PEXSIG Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pexsig (100 mg tablets).
Qualitative and quantitative composition
Perhexiline maleate 100mg tablets. Perhexiline maleate is 2-(2,2-Dicyclohexylethyl)piperidine maleate. Molecular formula is C<sub>19</sub>H<sub>35</sub>N,C<sub>4</sub>H<sub>4</sub>O<sub>4</sub> and molecular ...
Pharmaceutical form
Pexsig is a white to off-white, flat bevelled tablet, plain on one side and scored with a break line on reverse. Diameter 8.5 mm. Each tablet contains 100 mg perhexiline maleate.
Therapeutic indications
To reduce the frequency of moderate to severe attacks of angina pectoris due to coronary artery disease in patients who have not responded to other conventional therapy or in whom such therapy may be contraindicated. ...
Posology and method of administration
Adults Commence therapy with 100 mg daily. Adjust progressively, up or down, at 2 to 4 weekly intervals based on the results of plasma level monitoring. It is generally advised not to administer more than ...
Contraindications
Pexsig is not recommended in the presence of the following conditions: A history of porphyria; Impaired hepatic or renal function; Known hypersensitivity to perhexiline maleate or any of the ingredients. ...
Special warnings and precautions for use
Cardiovascular effects The safety and efficacy of perhexiline following myocardial infarction (when clinical and laboratory findings are not stable) have not been established. Pexsig has an effect on the ...
Interaction with other medicinal products and other forms of interaction
Alcohol: No information available. Food: No information available. Other Medicines Insulin and Antidiabetic agents: e.g. sulfonylurea: Because hypoglycaemia has been reported in association with the administration ...
Fertility, pregnancy and lactation
Fertility While no teratogenic effects have been established in animal studies, treatment of male and female rats causes a reduction in fertility and treatment of pregnant rabbits and rats then causes ...
Effects on ability to drive and use machines
Because of the possibility of dizziness, weakness, syncope or ataxia, caution should be used when driving vehicles or operating machinery.
Undesirable effects
Short Term (occurring after as little as 24 hours of therapy): nausea, dizziness (usually transient), hypoglycaemia in diabetic patients and torsade de pointes (very rare). Long Term (usually occurring ...
Overdose
Symptoms Reported symptoms following overdosage are nausea and vomiting. Other symptoms that have not been reported but would be anticipated are ataxia and headache. Hepatic damage and cardiac arrhythmias ...
Pharmacodynamic properties
Perhexiline maleate is an anti-anginal agent. Its mechanism of action as an anti-anginal agent has not been fully elucidated in humans; however, in vitro studies suggest that perhexiline causes inhibition ...
Pharmacokinetic properties
Absorption After oral administration, perhexiline maleate is well absorbed (>80%) from the gastrointestinal tract. Bioavailability Complete data on rate and extent of absorption are not available. Distribution ...
Preclinical safety data
No data available.
List of excipients
Lactose monohydrate Maize starch Sucrose Purified talc
Incompatibilities
No data available.
Shelf life
Shelf life: 24 months from the date of manufacture when stored below 30°C.
Special precautions for storage
Store in cool dry place below 30°C.
Nature and contents of container
Bottles (glass) containing 100 tablets.
Special precautions for disposal and other handling
No data available.
Marketing authorization holder
Pharmacy Retailing (NZ) Limited Trading as Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland
Date of first authorization / renewal of the authorization
Date of first approval: 12 October 2009
Date of revision of the text
21 April 2020
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