ESTRACYT Capsule (2019)
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Περιεχόμενα
Name of the medicinal product
Estracyt Capsules.
Qualitative and quantitative composition
Estramustine phosphate 140 mg as estramustine sodium phosphate. For the full list of excipients, see section 6.1
Pharmaceutical form
Capsule. White, hard, gelatin capsules with ESTRACYT and K Ph 750 printed in black ink.
Therapeutic indications
Carcinoma of the prostate, especially in cases unresponsive to, or relapsing after, treatment by conventional oestrogens (stilboestrol, polyoestradiol phosphate etc.) or by orchidectomy.
Posology and method of administration
Posology Adults and the elderly Dosage range may be from 1 to 10 capsules a day by mouth. The capsules should be taken not less than 1 hour before or 2 hours after meals. Milk, milk products or drugs containing ...
Contraindications
Hypersensitivity to estramustine sodium phosphate, oestradiol or nitrogen mustard or to any of the excipients listed in section 6.1. Use in patients with peptic ulceration, or those with severe liver dysfunction ...
Special warnings and precautions for use
Estramustine should be used with caution in patients with a history of thrombophelebitis, thrombosis or thromboembolic disorders, especially if associated with estrogen therapy. Caution should also be ...
Interaction with other medicinal products and other forms of interaction
Oestrogens have been reported to increase both therapeutic activity and toxicity of tricyclic antidepressants, probably via inhibition of their metabolism. Milk, milk products or drugs containing calcium, ...
Fertility, pregnancy and lactation
Estradiol and nitrogen mustard are potentially mutagenic, and therefore males undergoing treatment with estramustine should employ contraceptive measures (see section 5.3). Since Estracyt is indicated ...
Effects on ability to drive and use machines
The effect of estramustine on the ability to drive or use machinery has not been systematically evaluated.
Undesirable effects
The most common adverse reactions include gynaecomastia, nausea/vomiting and fluid retention/oedema. The most serious reactions are embolism, myocardial ischaemia, cardiac failure congestive and angioedema. ...
Overdose
There is no specific antidote. Treatment is symptomatic and supportive (as necessary the gastric contents should be evacuated by gastric lavage) and in the event of dangerously low red cell, white cell ...
Pharmacodynamic properties
ATC Code: L01XX11 Estracyt is a chemical compound of oestradiol and nitrogen mustard. It is effective in the treatment of advanced prostatic carcinoma. Estracyt has a dual mode of action. The intact molecule ...
Pharmacokinetic properties
Estramustine phosphate sodium is rapidly dephosphorylated in the intestine and prostate to estramustine and estromustine, which accumulate in the prostatic tissue. The plasma half-lives of these metabolites ...
Preclinical safety data
In repeat dose toxicity studies in rats, dogs and monkeys the main target organs are the hemolymphopoietic and endocrine systems and male and female reproductive organs, with changes related to both oestrogenic ...
List of excipients
Talcum Sodium lauryl sulfate Colloidal silicon dioxide Magnesium stearate Titanium dioxide (E171) Hard gelatin capsule Black ink (containing black iron oxide (E172), ammonium hydroxide (E527), propylene ...
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Brown glass bottle containing 100 capsules.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste product should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/0973
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 May 2002 Date of latest renewal: 13 Nov 2008
Date of revision of the text
02/2019
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