolved in water, 2–3 times daily. [2]
* **200 mg solution (Children 6-14 years):** Typically 200 mg twice daily. [2]
* **200 mg solution (Children 2-5 years):** Typically 100 mg 2-3 times daily (using the 200 mg sachet and dividing the dose if necessary, or a specific 100 mg formulation if available). [2]
* **600 mg solution (Paracetamol Overdose):** Administered as per local protocols (e.g., IV alternative or oral regimen), requiring immediate medical supervision. [2, 3]
* **600 mg solution (Contrast Prophylaxis):** As per physician's dosing protocol, often requiring concomitant IV hydration. [2]
* **Preparation & Administration:** Dissolve the entire contents of the sachet in approximately 100 mL of water; stir well; and drink immediately. Reconstitute fresh before each dose. [2]
* **Duration:** Depends on the condition. For chronic conditions, treatment may be long-term. [2]
Contraindications:
Acetylcysteine should not be used in individuals with the following conditions:
* Hypersensitivity to acetylcysteine or any of the excipients. [2]
* Active peptic ulcer disease (due to potential for gastric irritation). [2]
* Children under 2 years of age for mucolytic therapy (due to risk of airway obstruction in very young children). [2]
Warnings and Precautions:
* **Bronchospasm:** Patients with asthma may experience bronchoconstriction. If bronchospasm occurs, discontinue use immediately and seek medical attention. [2]
* **Anaphylactoid Reactions:** Rare, but can occur (more frequently with IV formulation); treat symptomatically if occurs. [2]
* **Gastrointestinal Effects:** Monitor for nausea, vomiting, or dyspepsia. Take with water to minimize GI irritation. [2]
* **Sulfur Odor:** The reconstituted solution may have a slight sulfur odor, which is normal and does not indicate degradation. [2]
* **Fluid Intake:** Adequate fluid intake is important during mucolytic therapy to aid in mucus clearance. [2]
* **Paracetamol Overdose:** For paracetamol overdose, acetylcysteine must be administered immediately after confirmed toxicity under strict medical supervision. [2]
* **Contrast Imaging:** Ensure adequate IV hydration before and after contrast administration to reduce nephrotoxicity risk. [2]
* **Pregnancy and Lactation:** Use only if clearly needed and under medical supervision, as data are limited. [2]
Pharmacokinetics:
* **Absorption:** Acetylcysteine is rapidly and almost completely absorbed from the GI tract after oral administration. Peak plasma concentrations are typically reached within 1-3 hours. [2, 3]
* **Metabolism:** It is rapidly converted to cysteine, which is then incorporated into glutathione. It also undergoes further metabolism in the liver. [2, 3]
* **Distribution:** It is widely distributed throughout the body, including the lungs. It is partially bound to plasma proteins. [2, 3]
* **Elimination:** The elimination half-life of oral acetylcysteine is approximately 6 hours (for total cysteine). Excretion occurs primarily via the kidneys as metabolites. [2, 3]
Side Effects:
| Frequency | Reactions |
|---|---|
| **Common** | Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, oral/GI irritation. [2] |
| **Uncommon** | Hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), headache, fever, tinnitus. [2] |
| **Rare / Serious** | Bronchospasm, anaphylactoid-like reactions (e.g., hypotension, rash), severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis - very rare). [2]
Drug Interactions:
Acetylcysteine may interact with several other medications:
* **Nitroglycerin:** May enhance the hypotensive effect of nitroglycerin. [2]
* **Activated Charcoal:** May reduce the absorption of acetylcysteine if given concurrently; separate dosing by at least 2 hours, especially in paracetamol overdose. [2]
* **Antibiotics:** Acetylcysteine may reduce the efficacy of some antibiotics (e.g., tetracyclines, aminoglycosides, penicillins). It is advisable to administer antibiotics 2 hours before or after NAC. [2]
* **Cough Suppressants:** Concomitant use with antitussives (cough suppressants) may lead to a dangerous accumulation of secretions due to inhibited cough reflex. [2]
* **No significant interactions** with antihypertensives, steroids, or bronchodilators have been reported. [2]
Patient Counseling:
* Dissolve the contents of each sachet completely in water (approximately 100 mL) and drink immediately. Do not prepare in advance. [2]
* Do not exceed the prescribed dose. [2]
* Maintain adequate fluid intake during treatment to help thin mucus and facilitate its clearance. [2]
* Expect increased mucus clearance and coughing. If coughing persists or worsens, or if you experience difficulty breathing or worsening of asthma symptoms, stop taking the medication and seek medical attention immediately. [2]
* The reconstituted solution may have a slight sulfur odor, which is normal. [2]
* Inform your doctor about all other medications, supplements, and herbal products you are taking. [2]
* Use the full prescribed course, especially in chronic respiratory conditions. [2]
* Seek emergency care if allergic reaction symptoms (difficulty breathing, rash, swelling) occur. [2]
* Store sachets in a cool, dry place (below 25 °C), away from light and children. [2]
Sources:
* Arax Pharmaceutical Industries Official Website (or product page for Acenewrax, if available): https://araxpharma.com/ [1]
* N-Acetylcysteine (NAC) - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc [2]
* N-Acetylcysteine - DrugBank Online: https://go.drugbank.com/drugs/DB06151 [3]
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