For the use of a Dermatologist only
Isotretinoin Capsules USP 20 mg
Acnenur may cause severe birth defects; female patients must not take this medicine if they are pregnant or may likely become pregnant during treatment. Pregnancy should be avoided for 6 months after stopping the treatment. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Acnenur in any amount, even for short periods of time. Potentially any foetus exposed during pregnancy can be affected. Presently, there are no accurate means of determining whether an exposed fetus has been affected.
Birth defects that have been documented following Acnenur exposure include abnormalities of the face, eyes, ears, skull, central nervous system (CNS), cardiovascular system, thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.
If pregnancy does occur during the treatment of a female patient who is taking Acnenur, Acnenur must be discontinued immediately and she should be referred to an obstetrician-gynaecologist experienced in reproductive toxicity for further evaluation and counselling.
Composition of Acnenur 20 mg:
Each soft gelatin capsule contains :
Isotretinoin USP………20 mg.
Excipients……………….q.s.
Appropriate overage is added Approved colours used in capsule shell.
Pharmacodynamics :
Acnenur is a retinoid, which when administered in pharmacologic dosages of 0.5 to 1.0 mg/kg/day, inhibits sebaceous gland function and keratinization. The exact mechanism of action of Acnenur is unknown.
Pharmacokinetics :
Absorption
Due to its high lipophilicity, oral absorption of Acnenur is enhanced when given with a high-fat meal. The time to peak concentration was also increased with food and may be related to a longer absorption phase. Therefore, Acnenur should always be taken with food. Clinical studies have shown that there is no difference in the pharmacokinetics of Acnenur between patients with nodular acne and healthy subjects with normal skin.
Distribution
Acnenur is more than 99.9% bound to plasma proteins, primarily albumin.
Dosage And Administration of Acnenur 20 mg:
The required laboratory testing must be completed prior to dosing Acnenur.
Pregnancy Testing and Contraceptive measures must be followed prior to dosing Acnenur. Acnenur should be administered with a meal.
The recommended dosage range for Acnenur is 0.5 to 1.0 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5 and 1.0 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for re-treatment with the lower dosages.
The optimal interval before re-treatment has not been defined for patients who have not completed skeletal growth. Long-term use of Acnenur, even in low doses, has not been studied and is not recommended. It is important that Acnenur be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Acnenur on bone loss is unknown.
Contraceptive measures must be followed for any subsequent course of therapy.
Warnings And Precautions of Acnenur 20 mg:
Teratogenicity
Acnenur may cause severe birth defects; female patients must not take this medicine if they are pregnant or may likely become pregnant during treatment. Pregnancy should be avoided for 6 months after stopping the treatment. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Acnenur in any amount, even for short periods of time.
Hypersensitivity
Anaphylactic reactions, and other allergic reactions have been reported in Acnenur-treated patients.
Drug Interactions :
Vitamin A, Tetracyclines, Oral contraceptives should be avoided.
Liver Function Tests:
Pre-treatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to Acnenur has been established. Since elevations of liver enzymes have been observed during clinical trials and hepatitis has been reported in patients on isotretinoin, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to isotretinoin has been established.
Serious Skin Reactions
Patients should be monitored closely for severe skin reactions and discontinuation of Acnenur should be considered if needed.
Lipid Abnormalities
Elevations of serum triglycerides have been reported in excess of 800 mg/dL have been reported in patients treated with Acnenur. If Acnenur therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended.
Hepatotoxicity
If hepatitis is suspected during treatment with Acnenur, the drug should be discontinued and the aetiology further investigated.
Overdosage :
In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness and ataxia. All symptoms are quickly resolved without apparent residual effects.
Storage:
Store below 30°C in a cool & dry place. Protect from direct light, heat & moisture. Keep out of reach of children.
Patient Information Leaflet for Acnenur 20 mg
1. What are Acnenur?
Acnenur contains isotretinoin and are prescribed to treat severe form of pimples, which in medical terminology is called as severe refractory nodulocystic acne.
2. What facts do I need to know about Acnenur?
- Acnenur are indicated in severe pimples in both males and females and is to be taken under a doctor’s supervision only.
- Acnenur are strictly a prescription-based drug. Under no circumstances should you suggest it to anyone else even if his or her condition resembles yours.
- You might have difficulty in using contact lenses.
- Vitamin A supplements should be avoided while on therapy.
- Patients with a family or personal history of diabetes, liver disease, heart disease or depression should inform their doctor before the start of the therapy.
- If your acne returns, do not take Acnenur of your own on your old prescription. Consult your doctor again.
3. What precautions do I need to take when I am on Acnenur therapy?
- Do not donate blood during the course of therapy and 1 month after discontinuation of therapy.
- Avoid prolonged exposure to sunlight. Use a sunscreen.
- Avoid night driving.
- Avoid removal of body hair by using wax due to the increased chances of scarring and for at least 6 months thereafter.
4. What special precautions to be taken by female patients of childbearing potential?
- Acnenur may cause severe birth defects; you must not take this medicine if you are pregnant or may likely become pregnant during treatment.
- You should also avoid pregnancy for 6 months after stopping the treatment.
- Patients should use effective contraceptive methods 1 month prior to starting the therapy, during the therapy and 6 months after stopping the therapy.
- Avoid breastfeeding during the therapy and one month after stopping the therapy.
You must sign a consent form before undertaking the treatment of Acnenur.
Presentation :
30 Softgel Capsules
Marketed by:
PYXUS PHARMACEUTICALS PVT. LTD.
