COMPOSITION:
Each ml contains Midazolam BP 1.0 mg.

PHARMOCOLOGY:
Hypozam (Midazolam) is a short acting benzodiazepine, used as a premedicament and sedative in surgical procedures and for the induction of anaesthesia. Onset time of sedative effects after IM administration is 15 minutes with peak sedation occurring in 30-60 minutes. Sedation after IV injection is achieved within 3-5 minutes. When given intravenously as an anaesthetic induction agent, induction occurs in approximately 1.5 minutes with narcotic pre-medication and in 2 to 2.5 minutes without narcotic pre-medication.

Bio-availability is higher but variable after intramuscular administration. Midazolam is lipophilic at physiological pH. It crosses the placenta. Midazolam is extensively (about 96%) bound to plasma proteins. Midazolam usually has a short elimination half-life of about 2 hours although half-lives longer than 7 hours have been reported in some patients. The half-life of Midazolam is prolonged in neonates, in the elderly, and in patients with liver disorders. Midazolam is metabolized in the liver, the major metabolites 1-hydroxy-methyl midazolam which is excreted through kidney.

INDICATION:

• For induction of general anaesthesia.
  
• For preoperative sedation (induction of sleepiness and relief of apprehension) and also to impair memory of preoperative events.
  
• In combination with nitrous oxide and oxygen (balanced anaesthesia) for short surgical procedures.
  
• As an agent for conscious sedation prior to diagnostic procedures e.g. bronchoscopy, gastroscopy, endoscopy, coronary angiography & cardiac catheterization.

DOSAGE AND ADMINISTRATION:
Hypozam (Midazolam) is a potent sedative agent which requies slow IM or IV administration with provision for monitoring and equipment to counteract cardio-respiratory events. Hypozam injection can safely be mixed in conventional drips and infusion.

INDUCTION OF ANAESTHESIA:
Individual response to the drug is variable. The dosage should be titrated to the desired effects according to patient's age and clinical status.

i. UNPREMEDICATED PATIENTS:
Initial dose of 0.3 to 0.35 mg/kg of body weight for induction, administered over 20 to 30 seconds and allowing 2 minutes for effects.

ii. PREMEDICATED PATIENTS:
When the patients have received sedative or narcotic pre-medication the range of recommended dose is 0.15 to 0.35 mg/kg body weight. In average adults below 55 years, a dose of 0.25 mg/kg of body weight administered over 20 to 30 seconds and allowing 2 minutes for effects.

PRE-OPERATIVE SEDATION:
IM for pre-operative sedation (Induction of sleepiness, drowsiness, release of apprehension and to impair memory of pre-operative events). For pre-medication the recommended dose of Hypozam is 0.07 to 0.08 mg / kg of body weight IM. For average adults, approximate dose is 5.0 mg IM one hour before surgery.

FOR CONSCIOUS SEDATION:
Hypozam (Midazolam) can be safely used for conscious sedation, dosage must be individualized and titrated. Individual response varies with age, physical status and concomitant medications.
Initially 1 mg IV then increase the dose up to 2.5 mg over a period of 2 minutes and then evaluate the sedative effects and if not achieved continue to titrate slowly to the appropriate level of sedation.

For maintenance, add 25% of dose used to first reach the sedative end point.

CONTRA-INDICATION:
Hypozam injection is contra-indicated in patients with known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow angle glaucoma.

SIDE-EFFECT:
Fluctuations in vital signs including decreased respiratory effects, variation in blood pressure and pulse rate are the most frequently seen findings.

RESPIRATORY:
Laryngospasm, bronchospasm, dyspnoea, hyperventilation and airway obstruction.

CARDIOVASCULAR:
Premature ventricular contraction, vasovagal episode and tachycardia.

CNS/NEUROMUSCULAR:
Retrograde amnesia, euphoria, confusion, nervousness, restlessness, nightmares dysphonia and parasthesia.

SPECIAL SENSES:
Blurred vision, diplopia, nystagamus, visual disturbances , blocked ears, loss of balance and light headedness.

OTHERS:
Headache, hiccough, nausea, vomiting, yawning, lethargy, weakness and faint feeling.

OVER DOSAGE:
Over dosage effects are expected to be similar to those observed with other benzodiazepines. No evidence of specific organ toxicity.

STORAGE:
Store in a cool place away from light.

PRESENTATION:
Pack of 10 x 3 ml ampoules.
Pack of 10 x 5 ml ampoules.