bisoprolol/hydrochlorothiazide (Rx)

Brand and Other Names:Ziac
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

bisoprolol/hydrochlorothiazide

tablet

  • 2.5mg/6.25mg
  • 5mg/6.25mg
  • 10mg/6.25mg
more...

Hypertension

Initial: 2.5 mg/6.25 mg tablet PO qDay

Increase based on clinical response q2 week

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy

Maximum: 20 mg bisoprolol /12.5 mg hydrochlorothiazide PO qDay

Renal Impairment

Use caution in dosing/titrating patients with renal dysfunction

Cumulative effects of thiazides may develop with impaired renal function; dose adjustment may be necessary; azotemia may be precipitated

Hepatic Impairment

Dose adjustment necessary in severe impairment; specific dosing recomendations not studied

Administration

Combination may be substituted for the titrated individual components

Withdraw gradually over about 2 weeks

Dosage adjustment for geriatric patients usually not necessary

Dosage Forms & Strengths

bisoprolol/hydrochlorothiazide

tablet

  • 2.5mg/6.25mg
  • 5mg/6.25mg
  • 10mg/6.25mg
more...

Hypertension (Off-label)

Initial: 2.5 mg/6.25 mg tablet PO qDay

Increase based on clinical response q2 week

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy

Maximum: 10 mg bisoprolol /6.25 mg hydrochlorothiazide PO qDay

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Interactions

Interaction Checker

and bisoprolol/hydrochlorothiazide

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            No adverse effects specific to the combination have been observed; adverse effects limited to those previously reported with bisoprolol fumarate and hydrochlorothiazide

            1-10%

            Bisoprolol fumarate

            • Arthralgia (2-3%)
            • Chest pain (1-2%)
            • Diarrhea (3%)
            • Dyspnea (1-2%)
            • Fatigue (6-8%)
            • Hypoaesthesia (1-2%)
            • Insomnia (2-3%)
            • Nausea/vomiting (2%)
            • Rhinitis (3-4%)
            • Sinusitis (2%)
            • Upper respiratory infection (5%)
            • Weakness (≤2%)

            <1%

            Acne

            Angioedema

            Abdominal pain

            Alopecia

            Bronchospasm

            Cutaneous

            Dermatitis

            Depression

            Edema

            Flushing

            Gout

            Impotence

            Psoriasis

            Tinnitus

            Tremor

            Xerostomia

            Vertigo

            Somnolence

            Rash

            Pharyngitis

            Hyperkalemia

            Hyperglycemia

            Hyperphosphatemia

            Frequency Not Defined

            Hydrochlorothiazide

            • Anorexia
            • Epigastric distress
            • Hypotension
            • Orthostatic hypotension
            • Photosensitivity
            • Anaphylaxis
            • Anemia
            • Confusion
            • Erythema multiforme
            • Stevens-Johnson syndrome
            • Exfoliative dermatitis including toxic epidermal necrolysis
            • Hypomagnesemia
            • Dizziness
            • Headache
            • Hyperuricemia
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            Warnings

            Contraindications

            Anuria

            Cardiogenic shock

            Heart block 2°/3°

            Hypersensitivity to either component or sulfonamide derivatives

            Overt cardiac failure

            Marked sinus bradycardia

            Cautions

            Anesthesia/surgery (myocardial depression): chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

            Bronchospastic disease

            Cerebrovascular insufficiency

            CHF, cardiomegaly

            DM, fluid or electrolyte imbalance, hyperuricemia or gout, SLE

            Hyperthyroidism or thyrotoxicosis

            Liver disease

            May aggravate digitalis toxicity

            Peripheral vascular disease

            Renal impairment

            Risk of male sexual dysfunction

            Sensitivity reactions may occur with or without history of allergy or asthma

            Acute transient myopia and acute angle-closure glaucoma has been reported, particularly with history of sulfonamide or penicillin allergy (hydrochlorothiazide is a sulfonamide)

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excreted in breast milk, use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Bisoprolol fumarate/hydrochlorothiazide is a fixed-combination tablet that combines a Beta adrenergic receptor blocker, bisoprolol fumarate, and a thiazide diuretic, hydrochlorothiazide

            Bisoprolol fumarate, a cardioselective inhibitor of beta(1)-adrenoceptor, has no significant intrinsic sympathomimetic activity or membrane stabilizing activity in its therapeutic dosage; exhibits beta(2)-adrenoceptors inhibition and negative chronotropic effect

            Hydrochlorothiazide is a thiazide diuretic that inhibits Na reabsorption in distal renal tubules resulting in increased excretion of Na+ and water, also K+ and H+ ions

            Pharmacokinetics

            Bisoprolol

            • Half-Life: 9-12 hr (normal renal function); 27-36 hr (CrCl <40mL/min); 8-22 hr (hepatic cirrhosis)
            • Bioavailability: 80%
            • Peak plasma time: 2-4 hr
            • Onset: 1-2 hr
            • Protein bound: 30%
            • Excretion: Urine (50%); feces (<2%)
            • Metabolism: Liver, not metabolized by P450 CYP2D6; about 20% first-pass metabolism  

            Hydrochlorothiazide

            • Half-Life: 6-15 hr
            • Bioavailability: 70%
            • Onset: 2 hr (diuresis); 4-6 hr (peak effect)
            • Duration: 6-12 hr (diuresis); 1 wk (HTN)
            • Vd: 3.6-7.8 L/kg
            • Peak Plasma:1.5-2.5 hr
            • Protein Bound: 68%
            • Metabolism: Minimally metabolized
            • Clearance: 335 mL/min
            • Excretion: Urine 50-70%
            • Dialyzable: No
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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