Metoprolol succinate and hydrochlorothiazide tablet
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION
See full prescribing information for complete Boxed Warning.
Following abrupt discontinuation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction have occurred.
When discontinuing chronically administered DUTOPROL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1–2 weeks and monitor the patient. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily, and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of DUTOPROL therapy even in patients treated only for hypertension [see Warnings and Precautions |
Overview
Metoprolol succinate and hydrochlorothiazide tablet is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- DUTOPROL (metoprolol succinate and hydrochlorothiazide) is a combination tablet of metoprolol succinate, a beta adrenoceptor blocking agent and hydrochlorothiazide, a diuretic. DUTOPROL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide.
- Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
- Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
- Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
- Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
- DUTOPROL may be administered with other antihypertensive agents.
Dosing
Dosing Information
- The recommended starting dose of DUTOPROL (metoprolol succinate extended release and hydrochlorothiazide) is 25 mg/12.5 mg taken orally once daily with or without food. Depending on the blood pressure response, the dose may be titrated at intervals of 2 weeks to a maximum recommended dose of 200 mg/25 mg (two DUTOPROL 100 mg/12.5 mg tablets) once daily.
- For specific advice on blood pressure goals, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Use with and Switching from other Anti-Hypertensive Drugs
- DUTOPROL may be administered with other antihypertensive drugs. Patients titrated to the individual components (metoprolol succinate and hydrochlorothiazide) may instead receive the corresponding dose of DUTOPROL.
- A patient whose blood pressure is inadequately controlled by metoprolol succinate alone or hydrochlorothiazide alone may be switched to DUTOPROL.
DOSAGE FORMS AND STRENGTHS
- 25/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side.
- 50/12.5 mg tablets: Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side.
- 100/12.5 mg tablets: Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Metoprolol succinate and hydrochlorothiazide tablet in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Metoprolol succinate and hydrochlorothiazide tablet in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Metoprolol succinate and hydrochlorothiazide tablet in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Metoprolol succinate and hydrochlorothiazide tablet in pediatric patients.
Contraindications
DUTOPROL is contraindicated in patients with:
- Cardiogenic shock or decompensated heart failure .
- Sinus bradycardia, sick sinus syndrome, and greater than first-degree block unless a permanent pacemaker is in place .
- Anuria
- Hypersensitivity to metoprolol succinate or hydrochlorothiazide or to other sulfonamide-derived drugs.
Warnings
|
WARNING: CARDIAC ISCHEMIA AFTER ABRUPT DISCONTINUATION
See full prescribing information for complete Boxed Warning.
Following abrupt discontinuation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction have occurred.
When discontinuing chronically administered DUTOPROL, particularly in patients with ischemic heart disease, gradually reduce the dose over a period of 1–2 weeks and monitor the patient. If angina markedly worsens or acute coronary insufficiency develops, promptly resume therapy, at least temporarily, and take other measures appropriate for the management of unstable angina. Warn patients against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of DUTOPROL therapy even in patients treated only for hypertension [see Warnings and Precautions |
Cardiac Ischemia after Abrupt Discontinuation
- Following abrupt cessation of therapy with beta adrenergic blockers, exacerbations of angina pectoris and myocardial infarction may occur. When discontinuing chronically administered DUTOPROL, particularly in patients with ischemic heart disease, gradually reduce the dosage over a period of 1–2 weeks and monitor the patient. If angina markedly worsens or acute coronary ischemia develops, promptly resume therapy and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without their physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abrupt discontinuation of DUTOPROL in patients treated only for hypertension.
Heart Failure
- Worsening cardiac failure may occur during up-titration of beta-blockers. If such symptoms occur, increase diuretics and restore clinical stability (compensated heart failure) before advancing the dose of DUTOPROL [see Dosage and Administration (2)]. It may be necessary to lower the dose of DUTOPROL or temporarily discontinue it [see BOXED WARNING.] Such episodes do not preclude subsequent successful titration of DUTOPROL.
Bronchospasm
- Beta adrenergic blockers can cause bronchospasm. Patients with bronchospastic disease should, in general, not receive beta adrenergic blockers. Because of its relative beta1 cardio-selectivity, however, metoprolol-containing products including DUTOPROL may be used in patients with bronchospastic disease who do not respond to or cannot tolerate other antihypertensive treatment. Because beta1-selectivity is not absolute, in such patients use the lowest possible DUTOPROL dose and have bronchodilators (e.g., beta2-agonists) readily available or administer concomitantly.
Bradycardia
- Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Dutoprol. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders (including Wolff-Parkinson-White) may be at increased risk. The concomitant use of beta adrenergic blockers and non-dihydropyridine calcium channel blockers (e.g., verapamil and diltiazem), digoxin or clonidine increases the risk of significant bradycardia. Monitor heart rate and rhythm in patients receiving Dutoprol. If severe bradycardia develops, reduce or stop Dutoprol.
Risks of Use in Major Surgery
- Avoid initiation of high-dose regimen of DUTOPROL in patients with cardiovascular risk factors undergoing non-cardiac surgery, since use in such patients has been associated with bradycardia, hypotension, stroke and death.
- Chronically administered beta adrenergic blockers 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 [see Warnings and Precautions (5.1)].
Masked Signs of Hypoglycemia
- Beta adrenergic blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.
Electrolyte and Metabolic Effects
- DUTOPROL contains hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Monitor serum electrolytesperiodically.
- Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.
- Hydrochlorothiazide reduces clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
- Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels.
Renal Impairment
- Patients with chronic kidney disease, severe heart failure, or volume depletion may be at increased risk for developing acute renal failure on drugs containing hydrochlorothiazide, including DUTOPROL.
Exacerbated Symptoms of Peripheral Vascular Disease
- Beta adrenergic blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
Increased Blood Pressure in Patients with Pheochromocytoma
- Administration of beta adrenergic blockers alone in patients with pheochromocytoma has been associated with a paradoxical increase in blood pressure because of the attenuation of beta-mediated vasodilatation in skeletal muscle. If DUTOPROL is used in patients with pheochromocytoma, first initiate an alpha-blocker.
Thyrotoxicosis after Discontinuation in Patients with Hyperthyroidism
- Beta adrenergic blockers may mask certain clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of a beta adrenergic blocker may precipitate a thyroid storm. Therefore, in patients with hyperthyroidism discontinue DUTOPROL gradually.
Reduced Effectiveness of Epinephrine in Treating Anaphylaxis
- Beta adrenergic blocker- treated patients treated with epinephrine for a severe anaphylactic reaction may be less responsive to the typical doses of epinephrine. In these patients, consider other medications.
Acute Myopia and Secondary Angle-Closure Glaucoma
- Hydrochlorothiazide, a sulfonamide, can cause acute transient myopia and acute angle-closure glaucoma (idiosyncratic reactions). Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of hydrochlorothiazide initiation. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
- Untreated acute angle-closure glaucoma can lead to permanent vision loss. Given that DUTOPROL contains hydrochlorothiazide, if these symptoms occur, discontinue DUTOPROL. Consider prompt medical or surgical treatment if the intraocular pressure remains uncontrolled.
Exacerbation of Systemic Lupus Erythematosus
- Hydrochlorothiazide can exacerbate or activate systemic lupus erythematosus
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Metoprolol succinate and hydrochlorothiazide tablet in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Metoprolol succinate and hydrochlorothiazide tablet in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Metoprolol succinate and hydrochlorothiazide tablet during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in geriatric settings.
Gender
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet with respect to specific gender populations.
Race
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Metoprolol succinate and hydrochlorothiazide tablet in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Metoprolol succinate and hydrochlorothiazide tablet in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Administration in the drug label.
Monitoring
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Metoprolol succinate and hydrochlorothiazide tablet and IV administrations.
Overdosage
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Mechanism of Action in the drug label.
Structure
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Structure in the drug label.
Pharmacodynamics
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Clinical Studies in the drug label.
How Supplied
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet How Supplied in the drug label.
Storage
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Metoprolol succinate and hydrochlorothiazide tablet |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Metoprolol succinate and hydrochlorothiazide tablet |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Metoprolol succinate and hydrochlorothiazide tablet interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Metoprolol succinate and hydrochlorothiazide tablet Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.