Description:

Acetylcysteine Injection BP is a sterile injectable solution used primarily as an antidote for paracetamol (acetaminophen) overdose to prevent or reduce liver damage. It replenishes glutathione stores in the liver, which neutralizes the toxic metabolite NAPQI. It is also used as a mucolytic in respiratory conditions with excessive mucus (e.g., bronchitis, cystic fibrosis, bronchiectasis) when administered by inhalation or nebulization (though the injectable form is mainly for IV use in overdose). The “SL” likely refers to Samarth Life Sciences branding or a specific variant.

Prescription:

Prescription-only.

Therapeutic Category:

Antidote (for paracetamol overdose) / Mucolytic Agent (Antioxidant and mucolytic.

Active Ingredients/Composition:

• Active ingredient: Acetylcysteine BP – 200 mg per ml (20% w/v solution).
  • Common presentation: 400 mg/2 ml ampoule or 1 g/5 ml (varies; Mucomix SL often 400 mg/2 ml or 1 g/5 ml). Other ingredients: Water for injection, disodium edetate (chelating agent), sodium hydroxide (pH adjustment to ~6–7), and nitrogen (for stability in some formulations). The solution is clear, colorless to pale yellow, sterile, and ready-to-use or diluted for infusion.

Vitamins: None.

Minerals: None.

Variant:

• Mucomix SL Acetylcysteine Injection BP (standard 200 mg/ml concentration; common ampoule sizes 2 ml [400 mg] or 5 ml [1 g]). Related variants: Mucomix in different volumes (e.g., 10 ml for higher doses), or other brands (e.g., Acetadote, Parvolex). The queried “Mucomix SL Samaryth” likely refers to Samarth Life Sciences’ Mucomix variant (SL = Samarth Life).

Consume Type:

Injectable – Intravenous (IV) infusion (preferred for paracetamol overdose) or intramuscular (rare); also used for nebulization/inhalation in mucolytic therapy (diluted). Administered only by healthcare professionals in clinical settings.

Directions/Usage: Administered only in hospital/clinic under medical supervision.

• Paracetamol overdose (IV protocol): Standard 20-hour regimen (e.g., loading dose 150 mg/kg over 1 hour, then 50 mg/kg over 4 hours, then 100 mg/kg over 16 hours; total 300 mg/kg). Dosing based on body weight and plasma paracetamol levels (nomogram-guided).
• Mucolytic use (inhalation): Diluted (e.g., 3–5 ml of 20% solution or 6–10 ml of 10% solution) via nebulizer 3–4 times daily.
• IV infusion: Diluted in compatible fluid (e.g., 5% dextrose); slow infusion to avoid adverse reactions.
• Monitor vital signs and liver function during treatment.

Common Side Effects: Common (during IV infusion):

• Flushing, rash, itching (anaphylactoid reaction – usually mild).
• Nausea, vomiting.
• Hypotension, tachycardia.
• Bronchospasm (rare, more in asthmatics). Rare/serious (seek immediate help): Severe anaphylaxis (swelling, breathing difficulty), angioedema, or bradycardia.

Package Type:

Glass ampoules or vials (commonly 2 ml [400 mg] or 5 ml [1 g]; packs of 5–10 ampoules; labelled carton with instructions).

Storage Advice: Store unopened ampoules at room temperature (below 25–30°C), protected from light. Do not freeze. Reconstituted/diluted solution: Use immediately or as per protocol (usually within hours). Out of reach of children.

Safety Advice:

• Administered only under medical supervision (high risk of anaphylactoid reactions—monitor closely for 30–60 minutes post-infusion).
• Contraindicated in hypersensitivity to acetylcysteine.
• Caution in asthma (risk of bronchospasm), peptic ulcer, or bleeding disorders.
• Test dose may be given in high-risk patients.
• If rash, flushing, hypotension, or breathing difficulty occurs during infusion, stop immediately and treat (antihistamines, steroids, epinephrine if needed).
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar acetylcysteine injections in Ghana include:

• Generic acetylcysteine 200 mg/ml injection (various importers).
• Acetadote or Parvolex (original brands if stocked).
• Mucomix or other Samarth Life Sciences variants. Consult doctor/pharmacist in Accra (e.g., Korle Bu Hospital pharmacy) for availability.

Manufacturer/Marketer:

Samarth Life Sciences Pvt Ltd (India-based; primary manufacturer of Mucomix SL Acetylcysteine Injection). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported emergency medication).

Country of Origin:

India (manufactured by Samarth Life Sciences Pvt Ltd; imported to Ghana and available in hospitals/pharmacies).