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

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 (i.e., 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 mg 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 mg 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 (e.g., occasional rash); those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., 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, e.g., bradycardia, diarrhea, asthenia and fatigue, and minimal dose-dependent adverse metabolic effects, i.e., decreases in serum potassium (see CLINICAL PHARMACOLOGY).

Therapy Guided by Clinical Effect

A patient whose blood pressure is not adequately controlled with 2.5 to 20 mg bisoprolol daily may instead be given bisoprolol fumarate and hydrochlorothiazide. 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.

Initial Therapy

Antihypertensive therapy may be initiated with the lowest dose of bisoprolol fumarate and hydrochlorothiazide, 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 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 USP are supplied as

2.5 mg/6.25 mg

Light yellow coloured, biconvex, round, film coated tablets debossed with UL on one side and | on other side.

Bottles of 30: NDC 29300-187-13

Bottles of 100: NDC 29300-187-01

Bottles of 500: NDC 29300-187-05

Bottles of 1000: NDC 29300-187-10

5 mg/6.25 mg

Salmon pink coloured, biconvex, round, film coated tablets debossed with UL on one side and | | on other side.

Bottles of 30: NDC 29300-188-13

Bottles of 100: NDC 29300-188-01

Bottles of 500: NDC 29300-188-05

Bottles of 1000: NDC 29300-188-10

10 mg/6.25 mg

White coloured, biconvex, round, film coated tablets debossed with UL on one side and | | | on other side.

Bottles of 30: NDC 29300-189-13

Bottles of 100: NDC 29300-189-01

Bottles of 500: NDC 29300-189-05

Bottles of 1000: NDC 29300-189-10

Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature].

Dispense in a tight container.

Please address medical inquiries to Unichem’s toll free # 1-866-562-4616.

Manufactured by:

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez,

Goa 403511, India

Manufactured for:

Company Logo
(click image for full-size original)

East Brunswick, NJ 08816

08-R-09/2019

13011522

DRUG: bisoprolol fumarate and hydrochlorothiazide

GENERIC: bisoprolol fumarate and hydrochlorothiazide

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-1947-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: UL;lll

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • BISOPROLOL FUMARATE 10mg in 1
  • HYDROCHLOROTHIAZIDE 6.25mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE
  • SILICON DIOXIDE
  • POLYETHYLENE GLYCOL 6000
  • STARCH, CORN
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • COPOVIDONE
  • HYPROMELLOSE 2910 (5 MPA.S)
  • TITANIUM DIOXIDE
Remedy_Label
(click image for full-size original)
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE bisoprolol fumarate and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1947(NDC:29300-189)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 6.25 mg
BISOPROLOL FUMARATE (BISOPROLOL) BISOPROLOL FUMARATE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
CELLULOSE, MICROCRYSTALLINE
COPOVIDONE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
SILICON DIOXIDE
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code UL;lll
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-1947-0 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079106 03/12/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 11/2019 REMEDYREPACK INC.

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