1. Clinical & Scientific Overview
Labetalol Hydrochloride (TIP-MED-000032, Reference Code [3.32]) is classified under
Cardiovascular & Antithrombotic Medicines (Ch 03) as a Combined Alpha-1 Selective & Non-Selective Beta Adrenoceptor Blocker (Schedule H | NLEM 2022).
Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).
Clopilet (Sun Pharma), Deplatt (Torrent), Clopitab (Lupin)
Oral Tablets: 100 mg, 200 mg; IV Injection: 5 mg/mL (20 mL ampoule = 100 mg)
3. Mechanism of Action & Pharmacodynamics
Combined Alpha-1 Selective & Non-Selective Beta Adrenoceptor Blocker (Schedule H | NLEM 2022) acting on target receptor/enzyme pathways in Cardiovascular & Antithrombotic Medicines (Ch 03): clinical efficacy is mediated via Combined Alpha-1 Selective & Non-Selective Beta Adrenoceptor Blocker (Schedule H | NLEM 2022) for First-line drug of choice for Gestational Hypertension, Pre-Eclampsia, and Severe Hypertensive Emergencies in Pregnancy; hypertensive crises (IV).
4. Therapeutic Indications & Evidence-Supported Uses
- First-line drug of choice for Gestational Hypertension, Pre-Eclampsia, and Severe Hypertensive Emergencies in Pregnancy
- hypertensive crises (IV)
5. Educational Dosage Context, Formulations & Administration
Educational Dosing & Regimen Summary: Pregnancy HTN (Oral): Start 100 mg PO BD; titrate every 2–3 days to 200–400 mg BD–TDS (Max 1200–2400 mg/day). Severe Pre-Eclampsia (IV): 20 mg slow IV over 2 min, then 40–80 mg q10min (Max 300 mg)
Administration & Meal Timing: Take oral tablets with food (food increases bioavailability and reduces postural dizziness) | Morning & Evening (BD) or Morning, Afternoon & Night (TDS)
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal: Safe in renal impairment. Hepatic: Contraindicated in active liver disease or elevated transaminases; reduce dose in hepatic dysfunction
Renal: Safe in renal impairment. Hepatic: Contraindicated in active liver disease or elevated transaminases; reduce dose in hepatic dysfunction
Renal: Safe in renal impairment. Hepatic: Contraindicated in active liver disease or elevated transaminases; reduce dose in hepatic dysfunction
7. Contraindications, Precautions & High-Risk Warnings
- CONTRAINDICATED in maternal asthma, COPD, heart block, severe bradycardia (<50 bpm), and decompensated heart failure
Key Clinical Precautions: Renal: Safe in renal impairment. Hepatic: Contraindicated in active liver disease or elevated transaminases; reduce dose in hepatic dysfunction
8. Adverse Effects Profile
- Postural dizziness, scalp tingling/piloerection (classic early transient effect), fatigue, nausea, nasal congestion
- Drug-induced hepatotoxicity (rare but serious — check LFTs if jaundice/dark urine), maternal/neonatal bradycardia or neonatal hypoglycaemia, bronchospasm
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Additive hypotension with Nifedipine or Methyldopa; Cimetidine increases bioavailability; blunts Beta-2 bronchodilators (Salbutamol)
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: First-line safe blood pressure medicine in pregnancy and breastfeeding; sit or lie down if dizzy after taking tablet; report any yellowing of eyes or dark urine immediately
- Meal & Clock Timing Instruction: Take oral tablets with food (food increases bioavailability and reduces postural dizziness) (Morning & Evening (BD) or Morning, Afternoon & Night (TDS))
- Missed Dose Protocol: Take as soon as remembered unless within 4 hours of next dose; never stop abruptly
- Geriatric Dispensing Pearl: In non-pregnant older adults, high risk of orthostatic hypotension; monitor standing BP
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Oral Tablets: 100 mg, 200 mg; IV Injection: 5 mg/mL (20 mL ampoule = 100 mg)
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 03 [3.32] (p. 36)
Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)
Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT
Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.