Drug Information

Drug Interaction:

Interacting drugs- summary

+ Midazolam

Barbiturates, alcohol, or CNS depress

may increase risk of underventilation or apnea and contribute

to prolonged effect when used with midazolam

Narcotics,

secobarbital or fentanyl and droperidol used as premedications

accentuate midozolams hynotic effect. Adjust dosage.

Thiopental -

moderate reduction in induction dosage requirements has

been noted.

Inhalation anesthetics-

may need to be reduced if midazolam is used as an induction

agent.

Indication:

Preoperative sedation

LIST OF DRUGS DURING 2006

Sr.No- 44

Name of the Drug- Midazolam (as maleate) 7.5mg/15mg tablet Pharmacological Classification- For insomnia

Date of Approval- 10-05-2006

Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Midazolam Anaesthetic General 15-04-1997

2.Midazolam Maleate 7.5mg/15mg 10-05-2006

Tablet

For insomnia

3.Midazolam Hcl syrup 2mg/ml 18-12-2009

For selection, Anxiolysis and amnesia prior to diagnostic ,therapeutic

or endoscopic procedure or before induction of anethesia

Adverse Reaction:

Headache. Laryngosapam, bronchospasm, dyspnea, hyperventilation, wheezing,shallow respirations airway obstruction, tachypnea. Acid taste exceessive salivation, retching.

Contra-Indications:

Hypersens to the drug

Special precaution:

Midazolam does not protect against the increase in intracranial pressure of circulatory effects.

Dosages/ Overdosage Etc:

Date of Approval 1997

Indication:

Preoperative sedation

Dosage:

Individualise dosage

Patient Information:

Ref - USP PDI Vol II 17th Edition (1997)

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

midazolam or other benzodiazepine derivatives such as alprozolam, bromazepam,

chlordiazepoxide , clonazepam etc.. Also tell your healthcare care professional

if you are allergic to any other substances such as foods. preservatives or dyes.

2.Pregnancy-

Midazolam is not recommended for use during pregnancy because it may cause

birth defects.

3. Breast-feeding-

It is known whether midazolam passes into breast milk.However, this medicine

has not been reported to cause problems in nursing babies

4.Children-

Although there is no specific information comparing use of midazolam in children

with use in other age groups, this medicine is not expected to cause different side effects or problems than it does in adults.

5.Older adults-

Elderly people are especially sensitive to the effects of midazolam. This may

increase the chance of side effects during use of this medicine. Also time

to complete recovery after midazolam is given may be slower in the elderly

than in younger adults

6. Other medicines-

Tell your doctor if you are using any of the following -

CNS depressants depressants ( medicine that cause drowsiness)-

CNS depressants and other effects of either these medicines or

midazolam, may be increased also of midazolam may be prolonged

7.Other medical problems-

Make sure you tell your doctor if you have any other medical problems

especially-

Heart disease or

Kidney disease or

Liver disease or

Obesity - the effects of midazolam may be prolonged

Lung disease or

Myasthenia gravis or other muscle and nerve disease -

Midazolam may make the condition worse.

Pharmacology/ Pharmacokinetics:

Pharmacology:

Midazolam is a short term acting benzodiazepine CNS depressant

Pharmacokinetics:

The mean absolute bioavailability following IM use is 90%. The mean time of of plasma concentration following Im dosing occurs within 15 minutes.

Interaction with Food:

Not reported

Pregnancy and lactation:

Pregnancy:

If this drug is used during pregnancy, appraise the patient of the potential hazard to the fetus.

Lactation:

Excercise caution while administering to a nursing mother.

Children:

Safety and efficacy for use in less than 18 years,chidren are not been establisahed

Midazolam - @- General anesthetics-(Apr 1997)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation