Testosterone (Testosterone)

Trade Name : Testosterone

Actavis Pharma, 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 (Testosterone) which is also known as Testosterone and Manufactured by Actavis Pharma, Inc.. It is available in strength of 10 mg/g per ml. Read more

Testosterone (Testosterone) 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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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. (n- Arrayn- , n- Arrayn- )
Children should avoid contact with unwashed or unclothed application sites in men usin- ng testosterone gel. (n- Arrayn- , n- Arrayn- )
Healthcare providers should advise patients to strictly adhere to recommended instructions for use. (n- Arrayn- , n- Arrayn- , n- Arrayn- )

Testosterone gelu00a01% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Limitations of use:
Testosterone gelu00a01% 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 n- testosteronen- geln- u00a0n- 1% differs from n- testosteronen- geln- u00a0n- 1.62%. For dosage and administration of n- testosteronen- geln- u00a0n- 1.62% refer to its full prescribing information. (n- Arrayn- )
Prior to initiating testosterone gelu00a01%,u00a0confirm 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 n- testosteronen- geln- u00a0n- 1% differs from n- testosteronen- geln- u00a0n- 1.62n- %. For dosage and administration of n- testosteronen- geln- u00a0n- 1.62% refer to its full prescribing information. (n- Arrayn- )
Prior to initiating testosterone gelu00a01%,u00a0confirm 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 ().n
Starting dose of testosterone gelu00a01% is 50 mg of testosterone (4 pump actuations, two 25 mg packets, or one 50 mg packet), applied once daily in the morning. () n
Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply testosterone gelu00a01% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. ()n
Dose adjustment: Testosterone gelu00a01% 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. () n
Patients should wash hands immediately with soap and water after applying testosterone gelu00a01% 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. ()

Testosterone gel 1% for topical use is available as follows:
Testosterone gel 1% for topical use is available as follows:

Metered-dose pump that delivers 12.5 mg of testosterone per actuation. () n
Packets containing 25 mg of testosterone. () n
Packets containing 50 mg of testosterone. ()

No data

Men with carcinoma of the breast or known or suspected prostate cancer. (, ) n
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. () n
Avoid unintentional exposure of women or children to testosterone gelu00a01%. Secondary exposure to testosterone can produce signs of virilization. Testosterone gelu00a01% should be discontinued until the cause of virilization is identified. ()u00a0n
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. () n
Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. ()n
Exogenous administration of androgens may lead to azoospermia. () n
Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease. (, ) n
Sleep apnea may occur in those with risk factors. () n
Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically. (, , , ) n
Testosterone gelu00a01% is flammable until dry. ()

Most common adverse reactions (incidence greater than or equal to 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ()

No data

Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. () n
Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. () n
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 testosterone gelu00a01% 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 testosterone gelu00a01%, washing the application site with soap and water, and appropriate symptomatic and supportive care.

Testosterone gel 1% is a clear, colorless hydroalcoholic gel containing testosterone, USP.
The active pharmacologic ingredient in testosterone gelu00a01% is testosterone, USP, 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 testosterone gelu00a01% are carbomer homopolymer type C, ethyl alcohol 68.9%, 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

Testosterone gelu00a01% is supplied in non-aerosol, metered-dose pumps that deliver 12.5 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.
Testosterone gel 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, USP, respectively.
Keep n- testosteronen- geln- out of the reach of children.
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Disposal
Used testosterone gelu00a01% pumps or used testosterone gelu00a01% 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 (n- Arrayn- )
Patients should be informed of the following:

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA
Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
Rev. A 5/2019

INSTRUCTIONS FOR USE
Testosterone (n- tes tosu02b9n- ter one) Gel 1% CIII
for topical use
Read this Instructions for Use for testosterone gel 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.
u00a0
Applying n- testosterone gel 1%:
How should I store testosterone gel n- 1%?
Keep n- testosterone gel 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.
Manufactured by:Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA
Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
Rev. A 5/2019
u00a0

Actavis
For topical use only.
Rx Only
NDC 0591-3216-30
Testosterone Gel 1%
CIII
2.5 grams per unit dose
Contains 25 mg of testosterone in 2.5 grams of gelper unit dose
Clear, colorless gel provides transdermaldelivery of testosterone through the skin of theshoulders, upper arms, or abdomen.*
PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
*See accompanying package insert.
30 Unit-Dose Packets

Actavis
For topical use only.
Rx Only
NDC 0591-3217-30
Testosterone Gel 1%
CIII
5 grams per unit dose
Containsu00a050 mg of testosterone in 5 grams of gelper unit dose
Clear, colorless gel provides transdermal delivery of testosterone through the skin of the shoulders, upper arms, or abdomen.*
PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
*See accompanying package insert.
30 Unit-Dose Packets

Actavis
NDC 0591-2921-02 n TestosteroneGel 1%Pump
CIII
12.5 mg of testosterone per pump actuation**Each actuation delivers 1.25 grams of gel.
This package contains 2 multi-dose pumps. Each pump is capable ofdispensing 75 grams or 60 metered 1.25 gram doses.
Use as prescribed. Topical testosterone products may have differentdoses, strengths, or application instructions that may result in differentsystemic exposure.
Clear, colorless gel provides transdermal delivery of testosteronethrough the skin of the shoulders, upper arms, or abdomen.*
PHARMACIST: Dispense the accompanyingMedication Guide to each patient.
Rx Only

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Testosterone (Testosterone)

Trade Name : Testosterone

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 (Testosterone)

Trade Name : Testosterone

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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