Description:

Aminophylline Injection 250mg/10ml (by Chupet Pharma) is a sterile, nonpyrogenic solution of aminophylline (a complex of theophylline and ethylenediamine) in water for injection. It is used as a bronchodilator to treat and prevent symptoms of reversible airway obstruction, including acute exacerbations of asthma, chronic obstructive pulmonary disease (COPD), bronchitis, emphysema, and other lung diseases. It relaxes bronchial smooth muscles, improves airflow, and stimulates respiration. In Ghana (Accra), it is a prescription injectable commonly used in hospitals and emergency settings for acute respiratory distress when rapid bronchodilation is needed.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; administered only by healthcare professionals via slow IV injection or infusion in hospitals/clinics; not for self-administration or OTC dispensing due to narrow therapeutic index, risk of toxicity, and need for monitoring of serum theophylline levels and vital signs).

Therapeutic Category:

Bronchodilator / Methylxanthine Derivative (Respiratory stimulant and smooth muscle relaxant).

Active Ingredients/Composition:

• Active ingredient: Aminophylline – 250 mg per 10 ml ampoule (25 mg/ml).
  • Aminophylline is a complex of theophylline (~80%) and ethylenediamine (~20%) for enhanced water solubility.
  • Provides approximately 200 mg theophylline per 10 ml ampoule. Other ingredients: Water for injection (solvent); may contain ethylenediamine or pH adjusters (sodium hydroxide/hydrochloric acid) to maintain pH 8.6–9.0. The solution is clear, colourless to pale yellow, sterile, and ready-to-use or diluted for infusion.

Vitamins: None.

Minerals: None.

Variant:

• Chupet Aminophylline Injection 250mg/10ml (standard 10 ml ampoule; common pack sizes 10 ampoules). Related variants: Aminophylline 500mg/20ml (higher volume/strength), or other brands (e.g., generic aminophylline 250mg/10ml). The 250mg/10ml is the most common adult emergency strength.

Consume Type:

Injectable – Intravenous (IV) injection or infusion (slow IV push or diluted infusion; administered only by healthcare professionals; never IM or SC).

Directions/Usage: Administered only in hospital/clinic with monitoring (ECG, serum theophylline levels if prolonged use).

• Adults (acute bronchospasm): Loading dose 5–6 mg/kg IV over 20–30 minutes (approx. 250–500 mg), followed by maintenance infusion 0.4–0.6 mg/kg/hour (adjusted for age, smoking, liver/heart disease).
• Children: Weight-based (loading 5–6 mg/kg IV over 20–30 minutes, maintenance 0.5–0.9 mg/kg/hour).
• Slow IV push: 250 mg (10 ml) over at least 5–10 minutes (undiluted or diluted).
• IV infusion: Dilute in compatible fluid (e.g., 5% dextrose or 0.9% NaCl) and infuse slowly.
• Monitor serum theophylline levels (therapeutic range 10–20 µg/ml; toxicity >20 µg/ml).
• Duration: Short-term (usually 24–48 hours); switch to oral theophylline or inhaled bronchodilators as soon as possible.

Common Side Effects: Common:

• Nausea, vomiting, abdominal pain.
• Tachycardia (fast heart rate), palpitations.
• Headache, restlessness, insomnia.
• Tremor, nervousness. Rare/serious (seek immediate help): Seizures, arrhythmias (ventricular tachycardia/fibrillation), severe hypotension, anaphylaxis, or theophylline toxicity (confusion, vomiting, tachycardia >150 bpm, seizures).

Package Type:

Glass ampoules of 10 ml (each containing 250 mg aminophylline; packs of 10 ampoules; labelled carton with dilution instructions and warnings).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only under medical supervision (narrow therapeutic index; toxicity risk – monitor heart rate, ECG, serum theophylline if prolonged).
• Contraindicated in hypersensitivity to aminophylline/theophylline, uncontrolled arrhythmias, or porphyria.
• Caution in elderly, heart failure, liver/renal impairment, peptic ulcer, seizure disorders, or concurrent use of drugs that interact (e.g., ciprofloxacin, erythromycin increase levels; rifampicin decreases levels).
• Reduce dose in smokers (increased clearance) or liver disease.
• If vomiting, seizures, tachycardia >150 bpm, or arrhythmias occur, stop infusion and seek urgent care (treat with activated charcoal, benzodiazepines for seizures, or beta-blockers for tachycardia if needed).
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar aminophylline injections in Ghana include:

• Generic aminophylline 250mg/10ml injection (various importers).
• Aminophylline injection BP (other brands like Martindale or local generics). Alternatives: Salbutamol IV/nebulized, ipratropium, theophylline IV (rare), or inhaled corticosteroids/long-acting beta-agonists for maintenance. Consult doctor/pharmacist in Accra (e.g., hospital pharmacy) for alternatives.

Manufacturer/Marketer:

Chupet Pharma Ltd (Nigeria-based pharmaceutical company; produces Chupet Aminophylline Injection 250mg/10ml). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported product).

Country of Origin:

Nigeria (manufactured by Chupet Pharma Ltd; imported to Ghana and available in local pharmacies/hospitals).