Metodura Retard Uses

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What is Metodura Retard?

Metodura Retard is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. A lower blood pressure can reduce the risk of strokes and heart attacks.

Metodura Retard is also used to treat severe chest pain (angina) and lowers the risk of repeated heart attacks. It is given to people who have already had a heart attack. In addition, Metodura Retard is used to treat patients with heart failure.

Metodura Retard is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Metodura Retard is available only with your doctor's prescription.

Metodura Retard indications

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Hypertension

Metodura Retard tartrate tablets, USP are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.

Angina Pectoris

Metodura Retard tartrate tablets, USP are indicated in the long-term treatment of angina pectoris.

Myocardial Infarction

Metodura Retard tartrate tablets, USP are indicated in the treatment of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality when used alone or in conjunction with intravenous Metodura Retard.

Oral Metodura Retard tartrate tablets, USP therapy can be initiated after intravenous Metodura Retard therapy or, alternatively, oral treatment can begin within 3 to 10 days of the acute event.

How should I use Metodura Retard?

Use Metodura Retard tartrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Metodura Retard tartrate.

Uses of Metodura Retard in details

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Use: Labeled Indications

Angina: Long-term treatment of angina pectoris.

Heart failure with reduced ejection fraction (ER oral formulation): Treatment of stable, symptomatic (NYHA class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin to reduce the rate of mortality plus hospitalization in patients already receiving angiotensin-converting enzyme inhibitors, diuretics, and/or digoxin.

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2017]).

Myocardial infarction: Treatment of hemodynamically stable acute myocardial infarction to reduce cardiovascular mortality (injection to be used in combination with Metodura Retard oral maintenance therapy).

Off Label Uses

Atrial fibrillation/flutter

Based on the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for the management of patients with atrial fibrillation (AF), the use of beta-blockers, including Metodura Retard, for ventricular rate control in patients with paroxysmal, persistent, or permanent AF is effective and recommended.

Atrial fibrillation prevention after cardiac surgery

Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for coronary artery bypass graft surgery, beta-blockers are recommended to help prevent postoperative atrial fibrillation.

Hypertrophic cardiomyopathy

Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for the diagnosis and treatment of hypertrophic cardiomyopathy, a beta blocker (eg, Metodura Retard) is an effective and recommended agent for the treatment of symptoms (eg, angina, dyspnea) in patients with obstructive or nonobstructive hypertrophic cardiomyopathy.

Marfan syndrome with aortic aneurysm

Based on the American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery (ACCF/AHA/AATS) guideline for the diagnosis and management of patients with thoracic aortic disease, a beta blocker (eg, Metodura Retard) is an effective and recommended agent to reduce the rate of aortic dilatation in patients with Marfan syndrome and aortic aneurysm, unless a contraindication exists.

Migraine prophylaxis

Data from small, randomized, active-controlled trials support the use of Metodura Retard for prevention of migraines.

Based on evidence-based guidelines for pharmacologic treatment for episodic migraine prevention in adults from the American Academy of Neurology and the American Headache Society, Metodura Retard is effective for migraine prevention in adults.

Supraventricular tachycardia (eg, atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia, focal atrial tachycardia)

Based on the American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) guidelines for the management of adult patients with supraventricular tachycardia, the use of an oral or intravenous beta-blocker, including Metodura Retard, is effective and recommended for a variety of symptomatic supraventricular tachycardias (atrioventricular nodal reentrant tachycardia [AVNRT], atrioventricular reentrant tachycardia [AVRT], focal atrial tachycardia [AT], and multifocal atrial tachycardia [MAT]). In patients without pre-excitation, intravenous Metodura Retard is recommended for acute treatment in hemodynamically stable patients and oral Metodura Retard is recommended for ongoing management of symptomatic supraventricular tachycardias in patients who are not candidates for, or prefer not to undergo, catheter ablation.

Intravenous or oral Metodura Retard may be useful for rate control in the acute treatment or ongoing management of hemodynamically stable patients with atrial flutter.

Thyrotoxicosis

Based on the American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis, beta-blockers, including Metodura Retard, are effective and recommended in the treatment of symptomatic thyrotoxicosis. Beta-blockers should also be considered in asymptomatic patients who are at increased risk of complications due to worsening hyperthyroidism.

Ventricular arrhythmias

Based on the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline for management of patients with ventricular arrhythmias and prevention of sudden cardiac death, beta-blockers are effective for control of ventricular arrhythmias and ventricular premature beats.

Metodura Retard description

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Metodura Retard is a cardioselective β1-adrenergic blocking agent used for acute myocardial infarction (MI), heart failure, angina pectoris and mild to moderate hypertension. It may also be used for supraventricular and tachyarrhythmias and prophylaxis for migraine headaches. Metodura Retard is structurally similar to bisoprolol, acebutolol and atenolol in that it has two substituents in the para position of the benzene ring. The β1-selectivity of these agents is thought to be due in part to the large substituents in the para position. At low doses, Metodura Retard selectively blocks cardiac β1-adrenergic receptors with little activity against β2-adrenergic receptors of the lungs and vascular smooth muscle. Receptor selectivity decreases with higher doses. Unlike propranolol and pindolol, Metodura Retard does not exhibit membrane-stabilizing or intrinsic sympathomimetic activity. Membrane-stabilizing effects are only observed at doses much higher than those needed for β-adrenergic blocking activity. Metodura Retard possesses a single chiral centre and is administered as a racemic mixture.

Metodura Retard dosage

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Metodura Retard Dosage

Generic name: Metodura Retard SUCCINATE 25mg

Dosage form: tablet, extended release

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Metodura Retard is an extended-release tablet intended for once daily administration. For treatment of hypertension and angina, when switching from immediate-release Metodura Retard to Metodura Retard, use the same total daily dose of Metodura Retard. Individualize the dosage of Metodura Retard. Titration may be needed in some patients.

Metodura Retard tablets are scored and can be divided; however, do not crush or chew the whole or half tablet.

Hypertension

Adults: The usual initial dosage is 25 to 100 mg daily in a single dose. The dosage may be increased at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. Dosages above 400 mg per day have not been studied.

Pediatric Hypertensive Patients ≥ 6 Years of age: A pediatric clinical hypertension study in patients 6 to 16 years of age did not meet its primary endpoint (dose response for reduction in SBP); however, some other endpoints demonstrated effectiveness. If selected for treatment, the recommended starting dose of Metodura Retard is 1 mg/kg once daily, but the maximum initial dose should not exceed 50 mg once daily. Dosage should be adjusted according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied in pediatric patients.

Metodura Retard is not recommended in pediatric patients < 6 years of age.

Angina Pectoris

Individualize the dosage of Metodura Retard. The usual initial dosage is 100 mg daily, given in a single dose. Gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is a pronounced slowing of the heart rate. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, reduce the dosage gradually over a period of 1 - 2 weeks.

Heart Failure

Dosage must be individualized and closely monitored during up-titration. Prior to initiation of Metodura Retard, stabilize the dose of other heart failure drug therapy. The recommended starting dose of Metodura Retard is 25 mg once daily for two weeks in patients with NYHA Class II heart failure and 12.5 mg once daily in patients with more severe heart failure. Double the dose every two weeks to the highest dosage level tolerated by the patient or up to 200 mg of Metodura Retard. Initial difficulty with titration should not preclude later attempts to introduce Metodura Retard. If patients experience symptomatic bradycardia, reduce the dose of Metodura Retard. If transient worsening of heart failure occurs, consider treating with increased doses of diuretics, lowering the dose of Metodura Retard or temporarily discontinuing it. The dose of Metodura Retard should not be increased until symptoms of worsening heart failure have been stabilized.

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Metodura Retard interactions

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What other drugs will affect Metodura Retard?

Catecholamine Depleting Drugs

Catecholamine depleting drugs (e.g., reserpine, monoamine oxidase (MAO) inhibitors) may have an additive effect when given with beta-blocking agents. Observe patients treated with Metodura Retard plus a catecholamine depletor for evidence of hypotension or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

CYP2D6 Inhibitors

Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine, and propafenone are likely to increase Metodura Retard concentration. In healthy subjects with CYP2D6 extensive metabolizer phenotype, coadministration of quinidine 100 mg and immediate-release Metodura Retard 200 mg tripled the concentration of S-Metodura Retard and doubled the Metodura Retard elimination half-life. In four patients with cardiovascular disease, coadministration of propafenone 150 mg t.i.d. with immediate-release Metodura Retard 50 mg t.i.d. resulted in two- to five-fold increases in the steady-state concentration of Metodura Retard. These increases in plasma concentration would decrease the cardioselectivity of Metodura Retard.

Digitalis, Clonidine, And Calcium Channel Blockers

Digitalis glycosides, clonidine, diltiazem and verapamil slow atrioventricular conduction and decrease heart rate. Concomitant use with beta blockers can increase the risk of bradycardia.

If clonidine and a beta blocker, such as Metodura Retard are coadministered, withdraw the beta-blocker several days before the gradual withdrawal of clonidine because beta-blockers may exacerbate the rebound hypertension that can follow the withdrawal of clonidine. If replacing clonidine by betablocker therapy, delay the introduction of beta-blockers for several days after clonidine administration has stopped.

Metodura Retard side effects

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What are the possible side effects of Metodura Retard?

The following adverse reactions are described elsewhere in labeling:

Worsening angina or myocardial infarction.
Worsening heart failure.
Worsening AV block.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Hypertension and Angina: Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea, shortness of breath, bradycardia, and rash.

Heart Failure: In the MERIT-HF study comparing Metodura Retard succinate in daily doses up to 200 mg (mean dose 159 mg once-daily; n=1990) to placebo (n=2001), 10.3% of Metodura Retard succinate patients discontinued for adverse events vs. 12.2% of placebo patients.

The table below lists adverse reactions in the MERIT-HF study that occurred at an incidence of ≥ 1% in the Metodura Retard succinate group and greater than placebo by more than 0.5%, regardless of the assessment of causality.

Adverse Reactions Occurring in the MERIT-HF Study at an Incidence ≥ 1% in the Metodura Retard Succinate Group and Greater Than Placebo by More Than 0.5%

Metodura Retard Succinate

n = 1990 % of patients

Placebo

n = 2001 % of patients

Dizziness/vertigo

1.8

1

Bradycardia

1.5

0.4

Post-operative Adverse Events: In a randomized, double-blind, placebo-controlled trial of 8351 patients with or at risk for atherosclerotic disease undergoing non-vascular surgery and who were not taking beta–blocker therapy, Metodura Retard succinate 100 mg was started 2 to 4 hours prior to surgery then continued for 30 days at 200 mg per day. Metodura Retard succinate use was associated with a higher incidence of bradycardia (6.6% vs. 2.4%; HR, 2.74; 95% CI 2.19, 3.43), hypotension (15% vs. 9.7%; HR 1.55; 95% CI 1.37, 1.74), stroke (1% vs. 0.5%; HR 2.17; 95% CI 1.26, 3.74) and death (3.1% vs. 2.3%; HR 1.33; 95% CI 1.03, 1.74) compared to placebo.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of extended-release Metodura Retard or immediate-release Metodura Retard. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Cold extremities, arterial insufficiency (usually of the Raynaud type), palpitations, peripheral edema, syncope, chest pain and hypotension.

Respiratory: Wheezing (bronchospasm), dyspnea.

Central Nervous System: Confusion, short-term memory loss, headache, somnolence, nightmares, insomnia, anxiety/nervousness, hallucinations, paresthesia.

Gastrointestinal: Nausea, dry mouth, constipation, flatulence, heartburn, hepatitis, vomiting.

Hypersensitive Reactions: Pruritus.

Miscellaneous: Musculoskeletal pain, arthralgia, blurred vision, decreased libido, male impotence, tinnitus, reversible alopecia, agranulocytosis, dry eyes, worsening of psoriasis, Peyronie’s disease, sweating, photosensitivity, taste disturbance.

Potential Adverse Reactions: In addition, there are adverse reactions not listed above that have been reported with other beta-adrenergic blocking agents and should be considered potential adverse reactions to Metodura Retard succinate.

Central Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, clouded sensorium, and decreased performance on neuropsychometrics.

Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic purpura.

Hypersensitive Reactions: Laryngospasm, respiratory distress.

Metodura Retard contraindications

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What is the most important information I should know about Metodura Retard?

You should not use this medication if you are allergic to Metodura Retard, or if you have a serious heart problem such as heart block, sick sinus syndrome, or slow heart rate.

Before taking Metodura Retard, tell your doctor if you have congestive heart failure, low blood pressure, circulation problems, pheochromocytoma, asthma or other breathing problems, diabetes, depression, liver or kidney disease, a thyroid disorder, or severe allergies.

Metodura Retard may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Metodura Retard.

Do not stop taking Metodura Retard without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need surgery, tell the surgeon ahead of time that you are using Metodura Retard.

Metodura Retard is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.



Active ingredient matches for Metodura Retard:

Metoprolol in Germany.


Unit description / dosage (Manufacturer)Price, USD
Tablet, Retard; Oral; Metoprolol Tartrate 200 mg
Tablets, Retard; Oral; Metoprolol Tartrate 200 mg

List of Metodura Retard substitutes (brand and generic names):

METOFID 12.5MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd)$ 0.23
METOFID 25MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd)$ 0.45
METOFID 50MG TABLET 1 strip / 10 tablets each (Fidelity Lifesciences Pvt Ltd)$ 0.46
Metofid 25mg Tablet (Fidelity Lifesciences Pvt Ltd)$ 0.05
Metofid 50mg Tablet (Fidelity Lifesciences Pvt Ltd)$ 0.05
Metofin 25mg ER-FC-TAB / 10 (Q Check)$ 0.41
Metofin 50mg ER-FC-TAB / 10 (Q Check)$ 0.60
25 mg x 10's (Q Check)$ 0.41
50 mg x 10's (Q Check)$ 0.60
METOFIN ER tab 25 mg x 10's (Q Check)$ 0.41
METOFIN ER tab 50 mg x 10's (Q Check)$ 0.60
METOGRAF 25MG TABLET 1 strip / 10 tablets each (GRAF Laboratories Pvt Ltd)$ 0.46
METOGRAF 50MG TABLET 1 strip / 10 tablets each (GRAF Laboratories Pvt Ltd)$ 0.76
Metograf 50mg Tablet (GRAF Laboratories Pvt Ltd)$ 0.08
Tablet; Oral; Metoprolol Tartrate 100 mg (Hexal)
Tablet; Oral; Metoprolol Tartrate 50 mg (Hexal)
Tablets; Oral; Metoprolol Tartrate 100 mg (Hexal)
Tablets; Oral; Metoprolol Tartrate 50 mg (Hexal)
MetoHEXAL 100 mg x 50 Tablet (Hexal)
Tablet, Retard; Oral; Metoprolol Tartrate 100 mg
Tablet, Retard; Oral; Metoprolol Tartrate 200 mg
Tablets, Retard; Oral; Metoprolol Tartrate 100 mg
Tablets, Retard; Oral; Metoprolol Tartrate 200 mg
Tablet, Retard; Oral; Metoprolol Tartrate 100 mg
Tablet, Retard; Oral; Metoprolol Tartrate 200 mg
Tablet, Retard; Oral; Metoprolol Tartrate 50 mg
Tablets, Retard; Oral; Metoprolol Tartrate 100 mg
Tablets, Retard; Oral; Metoprolol Tartrate 200 mg
Tablets, Retard; Oral; Metoprolol Tartrate 50 mg
Tablet, Retard; Oral; Metoprolol Tartrate 100 mg
Tablet, Retard; Oral; Metoprolol Tartrate 200 mg
Tablet, Retard; Oral; Metoprolol Tartrate 50 mg
Tablets, Retard; Oral; Metoprolol Tartrate 100 mg
Tablets, Retard; Oral; Metoprolol Tartrate 200 mg

References

  1. DailyMed. "METOPROLOL FUMARATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "metoprolol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "metoprolol". http://www.drugbank.ca/drugs/DB00264 (accessed September 17, 2018).

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