Labetalol: Package Insert and Label Information (Page 3 of 3)

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. 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 1,200 mg to 2,400 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 hydrochloride tablets are usually lower in patients also receiving a diuretic.

When transferring patients 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 and 200 mg b.i.d.

HOW SUPPLIED

Labetalol hydrochloride tablets, USP are available as follows:

Labetalol hydrochloride tablets, 100 mg, beige, film coated, round, scored, debossed MP 277
Bottles of 100 NDC 10135-0641-01

Labetalol hydrochloride tablets, 200 mg, white, film coated, round, scored, debossed MP 271
Bottles of 100 NDC 10135-0642-01

Labetalol hydrochloride tablets, 300 mg, blue, film coated, round, unscored, debossed MP 272
Bottles of 100 NDC 10135-0643-01

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

TOXI-LAB is a registered trademark of Varian, Inc.

EMIT and EMIT-d.a.u. are registered trademarks of Siemens Healthcare Diagnostics, Inc.

Manufactured for: Marlex Pharmaceuticals, Inc

New Castle, DE 19720

Distributed by: Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 03/18MP

PRINCIPAL DISPLAY PANEL

NDC 10135-0641-01
Labetalol
Hydrochloride
Tablets, USP
100 mg
Rx Only100 Tablets

NDC 10135-0641-01
Labetalol
Hydrochloride
Tablets, USP
100 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0642-01
Labetalol
Hydrochloride
Tablets, USP
200 mg
Rx Only100 Tablets

NDC 10135-0642-01
Labetalol
Hydrochloride
Tablets, USP
200 mg
Rx Only
100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 10135-0643-01
Labetalol
Hydrochloride
Tablets, USP
300 mg
Rx Only100 Tablets

NDC 10135-0643-01
Labetalol
Hydrochloride
Tablets, USP
300 mg
Rx Only
100 Tablets
(click image for full-size original)
LABETALOL labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-641(NDC:58657-605)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
STARCH, CORN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (beige) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code MP;277
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-641-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 04/01/2018
LABETALOL labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-642(NDC:58657-606)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 200 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
HYPROMELLOSES
MAGNESIUM STEARATE
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code MP;271
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-642-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 04/01/2018
LABETALOL labetalol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10135-643(NDC:58657-607)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LABETALOL (LABETALOL) LABETALOL 300 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CARNAUBA WAX
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POLYSORBATE 80
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code MP;272
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-643-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075215 04/01/2018
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 04/2018 Marlex Pharmaceuticals Inc

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