Description:

Promethazine Injection 50mg/2ml is a sterile solution containing promethazine hydrochloride, a first-generation phenothiazine derivative with potent antihistamine, antiemetic, sedative, and anticholinergic properties. It is administered parenterally (intramuscular or slow intravenous) for rapid relief or prevention of allergic reactions, severe nausea/vomiting (e.g., postoperative, chemotherapy-induced, or motion sickness), as an adjunct in anaphylaxis (after epinephrine), for sedation/preoperative medication, and to control motion sickness or vertigo when oral therapy is unsuitable. It is a common essential medicine in Ghana for hospital/emergency use in allergy, nausea, or sedation scenarios.

Prescription:

Prescription-only (requires a doctor’s prescription; administered by healthcare professionals in clinical settings like hospitals or clinics in Accra; not for self-administration or OTC purchase in Ghana).

Therapeutic Category:

First-Generation Antihistamine / Phenothiazine Derivative / Antiemetic / Sedative-Hypnotic / Anticholinergic (for parenteral use

Active Ingredients/Composition:

• Active ingredient: Promethazine hydrochloride 50 mg per 2 ml ampoule (equivalent to 25 mg/ml; provides 50 mg promethazine base activity). Other ingredients (typical excipients): Water for injection, sodium metabisulfite (antioxidant), edetate disodium (chelating agent), calcium chloride, phenol (preservative), acetic acid/sodium acetate (buffer for pH 4.0-5.5), and others. The solution is clear, colorless to pale yellow, light-sensitive, and pyrogen-free.

Variant:

• Standard Promethazine HCl Injection 50mg/2ml (ampoule/vial). Related variants: 25mg/ml in 1ml or 2ml ampoules (e.g., 25mg/1ml or 25mg/2ml for lower dosing); oral forms (elixir/tablets) or suppositories exist but this is the injectable strength. In Ghana, generics like Prometta or similar imported brands are common.

Consume Type:

Parenteral – Solution for injection (deep intramuscular [preferred] or slow intravenous [diluted, over 2-5 minutes to avoid vein irritation]; never subcutaneous or intra-arterial due to severe tissue damage risk).

Directions/Usage:

Administered only by trained healthcare professionals.

• Adults: Typically 25-50 mg IM or slow IV (e.g., 50 mg/2ml dose); may repeat in 2 hours if needed, max 150 mg/day.
• For nausea/vomiting: 12.5-25 mg IM/IV, repeat as required.
• Sedation/preop: 25-50 mg IM.
• Children: Lower doses (e.g., 0.25-1 mg/kg IM/IV; not recommended under 2 years due to risks). Dilute IV doses; monitor patient closely. Use lowest effective dose/shortest duration.

Common Side Effects: Common:

• Drowsiness/sedation (prominent; impairs driving/machinery)
• Dizziness, dry mouth, blurred vision
• Confusion, disorientation (especially elderly)
• Injection site pain/irritation Other frequent: Headache, restlessness (paradoxical in children), tachycardia. Serious (seek immediate help): Severe tissue necrosis/gangrene (if extravasation or intra-arterial), respiratory depression, neuroleptic malignant syndrome, severe hypotension, or allergic reactions.

Package Type:

Glass ampoule of 2 ml solution (single-dose; often in packs of 5x2ml, 10x2ml, or boxes of 100 ampoules for hospital use; light-protected packaging in some cases).

Storage Advice:

Store below 25-30°C in a cool, dry place, protected from light (keep in original carton/foil if provided). Do not freeze. Inspect for color/particulates before use; discard if discolored or cloudy. Out of reach of children.

Safety Advice:

• For IM/IV use only under supervision; never intra-arterial (risk of severe necrosis/gangrene) or subcutaneous.
• Contraindicated in coma, severe CNS depression, children <2 years (respiratory depression risk), or hypersensitivity.
• Caution in elderly, respiratory disease, glaucoma, prostate issues, epilepsy, liver impairment, or cardiovascular disease.
• Avoid in pregnancy (especially near term) or breastfeeding unless essential.
• May potentiate CNS depressants (alcohol, opioids, sedatives); monitor for extrapyramidal symptoms or QT prolongation.
• If extravasation occurs, stop infusion and seek urgent treatment.

Product Substitutes:

Other promethazine injections available in Ghana include:

• Generic Promethazine HCl 25mg/ml or 50mg/2ml (various importers, e.g., from India).
• Brands like Prometta, Philo-Promethazine, or similar (check pharmacies like Beybee, Meldinpharma, AlphaDelta). Alternatives (for nausea/allergy/sedation): Metoclopramide injection, Ondansetron injection, Dexamethasone, or Diphenhydramine injection (consult doctor for appropriate switch).

Manufacturer/Marketer:

Varies by batch; commonly generic from Indian manufacturers (e.g., Jayson Pharmaceuticals, Aeromatic Healthcare, or other exporters); marketed/distributed in Ghana by local importers/pharmacies (e.g., Beybee Pharmacy, Meldinpharma, AlphaDelta Pharmacy, or hospital suppliers).

Country of Origin:

India