NIMEGEN SOFT CAP. 10 MG [SIN10767P]

Product Info

NIMEGEN SOFT CAP. 10 MG

[SIN10767P]

INDICATIONS
Severe forms of acne (nodulo-cystic forms) which are resistant to previous therapy, particularly cystic acne and acne conglobata, especially when the lesions involve the trunk. NIMEGEN should only be prescribed by physicians who are experienced in the use of systemic retinoids – preferably dermatologists – and understand the risk of teratogenicity if NIMEGEN is used during pregnancy.

DOSAGE & ADMINISTRATION
Oral administration. The therapy should be started with 0.5mg/kg daily. It is not unusual for the acne to be aggravated for a short period at the beginning of treatment. Efficacy and side effects vary according to the individual patient; after about four weeks, therefore, dosage for the maintenance treatment should be adjusted within the range of 0.1–1.0mg/kg daily to meet individual needs. The maximum dosage of 1mg/kg daily should be given for only a limited period of time. Treatment usually lasts a total of 16 weeks. When assessing the result of the therapy, it should be borne in mind that there is often a further improvement after discontinuation of treatment. There should be an interval of at least 8 weeks before restarting treatment, which should be resumed in accordance with the above dosage guidelines. The capsules are taken with meals, low doses once daily and higher amounts as a single dose or in several doses spread over the day.

CONTRAINDICATIONS

1. Hepatic or renal insufficiency

2. Hyperlipidemia : When the serum lipid level is more than double the normal value

3. Hypervitaminosis A

4. Diabetes mellitus

5. Hypersensitivity to isotretinoin

6. Conditions predisposing to hypertriglyceridemia such as high alcohol intake, or history of hypertriglyceridemia, family history of obesity

7. Pregnancy & reproduction
   

   NIMEGEN is highly teratogenic. It is therefore contraindicated not only in women who are pregnant or who may become pregnant while undergoing treatment but in all women of childbearing potential. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking NIMEGEN in any amount even for short periods. Potentially all exposed fetuses can be affected.
   NIMEGEN is contraindicated in women of childbearing potential unless the female patient meets the following conditions:
   • She has severe disfiguring cystic acne resistant to standard therapies.
   • She is reliable in understanding and carrying out instruction.
   • She is capable of complying with the mandatory contraceptive measures.
   • She is informed by her physician of the hazards of becoming pregnant during and one month after treatment with NIMEGEN and she is warned of the possibility of contraceptive failure.
   • She confirms that she has understood the precaution.
   • She has a negative pregnancy test within two weeks prior to start of the therapy. Monthly repetition of pregnancy test is recommended.
   • She uses effective contraception without any interruption for one month before beginning NIMEGEN therapy, during therapy and for one month following discontinuation of therapy.
   • She starts NIMEGEN therapy only on the second or third day of the next normal menstrual period.
   • In the event of relapse treatment she must also use the same uninterrupted and effective contraceptive measures one month prior to, during and one month after NIMEGEN therapy.
   Even female patients who normally do not apply contraception because of a history of infertility should be advised to do so while taking NIMEGEN following the above guidelines. Should pregnancy occur in spite of these precautions during treatment with NIMEGEN or in the month following, there is a great risk of very severe malformation of the fetus (involving in particular the central nervous system, the heart and the large blood vessels). There is also an increased risk of spontaneous abortion. Major human fetal abnormalities related to NIMEGEN 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.

8. Nursing mothers
   NIMEGEN must not be given to nursing mothers