Cabolac0.5 mg

Cabolac is a dopamine receptor agonist used mainly to lower elevated blood prolactin levels and, in some clinical settings, to suppress breast milk production.

Established/Approved Uses

• Hyperprolactinemic disorders — treatment of high prolactin levels that are idiopathic or caused by prolactin-secreting pituitary tumors (prolactinomas), whether microadenomas or macroadenomas. This is the primary regulatory-approved indication for Cabolac.

Other Established Uses (widely used in clinical practice)

• Prevention or suppression of physiological (postpartum) lactation — Cabolac is used in many countries, including Bangladesh, to prevent breast engorgement when breastfeeding is not intended, or to stop already-established lactation, always under physician supervision.

Guideline-Supported / Adjunct Uses

• As part of the management of infertility associated with hyperprolactinemia, to restore ovulatory menstrual cycles, once other causes have been excluded.

Off-Label Use (not FDA-approved, used selectively by specialists)

• Adjunctive use in mild Parkinson's disease at higher doses in some countries, but this use is limited by the increased risk of cardiac valve disease at higher doses and is not the basis for the Bangladesh-marketed low-dose (0.5 mg/1 mg) formulations.

The exact indication and dosing must be confirmed and supervised by a physician.

Each tablet contains Cabergoline USP/BP 0.5 mg or 1 mg as the active ingredient, along with pharmaceutically approved excipients such as leucine and lactose. Strength and exact excipients vary slightly by manufacturer/brand; always check the product leaflet of the specific brand dispensed.

Cabolac is a synthetic ergot-derivative (ergoline) dopamine receptor agonist that selectively stimulates dopamine D2 receptors on pituitary lactotroph cells, thereby suppressing the secretion of the hormone prolactin. It is taken orally, and its long biological half-life allows it to be dosed only once or twice weekly, unlike older dopamine agonists such as bromocriptine that require daily dosing.

Cabolac is used to manage disorders of prolactin excess, including prolactin-secreting pituitary tumors, and to suppress unwanted or excessive breast milk production after childbirth.

Cabolac belongs to the dopamine receptor agonist class of medicines, specifically the ergot alkaloid (ergoline) derivative sub-class, used as a prolactin-lowering (antihyperprolactinemic) agent.

Cabergoline is a potent, long-acting dopamine receptor agonist with high selectivity and affinity for dopamine D2 receptors and lower affinity for D1 receptors. By stimulating D2 receptors on the lactotroph cells of the anterior pituitary gland, Cabergoline directly inhibits the synthesis and release of prolactin, lowering elevated serum prolactin concentrations in both healthy individuals and patients with hyperprolactinemia. It also shrinks prolactin-secreting pituitary tumors in many patients over time.

Cabergoline is well absorbed orally, undergoes hepatic metabolism largely independent of the cytochrome P450 system, and has a long elimination half-life of approximately 63–69 hours, which is the pharmacologic basis for its once- or twice-weekly dosing schedule. Prolactin-lowering effects can persist for several weeks after the last dose.

Cabolac is taken by mouth, with a meal to minimize stomach upset, at the same time(s) of day on the prescribed days each week. Tablets should be swallowed whole with water and should not be shared with another person. Do not miss or double doses; if a dose is missed, contact the physician for guidance rather than doubling the next dose.

Before starting Cabolac, tell the physician about all other medicines being used, including the following well-established interactions:

• Dopamine antagonists (e.g., typical/atypical antipsychotics such as phenothiazines and butyrophenones, and prokinetic agents such as metoclopramide): these drugs work against Cabolac and reduce its prolactin-lowering effect; concurrent use is generally avoided.
• Antihypertensive medicines: combined use with Cabolac may increase the risk of low blood pressure (hypotension), particularly with the first few doses; blood pressure should be monitored.
• Other ergot alkaloid derivatives (e.g., ergotamine, other ergoline dopamine agonists): concurrent use is generally avoided due to additive ergot-related vascular and fibrotic risks.
• Macrolide antibiotics (e.g., erythromycin): may increase systemic exposure to Cabolac; caution is advised if co-prescribed.

This list covers the clinically important interactions; it is not exhaustive. Always share a full medication list with the prescribing physician or pharmacist.

Common Side Effects

Less Common but Serious Side Effects

• Cardiac valve disease (valvulopathy) — see Precautions and Warnings.
• Fibrotic reactions affecting the lungs, heart lining (pericardium), or the area behind the abdomen (retroperitoneum).
• Impulse control disorders such as compulsive gambling, hypersexuality, or compulsive shopping/eating.
• Psychiatric disturbances, including worsening of pre-existing psychosis.
• Fainting (syncope), due to low blood pressure.
• Hair thinning (alopecia).

Patients should promptly report any unusual symptoms — such as shortness of breath, swelling of the ankles/legs, chest pain, unusual urges/behaviors, or fainting — to their physician while taking Cabolac.

Pregnancy: Cabolac should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; adequate and well-controlled studies in pregnant women are lacking. Cabolac is contraindicated specifically in pregnancy-induced hypertensive disorders (e.g., pre-eclampsia), unless a specialist determines the benefit outweighs the risk. If pregnancy occurs or is suspected during treatment, the physician should be informed immediately so that the need for continued therapy can be reassessed.

Lactation: Because Cabolac works by suppressing prolactin, it reduces breast milk supply and is used medically for that purpose when breastfeeding is not intended or needs to be stopped. It should not be used by a mother who intends to breastfeed her infant, except under direct medical guidance for that specific purpose. Whether Cabolac passes into breast milk in a mother who continues to breastfeed has not been well studied; a physician's guidance is required in all cases.

Cardiac Valve Disease (Valvulopathy)

Cases of cardiac valve regurgitation and related structural valve damage have been reported with dopamine agonists like Cabolac, more frequently at higher cumulative doses used for other conditions. A baseline echocardiogram is recommended before starting long-term therapy, with follow-up echocardiographic monitoring (roughly every 6–12 months, or as advised) during prolonged treatment. Report any new shortness of breath, swelling of the legs, or heart failure symptoms promptly.

Fibrotic Reactions

Pleural, pericardial, and retroperitoneal fibrosis have been reported. Symptoms such as persistent cough, chest pain, breathlessness, or abdominal/flank pain and swelling should be reported immediately; Cabolac should be discontinued if fibrosis is confirmed.

Low Blood Pressure (Hypotension)

Symptomatic hypotension, including fainting, can occur, particularly with the first few doses or with dose increases; caution is advised when combined with blood-pressure-lowering medicines.

Psychiatric Effects and Impulse Control Disorders

Cabolac may worsen pre-existing psychotic disorders and has been associated with impulse control disorders such as pathological gambling, hypersexuality, and compulsive spending. Patients and families should be counseled to watch for these behaviors; dose reduction or discontinuation should be considered if they occur.

Hepatic Impairment

Use with caution and closer monitoring in patients with significant liver impairment, since drug clearance may be reduced.

See Contraindications for situations where Cabolac must not be used at all.

Reported effects of Cabolac overdose include nasal congestion, fainting (syncope), and hallucinations, largely related to excessive dopaminergic and blood-pressure-lowering effects. There is no specific antidote. If an overdose of Cabolac is suspected, seek immediate medical attention or contact emergency services/a poison control center right away. Management is supportive, including monitoring and treatment of blood pressure, and should only be carried out by qualified medical personnel; do not attempt specific home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Specific dose adjustment data are limited; use Cabolac with caution and physician supervision in patients with significant kidney disease.

Hepatic Impairment

Use with caution, as clearance of Cabolac may be reduced in significant liver disease; closer monitoring is advised (see Precautions and Warnings).

Elderly

Limited specific data are available; use the lowest effective dose and monitor closely for hypotension and other side effects.

Pediatric Patients

Safety and efficacy of Cabolac have not been established in children; it is not generally recommended for pediatric use outside specialist care (see Pediatric Uses).

For hyperprolactinemic disorders, treatment with Cabolac is typically long-term, often continuing for months to years, with periodic prolactin testing and dose adjustment. After serum prolactin has remained normal for about 6 months, a physician may consider a supervised trial of discontinuation, with continued monitoring afterward since prolactin can rise again. For prevention or suppression of postpartum lactation, treatment is short — a single dose or a 2-day course, as prescribed. The exact duration should always be determined by the treating physician.

Dopamine receptor agonists; ergot alkaloid (ergoline) derivatives; antihyperprolactinemic agents.

Cabergoline acts as a potent and highly selective agonist at dopamine D2 receptors located on the lactotroph cells of the anterior pituitary gland, with minimal activity at D1 receptors. Activation of these D2 receptors inhibits the synthesis and secretion of prolactin, lowering elevated serum prolactin levels toward normal and, in many patients with prolactinomas, reducing tumor size over time. Its long elimination half-life (approximately 63–69 hours) and slow dissociation from the receptor account for its prolonged prolactin-lowering effect, permitting once- or twice-weekly oral dosing of Cabergoline.

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The safety and effectiveness of Cabolac in pediatric patients have not been established. Use in children and adolescents should only be considered by a specialist physician in carefully selected situations (such as pediatric prolactinoma) where the expected benefit is judged to outweigh the unknown risks, with close monitoring.