APO-MIRTAZAPINE TABLET 30MG [SIN14012P]

Product Info

APO-MIRTAZAPINE TABLET 30MG

[SIN14012P]

INDICATIONS AND CLINICAL USE

APO-MIRTAZAPINE (mirtazapine) is indicated for the symptomatic relief of depressive illness.

The efficacy of mirtazapine in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 – 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial.

APO-MIRTAZAPINE (mirtazapine) is not indicated for use in children under the 18 years of age (See WARNINGS AND PRECAUTIONS: Potential Association With Behavioural And Emotional Changes, Including Self-Harm – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

DOSAGE AND ADMINISTRATION

APO-MIRTAZAPINE (mirtazapine) is not indicated for use in children under the 18 years of age (see WARNINGS AND PRECAUTIONS: Potential Association With Behavioural And Emotional Changes, Including Self-Harm) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

ADULTS:

APO-MIRTAZAPINE Tablets should be administered as a single dose preferably in the evening prior to sleep. The recommended initial dose is 15 mg daily. In clinical trials, patients generally received doses of mirtazapine in the range of 15–45 mg/day. While a relationship between dose and antidepressant response for APO-MIRTAZAPINE has not been established, patients not responding to the initial 15 mg dose may benefit from dose increases up to a maximum of 45 mg/day. (See ACTIONS AND CLINICAL PHARMACOLOGY, Clinical Trials Showing Efficacy sub-section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Mirtazapine has an elimination half-life of approximately 20–40 hours, therefore, dose changes should occur in intervals of not less than one week. Dosage adjustments may be made according to the tolerance and based on the patient's response.

Treatment should preferably be continued until the patient has been completely symptom-free for 4–6 months. After this, treatment can be gradually discontinued. Mirtazapine begins to exert its effect in general after 1–2 weeks of treatment.

Treatment with an adequate dose should result in a positive response within 2–4 weeks. With an insufficient response, the dose can be increased up to the maximum dose. If there is no response within a further 2–4 weeks, then treatment should be stopped.

Discontinuation of APO-MIRTAZAPINE Treatment:

Symptoms associated with the discontinuation or dosage reduction of mirtazapine have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction (See WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

A gradual reduction in the dose over several weeks rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response. (See WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

TREATMENT OF PREGNANT WOMEN DURING THE THIRD TRIMESTER:

Post-marketing reports indicate that some neonates exposed to SSRIs, or other newer anti-depressants, such as mirtazapine, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). When treating pregnant women with APO-MIRTAZAPINE during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering APO-MIRTAZAPINE in the third trimester.

CHILDREN:

(see WARNINGS AND PRECAUTIONS: POTENTIAL ASSOCIATION WITH Behavioural AND EMOTIONAL CHANGES, INCLUDING SELF-HARM) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

ELDERLY AND PATIENTS WITH MODERATE TO SEVERE RENAL OR HEPATIC IMPAIRMENT:

In elderly patients, and patients with moderate to severe renal or hepatic impairment, limited pharmacokinetic data (see Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) demonstrates increased serum concentration and/or reduced clearance of mirtazapine. APO-MIRTAZAPINE should thus be dosed with care in these populations (See Pharmacokinetics Subsection of CLINICAL PHARMACOLOGY – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CONTRAINDICATIONS

APO-MIRTAZAPINE (mirtazapine) tablets are contraindicated in patients with a known hypersensitivity to mirtazapine and its excipients.