Plendil retard 5 mg Uses

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What is Plendil retard 5 mg?

Plendil retard 5 mg 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Plendil retard 5 mg is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. Plendil retard 5 mg relaxes blood vessels and increases the supply of blood and oxygen to the heart, which reduces the workload.

Plendil retard 5 mg is available only with your doctor's prescription.

Plendil retard 5 mg indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Plendil retard 5 mg is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Plendil retard 5 mg.

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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Plendil retard 5 mg may be administered with other antihypertensive agents.

How should I use Plendil retard 5 mg?

Use Plendil retard 5 mg 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 Plendil retard 5 mg.

Uses of Plendil retard 5 mg in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Hypertension: Management of hypertension

Off Label Uses

Chronic stable angina

Data from randomized, double-blind, placebo-controlled trials support the use of Plendil retard 5 mg for the management of chronic stable angina, primarily in patients who continue to be symptomatic on an optimal dose of a beta-blocker.

Based on the 2012 American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline for the diagnosis and management of patients with stable ischemic heart disease, a dihydropyridine calcium channel blocker (eg, Plendil retard 5 mg) is an effective and recommended agent in the management of chronic stable angina. A beta-blocker is the preferred initial therapy for chronic stable angina; however, a dihydropyridine calcium channel blocker (eg, Plendil retard 5 mg) may be added if there are ongoing anginal symptoms or may be used as alternative therapy if there are contraindications or unacceptable adverse effects with beta-blockade.

Plendil retard 5 mg description

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Plendil retard 5 mg is a long-acting 1,4-dihydropyridine calcium channel blocker (CCB)b. It acts primarily on vascular smooth muscle cells by stabilizing voltage-gated L-type calcium channels in their inactive conformation. By inhibiting the influx of calcium in smooth muscle cells, Plendil retard 5 mg prevents calcium-dependent myocyte contraction and vasoconstriction. Plendil retard 5 mg is the most potent CCB in use and is unique in that it exhibits fluorescent activity. In addition to binding to L-type calcium channels, Plendil retard 5 mg binds to a number of calcium-binding proteins, exhibits competitive antagonism of the mineralcorticoid receptor, inhibits the activity of calmodulin-dependent cyclic nucleotide phosphodiesterase, and blocks calcium influx through voltage-gated T-type calcium channels. Plendil retard 5 mg is used to treat mild to moderate essential hypertension.

Plendil retard 5 mg dosage

Plendil retard 5 mg Dosage

Generic name: Plendil retard 5 mg 2.5mg

Dosage form: tablet, extended release

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

The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5−10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events. Modification of the recommended dosage is usually not required in patients with renal impairment.

Plendil retard 5 mg should regularly be taken either without food or with a light meal. Plendil retard 5 mg should be swallowed whole and not crushed or chewed.

Geriatric Use – Patients over 65 years of age are likely to develop higher plasma concentrations of Plendil retard 5 mg. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment.

Patients with Impaired Liver Function – Patients with impaired liver function may have elevated plasma concentrations of Plendil retard 5 mg and may respond to lower doses of Plendil retard 5 mg; therefore, patients should have their blood pressure monitored closely during dosage adjustment of Plendil retard 5 mg.

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Plendil retard 5 mg interactions

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What other drugs will affect Plendil retard 5 mg?

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CYP3A4 Inhibitors

Plendil retard 5 mg is metabolized by CYP3A4. Co-administration of CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) with Plendil retard 5 mg may lead to several-fold increases in the plasma levels of Plendil retard 5 mg, either due to an increase in bioavailability or due to a decrease in metabolism. These increases in concentration may lead to increased effects, (lower blood pressure and increased heart rate). These effects have been observed with co-administration of itraconazole (a potent CYP3A4 inhibitor). Caution should be used when CYP3A4 inhibitors are co-administered with Plendil retard 5 mg. A conservative approach to dosing Plendil retard 5 mg should be taken. The following specific interactions have been reported:

Itraconazole

Co-administration of another extended release formulation of Plendil retard 5 mg with itraconazole resulted in approximately 8-fold increase in the AUC, more than 6-fold increase in the Cmax, and 2-fold prolongation in the half-life of Plendil retard 5 mg.

Erythromycin

Co-administration of Plendil retard 5 mg with erythromycin resulted in approximately 2.5-fold increase in the AUC and Cmax, and about 2-fold prolongation in the half-life of Plendil retard 5 mg.

Grapefruit juice

Co-administration of Plendil retard 5 mg with grapefruit juice resulted in more than 2fold increase in the AUC and Cmax, but no prolongation in the half-life of Plendil retard 5 mg.

Cimetidine

Co-administration of Plendil retard 5 mg with cimetidine (a non-specific CYP-450 inhibitor) resulted in an increase of approximately 50% in the AUC and the Cmax, of Plendil retard 5 mg.

Beta-Blocking Agents

A pharmacokinetic study of Plendil retard 5 mg in conjunction with metoprolol demonstrated no significant effects on the pharmacokinetics of Plendil retard 5 mg. The AUC and Cmax of metoprolol, however, were increased approximately 31 and 38%, respectively. In controlled clinical trials, however, beta blockers including metoprolol were concurrently administered with Plendil retard 5 mg and were well tolerated.

Digoxin

When given concomitantly with Plendil retard 5 mg the pharmacokinetics of digoxin in patients with heart failure were not significantly altered.

Anticonvulsants

In a pharmacokinetic study, maximum plasma concentrations of Plendil retard 5 mg were considerably lower in epileptic patients on long-term anticonvulsant therapy (eg, phenytoin, carbamazepine, or phenobarbital) than in healthy volunteers. In such patients, the mean area under the Plendil retard 5 mg plasma concentration-time curve was also reduced to approximately 6% of that observed in healthy volunteers. Since a clinically significant interaction may be anticipated, alternative antihypertensive therapy should be considered in these patients.

Tacrolimus

Plendil retard 5 mg may increase the blood concentration of tacrolimus. When given concomitantly with Plendil retard 5 mg, the tacrolimus blood concentration should be followed and the tacrolimus dose may need to be adjusted.

Other Concomitant Therapy

In healthy subjects there were no clinically significant interactions when Plendil retard 5 mg was given concomitantly with indomethacin or spironolactone.

Interaction with Food

Plendil retard 5 mg side effects

See also:
What are the possible side effects of Plendil retard 5 mg?

In controlled studies in the United States and overseas, approximately 3,000

patients were treated with Plendil retard 5 mg as either the extended-release or the

immediate-release formulation.

The most common clinical adverse events reported with Plendil retard 5 mg extendedrelease

tablets administered as monotherapy at the recommended dosage

range of 2.5 mg to 10 mg once a day were peripheral edema and headache.

Peripheral edema was generally mild, but it was age and dose related and

resulted in discontinuation of therapy in about 3% of the enrolled patients.

Discontinuation of therapy due to any clinical adverse event occurred in

about 6% of the patients receiving Plendil retard 5 mg extended-release tablets,

principally for peripheral edema, headache, or flushing.

Adverse events that occurred with an incidence of 1.5% or greater at any of

the recommended doses of 2.5 mg to 10 mg once a day (Plendil retard 5 mg extendedrelease

tablets, N = 861; Placebo, N = 334), without regard to causality, are

compared to placebo and are listed by dose in the table below. These events are

reported from controlled clinical trials with patients who were randomized to

a fixed dose of Plendil retard 5 mg extended-release tablets or titrated from an initial

dose of 2.5 mg or 5 mg once a day. A dose of 20 mg once a day has been

evaluated in some clinical studies. Although the antihypertensive effect of

Plendil retard 5 mg extended-release tablets is increased at 20 mg once a day,

there is a disproportionate increase in adverse events, especially those

associated with vasodilatory effects.

Adverse events that occurred in 0.5% up to 1.5% of patients who received

Plendil retard 5 mg extended-release tablets in all controlled clinical trials at the

recommended dosage range of 2.5 mg to 10 mg once a day, and serious

adverse events that occurred at a lower rate, or events reported during

marketing experience (those lower rate events are in italics) are listed

below. These events are listed in order of decreasing severity within each

category, and the relationship of these events to administration of Plendil retard 5 mg

extended-release tablets is uncertain:

Body as a Whole: Chest pain, facial edema, flu-like illness

Cardiovascular: Myocardial infarction, hypotension, syncope, angina pectoris,

arrhythmia, tachycardia, premature beats

Digestive: Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid

regurgitation

Endocrine: Gynecomastia

Hematologic: Anemia

Metabolic: ALT (SGPT) increased

Musculoskeletal: Arthralgia, back pain, leg pain, foot pain, muscle cramps,

myalgia, arm pain, knee pain, hip pain

Nervous/Psychiatric: Insomnia, depression, anxiety disorders, irritability,

nervousness, somnolence, decreased libido

Respiratory: Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis,

respiratory infection

Skin: Angioedema, contusion, erythema, urticaria, leukocytoclastic vasculitis

Special Senses: Visual disturbances

Urogenital: Impotence, urinary frequency, urinary urgency, dysuria, polyuria.

Gingival Hyperplasia: Gingival hyperplasia, usually mild, occurred in < 0.5%

of patients in controlled studies. This condition may be avoided or may regress

with improved dental hygiene.

Clinical Laboratory Test Findings

Serum Electrolytes

No significant effects on serum electrolytes were observed during short- and

long-term therapy (see CLINICAL

Pharmacology: Renal/Endocrine

Effects).

Serum Glucose

No significant effects on fasting serum glucose were observed in patients

treated with Plendil retard 5 mg extended-release tablets in the U.S. controlled study.

Liver Enzymes

One of two episodes of elevated serum transaminases decreased once drug

was discontinued in clinical studies; no follow-up was available for the other

patient.

Plendil retard 5 mg contraindications

See also:
What is the most important information I should know about Plendil retard 5 mg?

Hypersensitivity to Plendil retard 5 mg or to any of the excipients of Plendil retard 5 mg.

Plendil retard 5 mg must not be taken by patients with any of the following conditions: Stroke within the last 6 months, cardiovascular shock, valvular heart disease (higher-grade aortic or mitral stenosis), heart muscle disease with narrowing of the cardiac cavity (hypertrophic obstructive cardiomyopathy), unstable angina pectoris, acute myocardial infarction (within the last 8 weeks), higher-grade disturbances of impulse conduction from the atria to the ventricles of the heart (2nd and 3rd degree AV block), congestive heart failure, severe impairment of liver and kidney function [renal insufficiency: glomerular filtration rate (GFR) <30 mL/min; creatinine >1.8 mg/dL], pregnancy.

Use in pregnancy: Plendil retard 5 mg is contraindicated during the entire duration of pregnancy, as animal experiments have demonstrated fetal damage. Pregnancy must be excluded before starting treatment with Plendil retard 5 mg.

Active ingredient matches for Plendil retard 5 mg:

Felodipine in Austria.


List of Plendil retard 5 mg substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet, Sustained Release; Oral; Felodipine 2.5 mg (Sandoz)
200 mg x 10's$ 0.78
400 mg x 10's$ 1.24
50 mg x 5 mL x 30ml$ 0.44
Polo 5 mg x 30's
Polo 10 mg x 30's
Polo 200mg TAB / 10$ 0.78
Polo 400mg TAB / 10$ 1.24
Polo 50mg x 5mL SYR / 30ml$ 0.44
Polo 200mg TAB / 10$ 0.78
Polo 400mg TAB / 10$ 1.24
Polo 50mg x 5mL SYR / 30ml$ 0.44
Polo 0.1% Eye Drop (Yash Pharma Laboratories Pvt Ltd)$ 1.28
Polo NA Tablet (Total Healthcare)$ 0.18
Cream; Topical; Petrolatum 67% (Stiefel)
Tablet, Extended Release; Oral; Felodipine 10 mg (Sanofi Aventis)
Tablet, Extended Release; Oral; Felodipine 2.5 mg (Sanofi Aventis)
Tablet, Extended Release; Oral; Felodipine 5 mg (Sanofi Aventis)
Renedil 2.5mg TAB / 10 (Sanofi Aventis)$ 0.35
Renedil 5mg TAB / 10 (Sanofi Aventis)$ 0.62
Renedil 10mg TAB / 10 (Sanofi Aventis)$ 1.10
2.5 mg x 10's (Sanofi Aventis)$ 0.35
5 mg x 10's (Sanofi Aventis)$ 0.62
10 mg x 10's (Sanofi Aventis)$ 1.10
RENEDIL tab 2.5 mg x 10's (Sanofi Aventis)$ 0.35
RENEDIL tab 5 mg x 10's (Sanofi Aventis)$ 0.62
RENEDIL tab 10 mg x 10's (Sanofi Aventis)$ 1.10
Renedil tablet / extended-release 5 mg (Sanofi Aventis)
Renedil tablet / extended-release 10 mg (Sanofi Aventis)
Renedil tablet / extended-release 2.5 mg (Sanofi Aventis)
RiteMED Felodipine MR tab 5 mg 100's (RiteMED)
Tablet, Extended Release; Oral; Felodipine 10 mg
Tablet, Extended Release; Oral; Felodipine 5 mg
Sandoz Felodipine tablet / extended-release 10 mg (Sandoz Canada Incorporated (Canada))
Sandoz Felodipine tablet / extended-release 5 mg (Sandoz Canada Incorporated (Canada))
Tablet, Extended Release; Oral; Felodipine 10 mg (Astrazeneca)

References

  1. DailyMed. "FELODIPINE: 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. "felodipine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "felodipine". http://www.drugbank.ca/drugs/DB01023 (accessed September 17, 2018).

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