- Approval Id
- fe9e5c3bc97da36d
- Drug Name
- DEANXIT TABLET
- Product Name
- DEANXIT TABLET
- Approval Number
- SIN00913P
- Approval Date
- 1988-05-09
- Registrant
- ZUELLIG PHARMA PTE. LTD.
- Licence Holder
- ZUELLIG PHARMA PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Adults</u><br>
Usually 2 tablets daily: morning and noon.<br>
In severe cases the morning dose may be increased to 2 tablets.</p>
<p><u>Older people (> 65 years)</u><br>
1 tablet in the morning.</p>
<p>Maintenance dose: Usually 1 tablet in the morning.</p>
<p>In cases of insomnia or severe restlessness additional treatment with a sedative in the acute phase is recommended.</p>
<p><u>Paediatric population</u><br>
<u>Children and adolescents (<18 years)</u><br>
Deanxit is not recommended for use in children and adolescents due to lack of data on safety and efficacy.</p>
<p><u>Reduced renal function</u><br>
No clinical data of exposure in patients with reduced renal function are available.</p>
<p><u>Reduced liver function</u><br>
No clinical data of exposure in patients with reduced liver function are available.</p>
<p><u>Method of administration</u><br>
The tablets are swallowed with water.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Anxiety – Depression – Asthenia.</p>
<p>Psychogenic depression. Depressive neuroses. Masked depression. Psychosomatic affections accompanied by anxiety and apathy. Menopausal depressions. Dysphoria and depression in alcoholics and drug-addicts.</p>
- Contraindications
- <p><strong>4.3 Contra-indications</strong></p>
<p>Hypersensitivity to flupentixol and melitracen or to any of the excipients.</p>
<p>Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma, blood disorders, phaeochromocytoma.<br>
Recent myocardial infarction. Any degree of atrioventricular block or disorders of cardiac rhythm and coronary artery insufficiency.</p>
<p>Untreated narrow angle glaucoma.</p>
<p>Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).<br>
Simultaneous administration of melitracen and MAO inhibitors may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia).</p>
<p>As with other tricyclic antidepressants, melitracen should not be given to patients receiving monoamine oxidase inhibitors (MAOIs). Treatment with Deanxit may be instituted 14 days after discontinuation of nonselective MAOIs. Treatment with MAOIs may be introduced 14 days after discontinuation of Deanxit.</p>
<p>Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.</p>
- Atc Code
- N06CA02
- Atc Item Name
- melitracen and psycholeptics
- Pharma Manufacturer Name
- LUNDBECK SINGAPORE PTE. LTD.
