Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd., Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Amirol is indicated for:
Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increments.
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 150 mg daily divided into two doses.
The maintenance dose is the lowest effective dose.
Initially 10 mg-25 mg daily.
The daily dose may be increased up to 100 mg – 150 mg, depending on individual patient response and tolerability.
Daily doses above 100 mg should be used with caution.
The maintenance dose is the lowest effective dose.
Amitriptyline should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established (see section 4.4).
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.
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 25 mg – 75 mg in the evening. Doses above 100 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.
The analgesic effect is normally seen after 2 – 4 weeks of dosing.
A starting dose of 10 mg – 25 mg in the evening is recommended.
Doses above 75 mg 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.
Amitriptyline should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established (see section 4.4).
Neuropathic pain:
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. Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
h3.Nocturnal enuresis
The recommended doses for:
The dose should be increased gradually.
Dose to be administered 1-1½ hours before bedtime.
An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome.
The maximum period of treatment course should not exceed 3 months.
If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.
When stopping treatment, amitriptyline should be withdrawn gradually.
This medicinal product can be given in usual doses to patients with renal failure.
Careful dosing and, if possible, a serum level determination is advisable.
Depending on individual patient response, a lower dose of amitriptyline should be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to amitriptyline treatment (see section 4.5).
These patients may have higher plasma concentrations of amitriptyline and its active metabolite nortriptyline. Consider a 50% reduction of the recommended starting dose.
Amirol is for oral use.
The tablets should be swallowed with water.
When stopping therapy the drug should be gradually withdrawn over several weeks.
Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility. Convulsions. Fever. Sudden occurrence of CNS depression. Lowered consciousness progressing into coma. Respiratory depression.
Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation). The ECG characteristically show prolonged PR interval, widening of the QRS-complex, QT prolongation, T-wave flattening or inversion, ST segment depression, and varying degrees of heart block progressing to cardiac standstill. Widening of the QRS-complex usually correlates well with the severity of the toxicity following acute overdoses. Heart failure, hypotension, cardiogenic shock. Metabolic acidosis, hypokalemia, hyponatraemia. Post-marketing surveillance and literature reported cases of Brugada syndrome unmasking and Brugada ECG patterns (BEP) with amitriptyline overdose.
Ingestion of 750 mg or more by an adult may result in severe toxicity. The effects in overdose will be potentiated by simultaneous ingestion of alcohol and other psychotropic. There is considerably individual variability in response to overdose.
Overdose with amitriptyline in children could have serious consequences. Children are especially susceptible to coma, cardiotoxicity, respiratory depression, seizures, hyponatraemia, lethargy, sinus tachycardia, drowsiness, nausea, vomiting and hyperglycaemia.
During awakening possibly again confusion, agitation and hallucinations and ataxia.
Treatment:
1. Admission to hospital (intensive care unit) if required. Treatment is symptomatic and supportive.
2. Assess and treat ABC’s (airway, breathing and circulation) as appropriate. Secure an IV access. Close monitoring even in apparently uncomplicated cases.
3. Examine for clinical features. Check urea and electrolytes—look for low potassium and monitor urine output. Check arterial blood gases—look for acidosis. Perform electrocardiograph—look for QRS>0.16 seconds.
4. Do not give flumazenil to reverse benzodiazepine toxicity in mixed overdoses.
5. Consider gastric lavage only if within one hour of a potentially fatal overdose.
6. Give 50 g of charcoal if within one hour of ingestion.
7. Patency of the airway is maintained by intubation, where required. Treatment in respirator is advised to prevent a possible respiratory arrest. Continuous ECG-monitoring of cardiac function for 3-5 days. Treatment of the following will be decided on a case by case basis:
8. Unrest and convulsions may be treated with diazepam.
9. Patients who display signs of toxicity should be monitored for a minimum of 12 hours.
10. Monitor for rhabdomyolysis if the patient has been unconscious for a considerable time.
11. Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Deaths by deliberate or accidental overdosage have occurred with this class of medicament.
5 years.
Store below 25°C. Protect from light and moisture.
Amirol 10 mg film-coated tablets:
PVC/Aluminium blisters. Pack-size of 30 film-coated tablets.
PP containers with PE closure. Pack-sizes of 100, 500 and 1000 film-coated tablets.
Amirol 25 mg film-coated tablets:
PVC-PE-PVDC/Aluminium blisters. Pack-sizes of 30, 50, 100 and 1000 film-coated tablets.
PP containers with PE closure. Pack-size of 1000 film-coated tablets.
Not all pack-sizes may be marketed.
No special requirements.
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