Trandolapril and Verapamil Hydrochloride (Page 8 of 8)

Cardiac Failures

Inotropic agents (e.g., isoproterenol, dopamine, dobutamine), diuretics. Asystole should be handled by the usual measures including cardiopulmonary resuscitation.

Trandolapril Component

The oral LD50 of trandolapril in mice was 4875 mg/kg in males and 3990 mg/kg in females. In rats, an oral dose of 5000 mg/kg caused low mortality (1 male out of 5; 0 females). In dogs, an oral dose of 1000 mg/kg did not cause mortality and abnormal clinical signs were not observed.

In humans, the most likely clinical manifestation would be symptoms attributable to severe hypotension. Laboratory determinations of serum levels of trandolapril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of trandolapril overdose. No data are available to suggest that physiological maneuvers (e.g., maneuvers to change pH of the urine) might accelerate elimination of trandolapril and its metabolites. It is not known if trandolapril or trandolaprilat can be usefully removed from the body by hemodialysis.

Angiotensin II could presumably serve as a specific antagonist antidote in the setting of trandolapril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of trandolapril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat trandolapril overdose by infusion of normal saline solution.

DOSAGE AND ADMINISTRATION

The recommended usual dosage range of trandolapril for hypertension is 1 to 4 mg per day administered in a single dose or two divided doses. The recommended usual dosage range of verapamil hydrochloride sustained-release tablets for hypertension is 120 to 480 mg per day administered in a single dose or two divided doses.

The hazards (see WARNINGS) of trandolapril are generally independent of dose; those of verapamil are a mixture of dose-dependent phenomena (primarily dizziness, AV block, constipation) and dose-independent phenomena, the former much more common than the latter. Therapy with any combination of trandolapril and verapamil will thus be associated with both sets of dose-independent hazards. The dose-dependent side effects of verapamil have not been shown to be decreased by the addition of trandolapril nor vice versa.

Rarely, the dose-independent hazards of trandolapril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with trandolapril and verapamil hydrochloride extended-release tablets only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy at its respective maximally recommended dose and shortest dosing interval, or (b) the dose of one or the other monotherapy cannot be increased further because of dose-limiting side effects.

Clinical trials with trandolapril and verapamil hydrochloride extended-release tablets have explored only once-a-day doses. The antihypertensive effect and or adverse effects of adding 4 mg of trandolapril once-a-day to a dose of 240 mg verapamil hydrochloride sustained-release tablets administered twice-a-day has not been studied, nor have the effects of adding as little of 180 mg verapamil hydrochloride sustained-release tablets to 2 mg trandolapril administered twice-a-day been evaluated. Over the dose range of verapamil hydrochloride sustained-release tablets 120 to 240 mg once-a-day and trandolapril 0.5 to 8 mg once-a-day, the effects of the combination increase with increasing doses of either component.

Replacement Therapy

For convenience, patients receiving trandolapril (up to 8 mg) and verapamil (up to 240 mg) in separate tablets, administered once-a-day, may instead wish to receive trandolapril and verapamil hydrochloride extended-release tablets containing the same component doses.

Trandolapril and verapamil hydrochloride extended-release tablets should be administered with food.

HOW SUPPLIED

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 1 mg/240 mg are supplied as white to pinkish white colored, oval, biconvex, film-coated tablets with ‘294’ debossed on one side and plain on the other side containing 1 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form.

NDC 68462-294-90 — bottles of 90


NDC 68462-294-01 — bottles of 100


NDC 68462-294-10 — bottles of 1000

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 2 mg/180 mg are supplied as pink colored, oval, biconvex, film-coated tablets with ‘295’ debossed on one side and plain on the other side containing 2 mg trandolapril, USP in an immediate-release form and 180 mg verapamil hydrochloride, USP in an extended-release form.

NDC 68462-295-90 — bottles of 90


NDC 68462-295-01 — bottles of 100


NDC 68462-295-10 — bottles of 1000

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 2 mg/240 mg are supplied as cream colored, oval, biconvex, film-coated tablets with ‘296’ debossed on one side and plain on the other side containing 2 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form.

NDC 68462-296-90 — bottles of 90


NDC 68462-296-01 — bottles of 100


NDC 68462-296-10 — bottles of 1000

Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, 4 mg/240 mg are supplied as brown colored, oval, biconvex, film-coated tablets with ‘G38’ debossed on one side and plain on the other side containing 4 mg trandolapril, USP in an immediate-release form and 240 mg verapamil hydrochloride, USP in an extended-release form.

NDC 68462-329-01 — bottles of 100


NDC 68462-329-10 — bottles of 1000

Dispense in well-closed container with safety closure.

Storage:

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Manufactured by:

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403513, India

Manufactured for:
logo
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com

September 2019

Principle Display Panel — 1 mg/240 mg

Label1mg-240mg100s
(click image for full-size original)

Principle Display Panel — 2 mg/180 mg

Label2mg-180mg100s
(click image for full-size original)

Principle Display Panel — 2 mg/240 mg

Label2mg-240mg100s
(click image for full-size original)

Principle Display Panel — 4 mg/240 mg

Label4mg-240mg100s
(click image for full-size original)
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE trandolapril and verapamil hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-329
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANDOLAPRIL (TRANDOLAPRILAT) TRANDOLAPRIL 4 mg
VERAPAMIL HYDROCHLORIDE (VERAPAMIL) VERAPAMIL HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN Score no score
Shape OVAL Size 19mm
Flavor Imprint Code G38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-329-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-329-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079135 02/25/2015
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE trandolapril and verapamil hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-295
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANDOLAPRIL (TRANDOLAPRILAT) TRANDOLAPRIL 2 mg
VERAPAMIL HYDROCHLORIDE (VERAPAMIL) VERAPAMIL HYDROCHLORIDE 180 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FD&C BLUE NO. 2
Product Characteristics
Color PINK Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 295
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-295-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-295-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68462-295-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079135 02/25/2015
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE trandolapril and verapamil hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-296
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANDOLAPRIL (TRANDOLAPRILAT) TRANDOLAPRIL 2 mg
VERAPAMIL HYDROCHLORIDE (VERAPAMIL) VERAPAMIL HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (Cream) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 296
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-296-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-296-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68462-296-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079135 02/25/2015
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE trandolapril and verapamil hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-294
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRANDOLAPRIL (TRANDOLAPRILAT) TRANDOLAPRIL 1 mg
VERAPAMIL HYDROCHLORIDE (VERAPAMIL) VERAPAMIL HYDROCHLORIDE 240 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
POVIDONE, UNSPECIFIED
SODIUM ALGINATE
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color WHITE (to pinkish white) Score no score
Shape OVAL (biconvex) Size 19mm
Flavor Imprint Code 294
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-294-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:68462-294-10 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:68462-294-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079135 02/25/2015
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-329), ANALYSIS (68462-295), ANALYSIS (68462-296), ANALYSIS (68462-294), MANUFACTURE (68462-329), MANUFACTURE (68462-295), MANUFACTURE (68462-296), MANUFACTURE (68462-294)

Revised: 09/2019 Glenmark Pharmaceuticals Inc., USA

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