Prior to starting Xyosted, the patient's baseline cardiovascular risk should be considered and blood pressure should be adequately controlled.
Xyosted carries a Boxed Warning regarding blood pressure increases that may potentially increase the risk for major adverse cardiovascular events.
The patient was discharged from the hospital with a drug regimen which included aspirin, carvedilol, digoxin, valsartan, and furosemide.
The researchers found that total testosterone use increased among men from 0.52% in 2002 to 3.20% in 2013, but then decreased to 1.67% in 2016.
To evaluate safety and efficacy of this therapy, study authors gathered data on patients treated with the combination from 2014 to 2017.
Clinicians should use a total testosterone level below 300ng/dL as a reasonable cut-off in support of the diagnosis of low testosterone.
Men should only be diagnosed with hypogonadism, says the new guideline, if they display symptoms of a testosterone deficiency and their measurements of total or free testosterone are unequivocally and consistently low.
The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 6 in favor and 13 against the benefit/risk profile of Tlando (testosterone undecanoate) capsules.
For short term ibuprofen use the effects of compensated hypogonadism are reversible, however the researchers state how it is unknown whether these effects are reversible for long-term ibuprofen use.
The discontinuation is not due to the safety or efficacy of the drug but due to the the multiple manufacturers that currently provide supply to the U.S. market.
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of male sex organs and for the maintenance of secondary sex characteristics.
"Our results highlight the opportunity to intervene both at the provider and the site level to improve testosterone prescribing," the authors write.
The researchers found that of the 72 subjects taking testosterone, at each visit significant increases in hemoglobin/hematocrit levels and BMI were recorded, as was a decrease in high-density lipoprotein level.
Perrigo has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution, the generic version of Eli Lilly's Axiron Topical Solution.
According to a study published in the Journal of Cardiovascular Pharmacology and Therapeutics, long-term testosterone therapy may have protective cardiovascular (CV) effects in men with hypogonadism.
Chronic pain patients being treated with certain opioid and non-opioid medications had significantly lower serum concentrations of free testosterone (fTe) and free estradiol (fE2), highlighting the potential endocrinologic side effects of these drugs. These were the findings of a new study published in the journal Drug Testing and Analysis.
Antares Pharma announced the submission of a New Drug Application (NDA) for QuickShot Testosterone (testosterone enanthate auto-injector) to the Food and Drug Administration (FDA) to treat males with low testosterone associated with hypogonadism.
Despite initial recognition of opioid-induced androgen deficiency (OPIAD) as a possible consequence of opioid use more than four decades ago, few studies have systematically investigated hormonal changes induced by long-term opioid administration.
Men treated with implantable testosterone pellets have a statistically significant increase in mean hematocrit, but it is unlikely to be clinically relevant, according to research published in The Journal of Urology.
Once-daily 2% testosterone solution (T-sol) is safe and effective for sex drive and energy in hypogonadal men, according to a study published online in The Journal of Urology.