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Approved Indications:

• Symptomatic relief of upper respiratory tract conditions including:
• Nasal congestion associated with the common cold, allergic rhinitis, and sinusitis (pseudoephedrine).
• Cough suppression related to nonproductive cough (dextromethorphan).
• Allergic symptoms such as sneezing, rhinorrhea, and watery eyes (triprolidine).

Off-label / Clinically Accepted Uses:

• Relief of symptoms related to hay fever and other seasonal allergies.
• Adjunct therapy in mild sinusitis to improve patient comfort.
• Temporary symptomatic relief of cold symptoms where multiple manifestations occur.

• Route: Oral.
• Adults and Children ≥12 years:
• Typical dose: 1 tablet or capsule every 4 to 6 hours as needed.
• Maximum daily dose: Generally not to exceed 6 doses per 24 hours (follow specific product labeling).
• Children <12 years:
• Use is generally not recommended unless prescribed by a healthcare professional.
• Elderly:
• Use caution; start with lower doses due to increased susceptibility to side effects.
• Renal/Hepatic Impairment:
• Use with caution; dose adjustment may be necessary in severe impairment.
• Administration Notes:
• Take with water.
• Avoid other sympathomimetic drugs concurrently.
• Avoid alcohol during treatment.

• Dextromethorphan acts centrally on the medullary cough center by non-competitive antagonism of NMDA receptors and sigma-1 receptor agonism, suppressing the cough reflex without significant respiratory depression.
• Pseudoephedrine is a sympathomimetic amine that selectively stimulates α-adrenergic receptors causing vasoconstriction of nasal mucosal blood vessels, leading to decreased swelling and nasal congestion.
• Triprolidine is a first-generation H1 antihistamine that blocks histamine H1 receptors, thereby reducing allergic symptoms such as sneezing, rhinorrhea, and itching. It also causes sedation through central nervous system penetration.

This combination produces multi-symptom relief by addressing cough, nasal congestion, and allergic manifestations simultaneously.

• Absorption: All components are well absorbed orally.
• Distribution:
• Dextromethorphan and triprolidine cross the blood-brain barrier, exerting central effects.
• Metabolism:
• Dextromethorphan is metabolized mainly by hepatic CYP2D6 to dextrorphan (active metabolite).
• Pseudoephedrine undergoes minimal metabolism, primarily excreted unchanged.
• Triprolidine is extensively metabolized in the liver.
• Half-life:
• Dextromethorphan: 3–4 hours (prolonged in CYP2D6 poor metabolizers).
• Pseudoephedrine: Approximately 5–8 hours.
• Triprolidine: About 4–6 hours.
• Elimination: Mainly renal excretion of unchanged drug and metabolites.

• Pregnancy: Category C.
• Use only if clearly needed; pseudoephedrine poses potential risk of fetal vasoconstriction.
• Limited human data for dextromethorphan and triprolidine; caution advised.
• Lactation:
• Dextromethorphan and pseudoephedrine are excreted in breast milk in small amounts; use caution.
• Triprolidine may cause sedation in nursing infants; use with caution.

• Primary Class: Combination cold and allergy medication.
• Subclasses:
• Dextromethorphan: Antitussive.
• Pseudoephedrine: Nasal decongestant (sympathomimetic).
• Triprolidine: First-generation antihistamine.

• Hypersensitivity to dextromethorphan, pseudoephedrine, triprolidine, or excipients.
• Concurrent or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs).
• Severe hypertension or severe coronary artery disease.
• Narrow-angle glaucoma.
• Severe coronary insufficiency.
• Hyperthyroidism.
• Use in children under 12 years unless prescribed.

• Use cautiously in patients with hypertension, cardiovascular disease, diabetes, hyperthyroidism, glaucoma, or prostatic hypertrophy.
• Risk of elevated blood pressure and arrhythmias from pseudoephedrine.
• CNS depression and sedation from triprolidine; avoid driving or operating machinery.
• Risk of serotonin syndrome with concomitant serotonergic drugs (due to dextromethorphan).
• Avoid alcohol and other CNS depressants.
• Monitor elderly patients closely for anticholinergic side effects and cardiovascular risks.
• Monitor for allergic reactions.

Common:

• Drowsiness or sedation.
• Dry mouth.
• Nervousness or dizziness.
• Nausea or gastrointestinal discomfort.
• Headache.

Serious/Rare:

• Hypertension or tachycardia.
• Palpitations.
• Allergic reactions including rash and angioedema.
• Hallucinations or confusion (especially with dextromethorphan overdose).
• Urinary retention, especially in elderly or those with prostate enlargement.

• MAO inhibitors: Risk of hypertensive crisis and serotonin syndrome; contraindicated.
• Other CNS depressants: Additive sedation with alcohol, benzodiazepines, opioids.
• Other sympathomimetics: Additive cardiovascular effects.
• Serotonergic drugs: Increased risk of serotonin syndrome.
• Anticholinergic drugs: Additive anticholinergic effects (dry mouth, urinary retention).
• CYP2D6 inhibitors: May increase dextromethorphan levels and side effects.

• Emphasis on avoiding use with MAO inhibitors and serotonergic agents.
• Updated warnings about cardiovascular risks, especially in patients with pre-existing conditions.
• Recommendations to limit use duration to short-term symptomatic relief (generally ≤7 days).

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