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Testosterone (Androgel)

Trade Name : Androgel

AbbVie Inc.

GEL

Strength 10 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 10 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
  • Limitations of use:
  • AndroGel 1% 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% differs from AndroGel 1.62%. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. ()
  • Prior to initiating AndroGel 1%, 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% differs from AndroGel 1.62 %. For dosage and administration of AndroGel 1.62% refer to its full prescribing information. ()
  • Prior to initiating AndroGel 1%., 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% is 50 mg of testosterone (two 25 mg packets or one 50 mg packet), applied once daily in the morning. ()
  • Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply AndroGel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. ()
  • Dose adjustment: AndroGel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration. Additionally, serum testosterone concentration should be assessed periodically. ()
  • Patients should wash hands immediately with soap and water after applying AndroGel 1% 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% for topical use is available as follows:
  • AndroGel (testosterone gel) 1% for topical use is available as follows:
  • Packets containing 25 mg of testosterone. ()
  • Packets containing 50 mg of 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%. Secondary exposure to testosterone can produce signs of virilization. AndroGel 1% 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% is flammable until dry. ()
  • Most common adverse reactions (incidence u2265 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ()n n n
  • 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 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% to assess the potential risks of cardiovascular disease and prostate cancer. ()
  • No data
  • There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone concentrations of up to 11,400 ng/dL with a cerebrovascular accident.
  • Treatment of overdosage would consist of discontinuation of AndroGel 1%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
  • AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing testosterone.
  • The active pharmacologic ingredient in AndroGel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:
  • Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.
  • 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.
  • No data
  • AndroGel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5u00a0g or 5u00a0g gel contains 25u00a0mg or 50u00a0mg testosterone, respectively.
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].
  • Disposal
  • Used AndroGel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
  • See FDA-Approved Patient Labeling (Medication Guide)
  • Patients should be informed of the following:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 05/2019
  • 5044279
  • INSTRUCTIONS FOR USE
  • Read this Instructions for Use for ANDROGEL 1% 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%:
  • (Figure A)
  • How should I store ANDROGEL 1%?
  • Keep ANDROGEL 1% 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
  • 5044279
  • NDC 0051u20138425u201330
  • CIII
  • AndroGel(testosterone gel) 1%
  • 30 Unit-dose Packets
  • Contains 25 mg of testosterone in 2.5 Grams of gel per unit dose
  • Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.n
  • 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 0051u20138450u201330
  • CIII
  • AndroGel (testosterone gel) 1%
  • 30 Unit-dose Packets
  • Contains 50 mg of testosterone in 5 Grams of gel per unit dose
  • Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.n
  • 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 0051u20138488u201388

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