July 27, 2016
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Remeron

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Remeron




Indications
Dosage
How Supplied

INDICATIONS

Adults

is indicated for the symptomatic relief of depressive illness.

Long-term Use Of REMERON®

The efficacy of REMERON® 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. Nevertheless, the physician who elects to use REMERON® for extended periods should periodically evaluate the long-term response of the individual patient to the drug.

Geriatrics ( > 65 Years of Age)

Evidence from clinical trials and experience suggests that use in geriatric populations may be associated with differences in safety or effectiveness. A brief discussion can be found in the appropriate sections [see WARNINGS AND PRECAUTIONS, Neurologic, Somnolence; Special Populations, Geriatrics ( > 65 years of age); DOSAGE AND ADMINISTRATION; ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics].

Pediatrics ( < 18 Years of Age)

REMERON® is not indicated for use in patients below the age of 18 years (see WARNINGS AND PRECAUTIONS, General, Potential Association with Behavioural and Emotional Changes, Including Self-Harm; see also ADVERSE REACTIONS/Pediatrics, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY Special Populations and Conditions/Pediatrics).

DOSAGE AND ADMINISTRATION

REMERON® is not indicated for use in children under 18 years of age (see WARNINGS AND PRECAUTIONS, Potential Association With Behavioural And Emotional Changes, Including Self-Harm).

Dosing Considerations

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 REMERON®, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding (see WARNINGS AND PRECAUTIONS). When treating pregnant women with REMERON® during the third trimester, in the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Thephysician mayconsider tapering REMERON®in the third trimester.

Children

See WARNINGS AND PRECAUTIONS, Potential Association With Behavioural And Emotional Changes, Including Self-Harm.

Elderly And Patients With Moderate To Severe Renal Or Hepatic Impairment: In elderly patients, and patients with moderate to severe renal or hepaticimpairment, limited pharmacokinetic data (see ACTION AND CLINICAL PHARMACOLOGY) demonstrates increased serum concentration and/or reduced clearance of REMERON®. REMERON®should thus be dosed with care in these populations(see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).

Recommended Dose And Dosage Adjustment

Initial Treatment

Adults

REMERON®Tablets should be administered as a single dose, preferably in the evening prior to sleep. The recommended initial dose is 15mg daily. In clinical trials, patients generally received doses of REMERON®in the range of 15-45mg/day. (The sole available strength –a 30 mg tablet –can be divided into equal halves to achieve various doses)

While a relationship between dose and anti-depressant response for REMERON®has not been established, patients not responding to the initial 15mg dose may benefit from dose increases up to a maximum of 45mg/day(see ACTION AND CLINICAL PHARMACOLOGY, Clinical Trials Showing Efficacy). REMERON® has an elimination half-life of approximately 20-40hours, 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.

Longer-Term Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained therapy beyond response to the acute episode. Systematic evaluation of REMERON® has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to40 weeks following 8-12 weeks of initial treatment at a dose 15-45mg/day (see ACTION AND CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of REMERON® needed for continuation treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for continuation treatment and the appropriate dose for such treatment.

Discontinuation Of Remeron Treatment

Symptoms associated with the discontinuation or dose reduction of REMERON® 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).

A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever is 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).

Missed Dose

Do not take a double dose to make up for forgotten doses.

If a patient forgets to take the evening dose, advise the patient not to take the missed dose the next morning. Continue treatment in the evening (prior to sleep) with the normal dose.

Administration

Administration of REMERON® Tablets

Patients should be instructed to take the tablets at the same time each day, preferably as a single evening dose (prior to sleep). The tablets should be swallowed with water, without chewing (see CONSUMER INFORMATION).

HOW SUPPLIED

Dosage Forms, Composition And Packaging

REMERON® Tablets are supplied as:

30 mg Tablets – oval, scored, red-brown, coated, with “Organon” embossed on one side and “TZ5” on the other side on both sides of the score; available in a carton with 3 blisterpacks; each blisterpack contains 10 tablets. The tablet can be divided into equal halves.

Composition: Each film-coated tablet contains 30 mg of REMERON®. Corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hydroxypropylmethyl cellulose, polyethylene glycol 8000, titanium dioxide, yellow and red iron oxides are present as non-medicinal ingredients.

SUMMARY PRODUCT INFORMATION

Route of Administration Dosage Form/Strength Nonmedicinal Ingredients
oral Tablets, 30 mg Corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, hydroxypropylmethyl cellulose, polyethylene glycol 8000, titanium dioxide, yellow and red iron oxides

Storage And Stability

Store at controlled room temperature, 15°C - 30°C. Dispense in a tight, light-resistant container.

Special Handling Instructions

The tablets should be swallowed with water, without chewing. The patient should be instructed not to chew the tablet.

Merck Canada Inc., 16750 route Transcanadienne, Kirkland, QC Canada H9H 4M7. www.merck.ca.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/22/2015

Indications
Dosage
How Supplied

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