AMYDRAMINE-II SYRUP 120ML

Indications

Approved Uses

Symptomatic relief of cough and associated upper-respiratory symptoms (e.g., runny nose/sneezing/watery eyes) due to common cold or allergy where a sedating antihistamine is appropriate.

Off-Label Uses

For diphenhydramine (component): short-term insomnia (adults), motion sickness, and acute dystonic reactions (adjunct); it should not be used to sedate children.

Dosage & Administration

Dosing by Condition

Dose should follow the product label for this specific Julphar formulation; in general pediatric practice for diphenhydramine-containing cough/cold products, dosing is age/weight-based and many guidelines advise against routine OTC cough/cold use in children <6 years without clinician direction.

Dose Adjustment Notes

Use with caution in hepatic impairment (may require lower dose/longer interval); in renal impairment, clinically significant adjustment is usually not required but caution is advised; avoid use in older adults when possible due to high anticholinergic burden (Beers criteria).

How to Take

Shake well before use; administer orally using a calibrated measuring spoon/cup or oral syringe; may be taken with or without food; do not exceed the recommended dose/frequency and avoid duplicate antihistamine-containing products.

Side Effects

Common Side Effects

Drowsiness/sedation, dizziness, dry mouth/nose/throat, blurred vision, constipation, nausea/vomiting, and thickened bronchial secretions.

Safety & Warnings

Contraindications

Hypersensitivity to diphenhydramine or any component; neonates/premature infants; concomitant use of MAO inhibitors (or within 14 days); acute asthma/lower respiratory tract symptoms; narrow-angle glaucoma; urinary retention; pyloroduodenal obstruction/stenosing peptic ulcer.

Warnings & Precautions

May cause marked drowsiness-avoid alcohol/other sedatives and activities requiring alertness; paradoxical excitation can occur in children; avoid use in <2 years and do not use to induce sleep; avoid duplicate antihistamines; use caution in asthma/COPD, glaucoma, prostatic hypertrophy/urinary retention, cardiovascular disease, hyperthyroidism, and in hepatic/renal impairment.

Age Restriction

Not recommended in children <2 years (OTC cough/cold use); for ages 2-5 only on clinician advice and per label dosing.

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

MAO inhibitors (avoid; enhanced/prolonged anticholinergic/CNS effects); CNS depressants including alcohol, opioids, benzodiazepines/sedatives (additive sedation/respiratory depression); other anticholinergics incl. TCAs and some bladder antimuscarinics (additive anticholinergic toxicity); other antihistamines (additive sedation/anticholinergic effects).

Interaction Severity

MAJOR: other CNS depressants (alcohol, opioids, benzodiazepines, sedatives) due to additive sedation/respiratory depression; MODERATE: MAO inhibitors and tricyclic antidepressants due to enhanced/prolonged anticholinergic/CNS effects; MODERATE: other anticholinergics/first-generation antihistamines due to additive anticholinergic toxicity and sedation.

Food Interaction

No restriction

Alcohol Interaction

Dangerous

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Use with caution; may cause sleepiness and irritability in nursing infant

Elderly

Use with caution; elderly patients are more sensitive to anticholinergic and sedative effects. Start at lower doses and monitor for confusion, urinary retention, and excessive sedation.

Kidney Impairment

No specific renal dose adjustment established; use with caution in renal impairment and consider reduced dose/frequency in severe renal dysfunction.

Liver Impairment

No specific dose adjustment established; use with caution in hepatic impairment and consider lower dose/longer interval in severe impairment (not an absolute contraindication).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose. Do not double the dose.

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use

Overdose

Symptoms: anticholinergic toxidrome (dry mouth, mydriasis, flushing, hyperthermia, urinary retention, tachycardia), CNS depression or paradoxical excitation/delirium, seizures, arrhythmias/QRS widening; Management: urgent medical care, activated charcoal if appropriate, supportive care/benzodiazepines for seizures, sodium bicarbonate for wide-complex dysrhythmias; physostigmine may be considered in severe anticholinergic delirium by experienced clinicians when no contraindications.

Patient Counseling

May cause marked drowsiness-avoid driving/operating machinery; avoid alcohol and other sedatives; measure doses with a calibrated device; do not combine with other products containing antihistamines/anticholinergics; do not use to make a child sleepy; seek medical advice if symptoms persist/worsen or if the child is very young (especially <2 years) or has breathing difficulty.

Monitoring Requirements

No routine monitoring required for short-term use. Monitor for paradoxical excitation in young children.

Pharmacology

Mechanism of Action

Diphenhydramine competitively antagonizes H1 receptors and has central antitussive/sedative and anticholinergic effects; sodium citrate acts as an alkalinizing agent that can help reduce mucus acidity/irritation and is used as an expectorant component in cough mixtures.

Onset of Action

15-30 minutes.

Duration of Effect

4-6 hours.

Half-Life

Diphenhydramine elimination half-life is variable, typically ~4-9 hours in adults (often cited ~8-9 h), and can be shorter in children; sodium citrate is rapidly metabolized to bicarbonate/CO2.

Metabolism

Hepatic metabolism: diphenhydramine undergoes extensive first‑pass metabolism mainly via CYP2D6 with contributions from other CYPs (e.g., CYP1A2/CYP2C9/CYP2C19/CYP3A4) to N‑demethylation/deamination; sodium citrate is systemically metabolized to bicarbonate (alkalinizing effect) as part of normal citrate metabolism.

Excretion

Primarily renal excretion as metabolites (diphenhydramine), with minimal unchanged drug.

Product Information

Available Dosage Forms

Syrup

Composition per Dose

Each 5 ml: Diphenhydramine Hydrochloride 7 mg + Sodium Citrate 28.5 mg

Generic Availability

Yes

OTC Alternatives

For allergy symptoms: non-sedating antihistamines such as loratadine or cetirizine; for cough with mucus: an expectorant such as guaifenesin; for fever/pain with colds: paracetamol/ibuprofen as appropriate.

Symptom Target

Multi-symptom

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 28-06-2026