Norium
Generic Name
Norazepam
Manufacturer
MediCorp Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| norium 5 mg tablet | ৳ 4.00 | ৳ 40.00 |
Description
Overview of the medicine
Norium 5 mg Tablet contains norazepam, a novel anxiolytic agent used for the short-term relief of anxiety symptoms including generalized anxiety disorder and panic disorder.
Uses & Indications
Dosage
Adults
Initial dose 5 mg once daily, adjusted to 5-10 mg daily in divided doses, maximum 20 mg/day. Duration of treatment should be as short as possible.
Elderly
Initial dose 2.5 mg once daily, carefully titrated due to increased sensitivity and potential for adverse effects. Max 10 mg/day.
Renal_impairment
No dose adjustment needed for mild to moderate impairment. Use with caution in severe renal impairment.
How to Take
Administer orally with water, with or without food. Avoid crushing or chewing the tablet.
Mechanism of Action
Norazepam selectively modulates GABA-A receptors, enhancing inhibitory neurotransmission in the brain, leading to anxiolytic and mild sedative effects without significant respiratory depression at therapeutic doses.
Pharmacokinetics
Onset
Within 30-60 minutes.
Excretion
Mainly excreted via kidneys as inactive metabolites in urine.
Half life
Approximately 10-15 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract; peak plasma concentrations reached within 1-2 hours.
Metabolism
Primarily metabolized in the liver via CYP450 enzymes, particularly CYP3A4 and CYP2C19, into inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to norazepam or any component of the formulation
- Severe respiratory insufficiency
- Acute narrow-angle glaucoma
- Severe hepatic impairment
- Myasthenia gravis
- Sleep apnea syndrome
Drug Interactions
Alcohol
Potentiates central nervous system depressant effects, leading to increased sedation and impaired psychomotor function. Avoid alcohol.
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase norazepam plasma concentrations, leading to enhanced effects and adverse reactions.
Other CNS Depressants (e.g., Antihistamines, Antidepressants)
Increased risk of sedation and central nervous system depression.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children and pets.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management is primarily supportive; maintain airway, breathing, and circulation. Gastric lavage may be considered if ingestion is recent. Flumazenil may be used in severe cases (if indicated for benzodiazepine-like action) with careful monitoring.
Pregnancy & Lactation
Pregnancy Category D: Norazepam is not recommended during pregnancy due to potential risk of fetal harm and withdrawal symptoms in neonates. Avoid during breastfeeding as it is excreted in breast milk and may cause sedation in the infant.
Side Effects
Contraindications
- Hypersensitivity to norazepam or any component of the formulation
- Severe respiratory insufficiency
- Acute narrow-angle glaucoma
- Severe hepatic impairment
- Myasthenia gravis
- Sleep apnea syndrome
Drug Interactions
Alcohol
Potentiates central nervous system depressant effects, leading to increased sedation and impaired psychomotor function. Avoid alcohol.
Opioids
Increased risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase norazepam plasma concentrations, leading to enhanced effects and adverse reactions.
Other CNS Depressants (e.g., Antihistamines, Antidepressants)
Increased risk of sedation and central nervous system depression.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children and pets.
Overdose
Symptoms of overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. Management is primarily supportive; maintain airway, breathing, and circulation. Gastric lavage may be considered if ingestion is recent. Flumazenil may be used in severe cases (if indicated for benzodiazepine-like action) with careful monitoring.
Pregnancy & Lactation
Pregnancy Category D: Norazepam is not recommended during pregnancy due to potential risk of fetal harm and withdrawal symptoms in neonates. Avoid during breastfeeding as it is excreted in breast milk and may cause sedation in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture when stored as recommended.
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patented (Valid until 2040)
Clinical Trials
Extensive Phase III clinical trials demonstrated the efficacy of norazepam in reducing symptoms of generalized anxiety disorder and panic disorder, showing a favorable safety profile compared to placebo. Long-term studies are ongoing to further assess dependence potential.
Lab Monitoring
- Liver function tests (LFTs) should be monitored periodically, especially with prolonged use.
- Renal function tests should be performed periodically.
- Complete blood count (CBC) may be considered for long-term therapy.
Doctor Notes
- Prescribe Norium for the shortest effective duration to minimize the risk of dependence.
- Regularly monitor patients for signs of tolerance, dependence, and potential misuse.
- Emphasize to patients the importance of gradual tapering when discontinuing treatment.
- Advise patients about the potential for sedation and impairment, and counsel against driving or operating heavy machinery.
Patient Guidelines
- Take Norium exactly as prescribed by your doctor; do not increase the dose or duration of use.
- Do not stop treatment abruptly, as this can lead to withdrawal symptoms. Consult your doctor for a gradual tapering plan.
- Avoid alcohol and other central nervous system depressants while taking this medicine.
- Report any unusual or severe side effects, especially paradoxical reactions, to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it's close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Norium may cause drowsiness, dizziness, and impaired concentration. Do not drive, operate machinery, or perform other hazardous tasks until you know how this medicine affects you.
Lifestyle Advice
- Adopt stress-reducing techniques such as meditation, yoga, or deep breathing exercises.
- Maintain a regular sleep schedule and ensure adequate sleep.
- Engage in regular physical activity, which can help manage anxiety.
- Limit caffeine intake, as it can worsen anxiety symptoms.
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