Florium
Generic Name
Flurazepam Hydrochloride
Manufacturer
Global Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| florium 10 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Florium 10 mg Tablet contains Flurazepam Hydrochloride, a benzodiazepine derivative. It is primarily used for the short-term treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. It has hypnotic, sedative, anxiolytic, anticonvulsant, and muscle relaxant properties.
Uses & Indications
Dosage
Adults
15 mg to 30 mg orally at bedtime, as prescribed by a physician. In some cases, 10 mg may be sufficient.
Elderly
Initially, 15 mg orally at bedtime. Dosage should be carefully adjusted due to increased sensitivity and slower metabolism.
Renal_impairment
Use with caution; lower doses may be required due to potential accumulation of metabolites.
How to Take
Take Florium 10 mg Tablet orally just before bedtime. It should be swallowed whole with water. Do not crush, chew, or break the tablet.
Mechanism of Action
Flurazepam enhances the effect of gamma-aminobutyric acid (GABA) at the GABA-A receptor, a major inhibitory neurotransmitter in the central nervous system. This action results in generalized central nervous system depression, leading to its sedative, hypnotic, anxiolytic, and muscle relaxant effects.
Pharmacokinetics
Onset
Onset of action within 15-45 minutes.
Excretion
Excreted primarily in the urine as metabolites, with less than 1% as unchanged drug.
Half life
Parent drug: 2-3 hours; Active metabolites: 47-100 hours (due to desalkylflurazepam).
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations reached within 1-2 hours.
Metabolism
Extensively metabolized in the liver by oxidative pathways, primarily to N1-hydroxyethylflurazepam and N1-desalkylflurazepam, which are active.
Side Effects
Contraindications
- Hypersensitivity to flurazepam or other benzodiazepines
- Severe respiratory insufficiency
- Sleep apnea syndrome
- Severe hepatic impairment
- Myasthenia gravis
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Phenytoin
Benzodiazepines may affect phenytoin levels.
Alcohol/CNS Depressants
Potentiation of sedative effects, increased risk of respiratory depression.
CYP450 Inhibitors (e.g., cimetidine, erythromycin)
May increase flurazepam plasma levels and enhance its effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and monitoring vital signs. Flumazenil may be used as an antidote in severe cases but should be used with caution due to the risk of seizures.
Pregnancy & Lactation
Pregnancy Category D. Florium can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. Excreted in breast milk; avoid during lactation or discontinue breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to flurazepam or other benzodiazepines
- Severe respiratory insufficiency
- Sleep apnea syndrome
- Severe hepatic impairment
- Myasthenia gravis
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Phenytoin
Benzodiazepines may affect phenytoin levels.
Alcohol/CNS Depressants
Potentiation of sedative effects, increased risk of respiratory depression.
CYP450 Inhibitors (e.g., cimetidine, erythromycin)
May increase flurazepam plasma levels and enhance its effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and monitoring vital signs. Flumazenil may be used as an antidote in severe cases but should be used with caution due to the risk of seizures.
Pregnancy & Lactation
Pregnancy Category D. Florium can cause fetal harm when administered to a pregnant woman. Avoid during pregnancy. Excreted in breast milk; avoid during lactation or discontinue breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated Florium's efficacy in reducing sleep latency and improving sleep maintenance in adults with insomnia. Post-marketing surveillance continues to monitor long-term safety.
Lab Monitoring
- Liver function tests (periodically, especially with prolonged use)
- Renal function tests
Doctor Notes
- Emphasize short-term use only to minimize dependence and withdrawal risks.
- Assess for co-existing psychiatric disorders before prescribing.
- Counsel patients on risks of concomitant use with opioids and alcohol.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly, as it may cause withdrawal symptoms.
- Avoid alcohol and other CNS depressants while on this medication.
- Report any unusual or severe side effects to your doctor immediately.
Missed Dose Advice
If a dose is missed, do not take it unless you have several hours available for sleep. Do not take a double dose to make up for a missed one. Continue with your regular dosing schedule the next night.
Driving Precautions
Florium can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Practice good sleep hygiene (consistent sleep schedule, comfortable environment).
- Avoid caffeine and heavy meals before bedtime.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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