LABETALOL HYDROCHLORIDE (Page 4 of 4)

Potential Adverse Effects

In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.

Central Nervous System: Reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on psychometrics.

Cardiovascular: Intensification of A-V block (see CONTRAINDICATIONS).

Allergic: Fever combined with aching and sore throat, laryngospasm, respiratory distress.

Hematologic: Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.

Gastrointestinal: Mesenteric artery thrombosis, ischemic colitis.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.

Clinical Laboratory Tests

There have been reversible increases of serum transaminases in 4% of patients treated with labetalol HCl and tested and, more rarely, reversible increases in blood urea.

OVERDOSAGE

Overdosage with labetalol HCl causes excessive hypotension that is posture sensitive and, sometimes, excessive bradycardia. Patients should be placed supine and their legs raised if necessary to improve the blood supply to the brain. If overdosage with labetalol HCl follows oral ingestion, gastric lavage or pharmacologically induced emesis (using syrup of ipecac) may be useful for removal of the drug shortly after ingestion. The following additional measures should be employed if necessary: Excessive bradycardia —administer atropine or epinephrine. Cardiac failure —administer a digitalis glycoside and a diuretic. Dopamine or dobutamine may also be useful. Hypotension —administer vasopressors, e.g., norepinephrine. There is pharmacologic evidence that norepinephrine may be the drug of choice. Bronchospasm —administer epinephrine and/or an aerosolized beta2 -agonist. Seizures —administer diazepam.

In severe beta-blocker overdose resulting in hypotension and/or bradycardia, glucagon has been shown to be effective when administered in large doses (5 to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg per hour that can be reduced as the patient improves).

Neither hemodialysis nor peritoneal dialysis removes a significant amount of labetalol HCl from the general circulation (<1%).

The oral LD50 value of labetalol HCl in the mouse is approximately 600 mg/kg and in the rat > than 2 g/kg. The IV LD50 in these species is 50 to 60 mg/kg.

DOSAGE AND ADMINISTRATION

DOSAGE MUST BE INDIVIDUALIZED. The recommended initial dose 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. every 2 or 3 days. The usual maintenance dosage of labetalol HCl is between 200 and 400 mg twice daily.

Since the full antihypertensive effect of labetalol HCl 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. The antihypertensive effects of continued dosing can be measured at subsequent visits, approximately 12 hours after a dose, to determine whether further titration is necessary.

Patients with severe hypertension may require from 1200 to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered twice daily, the same total daily dose administered three times daily may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg twice daily.

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol HCl dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol HCl tablets are usually lower in patients also receiving a diuretic.

When transferring patients from other antihypertensive drugs, labetalol HCl tablets should be introduced as recommended and the dosage of the existing therapy progressively decreased.

Elderly Patients: As in the general patient population, labetalol therapy may be initiated at 100 mg twice daily and titrated upwards in increments of 100 mg b.i.d. as required for control of blood pressure. Since some elderly patients eliminate labetalol more slowly, however, adequate control of blood pressure may be achieved at a lower maintenance dosage compared to the general population. The majority of elderly patients will require between 100 and 200 mg b.i.d.

HOW SUPPLIED

Labetalol HCl Tablets USP, 100 mg are available as round, beige, film-coated tablets debossed with WATSON 605 on one side and scored on the other side. They are supplied in bottles of 100, 500, 1000.

Labetalol HCl Tablets USP, 200 mg are available as round, white, film-coated tablets debossed with WATSON 606 on one side and scored on the other side. They are supplied in bottles of 100, 500, 1000.

Labetalol HCl Tablets USP, 300 mg are available as round, blue, film-coated tablets debossed with WATSON 607 on one side and plain on the other side. They are supplied in bottles of 100, 500, 1000.

Labetalol HCl Tablets USP should be stored between 2°-30°C (36°-86°F).

Dispense in a tight, light resistant container as defined in USP/NF.

Manufactured By:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA
Distributed By:
Watson Pharma, Inc.
Corona, CA 92880 USA

Revised: July 2008 0708B 2000623

PACKAGE LABEL — LABETALOL 300 MG TABLET

Label Image
(click image for full-size original)

LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-994(NDC:0591-0607)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 300 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
COLLOIDAL SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, PREGELATINIZED CORN
WATER
TITANIUM DIOXIDE
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color blue Score no score
Shape ROUND Size 11mm
Flavor Imprint Code WATSON;607
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-994-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:16590-994-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:16590-994-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075133 08/03/1998
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 09/2011 STAT RX USA LLC

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