Calmepam (Bromazepam): A Guide to Uses, Risks, and Dosage in Egypt

WARNING: This medication has the potential for dependence, abuse, and withdrawal symptoms. It should only be used under the strict supervision of a healthcare professional, for the shortest possible duration, and exactly as prescribed. Do not stop taking this medication abruptly. This information is for educational purposes only and is not a substitute for professional medical advice.

Calmepam® (Bromazepam)

Summary

Calmepam, containing the active ingredient Bromazepam, is a potent medication belonging to the benzodiazepine class. It is primarily used for the short-term treatment of severe anxiety, tension, and agitation. It works by enhancing the effect of a natural chemical in the brain (GABA), which results in a calming (anxiolytic), sedative, and muscle-relaxant effect. Due to its high potential for dependence and significant side effects, Calmepam is reserved for cases where the disorder is severe and disabling, and its use is typically limited to a few weeks.

Manufacturer

GlaxoSmithKline (GSK) S.A.E., El Salam City, Cairo, A.R.E.

Category & Active Ingredient

• Category: Anxiolytic, Sedative-Hypnotic, Benzodiazepine.
• Active Ingredient: Bromazepam.

Available Forms & Strengths in Egypt

Calmepam is available as oral tablets in the following strengths:

• Calmepam 1.5 mg Tablets: Available in boxes of 10 or 30 tablets.
• Calmepam 3 mg Tablets: Available in boxes of 10 or 20 tablets.

Properties and Mechanism of Action

Bromazepam is a pyridylbenzodiazepine compound that enhances the activity of the neurotransmitter gamma-aminobutyric acid (GABA) at the GABA-A receptor. This action increases the influx of chloride ions into neurons, leading to hyperpolarization and making the neuron less excitable. The overall effect is a depression of the central nervous system, which manifests as anxiety reduction (anxiolysis), sedation, muscle relaxation, and anticonvulsant activity. It is absorbed completely after oral administration, with peak plasma concentrations reached within 1-4 hours.

Indications

Calmepam is indicated for the short-term relief of severe, disabling, or unacceptably distressing anxiety. It may also be used for:

• Tension states and agitation.
• Insomnia associated with anxiety.
• As an adjunct in managing alcohol withdrawal symptoms.
• To manage functional disturbances of various body systems where anxiety is a major factor (e.g., irritable bowel syndrome, emotiogenic hypertension, psychogenic headache).
• As a pre-medication for minor surgical or endoscopic procedures.

Note: It should not be used for minor, everyday anxiety.

Dosage and Administration

Dosage must be strictly individualized by a doctor. The lowest effective dose should be used for the shortest possible duration.

• Adults: The usual dosage ranges from 3 mg to 18 mg daily, taken in divided doses. In exceptional, hospital-based cases, the dose may be increased up to 60 mg daily.
• Elderly Patients: Elderly patients are more sensitive. The dose should not exceed half of the normally recommended adult dose and requires careful supervision.
• Duration of Treatment: Long-term chronic use is not recommended. Treatment should not be continued at the full dose beyond four weeks. Discontinuation should always be done by tapering the dose off gradually under medical supervision to avoid withdrawal symptoms.
• Pediatric Use: Calmepam is not for use in children.

Side Effects

Side effects are common, especially at the start of treatment, and are dose-related.

• Very Common: Drowsiness, sedation, unsteadiness, and ataxia (loss of coordination). These effects can impair performance of skilled tasks like driving.
• Common: Confusion (especially in the elderly), dizziness, headache, gastrointestinal upsets, skin rashes, and changes in libido.
• Amnesia: Anterograde amnesia (inability to form new memories) can occur, even at therapeutic doses.
• Paradoxical Reactions: In rare cases, it can cause paradoxical effects like aggressive outbursts, excitement, and uncovering of depression with suicidal tendencies. If these occur, the drug must be stopped.
• Dependence and Withdrawal: Physical and psychological dependence can develop. Abrupt cessation can lead to withdrawal symptoms like rebound insomnia, irritability, sweating, tremors, and in severe cases, confusion, psychosis, and convulsions.

Contraindications

Calmepam is contraindicated in patients with:

• Known hypersensitivity to benzodiazepines.
• Severe respiratory insufficiency or respiratory depression.
• Severe hepatic (liver) insufficiency.
• Myasthenia gravis (a severe muscle weakness disorder).
• Sleep apnea syndrome.
• Chronic psychosis, phobic or obsessional states.

Drug Interactions

The sedative effects of Calmepam are intensified when taken with other central nervous system depressants.

• Alcohol: Must be avoided. Alcohol significantly enhances the sedative and impairing effects.
• Other CNS Depressants: Increased sedation when taken with opioids, other tranquilizers, antidepressants, hypnotics, antipsychotics, and certain antihistamines.
• Hepatic Enzyme Inhibitors (e.g., Cimetidine, certain antifungals): Can reduce the clearance of bromazepam, potentiating its effects.
• Hepatic Enzyme Inducers (e.g., Rifampicin): Can increase the clearance of bromazepam, reducing its effects.

Precautions & Warnings

• Dependence and Withdrawal: This is the most significant risk. Use should be short-term. Do not stop suddenly.
• Impairment: Causes drowsiness and impairs coordination. Do not drive or operate machinery while taking this medication.
• Depression: Should not be used alone to treat depression, as it may unmask or worsen suicidal tendencies.
• Pregnancy and Lactation: Should not be used during pregnancy (especially first and last trimesters) or lactation unless there are compelling reasons, as it can harm the fetus and newborn.
• Elderly and Debilitated Patients: Require lower doses and careful monitoring due to increased sensitivity and risk of falls.

Overdosage

Overdose, especially when combined with alcohol or other CNS depressants, can be fatal. Signs include severe drowsiness, confusion, ataxia, coma, and respiratory depression. Management is symptomatic and supportive and requires immediate emergency medical attention. Flumazenil (Anexate) is a specific antidote that may be used in a hospital setting.

Frequently Asked Questions (FAQ)

Why is Calmepam prescribed for only a short time?
Because of the high risk of developing physical and psychological dependence. The body can become accustomed to the drug, leading to tolerance (needing more for the same effect) and severe withdrawal symptoms if stopped abruptly. [1]

Can I drink alcohol while taking Calmepam?
Absolutely not. Alcohol dangerously increases the sedative and respiratory depressant effects of Calmepam, which can lead to severe impairment, accidental overdose, and can be life-threatening.

What should I do if I miss a dose?
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 continue with your regular schedule. Do not take a double dose to make up for a missed one.

Is Calmepam a sleeping pill?
While it causes sedation and can be used for insomnia related to anxiety, it is not primarily a sleeping pill. Its main function is to reduce severe anxiety. Other medications are often preferred for long-term management of insomnia.

References

1. UK National Health Service (NHS): For patient-friendly information on Benzodiazepines. Benzodiazepines - NHS
2. World Health Organization (WHO): For clinical information on the use of anxiolytic medicines. WHO Model Formulary - Anxiolytics
3. Drug Information Pamphlet: Key information is also sourced from the internal leaflet provided with Calmepam® by GlaxoSmithKline (GSK) S.A.E.