Prescription Drug Information: Bisoprolol Fumarate and Hydrochlorothiazide (Page 6 of 6)

Hydrochlorothiazide

Hyperglycemia, glycosuria, hyperuricemia, hypokalemia and other electrolyte imbalances (see PRECAUTIONS), hyperlipidemia, hypercalcemia, leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, and hemolytic anemia have been associated with HCTZ therapy.

OVERDOSAGE

There are limited data on overdose with bisoprolol fumarate and hydrochlorothiazide tablets. However, several cases of overdose with bisoprolol fumarate have been reported (maximum: 2000 mg). Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients recovered.

The most frequently observed signs expected with overdosage of a beta-blocker are bradycardia and hypotension. Lethargy is also common, and with severe overdoses, delirium, coma, convulsions, and respiratory arrest have been reported to occur. Congestive heart failure, bronchospasm, and hypoglycemia may occur, particularly in patients with underlying conditions. With thiazide diuretics, acute intoxication is rare. The most prominent feature of overdose is acute loss of fluid and electrolytes. Signs and symptoms include cardiovascular (tachycardia, hypotension, shock), neuromuscular (weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness), gastrointestinal (nausea, vomiting, thirst), renal (polyuria, oliguria, or anuria [due to hemoconcentration]), and laboratory findings (hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN [especially in patients with renal insufficiency]).

If overdosage of bisoprolol fumarate and hydrochlorothiazide tablets is suspected, therapy with bisoprolol fumarate and hydrochlorothiazide tablets should be discontinued and the patient observed closely. Treatment is symptomatic and supportive; there is no specific antidote. Limited data suggest bisoprolol fumarate is not dialyzable; similarly, there is no indication that hydrochlorothiazide is dialyzable. Suggested general measures include induction of emesis and/or gastric lavage, administration of activated charcoal, respiratory support, correction of fluid and electrolyte imbalance, and treatment of convulsions. Based on the expected pharmacologic actions and recommendations for other beta-blockers and hydrochlorothiazide, the following measures should be considered when clinically warranted:

Bradycardia

Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.

Hypotension, Shock

The patient’s legs should be elevated. IV fluids should be administered and lost electrolytes (potassium, sodium) replaced. Intravenous glucagon may be useful. Vasopressors should be considered.

Heart Block (second or third degree)

Patients should be carefully monitored and treated with isoproterenol infusion or transvenous cardiac pacemaker insertion, as appropriate.

Congestive Heart Failure

Initiate conventional therapy (ie, digitalis, diuretics, vasodilating agents, inotropic agents).

Bronchospasm

Administer a bronchodilator such as isoproterenol and/or aminophylline.

Hypoglycemia

Administer IV glucose.

Surveillance

Fluid and electrolyte balance (especially serum potassium) and renal function should be monitored until normalized.

DOSAGE AND ADMINISTRATION

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

The adverse effects (see WARNINGS) of bisoprolol 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 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 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 2.5-20 mg bisoprolol daily may instead be given bisoprolol fumarate and hydrochlorothiazide tablets. Patients whose blood pressures are adequately controlled with 50 mg of hydrochlorothiazide 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 tablets.

Initial Therapy

Antihypertensive therapy may be initiated with the lowest dose of bisoprolol fumarate and hydrochlorothiazide tablets, 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 tablets 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 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 tablets.

HOW SUPPLIED

Bisoprolol Fumarate and Hydrochlorothiazide — 2.5 mg/6.25 mg Tablets (bisoprolol fumarate 2.5 mg and hydrochlorothiazide 6.25 mg): Yellow, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 47 on the other side, supplied as follows:

Bottle of 100 Tablets NDC 0093-3241-01

Bisoprolol Fumarate and Hydrochlorothiazide — 5 mg/6.25 mg Tablets (bisoprolol fumarate 5 mg and hydrochlorothiazide 6.25 mg): Pink, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 50 on the other side, supplied as follows:

Bottle of 100 Tablets NDC 0093-3242-01

Bisoprolol Fumarate and Hydrochlorothiazide — 10 mg/6.25 mg Tablets (bisoprolol fumarate 10 mg and hydrochlorothiazide 6.25 mg): White, round, film-coated, unscored tablets. Debossed with stylized b within an engraved heart shape on one side and 40 on the other side, supplied as follows:

Bottle of 30 Tablets with child resistant closure NDC 0093-3243-56

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

Dispense in a tight container.

Distributed by:

TEVA PHARMACEUTICALS USA, INC.

Parsippany, NJ 07054

BFHCTZ-003

Rev. 03/2021

Package/Label Display Panel

2.5 6.25 label impage
(click image for full-size original)

NDC 0093-3241-01

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 2.5 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

Package/Label Display Panel

biso HCTZ 5 -- 6.25mg label image
(click image for full-size original)

NDC 0093-3242-01

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 5 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 5 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

Package/Label Display Panel

biso HCTZ 10 -- 6.25mg label image
(click image for full-size original)

NDC 0093-3243-56

Bisoprolol Fumarate and Hydrochlorothiazide Tablets 10 mg/6.25 mg

Rx only 100 Tablets

Teva

Each tablet contains:

Bisoprolol fumarate 10 mg

Hydrochlorothiazide 6.25 mg

DOSAGE: For complete directions for use, see accompanying package brochure.

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 2.5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code b;47
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3241-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 7mm
Flavor Imprint Code b;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3242-01 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
bisoprolol fumarate and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-3243
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
TITANIUM DIOXIDE
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color white Score no score
Shape ROUND Size 7mm
Flavor Imprint Code b;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-3243-56 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020186 08/07/2019
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 04/2021 Teva Pharmaceuticals USA, Inc.

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