Fosinopril Sodium and Hydrochlorothiazide (Page 6 of 6)

DOSAGE AND ADMINISTRATION

Fosinopril is an effective treatment of hypertension in once-daily doses of 10 to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 to 50 mg per day. In clinical trials of fosinopril/hydrochlorothiazide combination therapy using fosinopril doses of 2.5 to 40 mg and hydrochlorothiazide doses at 5to 37.5 mg, the antihypertensive effects increased with increasing dose of either component.

The hazards (see WARNINGS) of fosinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of fosinopril and hydrochlorothiazide will be associated with both sets of dose-independent hazards. To minimize dose-independent hazards, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

Dose Titration by Clinical Effect

A patient whose blood pressure is not adequately controlled with fosinopril or hydrochlorothiazide monotherapy may be switched to combination therapy with fosinopril sodium and hydrochlorothiazide tablets. Dosage must be guided by clinical response; controlled clinical trials showed that the addition of 12.5 mg of hydrochlorothiazide to 10 to 20 mg of fosinopril will typically be associated with additional reduction in seated diastolic blood pressure at 24 hours after dosing. On average, the effect of the combination of 10 mg of fosinopril with 12.5 mg of hydrochlorothiazide was similar to the effect seen with monotherapy using either 40 mg of fosinopril or 37.5 mg of hydrochlorothiazide.

Use in Renal Impairment

In patients with severe renal impairment (creatinine clearance is < 30 mL/min/1.73 m2 , serum creatine roughly > 3 mg/dL or 265 µmol/L), loop diuretics are preferred to thiazides, so fosinopril sodium and hydrochlorothiazide tablets are not recommended. In patients with lesser degrees of renal impairment, fosinopril sodium and hydrochlorothiazide tablets may be used with no change in dosage.

HOW SUPPLIED

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg are white, round biconvex tablets debossed with “I” on one side and “3” on the other and are available in:

Bottles of 10 NDC 54868-5346-1
Bottles of 30 NDC 54868-5346-0

Fosinopril Sodium and Hydrochlorothiazide Tablets, 20 mg/12.5 mg are white, round biconvex tablets debossed with “15” on one side and bisect on the other and are available in:

Bottles of 10 NDC 54868-5469-1
Bottles of 30 NDC 54868-5469-0

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture by keeping bottle tightly closed.

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

Manufactured By:

InvaGen Pharmaceuticals, Inc.
Hauppage, NY 11788

Manufactured For:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

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

June 2009

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

20mg/12.5mg Principal Display Panel

20mg/12.5mg Label
(click image for full-size original)

10mg/12.5mg Principal Display Panel

10mg/12.5mg Label
(click image for full-size original)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5346(NDC:68462-554-01)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSPOVIDONE
POVIDONE
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARATE
TALC
Product Characteristics
Color white Score no score
Shape ROUND Size 5mm
Flavor Imprint Code I;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5346-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5346-1 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090228 07/06/2005
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE fosinopril sodium and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5469(NDC:68462-555)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSINOPRIL SODIUM (FOSINOPRILAT) FOSINOPRIL SODIUM 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSPOVIDONE
POVIDONE
CELLULOSE, MICROCRYSTALLINE
SODIUM STEARATE
TALC
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code I5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5469-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5469-1 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090228 11/15/2005
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 12/2009 Physicians Total Care, Inc.

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