Dosing & Uses
Dosage Forms & Strengths
Not indicated for initial therapy
If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components
Initial dose: Nadolol 40 mg/bendroflumethiazide 5 mg PO qDay
Increase to Nadolol 80 mg/bendroflumethiazide 5 mg PO qDay if needed
Bendroflumethiazide 5 mg in combination product is 30% more bioavailable than that of 5 mg in single entity tablets
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
Use caution in dosing/titrating patients with renal dysfunction
Cumulative effects of thiazides may develop with impaired renal function
CrCl >50 mL/min/1.73 m²: Administer qDay
CrCl 31-50 mL/min/1.73 m²: Administer q24-36 hr
CrCl 10-30 mL/min/1.73 m²: Administer q24-48 hr
CrCl <10 mL/min/1.73 m²: Administer q40-60 hr
Combination may be substituted for the titrated individual components, though conversion from 5 mg bendroflumethiazide in single entity tablets to combination product represents a 30 percent increase in dose of bendroflumethiazide
Withdraw gradually over a period of about 2 weeks
<18 years: Safety/efficacy not established
Dose reduction may be necessary depending on patient's renal function
Serious - Use Alternative
Significant - Monitor Closely
No adverse effects specific to the combination have been observed; adverse effects limited to those previously reported with nadolol and bendroflumethiazide
Frequency Not Defined
- Abdominal discomfort
- Nasal congestion
- Decreased sexual ability
- Anorexia, epigastric distress
- Hypokalemia (common)
- Glucose intolerance
Black Box Warnings
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 wk 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
Heart block 2°/3°
Hypersensitivity to either component or sulfonamides
Overt cardiac failure
Uncompensated cardiac failure
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
CHF, beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure
DM, fluid or electrolyte imbalance, hyperuricemia or gout, hypotension, SLE
May aggravate digitalis toxicity
Peripheral vascular disease
Risk of male sexual dysfunction
Sensitivity reactions may occur with or without history of allergy or asthma
May interfere with phenolsulfonphthalein test; may produce false negatives in phentolamine and tyramine tests
Avoid abrupt withdrawal
Pregnancy & Lactation
Pregnancy Category : C
Lactation: excreted in breast milk, use caution
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.
Mechanism of Action
Nadolol/bendroflumethiazide is a fixed-combination tablet that combines a Beta adrenergic receptor blocker nadolol and a diuretic, bendroflumethiazide
Nadolol blocks beta-1 & beta-2 adrenergic receptors
Bendroflumethiazide, a thiazide diuretic, inhibits Na+ reabsorption in distal renal tubules resulting in increased excrertion of Na+ & water, also K+ & H+ ions
- Half-Life: 10-24 hr; prolonged in renal impairment
- Bioavailability: 30-40%
- Onset: 3-4 hr
- Duration: 17-24 hr
- Vd: 1.9 L/kg
- Protein binding: 30%
- Excretion: Urine
- Peak plasma time: 2-4 hr
- Half-Life: 3-3.9 hr
- Bioavailability: In combination with nadolol increases 30% compared to bendroflumethiazide alone
- Onset: 2 hr (diuresis); 3-4 hr (hypertension)
- Duration: 18-24 hr (diuresis); 7 days (hypertension)
- Peak Plasma Time: 4 hr
- Excretion: Urine
- Dialyzable: No (HD)
Adding plans allows you to compare formulary status to other drugs in the same class.
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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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.