Drug Interaction:
Potentiates anticoagulants. Oral hypoglycaemic agents,rifampicin, phenobarb may increase rate of metabolism.
Indication:
U.S. FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
160. Testosterone Undeconate 250mg/ml injection 22-07-08
For Testosterone replacement therapy of male
hypogonadism when testosterone deficiency has
been confirmed by clinical feature or biochemical
tests
U.S.FDA APPROVED DRUGS DURING 2006
15. Testosterone Transdermal Spray 15-02-2006
(12.5mg/spray)
(Addl.Lower strength) For replacement therapy in males with
Testosterone deficency
U.S.FDA APPROVED DRUGS DURING 2007
14. Testosterone cypionate (100mg/200mg)+ 08-0 2-07
Cotton seed oil 736/566mg per ml injection
For Testosterone deficiency
(i.) primary hypogonadism
(ii.) hypogonadotropic hypogonadism
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Testosterone Cypionate 100mg/200mg 08-02-2007
+ Cotton Seed Oil 736/566 per ml injection
For Testotosterone Deficiency
i.Primary Hypogonadism
ii.Hypogomadotropine
2.Testosterone Transdermal Spray 15-02-2006
12.5mg/spray
Addl.lower stgth
For Replacement Therapy in Males with Testosterone deficiency
3.Testosterone Undecanoate 250mg/ml injection 22-07-2008
For Testosterone Replacement Therapy of Male Hypogonadism
when Testosterone Defeciency has been confirmed by clinical
feature or Biochemical tests
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Testosterone decanoate + Jan -1994
isocaproate
Hypogonadism in males, delayed puberty, metastatic cancer
Adverse Reaction:
Accelrate growth of Ca prostrate.Implicated in carcinoma liver,prostrate and renal cell carcinoma. Retension of nitrogen, sodium and water, increased vascularity of skin, hypercalaemia, impaired glucose tolerance, weight gain. Males: gynaecomastia, priapism.
Females: suppression of ovarian activity and menstruation, virilism Children: growth retardation, precocious puberty in boys.
I/M injection: mood swing prior to each injection. Transdermal admin: Reports of increased incidence of BHP, difficulty in patients with small testies.
Subcutaneous implants: Multiple implants needed. Difficulty in removal. Expulsion of implant.
Contra-Indications:
Prostrate carcinoma. Ca male breast,overt cardiac failure, pregnancy.
Special precautions:
Renal/hepatic impairment, epilepsy, migraine, diabetes.
Dosages/ Overdosage Etc:
Indications:
Hypogonadism in males, delayed puberty, metastatic cancer
Dosage:
For IM use only.. 25 to 50 mg 2 or 3 times weekly.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Manufacturer Details