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Cabergoline (Cabergoline)

Trade Name : Cabergoline

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 0.5 mg/1

CABERGOLINE Ergolines [CS],Ergot Derivative [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cabergoline (Cabergoline) which is also known as Cabergoline and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 0.5 mg/1 per ml. Read more

Cabergoline (Cabergoline) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Cabergoline Tablets USP contain cabergoline, USP, a dopamine receptor agonist. The chemical name for cabergoline, USP is 1-[(6-Allylergolin-8u03b2-yl)-carbonyl]-1-[3-(dimethylamino)propyl]-3-ethylurea and has the following structural formula:
  • CHNO tM.W. 451.6
  • Cabergoline, USP is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.
  • Each Cabergoline Tablet USP, for oral administration, contains 0.5 mg of cabergoline, USP and has the following inactive ingredients: anhydrous lactose and leucine.
  • No data
  • Cabergoline tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
  • Cabergoline tablets are contraindicated in patients with
  • No data
  • No data
  • The safety of cabergoline tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.
  • In a 4 week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.
  • 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
  • The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinsonu2019s disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinsonu2019s disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.
  • The following events have been reported in association with cabergoline: cardiac valvulopathy and extracardiac fibrotic reactions (see and ).
  • Other events have been reported in association with cabergoline: impulse control/compulsive behavior symptoms, including hypersexuality, increased libido, and pathological gambling (see ). In addition, cases of alopecia, aggression and psychotic disorder have been reported in patients taking cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.
  • Other events have been reported in association with cabergoline: hypersexuality, increased libido and pathological gambling (see ). In addition, cases of alopecia, aggression and psychotic disorder have been reported in patients taking cabergoline. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.
  • Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.
  • The recommended dosage of cabergoline tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patientu2019s serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.
  • Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patientu2019s response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long-term treatment with cabergoline should undergo periodic assessment of their cardiac status and echocardiography should be considered.
  • After a normal serum prolactin level has been maintained for 6 months, cabergoline may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with cabergoline should be reinstituted. The durability of efficacy beyond 24 months of therapy with cabergoline has not been established.
  • Cabergoline Tablets USP, 0.5 mg are available as white, oval-shaped, scored tablets, debossed u201chourglass logou201d, u201c0.5u201d with a score on one side and u201c5420u201d on the other side containing 0.5 mg cabergoline, USP packaged in unit-of-use bottles of 8 tablets (NDC 0093-5420-88).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in original container.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Czech Republic By:
  • Teva Czech Industries s.r.o.
  • Opava-Komarov, Czech Republic
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. Fu00a010/2019
  • No data
  • No data

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