Bromcamphor racemic (Tablets) Instructions for Use

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Dosage Form

Racemic bromocamphor

Tablets 250 mg: 30 pcs.

Dosage Form, Packaging, and Composition

30 pcs. – dark glass jars (1) – cardboard packs.
30 pcs. – polymer jars (100) – cardboard packs.

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Sedative

Pharmacological Action

Sedative agent – a bromine preparation.

Pharmacokinetics

Easily absorbed in the gastrointestinal tract. Penetrates through histohematic barriers, including the placental barrier.

Hydroxylated in the liver to oxymetabolites, which are excreted by the kidneys as glucuronides.

Indications

• Manage symptoms of increased nervous excitability and asthenia (general weakness and fatigue).
• Use for cardioneuroses presenting with specific cardiac symptoms such as cardialgia (pain in the heart region), tachycardia (accelerated heart rate), and labile blood pressure (unstable blood pressure readings).

ICD codes

Dosage Regimen

Administer orally, strictly after meals to minimize potential gastrointestinal irritation.

For adult patients, prescribe 150-500 mg taken two to three times daily. For pediatric patients, adjust the dose based on age: administer 50 mg for children under 2 years, 100 mg for ages 3-6 years, 150 mg for ages 7-9 years, and 150-250 mg for ages 10-14 years, with all pediatric doses given two to three times per day.

Limit the treatment course to a duration of 10 to 15 days to prevent the risk of bromism and cumulative side effects.

Adverse Reactions

Monitor for allergic reactions, which may include skin rash, itching, or urticaria.

Observe for dyspeptic symptoms such as nausea, stomach discomfort, or gastralgia. Be aware of the potential for bromism with chronic use, characterized by symptoms like rhinitis, conjunctivitis, skin eruptions (bromoderma), and neurological effects including cognitive impairment, ataxia, and lethargy.

Drug Interactions

Avoid concurrent use with other central nervous system (CNS) depressants, including alcohol, barbiturates, and opioids, due to risk of additive sedative effects.

Exercise caution with drugs that lower the seizure threshold. Bromide ions may be displaced from protein binding sites by other highly protein-bound drugs, potentially altering the effects of either medication.

Contraindications

• Do not use in patients with a known hypersensitivity or history of allergic reaction to bromocamphor or any other bromine-containing compounds.
• Strictly avoid use in patients with hepatic failure or renal failure due to impaired metabolism and excretion, which significantly increases the risk of bromide accumulation and toxicity (bromism).

Overdose

Recognize overdose by symptoms of severe bromism: CNS depression (profound sedation, coma), cardiovascular collapse, and respiratory depression.

Immediately initiate gastric lavage and administer activated charcoal if ingestion is recent. Provide symptomatic and supportive care, focusing on maintaining airway, breathing, and circulation. Enhance bromide elimination with intravenous administration of sodium chloride and potent diuretics; consider hemodialysis in severe, life-threatening cases.

Use in Hepatic Impairment

Contraindication — hepatic failure.

Use in Renal Impairment

Contraindication — renal failure.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.