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Re: Amisulpride and MAOI -- AndrewB

Posted by michael on May 29, 2000, at 16:21:37

In reply to Re: Amisulpride and MAOI -- AndrewB, posted by AndrewB on May 29, 2000, at 9:13:31

> Seamus,
>
> The pharmacist at Farmacia Ceratti said that an internal paper on amisulpride urged caution when combining amisulpride with other antidepressants and that your doctor should be consulted before making such combinations.
>
> I wonder what this advice means in practical terms!


Clinical particulars
Therapeutic indications: Solian (AMISULPRIDE) is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
Posology and method of administration: For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d are recommended. In individual cases, the daily dose may be increased up to 1200 mg/d. Doses above 1200 mg/d have not been extensively evaluated for safety and therefore should not be used. No specific titration is required when initiating the treatment with Solian. Doses should be adjusted according to individual response.

For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms.

Maintenance treatment should be established individually with the minimally effective dose.

For patients characterised by predominant nega- tive symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually.

Solian can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid.

Elderly: Solian should be used with particular caution because of a possible risk of hypotension or sedation.

Children: Solian is contra-indicated in childen under 15 years of age as its safety has not yet been established.

Renal insufficiency: Solian is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min.

As there is no experience in patients with severe renal impairment (CRCL65 years) show that a 10-30% rise occurs in Cmax, T1/2 and AUC after a single oral dose of 50 mg. No data are available after repeat dosing.

Preclinical safety data: An overall review of the completed safety studies indicates that Solian is devoid of any general, organ-specific, teratogenic, mutagenic or carcinogenic risk. Changes observed in rats and dogs at doses below the maximum tolerated dose are either pharmacological effects or are devoid of major toxicological significance under these conditions. Compared with the maximum recommended dosages in man, maximum tolerated doses are 2 and 7 times greater in the rat (200 mg/kg/d) and dog (120 mg/kg/d) respectively in terms of AUC. No carcinogenic risk, relevant to man, was identified in the rat at up to 1.5 to 4.5 times the expected human AUC.

A mouse carcinogenicity study (120 mg/kg/d) and reproductive studies (160, 300 and 500 mg/kg/d respectively in rat, rabbit and mouse) were performed. The exposure of the animals to amisulpride during these latter studies was not evaluated.


Incompatibilities: None known.

Shelf life: Solian 50 and Solian 200: 3 years.

Special precautions for storage: Solian 50 and 200: Store in a dry place below 25°C in its original container.


Instructions for use/handling: No special precautions.

Date of first authorisation/renewal of authorisation
11 August 1997.

Date of (partial) revision of the text
August 1997.


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poster:michael thread:34862
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