Consumer medicine information

1. Why am I using MIDAZOLAM VIATRIS?

MIDAZOLAM VIATRIS contains the active ingredient Midazolam. MIDAZOLAM VIATRIS is used as a sedative during some short medical procedures.
For more information, see Section 1. Why am I using MIDAZOLAM VIATRIS? in the full CMI.

2. What should I know before I use MIDAZOLAM VIATRIS?

Do not use if you have ever had an allergic reaction to Midazolam or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use MIDAZOLAM VIATRIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MIDAZOLAM VIATRIS and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How am I given MIDAZOLAM VIATRIS?

• MIDAZOLAM VIATRIS may be given to you as an injection into a vein or muscle. It may also be given through an infusion set in an intensive care unit. Other medications may also be given at the same time.

• Your doctor will adjust the dose necessary for you. This depends on which medical procedure you will be having, your age, weight and your general health. Elderly patients may need to receive less.

5. What should I know while using MIDAZOLAM VIATRIS?

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well after you have received MIDAZOLAM VIATRIS, especially if you are over 60 years of age or have pre-existing heart and lung conditions. All medicines can have side effects. Sometimes they are serious, most of the time they are not. All medical procedures which involve the use of an anaesthetic have risk which your doctor will discuss with you. In elderly, or high-risk patients, death has resulted rarely due to heart attack or a slowdown of the heart and lungs. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Midazolam.

2 Qualitative and Quantitative Composition

Midazolam Viatris, midazolam solution for injection is available as a 5 mg/5 mL, 5 mg/1 mL, 15 mg/3 mL and 50 mg/10 mL solution.
Midazolam Viatris 5 mg/5 mL. Each mL contains 1 mg of midazolam.
One 5 mL ampoule contains 5 mg of midazolam.
Midazolam Viatris 5 mg/1 mL. Each mL contains 5 mg of midazolam.
One 1 mL ampoule contains 5 mg of midazolam.
One 3 mL ampoule contains 15 mg of midazolam.
One 10 mL ampoule contains 50 mg of midazolam.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear, colourless solution.

4 Clinical Particulars

4.9 Overdose

Symptoms. The manifestations of midazolam overdosage are similar to those observed with other benzodiazepines ranging from drowsiness to coma. Overdose of midazolam is seldom life-threatening if the medicine is taken alone, but in mild cases, may lead to symptoms including drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, areflexia, apnoea, hypotonia, hypotension, respiratory depression, coma and very rarely death. Coma may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease.
Benzodiazepines increase the effects of other central nervous system depressants, including alcohol. When combined with other CNS depressants, the effects of overdosage are likely to be severe and may prove fatal.
Treatment. Treatment of midazolam overdose is the same as that followed for overdosage with other benzodiazepines. Respiration, pulse rate and blood pressure should be monitored and general supportive measures should be employed. In adults or children who have taken an overdose of benzodiazepines within 1 - 2 hours, consider activated charcoal with airway protection if indicated.
Flumazenil can be used to reverse the effects of midazolam (refer to Flumazenil Product Information) if CNS depression is severe. IV fluids should be administered and an adequate airway maintained. Hypotension may be combated by the judicious use of other accepted antihypotensive measures. There is no information as to whether peritoneal dialysis, forced diuresis or haemodialysis are of any value in the treatment of overdosage. Hepatic function should be monitored.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. The effects of midazolam on genotoxicity have not been established. Midazolam did not have mutagenic activity in Salmonella typhimurium (five bacterial strains), Chinese hamster lung cells (V79), human lymphocytes, or in the micronucleus test in mice.
Carcinogenicity. Midazolam maleate was administered with diet in mice and rats for two years at dosages of 1, 9 and 80 mg/kg/day. In female mice in the highest dose group there was a distinct increase in the incidence of hepatic tumours. In high dose male rats there was a small but statistically significant increase in benign thyroid follicular cell tumours. Dosages of 9 mg/kg/day of midazolam maleate do not increase the incidence of tumours. The pathogenesis of induction of these tumours is unknown. These tumours were found after chronic administration, whereas human use will ordinarily be of single dose or of short duration.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

The active ingredient of Midazolam Viatris is 8-chloro-6- (2-fluorophenyl)-1-methyl-4H-imidazo [1,5-a][1,4] benzodiazepine (midazolam).
Molecular Formula: C₁₈H₁₃ClFN₃ Molecular Weight: 325.8.
The free base of the active substance of Midazolam Viatris is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring enables the active substance, midazolam to form water-soluble salts with acids. These produce a stable injection solution.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMIDAZO.gif CAS number. 59467-70-8.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/MIDAZOST.gif