Dutoprol
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Side Effects & Adverse Reactions
Ischemic Heart Disease: Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. 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 reinstate DUTOPROL, and take measures appropriate for the management of unstable angina. Warn patients not to interrupt therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, avoid abruptly discontinuing DUTOPROL in patients treated only for hypertension.
Bronchospastic Disease: PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta1 cardio-selectivity, however, metoprolol succinate extended release/hydrochlorothiazide 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, use the lowest possible dose of DUTOPROL. Bronchodilators, including beta2—agonists, should be readily available or administered concomitantly (see DOSAGE AND ADMINISTRATION).
Pheochromocytoma: If DUTOPROL is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.
Major Surgery: Avoid initiation of high-dose regimen of extended— release metoprolol in patients undergoing non-cardiac surgery, since such use in patients with cardiovascular risk factors has been associated with bradycardia, hypotension, stroke and death.
Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and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.
Diabetes and Hypoglycemia: Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. (See PRECAUTIONS, General, Hydrochlorothiazide).
Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism, such as tachycardia. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta—blockade, which might precipitate a thyroid storm.
Peripheral Vascular Disease: Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease.
Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomitantly.
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Other Information
DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) combines a beta1-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 C7H8ClN3O4S2 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.
Sources
Dutoprol Manufacturers
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Astrazeneca Lp
![Dutoprol (Metoprolol Succinate And Hydrochlorothiazide) Tablet, Film Coated [Astrazeneca Lp]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dutoprol | Astrazeneca Lp
Dosing must be individualized considering baseline and target blood pressure as well as experience with individual agents.
The side effects (see WARNINGS) 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.
Replacement TherapyDUTOPROL may be substituted for treatment with individual components.
Dose Titration by Clinical EffectUse the dose necessary based on patient response once the need for combination product is established. Response rates are greater at higher doses.
Patients with insufficient blood pressure effects with metoprolol succinate extended release or hydrochlorothiazide alone may be switched to DUTOPROL.
The lowest DUTOPROL tablet available is 25/12.5 mg. A 50/6.25 mg dose can be achieved by splitting the 100/12.5 mg tablet. Subsequently titration may be carried out every 2 weeks up to a maximum of 200/25 mg (two DUTOPROL 100/12.5 mg tablets).
Patients with Renal ImpairmentThe usual regimens of therapy with DUTOPROL may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so DUTOPROL is not recommended.
Patients with Hepatic ImpairmentThe usual regimens of therapy with DUTOPROL may be followed in patients with mild hepatic impairment. In patients with moderate hepatic impairment, consideration should be given to initiation of DUTOPROL with lower doses of hydrochlorothiazide.
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Astrazeneca Pharmaceuticals Lp
Dutoprol | Astrazeneca Pharmaceuticals Lp
Dosing must be individualized considering baseline and target blood pressure as well as experience with individual agents.
The side effects (see WARNINGS) 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.
Replacement TherapyDUTOPROL may be substituted for treatment with individual components.
Dose Titration by Clinical EffectUse the dose necessary based on patient response once the need for combination product is established. Response rates are greater at higher doses.
Patients with insufficient blood pressure effects with metoprolol succinate extended release or hydrochlorothiazide alone may be switched to DUTOPROL.
The lowest DUTOPROL tablet available is 25/12.5 mg. A 50/6.25 mg dose can be achieved by splitting the 100/12.5 mg tablet. Subsequently titration may be carried out every 2 weeks up to a maximum of 200/25 mg (two DUTOPROL 100/12.5 mg tablets).
Patients with Renal ImpairmentThe usual regimens of therapy with DUTOPROL may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so DUTOPROL is not recommended.
Patients with Hepatic ImpairmentThe usual regimens of therapy with DUTOPROL may be followed in patients with mild hepatic impairment. In patients with moderate hepatic impairment, consideration should be given to initiation of DUTOPROL with lower doses of hydrochlorothiazide.
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Covis Pharmaceuticals Inc
Dutoprol | Par Pharmaceutical, Inc.
2.1 Timing of AdministrationEntecavir should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
2.2 Recommended Dosage in Adults Compensated Liver DiseaseThe recommended dose of entecavir for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.
The recommended dose of entecavir in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
Decompensated Liver DiseaseThe recommended dose of entecavir for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.
2.3 Recommended Dosage in Pediatric PatientsTable 1 describes the recommended dose of entecavir for pediatric patients 2 years of age or older and weighing at least 10 kg. The oral solution should be used for patients with body weight up to 30 kg.
Table 1: Dosing Schedule for Pediatric Patients Recommended Once-Daily Dose of Oral Solution (mL) Body Weight (kg) Treatment-Naïve
Patientsa Lamivudine-Experienced
Patientsb a Children with body weight greater than 30 kg should receive 10 mL (0.5 mg) of oral solution or one 0.5 mg tablet once daily.
b Children with body weight greater than 30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg tablet once daily.10 to 11
3
6
greater than 11 to 14
4
8
greater than 14 to 17
5
10
greater than 17 to 20
6
12
greater than 20 to 23
7
14
greater than 23 to 26
8
16
greater than 26 to 30
9
18
greater than 30
10
20
2.4 Renal ImpairmentIn adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred.
Table 2: Recommended Dosage of Entecavir in Adult Patients with Renal Impairment Creatinine Clearance
(mL/min) Usual Dose (0.5 mg) Lamivudine-Refractory or
Decompensated Liver Disease
(1 mg) a For doses less than 0.5 mg, oral solution is recommended.
b If administered on a hemodialysis day, administer the dose after the hemodialysis session.50 or greater
0.5 mg once daily
1 mg once daily
30 to less than 50
0.25 mg once dailya
OR
0.5 mg every 48 hours0.5 mg once daily
OR
1 mg every 48 hours10 to less than 30
0.15 mg once dailya
OR
0.5 mg every 72 hours0.3 mg once dailya
OR
1 mg every 72 hoursLess than 10
Hemodialysisb or CAPD0.05 mg once dailya
OR
0.5 mg every 7 days0.1 mg once dailya
OR
1 mg every 7 daysAlthough there are insufficient data to recommend a specific dose adjustment of entecavir in pediatric patients with renal impairment, a reduction in the dose or an increase in the dosing interval similar to adjustments for adults should be considered.
2.5 Hepatic ImpairmentNo dosage adjustment is necessary for patients with hepatic impairment.
2.6 Duration of TherapyThe optimal duration of treatment with entecavir for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.
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Concordia Pharmaceuticals Inc
Dutoprol | Concordia Pharmaceuticals Inc
2.1 Dosing InformationThe 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 [see Clinical Studies (14)].
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).
2.2 Use with and Switching from other Anti-Hypertensive DrugsDUTOPROL 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.
![Dutoprol (Metoprolol Succinate And Hydrochlorothiazide) Tablet, Film Coated [Astrazeneca Pharmaceuticals Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=23ab5537-5d5b-41d6-618c-974930319a48&name=ddea171e-59a4-41af-aebc-f7cb995127e6-03.jpg)
![Dutoprol (Metoprolol Succinate And Hydrochlorothiazide) Tablet [Covis Pharmaceuticals Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=92b37df9-4602-442f-b8ef-32744f5f412b&name=entecavir-tab-car-0pt5mg.jpg)
![Dutoprol (Metoprolol Succinate And Hydrochlorothiazide) Tablet [Concordia Pharmaceuticals Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=69ffe86d-7993-482d-b1bb-04287bdd6aa9&name=image-03.jpg)
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