propranolol/hydrochlorothiazide (Rx)

Brand and Other Names:Inderide
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Dosing & Uses

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Dosage Forms & Strengths

propranolol/hydrochlorothiazide

tablet

  • 40mg/25mg
  • 80mg/25mg
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Hypertension

Not indicated for initial therapy

Dosage must be determined by individual titration

Usual: propranolol 40 mg/hydrochlorothiazide 25 mg PO q12hr

For total daily propranolol doses >160 mg, combination is not appropriate; use would lead to excessive thiazide dose

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 a period of about 2 weeks

When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure

<18 years: Safety/efficacy not established

Dose reduction may be necessary depending on patient's renal function

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Interactions

Interaction Checker

and propranolol/hydrochlorothiazide

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            Adverse Effects

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

            Frequency Not Defined

            Propranolol

            • Bradyarrhythmia
            • Dyspnea
            • Fatigue
            • Angina
            • Increased AV conduction disturbance
            • Hypotension
            • Insomnia
            • Congestive heart failure
            • Syncope
            • Cardiogenic shock
            • Nausea/vomiting
            • Paresthesia
            • Pruritis
            • Psychotic disorder
            • Hyperlipidemia

            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

            Black Box Warnings

            Beta-blockers may exacerbate ischemic heart disease following abrupt withdrawal

            Hypersensitivity to catecholamines has been observed during withdrawal

            Exacerbation of angina and, in some cases, myocardial infarction occurrence after abrupt discontinuation

            When discontinuing chronically administered beta-blockers (particularly with ischemic heart disease) gradually reduce dose over 1-2 weeks and carefully monitor; if angina markedly worsens or acute coronary insufficiency develops, reinstate beta-blocker administration promptly, at least temporarily (in addition to other measures appropriate for unstable angina)

            Warn patients against interruption or discontinuation of beta-blocker without physician advice

            Because coronary artery disease is common and may be unrecognized, slowly discontinue beta-blocker therapy, even in patients treated only for hypertension

            Contraindications

            Anuria

            Bronchial asthma

            Cardiogenic shock

            CHF, unless secondary to tachyarrhythmia treatable with propranolol

            Heart block 2°/3°

            Hypersensitivity to either component or sulfonamides

            Overt cardiac failure

            Sinus bradycardia, sick sinus syndrome (unless permanent pacemaker in place)

            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

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

            Avoid abrupt withdrawal

            Bronchospastic disease

            Cerebrovascular insufficiency

            CHF, cardiomegaly

            Diabetes mellitus, fluid or electrolyte imbalance, hyperuricemia or gout, SLE

            Hyperthyroidism or thyrotoxicosis, liver disease

            May aggravate digitalis toxicity

            Myasthenic conditions

            Peripheral vascular disease

            Renal impairment

            Risk of male sexual dysfunction

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

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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

            Propranolol hydrochloride/hydrochlorothiazide is a fixed-combination tablet that combines a Beta adrenergic receptor blocker, propranolol hydrochloride, and a thiazide diuretic, hydrochlorothiazide

            Propranolol hydrochloride is a nonselective beta-blocker that reduces chronotropic, inotropic and vasodilator responses to beta-adrenergic stimulation by competing for available binding sites that stimulate the beta-adrenergic receptors. The drug controls hypertension through incompletely understood mechanisms

            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

            Propranolol

            • Half-Life: 1.1-9.9 hr
            • Bioavailability: 30-70%
            • Onset: 1-2 hr (Beta blockade); 2-3 wk (hypertension)
            • Duration: 6 hr
            • Vd: 6 L/kg
            • Peak plasma time: 2 hr
            • Protein bound: 93%
            • Metabolism: Liver (P450 enzyme CYP2D6, first-pass metabolism)
            • Excretion: Urine (40%); feces (55-60%)
            • Dialyzable: No

            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
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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