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Felodipine
Overview
What is PLENDIL?
PLENDIL (felodipine) is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its empirical formula is CHClNO and its structural formula is:
Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture.
Tablets PLENDIL provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: Tablets PLENDIL 2.5 mg — hydroxypropyl cellulose, lactose, FD&C Blue 2, sodium stearyl fumarate, titanium dioxide, yellow iron oxide, and other ingredients. Tablets PLENDIL 5 mg and 10 mg — cellulose, red and yellow oxide, lactose, polyethylene glycol, sodium stearyl fumarate, titanium dioxide, and other ingredients.
What does PLENDIL look like?
What are the available doses of PLENDIL?
Sorry No records found.
What should I talk to my health care provider before I take PLENDIL?
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How should I use PLENDIL?
PLENDIL 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 felodipine.
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 may be administered with other antihypertensive agents.
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 (see ). Modification of the recommended dosage is usually not required in patients with renal impairment.
PLENDIL should regularly be taken either without food or with a light meal (see ). PLENDIL should be swallowed whole and not crushed or chewed.
Geriatric Use
Patients with Impaired Liver Function
What interacts with PLENDIL?
PLENDIL is contraindicated in patients who are hypersensitive to this product.
What are the warnings of PLENDIL?
Sorry No Records found
What are the precautions of PLENDIL?
General
Hypotension
Heart Failure
Patients with Impaired Liver Function
Peripheral Edema
Information for Patients
Patients should be instructed to take PLENDIL whole and not to crush or chew the tablets. They should be told that mild gingival hyperplasia (gum swelling) has been reported. Good dental hygiene decreases its incidence and severity.
NOTE: As with many other drugs, certain advice to patients being treated with PLENDIL is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Drug Interactions
CYP3A4 Inhibitors
Itraconazole
Erythromycin
Grapefruit juice
Cimetidine
Beta-Blocking Agents
Digoxin
Anticonvulsants
Tacrolimus
Other Concomitant Therapy
Interaction with Food
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year carcinogenicity study in rats fed felodipine at doses of 7.7, 23.1 or 69.3 mg/kg/day (up to 61 times the maximum recommended human dose on a mg/m basis), a dose-related increase in the incidence of benign interstitial cell tumors of the testes (Leydig cell tumors) was observed in treated male rats. These tumors were not observed in a similar study in mice at doses up to 138.6 mg/kg/day (61 times the maximum recommended human dose on a mg/m basis). Felodipine, at the doses employed in the 2-year rat study, has been shown to lower testicular testosterone and to produce a corresponding increase in serum luteinizing hormone in rats. The Leydig cell tumor development is possibly secondary to these hormonal effects which have not been observed in man.
In this same rat study a dose-related increase in the incidence of focal squamous cell hyperplasia compared to control was observed in the esophageal groove of male and female rats in all dose groups. No other drug-related esophageal or gastric pathology was observed in the rats or with chronic administration in mice and dogs. The latter species, like man, has no anatomical structure comparable to the esophageal groove.
Felodipine was not carcinogenic when fed to mice at doses up to 138.6 mg/kg/day (61 times the maximum recommended human dose on a mg/m basis) for periods of up to 80 weeks in males and 99 weeks in females.
Felodipine did not display any mutagenic activity in the Ames microbial mutagenicity test or in the mouse lymphoma forward mutation assay. No clastogenic potential was seen in the mouse micronucleus test at oral doses up to 2500 mg/kg (1100 times the maximum recommended human dose on a mg/m basis) or in a human lymphocyte chromosome aberration assay.
A fertility study in which male and female rats were administered doses of 3.8, 9.6 or 26.9 mg/kg/day (up to 24 times the maximum recommended human dose on a mg/mbasis) showed no significant effect of felodipine on reproductive performance.
Pregnancy:
Pregnancy Category C.
Teratogenic Effects
In a teratology study in cynomolgus monkeys, no reduction in the size of the terminal phalanges was observed, but an abnormal position of the distal phalanges was noted in about 40% of the fetuses.
Array
Significant enlargement of the mammary glands, in excess of the normal enlargement for pregnant rabbits, was found with doses greater than or equal to 1.2 mg/kg/day (2.1 times the maximum human dose on a mg/m basis). This effect occurred only in pregnant rabbits and regressed during lactation.
Similar changes in the mammary glands were not observed in rats or monkeys.
There are no adequate and well-controlled studies in pregnant women. If felodipine is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus, possible digital anomalies of the infant, and the potential effects of felodipine on labor and delivery and on the mammary glands of pregnant females.
Nursing Mothers
It is not known whether this drug is secreted in human milk and because of the potential for serious adverse reactions from felodipine in the infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use:
Clinical studies of felodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Pharmacokinetics, however, indicate that the availability of felodipine is increased in older patients (see , Geriatric Use). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
What are the side effects of PLENDIL?
In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.
The most common clinical adverse events reported with PLENDIL 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, 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, 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 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 is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see ).
Adverse events that occurred in 0.5 up to 1.5% of patients who received PLENDIL 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 is uncertain: Chest pain, facial edema, flu-like illness; , , tachycardia, premature beats; Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation; Gynecomastia; ; ALT (SGPT) increased; Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain; Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido; Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection; contusion, erythema, urticaria; Visual disturbances; Impotence, urinary frequency, urinary urgency, dysuria, polyuria.
Gingival Hyperplasia –
| Body as a Whole | ||||
| Peripheral Edema | 3.3 (0.0) | 2.0 (0.0) | 8.8 (2.2) | 17.4 (2.5) |
| Asthenia | 3.3 (0.0) | 3.9 (0.0) | 3.3 (0.0) | 2.2 (0.0) |
| Warm Sensation | 0.0 (0.0) | 0.0 (0.0) | 0.9 (0.2) | 1.5 (0.0) |
| Cardiovascular | ||||
| Palpitation | 2.4 (0.0) | 0.4 (0.0) | 1.4 (0.3) | 2.5 (0.5) |
| Digestive | ||||
| Nausea | 1.5 (0.9) | 1.2 (0.0) | 1.7 (0.3) | 1.0 (0.7) |
| Dyspepsia | 1.2 (0.0) | 3.9 (0.0) | 0.7 (0.0) | 0.5 (0.0) |
| Constipation | 0.9 (0.0) | 1.2 (0.0) | 0.3 (0.0) | 1.5 (0.2) |
| Headache | 10.2 (0.9) | 10.6 (0.4) | 11.0 (1.7) | 14.7 (2.0) |
| Dizziness | 2.7 (0.3) | 2.7 (0.0) | 3.6 (0.5) | 3.7 (0.5) |
| Paresthesia | 1.5 (0.3) | 1.6 (0.0) | 1.2 (0.0) | 1.2 (0.2) |
| Respiratory | ||||
| Upper Respiratory Infection | 1.8 (0.0) | 3.9 (0.0) | 1.9 (0.0) | 0.7 (0.0) |
| Cough | 0.3 (0.0) | 0.8 (0.0) | 1.2 (0.0) | 1.7 (0.0) |
| Rhinorrhea | 0.0 (0.0) | 1.6 (0.0) | 0.2 (0.0) | 0.2 (0.0) |
| Sneezing | 0.0 (0.0) | 1.6 (0.0) | 0.0 (0.0) | 0.0 (0.0) |
| Skin | ||||
| Rash | 0.9 (0.0) | 2.0 (0.0) | 0.2 (0.0) | 0.2 (0.0) |
| Flushing | 0.9 (0.3) | 3.9 (0.0) | 5.3 (0.7) | 6.9 (1.2) |
Clinical Laboratory Test Findings
Serum Electrolytes
Serum Glucose
Liver Enzymes
What should I look out for while using PLENDIL?
PLENDIL is contraindicated in patients who are hypersensitive to this product.
What might happen if I take too much PLENDIL?
Oral doses of 240 mg/kg and 264 mg/kg in male and female mice, respectively, and 2390 mg/kg and 2250 mg/kg in male and female rats, respectively, caused significant lethality.
In a suicide attempt, one patient took 150 mg felodipine together with 15 tablets each of atenolol and spironolactone and 20 tablets of nitrazepam. The patient's blood pressure and heart rate were normal on admission to hospital; he subsequently recovered without significant sequelae.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly bradycardia.
If severe hypotension occurs, symptomatic treatment should be instituted. The patient should be placed supine with the legs elevated. The administration of intravenous fluids may be useful to treat hypotension due to overdosage with calcium antagonists. In case of accompanying bradycardia, atropine (0.5−1 mg) should be administered intravenously. Sympathomimetic drugs may also be given if the physician feels they are warranted.
It has not been established whether felodipine can be removed from the circulation by hemodialysis.
To obtain up-to-date information about the treatment of overdose, consult your Regional Poison-Control Center. Telephone numbers of certified poison-control centers are listed in the . In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and unusual drug kinetics in your patient.
How should I store and handle PLENDIL?
Store between 2°C and 25°C (36°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product. Product: 63629-1596NDC: 63629-1596-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 63629-1596-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 63629-1596NDC: 63629-1596-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 63629-1596-2 90 TABLET, EXTENDED RELEASE in a BOTTLEProduct: 63629-1596NDC: 63629-1596-1 30 TABLET, EXTENDED RELEASE in a BOTTLENDC: 63629-1596-2 90 TABLET, EXTENDED RELEASE in a BOTTLE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Felodipine is a member of the dihydropyridine class of calcium channel antagonists (calcium channel blockers). It reversibly competes with nitrendipine and/or other calcium channel blockers for dihydropyridine binding sites, blocks voltage-dependent Cacurrents in vascular smooth muscle and cultured rabbit atrial cells, and blocks potassium-induced contracture of the rat portal vein.
In vitro
in vitro
The effect of felodipine on blood pressure is principally a consequence of a dose-related decrease of peripheral vascular resistance in man, with a modest reflex increase in heart rate (see ). With the exception of a mild diuretic effect seen in several animal species and man, the effects of felodipine are accounted for by its effects on peripheral vascular resistance.
Non-Clinical Toxicology
PLENDIL is contraindicated in patients who are hypersensitive to this product.CYP3A4 Inhibitors
Itraconazole
Erythromycin
Grapefruit juice
Cimetidine
Beta-Blocking Agents
Digoxin
Anticonvulsants
Tacrolimus
Other Concomitant Therapy
Interaction with Food
Hypotension
Heart Failure
Patients with Impaired Liver Function
Peripheral Edema
In controlled studies in the United States and overseas, approximately 3000 patients were treated with felodipine as either the extended-release or the immediate-release formulation.
The most common clinical adverse events reported with PLENDIL 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, 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, 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 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 is increased at 20 mg once a day, there is a disproportionate increase in adverse events, especially those associated with vasodilatory effects (see ).
Adverse events that occurred in 0.5 up to 1.5% of patients who received PLENDIL 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 is uncertain: Chest pain, facial edema, flu-like illness; , , tachycardia, premature beats; Abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation; Gynecomastia; ; ALT (SGPT) increased; Arthralgia, back pain, leg pain, foot pain, muscle cramps, myalgia, arm pain, knee pain, hip pain; Insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido; Dyspnea, pharyngitis, bronchitis, influenza, sinusitis, epistaxis, respiratory infection; contusion, erythema, urticaria; Visual disturbances; Impotence, urinary frequency, urinary urgency, dysuria, polyuria.
Gingival Hyperplasia –
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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