Bisoprolol Fumarate Hydrochlorothiazide (Page 6 of 6)

DOSAGE AND ADMINISTRATION

Bisoprolol fumarate is an effective treatment of hypertension in once-daily doses of 2.5 mg to 40 mg, while hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg. In clinical trials of bisoprolol fumarate/hydrochlorothiazide combination therapy using bisoprolol fumarate doses of 2.5 mg to 20 mg and hydrochlorothiazide doses of 6.25 mg to 25 mg, the antihypertensive effects increased with increasing doses of either component.

The adverse effects (see WARNINGS) of bisoprolol fumarate are a mixture of dose-dependent phenomena (primarily bradycardia, diarrhea, asthenia and fatigue) and dose-independent phenomena (eg, occasional rash); those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (eg, possibly pancreatitis); the dose-dependent phenomena for each being much more common than the dose-independent phenomena. The latter consist of those few that are truly idiosyncratic in nature or those that occur with such low frequency that a dose relationship may be difficult to discern. Therapy with a combination of bisoprolol fumarate and hydrochlorothiazide will be associated with both sets of dose-independent adverse effects, and to minimize these, it may be appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. On the other hand, regimens that combine low doses of bisoprolol fumarate and hydrochlorothiazide should produce minimal dose dependent adverse effects, eg, bradycardia, diarrhea, asthenia and fatigue, and minimal dose-dependent adverse metabolic effects, ie, decreases in serum potassium (see CLINICAL PHARMACOLOGY).

Therapy Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with 2.5 mg to 20 mg bisoprolol fumarate daily may instead be given bisoprolol fumarate and hydrochlorothiazide. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorthiazide daily, but who experience significant potassium loss with this regimen, may achieve similar blood pressure control without electrolyte disturbance if they are switched to bisoprolol fumarate and hydrochlorothiazide.

Initial Therapy

Antihypertensive therapy may be initiated with the lowest dose of bisoprolol fumarate, one 2.5/6.25 mg tablet once daily. Subsequent titration (14 day intervals) may be carried out with bisoprolol fumarate and hydrochlorothiazide tablets up to the maximum recommended dose 20/12.5 mg (two 10/6.25 mg tablets) once daily, as appropriate.

Replacement Therapy

The combination may be substituted for the titrated individual components.

Cessation of Therapy

If withdrawal of bisoprolol fumarate and hydrochlorothiazide therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.

Patients with Renal or Hepatic Impairment: As noted in the WARNINGS section, caution must be used in dosing/titrating patients with hepatic impairment or renal dysfunction. Since there is no indication that hydrochlorothiazide is dialyzable, and limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis.

Geriatric Patients: Dosage adjustment on the basis of age is not usually necessary, unless there is also significant renal or hepatic dysfunction (see above and WARNINGS section).

Pediatric Patients: There is no pediatric experience with bisoprolol fumarate and hydrochlorothiazide.

HOW SUPPLIED

Bisoprolol Fumarate and Hydrochlorothiazide Tablets (film-coated) are supplied as follows:

2.5 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: Yellow, round, biconvex, film-coated tablets debossed WATSON and 841 , in bottles of 100 and 500.

5 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: Pink, round, biconvex, film-coated tablets debossed WATSON and 842 , in bottles of 100 and 500.

10 mg Bisoprolol fumarate/6.25 mg hydrochlorothiazide tablets: White, round, biconvex, film-coated tablets debossed WATSON and 843 , in bottles of 30 and 100.

Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a well-closed container as defined in USP/NF.

Manufactured for:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45215 USA
Revised: July 2003

BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0841
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bisoprolol Fumarate (Bisoprolol) Bisoprolol 2.5 mg
Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 6.25 mg
Inactive Ingredients
Ingredient Name Strength
Collodial silicon dioxide
Dibasic calcium phosphate
Magnesium stearate
Microcrystalline cellulose
Pregelatinized starch
Hypromellose
Lactose monohydrate
Synthetic yellow oxide
Titanium dioxide
Triacetin
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 8mm
Flavor Imprint Code WATSON;841
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0841-01 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE None
2 NDC:0591-0841-05 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE None
BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0842
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bisoprolol Fumarate (Bisoprolol) Bisoprolol 5 mg
Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 6.25 mg
Inactive Ingredients
Ingredient Name Strength
Collodial silicon dioxide
Dibasic calcium phosphate
Magnesium stearate
Microcrystalline cellulose
Pregelatinized starch
Hypromellose
Lactose monohydrate
Synthetic yellow oxide
Titanium dioxide
Triacetin
Purified stearic acid
Synthetic red oxide
Synthetic yellow oxide
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code WATSON;842
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0842-01 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE None
2 NDC:0591-0842-05 500 TABLET, FILM COATED (500 TABLET) in 1 BOTTLE None
BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-0843
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Bisoprolol Fumarate (Bisoprolol) Bisoprolol 10 mg
Hydrochlorothiazide (Hydrochlorothiazide) Hydrochlorothiazide 6.25 mg
Inactive Ingredients
Ingredient Name Strength
Collodial silicon dioxide
Dibasic calcium phosphate
Magnesium stearate
Microcrystalline cellulose
Pregelatinized starch
Polyethylene glycol
Polydextrose
Titanium dioxide
Triacetin
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code WATSON;843
Contains
Coating true Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-0843-30 30 TABLET, FILM COATED (30 TABLET) in 1 BOTTLE None
2 NDC:0591-0843-01 100 TABLET, FILM COATED (100 TABLET) in 1 BOTTLE None
Labeler — Watson Laboratories, Inc.

Revised: 11/2006 Watson Laboratories, Inc.

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