Acnotin

Global Market size:

 Innovators information :

Generic Name                                                                     :  Isotretinoin

Company                                                                              :  Roche

Strengths                                                                              :  5 / 10 & 20 mg

Dosage Form                                                                      :  Capsule

Packing                                                                                 :  30’s

Mega’s Specification :

Brand Name                                                                         : Acnotin 10 and Acnotin 20

Dosage form                                                     : Soft gelatin capsule

Packing                                                            : Alu - Alu blister packing of 5 tablets. 6 blisters 

                                                                                                  in one carton.

Composition :

Acnotin 10

Each soft gelatin capsule contains

Isotretinoin………………………………………………………………………………… ……….10 mg

Acnotin 20

Each soft gelatin capsule contains

                  Isotretinoin………………………………………………………………………………… ……….20 mg

Product Source                                                                  : Inhouse

Clinical Pharmacology :

Indication and Dosage :

The usual adult and adolescent dose is 0.5 to 1 mg/kg of body weight per day (in two divided doses) for 15 to 20 weeks; the maximum recommended dose is2 mg/kg of body weight per day and may be required in patients whose disease is very severe or is primarily located on the chest or back instead of on the face. During the initial period of isotretinoin therapy, transient exacerbation of acne may occur; concomitant adrenocorticoid therapy may be required.

Efficacy and side effects vary according to the individual patient; after about 4 weeks therefore, dosage for the maintenance treatment should be adjusted within the range of 0.1-1 mg/kg daily to meet individual needs. Treatment usually lasts a total of 16 weeks. When assessing the results of the therapy, it should be borne in mind that there is often a further improvement after discontinuation of treatment. There should therefore be an interval of at least 8 weeks before re-starting treatment, which should be resumed in accordance with the previously mentioned 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.

Concurrent Topical Therapy: Concurrent administration of other keratolytic or exfoliative antiacne agents is not indicated, nor is concurrent radiation therapy with ultraviolet light indicated. Patients should avoid exposure to the sun. adjuvant therapy with mild topical antiacne drugs may be given, as required.