Excel Capsule 12.5 mg (Milnacipran Hydrochloride)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the minimum effective dose should be administered whenever possible. Adults Depression Start with milnacipran hydrochloride 25 mg daily and gradually increase the dose to 50 mg per dose twice daily, taken orally in the morning and evening. It is preferable to take it with meals. Determine the treatment duration according to symptoms; treatment should continue for at least several months (usually 6 months) to prevent the risk of recurrence of depression. As with other antidepressants, the effect of this medicine becomes apparent only after 1～3 weeks of administration. If this medicine is discontinued, the dose should be reduced gradually. Concomitant use of a tranquilizer or anxiolytic during initial treatment may prevent anxiety symptoms or their worsening. However, anxiolytics cannot be considered to necessarily prevent suicide attempts. Treatment of fibromyalgia The recommended dose of this medicine is 50 mg per dose twice daily (100 mg daily). Based on efficacy and tolerability in individual patients, the dose of this medicine may be increased as follows. Administer 12.5 mg once daily as the starting dose, then increase to 12.5 mg twice daily (25 mg daily) on days 2～3, and to 25 mg twice daily (50 mg daily) on days 4～7. From day 7 onward, increase the dose to 50 mg twice daily (100 mg daily). Depending on the patient's response, the dose may be increased up to 100 mg twice daily (200 mg daily). In placebo-controlled trials of this medicine for the treatment of fibromyalgia, efficacy was not observed in long-term trials exceeding 3 months. Administration in specific populations Elderly patients For the treatment of depression, administer milnacipran hydrochloride 25 mg orally in 2∼3 divided doses daily. Up to 60 mg daily may be administered. Patients with renal impairment Dose adjustment is required in patients with renal impairment. Reduce the dose from 50 mg to 25 mg according to the degree of worsening renal function. Creatinine clearance ≥ 60: 50 mg × 2 60＞creatinine clearance≥30: 25 mg × 2 30＞creatinine clearance≥10: 25 mg Discontinuation of treatment Based on current clinical experience, withdrawal symptoms have been observed upon discontinuation of this medicine, as with other serotonin-norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs). Therefore, when discontinuing this medicine, rather than stopping it abruptly, gradually reduce the dose over at least 1∼2 weeks while closely monitoring for these symptoms.

This medication may increase the risk of suicidal thoughts or behaviors in young people with major depressive disorder or psychiatric conditions, so it should not be used in children and adolescents under 18 years of age. This medication can cause a serious side effect known as serotonin syndrome, so caution is necessary when taken with other serotonergic drugs. It may increase blood pressure and heart rate, necessitating regular monitoring of blood pressure and heart rate in patients with hypertension or heart diseases, both before and during the use of this medication. During treatment with this medication, patients should consult healthcare professionals immediately if they experience unusual behavior, mood changes, or suicidal thoughts, and family members or caregivers should closely monitor the patient. Women who are pregnant or breastfeeding should avoid taking this medication, and women of childbearing potential should consult with a physician before use. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as dizziness, anxiety, and insomnia, so the dosage should be gradually reduced under medical supervision. Additionally, it should not be administered to children and adolescents under 18 years of age as safety and efficacy have not been established. In case of overdose, symptoms may include vomiting, difficulty breathing, increased heart rate, so it is crucial to adhere to the prescribed dose, and seek medical attention immediately if an overdose is suspected. This medication should be stored out of reach of children, and it is safer not to transfer it to another container.

• suicidal ideation
• suicidal tendencies
• suicide attempts
• dizziness
• hyperhidrosis
• anxiety
• sudden facial flushing
• urinary difficulty
• nausea
• vomiting

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1°C and 30°C to preserve the medication's efficacy and safety.

Appearance

An opaque, hard capsule with a brownish-yellow color containing a white to cream-white powder.

Package unit

Bottle - 28 capsules/bottle, PTP - 56 capsules/PTP [(14 capsules/PTP × 4)]