Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: AFT Pharmaceuticals Ltd., PO Box 33.203, Takapuna, Auckland Email:customer.service@aftpharm.com
The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) and the International Statistical Classification of Diseases and Related Health Problems (ICD-10) are standard classifications of mental disorders used by mental health professionals and describe the above mentioned disorders as follows: Treatment of depressive episodes, recurrent depressive disorder or major depression.
During treatment with Ludiomil the patient should be kept under medical surveillance.
The recommended dose range is between 75 and 150 mg daily. Depending on the severity of the symptoms, patient response and tolerance, the daily dose may start at 25 mg (one to three times daily) or 75 mg (once daily) then gradually titrated up to the effective dose. Daily doses above 150 mg are not recommended.
The dosage schedule should be determined individually and adapted to the patient’s condition and response, e.g. by increasing the evening dose while lowering the doses given during the day or, alternatively, by administering only one daily dose. The aim is to achieve a therapeutic effect using the lowest possible doses, particularly in patients who are still growing or elderly patients with an unstable autonomic nervous system, since these patients are generally more likely to experience adverse events.
Ludiomil tablets should be swallowed whole with sufficient liquid. Do not halve the 75 mg tablets. Dose equivalence when the 75 mg tablet is divided has not been established.
In general, lower dosages are recommended. Initially, 10 mg 3 times daily or 25 mg once daily. If necessary, the daily dosage should be gradually increased in small increments up to 25 mg 3 times daily or 75 mg once daily, depending on tolerance and response.
The safety and efficacy of Ludiomil in children and adolescents have not been established. Use in this age group is therefore not recommended.
Abrupt withdrawal or abrupt dose reduction should be avoided because of possible adverse reactions.
The signs and symptoms of overdose with Ludiomil are similar to those reported with tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. In children accidental ingestion of any amount should be regarded as serious and potentially fatal.
Symptoms generally appear within 4 hours of ingestion and reach maximum severity at 24 hours. Due to delayed absorption (anticholinergic effect), long half-life, and enterohepatic recycling, the patient may remain at risk for up to 4 to 6 days. The following signs and symptoms occur.
Central nervous system: somnolence, stupor, coma, ataxia, restlessness, agitation, enhanced reflexes, muscular rigidity and choreo-athetotic movements, convulsions.
Cardiovascular system: hypotension, tachycardia, QTc prolongation, arrhythmias, conduction disorders, shock, heart failure; ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, cardiac arrest, some of which have been fatal. In addition, respiratory depression, cyanosis, vomiting, fever, mydriasis, sweating, and oliguria or anuria may occur.
There is no specific antidote and treatment is essentially symptomatic and supportive.
Patients, particularly children, who may have ingested an overdose of Ludiomil should be hospitalised and kept under close surveillance for at least 72 hours.
The stomach should be emptied as quickly as possible by lavage, or induced emesis if the patient is alert. If the patient is not alert, the airway should be secured with a cuffed endotracheal tube before beginning lavage, and emesis should not be induced. These measures are recommended for up to 12 hours or even longer after the overdose, since the anticholinergic effect of the drug may delay gastric emptying. Administration of activated charcoal may help to reduce drug absorption.
Symptomatic treatment is based on modern methods of intensive care with continuous monitoring of cardiac function, blood gases and electrolytes, and possible need for emergency measures, such as anticonvulsive therapy, artificial respiration, and resuscitation. Physostigmine has been reported to cause severe bradycardia, asystole and convulsions, and its use is therefore not recommended in cases of overdosage with Ludiomil. Haemodialysis and peritoneal dialysis are ineffective because of the low plasma concentrations of maprotiline.
Alkalinisation with sodium bicarbonate or sodium lactate plasma has proved successful in the treatment of cardiac complications. A clinical-toxic test of the blood or plasma is recommended.
36 months.
Store below 30°C.
25 mg: Blister packs of 30, 50 and 100 tablets.
75 mg: Blister packs of 20 and 30 tablets.
No special requirements.
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