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Androgel

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Overview

What is Androgel?

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.



What does Androgel look like?



What are the available doses of Androgel?

AndroGel (testosterone gel) 1% for topical use is available as follows:

What should I talk to my health care provider before I take Androgel?

There are insufficient long-term safety data in geriatric patients using AndroGel 1% to assess the potential risks of cardiovascular disease and prostate cancer. ()

How should I use Androgel?

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.


What interacts with Androgel?

Sorry No Records found


What are the warnings of Androgel?

Sorry No Records found


What are the precautions of Androgel?

Sorry No Records found


What are the side effects of Androgel?

Sorry No records found


What should I look out for while using Androgel?

Men with carcinoma of the breast or known or suspected prostate cancer. (, )

Pregnant or breastfeeding women. Testosterone may cause fetal harm. (, , )


What might happen if I take too much Androgel?

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.


How should I store and handle Androgel?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. AndroGel 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, respectively.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.

Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Non-Clinical Toxicology
Men with carcinoma of the breast or known or suspected prostate cancer. (, )

Pregnant or breastfeeding women. Testosterone may cause fetal harm. (, , )





Furosemide

Nifedipine

Drugs that reduce metformin clearance

In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.  

Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins.  

Other

Carbonic anhydrase inhibitors

Alcohol

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. ()

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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