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PMS-CARVEDILOL is a brand name for Carvedilol, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-CARVEDILOL (carvedilol) is indicated: for the treatment of mild, moderate or severe heart failure of ischemic or non-ischemic origin to increase survival and also, to reduce the combined risk of all-cause mortality and cardiovascular or non-cardiovascular hospitalizations In general, pms-CARVEDILOL is used in…
Verbatim from this product's HC label. Tap a section to expand.
). 1 Dosing Considerations Dosage must be individualized and patients closely monitored during initiation and up- titration by a physician experienced in the treatment of heart failure. All patients in whom pms-CARVEDILOL therapy is to be considered must be clinically stable for 4 weeks prior to initiation of pms-CARVEDILOL.
Prior to initiation of pms-CARVEDILOL therapy, patients should be on stable doses of diuretics and angiotensin converting enzyme (ACE) inhibitors, with or without digitalis. In clinical trials, all patients shown to have benefit were on the above regimen unless they were intolerant to an ACE inhibitor.
125 mg twice daily for two weeks. 5 and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on the h ighest tolerated dose. The maximum recommended dose is 25 mg twice daily. The dose of pms - CARVEDILOL should not be increased until symptoms of worsening heart failure or vasodilation have stabilized.
pms-CARVEDILOL Product Monograph Page 6 of 42 Patients should be advised that initiation of treatment and, to a lesser extent, dosage increases may be associated with transient symptoms of dizziness or light-headedness, and rarely syncope, within the first 2 hours after dosing.
During these periods, they should avoid situations such as driving or dangerous tasks where symptoms could result in injury. In addition, pms-CARVEDILOL should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects, especially during up-titration.
Symptoms of hypotension do not often require treatment, but it may be useful to separate the time of dosing of pms-CARVEDILOL from that of the ACE inhibitor, or to reduce temporarily the dose of the ACE inhibitor. The risk/benefit of carvedilol therapy in clinically stable heart failure patients with a heart rate lower than 68 beats per minute should be carefully considered prior to initiation of pms - CARVEDILOL since carvedilol has not been studied in these patients (see 7 WARNINGS AND PRECAUTIONS).
Before each dose increase the patient should be seen in the office and evaluated for symptoms of worsening heart failure, vasodilation (dizziness, light-headedness, symptomatic hypotension) or bradycardia, in order to determine tolerability of pms-CARVEDILOL.
). The risk of these events was highest during initiation of therapy and during the first 30 days of dosing corresponding to the up-titration period. Therefore, it is of critical importance that the dosing recommendation be followed (see 4 DOSAGE AND ADMINISTRATION).
Peripheral Vascular Disease Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals. Primary Regurgitative Valvular Heart Disease Carvedilol should be used with caution in patients with primary regurgitative valvular disease as experience in this patient population is limited.
Prinzmetal’s Angina Beta-blocking agents may provoke chest pain in patients with Prinzmetal’s angina. There has been no clinical experience with carvedilol in these patients. Caution should be taken in the administration of carvedilol to patients suspected of having Prinzmetal’s variant angina.
Sinus Bradycardia Severe sinus bradycardia may occur with the use of carvedilol. In such cases, dosage should be discontinued. pms-CARVEDILOL Product Monograph Page 12 of 42 In clinical trials, patients with a resting heart rate of less than or equal to 68 beats/minute prior to initiation of carvedilol were not studied.
Endocrine and Metabolism Diabetes Carvedilol should be administered with caution to patients subject to spontaneous hypoglycemia, or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
Beta-adrenergic blocking drugs may enhance hypoglycemia, in patients prone to this condition. Also, diabetics on insulin or oral hypoglycemic medication may have an increased tendency towards hypoglycemia when treated with these drugs.
It may also be necessary to adjust the dosage of oral hypoglycemics or insulin. Early signs of acute hypoglycemia, especially tachycardia, may be masked or attenuated. Regular monitoring of blood glucose is therefore recommended when carvedilol is initiated, adjusted or discontinued.
g. severe Alzheimer's, alcoholism, drug abuse), unless closely supervised by an appropriate caregiver hypersensitivity to carvedilol or any ingredient in the formulation of pms-CARVEDILOL, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Beta blockers can cause worsening heart failure (see 7 WARNINGS AND PRECAUTIONS).
Since carvedilol has beta-blocking properties, care must be taken during initiation and up-titration of the drug in heart failure patients, since worsening heart failure has been observed during this phase of treatment. In order to minimize the risk of these events, it is critical to carefully follow the recommended dosing for pms-CARVEDILOL in patients with congestive heart failure (see 4 DOSAGE AND ADMINISTRATION).
1 Dosing Considerations Dosage must be individualized and patients closely monitored during initiation and up- titration by a physician experienced in the treatment of heart failure. All patients in whom pms-CARVEDILOL therapy is to be considered must be clinically stable for 4 weeks prior to initiation of pms-CARVEDILOL.
Prior to initiation of pms-CARVEDILOL therapy, patients should be on stable doses of diuretics and angiotensin converting enzyme (ACE) inhibitors, with or without digitalis. In clinical trials, all patients shown to have benefit were on the above regimen unless they were intolerant to an ACE inhibitor.
125 mg twice daily for two weeks. 5 and 25 mg twice daily over successive intervals of at least 2 weeks. Patients should be maintained on the h ighest tolerated dose. The maximum recommended dose is 25 mg twice daily. The dose of pms - CARVEDILOL should not be increased until symptoms of worsening heart failure or vasodilation have stabilized.
g. severe Alzheimer's, alcoholism, drug abuse), unless closely supervised by an appropriate caregiver hypersensitivity to carvedilol or any ingredient in the formulation of pms-CARVEDILOL, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Transient worsening of heart failure may be treated with increased doses of diuretics, lowering the dose of pms-CARVEDILOL or, if necessary, discontinuation of pms-CARVEDILOL. Symptoms of vasodilation such as dizziness, light-headedness or decreasing blood pressure may respond to a reduction in the dose of diuretics.
If these changes do not relieve symptoms, the dose of pms-CARVEDILOL should be decreased. If the dose of pms-CARVEDILOL was decreased, it should not be increased again until symptoms of worsening heart failure or vasodilation have been stabilized for 2 weeks.
Initial difficulty with titration may not preclude later attempts to re-introduce or resume titration of pms-CARVEDILOL; however, caution is required in these circumstances. ), the dose of pms-CARVEDILOL should be reduced, or may require discontinuation.
Elderly The frequency and pattern of adverse reactions in patients ≥ 65 years was similar to that in younger patients. However, plasma levels of carvedilol are higher in older patients compared to younger patients (see 7 WARNINGS AND PRECAUTIONS).
Therefore, after initiating pms- CARVEDILOL at the same dose in the elderly as in younger patients, up-titration should be done more cautiously in the elderly. A lower total daily dose may be reached at the end of up - titration in such patients compared to younger patients.
Hepatic Insufficiency pms-CARVEDILOL is contraindicated in patients with clinically manifest liver disease (see 2 CONTRAINDICATIONS). 3 Pharmacokinetics, and 7 WARNINGS AND PRECAUTIONS). Therefore, after initiating pms- CARVEDILOL at the same dose in patients with hepatic impairment as in other patients, up- pms-CARVEDILOL Product Monograph Page 7 of 42 titration should be done more cautiously in patients with hepatic impairment.
A lower total daily dose may be reached at the end of up-titration in such patients compared to other patients. Renal Insufficiency Acute, reversible renal failure has been seen in some patients treated with carvedilol; particularly those with underlying renal impairment (see 7 WARNINGS AND PRECAUTIONS).
Therefore, after initiating pms-CARVEDILOL at the same dose in patients with renal impairment as in other patients, up-titration should be done more cautiously in patients with renal impairment. Renal function (BUN and creatinine) should be checked in such patients as appropriate.
If renal function has deteriorated, the dose of pms-CARVEDILOL may need to be reduced or discontinued. Discontinuation pms-CARVEDILOL should be gradually reduced over a period of about 2 weeks, if possible, and the patient should be carefully observed (see 7 WARNINGS AND PRECAUTIONS, Abrupt Cessation of Therapy).
4 Administration pms-CARVEDILOL tablets should be swallowed whole with water. pms-CARVEDILOL tablets should not be chewed, crushed, or broken. 5 Missed Dose If a patient misses a dose, advise the patient to take the dose as soon as possible and continue with their regular schedule, however, 2 doses should NOT be taken within 6 hours of each other.
The patient must contact a Health professional if more than 2 doses of pms-CARVEDILOL were missed. The patient should NOT restart taking pms-CARVEDILOL until they have spoken to a Health […]
Hyperthyroidism In patients with thyrotoxicosis, possible deleterious effects from long-term use of carvedilol have not been appraised. Beta-blockade, in general, may mask the clinical signs of continuing hyperthyroidism or complications, and give a false impression of improvement.
Therefore, abrupt withdrawal of carvedilol may be followed by an exacerbation of the symptoms of hyperthyroidism, including thyroid storm. Pheochromocytoma The effect of carvedilol in patients with pheochromocytoma has not been studied.
Since paradoxical hypertensive responses have been reported in a few patients with this tumor when treated with β-blockers, Health professionals should use caution when administering carvedilol to patients with pheochromocytoma. Hepatic Hepatocellular injury, confirmed by rechallenge, has occurred rarely with carvedilol therapy.
Hepatic injury has been reversible and has occurred after short-and/or long-term therapy with minimal clinical symptomatology. No deaths due to liver function abnormalities have been reported in association with the use of carvedilol.
g. pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness or unexplained "flu-like" symptoms) laboratory testing should be performed. If the patient has laboratory evidence of liver injury or jaundice, carvedilol treatment should be stopped and not restarted.
Since carvedilol undergoes first-pass metabolism in the liver, reduced hepatic metabolism pms-CARVEDILOL Product Monograph Page 13 of 42 could lead to greater systemic bioavailability of carvedilol in patients with hepatic impairment.
Care should be taken in selecting an appropriate dosage regimen for these patients (see 2 CONTRAINDICATIONS and 4 DOSAGE AND ADMINISTRATION). Health professionals should be aware of the potential for increased manifestations of vasodilation (dizziness, postural hypotension, hypotension, syncope) or beta-blockade (bradycardia, AV block) in patients with mild hepatic impairment receiving carvedilol (see 4 DOSAGE AND ADMINISTRATION).
Immune Allergic Reaction There may be increased difficulty in treating an allergic-type reaction in patients on beta- blockers. In these patients, the reaction may be more severe due to pharmacological effects of beta-blockers and problems with fluid changes.
Epinephrine should be administered with caution since it may not have its usual effects in the treatment of anaphylaxis. On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other; these doses can be associated with excessive alpha-adrenergic stimulation with consequent hypertension, reflex bradycardia and heart block and possible potentiation of bronchospasm.
Alternatives to the use of large doses of epinephrine include vigorous supportive care such as fluids and the use of beta agonists including parenteral salbutamol or isoproterenol to overcome bronchospasm and norepinephrine to overcome hypotension.
Ophthalmologic Contact Lens Use Wearers of contact lenses should bear in mind the possibility of reduced lacrimation. Uveal Binding Animal studies have shown that carvedilol binds to the melanin of the uveal tract. The significance of this in humans is not known but periodic ophthalmic examinations are advisable while the patient is taking carvedilol.
Peri-Operative Considerations Because of the synergistic negative inotropic and vasodilating effects of carvedilol and anesthetic drugs, the potential for pronounced hypotension during anesthesia exists. If carvedilol treatment is to be continued preoperatively, particular care should be taken when anesthetic agents which depress myocardial function are used.
Renal Rarely, use of carvedilol in patients with congestive heart failure has resulted in acute renal failure and deterioration of renal function, likely on a pre-renal basis. Patients at risk appear pms-CARVEDILOL […]
pms-CARVEDILOL Product Monograph Page 6 of 42 Patients should be advised that initiation of treatment and, to a lesser extent, dosage increases may be associated with transient symptoms of dizziness or light-headedness, and rarely syncope, within the first 2 hours after dosing.
During these periods, they should avoid situations such as driving or dangerous tasks where symptoms could result in injury. In addition, pms-CARVEDILOL should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects, especially during up-titration.
Symptoms of hypotension do not often require treatment, but it may be useful to separate the time of dosing of pms-CARVEDILOL from that of the ACE inhibitor, or to reduce temporarily the dose of the ACE inhibitor. The risk/benefit of carvedilol therapy in clinically stable heart failure patients with a heart rate lower than 68 beats per minute should be carefully considered prior to initiation of pms - CARVEDILOL since carvedilol has not been studied in these patients (see 7 WARNINGS AND PRECAUTIONS).
Before each dose increase the patient should be seen in the office and evaluated for symptoms of worsening heart failure, vasodilation (dizziness, light-headedness, symptomatic hypotension) or bradycardia, in order to determine tolerability of pms-CARVEDILOL.
Transient worsening of heart failure may be treated with increased doses of diuretics, lowering the dose of pms-CARVEDILOL or, if necessary, discontinuation of pms-CARVEDILOL. Symptoms of vasodilation such as dizziness, light-headedness or decreasing blood pressure may respond to a reduction in the dose of diuretics.
If these changes do not relieve symptoms, the dose of pms-CARVEDILOL should be decreased. If the dose of pms-CARVEDILOL was decreased, it should not be increased again until symptoms of worsening heart failure or vasodilation have been stabilized for 2 weeks.
Initial difficulty with titration may not preclude later attempts to re-introduce or resume titration of pms-CARVEDILOL; however, caution is required in these circumstances. ), the dose of pms-CARVEDILOL should be reduced, or may require discontinuation.
Elderly The frequency and pattern of adverse reactions in patients ≥ 65 years was similar to that in younger patients. However, plasma levels of carvedilol are higher in older patients compared to younger patients (see 7 WARNINGS AND PRECAUTIONS).
Therefore, after initiating pms- CARVEDILOL at the same dose in the elderly as in younger patients, up-titration should be done more cautiously in the elderly. A lower total daily dose may be reached at the end of up - titration in such patients compared to younger patients.
Hepatic Insufficiency pms-CARVEDILOL is contraindicated in patients with clinically manifest liver disease (see 2 CONTRAINDICATIONS). 3 Pharmacokinetics, and 7 WARNINGS AND PRECAUTIONS). Therefore, after initiating pms- CARVEDILOL at the same dose in patients with hepatic impairment as in other patients, up- pms-CARVEDILOL Product Monograph Page 7 of 42 titration should be done more cautiously in patients with hepatic impairment.
A lower total daily dose may be reached at the end of up-titration in such patients […]