AMYDRAMINE EXPECTORANT SYRUP 120ML

Indications

Approved Uses

Symptomatic relief of cough associated with upper respiratory tract infections/common cold where mucus is present (expectorant use), and relief of associated allergic/irritative symptoms (e.g., rhinorrhea/sneezing) due to diphenhydramine.

Dosage & Administration

Dose Adjustment Notes

Elderly: use the lowest effective dose and avoid if possible due to strong anticholinergic/sedative burden. Hepatic impairment: use caution (diphenhydramine is hepatically metabolized). Renal impairment: use caution (metabolites/excretion are renal). No routine dose adjustment is specified; avoid excessive dosing and monitor for toxicity.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth, blurred vision, nausea/GI upset, constipation, and urinary retention (especially in men with BPH).

Side Effect Frequency

Frequency categories cannot be reliably assigned (e.g., very common/common/rare) for this specific combination product from the provided authoritative API data; expected adverse effects include drowsiness/sedation, dizziness, dry mouth, blurred vision, GI upset (nausea/vomiting/epigastric discomfort), urinary retention, palpitations and hypotension, and paradoxical excitation (especially in children).

Safety & Warnings

Warnings & Precautions

May cause significant drowsiness-avoid driving/operating machinery; avoid alcohol and other CNS depressants; caution in glaucoma, prostatic hypertrophy/urinary retention, cardiovascular disease, epilepsy; caution in asthma/COPD/chronic bronchitis due to secretion thickening; avoid MAOIs; caution in renal/hepatic impairment and in children due to paradoxical excitation.

Age Restriction

Do not use in children <2 years unless directed by a physician; contraindicated in neonates/premature infants.

Drug Interactions

Drug Interactions

MAO inhibitors (contraindicated/avoid); CNS depressants including alcohol, opioids, benzodiazepines and sedatives (additive sedation/respiratory depression); other anticholinergics and TCAs (additive anticholinergic effects); caution with other sedating antihistamines.

Interaction Severity

MAJOR: Alcohol and other CNS depressants (opioids, benzodiazepines, sedative-hypnotics) due to additive sedation/respiratory/CNS depression. MODERATE: Other anticholinergics (e.g., TCAs, antipsychotics, antiparkinsonian antimuscarinics) due to additive anticholinergic toxicity. MAJOR/AVOID: MAO inhibitors within 14 days-may potentiate anticholinergic/CNS effects (and can intensify adverse reactions).

Food Interaction

Avoid alcohol.

Storage & Patient Advice

Stopping the Medicine

May be stopped at any time; no tapering required (stop when symptoms resolve or if adverse effects occur).

Overdose

Symptoms: marked drowsiness or paradoxical excitation (children), confusion/hallucinations, seizures, anticholinergic signs (dry/flushed skin, mydriasis, tachycardia, urinary retention), possible coma/arrhythmias; Management: urgent medical care, activated charcoal if appropriate, supportive/symptomatic treatment (airway/ventilation, seizure control).

Patient Counseling

May cause marked drowsiness-avoid driving/operating machinery. Avoid alcohol and other sedatives. Use a calibrated measuring device; do not exceed the recommended dose/frequency. Do not use in children <2 years; for 2-6 years use only with medical advice. Seek medical care if symptoms persist >7 days, worsen, or are accompanied by high fever, rash, shortness of breath, or persistent productive cough. Maintain hydration; store below 30°C (SFDA).

Monitoring Requirements

No routine monitoring required for short-term OTC use; monitor for signs of CNS depression in elderly and pediatric patients

Pharmacology

Mechanism of Action

Diphenhydramine: H1-receptor antagonism with anticholinergic and central sedative effects that can reduce cough reflex. Ammonium chloride: expectorant by increasing respiratory tract fluid/secretions to help mobilize mucus. Sodium citrate: alkalinizing/saline expectorant that can help loosen mucus and soothe irritated mucosa.

Onset of Action

15-30 minutes

Bioavailability

Diphenhydramine oral bioavailability is variable due to first-pass metabolism, commonly cited around ~40-60%.

Metabolism

Diphenhydramine: extensive hepatic metabolism (primarily via CYP2D6; also other pathways) to inactive metabolites. Ammonium chloride: metabolized to urea with systemic acidifying effect; sodium citrate is metabolized to bicarbonate.

Excretion

Diphenhydramine: primarily renal excretion as metabolites (minimal unchanged drug). Ammonium chloride: renal excretion (as chloride/ammonium with systemic acidifying effect).

Product Information

Available Dosage Forms

Syrup

Composition per Dose

Each 5 ml: Diphenhydramine hydrochloride 13.5 mg + Sodium citrate 57 mg + Ammonium chloride 131.5 mg

Generic Availability

Yes

OTC Alternatives

Guaifenesin expectorant syrups; dextromethorphan-containing antitussives (for dry cough); non-sedating antihistamines for allergic rhinitis (e.g., loratadine/cetirizine) if cough is allergy-related; simple supportive care (honey for >1 year, saline, hydration).

Symptom Target

Cough, Runny Nose, Allergy

Sedating

Yes

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