ORATANE CAPSULE 5 MG [SIN14628P]

Product Info

ORATANE CAPSULE 5 MG

[SIN14628P]

Indications
Oratane is indicated for the treatment of severe forms of acne (nodulo-cystic forms) and acne, which has failed to respond to other therapies.

Oratane should only be prescribed by physicians who are experienced in the use of systemic retinoids – preferably dermatologists – and understand the risk of teratogenicity if Oratane is used during pregnancy.

Dosage and Administration
The therapeutic response to Oratane and its adverse events are dose-related and varies between patients. This necessitates individual dosage adjustment during therapy. Oratane therapy should be started at a dose of 0.5 mg/kg daily. For most patients the dose ranges from 0.5–1.0 mg/kg per day. Patients with very severe disease or with truncal acne may require higher daily doses up to 2.0 mg/kg.

A cumulative dose of 120 mg/kg per treatment has been documented to increase remission rates and prevent relapse. The therapy duration in individual patients therefore varies as a function of the daily dose. Complete remission of the acne is often achieved by a therapy course of 16–24 weeks. In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequence of a longer therapy duration.

In the majority of patients complete clearing of the acne is obtained with a single treatment course. In case of a definite relapse, a renewed course of Oratane therapy should be given with the same daily dose and cumulative treatment dose as previously. Since further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, retreatment should not be initiated until after this period.
The capsules should be taken with food once or twice daily.

Overdosage
Although the acute toxicity of overdosage is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Such symptoms are reversible. Nevertheless, evacuation of the stomach may be indicated in the first few hours after overdosage.

Contraindications
Pregnancy (Category X)
Isotretinoin is highly teratogenic. It is, therefore, contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but also in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking ORATANE in any amount even for short periods. Potentially all exposed foetuses can be affected.

Isotretinoin is contraindicated in women of childbearing potential unless the female patient meets all of the following conditions:

• She has severe disfiguring cystic acne resistant to standard therapies.

• She must be reliable in understanding and carrying out instructions.

• She is capable of complying with the mandatory contraceptive measures.

• She is informed by the physicians of the hazards of becoming pregnant during and 1 month after treatment with isotretinoin and she is warned of the possibility of contraceptive failure.

• She confirms that she has understood the warnings.

• She has a negative pregnancy test within two weeks prior to beginning therapy. Monthly repetition of pregnancy testing is recommended.

• She must use effective contraception without any interruption for 1 month before beginning isotretinoin therapy, during therapy and for 1 month following discontinuation of therapy.

At least one and preferably two complementary forms of contraception including a barrier method should be used. Microdosed progesterone preparations (minipills) may be an inadequate method of contraceptive during isotretinoin therapy.

• She starts isotretinoin therapy only on the second or third day of the next menstrual period.

• In the event of relapse treatments she must also use the same uninterrupted and effective contraceptive measures 1 month prior to, during and for 1 month after isotretinoin therapy.

• She must fully understand the precautions and confirm her understanding and her willingness to comply with reliable contraceptive measures as explained to her.

Even female patients, who normally do not employ contraception because of a history of infertility, should be advised to do so while taking isotretinoin, following the above guidelines.

Should pregnancy occur in spite of these precautions during treatment with isotretinoin or in the month following, there is a great risk of very severe malformation of the foetus (involving in particular the central nervous system, the heart and the large blood vessels). If pregnancy does occur, the doctor and patient should discuss the advisability of continuing the pregnancy.

Major human foetal abnormalities related to isotretinoin administration have been documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities, facial dysmorphia, thymus gland abnormalities, parathyroid hormone deficiency and cerebellar malformation. There is also an increased risk of spontaneous abortion.

Isotretinoin is also contraindicated in hepatic and renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values; hypersensitivity to the medicine or any of the excipients.