Alliance Pharmaceuticals

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

Summary of Product Characteristics last updated on the eMC: 22/11/2011
SPC Isocarboxazid Tablets 10mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 22/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   16-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes/additions highlighted in red text below:

4.1         Contraindications

 

Isocarboxazid is contra-indicated in patients with any impairment of hepatic function, cerebrovascular disorders or severe cardiovascular disease, and in those with actual or suspected phaeochromocytoma.

 

Selective serotonin reuptake inhibitors (SSRIs): Cases of serious and sometimes fatal reactions (serotonin syndrome) have been reported in patients receiving monoamine oxidase inhibitors (MAOIs) in combination with SSRIs, and in patients who have recently discontinued an SSRI and have been started on a MAOI. Treatment with SSRIs should only be started 2 weeks after discontinuation of Isocarboxazid.

 

Conversely, treatment with Isocarboxazid should not be started until at least a week after stopping a SSRI or related anti-depressant (at least 5 weeks for fluoxetine).


 

4.1         Interaction with other medicinal products and other forms of interaction

 

Like other monoamine oxidase inhibitors, Isocarboxazid potentiates the action of a number of drugs and foods. Patients being treated with a monoamine oxidase inhibitor should not receive indirectly-acting sympathomimetic agents such as amphetamines, metaraminol, fenfluramine or similar anorectic agents, ephedrine or phenylpropanolamine (contained in many proprietary 'cold-cure' medications), dopamine or levodopa. Patients should also be warned to avoid foodstuffs and beverages with a high tyramine content: mature cheeses (including processed cheeses), hydrolysed yeast or meat extracts, alcoholic beverages, particularly heavy red wines such as Chianti, non-alcoholic beers, lagers and wines, and other foods which are not fresh and are fermented, pickled, 'hung', 'matured' or otherwise subject to protein degradation before consumption. Broad bean pods (which contain levodopa) and banana skins may also present a hazard. In extreme cases interactions may result in severe hypertensive episodes. Isocarboxazid should therefore be discontinued immediately upon the occurrence of palpitations or frequent headaches.

 

Pethidine should not be given to patients receiving monoamine oxidase inhibitors as serious, potentially fatal reactions, including central excitation, muscle rigidity, hyperpyrexia, circulatory collapse, respiratory depression and coma, can result. Such reactions are less likely with morphine, but experience of the interaction of Isocarboxazid with narcotic analgesics other than pethidine is limited and extreme caution is therefore necessary when administering morphine to patients undergoing therapy with Isocarboxazid.

 

Isocarboxazid should not be administered together with other monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs) or most tricyclic antidepressants (clomipramine, desipramine, imipramine, butriptyline, nortriptyline or protriptyline). Although there is no proof that combined therapy will be effective, refractory cases of depression may be treated with Isocarboxazid in combination with amitriptyline or trimipramine, provided appropriate care is taken. Hypotensive and other adverse reactions are likely to be increased.

 

Updated on 11/08/2011 and displayed until 22/11/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   22-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7 - Change of ownership Cambridge Labs removed and Alliance Pharmaceuticals added.
Updated on 17/03/2008 and displayed until 11/08/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Changes to Sections 4.4 Special Warnings and Precautions for Use, and 4.8 Undesirable Effects.
Updated on 15/10/2001 and displayed until 17/03/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/07/2001 and displayed until 15/10/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 06/09/1999 and displayed until 06/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   isocarboxazid