sure.
9.3 Dependence
Behaviors Associated with Addiction
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterizedby the following behaviors:
Taking greater dosages than prescribed
Continued drug use despite medical and social problems due to drug use
Spending significant time to obtain the drug when supplies of the drug are interrupted
Giving a higher priority to drug use than other obligations
Having difficulty in discontinuing the drug despite desires and attempts to do so
Experiencing withdrawal symptoms upon abrupt discontinuation of use Geriatric patients treated with androgens may also be at risk for worsening of signs andsymptoms of BPH [see Warnings and Precautions (5.4)].
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuationor a significant dose reduction of a drug. Individuals taking supratherapeutic doses oftestosterone may experience withdrawal symptoms lasting for weeks or months which includedepressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia,decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indicationshas not been documented.
10 OVERDOSAGE
There is a single report of acute overdosage with use of an approved injectable testosteroneproduct: this subject had serum testosterone concentrations of up to 11,400 ng/dL which wereimplicated in a cerebrovascular accident.
One case of overdose with JATENZO was reported in clinical trials. This patient inadvertentlytook a higher dose than prescribed (474 mg twice daily, which is 20% higher than the maximumrecommended dose). He did not report any adverse reactions associated with the overdose.
Treatment of overdosage consists of discontinuation of JATENZO and appropriate symptomaticand supportive care.
11 DESCRIPTION
JATENZO for oral use is provided as a gelatin capsule containing testosterone undecanoate, afatty-acid ester of testosterone. Testosterone undecanoate is a white to off-white yellowcrystalline powder. Testosterone, an androgen, is formed by cleavage of the ester side chain oftestosterone undecanoate.
Testosterone undecanoate is chemically described as 17β-hydroxyandrost-4-en-3-oneundecanoate. It has the empirical formula of C30H48O3 and the molecular weight of 456.7. Thestructural formula for testosterone undecanoate is presented in Figure 1.
Figure 1: Testosterone Undecanoate
JATENZO capsules are available in three strengths of 158 mg, 198 mg, and 237 mg.
The 158 mg strength is an opaque red capsule that contains 158 mg of testosterone undecanoateand is imprinted with “158” in white ink. The 198 mg strength is an opaque white capsule thatcontains 198 mg of testosterone undecanoate and is imprinted with “198” in red ink. The 237mg strength is an opaque orange capsule that contains 237 mg of testosterone undecanoate and is imprinted with “237” in white ink. All capsule strengths also contain oleic acid, polyoxyl 40hydrogenated castor oil (Cremophor RH 40), borage seed oil, peppermint oil, and butylatedhydroxytoluene as inactive ingredients.
Gelatin capsule shells are composed of the following inactive ingredients: Gelatin, sorbitol,glycerin, purified water, iron oxide red, |
