Testosterone (Androgel)

Trade Name : Androgel

AbbVie Inc.

GEL

Strength 16.2 mg/g

TESTOSTERONE Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Testosterone (Androgel) which is also known as Androgel and Manufactured by AbbVie Inc.. It is available in strength of 16.2 mg/g per ml. Read more

Testosterone (Androgel) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
See full prescribing information for complete boxed warning.

Virilization has been reported in children who were secondarily exposed to testosterone gel (, ).
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel (, ).
Healthcare providers should advise patients to strictly adhere to recommended instructions for use (, , ).

AndroGel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Limitations of use:
AndroGel 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Limitations of use:

Dosage and Administration for AndroGel 1.62% differs from AndroGel 1%. For dosage and administration of AndroGel 1% refer to its full prescribing information. ()
Prior to initiating AndroGel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range.

Dosage and Administration for AndroGel 1.62% differs from AndroGel 1%. For dosage and administration of AndroGel 1% refer to its full prescribing information. ()
Prior to initiating AndroGel 1.62%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ().
Starting dose of AndroGel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet), applied topically once daily in the morning. ()
Apply to clean, dry, intact skin of the shoulders and upper arms. Do not apply AndroGel 1.62% to any other parts of the body including the abdomen, genitals, chest, armpits (axillae), or knees. (, )
Dose adjustment: AndroGel 1.62% can be dose adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter. ()
Patients should wash hands immediately with soap and water after applying AndroGel 1.62% and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. ()

AndroGel (testosterone gel) 1.62% for topical use only, is available as follows:
AndroGel (testosterone gel) 1.62% for topical use is available as follows:

a metered-dose pump that delivers 20.25 mg testosterone per actuation. ()
packets containing 20.25 mg testosterone. ()
packets containing 40.5 mg testosterone. ()

No data

Men with carcinoma of the breast or known or suspected prostate cancer (,u00a0)
Women who are pregnant. Testosterone may cause fetal harm (, )

No data

Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH ()
Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization. AndroGel 1.62% should be discontinued until the cause of virilization is identified ()
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE. ()
Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. ()
Exogenous administration of androgens may lead to azoospermia ()
Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease ()
Sleep apnea may occur in those with risk factors ()
Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically (, , , )
AndroGel 1.62% is flammable until dry ()

The most common adverse reaction (incidence u2265 5%) is an increase in prostate specific antigen (PSA). ()

No data

Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients ()
Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended ()
Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease ()

There are insufficient long-term safety data in geriatric patients using AndroGel 1.62% to assess the potential risks of cardiovascular disease and prostate cancer. ()

No data

There is a single report of acute overdosage after parenteral administration of an approved testosterone product in the literature. This subject had serum testosterone concentrations of up to 11,400u00a0ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdosage in the AndroGel 1.62% clinical trial.
Treatment of overdosage would consist of discontinuation of AndroGel 1.62%, washing the application site with soap and water, and appropriate symptomatic and supportive care.

AndroGel 1.62% for topical use is a clear, colorless gel containing testosterone. Testosterone is an androgen. AndroGel 1.62% is available in a metered-dose pump or unit dose packets.
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:
The inactive ingredients in AndroGel 1.62% are: carbopol 980, ethyl alcohol, isopropyl myristate, purified water, and sodium hydroxide.

No data

Carcinogenesis
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenesis
Testosterone was negative in the Ames and in the mouse micronucleus assays.
Impairment of Fertility
The administration of exogenous testosterone has been reported to suppress spermatogenesis in rats, dogs, and non-human primates, which was reversible on cessation of the treatment.

AndroGel 1.62% was evaluated in a multi-center, randomized, double-blind, parallel-group, placebo-controlled study (182-day double-blind period) in 274 hypogonadal men with body mass index (BMI) 18-40 kg/m and 18-80 years of age (mean age 53.8 years). The patients had an average serum testosterone concentration of <300 ng/dL, as determined by two morning samples collected on the same visit. Patients were Caucasian 83%, Black 13%, Asian or Native American 4%. 7.5% of patients were Hispanic.
Patients were randomized to receive active treatment or placebo using a rotation method utilizing the abdomen and upper arms/shoulders for 182 days. All patients were started at a daily dose of 40.5 mg (two pump actuations) AndroGel 1.62% or matching placebo on Dayu00a01 of the study. Patients returned to the clinic on Day 14, Day 28, and Day 42 for predose serum total testosterone assessments. The patient's daily dose was titrated up or down in 20.25 mg increments if the predose serum testosterone value was outside the range of 350-750u00a0ng/dL. The study included four active AndroGel 1.62% doses: 20.25 mg, 40.5 mg, 60.75 mg, and 81 mg daily.
The primary endpoint was the percentage of patients with C within the normal range of 300-1000 ng/dL on Day 112. In patients treated with AndroGel 1.62%, 81.6% (146/179) had C within the normal range at Day 112. The secondary endpoint was the percentage of patients, with C above three pre-determined limits. The percentages of patients with C greater than 1500 ng/dL, and between 1800 and 2499 ng/dL on Day 112 were 11.2% and 5.5%, respectively. Two patients had a C >2500 ng/dL on Day 112 (2510 ng/dL and 2550 ng/dL, respectively); neither of these 2 patients demonstrated an abnormal C on prior or subsequent assessments at the same dose.
Patients could agree to continue in an open-label, active treatment maintenance period of the study for an additional 182 days.
Dose titrations on Days 14, 28, and 42 resulted in final doses of 20.25 mg u2013 81 mg on Day 112 as shown in .
Figure 3: Mean (u00b1SD) Steady-State Serum Total Testosterone Concentrations on Day 112
Efficacy was maintained in the group of men that received AndroGel 1.62% for one full year. In that group, 78% (106/136) had average serum testosterone concentrations in the normal range at Day 364. summarizes the mean total testosterone profile for these patients on Day 364.
Figure 4: Mean (u00b1SD) Steady-State Serum Total Testosterone Concentrations on Day 364
The mean estradiol and DHT concentration profiles paralleled the changes observed in testosterone. The levels of LH and FSH decreased with testosterone treatment. The decreases in levels of LH and FSH are consistent with reports published in the literature of long-term treatment with testosterone.

AndroGel 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered-dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel.
AndroGel 1.62% is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 1.25 g or 2.5 g gel contains 20.25 mg or 40.5 mg testosterone, respectively.
Store at controlled room temperature 20u00b0-25u00b0C (68u00b0-77u00b0F); excursions permitted to 15u00b0- 30u00b0C (59u00b0- 86u00b0F) [see USP Controlled Room Temperature].
Used AndroGel 1.62% pumps or used AndroGel 1.62% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

See FDA-Approved Medication Guide
Patients should be informed of the following:

This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: 05/2019
5044281

INSTRUCTIONS FOR USE
Read this Instructions for Use for ANDROGEL1.62% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Applying ANDROGEL 1.62%:
If you are using ANDROGEL 1.62% pump:
If you are using ANDROGEL 1.62% packets:
How should I store ANDROGEL 1.62%?
Keep ANDROGEL 1.62% and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: 05/2019
5044281

NDC 0051u20138462u201331
Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, and upper armsn
AndroGel (testosterone gel) 1.62% CIII
30 Unit-dose Packets
Contains 20.25 mg of testosterone in 1.25 Grams of gel per unit dose
Rx only
For Topical Use Only
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. Dispense the enclosed Medication Guide to each patient.
abbvie
NDC 0051u20138462u201330
Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, and upper armsn
AndroGel (testosterone gel) 1.62% CIII
30 Unit-dose Packets
Contains 40.5 mg of testosterone in 2.5 Grams of gel per unit dose
Rx Only
For Topical Use Only
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. Dispense the enclosed Medication Guide to each patient.
abbvie
NDC 0051u20138462u201333
Dispense the accompanying Medication Guide to each patient.
AndroGel (testosterone gel) 1.62% CIII
20.25 mg of testosterone per pump actuationn
For Topical Use Only
Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.
Rx only
Multi-dose pump capable of dispensing 60 metered pump actuations.
abbvie

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Testosterone (Androgel)

Trade Name : Androgel

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Testosterone (Androgel)

Trade Name : Androgel

GEL

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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