Medication info
Dostinen 0.5 mg Tablet (Cabergoline)

Dostinen 0.5 mg Tablet (Cabergoline)

Prescription medicationTabletOral
Ingredient · strength
Cabergoline›0.5mg / 1 tablet
Manufacturer / importer
Darim Biotech Co., Ltd.
Appearance
White oblong tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201800318 · Notified 2018.01.23 · Insurance code 664602270

Summary

Main use
Treatment of hyperprolactinemia (e.g., amenorrhea and galactorrhea); prevention and suppression of milk secretion
Who takes it
Adults
Adult dose
This medication is administered orally. Dopamine agonists such as this medication are better tolerated when taken with food; therefore, take this medication immediately after a meal for all indications. 1. Prevention and suppression of lactation 1) Suppression of lactation: Take cabergoline 1mg as a single dose on the first day after delivery 2) Suppression of established lactation: Take cabergoline 0.25mg every 12 hours for 2 days (total 1mg) 2. Treatment of hyperprolactinemia: The recommended initial dose is cabergoline 0.5mg 1∼2 times a week (e.g., 1/2 tablet on Monday and Thursday). Gradually increase the dose by 0.5mg of cabergoline per week, preferably at monthly intervals, until an optimal therapeutic response is achieved. The usual therapeutic dose is cabergoline 1mg per week, administered within a range of 0.5mg∼2mg per week. However, the maximum dose should not exceed cabergoline 4.5mg per week or 3mg per day. Adjust the number of doses to once weekly or 2 or more times weekly according to the patient's adherence. Tolerability when taking cabergoline 1mg or more once weekly has been evaluated in only a small number of patients; therefore, divided doses are recommended when taking cabergoline 1mg or more per week. During dose escalation, evaluate the patient to determine the minimum dose that produces a therapeutic response. Monitor serum prolactin levels monthly. Once an effective therapeutic dose is reached, serum prolactin levels generally return to normal within 2∼4 weeks. Symptoms of hyperprolactinemia may recur after discontinuing this medication. In some patients, prolactin levels have been observed to remain low for several months. Follow-up of a group of women who discontinued this medication found that 23 of 29 continued to have ovulatory cycles for at least 6 months after discontinuation.

Ingredients

Manufacturer
Darim Biotech Co., Ltd.

Efficacy & effects

Treatment of hyperprolactinemia (e.g., amenorrhea and galactorrhea); prevention and suppression of milk secretion

  • Milk secretion
  • amenorrhea
  • oligomenorrhea
  • anovulation
  • galactorrhea
View approved original text

This medication is used to prevent and suppress milk secretion when a mother does not wish to breastfeed after childbirth, or when breastfeeding is difficult due to health reasons for the mother or newborn. It is also effective in suppressing milk secretion after stillbirth or miscarriage. This medication is used to treat symptoms related to hyperprolactinemia such as amenorrhea, oligomenorrhea, anovulation, and galactorrhea. It helps patients with prolactin-secreting pituitary adenomas or empty sella syndrome. In short, this medication is used to regulate milk secretion and improve symptoms of hyperprolactinemia.

How to take

Adult dose

This medication is administered orally. Dopamine agonists such as this medication are better tolerated when taken with food; therefore, take this medication immediately after a meal for all indications. 1. Prevention and suppression of lactation 1) Suppression of lactation: Take cabergoline 1mg as a single dose on the first day after delivery 2) Suppression of established lactation: Take cabergoline 0.25mg every 12 hours for 2 days (total 1mg) 2. Treatment of hyperprolactinemia: The recommended initial dose is cabergoline 0.5mg 1∼2 times a week (e.g., 1/2 tablet on Monday and Thursday). Gradually increase the dose by 0.5mg of cabergoline per week, preferably at monthly intervals, until an optimal therapeutic response is achieved. The usual therapeutic dose is cabergoline 1mg per week, administered within a range of 0.5mg∼2mg per week. However, the maximum dose should not exceed cabergoline 4.5mg per week or 3mg per day. Adjust the number of doses to once weekly or 2 or more times weekly according to the patient's adherence. Tolerability when taking cabergoline 1mg or more once weekly has been evaluated in only a small number of patients; therefore, divided doses are recommended when taking cabergoline 1mg or more per week. During dose escalation, evaluate the patient to determine the minimum dose that produces a therapeutic response. Monitor serum prolactin levels monthly. Once an effective therapeutic dose is reached, serum prolactin levels generally return to normal within 2∼4 weeks. Symptoms of hyperprolactinemia may recur after discontinuing this medication. In some patients, prolactin levels have been observed to remain low for several months. Follow-up of a group of women who discontinued this medication found that 23 of 29 continued to have ovulatory cycles for at least 6 months after discontinuation.

Precautions

This medication is made with cabergoline and should not be administered to patients with certain diseases or conditions. For instance, patients allergic to any of its components, those with fibrosis in the lungs, heart, or liver, patients with severely impaired liver function, those with preeclampsia, and those currently taking psychiatric medications should not use it. Additionally, patients with liver or kidney function problems, cardiovascular diseases, gastrointestinal bleeding, or a history of mental illness should use this medication cautiously. It may cause hypotension, so patients taking antihypertensives should be careful. This medication contains lactose, thus patients with lactose intolerance or related genetic diseases should not take it. Caution is also required if a pituitary tumor affects vision. Various side effects may occur, including dizziness, headache, dyspepsia, hypotension, and cardiac valve disease; if symptoms are severe or persistent, consult a doctor. If taken long-term, there is a risk of fibrosis in the heart, lungs, and peritoneum, necessitating regular monitoring with cardiac ultrasound and chest X-ray. Since this medication affects dopamine receptors, it should not be taken with dopamine antagonists, and certain antibiotics should also be avoided. Women who are pregnant or planning to become pregnant must consult a doctor before taking this medication and should discontinue use during pregnancy. Nursing mothers should avoid this medication as it can be passed through breast milk; it is advisable to avoid use to continue breastfeeding. Safety for children and adolescents under 19 years has not been established, and experience in the elderly is limited. Overdose may result in symptoms such as dizziness, low blood pressure, and mental confusion, necessitating immediate medical attention. This medication should be stored out of the reach of children and should not be transferred to other containers. Caution is required when driving or operating machinery; if sudden drowsiness or sleepiness occurs, activities should be halted, and a doctor should be consulted. Changes in mental behavior such as impulse control disorders may occur, so any such symptoms should be promptly reported to medical personnel for dosage adjustment or discontinuation consideration.

Side effects

Postural hypotension, vascular spasm of the fingers, syncope, leg cramps, muscle weakness, hair loss, pruritus, rash, allergic skin reactions, decreased hemoglobin levels, depression, sleep disorders, aggression, excessive libido, pathological gambling, increased libido, dizziness, vertigo, headache, sensory disturbances, hypersomnia, facial flushing, abdominal pain, dyspepsia, gastritis, nausea, constipation, vomiting, breast pain, asthenia, fatigue, amnesia, valvular heart disease, pericarditis, pericardial effusion, palpitations, epistaxis, asymptomatic hypotension, pleural effusion, pulmonary fibrosis, upper abdominal pain, lethargy, transient hemianopia, hypersensitivity, delusions, dyspnea, respiratory disease, respiratory failure, liver dysfunction, edema, increased serum creatine phosphokinase levels, nausea, gastric discomfort, confusion, psychosis, hallucinations

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a container that blocks light. It is also advised to keep the medication at room temperature, ideally below 25 degrees Celsius.

Appearance and packaging

Appearance

White oblong tablet

Package unit

30 tablets (10 tablets/PTP x 3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.