ROMIN SYRUP 120ML

Indications

Approved Uses

Symptomatic relief of non-productive (dry) cough.

Off-Label Uses

Pseudobulbar affect when combined with quinidine (approved in some jurisdictions as a fixed-dose product); other off-label uses are not well-established for routine practice.

Dosage & Administration

Dosing by Condition

Cough suppression (immediate-release dextromethorphan): Adults and ≥12 years: 10-20 mg every 4 hours or 30 mg every 6-8 hours (max 120 mg/day). For this product (15 mg/5 mL): 5 mL every 6-8 hours or 3.3 mL every 4 hours (do not exceed 40 mL/day).

Initial Dose

15 mg (5 ml) every 4-8 hours in adults

Maintenance Dose

15 mg (5 ml) every 4-8 hours as needed

Maximum Dose

120 mg per day in adults

Children's Dosage

Children 6 to 11 years: 5 mL (15 mg) every 6-8 hours, not to exceed 4 doses (60 mg)/day. Children under 6 years: do not use.

Dose Adjustment Notes

CYP2D6 poor metabolizers or use with strong CYP2D6 inhibitors may have increased/prolonged effects; no specific evidence-based dose-adjustment recommendations are established-use caution. Use caution in hepatic impairment; no routine renal adjustment is typically required.

How to Take

Shake well before use. Measure the dose with a calibrated measuring spoon/cup or oral syringe. Take by mouth; may be taken with or without food.

Side Effects

Common Side Effects

Drowsiness, dizziness, nausea, vomiting, and gastrointestinal upset (e.g., abdominal discomfort).

Side Effect Frequency

Common (1-10%): drowsiness/somnolence, dizziness, nausea, vomiting, gastrointestinal discomfort/abdominal pain. Uncommon (<1%): constipation, confusion, nervousness/restlessness/excitability, skin rash; rare but clinically important: serotonin syndrome when combined with serotonergic drugs/MAOIs.

Safety & Warnings

Contraindications

Hypersensitivity to dextromethorphan; concomitant use with MAO inhibitors or use within 14 days of stopping an MAOI.

Warnings & Precautions

Avoid use with MAOIs or within 14 days; caution with other serotonergic drugs (serotonin syndrome); do not use for chronic/persistent cough (e.g., asthma, smoking) or cough with excessive mucus unless medically evaluated; caution in hepatic impairment; avoid alcohol/other CNS depressants; potential for misuse/abuse at supratherapeutic doses; CYP2D6 poor metabolizers or use with CYP2D6 inhibitors may increase adverse effects.

Age Restriction

Not recommended for children under 4 years of age (unless specifically directed by a clinician).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

MAOIs (and within 14 days); serotonergic drugs (e.g., SSRIs/SNRIs/TCAs, linezolid, methylene blue, triptans) due to serotonin syndrome risk; strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine, bupropion) which can increase dextromethorphan exposure; alcohol and other CNS depressants (additive sedation/impairment).

Interaction Severity

MAJOR: MAO inhibitors (and within 14 days of use) due to risk of serious serotonin toxicity. MODERATE: Other serotonergic drugs (e.g., SSRIs/SNRIs, linezolid) and strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) increasing serotonin-toxicity/CNS-toxicity risk; CNS depressants/alcohol (additive sedation).

Food Interaction

May be taken with or without food; taking with food/milk may reduce nausea. No clinically established grapefruit restriction for routine use.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Children 6 to 11 years: 5 mL (15 mg) every 6-8 hours, not to exceed 4 doses (60 mg)/day. Children under 6 years: do not use.

Elderly

Use with caution; start at lower end of dosing range due to increased sensitivity to CNS effects and potential for drug accumulation

Kidney Impairment

No established dose adjustment; use with caution in severe renal impairment.

Liver Impairment

No established dose adjustment; use with caution in hepatic impairment (especially moderate-severe).

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is nearly time for the next dose. Do not double the dose

Stopping the Medicine

No tapering is required for dextromethorphan when used short-term as directed. Stop when the cough resolves or if adverse effects occur. Do not use longer than 7 days without medical advice; seek evaluation if cough persists/recurs or is accompanied by fever, rash, persistent headache, shortness of breath, or worsening symptoms.

Overdose

Symptoms may include nausea/vomiting, drowsiness/dizziness, ataxia, agitation/confusion, hallucinations/dissociation, tachycardia/hypertension, seizures, respiratory depression/coma; management is urgent medical care with supportive treatment, activated charcoal if early, and naloxone may be considered for significant CNS/respiratory depression.

Patient Counseling

Shake well; measure doses accurately; do not exceed recommended dose/max 120 mg/day; avoid alcohol and other sedatives; avoid use with MAOIs (and within 14 days) and use caution with SSRIs/SNRIs/other serotonergic drugs and strong CYP2D6 inhibitors; may cause drowsiness/dizziness-avoid driving until effects known; seek medical advice if cough persists >7 days or is accompanied by fever/rash/persistent headache; store below 25°C and keep out of reach of children.

Monitoring Requirements

No routine monitoring required at therapeutic doses; monitor for signs of serotonin syndrome if used with serotonergic agents

Pharmacology

Mechanism of Action

Centrally suppresses the cough reflex (raises cough threshold) via sigma-1 receptor agonism and NMDA receptor antagonism (among other CNS actions).

Onset of Action

15-30 minutes.

Duration of Effect

Approximately 3-6 hours (immediate-release).

Bioavailability

Approximately 11% in extensive metabolizers (higher and variable in CYP2D6 poor metabolizers due to reduced first-pass metabolism).

Metabolism

Hepatic metabolism primarily via CYP2D6 to the active metabolite dextrorphan; minor contribution via CYP3A4 (e.g., N-demethylation).

Excretion

Renal, primarily as metabolites; only a small fraction is excreted unchanged.

Product Information

Available Dosage Forms

Syrup (oral).

Composition per Dose

Each 5 ml: Dextromethorphan hydrobromide 15 mg (equivalent to 3 mg/ml)

Generic Availability

Yes

OTC Alternatives

Non-prescription symptomatic options for cough include honey (age-appropriate), throat lozenges, and (for productive cough) guaifenesin where available; availability depends on local (SFDA) scheduling.

Symptom Target

Cough

Sedating

Yes

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