CYTOTEC Tablet (2018)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Cytotec 200 microgram tablets.
Qualitative and quantitative composition
Each tablet contains 200 micrograms misoprostol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white hexagonal tablets scored both sides, engraved SEARLE 1461 on one side for oral administration.
Therapeutic indications
Cytotec is indicated for the healing of duodenal ulcer and gastric ulcer including those induced by nonsteroidal anti-inflammatory drugs (NSAID) in arthritic patients at risk, whilst continuing their NSAID ...
Posology and method of administration
Posology Adults Healing of duodenal ulcer, gastric ulcer and NSAID-induced peptic ulcer: 800 micrograms daily in two or four divided doses taken with breakfast and / or each main meal and at bedtime. ...
Contraindications
Misoprostol is contraindicated: In women of childbearing potential who are not using effective contraception (see sections 4.4, 4.6 and 4.8) In women who are pregnant, or in whom pregnancy has not been ...
Special warnings and precautions for use
In women of childbearing potential Cytotec must not bestarted on misoprostol until pregnancy is excluded, and should be fully counselled on the importance of adequate contraception while undergoing treatment. ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of NSAIDs and misoprostol in rare cases can cause a transaminase increase and peripheral oedema. Cytotec is predominantly metabolised via fatty acid oxidising systems and has ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential must be informed about the risk of teratogenicity prior to treatment with Cytotec. Treatment must not be initiated until pregnancy is excluded, ...
Effects on ability to drive and use machines
Cytotec can cause dizziness. Patients should be cautioned about operating machinery and driving.
Undesirable effects
The Adverse reaction terms were then categorised utilising the incidence rate as follows: Very Common: ≥1/10 (≥10%) Common: ≥1/100 and <1/10, (≥1% and <10%) Uncommon: ≥1/1000 and <1/100, (≥0.1% and <1%) ...
Overdose
Signs and symptoms of overdose The toxic dose of misoprostol in humans has not been determined. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, ...
Pharmacodynamic properties
Pharmacotherapeutic group: prostaglandins ATC code: A02BB01 Cytotec is an analogue of naturally occurring prostaglandin E1 which promotes peptic ulcer healing and symptomatic relief. Mechanism of action ...
Pharmacokinetic properties
Cytotec is rapidly absorbed following oral administration, with peak plasma levels of the active metabolite (misoprostol acid) occurring after about 30 minutes. The plasma elimination half-life of misoprostol ...
Preclinical safety data
In single and repeat-dose studies in dogs, rats and mice at multiples of the human dose, toxicological findings were consistent with the known pharmacological effects of the E-type prostaglandins, the ...
List of excipients
Microcrystalline cellulose Sodium starch glycolate (Type A) Hydrogenated castor oil Hypromellose
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original package to protect from moisture.
Nature and contents of container
Cold-formed aluminium blister packs of 56, 60, 112, 120 or 140 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0956
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 May 2002 Date of latest renewal: 24 June 2013
Date of revision of the text
07/2018
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
