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Dilatrend

Dilatrend

carvedilol

Manufacturer:

Delpharm

Distributor:

Distriphil

Marketer:

Distriphil
Concise Prescribing Info
Contents
Carvedilol
Indications/Uses
6.25-mg tab: HTN & angina pectoris. Adjunct to standard therapy in symptomatic heart failure. 25-mg tab: Essential (non-organically induced) high BP.
Dosage/Direction for Use
HTN Initially 12.5 mg once daily for the 1st 2 days. Thereafter, 25 mg once daily. May subsequently be increased at intervals of at least 2 wk to max daily dose of 50 mg once daily or bid. CHD Initially 12.5 mg bid for the 1st 2 days. Thereafter, 25 mg bid. May be increased at intervals of at least 2 wk, up to max daily dose of 100 mg in divided doses (bid). CHF Initially 3.125 mg bid for 2 wk. May be increased thereafter at intervals not <2 wk to 6.25 mg, 12.5 mg & 25 mg bid. Doses should be increased to the highest level tolerated by the patient. Patient w/ severe CHF & mild to moderate CHF weighing <85 kg Max: 25 mg bid. Patient w/ mild or moderate CHF weighing >85 kg Max: 50 mg bid. Left ventricular dysfunction following acute MI Individualized dosage. Prior to initiating carvedilol: Stable patients should receive ACE inhibitor for at least 48 hr at a stable dose during at least the preceding 24 hr. Start carvedilol between day 3 & 21 after MI. 1st dose: Initially 6.25 mg w/ close supervision for at least 3 hr after. Subsequent doses: If 1st dose is tolerated, may be increased to 6.25 mg bid & maintained for 3-10 days. May be reduced to 3.125 mg bid if signs of intolerance develops. If well tolerated, should be increased again to 6.25 mg bid after 3-10 days. Subsequent up-titration: If 6.25 mg dose bid is well tolerated, should be increased at intervals of 3-10 days to 12.5 mg bid & then to 25 mg bid. Maintenance: Max dose tolerated by the patient. Max: 25 mg bid (irrespective of patient's wt).
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Unstable/decompensated heart failure, clinically manifest liver dysfunction. 2nd & 3rd degree AV block (unless a permanent pacemaker is in place), severe bradycardia (<50 bpm), sick sinus syndrome (including SA block), severe hypotension (systolic BP <85 mmHg), cardiogenic shock, history of bronchospasm or asthma.
Special Precautions
Chronic CHF; Prinzmetal's variant angina; COPD; DM; peripheral vascular disease (eg, Raynaud's phenomenon); pheochromocytoma; history of serious hypersensitivity reactions & undergoing desensitization therapy; history of psoriasis associated w/ β-blocker therapy. Reversible deterioration of renal function in CHF patients w/ low BP (systolic BP <100 mmHg), ischemic heart disease & diffuse vascular disease &/or underlying renal insufficiency. Patient w/ left ventricular dysfunction following acute MI must be clinically stable & received an ACE inhibitor for at least the preceding 48 hr & ACE inhibitor dose should have been stable for at least the preceding 24 hr. May induced bradycardia; masked signs of hypoglycemia; obscure thyrotoxicosis symptoms. Discontinue use permanently if toxic epidermal necrolysis & Stevens-Johnson syndrome occur. Reduced lacrimation in contact lenses wearers. Avoid abrupt w/drawal, particularly in ischemic heart disease patients. Concomitant use w/ digitalis glycosides; digoxin, cyclosporin, rifampicin, anesth & antiarrhythmic drugs. May impair ability to drive, operate machinery or work w/o firm support. Renal impairment. Not to be used during pregnancy. Not recommended during lactation. Childn & adolescent (<18 yr).
Adverse Reactions
Cardiac failure; asthenia (fatigue); dizziness, headache; hypotension. Anemia; bradycardia, hypervolemia, fluid overload; visual impairment, decreased lacrimation (dry eye), eye irritation; nausea, diarrhea, vomiting, dyspepsia, abdominal pain; edema, pain; pneumonia, bronchitis, upper resp tract infection, UTI; wt increase, hypercholesterolemia, impaired blood glucose control (hyperglycemia, hypoglycemia) in patients w/ preexisting diabetes; pain in extremities; syncope, presyncope; depression, depressed mood; renal failure & renal function abnormalities in patients w/ diffuse vascular disease &/or underlying renal insufficiency; dyspnea, pulmonary edema, asthma in predisposed patients; orthostatic hypotension, disturbances of peripheral circulation (cold extremities, peripheral vascular disease, exacerbation of intermittent claudication & Raynaud's phenomenon), HTN.
Drug Interactions
May increase bioavailability of drugs transported by P-glycoprotein. Modified bioavailability w/ P-glycoprotein inducers or inhibitors. May increase exposure of digoxin & cyclosporin. Increased conc w/ amiodarone. Decreased exposure & effect w/ rifampicin. Inhibited metabolism w/ fluoxetine & paroxetine. May enhance blood-sugar-reducing effect of insulin & oral hypoglycemics. Signs of hypotension &/or severe bradycardia w/ catecholamine-depleting agents (eg, reserpine & MAOIs). Additive prolongation of AV conduction time w/ digoxin. May increase risk of AV conduction disturbances w/ non-dihydropyridines Ca channel blockers (verapamil or diltiazem type), amiodarone or other antiarrhythmics. May potentiate BP- & heart-rate-lowering effects w/ clonidine; effect of other antihypertensives (eg, α1-receptor antagonists). Synergistic -ve inotropic & hypotensive effects w/ anesth. Increase in BP & impairment of BP control w/ NSAIDs. Oppose bronchodilator effects of β-agonist bronchodilators.
MIMS Class
Beta-Blockers
ATC Classification
C07AG02 - carvedilol ; Belongs to the class of alpha and beta blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Dilatrend tab 25 mg
Packing/Price
100's
Form
Dilatrend tab 6.25 mg
Packing/Price
30's
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