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Cardiam-5 Dosage |
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Usual Adult Dose of Cardiam-5 for Hypertension:
Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day
Comments:
-Patients who are small or fragile may be started on 2.5 mg orally once a day.
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Use:
-Alone or in combination with other antihypertensive agents to treat hypertension
Usual Adult Dose of Cardiam-5 for Angina Pectoris:
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day
Comments:
-In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Uses:
-Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
-Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
-To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%
Usual Adult Dose of Cardiam-5 for Coronary Artery Disease:
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day
Comments:
-In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Uses:
-Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
-Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
-To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%
Usual Geriatric Dose of Cardiam-5 for Hypertension:
Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 10 mg orally once a day
Maximum dose: 10 mg/day
Comment:
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Use:
-Alone or in combination with other antihypertensive agents to treat hypertension
Usual Geriatric Dose of Cardiam-5 for Angina Pectoris:
Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day
Comments:
-In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
-The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Uses:
-Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
-Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
-To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%
Usual Pediatric Dose of Cardiam-5 for Hypertension:
6 to 17 years:
-Maintenance dose: 2.5 to 5 mg orally once a day
-Maximum dose: 5 mg/day
Comments:
-Doses higher than 5 mg have not been studied in pediatric patients.
The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.
Use:
-Alone or in combination with other antihypertensive agents to treat hypertension
Tell your doctor about all your current medicines and any you start or stop using, especially:
nitroglycerin;
simvastatin (Zocor, Simcor, Vytorin); or
any other heart or blood pressure medications.
This list is not complete. Other drugs may interact with Cardiam-5, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Cardiam-5 has been safely administered with thiazide diuretics, alpha blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
In vitro data from studies with human plasma indicate that Cardiam-5 has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Cardiam-5 with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Cardiam-5 to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Cardiam-5 in 20 healthy volunteers had no significant effect on the pharmacokinetics of Cardiam-5. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Cardiam-5; therefore, administration of Cardiam-5 with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Cardiam-5 in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Cardiam-5 systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Cardiam-5 systemic exposure (22% increase in area under the concentration versus time curve [AUC]). Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.
Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Cardiam-5 to a greater extent than diltiazem. Cardiam-5 should be used with caution when administered with CYP3A4 inhibitors.
Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Cardiam-5. Close observation of patients is recommended when Cardiam-5 is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Cardiam-5. Concomitant use of CYP3A4 inducers (e.g., rifampicin, hypericum perforatum) may decrease the plasma concentrations of Cardiam-5. Cardiam-5 should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Cardiam-5 or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Cardiam-5: Cimetidine: Co-administration of Cardiam-5 with cimetidine did not alter the pharmacokinetics of Cardiam-5.
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Cardiam-5 had no significant effect on the pharmacokinetics of Cardiam-5.
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Cardiam-5. When Cardiam-5 and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Cardiam-5 on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Cardiam-5 with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Cardiam-5 with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Cardiam-5 had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Cardiam-5 with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: No drug interaction studies have been conducted with cyclosporin and Cardiam-5 in healthy volunteers or other populations, with the exception of renal transplant patients. Various studies in renal transplant patients report that co-administration of Cardiam-5 with cyclosporin affects the trough concentrations of cyclosporin, from no change up to an average increase of 40%. Consideration should be given for monitoring cyclosporin levels in renal transplant patients on Cardiam-5.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Cardiam-5. In order to avoid toxicity of tacrolimus, administration of Cardiam-5 in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Drug/Laboratory Test Interactions: None known.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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