Description:

Fentanyl 50 micrograms/ml solution for injection (100 micrograms in 2 ml ampoule) is a potent opioid analgesic used for the management of severe acute pain, procedural analgesia, anaesthesia induction/maintenance, and postoperative pain relief. It is a synthetic opioid agonist that acts primarily on mu-opioid receptors in the central nervous system to produce analgesia, sedation, and respiratory depression. It is approximately 50–100 times more potent than morphine and provides rapid onset (IV: 1–2 minutes) and short duration of action (30–60 minutes).

Prescription:

Prescription-only.

Therapeutic Category:

Opioid Analgesic (Synthetic phenylpiperidine opioid).

Active Ingredients/Composition:

• Active ingredient: Fentanyl citrate – 50 micrograms per ml (100 micrograms in 2 ml ampoule). Other ingredients: Sodium chloride (for isotonicity), water for injection, and hydrochloric acid/sodium hydroxide (pH adjustment to ~4.0–7.5). The solution is clear, colourless, sterile, and preservative-free.

Vitamins: None.

Minerals: None.

Variant:

• Fentanyl 50 mcg/ml solution for injection (2 ml ampoule containing 100 micrograms). Related variants: Fentanyl 50 mcg/ml in 10 ml ampoules (500 mcg total), fentanyl 100 mcg/ml (higher concentration), transdermal patches (Duragesic), lozenges (Actiq), or nasal spray (for breakthrough pain). The 2 ml ampoule (100 mcg) is the most common unit for bolus dosing in anaesthesia and acute pain.

Consume Type:

Injectable – Intravenous (IV) bolus or infusion, Intramuscular (IM), or Epidural/Intrathecal (in anaesthesia) (administered only by healthcare professionals; never oral or self-administered).

Directions/Usage: Administered only in controlled clinical settings (operating theatre, ICU, emergency) with respiratory and hemodynamic monitoring.

• Adults (acute pain/analgesia): 50–200 mcg IV bolus (0.5–2 ml), repeated as needed every 2–5 minutes (titrate to effect).
• Anaesthesia induction/maintenance: 1–5 mcg/kg IV bolus, then infusion 0.5–2 mcg/kg/hour or boluses.
• Postoperative pain: 25–100 mcg IV boluses or patient-controlled analgesia (PCA).
• Children: Weight-based (1–2 mcg/kg IV bolus; lower doses in neonates).
• Slow IV push (over 30–60 seconds) to minimize chest wall rigidity and respiratory depression.
• Always have airway support (oxygen, ventilation equipment) and naloxone available.
• Duration: Short-term (hours); not for chronic pain.

Common Side Effects: Common:

• Respiratory depression (dose-dependent, may be delayed).
• Nausea, vomiting.
• Drowsiness, sedation.
• Bradycardia (slow heart rate).
• Muscle rigidity (especially chest wall with rapid/high-dose IV).
• Hypotension. Rare/serious (seek immediate help): Severe respiratory depression/apnea, laryngospasm, anaphylaxis, serotonin syndrome (if combined with serotonergic drugs), or dependence/abuse.

Package Type:

Glass ampoules of 2 ml (each containing 100 micrograms fentanyl; packs of 5 or 10 ampoules; 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. Keep locked in secure storage (controlled substance). Out of reach of unauthorized personnel.

Safety Advice:

• Administered only under medical supervision with continuous monitoring (oxygen saturation, respiratory rate, blood pressure, ECG).
• Contraindicated in respiratory depression, acute asthma, paralytic ileus, or hypersensitivity.
• High risk of respiratory arrest – have naloxone (opioid antagonist) and airway equipment immediately available.
• Caution in elderly, debilitated patients, head injury, increased intracranial pressure, hepatic/renal impairment, or concurrent CNS depressants (opioids, benzodiazepines, alcohol – additive respiratory depression).
• Risk of chest wall rigidity (especially rapid IV or high dose) – treat with muscle relaxants or naloxone.
• Controlled substance – high abuse potential; strict accountability required.
• If respiratory depression, severe bradycardia, or unconsciousness occurs, stop administration, support ventilation, and give naloxone.
• Keep locked and out of reach of unauthorized persons.

Product Substitutes: Similar fentanyl injections in Ghana include:

• Generic fentanyl citrate 50 mcg/ml injection (various importers).
• Fentanyl injection BP 100 mcg/2 ml (other brands like Hospira, Sandoz).
• Other opioid injectables: Morphine sulphate, pethidine (pethidine), or remifentanil (ultra-short-acting). Consult anaesthesiologist or hospital pharmacist in Accra for alternatives.

Manufacturer/Marketer:

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

Country of Origin:

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