NOSTIFIX 0.5MG 8TAB

Indications

Approved Uses

Treatment of hyperprolactinemic disorders (idiopathic hyperprolactinemia or due to prolactin‑secreting pituitary adenomas).

Off-Label Uses

Off-label: Parkinson’s disease (rarely used now), restless legs syndrome, Cushing’s disease (selected cases), and adjunctive use in infertility/ovulation restoration in hyperprolactinemic women (often considered part of hyperprolactinemia management rather than a separate indication).

Dosage & Administration

Dosing by Condition

Hyperprolactinemic disorders: start 0.25 mg twice weekly (or 0.5 mg/week total), then increase by 0.25 mg twice weekly (0.5 mg/week) at intervals of at least 4 weeks as needed; usual maintenance 0.5-1 mg/week (often 1-2 mg/week in practice); maximum commonly referenced is 1 mg twice weekly (2 mg/week) per many product labels, though higher weekly doses may be used under specialist supervision for resistant cases. Lactation inhibition/suppression: do not list as an approved regimen unless confirmed on the local SFDA label for this specific product.

Initial Dose

0.25 mg twice weekly (0.5 mg total per week), with dose increases every 4 weeks as needed based on prolactin levels

Maintenance Dose

1-2 mg per week in divided doses (twice weekly) for hyperprolactinemia

Maximum Dose

Adults-At first, 0.25 mg 2 times a week. Your doctor may increase your dose every 4 weeks as needed, according to body prolactin levels, up to 1 mg two times a week.

Children's Dosage

Safety and efficacy have not been established in patients younger than 18 years.

Dose Adjustment Notes

Titrate gradually based on serum prolactin and tolerability; dose increases should generally not occur more frequently than every 4 weeks; after prolactin is normalized and maintained for ~6 months, a supervised trial of dose reduction/discontinuation may be considered; use caution in hepatic impairment (consider lower doses/longer intervals); no routine renal dose adjustment is required but use caution in severe impairment.

Side Effects

Common Side Effects

Nausea, headache, dizziness/vertigo, constipation, abdominal pain/dyspepsia, asthenia/fatigue, somnolence/drowsiness, and orthostatic hypotension.

Safety & Warnings

Contraindications

Hypersensitivity to cabergoline, other ergot alkaloids/derivatives, or any excipients; uncontrolled hypertension; history or evidence of cardiac valvular disorders/valvulopathy; history of pulmonary, pericardial, or retroperitoneal fibrotic disorders; pregnancy-induced hypertension (e.g., pre-eclampsia/eclampsia) and postpartum hypertension (particularly when used for lactation suppression).

Warnings & Precautions

Baseline and periodic cardiovascular evaluation including echocardiography for valvulopathy risk (especially with long-term/higher doses); monitor for fibrotic reactions (pulmonary/pericardial/retroperitoneal) and discontinue if suspected; risk of orthostatic/first-dose hypotension-monitor blood pressure and counsel on dizziness/syncope; monitor for somnolence/sudden sleep onset; monitor for impulse control disorders and psychiatric symptoms; use caution in hepatic impairment; avoid use in hypertensive disorders of pregnancy/postpartum when used for lactation suppression.

Driving Warning

May Cause Drowsiness

Special Populations

Breastfeeding

Contraindicated

Children

Safety and efficacy have not been established in patients younger than 18 years.

Elderly

Start at lower dose, titrate slowly, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.

Liver Impairment

Hepatic impairment: use with caution; in severe hepatic impairment (Child-Pugh C), use lower doses and titrate more slowly due to increased exposure.

Storage & Patient Advice

Stopping the Medicine

Do not discontinue without prescriber guidance; for hyperprolactinemia, consider a trial withdrawal after prolactin has been normal for ~6 months (and tumor stable if applicable), with ongoing prolactin (and clinical) monitoring for recurrence and re-initiation if needed.

Overdose

Symptoms: nausea/vomiting, abdominal discomfort, dizziness/orthostatic hypotension, syncope, confusion, hallucinations/psychosis (and other dopaminergic effects). Management: urgent medical evaluation, supportive care with blood pressure monitoring; consider activated charcoal if early; dopamine antagonists (e.g., metoclopramide) may be used to counter severe dopaminergic symptoms.

Patient Counseling

Take with food to reduce nausea; take on the same day(s) each week as prescribed; rise slowly to reduce dizziness/orthostatic hypotension and avoid alcohol/other contributors if symptomatic; avoid driving/operating machinery if drowsy or dizzy or if sudden sleep episodes occur; report shortness of breath, persistent cough, chest pain, leg swelling, or new back/abdominal pain (possible fibrotic reactions) and report palpitations or new murmur symptoms; report new or increased impulse-control behaviors (e.g., gambling, hypersexuality, compulsive shopping); keep follow-up appointments for prolactin checks and echocardiography if on long-term therapy.

Pharmacology

Mechanism of Action

Long-acting dopamine D2 receptor agonist that inhibits prolactin secretion from lactotroph cells in the anterior pituitary.

Duration of Effect

Prolactin suppression is prolonged; a single dose can have effects for about 7-14 days (sometimes longer depending on dose and patient factors).

Half-Life

63-69 hours.

Product Information

Available Dosage Forms

Tablet.

Composition per Dose

Each tablet: 0.5 mg cabergoline

Generic Availability

Yes

Hormone Type

Non-hormonal

Method

Oral

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