Brofex TS

• Approved Indications:
• Temporary relief of cough caused by minor throat and bronchial irritation associated with the common cold or inhaled irritants.
• Suppression of nonproductive (dry) cough to improve patient comfort.
• Off-label / Clinically Accepted Uses:
• Adjunctive treatment in pseudobulbar affect (in combination formulations).
• Investigational use in neuropathic pain and neuropsychiatric disorders.
• Off-label management of chronic cough under specialist supervision.

• Route: Oral.
• Adults and Children 12 years and older:
• Extended-release formulations typically dosed at 60 mg every 12 hours.
• Maximum daily dose generally 120 mg.
• Children under 12 years:
• Safety and efficacy not established; use generally not recommended.
• Elderly:
• Use caution; initiate at lower doses and monitor for side effects.
• Renal and Hepatic Impairment:
• Use with caution; dosage adjustment may be required in severe impairment.
• Administration Notes:
• Swallow capsules/tablets whole; do not crush or chew to maintain extended-release effect.
• Can be taken with or without food.
• Avoid alcohol and other CNS depressants during therapy.

Dextromethorphan Polistirex is a sustained-release formulation of dextromethorphan, a non-opioid antitussive agent. It acts centrally by non-competitive antagonism of N-methyl-D-aspartate (NMDA) receptors and agonism at sigma-1 receptors within the medullary cough center. This action elevates the cough threshold, suppressing the cough reflex without significant respiratory depression or analgesic effects. The polistirex polymer matrix allows gradual release, prolonging therapeutic effects and reducing dosing frequency.

• Absorption: Slowly and steadily absorbed from the gastrointestinal tract due to the polistirex polymer matrix, resulting in prolonged plasma levels.
• Distribution: Crosses the blood-brain barrier to exert central effects.
• Metabolism: Metabolized primarily by hepatic cytochrome P450 2D6 (CYP2D6) to dextrorphan, an active metabolite.
• Half-life: Approximately 12 hours due to extended-release formulation, compared to 3–4 hours for immediate-release dextromethorphan.
• Elimination: Mainly renal excretion of metabolites.

• Pregnancy: FDA Category C. Limited human data; use only if potential benefits justify potential risks.
• Lactation: Excreted in breast milk in small amounts; caution advised when administered to nursing mothers.

• Primary Therapeutic Class: Antitussive (cough suppressant).
• Subclass: Non-opioid centrally acting antitussive; extended-release formulation.

• Known hypersensitivity to dextromethorphan or formulation excipients.
• Concomitant or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs).
• Severe respiratory depression.
• Use in children under 12 years (for polistirex formulation).

• Risk of serotonin syndrome when combined with serotonergic agents.
• Potential for abuse or misuse at high doses.
• Caution in patients with hepatic impairment.
• May cause dizziness or sedation; avoid driving or operating machinery if affected.
• Avoid concomitant use with other CNS depressants or alcohol.
• Monitor for signs of hypersensitivity or allergic reactions.

• Common:
• Dizziness
• Nausea
• Drowsiness
• Gastrointestinal upset
• Headache
• Serious/Rare:
• Serotonin syndrome (especially with interacting drugs)
• Allergic reactions (rash, angioedema)
• Hallucinations or confusion (with overdose or misuse)
• Respiratory depression (rare)

• MAO inhibitors: Contraindicated due to risk of serotonin syndrome.
• Serotonergic drugs: Increased risk of serotonin syndrome.
• CYP2D6 inhibitors: May increase dextromethorphan plasma concentrations, increasing toxicity risk.
• CNS depressants: Additive sedation with alcohol, benzodiazepines, opioids.
• Other cough suppressants: Use cautiously to avoid additive effects.

• FDA emphasizes risk of misuse and serotonin syndrome with dextromethorphan-containing products.
• Labeling updates recommend avoiding use in children under 12 years.
• Guidance encourages limiting use to short-term symptomatic relief.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• Keep out of reach of children.
• Do not freeze.