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 non thrombocytopenic purpura.

Gastrointestinal: Mesenteric artery thrombosis; ischemic colitis.

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

Clinical Laboratory Tests

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

OVERDOSAGE

Overdosage with labetalol hydrochloride 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 hydrochloride 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 pharmacological 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 mg to 10 mg rapidly over 30 seconds, followed by continuous infusion of 5 mg/hr that can be reduced as the patient improves).

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

The oral LD50 value of labetalol hydrochloride in the mouse is approximately 600 mg/kg and in the rat is greater than 2 g/kg. The intravenous LD50 in these species is 50 mg/kg 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 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 1to 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 mg to 2400 mg per day, with or without thiazide diuretics. Should side effects (principally nausea or dizziness) occur with these doses administered b.i.d.(twice daily), the same total daily dose administered t.i.d. (three times daily) may improve tolerability and facilitate further titration. Titration increments should not exceed 200 mg b.i.d.(twice daily).

When a diuretic is added, an additive antihypertensive effect can be expected. In some cases this may necessitate a labetalol hydrochloride tablet dosage adjustment. As with most antihypertensive drugs, optimal dosages of labetalol hydrochloride tablets are usually lower in patients also receiving a diuretic. When transferring a patient from other antihypertensive drugs, labetalol hydrochloride 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 mg and 200 mg b.i.d.

HOW SUPPLIED

Labetalol Hydrochloride Tablets USP for oral administration are available as:

Labetalol Hydrochloride Tablets USP, 100 mg are yellow colored, round, biconvex, film-coated tablets debossed with “7” and “98” on either side of score line on one side and plain on other side and are supplied as:

NDC 68382-798-06 in bottle of 30 tablets

NDC 68382-798-16 in bottle of 90 tablets

NDC 68382-798-01 in bottle of 100 tablets

NDC 68382-798-05 in bottle of 500 tablets

Labetalol Hydrochloride Tablets USP, 200 mg are white to off white colored, round, biconvex, film-coated tablets debossed with “7” and “99” on either side of score line on one side and plain on other side and are supplied as:

NDC 68382-799-06 in bottle of 30 tablets

NDC 68382-799-16 in bottle of 90 tablets

NDC 68382-799-01 in bottle of 100 tablets

NDC 68382-799-05 in bottle of 500 tablets

Labetalol Hydrochloride Tablets USP, 300 mg are light green colored, round, biconvex, beveled edge, film-coated tablets debossed with “800” on one side and plain on other side and are supplied as:

NDC 68382-800-06 in bottle of 30 tablets

NDC 68382-800-16 in bottle of 90 tablets

NDC 68382-800-01 in bottle of 100 tablets

NDC 68382-800-05 in bottle of 500 tablets

Labetalol Hydrochloride Tablets USP should be Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure as required.

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This product’s package insert may have been updated. For current package insert, please visit www.zydususa.com

Manufactured by:

Cadila Healthcare Ltd.

Matoda, Ahmedabad, India

Distributed by:

Zydus Pharmaceuticals USA Inc.

Pennington, NJ 08534

Rev.: 05/17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-798-05

Labetalol hydrochloride tablets, 100 mg

Rx only

500 tablets

Zydus

Labetalol  hydrochloride tablets
(click image for full-size original)

NDC 68382-799-05

Labetalol hydrochloride tablets, 200 mg

Rx only

500 tablets

Zydus

Labetalol  hydrochloride tablets
(click image for full-size original)

NDC 68382-800-05

Labetalol hydrochloride tablets, 300 mg

Rx only

500 tablets

Zydus

Labetalol  hydrochloride tablets
(click image for full-size original)
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-798
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape ROUND (BICONVEX) Size 8mm
Flavor Imprint Code 7;98
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-798-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-798-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-798-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-798-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-799
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (OFF-WHITE) Score 2 pieces
Shape ROUND (BICONVEX) Size 11mm
Flavor Imprint Code 7;99
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-799-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-799-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-799-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-799-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
LABETALOL HYDROCHLORIDE labetalol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-800
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
FD&C BLUE NO. 1–ALUMINUM LAKE
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color GREEN (LIGHT GREEN) Score no score
Shape ROUND (BICONVEX) Size 11mm
Flavor Imprint Code 800
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-800-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68382-800-16 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68382-800-01 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68382-800-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207743 12/05/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (68382-798), ANALYSIS (68382-799), ANALYSIS (68382-800), MANUFACTURE (68382-798), MANUFACTURE (68382-799), MANUFACTURE (68382-800)

Revised: 12/2020 Zydus Pharmaceuticals (USA) Inc.

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