Cabergoline .5 mg/1
Cabergoline · TABLET · A-S Medication Solutions
Cabergoline is a tablet containing cabergoline at .5 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Cabergoline
- Generic Name
- Cabergoline
- NDC Code (Product)
50090-7642- Manufacturer
- A-S Medication Solutions
- Strength
- .5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA218618
- Drug Class
- Ergot Derivative [EPC]
- Marketing Start
- 10/03/2024
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Teva Pharmaceuticals USA, Inc.
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
Dosage & Administration
DOSAGE AND ADMINISTRATION The recommended dosage of Cabergoline Tablets, USP 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 patient’s 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 patient's 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 mon…
Warnings
WARNINGS 1. Pregnancy: Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia, eclampsia, and postpartum hypertension, unless the potential benefit is judged to outweigh the possible risk. 2. Fibrotic Complications: a. Cardiac Valvulopathy: All patients should undergo a cardiovascular evaluation, including echocardiogram to assess the potential presence of valvular disease. If valvular disease is detected, the patient should not be treated with Cabergoline (See CONTRAINDICATIONS ) . Post-marketing cases of cardiac valvulopathy have been reported in patients receiving Cabergoline. These cases have generally occurred during administration of high doses of Cabergoline (>2mg/day) used for the treatment of Parkinson’s disease. Cases of cardiac valvulopathy have also been reported in patients receiving lower doses for the treatment of hyperprolactinemic disorders. A multi-country, retrospective cohort study using general practice records and record linkage systems in the UK, Italy and the Netherlands was conducted to assess the association between new use of dopamine agonists including cabergoline (n=27,812) for Parkinso…
Contraindications
CONTRAINDICATIONS Cabergoline Tablets, USP are contraindicated in patients with Uncontrolled hypertension or known hypersensitivity to ergot derivatives. 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 (See WARNINGS ). History of pulmonary, pericardial, or retroperitoneal fibrotic disorders (See WARNINGS ).
Drug Interactions
Drug Interactions: Cabergoline should not be administered concurrently with D 2 -antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
Adverse Reactions
ADVERSE REACTIONS 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. Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo-Controlled Trial Adverse Event Reported at ≥1% for cabergoline Cabergoline (n=168) 0.125 to 1 mg two times a week Placebo (n=20) Number (percent) Gastrointestinal Nausea 45 (27) 4 (20) Constipation 16 (10) 0 Abdominal pain 9 (5) 1 (5) Dyspepsia 4 (2) 0 Vomiting 4 (2) 0 Central and Peripheral Nervous System Headache 43 (26) 5 (25) Dizziness 25 (15) 1 (5) Paresthesia 2 (1) 0 Vertigo 2 (1) 0 Body As a Whole Asthenia 15 (9) 2 (10) Fatigue 12 (7) 0 Hot flashes 2 (1) 1 (5) Psychiatric Somnole…
Frequently Asked Questions
What is Cabergoline used for?
Cabergoline contains Cabergoline. It is a tablet taken oral. Consult your doctor for specific uses.
Is Cabergoline a controlled substance?
Cabergoline is not classified as a controlled substance by the DEA.
What is the generic name for Cabergoline?
The generic name for Cabergoline is Cabergoline. There are 1 other brand versions of Cabergoline.
What is the NDC code for Cabergoline .5 mg/1?
The NDC (National Drug Code) for Cabergoline .5 mg/1 is 50090-7642, listed by A-S Medication Solutions.