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This medicinal product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis. Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability. Initially 25 mg 2 times daily 50 mg daily. If necessary, the dose can be increased by 25 mg every other day up to mg daily divided into two doses. The daily dose may be increased up to mg — mg, divided into two doses, depending on individual patient response and tolerability. Amitriptyline should not be used in children and adolescents aged less than 18 years, as long term safety and efficacy have not been established see section 4.
The antidepressant effect usually sets in after 2 - 4 weeks. Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time usually up to 6 months after recovery in order to prevent relapse. Neuropathic pain, prophylactic Amt side effects of chronic tension type headache and prophylactic treatment of migraine in adults. Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. Generally, the lowest effective dose should be used for the shortest duration required to treat the symptoms.
Recommended doses are 25mg - 75mg daily in the evening. Doses above mg should be used with caution. The initial dose should be 10 mg - 25 mg in the evening. Doses can be increased with 10 mg - 25 mg every 3 — 7 days as tolerated. The dose can be taken once daily, or be divided into two doses. A single dose above 75 mg is not recommended.
A starting dose of 10mg - 25mg in the evening is recommended. Doses above 75mg should be used with caution. It is generally recommended to initiate treatment in the lower dose range as recommended for adult. The dose may be increased depending on individual patient response and tolerability.
Treatment is symptomatic and should therefore be continued for an appropriate length of time. In many patients, therapy may be needed for several years. Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient. Prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine in adults.
Treatment must be continued for an appropriate length of time. A more suitable dosage form should be used for this age group. An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome. If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.
Depending on individual patient response, a lower dose of amitriptyline should be considered if a strong CYP2D6 inhibitor e. These patients may have higher plasma concentrations of amitriptyline and its active metabolite nortriptyline. Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency. Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline. Amitriptyline should be used with caution in patients with a history of epilepsy, and in those with impaired liver function or phaeochromocytoma.
When used for the depressive component of schizophrenia, amitriptyline may aggravate psychotic symptoms. Cardiac arrhythmias and severe hypotension are likely Amt side effects occur with high dosage. They may also occur in patients with pre-existing heart disease taking normal dosage. Cases of QT interval prolongation and arrhythmia have been reported during the post-marketing period.
Caution is advised in patients with ificant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs. Electrolyte disturbances hypokalaemia, hyperkalaemia, hypomagnesaemia are known to be conditions increasing the proarrhythmic risk. If possible, discontinue this medicinal product several days before surgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated. Great care is necessary if amitriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
This medical product should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus. In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked. Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide suicide- related events. This risk persists until ificant remission occurs.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience Amt side effects the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events, or those exhibiting a ificant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo- controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
In manic-depressives, a shift towards the manic phase may occur; should the patient enter a manic phase amitriptyline should be discontinued. As described for other psychotropics, amitriptyline may modify insulin and glucose responses calling Amt side effects adjustment of the antidiabetic therapy in diabetic patients; in addition the depressive illness itself may affect patients' glucose balance. Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather.
After prolonged administration, abrupt cessation of therapy may produce withdrawal symptoms such as headache, malaise, insomnia and irritability. Amitriptyline should be used with caution in patients receiving SSRIs see sections 4.
Suicidal thoughts and behaviours may also develop during early treatment with antidepressants for disorders other than depression; the same precautions observed when treating patients Amt side effects depression should therefore be followed when treating patients with enuresis. Concomitant administration of amitriptyline with buprenorphine may result in serotonin syndrome, a potentially life-threatening condition see section 4.
If concomitant treatment with buprenorphine is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available see section 4. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Analgesics : increased anticholinergic side-effects with nefopam; increased analgesia with morphine. Increased risk of CNS toxicity when tricyclics given with tramadol. Sympathomimetic agents : Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine e. 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. There is an increased risk of hypertension on clonidine withdrawal. 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 sertindolecisapride, 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. 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 TCAssuch 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. Buprenorphine: Concomitant use of buprenorphine and tricyclic antidepressants TCAssuch as amitriptyline may Amt side effects the risk of serotonin syndrome, a potentially life-threatening condition section 4. Antifungals such as fluconazole and terbinafine increase serum concentrations of tricyclics and accompanying toxicity.
Syncope and torsade de pointes have occurred. Examples of strong CYP2D6 inhibitors include bupropion, fluoxetine, paroxetine and quinidine. These drugs may produce substantial decreases in TCA metabolism and marked increases in plasma concentrations. Dose adjustment of amitriptyline may be necessary see section 4. Other Cytochrome Amt side effects inhibitors : Cimetidine, methylphenidate and calcium-channel blockers e. Antifungals such as fluconazole CYP2C9 inhibitor and terbinafine CYP2D6 inhibitor have been observed to increase serum levels of amitriptyline and nortriptyline.
However, fluvoxamine strong CYP1A2 inhibitor was shown to increase amitriptyline plasma concentrations and this combination should be avoided. Clinically relevant interactions may be expected with concomitant use of amitriptyline and strong CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir. Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each other; this may lead to a lowered convulsion threshold, and seizures.
It may be necessary to adjust the dosage of these drugs. Cytochrome P inducers : Oral contraceptives, rifampicin, phenytoin, barbiturates, carbamazepine and St. John's Wort Hypericum perforatum may increase the metabolism of tricyclic antidepressants and result in lowered plasma levels of tricyclic antidepressants and reduced antidepressant response. In the presence of ethanol amitriptyline free plasma concentrations and nortriptyline concentrations were increased.
Amitriptyline plasma concentration can be increased by sodium valproate and valpromide. Clinical monitoring is therefore recommended. For amitriptyline only limited clinical data are available regarding exposed pregnancies. Animal studies have shown reproductive toxicity see section 5. During chronic use and after administration in the final weeks of pregnancy, neonatal withdrawal symptoms can occur. This may include irritability, hypertonia, tremor, irregular breathing, poor drinking and loud crying and possibly anticholinergic symptoms urinary retention, constipation.
Amitriptyline and its metabolites are excreted into breast milk corresponding to 0. A risk to the suckling child cannot be excluded. Patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about their ability to drive or operate machinery.
These adverse effects can be potentiated by the concomitant intake of alcohol. Amitriptyline may induce side effects similar to other tricyclic antidepressants. Some of the below mentioned side effects e. Electrocardiogram abnormal, electrocardiogram QT prolonged, electrocardiogram QRS complex prolonged, hyponatremia. Weight decreased.
Liver function test abnormal, blood alkaline phosphatase increased, transaminases increased. Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. Behavioural changes have been observed in children receiving tricyclics for treatments of enuresis. Dosages used in enuresis are low compared with those used in depression and side-effects are therefore less frequent. The most common are drowsiness and anticholinergic effects.
The only other side-effects, reported infrequently at these dosages, have been mild sweating and itching. The recommended dosage must not be exceeded. The symptoms associated with withdrawal of tricyclic antidepressants, particularly after prolonged administration, include gastrointestinal disturbances such as nausea; generalised somatic symptoms such as malaise, chills, headache and increased perspiration; irritability, restlessness, anxiety and agitation; sleep disturbances insomnia and vivid dreams ; parkinsonism or akasthisia; hypomania or mania reported rarely, occurring within days of stopping chronic therapy with tricyclic antidepressants ; cardiac arrhythmias.
These symptoms are not indicative of addiction. Withdrawal symptoms seem to be more common and more severe in children. Adverse reactions such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers had taken tricyclic antidepressants in the last trimester of pregnancy.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www. Anticholinergic symptoms : Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility.
Sudden occurrence of CNS depression. Lowered consciousness progressing into coma. Respiratory depression.Amt side effects
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