Cardivas-3.125mg
Manufactured By
Sun Pharma-cvs Division
Drug Facts
Carvedilol
Action Indications Contraindications Route/Dosage Interactions Lab Test Interferences Adverse Reactions Precautions Patient Care Considerations Administration/Storage Assessment/Interventions Patient/Family Education
(CAR-veh-DILL-ole) Coreg Tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mg Class: Alpha-adrenergic blocker/Beta-adrenergic blocker
Action Blocks alpha-1 receptors and nonselective beta-receptors to decrease BP.
Indications Management of essential hypertension; treatment of mild or moderate NYHA class II or III heart failure of ischemic or cardiomyopathic origin. Unlabeled uses: Angina pectoris; idiopathic cardiomyopathy.
Contraindications NYHA class IV decompensated cardiac failure; bronchial asthma or related bronchospastic conditions; second- or third-degree AV block; sick sinus syndrome (unless a permanent pacemaker is in place); cardiogenic shock; severe bradycardia; hypersensitivity to the drug.
Route/Dosage
Essential Hypertension
ADULTS: PO Start with 6.25 mg bid, then if tolerated (based on standing BP about 1 hr after dosing), maintain the dose for 7 to 14 days; then increase to 12.5 mg bid, if tolerated, maintain the dose for 7 to 14 days; then increase to 25 mg bid (max 50 mg/day).
CHF
ADULTS: PO Start with 3.125 mg bid for 14 days, then, if tolerated, dose may be increased to 6.25 mg bid; dosing may be doubled every 2 wk to the highest amount tolerated by patient (max, 25 mg bid/patients less than 85 kg [187 lbs]; 50 mg bid/patients over 85 kg).
Interactions
Antidiabetic agents (insulin and oral agents): Blood glucose-lowering effect may be enhanced. Calcium channel blockers (eg, diltiazem): Conduction disturbances may occur and BP may be altered. Catecholamine-depleting agents (eg, reserpine): Monitor for hypotension or severe bradycardia. Clonidine: Heart rate- and BP-lowering effects may be potentiated. Cyclosporine, digoxin: Plasma levels may be elevated by carvedilol, increasing the therapeutic and adverse effects. Inhibitors of CYP2D6 (eg, fluoxetine, paroxetine, propafenone, quinidine), poor metabolizers of debrisoquine: Expected to increase carvedilol blood levels.
Lab Test Interferences None well documented.
Adverse Reactions
CV: Hypotension; postural hypotension; bradycardia; syncope; hypertension; AV block; aggravated angina pectoris; cardiac failure; palpitations; extrasystoles; angina; fluid overload; peripheral ischemia; tachycardia. CNS: Dizziness; headache; paresthesia; insomnia; somnolence; depression; hypesthesia; vertigo; malaise. DERM: Rash; pruritis; photosensitive reaction. EENT: Abnormal vision; sinusitis; pharyngitis; rhinitis; coughing. GI: Diarrhea; nausea; abdominal pain; vomiting; flatulence; anorexia; dyspepsia; melena; periodontitis. GU: UTI; hematuria; abnormal renal function; albuminuria; glucosuria; impotence. HEMA: Thrombocytopenia; anemia; decreased PT; purpura. HEPA: Hepatotoxicity; leukopenia. META: Hyperglycemia; weight increase; gout; BUN increase; nonprotein nitrogen increase; hypercholesterolemia; dehydration; hypervolemia; hypertriglyceridemia; hypoglycemia; hyponatremia; increased alkaline phosphatase; hyperkalemia; hypovolemia; glycosuria. RESP: Upper respiratory infection; bronchitis; dyspnea; respiratory disorder; asthma. OTHER: Fatigue; chest pain; pain; injury; edema (generalized, dependent, peripheral, and legs); sweating; fever; infection; back pain; arthralgia; myalgia; asthenia; arthritis; viral infection; leg cramps; allergy; sudden death.
Precautions
Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Carvedilol plasma levels average 50% higher in elderly compared with young subjects; however, there were no notable differences in efficacy or adverse events. Anesthesia and major surgery: If carvedilol is continued perioperatively, use with caution with anesthetic agents that depress myocardial function (eg, ether). Bronchial asthma: Death in patients with status asthmaticus has occurred. Diabetes and hypoglycemia: May mask symptoms of hypoglycemia, particularly tachycardia; may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Peripheral vascular disease: Because symptoms of arterial insufficiency may be aggravated or precipitated in patients with peripheral vascular disease, use with caution in such patients. Renal function impairment: May result in deterioration of renal function. Special risk patients: Use with caution in patients with pheochromocytoma, CHF, or Prinzmetal variant angina. Thyrotoxicosis: May mask signs of hyperthyroidism, such as tachycardia; abrupt withdrawal may exacerbate symptoms of hyperthyroidism and precipitate thyroid storm.
PATIENT CARE CONSIDERATIONS
Administration/Storage
Give each dose with food to minimize risk of orthostatic hypotension.
Do not chew or crush. Instruct patient to swallow tablet whole.
Store tablets at controlled room temperature. Protect from moisture.
Assessment/Interventions
Obtain patient history, including drug history and any known allergies. Note history of asthma, AV block, sick sinus syndrome, bradycardia, or liver disease.
Monitor CHF patient for orthostatic hypotension (eg, dizziness, lightheadedness, change in BP) for 1 hr after first dose and at initiation of each dose increase.
Monitor and record BP and pulse in hypertensive patient. Should hypotenstion result, hold medication.
Take safety precautions if orthostatic hypotension occurs.
Monitor weight and respiratory status in CHF patients.
Monitor blood sugar in diabetic patient when drug is started or dose is changed.
OVERDOSAGE: SIGNS & SYMPTOMS Severe hypotension, bradycardia, cardiac insufficiency, cardiogenic shock, cardiac arrest, respiratory problems, bronchospasms, vomiting, lapses of consciousness, and generalized seizures
Patient/Family Education
Explain name, dose, action, and potential side effects of drug.
Advise patient that medication is started at a low dose and gradually increased as needed and tolerated.
Instruct patient to not interrupt therapy or discontinue drug abruptly.
Remind patient to take each dose with food to reduce risk of orthostatic hypotension.
Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
Instruct patient to lie or sit down if experiencing dizziness or lightheadedness when standing.
Instruct patient in BP and pulse measurement skills.
Instruct CHF patient to measure and record BP, pulse, weight, and symptoms every day and to take record to each follow-up office visit.
Advise patient to monitor and record BP and pulse at home and to inform health care provider should abnormal measurements be noted. Also advise patient to take record of BP and pulse to each follow-up visit.
Emphasize importance of other modalities on BP (eg, weight control, regular exercise, smoking cessation, moderate intake of alcohol and salt) to hypertensive patient.
Instruct patients to notify health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
Instruct diabetic patient to monitor blood glucose more frequently when dose is changed or drug is stopped. Patient should inform health care provider of significant changes in readings.
Advise patients who wear contact lenses that drug may cause decreased tearing and dry eyes.
Instruct patient to report any of these symptoms to health care provider: dark urine, persistent anorexia, pruritis, right upper quadrant tenderness, unexplained flu-like symptoms, bradycardia, fainting or persisent dizziness when arising from a sitting or lying position, weight gain, swelling of feet or ankles, increasing shortness of breath, or fatigue.
Caution patient that drug may cause dizziness or fainting and to avoid situations such as driving or performing other hazardous tasks until tolerance is determined.
Caution patient to not take any prescription or OTC medications or dietary supplements unless advised by health care provider.
Remind CHF patients that they should be seen by health care provider before each dose change and to be sure and keep appointments.
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Copyright © 2003 Facts and Comparisons
David S. Tatro
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