Uses
Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure. Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker.
Source: US FDA prescribing information
- Presentations
- 10
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Labetalol is a beta-adrenergic blocker indicated in severe hypertension, to lower blood pressure. It is available as tablets and injection for oral and intravenous use. MedsAcross supplies Labetalol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Beta-Adrenergic Blocker, Adrenergic beta-Antagonists
- ATC classification
- C07AG01 Labetalol · Beta blockers, subgroup C07A, subgroup C07AG
- US FDA first approval
- 1 August 1984
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral, Intravenous
- Dosage forms
- Tablet, Injection
- Identifiers
- UNII R5H8897N95RxCUI 6185CAS 36894-69-6DrugBank DB00598Q958087
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Labetalol has both competitive alpha1-adrenergic blocking and competitive beta-adrenergic blocking activity. In man, the ratio of alpha- to beta-blockade has been estimated to be approximately 1:7 following intravenous administration. Beta 2 -agonist activity has been demonstrated in animals with minimal beta 1 -agonist activity detected.
Source: US FDA prescribing information
Dosing overview
Administer Labetalol Hydrochloride in Sodium Chloride Injection or Dextrose Injection as a slow continuous intravenous infusion at a rate of 2 mL/min (2 mg/min). Alternatively, administer Labetalol Hydrochloride Injection in a prefilled syringe or vial at 0.25 mg/kg (up to a maximum of 20 mg) intravenously over 2 minutes. Additional injections of 40 mg or 80 mg can be given at 10-minute intervals.
Source: US FDA prescribing information
Contraindications
Labetalol Hydrochloride Injection is contraindicated in patients with: Bronchial asthma or obstructive airway disease. Severe sinus bradycardia: Heart block greater than first degree. Cardiogenic shock. IV administration of non-dihydropyridine calcium-channel antagonists (e.g., verapamil) Hypersensitivity reactions, including anaphylaxis, to labetalol Bronchial asthma. Overt cardiac failure. Greater-than-first-degree heart block. Cardiogenic shock. Severe bradycardia
Source: US FDA prescribing information
Warnings and precautions
Exacerbation of heart failure: Avoid use. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid since it has not been studied. Diabetes: May mask symptoms of hypoglycemia and alter glucose levels, monitor. Exacerbation of pheochromocytoma: Paradoxical increases in blood pressure may occur. Severe hepatocellular injury: Discontinue permanently for liver injury or jaundice
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypotension Bradycardia Depression of myocardial contractility in patients with overt congestive heart failure Aggravation of angina Significant decline in cardiac output following coronary bypass Bronchospasm in patients with reactive airway disease Paradoxical hypertensive responses in patients with pheochromocytoma Hepatic injury Acute hypersensitivity reaction Most common adverse events: Symptomatic postural hypotension. Nausea13%, dizziness 9%. For product Inquiry call 1-877-845-0689.
Source: US FDA prescribing information
Interactions
Beta blockers antagonize the bronchodilator effect of beta-receptor agonists. Increase hypotension may occur with halothane anesthesia. Nitroglycerin may result in additional hypotensive effects.
Source: US FDA prescribing information
Storage
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30° C (59°F to 86° F). DO NOT FREEZE. PROTECT FROM LIGHT.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
10 presentations of Labetalol, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Labetalol 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Labetalol 200 mg tabletOralGeneric name | — | US FDA | Available on request |
| Labetalol 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Labetalol 100 mg/20 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Labetalol 200 mg/40 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Labetalol 20 mg/4 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Labetalol 400 mg tabletOralGeneric name | — | US FDA | Available on request |
| Labetalol 200 mg/200 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Labetalol 100 mg/100 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Labetalol 300 mg/300 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 1 August 1984 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions
Conditions linked to Labetalol in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Labetalol available for export from India?
Yes, on request. MedsAcross lists 10 presentations of Labetalol and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Labetalol approved by the US FDA?
Yes. The US FDA first approved Labetalol on 1 August 1984, according to Drugs@FDA.
Does Labetalol need cold chain shipping?
No listed presentation of Labetalol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Labetalol in?
Labetalol is classified under ATC code C07AG01 (Labetalol).
References
- Labetalol Hydrochloride prescribing information (Hikma Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 19 December 2025
Request Labetalol for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.