Neo-Hombreol F Uses

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What is Neo-Hombreol F?

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

Neo-Hombreol F 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 Neo-Hombreol F without certain medical conditions or due to getting older.

Neo-Hombreol F 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.

Neo-Hombreol F will not enhance athletic performance and should not be used for that purpose.

Neo-Hombreol F may also be used for purposes not listed in this medication guide.

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

Limitations of use:

How should I use Neo-Hombreol F?

Use Neo-Hombreol F 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 Neo-Hombreol F solution.

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

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

Neo-Hombreol F description

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

Neo-Hombreol F dosage

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Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) and Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE

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

How supplied

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS

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

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) and Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE

Neo-Hombreol F (Neo-Hombreol F (transdermal)) and Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.

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

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) and Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE

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

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

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

Storage

Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) and Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE

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

Disposal

Neo-Hombreol F (Neo-Hombreol F (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. Neo-Hombreol F 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 Neo-Hombreol F 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

Neo-Hombreol F interactions

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What other drugs will affect Neo-Hombreol F?

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Drug Interactions

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

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

Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

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

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

Neo-Hombreol F side effects

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What are the possible side effects of Neo-Hombreol F?

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 Neo-Hombreol F (Neo-Hombreol F (transdermal)) product.

Adverse Events with Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Neo-Hombreol F (Neo-Hombreol F (transdermal))

In clinical studies of 104 patients treated with Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Neo-Hombreol F (Neo-Hombreol F (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Neo-Hombreol F (Neo-Hombreol F (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 Neo-Hombreol F (Neo-Hombreol F (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Neo-Hombreol F (Neo-Hombreol F (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

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

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

Neo-Hombreol F contraindications

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What is the most important information I should know about Neo-Hombreol F?

Active ingredient matches for Neo-Hombreol F:

Testosterone


List of Neo-Hombreol F substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
NUVIR Capsule/ Tablet / 40mg / 30 units (Organon (India) Ltd.)$ 4.60
Nuvir Testosterone Undecanoate 40mg CAP / 30 (Organon (India) Ltd.)$ 4.60
40 mg x 30's (Organon (India) Ltd.)$ 4.60
Nuvir 40 mg Capsule (Organon (India) Ltd.)$ 0.18
NUVIR 40 MG CAPSULE 1 strip / 30 capsules each (Organon (India) Ltd.)$ 5.35
NUVIR cap 40 mg x 10's (Organon (India) Ltd.)$ 1.53
Nuvir 40mg Capsule (Organon (India) Ltd.)$ 0.18
Injectable; Injection; Testosterone Caproate 100 mg; Testosterone Isocaproate 60 mg; Testosterone Phenylpropionate 60 mg; Testosterone Propionate 30 mg / ml
Injectable; Injection; Testosterone Caproate 100 mg; Testosterone Isocaproate 60 mg; Testosterone Phenylpropionate 60 mg; Testosterone Propionate 30 mg / ml
Capsule; Oral; Testosterone Undecanoate 40 mg
Capsule; Oral; Testosterone Undecanoate 40 mg (Filaxis)
PMS-testosterone capsule 40 mg (Pharmascience Inc (Canada))
Injectable; Injection; Testosterone Enanthate 200 mg / ml
Capsule; Oral; Testosterone Undecanoate 40 mg
Injectable; Injection; Testosterone Enanthate 250 mg / ml
Injectable; Injection; Testosterone Enanthate
Injectable; Injection; Testosterone Undecanoate 250 mg / ml

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).

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