Labetalol Hydrochloride

What it is and how it works

Mechanism class: Adrenergic beta-Antagonists

Indications

INDICATIONS AND USAGE Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d. (twice daily) every 2 or 3 days. The usual maintenance dosage of labetalol hydrochloride tablets is between 200 mg and 400 mg twice daily. Since the full antihypertensive effect of labetalol hydrochloride tablets is usually seen within the first 1 to 3 hours of the initial dose or dose increment, the assurance of a lack of an exaggerated hypotensive response can be clinically established in the office setting.

Contraindications

CONTRAINDICATIONS Labetalol hydrochloride is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product . Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Warnings and precautions

WARNINGS Hepatic Injury Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology. Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol hydrochloride.

Pregnancy

Pregnancy Teratogenic Effects Pregnancy Category C Teratogenic studies were performed with labetalol in rats and rabbits at oral doses up to approximately six and four times the maximum recommended human dose (MRHD), respectively. No reproducible evidence of fetal malformations was observed.

Storage and supply

HOW SUPPLIED Labetalol Hydrochloride Tablets, USP, for oral administration, are available as 300 mg Round, blue film-coated tablets, plain on one side, and debossed with “I/130” on the other side: NDC 71335-9690-1: 30 Tablets in a BOTTLE NDC 71335-9690-2: 60 Tablets in a BOTTLE NDC 71335-9690-3: 58 Tablets in a BOTTLE NDC 71335-9690-4: 90 Tablets i…

Source: Labetalol Hydrochloride (Labetalol Hydrochloride) — US FDA prescribing information, 2026-02-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.