TOCTINO Capsule, soft (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Stiefel |
---|---|
Διεύθυνση | Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK |
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Περιεχόμενα
Name of the medicinal product
Toctino 10 mg capsules, soft. Toctino 30 mg capsules, soft.
Qualitative and quantitative composition
Each capsule, soft contains 10 mg or 30 mg of alitretinoin. Excipients with known effect: Soya-bean oil. Each 10 mg capsule contains 176.50 mg soya-bean oil. Each 30 mg capsule contains 282.40 mg soya-bean ...
Pharmaceutical form
Capsule, soft. The Toctino 10 mg capsule is a brown oval capsule approximately 11 mm in length and 7 mm in width marked with A1. The Toctino 30 mg capsule is a red-brown oval capsule approximately 13 mm ...
Therapeutic indications
Toctino is indicated for use in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Patients in whom the eczema has predominantly hyperkeratotic ...
Posology and method of administration
Toctino should only be prescribed by dermatologists, or physicians with experience in the use of systemic retinoids who have full understanding of the risks of systemic retinoid therapy and monitoring ...
Contraindications
Pregnancy is an absolute contraindication to treatment with Toctino (see section 4.6). Toctino is contraindicated in woman of childbearing potential unless all of the conditions of the Pregnancy Prevention ...
Special warnings and precautions for use
Teratogenic effects Toctino is a powerful human teratogen inducing a high frequency of severe and life threatening birth defects. Toctino is strictly contraindicated in: Pregnant women Women of childbearing ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interaction Alitretinoin is metabolized by cytochrome P450 (CYP) 2C9, CYP2C8, CYP3A4 and undergoes isomerisation. Concomitant medications that may affect the pharmacokinetics of alitretinoin ...
Fertility, pregnancy and lactation
Pregnancy Pregnancy is an absolute contraindication to treatment with Toctino (see section 4.3). If pregnancy does occur in spite of the pregnancy prevention precautions during treatment with Toctino or ...
Effects on ability to drive and use machines
Decreased night vision has been reported in patients treated with alitretinoin and other retinoids. Patients should be advised of this potential problem and warned to be cautious when driving or operating ...
Undesirable effects
The safety and efficacy of Toctino in patients with severe chronic hand eczema (CHE) unresponsive to treatment with potent topical corticosteroids has been evaluated in two randomised, double blind, placebo-controlled ...
Overdose
Alitretinoin is a derivative of vitamin A. Alitretinoin has been administered in oncological clinical studies at dosages of more than 10-times of the therapeutic dosage given for chronic hand eczema. The ...
Pharmacodynamic properties
Pharmacotherapeutic group: other dermatologicals ATC code: D11AH04 Mechanism of action The pharmacological action of retinoids may be explained by their effects on cell proliferation, cell differentiation, ...
Pharmacokinetic properties
Absorption Alitretinoin is a low solubility, low permeability compound with a low and variable bioavailability. Alitretinoin is not consistently absorbed from the gastrointestinal tract in fasted state. ...
Preclinical safety data
Acute toxicity As with other retinoids, the acute toxicity of alitretinoin was low in mice and rats. The LD<sub>50</sub> after intraperitoneal administration was >4000 mg/kg after 24 hours and 1400 mg/kg ...
List of excipients
Capsule content: Soya-bean oil, refined Partially hydrogenated soya-bean oil Triglycerides, medium chain Beeswax, yellow All-rac-α-tocopherol Capsule shell: Gelatin Glycerol Sorbitol, liquid (non-crystallising) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C. Store in the original package. Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
PVC/PE/PVDC/Aluminum blisters. Pack sizes of 30 capsules, soft.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Marketing authorization holder
GlaxoSmithKline UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS Trading as Stiefel
Marketing authorization number(s)
10mg, 30 capsules PL 19494/0252 30mg, 30 capsules PL 19494/0253
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 May 2013 Date of latest renewal: 30 July 2013
Date of revision of the text
15 June 2020
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