Curatane

/ Taro

The capsules should be taken with food once or twice daily.
Pediatric Population: The medicine should not be used for the treatment of prepubertal acne and is not recommended in children less than 12 years of age due to a lack of data on efficacy and safety.
Adults including adolescents and the elderly: Isotretinoin therapy should be started at a dose of 0.5 mg/kg daily. The therapeutic response to isotretinoin and some of the adverse effects are dose-related and vary between patients. This necessitates individual dosage adjustment during therapy. For most patients, the dose ranges from 0.5-1.0 mg/kg per day.
Long-term remission and relapse rates are more closely related to the total dose administered than to either duration of treatment or daily dose. It has been shown that no substantial additional benefit is to be expected beyond a cumulative treatment dose of 120- 150 mg/kg. The duration of treatment will depend on the individual daily dose. A treatment course of 16-24 weeks is normally sufficient to achieve remission.
In the majority of patients, complete clearing of the acne is obtained with a single treatment course. In the event of a definite relapse a further course of isotretinoin therapy may be considered using the same daily dose and cumulative treatment dose. As further improvement of the acne can be observed up to 8 weeks after discontinuation of treatment, a further course of treatment should not be considered until at least this period has elapsed.
Patients with severe renal insufficiency: In patients with severe renal insufficiency treatment should be started at a lower dose (e.g. 10 mg/day). The dose should then be increased up to 1 mg/kg/day or until the patient is
receiving the maximum tolerated dose.
Patients with intolerance: In patients who show severe intolerance to the recommended dose, treatment may be continued at a lower dose with the consequences of a longer therapy duration and a higher risk of relapse. In order to achieve the maximum possible efficacy in these patients the dose should normally be continued at the highest tolerated dose.

Treatment of severe cystic acne that does not respond to other treatments.

Isotretinoin is contraindicated in women who are pregnant or breastfeeding.
Isotretinoin is contraindicated in women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met.
Isotretinoin is also contraindicated in patients with hypersensitivity to isotretinoin or to any of the excipients. Isotretinoin 5 mg, 10 mg, 20 mg, 30 mg & 40 mg Capsules contain refined soyabean oil. Therefore, Isotretinoin Capsules are contraindicated in patients allergic to peanut or soya.
Isotretinoin is also contraindicated in patients:
• With hepatic insufficiency
• With excessively elevated blood lipid values
• With hypervitaminosis A
• Receiving concomitant treatment with tetracyclines

Pregnancy Prevention Programme: This medicinal product is TERATOGENIC. See prescribing information for full details.
Psychiatric disorders: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with isotretinoin.
Skin and subcutaneous tissues disorders: Acute exacerbation of acne is occasionally seen during the initial period but this subsides with continued treatment, usually within 7 – 10 days, and usually does not require dose adjustment.
Exposure to intense sunlight or to UV rays should be avoided. Where necessary a sunprotection product with a high protection factor of at least SPF 15 should be used.
Aggressive chemical dermabrasion and cutaneous laser treatment should be avoided in patients on isotretinoin for a period of 5-6 months after the end of the treatment because of the risk of hypertrophic scarring in atypical areas and more rarely post inflammatory hyper or hypopigmentation in treated areas. Wax depilation should be avoided in patients on isotretinoin for at least a period of 6 months after treatment because of the risk of epidermal stripping.
Concurrent administration of isotretinoin with topical keratolytic or exfoliative anti-acne agents should be avoided as local irritation may increase.
Allergic reactions: Anaphylactic reactions have been rarely reported, in some cases after previous topical exposure to retinoids.
Eye disorders: Decreased night vision has also been reported and the onset in some patients was sudden. Patients experiencing visual difficulties should be referred for an expert ophthalmological opinion. Withdrawal of isotretinoin may be necessary.
Musculo-skeletal and connective tissue disorders: Myalgia, arthralgia and increased serum creatine phosphokinase values have been reported in patients receiving isotretinoin, particularly in those undertaking vigorous physical activity. In some cases, this may progress to potentially life threatening rhabdomyolysis.
Hepatobiliary disorders: Liver enzymes should be checked before treatment, 1 month after the start of treatment, and subsequently at 3 monthly intervals unless more frequent monitoring is clinically indicated.
Gastrointestinal disorders: Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing severe (hemorrhagic) diarrhea should discontinue isotretinoin immediately.
Fructose intolerance: Curatane contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
High Risk Patients: In patients with diabetes, obesity, alcoholism or a lipid metabolism disorder undergoing treatment with isotretinoin, more frequent checks of serum values for lipids and/or blood glucose may be necessary. Elevated fasting blood sugars have been reported, and new cases of diabetes have been diagnosed during isotretinoin therapy.
See prescribing information for full details.

The following symptoms are the most commonly reported undesirable effects with isotretinoin: dryness of the mucosa e.g. of the lips, cheilitis, the nasal mucosa, epistaxis, and the eyes, conjunctivitis, dryness of the skin. Some of the side effects associated with the use of isotretinoin are dose-related. The side effects are generally reversible after altering the dose or discontinuation of treatment; however some may persist after treatment has stopped.
See prescribing information for full details.

Patients should not take vitamin A as concurrent medication due to the risk of developing hypervitaminosis A.
Cases of benign intracranial hypertension (pseudotumor cerebri) have been reported with concomitant use of isotretinoin and tetracyclines. Therefore, concomitant treatment with tetracyclines must be avoided.
Concurrent administration of isotretinoin with topical keratolytic or exfoliative anti-acne agents should be avoided as local irritation may increase.

Pregnancy: Pregnancy is an absolute contraindication to treatment with isotretinoin. Women of childbearing potential have to use effective contraception one month before treatment, during and up to one month after treatment. If pregnancy does occur in spite of these precautions during treatment with isotretinoin or in the month following, there is a great risk of very severe and serious malformation of the foetus.
Lactation: Isotretinoin is highly lipophilic, therefore the passage of isotretinoin into human milk is very likely. Due to the potential for adverse effects in child exposed via mothers’ milk, the use of isotretinoin is contraindicated during breast-feeding.
See prescribing information for full details.

Isotretinoin is a derivative of vitamin A. Although the acute toxicity of isotretinoin is low, signs of hypervitaminosis A could appear in cases of accidental overdose. Manifestations of acute vitamin A toxicity include severe headache, nausea or vomiting, drowsiness, irritability and pruritus. Signs and symptoms of accidental or deliberate overdosage with isotretinoin would probably be similar. These symptoms would be expected to be reversible and to subside without the need for treatment.