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AXIRON

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Overview

What is AXIRON?

AXIRON (testosterone) topical solution is a clear, colorless, single phase solution containing 30 mg of testosterone in 1.5 mL of AXIRON solution for topical administration through the axilla. The active pharmacologic ingredient in AXIRON is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is:

The inactive ingredients are ethanol, isopropyl alcohol, octisalate, and povidone.



What does AXIRON look like?



What are the available doses of AXIRON?

AXIRON (testosterone) topical solution is available as follows:

Each metered-dose pump is supplied with an applicator. ()

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

How should I use AXIRON?

AXIRON is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Limitations of use:

Prior to initiating AXIRON, 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 AXIRON?

Sorry No Records found


What are the warnings of AXIRON?

Sorry No Records found


What are the precautions of AXIRON?

Sorry No Records found


What are the side effects of AXIRON?

Sorry No records found


What should I look out for while using AXIRON?

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

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

• Virilization has been reported in children who were secondarily exposed to topical testosterone products

[see Warnings and Precautions ()]

• Children should avoid contact with unwashed or unclothed application sites in men using AXIRON

[see Dosage and Administration () and Warnings and Precautions ()]

• Healthcare providers should advise patients to strictly adhere to recommended instructions for use

[see Dosage and Administration (), Warnings and Precautions () and Patient Counseling Information ()]


What might happen if I take too much AXIRON?

No cases of overdose with AXIRON have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of AXIRON together with appropriate symptomatic and supportive care.


How should I store and handle AXIRON?

Keep AXIRON out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used AXIRON bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Keep AXIRON out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used AXIRON bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Keep AXIRON out of reach of children.Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Used AXIRON bottles and applicators should be discarded in household trash in a manner that prevents accidental exposure of children or pets. Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Tramadol hydrochloride extended-release tablets USP are supplied in the following package and dose strength forms:100 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L010' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-697-06Bottles of 100 tablets:             NDC 68180-697-01Bottles of 500 tablets:             NDC 68180-697-02200 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L011' on one side and plain on the other side.Bottles of 30 tablets:               NDC 68180-698-06Bottles of 100 tablets:             NDC 68180-698-01Bottles of 500 tablets:             NDC 68180-698-02300 mg tablets (white to off-white circular, biconvex, beveled edge, coated) imprinted with 'L012' on one side and plain on the other sideBottles of 30 tablets:               NDC 68180-699-06Bottles of 100 tablets:             NDC 68180-699-01Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
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 cord 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 carcinoma of the prostate (, )

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

• Virilization has been reported in children who were secondarily exposed to topical testosterone products

[see Warnings and Precautions ()]

• Children should avoid contact with unwashed or unclothed application sites in men using AXIRON

[see Dosage and Administration () and Warnings and Precautions ()]

• Healthcare providers should advise patients to strictly adhere to recommended instructions for use

[see Dosage and Administration (), Warnings and Precautions () and Patient Counseling Information ()]

There has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by Thorazine * solution. Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril , resulted in the occurrence of this precipitate. Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (see ).

Clinically meaningful drug interactions have occurred with concomitant medications and include (but are not limited to) the following:

Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH ()

Avoid unintentional exposure of women or children to AXIRON. Secondary exposure to testosterone can produce signs of virilization. AXIRON should be discontinued until the cause of the 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 testosterone may lead to azoospermia ()

Edema with or without congestive heart failure, 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), liver function, lipid concentrations, hematocrit and hemoglobin periodically (, , , )

AXIRON 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

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).