Indication:
Cystic and conglobate acne
Severe and acne unresponsive to antibiotic therapy
LIST OF DRUGS DURING 2004
Sr.No- 247
Name of the Drug- Isotretinonin Gel ().05%) Pharmacological Classification- For acne
Date of Approval- 11-10-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
LIST OF DRUGS DURING 2007
Sr.No- 80
Name of the Drug- Isotretinoin 0.05% +
Erythromycin 2% gel
Pharmacological Classification- For acne
Date of Approval- 08-06-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007) Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Isotretinon Soft Acne Vulgaris 21-06-2002
Gel capsules
2.Isotretinon 0.5% For Acne 08-06-2007
+ Erythromycin 2% gel
3.Isotretinon Gel (0.05%) For Acne 11-10-2004
Adverse Reaction:
Dryness, erosion of mucosa dryness of nose, skin and eyes monitor for keratitis with dry eye Alopecia rise in liver enzymes and serum triglycercides and risk of fatal pancreatitis nausea, headache droesiness, dizziness, sweating, mood changes
Contra-Indications:
Renal or hepatic impairment hyperliperlipdaemia pre-existing hypervitaminosis A vitamin a supplementation tetracyclines
Special precautions-
Exclude pregnancy before starting therapy Effective contraceptive measures must be taken by women of child-bearing potential for 1 month before , during therapy and at least for 4 weeks after therapy Monitor liver functions before starting therapy.
1 month later and then at 3 months intervals Reduce dose or discontinue if transaminase levels exceed normal Monitor fasting serum lipids before starting treatment, 1 month later and and then at the end of treatment History of intestinal disorders- discontinue if severe diarrhea occurs
Dosages/ Overdosage Etc:
Cystic and conglobate acne Severe and acne unresponsive to antibiotic therapy
Prescriptions by dermatologists only
Initially - 0.5mg/kg body weight as a single dose or in two divided doses with food for 4 weeks adjust according to rrsponse in range 0.1 - 1mg/kg body weight daily for a further 8 -12 weeks
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
isotretinon, etertinate, tretinoin or Vitamin A preparations. Also tell your
healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
2.Pregnancy-
Isotretinoin must not taken during pregnancy because it causes birth defects
in humans. It should not be taken if there is chance that you may become
pregnant during treatment or within one month following treatment.
3. Breast-feeding-
It is known whether isotretinoin passes into breast milk. However, isotretinoin is
not recommended during breast feedding.
4.Children-
Children are more sensitive to the effects of isotretinoin. This may increase the
chance of side effects.
5.Older adults-
There is no specific information comparing use of isotretinoin in the elderly with use
in other age groups
6. Other medicines-
Tell your doctor if you are using any of the following -
Etretinate eg. Tegison or
Tretinoin or
Vitamin A - use of isotretinoin with these medicines will result in increase
in side effects.
Tetracyclines- use of isotretinoin may increase the chance of side effects
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Alcoholism or
Diabetes or
Family history of high triglyceride levels in the blood or
Severe weight problems - use of isotretinoin may increase the chance
of side effects
Manufacturer Details