Medicine Information

DAM

Tablet0.5 mgAnxiolytic, Sedative-HypnoticATC: N05BA12

Generic Name

Alprazolam

Manufacturer

Renata Limited

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
dam 05 mg tablet	৳ 5.00	৳ 50.00

Description

Overview of the medicine

DAM 0.5 mg tablet, containing Alprazolam, is a benzodiazepine medication used to treat anxiety disorders, panic disorder, and anxiety associated with depression. It works by affecting brain chemicals that may be unbalanced in people with anxiety.

Uses & Indications

Management of anxiety disorders

Short-term relief of anxiety symptoms (generalized anxiety disorder, transient situational anxiety)

Treatment of panic disorder, with or without agoraphobia

Dosage

Adults

Anxiety: Initially 0.25 mg to 0.5 mg three times daily. Maximum dose is 4 mg/day in divided doses. Panic disorder: Initially 0.5 mg three times daily. May be increased up to a maximum of 10 mg/day in divided doses, depending on patient response.

Elderly

Initially 0.25 mg two or three times daily. Dosage should be started at the lowest effective dose and increased gradually to minimize the risk of adverse effects.

Renal_impairment

No specific dosage adjustments are typically recommended, but caution is advised in patients with severe renal impairment due to potential accumulation of metabolites. Monitor patients closely.

How to Take

Take DAM 0.5 mg tablet orally, with or without food. Swallow the tablet whole; do not crush, chew, or break it, especially for extended-release formulations. Follow your doctor's instructions regarding dose and duration.

Mechanism of Action

Alprazolam, a triazolo analog of the 1,4 benzodiazepine class, exerts its effects by binding to specific benzodiazepine receptors on the GABA-A receptor complex in the central nervous system. This binding enhances the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), leading to a reduction in neuronal excitability and producing anxiolytic, sedative, hypnotic, and anticonvulsant effects.

Pharmacokinetics

Onset

Anxiolytic effects typically begin within 30-60 minutes.

Excretion

Metabolites are primarily excreted in the urine, with less than 20% excreted unchanged.

Half life

The plasma elimination half-life ranges from approximately 11 to 16 hours (average 12 hours) in healthy adults.

Absorption

Rapidly and well absorbed from the gastrointestinal tract. Peak plasma concentrations are achieved within 1-2 hours after oral administration.

Metabolism

Extensively metabolized in the liver, primarily by cytochrome P450 3A4 (CYP3A4) to two main active metabolites (4-hydroxyalprazolam and α-hydroxyalprazolam) and an inactive benzophenone derivative.

Side Effects

Contraindications

Known hypersensitivity to alprazolam, other benzodiazepines, or any component of the formulation
Acute narrow-angle glaucoma
Concomitant use with strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, itraconazole)

Drug Interactions

Alcohol

Potentiates CNS depressant effects, leading to increased sedation, respiratory depression, and impaired psychomotor performance.

Digoxin

Increased digoxin plasma levels have been reported with concomitant alprazolam, monitor digoxin levels.

Opioids

Increased risk of profound sedation, respiratory depression, coma, and death. Avoid concomitant use unless benefits outweigh risks.

Strong CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Nefazodone)

Significantly increase alprazolam plasma concentrations, potentially leading to increased adverse effects. Concomitant use is contraindicated.

Other CNS Depressants (e.g., Antidepressants, Antihistamines, Barbiturates)

Additive CNS depressant effects, increasing drowsiness and sedation.

Storage

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date.

Overdose

Symptoms of alprazolam overdose include somnolence, confusion, impaired coordination, diminished reflexes, and coma. In severe cases, respiratory depression and hypotension may occur. Management involves supportive care (e.g., maintaining airway, monitoring vital signs), gastric lavage or activated charcoal if ingestion is recent, and flumazenil (a benzodiazepine receptor antagonist) may be considered to reverse CNS effects, but use with caution due to risk of withdrawal seizures.

Pregnancy & Lactation

Pregnancy Category D: Alprazolam may cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy, especially during the first trimester. Lactation: Alprazolam is excreted in breast milk and may cause sedation and feeding difficulties in nursing infants. Use is not recommended during breastfeeding.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

30 tablets (10x3 blister)50 tablets (10x5 blister)100 tablets (bottle pack)

Shelf Life

24 months from the date of manufacture

Availability

Available in pharmacies nationwide in Bangladesh and globally with varying brand names.

Approval Status

Approved by DGDA (Bangladesh) and other international regulatory bodies (e.g., FDA).

Patent Status

Generic available, patent expired

Clinical Trials

Alprazolam has been extensively studied in numerous randomized, placebo-controlled clinical trials for its efficacy in generalized anxiety disorder, panic disorder, and anxiety with depressive symptoms. Studies have consistently demonstrated its anxiolytic and anti-panic effects, though with a known risk profile for dependence and withdrawal.

Lab Monitoring

Liver function tests (baseline and periodically, especially in long-term use or in patients with hepatic impairment)
Renal function tests (in patients with renal impairment)
Blood counts (if clinically indicated)

Doctor Notes

Counsel patients thoroughly on the risks of dependence, abuse, and withdrawal symptoms, emphasizing the importance of not discontinuing abruptly.
When prescribing with opioids, clearly communicate the risks of profound sedation and respiratory depression.
Initiate treatment at the lowest effective dose and monitor for adverse effects, particularly in elderly or debilitated patients.
Regularly reassess the need for continued treatment and consider gradual tapering when discontinuing.

Patient Guidelines

Do not stop taking this medicine suddenly without consulting your doctor, as it can lead to severe withdrawal symptoms.
Avoid alcohol and other central nervous system depressants while on this medication.
This medicine can cause drowsiness or dizziness; avoid driving or operating heavy machinery until you know how it affects you.
Inform your doctor about all other medications, herbal products, and supplements you are taking.
Report any unusual mood changes, thoughts of self-harm, or severe side effects to your doctor immediately.

Missed Dose Advice

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once to make up for a missed one.

Driving Precautions

DAM 0.5 mg tablet may cause drowsiness, dizziness, or impaired coordination, which can affect your ability to drive or operate machinery safely. Do not drive or engage in activities requiring mental alertness until you know how this medicine affects you.

Lifestyle Advice

Practice stress management techniques such as meditation, deep breathing, or yoga.
Maintain a regular sleep schedule and ensure adequate sleep.
Engage in regular physical activity.
Avoid excessive caffeine and other stimulants.
Seek counseling or therapy to manage underlying anxiety or panic issues.