Acnotin

Acnotin

isotretinoin

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Full Prescribing Info
Contents
Isotretinoin.
Description
Isotretinoin, a stereoisomer of retinoic acid, is 13-cis retinoic acid.
Action
Improvement observed in the clinical picture of severe acne is associated with dose- and time-related suppression of sebaceous gland activity and reduction in the size of sebaceous glands.
Indications/Uses
Severe form of nodulo-cystic acne which is resistant to previous therapy, particularly cystic acne.
Dosage/Direction for Use
The therapy should be started with 0.5-1 mg/kg bodyweight daily in 2 divided doses for 15-20 weeks.
Maximum Dose: 2 mg/kg bodyweight daily. There should be an interval of at least 2 months before restarting treatment.
Administration: The capsules should be taken with meals, without chewing. Avoid sun exposure and alcohol during treatment.
Contraindications
Patients with hepatic and renal insufficiency.
Use in pregnancy & lactation: Isotretinoin is highly teratogenic. Therefore, it is contraindicated in women who are pregnant or who may become pregnant. The female patient should have negative pregnancy test 2 weeks prior to the start of therapy. The patient should use effective contraception without any interruption for 1 month before beginning therapy, during therapy and for 1 month following discontinuation of therapy.
Isotretinoin is contraindicated in nursing mothers.
Use In Pregnancy & Lactation
Isotretinoin is highly teratogenic. Therefore, it is contraindicated in women who are pregnant or who may become pregnant. The female patient should have negative pregnancy test 2 weeks prior to the start of therapy. The patient should use effective contraception without any interruption for 1 month before beginning therapy, during therapy and for 1 month following discontinuation of therapy.
Isotretinoin is contraindicated in nursing mothers.
Side Effects
Most of the side effects of isotretinoin are dose related. Symptoms associated with hypervitaminosis A are the most frequently reported. Unwanted effects, eg:
Skin: Dryness of skin and photosensitivity.
GI Tract: Dryness of the lip, nausea, vomiting, abdominal pain, anorexia and gingivitis.
Eyes: Conjunctivitis, dark adaptation disturbances and lenticular cataract.
CNS: Visual disturbances, headache and depression.
Drug Interactions
Concurrent therapy of isotretinoin with vitamin A, minocyclines, tetracyclines and alcohol must be avoided. Stop applying benzoyl peroxide, sulfur, tretinoin or other topical antiacne drugs before starting treatment with isotretinoin.
Storage
Store below 25°C. Protect from heat and light.
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Presentation/Packing
Cap 10 mg x 3 x 10's.
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