Fortigel Uses

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What is Fortigel?

Fortigel is a naturally occurring sex hormone produced in a man's testicles. Small amounts of Fortigel are also produced in a woman's ovaries and adrenal system.

Fortigel is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances. This medicine is not for use in treating low Fortigel without certain medical conditions or due to getting older.

Fortigel enanthate is used in women to treat breast cancer that has spread to other parts of the body (metastatic) and cannot be treated with surgery.

Fortigel will not enhance athletic performance and should not be used for that purpose.

Fortigel may also be used for purposes not listed in this medication guide.

Fortigel 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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Fortigel Gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous Fortigel:

Limitations of use:

How should I use Fortigel?

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

Ask your health care provider any questions you may have about how to use Fortigel solution.

Uses of Fortigel 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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Fortigel is a male hormone primarily used to treat deficiency or absence of naturally produced hormone Fortigel in men (hypogonadal disorders). The conditions include,

In women, Fortigel may be used as a treatment to improve quality of life in women with advanced breast cancer.

Fortigel description

Fortigel is a steroid sex hormone found in both men and women. In men, Fortigel 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, Fortigel 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. Fortigel exerts a negative feedback mechanism on pituitary release of LH and follicle-stimulating hormone (FSH). Fortigel may be further converted to dihydrotestosterone or estradiol depending on the tissue.

Fortigel dosage

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Fortigel (Fortigel (transdermal)) TTS

One system is applied at about the same time each day. The adhesive side of the Fortigel (Fortigel (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 Fortigel (Fortigel (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum Fortigel concentration may be measured 2-4 hours after an application of Fortigel (Fortigel (transdermal)) TTS. If the serum Fortigel concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all Fortigel measurements should be performed at the same laboratory.

Fortigel (Fortigel (transdermal)) and Fortigel (Fortigel (transdermal)) WITH ADHESIVE

Patients should start therapy with a 6 mg/d system of either Fortigel (Fortigel (transdermal)) or Fortigel (Fortigel (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d Fortigel (Fortigel (transdermal)) system should be used. One Fortigel (Fortigel (transdermal)) or Fortigel (Fortigel (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. Fortigel (Fortigel (transdermal)) or Fortigel (Fortigel (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 Fortigel. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the Fortigel (Fortigel (transdermal)) and Fortigel (Fortigel (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 Fortigel (Fortigel (transdermal)) products, another form of Fortigel replacement therapy should be considered.

How supplied

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

Fortigel (Fortigel (transdermal)) TTS

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

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

Fortigel (Fortigel (transdermal)) and Fortigel (Fortigel (transdermal)) WITH ADHESIVE

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

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

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

Fortigel (Fortigel (transdermal)) and Fortigel (Fortigel (transdermal)) WITH ADHESIVE

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

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

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

Storage

Fortigel (Fortigel (transdermal)) TTS

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

Fortigel (Fortigel (transdermal)) and Fortigel (Fortigel (transdermal)) WITH ADHESIVE

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

Disposal

Fortigel (Fortigel (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. Fortigel 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 Fortigel 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

Fortigel interactions

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What other drugs will affect Fortigel?

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Drug Interactions

Anticoagulants: C-17 substituted derivatives of Fortigel, 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 Fortigel product, administration of Fortigel cypionate led to an increased clearance of propranolol in the majority of men tested.6

Corticosteroids: The concurrent administration of Fortigel 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 Fortigel (Fortigel (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

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

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

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

Fortigel side effects

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What are the possible side effects of Fortigel?

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 Fortigel (Fortigel (transdermal)) product.

Adverse Events with Fortigel (Fortigel (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Fortigel (Fortigel (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 Fortigel (Fortigel (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 Reactions

Of 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 Fortigel (Fortigel (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 Fortigel (Fortigel (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Fortigel (Fortigel (transdermal))

In clinical studies of 104 patients treated with Fortigel (Fortigel (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 Fortigel (Fortigel (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 Fortigel (Fortigel (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Fortigel (Fortigel (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Fortigel (Fortigel (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 DEPENDENCE

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

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

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

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

Fortigel contraindications

See also:
What is the most important information I should know about Fortigel?

Active ingredient matches for Fortigel:

Testosterone in France.


Unit description / dosage (Manufacturer)Price, USD
Gel; Topical; Testosterone 2%

List of Fortigel substitutes (brand and generic names):

Patch; Topical; Testosterone 300 mcg / 24 h (Procter & Gamble)
Intrinsa Transdermal patch 300 micrograms/24hours (Procter & Gamble)
Livensa Transdermal patch 300 micrograms/24hours (Procter & Gamble)
Gel; Topical; Testosterone 1%
Injectable; Injection; Testosterone 100 mg / ml
Injectable; Injection; Testosterone Propionate 100 mg / ml
Injectable; Injection; Testosterone Enanthate 200 mg / ml
Injectable; Injection; Testosterone Propionate 100 mg / ml
MENOLON INJECTION 1 vial / 1 ML injection each (Mac Millon Pharmaceuticals Pvt Ltd)$ 3.00
MENOLON SOFT GELATIN CAPSULE 1 strip / 10 soft gelatin capsules each (Mac Millon Pharmaceuticals Pvt Ltd)$ 2.60
Menolon NA Soft Gelatin Capsule (Mac Millon Pharmaceuticals Pvt Ltd)$ 2.67
Injectable; Injection; Testosterone Undecanoate 250 mg / ml (Bayer)
Nebido 1000 mg/4 mL x 1's (Bayer)$ 196.57
Nebido 250 mg/1 mL x 4 mL (Bayer)$ 200.07
Nebido / amp 250 mg/1 mL x 4 mL x 1's (Bayer)
Nebido inj 1000 mg/4 mL 1's (Bayer)

References

  1. 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).
  2. PubChem. "testosterone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "testosterone". http://www.drugbank.ca/drugs/DB00624 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Fortigel are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fortigel. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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4 consumers reported age

Users%
46-602
50.0%
> 601
25.0%
30-451
25.0%


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