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Related to Trandate: Normodyne

labetalol hydrochloride


Pharmacologic class: Beta-adrenergic blocker (nonselective), alpha-adrenergic blocker (selective)

Therapeutic class: Antihypertensive

Pregnancy risk category C


Blocks stimulation of beta1- and beta2-adrenergic receptor sites and alpha1-adrenergic receptors, decreasing myocardial contractile force and enhancing coronary artery blood flow and myocardial perfusion. Net effect is decreased heart rate and blood pressure.


Injection: 5 mg/ml

Tablets: 100 mg, 200 mg, 300 mg

Indications and dosages


Adults: Initially, 100 mg P.O. b.i.d., alone or combined with a diuretic; may increase by 100 mg b.i.d. q 2 to 3 days as needed. Usual range is 400 to 800 mg/day in two divided doses; up to 2.4 g/day have been given.

Hypertensive crisis

Adults: Initially, 20 mg I.V. bolus over 2 minutes, then I.V. injection of 40 to 80 mg q 10 minutes until blood pressure falls to desired level; maximum dosage is 300 mg. Alternatively, 50 to 200 mg by continuous I.V. infusion at 2 mg/minute; continue infusion until desired blood pressure is reached. Follow I.V. dosing with P.O. dosing.

Conversion from I.V. to P.O. dosing

Hospitalized adults: Discontinue I.V. therapy when desired blood pressure is reached; start P.O. dosing when supine diastolic pressure begins to rise. Initial P.O. dosage is 200 mg, followed 6 to 12 hours later with additional dose of 200 to 400 mg P.O., depending on blood pressure response. Then titrate at 1-day intervals to dosage ranging from 400 to 2,400 mg/day P.O. in two or three divided doses.

Dosage adjustment

• Chronic hepatic disease
• Elderly patients

Off-label uses

• Hypertension secondary to pheochromocytoma or clonidine withdrawal


• Hypersensitivity to drug
• Bronchospastic disease
• Overt heart failure, cardiogenic shock
• Second- or third-degree atrioventricular block
• Severe bradycardia
• Conditions associated with severe and prolonged hypotension


Use cautiously in:
• hepatic impairment, pulmonary disease, diabetes mellitus, hyperthyroidism, thyrotoxicosis
• elderly patients
• pregnant or breastfeeding patients
• children.


• Know that drug may be given as I.V. bolus or continuous infusion.
• Be aware that drug may be given undiluted for I.V. bolus injection. For continuous infusion, dilute in dextrose 5% in water or normal saline solution, and deliver with infusion control pump.
• Don't mix with 5% sodium bicarbonate injection.
• Give direct I.V. injection over 2 minutes at 10-minute intervals.

Adverse reactions

CNS: fatigue, asthenia, anxiety, depression, dizziness, paresthesia, drowsiness, insomnia, memory loss, nightmares, mental status changes

CV: orthostatic hypotension, peripheral vasoconstriction, bradycardia, arrhythmias, heart failure

EENT: blurred vision, dry eyes, nasal congestion

GI: nausea, diarrhea, constipation

GU: erectile dysfunction, decreased libido

Hematologic: purpura, agranulocytosis, thrombocytopenia

Metabolic: hyperglycemia, hypoglycemia

Musculoskeletal: joint pain, back pain, muscle cramps

Respiratory: wheezing, bronchospasm, pulmonary edema

Skin: rash, pruritus


Drug-drug.Adrenergic bronchodilators, theophylline: decreased efficacy of these drugs

Antihypertensives, nitrates: additive hypotension

Cimetidine, propranolol: increased labetalol effects

Digoxin: additive bradycardia

Dobutamine, dopamine: reduced beneficial cardiovascular effects of these drugs

General anesthetics, verapamil: additive myocardial depression

Insulin, oral hypoglycemics: altered hypoglycemic efficacy

MAO inhibitors: hypertension

Nonsteroidal anti-inflammatory drugs: decreased antihypertensive action

Drug-diagnostic tests.Alanine aminotransferase, alkaline phosphatase, antinuclear antibodies, aspartate aminotransferase, blood urea nitrogen, glucose, liver function tests, low-density lipoproteins, potassium, triglycerides, uric acid: increased values

Patient monitoring

• Monitor ECG and vital signs, especially blood pressure.
• Assess cardiovascular, respiratory, and neurologic status closely to detect adverse reactions.
• Monitor CBC, blood glucose level, and liver function tests.

Patient teaching

Instruct patient to immediately report adverse reactions, such as easy bruising or bleeding or respiratory problems.
• Tell patient he may feel dizzy when starting therapy, especially if he's also taking a diuretic.
• Advise patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness from sudden blood pressure decrease.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, vision, and alertness.
• Emphasize need for follow-up care and regular blood pressure monitoring.

Caution patient not to stop taking drug abruptly, because this may cause myocardial infarction or worsen angina.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.


A trademark for the drug labetalol hydrochloride.


a trademark for an antihypertensive drug (labetalol hydrochloride).


Labetalol, see there.


A brand name for the beta-blocker drug LABETALOL.
References in periodicals archive ?
NYSE: PRX) today announced that its operating subsidiary, Par Formulations Private Limited, (formerly Edict Pharmaceuticals Private Limited), received its first USFDA approval for Labetalol HCl Tablets 100 mg, 200 mg & 300 mg, the generic version of Trandate.
Trandate is used in the treatment of hypertension, while Zyloprim is approved for the treatment of high levels of uric acid.
These included; Trandate (an alpha/beta blocker for treating high blood pressure); Micanol (for treating psoriasis); Crystacide (for treating skin infections); and our own developments, the Spacehaler range (for the treatment of asthma) and Bettamousse (a novel steroid formulation for the scalp).