Midasan

Midasan

midazolam

Manufacturer:

Sanbe

Marketer:

Sanbe
Concise Prescribing Info
Contents
Midazolam
Indications/Uses
Premed before induction of anesth. Basal sedation before diagnostic or surgical interventions carried out under local anesth. Induction & conscious sedation; as an induction agent in inhalation anesth or sleep induction component in combined anesth including total IV.
Dosage/Direction for Use
IV Elderly patients w/ organic cerebral changes or impaired cardiac & resp function Slow inj of approx 2.5 mg in 10 sec for induction of anesth & 1 mg in 30 sec for basal sedation. Induction of anesth & conscious sedation ± 10 mg. Dosage should be reduced for elderly patients >55 yr. Maintenance of anesth Small dose inj (dose & interval may vary individually). Basal sedation Initially 2.5 mg 5-20 min before operation. Further 1 mg doses if necessary. Total dose: 5 mg. Patient w/ severe illness, in poor general condition or advanced age Initially 1-1.5 mg. Total dose: 3.5 mg. IM Premed Patients suffering from pain before an intervention 5 mg. Adult 0.07-0.1 mg/kg. Elderly & debilitated patients 0.025-0.05 mg/kg to be administered 30 min before induction anesth.
Contraindications
Hypersensitivity to benzodiazepines. Myasthenia gravis, shock or coma, or in acute alcoholic intoxication w/ depression of vital signs. Patients w/ acute narrow-angle glaucoma. Premature infants.
Special Precautions
Intensified sedative effect & possible severe resp or CV depression w/ CNS depressants. Avoid alcohol before & for at least 8 hr after administration. Avoid abrupt discontinuation of treatment, decrease doses gradually. Patients w/ pulmonary insufficiency or resp depression; myasthenia gravis. Possible disinhibition in patients w/ history of personality disorders. Do not drive a vehicle or operate a machine for at least 12 hr after administration. Renal or hepatic impairment. Increased risk of congenital malformations associated w/ benzodiazepines. Not to be used in the 1st 3 mth of pregnancy. Lactation. Slow dose titration in adult & ped patients when used for sedation. Avoid rapid inj in preterm infants & neonates. Elderly or debilitated patients.
Adverse Reactions
Serious cardioresp events, paradoxical reactions; fluctuations in vital signs, decreased tidal vol &/or resp rate, apnea, BP & pulse rate variations; CNS depression; headache, local effects at IM inj (eg, pain, induration, redness, muscle stiffness); resp depression & arrest; hiccoughs, nausea, vomiting, coughing, oversedation, drowsiness; hallucinations; decreased mean arterial pressure, cardiac output, stroke vol, systemic vascular resistance.
Drug Interactions
Increased sedative effects w/ narcotics (eg, morphine, meperidine, fentanyl), secobarbital & droperidol. Prolonged sedation due to decrease in plasma clearance w/ P450 3A4 inhibitors (eg, cimetidine, erythromycin, diltiazem, verapamil, ketoconazole & itraconazole). Enhanced central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing drugs, analgesics & anesth.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CD08 - midazolam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.
Presentation/Packing
Form
Midasan inj 1 mg/mL
Packing/Price
5 mL x 10 × 1's (Rp195,000/boks)
Form
Midasan inj 5 mg/mL
Packing/Price
3 mL x 5 × 1's (Rp220,000/boks)
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