Testosterone injection is used for the treatment of men whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.
Testosterone injection is also used in women with breast cancer that has spread to other parts of the body (metastatic).
Testosterone injection is also used to stimulate delayed puberty in male teenagers.
This medicine is to be given only by or under the direct supervision of your doctor. The Testosterone injection® brand is only available under a restricted distribution program called the Testosterone injection® REMS program.
Testosterone injection indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Testosterone injection is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter"s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Testosterone injection should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.
Limitations of use:
Safety and efficacy of Testosterone injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
Safety and efficacy of Testosterone injection in males less than 18 years old have not been established.
How should I use Testosterone injection?
Use Testosterone injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Testosterone injection comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Testosterone injection refilled.
Apply Testosterone injection to clean, dry skin on the shoulders and/or upper arms. Some brands of Testosterone injection may be applied to the stomach area. Check with your pharmacist to see if your brand may be applied to the stomach area.
Apply Testosterone injection to clean, dry skin.
Do not allow another person to apply Testosterone injection for you.
Do not apply Testosterone injection to the scrotum or genitals. Do not apply it over open sores, wounds, or irritated skin.
Wash your hands with soap and water immediately after using Testosterone injection.
Allow Testosterone injection to dry for a few minutes before dressing.
Cover the application site (eg, with a shirt) to prevent others from coming into contact with Testosterone injection. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
For best results, wait 5 hours after applying Testosterone injection before showering or swimming. You may shower or swim after 2 hours with some brands of Testosterone injection. Check with your pharmacist if you have questions about how long you should wait after applying Testosterone injection before you shower or swim.
If you miss a dose of Testosterone injection, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Testosterone injection.
Uses of Testosterone injection in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used by men who do not make enough of a natural substance called testosterone (hypogonadism). Testosterone belongs to a class of drugs known as androgens. Testosterone helps the body to develop and maintain male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.
This drug should not be used by women.
How to use Testosterone injection nasal
Read the Patient Information Leaflet if available from your pharmacist before you start using testosterone and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.
Gently blow your nose before using this medication. Follow the instructions on how to properly prime the bottle if you are using it for the first time.
Use this medication in the nose as directed by your doctor, usually 3 times a day (6 to 8 hours apart). After applying the medication into both nostrils, gently squeeze your nostrils together and lightly massage. Do not apply this medication to other areas of your body. If another part of your body comes in contact with this medication, wash the area with warm water and soap.
Do not blow your nose or sniff for 1 hour after using this medication. Wipe the tip of the applicator with a clean, dry tissue after each use.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Since this drug can be absorbed through the skin and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication.
Tell your doctor if your condition does not improve or if it worsens.
Testosterone injection description
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A potent androgenic steroid and major product secreted by the leydig cells of the testis. Its production is stimulated by luteinizing hormone from the pituitary gland. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to dihydrotestosterone or estradiol.
Testosterone injection dosage
Testosterone injection Dosage
Generic name: TESTOSTERONE 30mg
Dosage form: buccal tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Dosage Information
The recommended dosage for Testosterone injection is the application of one buccal system (30 mg) to the gum region twice daily; morning and evening (about 12 hours apart).
To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured at 4 to 12 weeks after initiation of therapy to ensure proper serum testosterone concentrations are achieved. Testosterone injection therapy should be discontinued if serum testosterone concentrations are consistently outside of the normal range (300 to 1050 ng/dL) despite the use of one buccal system applied twice daily.
Administration Instructions
Testosterone injection should be placed in a comfortable position just above the incisor tooth (on either side of the mouth). With each application, Testosterone injection should be rotated to alternate sides of the mouth.
Upon opening the packet, the rounded side surface of the buccal system should be placed against the gum and held firmly in place with a finger over the lip and against the product for 30 seconds to ensure adhesion. Testosterone injection is designed to stay in position until removed. If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old buccal system should be removed and a new one applied.
If the buccal system falls out of position within the first 8 hours of dosing, replace with a new system and continue for a total of 12 hours from the placement of the first system. If the system falls out of position after 8 hours of dosing, a new buccal system should be applied and it may remain in place for 12 hours then continue with the next regularly scheduled dosing.
Patients should take care to avoid dislodging the buccal system. Patients should check to see if Testosterone injection is in place following consumption of food or alcoholic/non-alcoholic beverages. Testosterone injection should not be chewed or swallowed. To remove Testosterone injection, gently slide it downwards from the gum toward the tooth to avoid scratching the gum. The Testosterone injection buccal system should be removed before routine morning and evening oral care is performed, followed by application of a new buccal system.
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Testosterone injection
Testosterone injection (Advanced Reading)
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Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may necessitate a decrease in the dose of anti-diabetic medication.
Oral Anticoagulants
Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ration (INR) and prothrombin time is recommended in patients taking warfarin, especially at the initiation and termination of androgen therapy.
Corticosteroids
The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires monitoring particularly in patients with cardiac, renal, or hepatic disease.
Oxymetazoline
A 2.6% decrease in mean AUC(0-24) and 3.6% decrease in mean Cmax of total testosterone was observed in males with symptomatic seasonal rhinitis when treated with oxymetazoline 30 minutes prior to Testosterone injection compared to when left untreated. Oxymetazoline does not impact the absorption of testosterone when concomitantly administered with Testosterone injection. Drug interaction potential with other nasally administered drugs other than oxymetazoline has not been studied.
Drug Abuse And Dependence
Controlled Substance
Testosterone injection contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
Abuse
Anabolic steroids, such as testosterone, are abused. Abuse is often associated with adverse physical and psychological effects.
Dependence
Although drug dependence is not documented in individuals using therapeutic doses of anabolic steroids for approved indications, dependence is observed in some individuals abusing high doses of anabolic steroids. In general, anabolic steroid dependence is characterized by any three of the following:
Taking more drug than intended
Continued drug use despite medical and social problems
Significant time spent in obtaining adequate amounts of drug
Desire for anabolic steroids when supplies of the drug are interrupted
Difficulty in discontinuing use of the drug despite desires and attempts to do so
Experience of withdrawal syndrome upon discontinuation of anabolic steroid use
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug can not be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Twelve Week Clinical Trials in Hypogonadal Men
In the Phase 3, open-label study, 98 patients received Testosterone injection for up to 12 weeks. Adverse reactions to Testosterone injection reported by ≥ 1% of patients are listed in Table 1.
Table 1: Adverse Reactions Observed With the Use of Testosterone injection in ≥ 1% of Patients
Adverse Reaction
Testosterone injection
(n=98)
Gum or Mouth Irritation
9.2%
Taste Bitter
4.1%
Gum Pain
3.1%
Gum Tenderness
3.1%
Headache
3.1%
Gum Edema
2.0%
Taste Perversion
2.0%
Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
The following adverse reactions to Testosterone injection occurred in 1 patient each: acne, anxiety, breast enlargement, breast pain, buccal mucosal roughening, difficulty in micturition, fatigue, gingivitis, gum blister, gustatory sense diminished, hematocrit increased, lipids serum increased, liver function tests abnormal, nose edema, stinging of lips, and toothache.
There was one additional 12-week study in 12 patients. In this study, additional adverse reactions to Testosterone injection and reported by 1 patient each included emotional lability and hypertension.
Long-Term Extension Clinical Trials in Hypogonadal Men
In two extension trials, a total of 117 and 51 patients received Testosterone injection for at least 6 months and 1 year, respectively.
Of 117 patients treated for at least 6 months, adverse reactions reported by 1 patient each included: anxiety, buccal inflammation, depression, dry mouth, gum redness, hypertension, infection, medication error, nausea, pruritus, renal function abnormal, stomatitis, taste bitter, taste perversion and toothache. Polycythemia and increased serum prostate specific antigen (PSA) were reported in three and two patients, respectively.
In these two extension studies, a total of 48 patients received Testosterone injection for at least 2 years. In these patients, adverse reactions included: gingival recession, lip ulceration, stomatitis, rash, prostate cancer, increased PSA, abdominal pain, diarrhea, hypertension aggravated, headache, nervousness, polycythemia, taste perversion, aggressiveness, hyperlipidemia, peripheral edema, and anxiety.
Gum-related Adverse Events And Gum Examinations
In the open-label study, all reported gum-related adverse events were collected and gum examinations were conducted at Baseline and every month thereafter.
A total of 16 patients reported 19 gum-related adverse reactions. Of these, ten patients (10.2%) reported 12 reactions of mild intensity, four patients (4.1%) reported 5 reactions of moderate intensity, and two patients (2.0%) reported 2 reactions of severe intensity. Four patients (4.1%) discontinued treatment with Testosterone injection due to gum or mouth-related adverse reactions including two with severe gum irritation, one with mouth irritation, and one with “bad taste in mouth.” Gum irritation generally resolved in 1 to 8 days. Gum tenderness resolved in 1 to 14 days.
Monthly gum examinations were conducted to assess for gingivitis, gum edema, oral lesions, ulcerations or leukoplakia. No cases of ulceration or leukoplakia were observed. No new oral lesions were observed. The incidence of gingivitis and gum edema was not increased during treatment.
In the two extension trials, gum examinations were conducted every 3 months while on treatment. In one of these trials, no patient had a gum abnormality, and in the other trial, moderate gingivitis and mild gum edema were reported by 1 patient each.
In these two extension studies, patient-reported information on Testosterone injection gum adherence was collected every 3 months for 1 year. At each visit, 37% to 52% of patients reported problems with Testosterone injection adhering to the gum. Circumstances surrounding Testosterone injection detachment included eating, drinking and oral care. Hot foods and hot beverages were more likely to be associated with detachment than cold food and cold beverages.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Testosterone injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis, red blood cell increased, dysgeusia, venous thromboembolism, myocardial infarction, and stroke.
Testosterone injection is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
Testosterone injection is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testosterone injection may cause fetal harm when administered to a pregnant woman. Testosterone injection may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with Testosterone injection. If a pregnant woman is exposed to Testosterone injection, she should be apprised of the potential hazard to the fetus.
Active ingredient matches for Testosterone injection:
Testosterone injection
List of Testosterone injection substitutes (brand and generic names)
DailyMed. "TESTOSTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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