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Dutoprol
Overview
What is Dutoprol?
DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) combines a beta-selective (cardioselective) adrenoceptor blocking agent and a diuretic, hydrochlorothiazide.
Metoprolol succinate is chemically described as (±)1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt). Its structural formula is:
Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2-propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS and its structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
DUTOPROL is available for oral administration in 3 tablet strengths of metoprolol succinate extended release and hydrochlorothiazide.
DUTOPROL 25/12.5 contains 23.75 mg of metoprolol succinate extended release equivalent to 25 mg of metoprolol tartrate and 12.5 mg of hydrochlorothiazide. DUTOPROL 50/12.5 contains 47.5 mg of metoprolol succinate extended release equivalent to 50 mg of metoprolol tartrate and 12.5 mg of hydrochlorothiazide. DUTOPROL 100/12.5 contains 95 mg of metoprolol succinate extended release equivalent to 100 mg of metoprolol tartrate and 12.5 mg of hydrochlorothiazide. The inactive ingredients of the tablets are silicon dioxide, ethylcellulose, hydroxypropyl cellulose, cornstarch, microcrystalline cellulose, polyvinyl pyrrolidone, sodium stearyl fumarate, hydroxypropyl methylcellulose, polyethylene glycol 6000, titanium dioxide, iron oxide (yellow), iron oxide (red) and paraffin.
What does Dutoprol look like?
What are the available doses of Dutoprol?
Sorry No records found.
What should I talk to my health care provider before I take Dutoprol?
Sorry No records found
How should I use Dutoprol?
Dosing must be individualized considering baseline and target blood pressure as well as experience with individual agents.
The side effects (see ) of metoprolol succinate extended release are a mixture of dose-dependent phenomena (primarily bradycardia and fatigue); those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of metoprolol succinate extended release and hydrochlorothiazide will be associated with both sets of dose independent side effects. To minimize the known dose-related tolerability and safety-related effects of the individual agents, consideration should be given to initiating treatment at less than their maximum doses.
DUTOPROL may be administered with other antihypertensive agents.
DUTOPROL may be administered with or without food.
DUTOPROL is administered once daily.
Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily.
Patients usually do not require doses in excess of 50 mg hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.
The usual initial dose of metoprolol succinate extended release is 25 to 100 mg daily in a single dose.
Metoprolol succinate extended release doses greater than 400 mg have not been studied.
What interacts with Dutoprol?
Metoprolol succinate extended release/hydrochlorothiazide is contraindicated in patients in cardiogenic shock, overt cardiac failure (see ), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
What are the warnings of Dutoprol?
Metoprolol succinate extended release
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Ischemic Heart Disease:
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What are the precautions of Dutoprol?
General
Metoprolol succinate extended release/hydrochlorothiazide
Metoprolol succinate extended release
Worsening cardiac failure may occur during up-titration of beta blockers. If such symptoms occur, diuretics should be increased and the dose of beta-blocking agent should not be advanced until clinical stability is restored. It may be necessary to lower the dose of DUTOPROL or temporarily discontinue it. (See .) Such episodes do not preclude subsequent successful titration of DUTOPROL.
Hydrochlorothiazide
Anaphylactic Reactions
While taking beta-blockers, patients with a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated challenge and may be unresponsive to the usual doses of epinephrine used to treat an allergic reaction.
Information for Patients
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Drug Interactions
Metoprolol
Hydrochlorothiazide
Carcinogenesis, Mutagenesis, Impairment of Fertility
Metoprolol/Hydrochlorothiazide
Metoprolol
Hydrochlorothiazide
Pregnancy
Pregnancy Category C
Metoprolol/Hydrochlorothiazide
Oral administration of metoprolol tartrate/hydrochlorothiazide combinations to pregnant rats during organogenesis at doses up to 200/50 mg/kg/day (10 and 20 times the MRHD for metoprolol and hydrochlorothiazide, respectively) or to pregnant rabbits at doses up to 25/6.25 mg/kg/day (about 2.5 and 5 times the MRHD for metoprolol and hydrochlorothiazide, respectively) produced no teratogenic effects. A 200/50 mg/kg/day metoprolol tartrate/hydrochlorothiazide combination administered to rats from mid-late gestation through lactation produced increased post-implantation loss and decreased neonatal survival.
Metoprolol
Metoprolol tartrate has been shown to increased post-implantation loss and decreased neonatal survival in rats at doses up to 22 times, on a mg/m basis, the daily dose of 200 mg in a 60-kg patient. Distribution studies in mice confirm exposure of the fetus when metoprolol tartrate is administered to the pregnant animal. These studies have revealed no evidence of impaired fertility or teratoenicity. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, use this drug during pregnancy only if clearly needed.
Hydrochlorothiazide
Hydrochlorothiazide administered to pregnant mice and rats during organogenesis at doses up to 3000 and 1000 mg/kg/day (600 and 400 times the MRHD), respectively, produced no harm to the fetus. Thiazides cross the placental barrier and appear in the cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, pancreatitis, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.
Nursing Mothers
Metoprolol is excreted in breast milk in very small quantities. An infant consuming 1 liter of breast milk daily would receive a dose of less than 1 mg of the drug. Thiazides appear in human milk. Consider possible infant exposure when DUTOPROL is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
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What are the side effects of Dutoprol?
Metoprolol succinate extended release/hydrochlorothiazide
The metoprolol succinate extended release and hydrochlorothiazide combination was evaluated for safety in 891 patients treated for hypertension in clinical trials. In a placebo-controlled trial, 843 patients were treated with various combinations of metoprolol succinate (doses of 25 to 200 mg) and hydrochlorothiazide (doses of 6.25 to 25 mg). Overall, the incidence of adverse experiences reported with the combination was comparable to placebo. Adverse events, whether or not attributed to treatment, occurring in greater than 1% of patients treated with DUTOPROL and at a rate equal to or greater than with placebo were: nasopharyngitis (3.4% vs 1.3%), fatigue (2.6% vs 0.7%), dizziness (2.6% vs 2.6%), back pain (1.7% vs 1.3%), and nausea (1.4% vs 0.7%). Adverse experiences were usually mild and transient in nature and infrequently required discontinuation of therapy (2.7% vs 2.6% with placebo).
Metoprolol
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Potential Adverse Reactions
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Post-Marketing Experience
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Hydrochlorothiazide
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LABORATORY TEST FINDINGS
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Creatinine, Blood Urea Nitrogen
Serum Electrolytes
Glucose
Lipids
Liver Function Tests
What should I look out for while using Dutoprol?
Metoprolol succinate extended release/hydrochlorothiazide is contraindicated in patients in cardiogenic shock, overt cardiac failure (see ), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.
What might happen if I take too much Dutoprol?
How should I store and handle Dutoprol?
Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Avoid excessive or vigorous agitation. . An unused vial of ACTIMMUNE can be stored at room temperature up to 12 hours prior to use. Discard vials if not used within the 12 hour period. Do not return to the refrigerator.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.DUTOPROL 25/12.5 (NDC 0310-1087-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 30.DUTOPROL 50/12.5 (NDC 0310-1095-30)Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 30.DUTOPROL 100/12.5 (NDC 0310-1097-30)Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 30.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Metoprolol succinate extended release/hydrochlorothiazide is contraindicated in patients in cardiogenic shock, overt cardiac failure (see ), second or third degree AV block, marked sinus bradycardia, anuria, and hypersensitivity to either component of this product or to other sulfonamide-derived drugs.Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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