Comment
Author: Admin | 2025-04-28
Fatal, have been reported in association with amitriptyline treatment. Most of these reactions occurred within 2 to 6 weeks. At the time of prescription patients should be advised of the signs and symptoms and monitored closely for cutaneous reactions. If signs and symptoms suggestive of these reactions appear, Amitriptyline should be withdrawn immediately, treatment with Amitriptyline must not be restarted in this patient at any time and, an alternative treatment should be considered (as appropriate). Paediatric population Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2). Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. 4.5 Interaction with other medicinal products and other forms of interaction Potential for amitriptyline to affect other medicinal products Contraindicated combinations MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of "serotonin syndrome" (see section 4.3). Combinations that are not recommended Sympathomimetic agents: Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants). Adrenergic neurone blockers: Tricyclic antidepressants may counteract the antihypertensive effects of centrally acting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and methyldopa. It is advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants. Anticholinergic agents: Tricyclic antidepressants may potentiate the effects of these drugs on the eye, central nervous system, bowel and bladder; concomitant use of these should be avoided due to an increased risk of paralytic ileus, hyperpyrexia, etc. Drugs which prolong the QT-interval including antiarrhythmics such as quinidine, the antihistamines astemizole and terfenadine, some antipsychotics (notably pimozide and sertindole), cisapride,halofantrine, and sotalol, may increase the likelihood of ventricular arrhythmias when taken with tricyclic antidepressants. Use caution when using amitriptyline and methadone concomitantly due to a potential for additive effects on the QT interval and increased risk of serious cardiovascular effects. Caution is also advised for co-administration of amitriptyline and diuretics inducing hypokalaemia (e.g. furosemide) Thioridazine: Co-administration of amitriptyline and thioridazine (CYP2D6 substrate) should be avoided due to inhibition of thioridazine metabolism and consequently increased risk of cardiac side effects Tramadol: Concomitant use of tramadol (a CYP2D6 substrate) and tricyclic antidepressants (TCAs), such as amitriptyline increases the risk for seizures and serotonin syndrome. Additionally, this combination can inhibit the metabolism of tramadol to the active metabolite and thereby increasing tramadol concentrations potentially causing opioid toxicity. Antifungals such as fluconazole and terbinafine increase serum concentrations of tricyclics and accompanying toxicity. Syncope and torsade de pointes have occurred. Combinations
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