Cabgolin Tablets (Generic Cabergoline Tablets)

1. Cabgolin Tablets (Generic Cabergoline Tablets) © The Swiss Pharmacy

2. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin (Generic Cabergoline Tablets) is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. Cabgolin can also be prescribed to prevent the production of milk in women after birth, if breast- feeding is to be prevented for medical reasons. © The Swiss Pharmacy

3. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin Tablets are manufactured by Sun Pharmaceutical Industries Limited, India in the strengths of 0.25 mg and 0.50 mg. © The Swiss Pharmacy

4. Cabgolin Tablets (Generic Cabergoline Tablets) Chemical Structure © The Swiss Pharmacy

5. Cabgolin Tablets (Generic Cabergoline Tablets) The active ingredient contained in Cabgolin tablets is Cabergoline. Each uncoated Cabgolin tablet contains 0.25 mg or 0.5 mg of Cabergoline. © The Swiss Pharmacy

6. Cabgolin Tablets (Generic Cabergoline Tablets) Uses of Cabgolin 0.25 mg and 0.5 mg Tablets: Cabgolin (Generic Cabergoline Tablets) is used to treat different types of Hyperprolactinemic disorders (medical problems that occur when too much of the hormone prolactin is produced). It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas (tumors of the pituitary gland). It works by stopping the brain from making and releasing the prolactin hormone from the pituitary gland. Cabergoline use is usually stopped when prolactin levels are normal for 6 months. It may be given again if symptoms of too much prolactin occur again. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

7. Cabgolin Tablets (Generic Cabergoline Tablets) Recommended Adult Dosage The dose of Cabgolin Tablets Cabgolin Tablets (Generic Cabergoline Tablets) for inhibition/suppression of physiological lactation is 1 mg (two 0.5 mg tablets) given as a single dose taken during the first day post-partum. For suppression of established lactation the recommended therapeutic dosage regimen is 0.25 mg (one-half 0.5 mg tablet) every 12 hours for two days (1 mg total dose). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

8. Cabgolin Tablets (Generic Cabergoline Tablets) Recommended Adult Dosage The recommended initial dosage of Cabergoline for treatment of hyperprolactinaemic disorders is 0.5 mg per week given in one or two (one-half of one 0.5 mg tablet) doses (e.g. on Monday and Thursday) per week. The weekly dose should be increased gradually, preferably by adding 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1 mg per week and ranges from 0.25 mg to 2 mg per week. Doses of Cabergoline (Cabgolin Tablets) up to 4.5 mg per week have been used in hyperprolactinaemic patients. The maximum dose should not exceed 3 mg per day. © The Swiss Pharmacy

9. Cabgolin Tablets (Generic Cabergoline Tablets) Contraindications ➔Cabgolin is contraindicated in patients with a known hypersensitivity to Cabergoline, ergot derivatives, or any component of the tablet. ➔History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis. ➔Uncontrolled hypertension. ➔History of pulmonary, pericardial, or retroperitoneal fibrotic disorders. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

10. Cabgolin Tablets (Generic Cabergoline Tablets) Storage Instructions Cabgolin Tablets (Generic Cabergoline Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

11. Cabgolin Tablets (Generic Cabergoline Tablets) Warnings As with other ergot derivatives, Cabgolin (Generic Cabergoline Tablets) should be given with caution to patients with severe cardiovascular disease, Raynaud's syndrome, liver disease, renal insufficiency, peptic ulcer or gastrointestinal bleeding, or with a history of serious, particularly psychotic, mental disorders. The safety and efficacy of Cabergoline tablets have not yet been established in patients with renal and hepatic disease. As with other ergotderivatives, fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy or retroperitoneal fibrosis have occurred after prolonged usage of Cabergoline. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

12. Cabgolin Tablets (Generic Cabergoline Tablets) Warnings It is recommended that before initiating treatment with Cabergoline tablets all patients undergo a cardiovascular evaluation, including an echocardiogram, to assess potential presence of an occult valvular disease. Fibrotic disorders can havean insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. By analogy with other ergot derivatives, Cabgolin should not be used in women with preeclampsia or post-partum hypertension. Symptomatic hypotension can occur with Cabgolin administration for any indication: periodic monitoring of blood pressure is advised and care should be exercised when administering Cabgolin concomitantly with other medicines known to lower blood pressure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

13. Cabgolin Tablets (Generic Cabergoline Tablets) Warnings Since hyperprolactinaemia with amenorrhoea/galactorrhoea and infertility may be associated with pituitary tumours, a complete evaluation of the pituitary is indicated before treatment with Cabgolin is initiated. Cabergoline has been associated with somnolence. Dopamine agonists can be associated with sudden sleep onset episodes in patients with Parkinson’s disease. A reduction of Cabgolin dosage or termination of therapy may be considered. Impulse control disorders such aspathological gambling, increased libido, hypersexuality, compulsive shopping, eating or medication use, and punding (repetitive purposeless activity) have been reported in patients treated with dopamine agonists including Cabergoline (Cabgolin tablets). © The Swiss Pharmacy

14. Cabgolin Tablets (Generic Cabergoline Tablets) Possible Side Effects The most common Cabergoline (Cabgolin tablets) side effects observed during the placebo-controlled study are Nausea, Constipation, Abdominal pain, Dyspepsia, Vomiting, Headache, Dizziness, Paresthesia, Vertigo, Asthenia, Fatigue, Hot flashes, Somnolence, Depression, Nervousness, Postural hypotension, Breast pain, Dysmenorrhea and Abnormal vision. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

15. Cabgolin Tablets (Generic Cabergoline Tablets) Possible Side Effects Other Cabergoline tablets side effects that were reported at an incidence of less than 1% of patients in the overall clinical studies: Body as a Whole: Facial edema, influenza-like symptoms, malaise Cardiovascular System: Hypotension, syncope, palpitations Digestive System: Dry mouth, flatulence, diarrhea, anorexia Metabolic and Nutritional System: Weight loss, weight gain Nervous System: Somnolence, nervousness, paresthesia, insomnia, anxiety Respiratory System: Nasal stuffiness, epistaxis Skin and Appendages: Acne, pruritus Special Senses: Abnormal vision Urogenital System: Dysmenorrhea, increased libido URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

16. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin Tablets Overdosage There is no experience with Cabergoline (Cabgolin tablets) in humans of overdosage when used in the proposed indications. Doses of Cabergoline tablets up to 4.5 mg per week have been used in hyperprolactinemic patients. Symptoms of overdose would likely be those of over-stimulation of dopamine receptors. These might include nausea, vomiting, gastric complaints, hypotension, or thought/perception disturbances (hallucinations), nasal congestion and syncope. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

17. Cabgolin Tablets (Generic Cabergoline Tablets) Treatment of Cabgolin Tablets Overdosage General supportive measures should be undertaken to remove any unabsorbed drug and maintain blood pressure if necessary. In addition, the administration of dopamine antagonist drug may be advisable. Measures to support blood pressure should be taken if necessary. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

18. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin Tablets During Pregnancy Cabergoline (Cabgolin tablets) has been classified by the US FDA as Pregnancy Category B. Animal studies with Cabergoline (Cabgolin tablets) have not demonstrated teratogenic effects or effects on overall reproductive performance. Reproduction studies have been performed with Cabergoline in mice, rats, and rabbits administered by gavage. There were maternotoxic effects but no teratogenic effects in mice given Cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis. However, there are no adequate and well-controlled studies in pregnant women. © The Swiss Pharmacy

19. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin Tablets During Pregnancy Cabgolin tablets should be used during pregnancy only if clearly needed. If conception occurs during therapy with Cabgolin tablets, discontinuation of treatment should be considered, after careful evaluation of the risks and benefits to mother and foetus. Pregnancy should be avoided for at least one month following discontinuation of treatment with Cabgolin tablets due to the long half-life of the drug and the limited data on in uteroexposure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy

20. Cabgolin Tablets (Generic Cabergoline Tablets) Cabgolin Tablets Cabgolin Tablets (Generic Cabergoline Tablets) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9542_Cabergoline-Tablets.html © The Swiss Pharmacy