Description

Hypnovel Amp is a prescription-only medication containing the active ingredient Midazolam, a member of the benzodiazepine class. It is primarily used as a hypnotic and sedative, suitable for various medical settings. This product is available as a clear, colourless solution for injection, presented in ampoules made from colourless glass.

Available Strengths

• 5 mg/5 mL (1 mg/mL): Pack of 10 ampoules
• 5 mg/1 mL (5 mg/mL): Pack of 10 ampoules
• 15 mg/3 mL (5 mg/mL): Pack of 5 ampoules

Indications

Hypnovel Amp is indicated for:

• Intravenous conscious sedation prior to short surgical, diagnostic, therapeutic, or endoscopic procedures.
• Induction of anaesthesia.
• Sedation in intensive care units (ICU), including prolonged sedation by infusion.
• Intramuscular preoperative sedation.

Administration

Administration should be conducted by a doctor trained in its use, with routes including intravenous (IV) injection or infusion and intramuscular (IM) injection. Dosage is individualized based on the procedure, patient age, weight, and health status. Special considerations are required for elderly or debilitated patients and those with hepatic or renal impairment.

Mechanism of Action

Midazolam enhances the inhibitory effects of gamma aminobutyric acid (GABA) in the brain, leading to sedation, hypnosis, amnesia, and/or anaesthesia depending on the dose. The onset of sedation is rapid, with different timings for IM and IV administration.

Pharmacokinetics

• IM Administration: Sedation occurs in approximately 15 minutes, peaking at 30–60 minutes.
• IV Administration: Sedation occurs within 2.8–4.8 minutes, with anaesthesia onset in 1.5–2.5 minutes.
• Recovery from anaesthesia typically occurs within 2 hours.

Contraindications

Hypnovel Amp should not be used in patients with:

• Myasthenia gravis
• Hypersensitivity to benzodiazepines or excipients
• Acute narrow angle glaucoma
• Conditions such as shock, coma, or acute alcoholic intoxication with depression of vital signs

Special Precautions

Use is recommended only in settings equipped with appropriate monitoring and resuscitation equipment. Caution is advised in specific patient groups, including the elderly, those with certain impairments, and during pregnancy or breastfeeding.

Drug Interactions

Significant interactions may occur with CYP3A inhibitors and inducers, other CNS depressants, and certain foods like grapefruit juice. Monitoring and dose adjustments may be necessary.

Adverse Effects

Common adverse effects include drowsiness, dizziness, and local injection site reactions. Serious effects may involve respiratory depression and cardiac issues, particularly in high-risk patients.

Storage

Store below 30°C, protect from light, and ensure ampoules are used only once. Discard any unused solution and adhere to the expiry date.

Legal Status

Hypnovel Amp is classified as a Schedule 4 medication in Australia, requiring a prescription for use. This ensures its administration is carefully controlled within medical environments.