Drug Information

Drug Interaction:

Plasma levels reduced by tamoxifen

Indication:

LIST OF DRUGS DURING 2007

Sr.No- 53

Name of the Drug- Letrozole 2.5mg tablet

(addl.stgth)

Pharmacological Classification- For induction of ovulation in anavulotory infertility

(addl.indcn)

Date of Approval- 10-04-07

Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)

Advanced or locally advanced breast cancer

Adjuvant therapy for postmenopausal women with hormone receptor postive breast cancer

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Letrozole Anti-cancer 12-03-1998

2.Letrozole 2.5mg tablet 10-04-2007

(Addl.stgth.)

For induction of ovulation in anovolatory infertility

INFORMATION- UPDATE

LETROZOLE - USE IN INFERTILITY BANNED

The drug Controller of India (DCGI ) has banned the use of Letrozole in the treatment of
female infertility. Globally the drug is approved for thetreatment of breast cancer in
post-menopausal women only.(MIMS)

Adverse Reaction:

Hotflushes, arthagia, nausea, vomiting Dizziness, headache

Dyspepsia, constiption Diarrhea Anorexia, alopoecia

Increasedsweating, rash Peripheral odema

Osteoporosis Musculoskeletal pain

Vaginal irritation Thromboembolitic events

Contra-Indications:

Premenopausal women and children Hypersensitivity

Special precautions-

Severe renal impairment Severe hepatic impairment Osteoporosi

Caution when driving or operating machinery

Dosages/ Overdosage Etc:

Indication-

Advanced or locally advanced breast cancer Adjuvant therapy for postmenopausal women with hormone receptor postive breast cancer

Dosage-

Adult- 2.5mg once daily

Letrozole - Aromatase Inhibitors- Hormones- (Mar 1998)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Drug Interaction:

Indication:

Adverse Reaction:

Contra-Indications:

Dosages/ Overdosage Etc:

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