carvedilol- Carvedilol tablet, coated for oral use

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

carvedilol (UNII: 0K47UL67F2) (carvedilol - UNII:0K47UL67F2)

제공처:

Ranbaxy Pharmaceuticals Inc.

INN (국제 이름):

Carvedilol

약제 형태:

TABLET, COATED

구성:

3.125 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Carvedilol is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.1)] . Carvedilol is indicated for the management of essential. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)] . Carvedilol is contraindicated in the following conditions: - Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of carvedilol. - Second- or third-degree AV block - Sick sinus syndrome - Severe bradycardia (unless a permanent pacemaker is in place) - Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating carvedilol - P

제품 요약:

Carvedilol tablets are supplied as: 3.125 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX4 ’ , on one side and plain on the other side. 6.25 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX ’ on one side and ‘824 ’ on the other side. 12.5 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX825 ’ on one side and plain on the other side. 25 mg tablets: White to off-white, oval-shaped, biconvex, film coated tablets, debossed with ‘ RX826 ’ on one side and plain on the other side. Store at 20 - 25°C (68 - 77°F). (See USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

제품 특성 요약

CARVEDILOL- CARVEDILOL TABLET, COATED
RANBAXY PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CARVEDILOL TABLETS
INDICATIONS AND USAGE
Carvedilol is an alpha/beta-adrenergic blocking agent indicated for
the treatment of: (2)
Left ventricular dysfunction following myocardial infarction in
clinically stable patients (1.1)
Hypertension (1.2)
DOSAGE AND ADMINISTRATION
Take with food. Individualize dosages and monitor during up-titration.
(2) (3)
Left ventricular dysfunction following myocardial infarction: Start at
6.25 mg twice daily and increase to 12.5 mg then 25
mg twice daily after intervals of 3 to 10 days. A lower starting dose
or slower titration may be used. (2.1)
Hypertension: Start at 6.25 mg twice daily and increase if needed for
blood pressure control to 12.5 mg then 25 mg
twice daily over intervals of 1 to 2 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 3.125, 6.25, 12.5, 25 mg (3) (4)
CONTRAINDICATIONS
Bronchial asthma or related bronchospastic conditions (4)
Second- or third-degree AV block (4)
Sick sinus syndrome (4)
Severe bradycardia (unless permanent pacemaker in place) (4)
Patients in cardiogenic shock or decompensated heart failure requiring
the use of IV inotropic therapy. (4)
Severe hepatic impairment (2.3, 4)
Hypersensitivity to carvedilol (e.g. Stevens-Johnson syndrome) (4)
WARNINGS AND PRECAUTIONS
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discontinue. (5.1)
Bradycardia, hypotension, worsening heart failure/fluid retention may
occur. Reduce the dose as needed. (5.2, 5.3, 5.4)
Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema):
Avoid β-blockers. (4) However, if deemed
necessary, use with caution and at lowest effective dose. (5.5)
Diabetes: Monitor glucose as β-blockers may mask symptoms of
hypoglycemia or worsen hyperglycemia. (5.6)
ADVERSE REACTIONS
Most common adverse events (6.1): (7)
Left ventricular dysfunction following myocardial infarction (≥10%):
Dizziness, fatigue, hypotension, diarrhea,
hyp