Cabgolin Tablets

Class: Dopamine receptor agonist

Manufacturer: Relax Biotech Pvt. Ltd. 862/1, GIDC, Makarpura, Vadodara – 390010, Gujarat, India.

Dosage Form: Tablet

Similar Brands:

Uses:

1. Cabergolin is indicated for the inhibition of physiological lactation soon after delivery and for suppression of already established lactation.
2. After parturition, when the mother elects not to breast feed the infant or when breast feeding is contraindicated due to medical reasons related to the mother or new born.
3. After still birth or abortion
4. Cabergoline is indicated for the treatment of dysfunction associated with hyperprolactinemia, including amenorrhea, oligomenorrhoea, anovulation and galactorrhea. Cabergoline is indicated in patients with prolactin-secreting pituitary adenomas (micro-and macroprolactinomas), idiopathic hyperprolactinaemia, or empty sella syndrome with associated hyperprolactinaemia, which represent the basic underlying pathologies contributing to the above clinical manifestations.

Dosage:

Inhibition/suppression of physiological lactation

For inhibition of lactation cabergoline should be administered during the first day post-partum. The recommended therapeutic dose is 1mg (two 0.5mg tablets) given as a single dose.

For suppression of established lactation the recommended therapeutic dosage regimen is 0.25mg (half 0.5mg tablet) every 12 hours for two days (1mg total dose). This dosage regimen has been demonstrated to be better tolerated than the single dose regimen in women electing to suppress lactation having a lower incidence of adverse events, in particular of hypotensive symptoms.

Treatment of hyperprolactinemic disorders

The recommended initial dosage of cabergoline is 0.5mg per week given in one or two (one-half of one 0.5mg tablet) doses (e.g. on Monday and Tuesday) per week. The weekly dose should be increased gradually, preferably by adding 0.5mg per week at monthly intervals until an optimal therapeutic response is achieved. The therapeutic dosage is usually 1mg per week and ranges from 0.25mg to 2mg per week. Doses of cabergoline up to 4.5mg per week have been used in hyperprolactinemic patients.

The maximum dose should not exceed 3mg per day.

Side Effects:

Valvulopathy, Pleural fibrosis, palpitations, somnolence, depression, cabergoline generally exerts a hypotensive effects in patients on long term treatment, breast pain.

Warnings & Precautions:

If the conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug.

Hepatic insufficiency: Lower doses should be considered in patients with severe hepatic insufficiency who receive prolonged treatment with cabergoline. Compared to normal volunteers and those with lesser degrees of hepatic insufficiency, an increase in AUC has been seen in patients with severe hepatic insufficiency (Child-Pugh Class C) who received a single 1mg dose.

Postural Hypotension: Postural hypotension can occur following administration of cabergolin. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure.

Somnolence/Sudden sleep onset: Cabergoline has been associated with somnolence.

Pregnancy & Lactation:

Pregnancy should be ruled out before starting therapy

Drug Interactions:

The concomitant use of other drugs during early puerperium, particularly of ergot alkaloids, was not associated with detectable interactions modifying the efficacy and safety of cabergoline.

No in information is available about the interaction between cabergoline and other ergot alkaloids; therefore, the concomitant use of these medication during long term treatment with cabergoline is not recommended.

Cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, it should not be concurrently administered with drugs which have dopamine-antagonist activity (such as phenothiazines, butyrophenones, thioxanthenes, metoclopromide) since these might reduce prolactin-lowering effect of cabergoline.

Contraindications:

Hypersensitivity to the active substance, any ergot alkaloid or to any of the excipients listed in section.

History of psychosis or risk of post-partum psychosis

Pre-eclampsia, eclampsia.

Post-partum hypertension or uncontrolled hypertension.

Severe hepatic impairment.

History of pulmonary, pericardial and retroperitoneal fibrotic disorders

Price: Ksh 2,400

Notes:

Cabgolin® is a registered trademark of Krishna Chemists Ltd

Manufactured for and marketed by;

KRISHNA CHEMISTS LTD

P.O BOX 3328-00506

NAIROBI, KENYA.