FLORMIDAL (MIDAZOLAM) 15MG 30 TABLETS

Description

FLORMIDAL 15MG 30 TABLETS

Flormidal is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Flormidal is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure. It is also used to produce loss of consciousness before and during surgery. Flormidal is sometimes used in patients in hospital intensive care units to cause unconsciousness. This may allow the patient to withstand the stress of being in the intensive care unit and help the patient cooperate when a machine must be used to assist with breathing.

Flormidal is given only by or under the immediate supervision of a doctor trained to use Flormidal. If you will be receiving Flormidal during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, Flormidal is used in certain patients with the following medical condition:

Epilepsy

Dosage and method of administration

Benzodiazepines should only be administered after careful consideration of the indications and as briefly as possible to avoid the risk of addiction. Generally, treatment lasts from a few days to a maximum of two weeks. Treatment should not be interrupted abruptly and the exclusion of the drug should be adjusted individually for each patient. If prolonged treatment is required (longer than two weeks), the patient should be monitored.
In cases where treatment should be extended beyond two weeks, a prior reassessment of the patient’s condition is required. Due to the rapid onset of action, midazolam tablets are taken immediately before going to bed with fluid. Midazolam tablets can be taken at any time of the day, providing the patient with at least 7-8 hours of undisturbed sleep.
The standard dose of midazolam is 7.5 mg to 15 mg.
Treatment should be started with the lowest recommended dose. The maximum recommended dose should not be exceeded because of an increased risk of CNS side effects, including clinically significant depression of the cardiovascular and respiratory systems.
Premedication
In premedication, the drug is administered 30-60 minutes before the planned intervention.
Specific dosage
Elderly and / or exhausted patients
For elderly and / or exhausted patients, the recommended dose is 7.5 mg. In elderly patients, midazolam has a more pronounced sedative effect, which is why these individuals may be at increased risk of cardiovascular and respiratory depression. In these patients, the drug should be used with extreme caution and consideration of a lower dose may be considered if necessary.
Patients with impaired liver function
In patients with impaired hepatic function, the recommended dose is 7.5 mg and the drug should be administered very carefully. If necessary, a lower dose may be considered.
Patients with impaired renal function
Patients with severe renal impairment may experience accumulation of the major metabolite midazolam, 1′-hydroxymidazolam glucuronide, leading to more pronounced and longer sedation, which can cause clinically significant depression of the respiratory and cardiovascular systems. Therefore, midazolam should be used with caution in these patients. The recommended dose is 7.5 mg and a lower dose may be considered if necessary.

SIDE EFFECTS

What are the possible side effects of Flormidal?

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

Risks from Concomitant Use with Opioids
Risks of Cardiorespiratory Adverse Reactions
CNS Depression from Concomitant Use with Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors
Suicidal Behavior and Ideation
Impaired Cognitive Function
Glaucoma
Other Adverse Reactions

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