DOGMATIL 50/MG CAP 30/CAP

Indications

Approved Uses

Schizophrenia and other psychotic disorders (acute and chronic).

Off-Label Uses

Functional GI disorders (e.g., functional dyspepsia/IBS) and vertigo are commonly cited off-label uses in some settings; use for dysthymia/panic or depression augmentation may be described but is jurisdiction- and evidence-dependent.

Dosage & Administration

Initial Dose

For schizophrenia: 200-800mg daily in divided doses

Maintenance Dose

150-300mg/day for depressive disorders; 400-800mg/day for schizophrenia

Maximum Dose

2400mg/day (hospitalized schizophrenic patients); 600mg/day (depressive/anxiety disorders)

Dose Adjustment Notes

Reduce dose in renal impairment (dose/interval adjustment based on creatinine clearance); use lower starting doses and slower titration in older adults; hepatic adjustment is generally not required.

Safety & Warnings

Contraindications

Hypersensitivity to sulpiride; pheochromocytoma; prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer); concomitant use with levodopa (and generally dopamine agonists used in Parkinson’s disease); acute porphyria (per many EU/UK product labels).

Warnings & Precautions

QT prolongation risk (consider baseline ECG in at-risk patients; correct hypokalemia/hypomagnesemia; avoid other QT-prolonging drugs); monitor for NMS; risk of tardive dyskinesia with long-term use; hyperprolactinemia (caution in prolactin-sensitive conditions); lowers seizure threshold (caution in epilepsy); caution in Parkinson’s disease; increased stroke/mortality risk in elderly with dementia-related psychosis; VTE risk; renal impairment requires dose reduction; caution with hypotension/sedation and driving.

Drug Interactions

Interaction Severity

MAJOR/CONTRAINDICATED: levodopa and dopamine agonists (pharmacodynamic antagonism). MODERATE-MAJOR: other QT-prolonging drugs (torsades risk), lithium (neurotoxicity/NMS risk), CNS depressants/alcohol (additive sedation), antihypertensives (additive hypotension), metoclopramide/other dopamine blockers (additive EPS). MINOR: antacids/sucralfate (reduced absorption).

Special Populations

Elderly

Start at lowest effective dose (50mg/day), titrate slowly; increased risk of extrapyramidal symptoms, sedation, hypotension, and QT prolongation; avoid use in dementia-related psychosis

Liver Impairment

No routine hepatic dose adjustment required.

Storage & Patient Advice

Patient Counseling

Take exactly as prescribed; swallow whole with water; may take with or without food; avoid alcohol and use caution driving until effects are known; do not stop abruptly without medical advice; separate antacids/sucralfate by ≥2 hours; report urgently fever/rigidity/confusion (possible NMS), abnormal movements, or palpitations/syncope; discuss menstrual/breast changes (prolactin effects) and pregnancy/breastfeeding with the prescriber.

Monitoring Requirements

Monitor for EPS/tardive dyskinesia and NMS; baseline and follow-up renal function; weight/BMI and metabolic parameters as clinically indicated; prolactin if symptomatic; ECG and electrolytes (K/Mg) in patients with cardiac risk factors, QT risk, or when combined with QT-prolonging drugs.

Pharmacology

Mechanism of Action

Selective dopamine receptor antagonist (primarily D2; also D3) with dose-dependent effects: at low doses preferential blockade of presynaptic autoreceptors may increase dopaminergic transmission, while at higher doses postsynaptic D2 blockade produces antipsychotic effects; minimal anticholinergic/antihistaminic activity.

Duration of Effect

Clinical effect persists beyond the plasma half-life; with regular dosing, therapeutic effects are maintained over 24 hours, so dosing is typically once to twice daily depending on indication and tolerability.

Half-Life

6 hours

Bioavailability

Approximately 25-35% (oral bioavailability)

Metabolism

Minimal hepatic metabolism; excreted largely unchanged

Excretion

Primarily renal; ~70% excreted unchanged in urine (fecal excretion is minor)

Protein Binding

Low protein binding, approximately 40% (often cited as <40%)

Product Information

Available Dosage Forms

For this SFDA-registered product: hard capsule for oral use (blister pack). Other sulpiride dosage forms may exist in some markets (e.g., tablets, oral solution, IM injection), but they are not confirmed for this specific SFDA product record.

Composition per Dose

Each capsule: 50mg sulpiride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 11-07-2026