Description:

Ketamine Hydrochloride Injection USP 50mg/ml (10ml vial by Swiss Pharma) is a sterile, non-narcotic dissociative anaesthetic and analgesic used for induction and maintenance of general anaesthesia, procedural sedation, emergency analgesia, and certain pain management scenarios. It produces a dissociative state (cataleptic immobility, amnesia, analgesia) while maintaining airway reflexes and cardiovascular stability better than many other anaesthetics. It is indicated for short surgical procedures, emergency department sedation, paediatric procedures, burn dressing changes, and as an adjunct in status asthmaticus or severe pain. In Ghana (Accra), it is a controlled prescription injectable used exclusively in hospital operating theatres, emergency departments, and ICUs for anaesthesia and sedation.

Prescription: Prescription-only / Controlled Substance (Schedule H1 in many systems). Requires a doctor’s prescription in Ghana; administered only by trained healthcare professionals (anaesthesiologist’s, emergency physicians, intensivists) in hospitals/clinics with airway monitoring equipment. Not OTC or for outpatient dispensing due to high abuse potential, risk of respiratory depression, hallucinations, and emergence reactions.

Therapeutic Category:

General Anaesthetic / Dissociative Anaesthetic / Analgesic.

Active Ingredients/Composition:

• Active ingredient: Ketamine hydrochloride USP – 50 mg per ml (500 mg in 10 ml vial). Other ingredients: Water for injection (solvent), benzethonium chloride or benzalkonium chloride (preservative in multi-dose vials), sodium chloride (for isotonicity), hydrochloric acid/sodium hydroxide (pH adjustment to 3.5–5.5). The solution is clear, colourless to pale yellow, sterile, and multi-dose.

Vitamins: None.

Minerals: None.

Variant:

• Ketamine Hydrochloride 50mg/ml Injection 10ml vial (standard multi-dose vial). Related variants: Ketamine 10mg/ml or 100mg/ml (different concentrations), preservative-free single-dose vials (for spinal/epidural use), or ketamine-esketamine nasal spray (for depression). The 50mg/ml 10ml vial is the most common strength for IV/IM anaesthesia and sedation.

Consume Type:

Injectable – Intravenous (IV) bolus or infusion, or Intramuscular (IM) injection (administered only by healthcare professionals in controlled settings).

Directions/Usage: Administered only in hospital/clinic with full monitoring (oxygen saturation, BP, airway, capnography).

• Induction of anaesthesia (IV): 1–4.5 mg/kg slow IV over 60 seconds (usual 2 mg/kg).
• Maintenance: 0.1–0.5 mg/kg IV boluses or infusion 0.1–0.5 mg/kg/hour.
• Procedural sedation (IV): 0.5–2 mg/kg slow IV bolus.
• IM (alternative): 4–10 mg/kg for induction.
• Emergence reactions minimized by co-administration of benzodiazepines (e.g., midazolam).
• Always have airway equipment, oxygen, and reversal agents available.
• Duration: Short-term (minutes to hours); not for chronic use.

Common Side Effects: Common:

• Emergence reactions (hallucinations, vivid dreams, agitation, delirium – 10–20% of patients, more in adults).
• Increased blood pressure and heart rate (hypertension, tachycardia).
• Nausea, vomiting.
• Hypersalivation, increased airway secretions.
• Dizziness, drowsiness after recovery. Rare/serious: Respiratory depression (dose-dependent), laryngospasm, apnea, severe hypertension, arrhythmias, or psychological dependence.

Package Type:

Glass multi-dose vial of 10 ml (containing 500 mg ketamine hydrochloride; single vial or pack of 5–10 vials; labelled carton with controlled substance warnings, dilution instructions, and safety alerts).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Once opened, use within 28 days (check label) or discard unused portion. Keep locked in secure storage (controlled substance).

Safety Advice:

• Administered only under specialist supervision with continuous monitoring (oxygen saturation, BP, heart rate, capnography).
• Contraindicated in hypersensitivity to ketamine, conditions where hypertension is dangerous (e.g., uncontrolled hypertension, aneurysm), or raised intracranial pressure (unless benefits outweigh risks).
• Caution in psychiatric history (may exacerbate psychosis), glaucoma, hyperthyroidism, or cardiovascular disease.
• Emergence reactions minimized by benzodiazepines and quiet recovery environment.
• High abuse potential – strict accountability and secure storage required.
• If severe agitation, hallucinations, respiratory depression, or hypertension occurs, provide supportive care and consider benzodiazepines or haloperidol.
• Keep locked and out of reach of unauthorized persons.

Product Substitutes: Similar ketamine 50mg/ml injections in Ghana include:

• Generic ketamine hydrochloride 50mg/ml injection (various importers).
• Ketalar (original Pfizer brand if stocked).
• Other brands like Ketamax, Ketmin, or local generics. Alternatives: Propofol, etomidate, midazolam + fentanyl (for sedation/anaesthesia). Consult anaesthesiologist or emergency physician in Accra for alternatives.

Manufacturer/Marketer:

Varies by exact batch (Ketamine 50mg/ml injections often by Indian manufacturers like Neon Laboratories, Samarth Life Sciences, or local Ghanaian partners for generics). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked in hospital pharmacies).

Country of Origin:

India (primary source for generic ketamine 50mg/ml injections imported to Ghana; BP/USP-compliant generics common in African markets).