CARVEDILOL PHOSPHATE- carvedilol phosphate capsule, extended release
1 INDICATIONS AND USAGE
Carvedilol phosphate extended-release capsules are indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].
2 DOSAGE AND ADMINISTRATION
Carvedilol phosphate extended-release capsules are intended for once-daily administration. Patients controlled with immediate-release carvedilol tablets alone or in combination with other medications may be switched to carvedilol phosphate extended-release capsules based on the total daily doses shown in Table 1.
| Daily Dose of Immediate-Release |
|Daily Dose of Carvedilol Phosphate Extended-Release Capsules *|
6.25 mg (3.125 mg twice daily)
10 mg once daily
12.5 mg (6.25 mg twice daily)
20 mg once daily
25 mg (12.5 mg twice daily)
40 mg once daily
50 mg (25 mg twice daily)
80 mg once daily
Carvedilol phosphate extended-release capsules should be taken once daily in the morning with food. Carvedilol phosphate extended-release capsules should be swallowed as a whole capsule. Carvedilol phosphate extended-release capsules and/or its contents should not be crushed, chewed, or taken in divided doses.
Alternative Administration: The capsules may be carefully opened and the contents sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified-release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Absorption of the contents sprinkled on other foods has not been tested.
DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of carvedilol phosphate extended-release capsules is 20 mg once daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 40 mg once daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 80 mg once daily if tolerated and needed. Although not specifically studied, it is anticipated the full antihypertensive effect of carvedilol phosphate extended-release capsules would be seen within 7 to 14 days as had been demonstrated with immediate-release carvedilol. Total daily dose should not exceed 80 mg.
Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of carvedilol action.
2.4 Hepatic Impairment
Carvedilol phosphate extended-release capsules should not be given to patients with severe hepatic impairment [see Contraindications (4)].
2.5 Geriatric Use
When switching elderly patients (aged 65 years or older) who are taking the higher doses of immediate-release carvedilol tablets (25 mg twice daily) to carvedilol phosphate extended-release capsules, a lower starting dose (40 mg) of carvedilol phosphate extended-release capsules is recommended to minimize the potential for dizziness, syncope, or hypotension [see Dosage and Administration (2)]. Patients who have switched and who tolerate carvedilol phosphate extended-release capsules should, as appropriate, have their dose increased after an interval of at least 2 weeks [see Use in Specific Populations (8.5)].
3 DOSAGE FORMS AND STRENGTHS
The hard gelatin capsules are filled with carvedilol phosphate controlled-release minitablets that are coated with methacrylic acid copolymers and are available in the following strengths:
- 10 mg – white opaque/white opaque capsules, imprinted MUTUAL 899
- 20 mg – dark green opaque/dark green opaque capsules, imprinted MUTUAL 900
- 40 mg – yellow opaque/yellow opaque capsules, imprinted MUTUAL 901
- 80 mg – green opaque/green opaque capsules, imprinted MUTUAL 902
Carvedilol phosphate extended-release capsules are contraindicated in the following conditions:
- Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release 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 phosphate extended-release capsules.
- Patients with severe hepatic impairment.
- Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of carvedilol phosphate extended-release capsules.
5 WARNINGS AND PRECAUTIONS
In clinical trials of carvedilol phosphate extended-release capsules in subjects with hypertension (338 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with carvedilol phosphate extended-release capsules as well as immediate-release carvedilol.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
5.1 Cessation of Therapy
Patients with coronary artery disease, who are being treated with carvedilol phosphate extended-release capsules, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in patients with angina following the abrupt discontinuation of therapy with beta-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of carvedilol phosphate extended-release capsules is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. Carvedilol phosphate extended-release capsules should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that carvedilol phosphate extended-release capsules be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with carvedilol phosphate extended-release capsules abruptly even in patients treated only for hypertension.
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