Versant-XR

Versant-XR

felodipine

Manufacturer:

Amherst Lab

Distributor:

UNILAB, Inc

Marketer:

Westmont
Concise Prescribing Info
Contents
Felodipine
Indications/Uses
HTN, either alone or w/ other antihypertensives. Chronic stable angina pectoris, either alone or w/ other antianginals.
Dosage/Direction for Use
Individualized dose. Adult HTN Initially 5 mg once daily. May be decreased to 2.5 mg once daily or increased to 10 mg once daily, or add another antihypertensive. Dose adjustment should occur at intervals of not <2 wk. Maintenance dose: 5-10 mg once daily. Recommended dose range: 2.5-10 mg once daily. Angina pectoris Initially 5 mg once daily. May be increased to 10 mg once daily if needed. Elderly >65 yr HTN Initially 2.5 mg once daily. Angina pectoris Initially 5 mg once daily. Hepatic impairment 2.5 mg once daily.
Administration
May be taken with or without food: Take ER tab in the morning either w/o food or w/ a light meal not rich in fat or carbohydrate. Swallow whole w/ water, do not divide/chew/crush.
Contraindications
Hypersensitivity. History of previous allergic reaction to other dihydropyridine Ca channel blockers. Clinically significant aortic stenosis. Uncompensated heart failure. Acute MI. Unstable angina pectoris. Discontinue use in patients who develop cardiogenic shock. Pregnancy.
Special Precautions
May cause mild gingival hyperplasia. May occasionally precipitate significant hypotension, & rarely, syncope, which may lead to reflex tachycardia which may precipitate angina pectoris in susceptible individuals. Exercise caution in patients w/ heart failure or compromised ventricular function particularly in combination w/ β-blocker. Peripheral edema. Should not be given during pregnancy. Discontinue breastfeeding or discontinue therapy, considering importance of drug to the mother. Caution in dosing for the elderly ≥65 yr. Safety & efficacy in childn have not been established.
Adverse Reactions
Peripheral edema, asthenia, warm sensation, chest pain, edema (facial, ankle), flu-like illness, fatigue, fever; palpitation, MI, hypotension, syncope, angina pectoris, arrhythmia, tachycardia, premature beats; gynecomastia, increased liver enzymes/ALT; nausea, dyspepsia, constipation, abdominal pain, diarrhea, vomiting, dry mouth, flatulence, acid regurgitation, mild gingival hyperplasia, gingivitis; anemia, epistaxis; arthralgia, myalgia, muscle cramps, pain (back, arm, knee, hip, leg, foot), ankle edema; headache, dizziness, paresthesia, insomnia, depression, anxiety disorders, irritability, nervousness, somnolence, decreased libido, impotence, sexual dysfunction; upper resp infection, cough, rhinorrhea, sneezing, dyspnea, pharyngitis, bronchitis, flu, sinusitis, resp infection; flushing, rash, pruritus, contusion, erythema, photosensitivity reactions, leukocytoclastic vasculitis, hypersensitivity reactions (eg, angioedema, urticaria); vision disturbances; urinary frequency/pollakisuria, urinary urgency, dysuria, polyuria.
Drug Interactions
Increased AUC & Cmax of β-blockers (eg, metoprolol). Plasma levels may be increased w/ CYP3A4 inhibitors (eg, ketoconazole, itraconazole, erythromycin, cimetidine). Plasma conc may be decreased w/ anticonvulsants & other enzyme inducers (eg, phenytoin, carbamazepine, phenobarb). May increase tacrolimus blood conc. Increased peak plasma levels & bioavailability w/ grapefruit juice.
MIMS Class
Calcium Antagonists
ATC Classification
C08CA02 - felodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Versant-XR ER tab 10 mg
Packing/Price
100's
Form
Versant-XR ER tab 5 mg
Packing/Price
100's