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DOSTINEX is a brand name for Cabergoline, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
DOSTINEX (cabergoline) is contraindicated in patients with: uncontrolled hypertension, a history of pulmonary, pericardial and retroperitoneal fibrotic disorders. (See WARNINGS AND PRECAUTIONS), anatomical evidence of cardiac valvulopathy of any valve (eg, echocardiogram showing valve leaflet thickening, valve restriction, valve mixed restriction-stenosis) Echocardiogram is required at pretreatment in patients being treated for hyperprolactinemic disorders (see WARNINGS AND PRECAUTIONS), a known hypersensitivity to this drug or any ergot derivatives and to any ingredient in the formulation.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. WARNINGS AND PRECAUTIONS General Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia and eclampsia, unless the potential benefit is judged to outweigh the possible risk.
0 mg may produce orthostatic hypotension. Care should be exercised when administering DOSTINEX (cabergoline) with other medications known to lower blood pressure. The effects of alcohol on overall tolerability of DOSTINEX are currently unknown.
Before DOSTINEX administration, pregnancy should be excluded and after treatment pregnancy should be prevented for at least one month. Carcinogenesis and Mutagenesis Please see also TOXICOLOGY. Cardiovascular DOSTINEX should be given with caution to subjects with cardiovascular disease and Raynaud’s syndrome.
Symptomatic hypotension can occur with DOSTINEX administration. Care should be exercised when administering DOSTINEX concomitantly with other drugs known to lower blood pressure.
DOSTINEX* (cabergoline) Product Monograph Page 5 of 28 Fibrosis:
As with other ergot derivatives, pleural effusion/pulmonary fibrosis has been reported following long-term administration of cabergoline. Therefore, DOSTINEX should not be used in patients with a history of, or current signs and /or symptoms of respiratory or cardiac disorders linked to fibrotic tissue (see CONTRAINDICATIONS).
Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis. Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values. Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cabergoline in Canada.
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Following diagnosis of pleural effusion/pulmonary fibrosis, the discontinuance of cabergoline has been reported to result in improvement of signs and symptoms.
Treatement for Hyperprolactinemia:
Before initiating treatment: All patients must undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of asymptomatic valvular disease. It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation of therapy.
During treatment:
Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of: Pleuro-pulmonary disease such as dyspnoea, shortness of breath, persistent cough or chest pain Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank and lower limb oedema as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis.
Cardiac failure: cases of valvular and pericardial fibrosis have often manifested as cardiac failure. Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur. Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential.
Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder. , physical examination including cardiac auscultation, X-ray, CT scan) should be determined on an individual basis.
DOSTINEX* (cabergoline) Product Monograph Page 6 of 28 Cardiac Valvulopathy:
There have been post-marketing reports of cardiac valvulopathy involving one or more valves in patients taking DOSTINEX. The incidence of treatment emergent cardiac valvulopathy has not yet been determined, although some studies have suggested that the risk is cumulative, and asymptomatic cases of valvulopathy have been identified using echocardiography.
Valvulopathy has been reported with substantially greater frequency during treatment with ergot derivatives with 5-HT2B agonist activity, including cabergoline, compared to non-ergot dopamine agonists. DOSTINEX is contraindicated in patients with a history of cardiac valvulopathy (see CONTRAINDICATIONS).
Physicians should inform patients/caregivers of the risk of cardiac valvulopathy.
Treatment of Hyperprolactinemia:
Before initiating treatment: All patients must undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of asymptomatic valvular disease. In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease.
If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (See CONTRAINDICATIONS).
During treatment:
Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. Therefore, during treatment, attention should be paid to the signs and symptoms of: Cardiac failure: cases of valvular and pericardial fibrosis have often manifested as cardiac failure.
Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur. Following treatment initiation, the first echocardiogram must occur within 3-6 months; […]