Nortriptyline

Source: UK SPC (eMC) for Nortriptyline 10 mg Film-coated Tablets, §4.2 (https://www.medicines.org.uk/emc/product/11543/smpc). ADULTS: dosage should begin at a low level (50 mg once daily or 25 mg 2-3 times daily); if necessary the dose can be increased gradually in 25 mg increments, no more rapidly than every other day, added to the morning dose. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/ml. Doses above 150 mg per day are not recommended. Lower than usual dosages are recommended for elderly patients, and lower dosages for outpatients than for hospitalised patients under close supervision. Initiate at a low level and increase gradually, noting the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period at the lowest dose that will maintain remission; the maintenance dose should be the same as the optimal therapeutic dose. If minor side-effects develop the dosage should be reduced; discontinue promptly if serious adverse effects or allergic manifestations occur. ELDERLY: 30 to 50 mg/day in divided doses; begin at 10-20 mg daily and increase as required to a maximum of 50 mg — if higher dosing is considered necessary in an elderly patient an ECG should be checked and plasma levels monitored. PLASMA LEVELS: optimal responses have been associated with plasma concentrations of 50 to 150 ng/ml; higher concentrations may be associated with more adverse experiences. Nortriptyline is metabolised by CYP2D6 — 3-10% of the population are 'poor metabolisers' and may have higher than expected plasma concentrations at usual doses; older patients have been reported to have higher plasma concentrations of the active metabolite 10-hydroxynortriptyline. Clinical findings should predominate over plasma concentrations as primary determinants of dosage changes. HEPATIC IMPAIRMENT / POLYPHARMACY: a lower or less frequent dose should be considered in patients with hepatic impairment, concurrent diseases, or who are taking multiple medications. PAEDIATRIC/ADOLESCENT (not expressed as a per-kg dose in the SPC): the use of nortriptyline in children and adolescents to treat depression is NOT recommended due to a lack of evidence regarding its safety and efficacy. Verify any under-18 use against a children's formulary. DURATION: the antidepressive effect usually sets in after 2-4 weeks; treatment is symptomatic and should be continued for a sufficient period, usually 6 months or longer, to prevent recurrence. DISCONTINUATION: discontinue gradually, otherwise withdrawal symptoms such as headache, sleep disturbances, irritability and malaise could develop (these are not indicative of addiction). METHOD OF ADMINISTRATION: for oral administration. §4.5 Interactions was not retrieved in this bundle — the interactions listed below are taken from the §4.3 Contraindications text; verify the full §4.5.