Andriol Testocaps (Testosterone) 40 mg


Price/Pill: $1.65
Generic Name: Testosterone Undecanoate
Manufacturer: Sun Pharma Pharma

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Testosterone is used to treat symptoms of low testosterone in men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland, (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain lab tests to check your testosterone levels to see if they are low before you begin to take testosterone. Testosterone should not be used treat the symptoms of low testosterone in men who have low testosterone due to aging (‘age-related hypogonadism’). Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone works by replacing testosterone that is normally produced by the body.

How should this medicine be used?

Testosterone comes as a capsule to take by mouth. It is usually taken with food twice a day (in the morning and in the evening). Take testosterone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take testosterone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Testosterone may control your symptoms but will not cure your condition. Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment and your reaction to the medication.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking testosterone,

  • tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in testosterone capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven), insulin (Apridra, Humalog, Humulin, others), medications for diabetes, oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not take testosterone.
  • tell your doctor if you have or have ever had high cholesterol; sleep apnea (breathing stops for short periods of time during sleep); benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; cancer; diabetes; depression or other mental illness; or kidney, liver, or lung disease.
  • you should know that testosterone is only for use in adult men. Children, teenagers, and women should not use this medication. Testosterone may stop bone growth and cause precocious puberty (early puberty) in children and teenagers. Testosterone may cause deepening of voice, hair growth in unusual places, genital enlargement, decrease in breast size, male-pattern hair loss, and unusual menstrual cycles in women. If testosterone is used by women who are pregnant, may become pregnant, or are breastfeeding, it may harm the baby.
  • you should know that there have been reports of serious side effects in people who take testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone. Be sure to take testosterone exactly as directed by your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Testosterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • heartburn
  • diarrhea
  • gas
  • headache
  • breast pain or enlargement

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • lower leg pain, swelling, warmth, or redness
  • difficulty breathing, especially at night
  • swelling of the hands, feet, and ankles
  • sudden unexplained weight gain
  • erections that happen too often or that last too long
  • difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
  • vomiting
  • nausea
  • extreme tiredness
  • yellowing of the skin or eyes
  • dark urine
  • pain in the upper right part of the stomach
  • mood changes including depression, anxiety, or becoming suicidal (thinking about harming or killing oneself or planning or trying to do so)

Testosterone may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of receiving this medication.

Testosterone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

What other information should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking testosterone.

Do not let anyone else use your medication. Testosterone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

What is Andriol Testocaps?

Andriol Testocaps injection is used for the treatment of men whose bodies do not make enough natural Andriol Testocaps, a condition called hypogonadism. Andriol Testocaps is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.

Andriol Testocaps injection is also used in women with breast cancer that has spread to other parts of the body (metastatic).

Andriol Testocaps 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 Andriol Testocaps® brand is only available under a restricted distribution program called the Andriol Testocaps® REMS program.

Andriol Testocaps 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.

Males

Andriol Testocaps® (Andriol Testocaps Enanthate Injection, USP) is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous Andriol Testocaps.

Primary hypogonadism (congenital or acquired) – Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.

Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)

If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop Andriol Testocaps deficiency after puberty.

Safety and efficacy of Andriol Testocaps in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Delayed puberty – Andriol Testocaps® (Andriol Testocaps Enanthate Injection, USP) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An X-ray of the hand and wrist to determine bone age should be obtained every six months to assess the effect of treatment on the epiphyseal centers.

Females

Metastatic mammary cancer – Andriol Testocaps® (Andriol Testocaps Enanthate Injection, USP) may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are one to five years postmenopausal. Primary goals of therapy in these women include ablation of the ovaries. Other methods of counteracting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy. This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor. Judgment concerning androgen therapy should be made by an oncologist with expertise in this field.

How should I use Andriol Testocaps?

Use Andriol Testocaps solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Andriol Testocaps solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Andriol Testocaps solution refilled.
  • Prime this product before the first use. To prime it, depress the pump 3 times and wash any product that is dispensed down the sink.
  • Depress the pump once to fill the applicator cup. Holding the applicator upright, wipe Andriol Testocaps solution steadily up and down onto clean, dry skin in the armpit. If Andriol Testocaps solution drips or runs, it can be wiped back up with the applicator cup. Do NOT apply Andriol Testocaps solution to other parts of your body (eg, scrotum, penis, stomach, shoulders, upper arms). Do NOT apply it over open sores, wounds, or irritated skin.
  • Do NOT use your fingers or hand to rub the medicine into the skin.
  • You may need to alternate between armpits when applying Andriol Testocaps solution. Be sure you understand how to apply Andriol Testocaps solution. Contact your doctor or pharmacist if you have questions or concerns about how to apply Andriol Testocaps solution.
  • Wash your hands with soap and water immediately after using Andriol Testocaps solution.
  • Allow Andriol Testocaps solution to dry completely before dressing.
  • After Andriol Testocaps solution has dried, cover the application site (eg, with a shirt) to prevent others from coming into contact with Andriol Testocaps solution. If direct skin-to-skin contact with another person is expected, wash the application site well with soap and water to remove the medicine.
  • After using Andriol Testocaps solution, rinse the applicator with room temperature water and pat it dry with a tissue. Replace the applicator and cap on the bottle for storage.
  • Do NOT get Andriol Testocaps solution in your eyes. If you do, rinse thoroughly with water. If eye irritation persists, contact your doctor.
  • Apply Andriol Testocaps solution at the same time every morning after showering or bathing, unless your doctor tells you otherwise.
  • If you are also using an antiperspirant or deodorant (stick or roll-on), apply it at least 2 minutes before you apply Andriol Testocaps solution.
  • For best results, wait 2 hours after applying Andriol Testocaps solution before you wash the application site or swim.
  • If you miss a dose of Andriol Testocaps solution, 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 Andriol Testocaps solution.

Uses of Andriol Testocaps 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.

This medication is used by men who do not make enough of a natural substance called Andriol Testocaps (hypogonadism). Andriol Testocaps belongs to a class of drugs known as androgens. Andriol Testocaps 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 Andriol Testocaps nasal

Read the Patient Information Leaflet if available from your pharmacist before you start using Andriol Testocaps 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.

Andriol Testocaps description

Andriol Testocaps is a steroid sex hormone found in both men and women. In men, Andriol Testocaps is produced primarily by the Leydig (interstitial) cells of the testes when stimulated by luteinizing hormone (LH). It functions to stimulate spermatogenesis, promote physical and functional maturation of spermatozoa, maintain accessory organs of the male reproductive tract, support development of secondary sexual characteristics, stimulate growth and metabolism throughout the body and influence brain development by stimulating sexual behaviors and sexual drive. In women, Andriol Testocaps is produced by the ovaries (25%), adrenals (25%) and via peripheral conversion from androstenedione (50%). Testerone in women functions to maintain libido and general wellbeing. Andriol Testocaps exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Andriol Testocaps may be further converted to dihydrotestosterone or estradiol depending on the tissue.

Andriol Testocaps dosage

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS

One system is applied at about the same time each day. The adhesive side of the Andriol Testocaps (Andriol Testocaps (transdermal)) TTS system should be placed on a clean, dry area of skin on the arm, back or upper buttocks immediately upon removal from the protective pouch. DO NOT APPLY TO THE SCROTUM. The area selected should not be oily, damaged, or irritated. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the system comes off after it has been worn for more than 12 hours and it cannot be reapplied, a new system may be applied at the next routine application time. In either case, the daily treatment schedule should be continued. The Andriol Testocaps (Andriol Testocaps (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum Andriol Testocaps concentration may be measured 2-4 hours after an application of Andriol Testocaps (Andriol Testocaps (transdermal)) TTS. If the serum Andriol Testocaps concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all Andriol Testocaps measurements should be performed at the same laboratory.

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE

Patients should start therapy with a 6 mg/d system of either Andriol Testocaps (Andriol Testocaps (transdermal)) or Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d Andriol Testocaps (Andriol Testocaps (transdermal)) system should be used. One Andriol Testocaps (Andriol Testocaps (transdermal)) or Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE system should be placed on clean, dry, scrotal skin. Scrotal hair should be dry-shaved for optimal skin contact. Chemical depilatories should not be used. Andriol Testocaps (Andriol Testocaps (transdermal)) or Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE should be worn 22-24 hours.

After 3-4 weeks of daily system use, blood should be drawn 2-4 hours after system application for determination of serum total Andriol Testocaps. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE therapy should be performed at the same laboratory.

If patients have not achieved desired results by the end of 6-8 weeks of treatment with any of the Andriol Testocaps (Andriol Testocaps (transdermal)) products, another form of Andriol Testocaps replacement therapy should be considered.

How supplied

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS, Andriol Testocaps (Andriol Testocaps (transdermal)), and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE Andriol Testocaps transdermal systems contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS systems are supplied as individually pouched systems, 30 per carton. Andriol Testocaps (Andriol Testocaps (transdermal)) TTS 5 mg/d (Andriol Testocaps Transdermal System) — each 60 cm2 system contains 328 mg Andriol Testocaps USP for nominal dose of 5 mg/day

Carton of 30 Andriol Testocaps (Andriol Testocaps (transdermal)) TTS 5 mg/d systemsNDC 17314-4717-3

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.

Andriol Testocaps (Andriol Testocaps (transdermal)) 4 mg/d (Andriol Testocaps Transdermal System) — each 40 cm2 system contains 10 mg Andriol Testocaps USP for nominal delivery of 4 mg for one day.

Carton of 30 Andriol Testocaps (Andriol Testocaps (transdermal)) 4 mg/d systems. NDC 17314-4608-3

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE

6 mg/d (Andriol Testocaps Transdermal System) — each 60 cm2 system contains 15 mg Andriol Testocaps USP for nominal delivery of 6 mg for one day.

Carton of 30 Andriol Testocaps (Andriol Testocaps (transdermal)) 6 mg/d systems. NDC 17314-4609-3

Carton of 30 Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE 6 mg/d systemsNDC 17314-2836-3

Storage

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS

Store at controlled room temperature below 25oC (77oF).

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE

Store at room temperature 15-30oC (59-86oF).

Disposal

Andriol Testocaps (Andriol Testocaps (transdermal)) products should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Caution: Federal law prohibits dispensing without prescription.

REFERENCE

1. Matsumoto AM, Sandblom RE, Schoene RB et al. Andriol Testocaps replacement in hypogonadal men: Effects on obstructive sleep apnoea, respiratory drives, and sleep. Clin Endocrinol (1985) 22: 713-721.

2. Schneider BK, Pickett CK, Zwillich CW et al. Influence of Andriol Testocaps on breathing during sleep. J Appl Physiol (1986) 61: 618-623.

3. Matsumoto AM. Hormonal therapy of male hypogonadism. Endocrinol Metab Clin North Am. (1994) 23: 857-875.

4. Bardin CW, Swerdloff RS, Santen RJ. Androgens: Risks and benefits. J Clin Endocinol Metab (1991) 73: 4-7.

5. Nieschlag E, Wang CCL. Guidelines for the use of androgens in men. Geneva: World Health Organization (1992); 1-16.

6. Walle T, Walle UK, Mathur RS et al. Propranolol metabolism in normal subjects: Association with sex steroid hormones. Curr Pharmacol Ther (1994) 56:127-132.

7. Physicians Generic Rx: The Complete Drug Reference. (1996); II-1972

Andriol Testocaps interactions

Drug Interactions

Anticoagulants: C-17 substituted derivatives of Andriol Testocaps, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.

Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.

Propranolol: In a published pharmacokinetic study of an injectable Andriol Testocaps product, administration of Andriol Testocaps cypionate led to an increased clearance of propranolol in the majority of men tested.6

Corticosteroids: The concurrent administration of Andriol Testocaps with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7

Drug/Laboratory Test Interactions

Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

The Andriol Testocaps (Andriol Testocaps (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Andriol Testocaps than other skin sites, Andriol Testocaps (Andriol Testocaps (transdermal)) or Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE will not produce adequate serum Andriol Testocaps concentrations if applied to non-scrotalskin.

Ingestion of Andriol Testocaps, or the contents of any of the Andriol Testocaps (Andriol Testocaps (transdermal)) products will not result in clinically significant serum Andriol Testocaps concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Andriol Testocaps from any of the Andriol Testocaps (Andriol Testocaps (transdermal)) products will not produce adequate serum Andriol Testocaps levels due to its short half-life (about 10 minutes).

Andriol Testocaps side effects

Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any Andriol Testocaps (Andriol Testocaps (transdermal)) product.

Adverse Events with Andriol Testocaps (Andriol Testocaps (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Andriol Testocaps (Andriol Testocaps (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).

Adverse events reported by less than 1% of Andriol Testocaps (Andriol Testocaps (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:

Body as a Whole: abdominal pain, back pain, infection; Cardiovascular System: congestive heart failure, hypertension, tachycardia; Digestive System: diarrhea, nausea; Metabolic and Nutritional System: hyperglycemia, hyperlipemia, hyponatremia; Musculoskeletal System: arthralgia; Nervous System: nervousness, depression, dizziness, dry mouth, insomnia, decreased libido, personality disorder, CNS stimulation; Respiratory System: bronchitis; Skin System:application site reactions–papules/pustules, edema, vesicles, pain, other–, acne, alopecia, hirsutism; Urogenital System: abnormal ejaculation, breast pain, dysuria, urinary tract infection, and impaired urination. Topical ReactionsOf 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.

There were no clinically significant differences in skin tolerability in younger (<65 years old) and older (³ 65 years old) subjects.

A contact sensitization rate of 0.5% for Andriol Testocaps (Andriol Testocaps (transdermal)) TTS was observed in a 6-week study of 233 normal male volunteers.

In one study with 14 days of daily use, 42% of patients reported 3 or more detachments of their Andriol Testocaps (Andriol Testocaps (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Andriol Testocaps (Andriol Testocaps (transdermal))

In clinical studies of 104 patients treated with Andriol Testocaps (Andriol Testocaps (transdermal)), the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation. All topical reactions decreased with duration of use.

The following adverse effects (greater than 1%) were reported in association with Andriol Testocaps (Andriol Testocaps (transdermal)) therapy in 104 patients using the product for up to three years. These effects are listed in decreasing frequency of occurrence with the percentages of patients reporting the effect in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary tract infection (4%), breast tenderness (3%), stroke (2%). For this same patient population, the following adverse effects were reported by 1% of users: memory loss, pupillary dilation, abnormal liver enzymes, scrotal cellulitis, deep vein phlebitis, benign prostatic hyperplasia, rectal mucosal lesion over prostate, hematuria/bladder cancer, papilloma on scrotum, and congestive heart failure.

Adverse Events with Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Andriol Testocaps (Andriol Testocaps (transdermal)). Other adverse events reported during the study were headache (6%), dizziness (6%), back pain, pain, nausea, and pustular rash (1% each).

General Adverse Events with Androgen Replacement Therapy

Skin and Appendages: Hirsutism, male pattern baldness, seborrhea, and acne.

Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high doses.

Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests. Rare instances of hepatocellular neoplasms and peliosis hepatis have occurred.

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Metabolic: Increased serum cholesterol.

Miscellaneous:Rarely, anaphylactoid reactions.

DRUG ABUSE AND DEPENDENCEThe Andriol Testocaps (Andriol Testocaps (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Andriol Testocaps (Andriol Testocaps (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

Andriol Testocaps (Andriol Testocaps (transdermal)) and Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Andriol Testocaps than other skin sites, Andriol Testocaps (Andriol Testocaps (transdermal)) or Andriol Testocaps (Andriol Testocaps (transdermal)) WITH ADHESIVE will not produce adequate serum Andriol Testocaps concentrations if applied to non-scrotalskin.

Ingestion of Andriol Testocaps, or the contents of any of the Andriol Testocaps (Andriol Testocaps (transdermal)) products will not result in clinically significant serum Andriol Testocaps concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Andriol Testocaps from any of the Andriol Testocaps (Andriol Testocaps (transdermal)) products will not produce adequate serum Andriol Testocaps levels due to its short half-life (about 10 minutes).

Andriol Testocaps contraindications

  • Andriol Testocaps 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • Andriol Testocaps 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Andriol Testocaps 1% may cause fetal harm when administered to a pregnant woman. Andriol Testocaps 1% 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 Andriol Testocaps from men treated with Andriol Testocaps 1%. If a pregnant woman is exposed to Andriol Testocaps 1%, she should be apprised of the potential hazard to the fetus.

Active ingredient matches for Andriol Testocaps:

Testosterone in Austria, Hong Kong, Indonesia, Latvia, New Zealand, Serbia, Vietnam.

Brand names

  • Jatenzo®

Other names

  • testosterone undecanoate
  • Andriol Testocaps contraindications
SKU: 12358 Category: Tag:
  • 30 tabs for $89.00 – $2.96 Per/Pill
  • 60 tabs for $119.00 – $1.98 Per/Pill
  • 90 tabs for $149.00 – $1.65 Per/Pill
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