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Buy Androgel 1.62



The active pharmacologic ingredient in AndroGel 1.62% is testosterone. Testosterone USP is a white to almost white powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:




buy androgel 1.62


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Prior to initiating AndroGel1.62%, confirm the diagnosis of hypogonadism by ensuring that serumtestosterone concentrations have been measured in the morning on at least twoseparate days and that these serum testosterone concentrations are below the normal range.


AndroGel 1.62% should beapplied to clean, dry, intact skin of the upper arms and shoulders. Do notapply AndroGel 1.62% to any other parts of the body, including the abdomen,genitals, chest, armpits (axillae), or knees [see CLINICAL PHARMACOLOGY].Area of application should be limited to the area that will be covered by thepatient's short sleeve t-shirt. Patients should be instructed to use the palmof the hand to apply AndroGel 1.62% and spread across the maximum surface areaas directed in Table 2 (for pump) and Table 3 (for packets) and in Figure 1.


Once the application site isdry, the site should be covered with clothing [see CLINICAL PHARMACOLOGY].Wash hands thoroughly with soap and water. Avoid fire, flames or smoking untilthe gel has dried since alcohol based products, including AndroGel 1.62%, are flammable.


After the priming procedure,fully depress the actuator once for every 20.25 mg of AndroGel 1.62%. AndroGel1.62% should be delivered directly into the palm of the hand and then applied tothe application sites.


When using packets, the entirecontents should be squeezed into the palm of the hand and immediately appliedto the application sites. When 40.5 mg packets need to be split between the leftand right shoulder, patients may squeeze a portion of the gel from the packetinto the palm of the hand and apply to application sites. Repeat until entirecontents have been applied. Alternatively, AndroGel 1.62% can be applieddirectly to the application sites from the pump or packets.


AndroGel 1.62% is supplied innon-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone percomplete pump actuation. The pumps are composed of plastic and stainless steel andan LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylenecap. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or60-metered pump actuations; each pump actuation dispenses 1.25 g of gel.


AndroGel 1.62% was evaluated ina two-phase, 364-day, controlled clinical study. The first phase was amulti-center, randomized, double-blind, parallel-group, placebo-controlledperiod of 182 days, in which 234 hypogonadal men were treated with AndroGel1.62% and 40 received placebo. Patients could continue in an open-label,non-comparative, maintenance period for an additional 182 days [see ClinicalStudies].


The most common adversereaction reported in the double-blind period was increased prostate specific antigen (PSA) reported in 26 AndroGel 1.62%-treated patients (11.1%). In 17patients, increased PSA was considered an adverse event by meeting one of thetwo pre-specified criteria for abnormal PSA values, defined as (1) averageserum PSA > 4 ng/mL based on two separate determinations, or (2) an averagechange from baseline in serum PSA of greater than 0.75 ng/Ml on twodeterminations.


During the 182-day,double-blind period of the clinical trial, the mean change in serum PSA valuewas 0.14 ng/mL for patients receiving AndroGel 1.62% and -0.12 ng/mL for thepatients in the placebo group. During the double-blind period, seven patientshad a PSA value > 4.0 ng/mL, four of these seven patients had PSA less thanor equal to 4.0 ng/mL upon repeat testing. The other three patients did notundergo repeat PSA testing.


Table 4 shows adverse reactionsreported by > 2% of patients in the 182-day, double-blind period of theAndroGel 1.62% clinical trial and more frequent in the AndroGel 1.62% treatedgroup versus placebo.


In the 182-day double-blindperiod of the study, application site reactions were reported in two (2/234;0.9%) patients receiving AndroGel 1.62%, both of which resolved. Neither ofthese patients discontinued the study due to application site adverse reactions.In the open-label period of the study, application site reactions were reportedin three (3/219; 1.4%) additional patients that were treated with AndroGel1.62%. None of these subjects were discontinued from the study due toapplication site reactions.


Cases of secondary exposureresulting in virilization of children have been reported in postmarketingsurveillance of testosterone gel products. Signs and symptoms have included enlargementof the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signsand symptoms regressed with removal of the exposure to testosterone gel. In afew cases, however, enlarged genitalia did not fully return to age-appropriatenormal size, and bone age remained modestly greater than chronological age. Therisk of transfer was increased in some of these cases by not adhering to precautionsfor the appropriate use of the topical testosterone product. Children and womenshould avoid contact with unwashed or unclothed application sites in men usingAndroGel 1.62% [see DOSAGE AND ADMINISTRATION, Use in SpecificPopulations and CLINICAL PHARMACOLOGY].


There have been postmarketingreports of venous thromboembolic events, including deep vein thrombosis (DVT)and pulmonary embolism (PE), in patients using testosterone products such as AndroGel1.62%. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acuteshortness of breath for PE. If a venous thromboembolic event is suspected,discontinue treatment with AndroGel 1.62% and initiate appropriate workup andmanagement [see ADVERSE REACTIONS].


Due to the lack of controlledevaluations in women and potential virilizing effects, AndroGel 1.62% is notindicated for use in women [see CONTRAINDICATIONS and Use in SpecificPopulations].


With large doses of exogenous androgens, including AndroGel 1.62%, spermatogenesis may be suppressed throughfeedback inhibition of pituitary FSH possibly leading to adverse effects on semenparameters including sperm count.


Prolonged use of high doses oforally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has beenassociated with serious hepatic adverse effects (peliosis hepatis, hepaticneoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be alife-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. AndroGel 1.62%is not known to cause these adverse effects.


Androgens, including AndroGel1.62%, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexistingcardiac, renal, or hepatic disease [see ADVERSE REACTIONS].


Androgens, including AndroGel1.62 %, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrationsis recommended in these patients.


Androgens, including AndroGel1.62%, may decrease concentrations of thyroxin-binding globulins, resulting indecreased total T4 serum concentrations and increased resin uptake of T3 andT4. Free thyroid hormone concentrations remain unchanged, however, and there isno clinical evidence of thyroid dysfunction.


Pregnancy Category X [see CONTRAINDICATIONS]:AndroGel 1.62% is contraindicated during pregnancy or in women who may becomepregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of afetus to androgens may result in varying degrees of virilization. If this drugis used during pregnancy, or if the patient becomes pregnant while taking thisdrug, the patient should be made aware of the potential hazard to the fetus.


Although it is not known howmuch testosterone transfers into human milk, AndroGel 1.62% is contraindicatedin nursing women because of the potential for serious adverse reactions in nursinginfants. Testosterone and other androgens may adversely affect lactation [seeCONTRAINDICATIONS].


The safety and effectiveness ofAndroGel 1.62% in pediatric patients less than 18 years old has not beenestablished. Improper use may result in acceleration of bone age and prematureclosure of epiphyses.


There have not been sufficientnumbers of geriatric patients involved in controlled clinical studies utilizingAndroGel 1.62% to determine whether efficacy in those over 65 years of age differsfrom younger subjects. Of the 234 patients enrolled in the clinical trialutilizing AndroGel 1.62%, 21 were over 65 years of age. Additionally, there isinsufficient long-term safety data in geriatric patients to assess thepotentially increased risks of cardiovascular disease and prostate cancer.


There is a single report ofacute overdosage after parenteral administration of an approved testosterone product in the literature. This subject had serum testosterone concentrationsof up to 11,400 ng/dL, which were implicated in a cerebrovascular accident.There were no reports of overdosage in the AndroGel 1.62% clinical trial.


The potential for testosteronetransfer following administration of AndroGel 1.62% when it was applied only toupper arms/shoulders was evaluated in two clinical studies of males dosed with AndroGel1.62% and their untreated female partners. In one study, 8 male subjectsapplied a single dose of AndroGel 1.62% 81 mg to their shoulders and upperarms. Two (2) hours after application, female subjects rubbed their hands,wrists, arms, and shoulders to the application site of the male subjects for 15minutes. Serum concentrations of testosterone were monitored in female subjectsfor 24 hours after contact occurred. After direct skin-to-skin contact with thesite of application, mean testosterone Cavg and Cmax in female subjectsincreased by 280% and 267%, respectively, compared to mean baselinetestosterone concentrations. In a second study evaluating transfer oftestosterone, 12 male subjects applied a single dose of AndroGel 1.62% 81 mg totheir shoulders and upper arms. Two (2) hours after application, femalesubjects rubbed their hands, wrists, arms, and shoulders to the applicationsite of the male subjects for 15 minutes while the site of application wascovered by a t-shirt. When a t-shirt was used to cover the site of application,mean testosterone Cavg and Cmax in female subjects increased by 6% and 11%, respectively,compared to mean baseline testosterone concentrations. 041b061a72


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