Fluniam
Generic Name
Fluniazepam
Manufacturer
Meditopix Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| fluniam 5 mg tablet | ৳ 3.00 | ৳ 30.00 |
Description
Overview of the medicine
Fluniam 5 mg Tablet is a benzodiazepine-type medication used for the short-term treatment of anxiety disorders, insomnia, and as a muscle relaxant. It works by enhancing the effect of a natural chemical in the body (GABA) that calms the brain and nerves.
Uses & Indications
Dosage
Adults
Anxiety: 2-5 mg, 2-3 times daily. Insomnia: 5-10 mg at bedtime. Max 20 mg/day.
Elderly
Initiate with lower doses (e.g., 2 mg, 1-2 times daily) and titrate carefully due to increased sensitivity and risk of adverse effects.
Renal_impairment
No specific dose adjustment for mild to moderate impairment; use with caution in severe impairment. Start with lower doses.
How to Take
Take orally with or without food. Swallow the tablet whole with water. Do not crush or chew.
Mechanism of Action
Fluniazepam binds to specific benzodiazepine receptors on the GABA-A receptor complex in the central nervous system. This binding enhances the affinity of GABA for its receptor, leading to an increased frequency of chloride channel opening, hyperpolarization of the neuronal membrane, and ultimately, inhibition of neuronal excitation. This results in anxiolytic, sedative, hypnotic, muscle relaxant, and anticonvulsant effects.
Pharmacokinetics
Onset
Within 30-60 minutes.
Excretion
Mainly excreted via the kidneys (urine) as glucuronide conjugates and oxidized metabolites.
Half life
Approximately 10-20 hours (parent drug and active metabolites).
Absorption
Rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are achieved within 1-2 hours.
Metabolism
Primarily metabolized in the liver by cytochrome P450 enzymes (e.g., CYP3A4) into active and inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to fluniazepam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Myasthenia gravis.
- Sleep apnea syndrome.
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Antacids
May delay absorption of fluniazepam.
Alcohol and CNS depressants
Additive CNS depressant effects.
Antifungals (e.g., Ketoconazole)
May inhibit metabolism, leading to increased fluniazepam levels.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and if severe, administration of flumazenil (a benzodiazepine antagonist), with careful monitoring.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Use only if potential benefit justifies potential risk to the fetus. Excreted in breast milk; advise against breastfeeding.
Side Effects
Contraindications
- Known hypersensitivity to fluniazepam or other benzodiazepines.
- Acute narrow-angle glaucoma.
- Severe respiratory insufficiency.
- Severe hepatic insufficiency.
- Myasthenia gravis.
- Sleep apnea syndrome.
Drug Interactions
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death.
Antacids
May delay absorption of fluniazepam.
Alcohol and CNS depressants
Additive CNS depressant effects.
Antifungals (e.g., Ketoconazole)
May inhibit metabolism, leading to increased fluniazepam levels.
Storage
Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management involves supportive care, maintaining a patent airway, and if severe, administration of flumazenil (a benzodiazepine antagonist), with careful monitoring.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Use only if potential benefit justifies potential risk to the fetus. Excreted in breast milk; advise against breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Clinical trials for fluniazepam have demonstrated efficacy in reducing anxiety symptoms and improving sleep latency and duration. Long-term safety and efficacy studies are ongoing for specific indications. Post-marketing surveillance data continues to be collected.
Lab Monitoring
- Liver function tests (baseline and periodically, especially in long-term use or hepatic impairment).
- Renal function tests (periodically, in renal impairment).
Doctor Notes
- Educate patients on the risks of dependence and withdrawal, emphasizing short-term use.
- Assess for history of substance abuse or psychiatric disorders prior to initiation.
- Caution against abrupt discontinuation; recommend gradual tapering.
- Monitor for respiratory depression, especially with concomitant opioid use.
Patient Guidelines
- Do not stop taking this medication suddenly, as withdrawal symptoms may occur. Consult your doctor for gradual dose reduction.
- Avoid alcohol and other CNS depressants during treatment.
- Be cautious about driving or operating machinery until you know how this medicine affects you.
- Take exactly as prescribed by your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
May cause drowsiness, dizziness, and impaired coordination. Patients should be warned against engaging in hazardous occupations requiring complete mental alertness, such as driving an automobile or operating hazardous machinery, until it is known that they do not become drowsy or dizzy from the drug.
Lifestyle Advice
- Practice good sleep hygiene (e.g., regular sleep schedule, dark quiet room).
- Manage stress through relaxation techniques or therapy.
- Avoid caffeine and heavy meals before bedtime.
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