What happens if I overdose Nuo Shi?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include blurred vision or other vision changes; confusion; one-sided weakness; slurred speech.
Proper storage of Nuo Shi solution:
Store Nuo Shi solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, fire, moisture, and light. Do not store in the bathroom. When it is time to throw Nuo Shi solution away, throw away the applicator and cap as well. Keep Nuo Shi solution out of the reach of children and away from pets.
Overdose of Nuo Shi in details
There is a single report of acute overdosage after parenteral administration of an approved Nuo Shi product in the literature. This subject had serum Nuo Shi concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdosage in the Nuo Shi% clinical trial.
Treatment of overdosage would consist of discontinuation of Nuo Shi%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
What should I avoid while taking Nuo Shi?
Do not apply AndroGel or Nuo Shi Nuo Shi gel to your penis or your scrotum. Nuo Shi gel should also not be applied to your stomach area.
Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel Nuo Shi gel, or 2 hours after applying Nuo Shi Nuo Shi gel.
Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.
If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a Nuo Shi skin patch, avoid using an ointment form of the steroid.
Nuo Shi gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
Nuo Shi warnings
Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer
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Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms.
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Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens.
Potential for Secondary Exposure to Nuo Shi
Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to Nuo Shi Gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical Nuo Shi product. Children and women should avoid contact with unwashed or unclothed application sites in men using Nuo Shi Gel 1%.
Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to Nuo Shi Gel should also be brought to the attention of a physician. Nuo Shi Gel should be promptly discontinued until the cause of virilization has been identified.
Polycythemia
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of Nuo Shi. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
Venous Thromboembolism
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Nuo Shi products such as Nuo Shi Gel 1%. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Nuo Shi Gel 1% and initiate appropriate workup and management.
Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Nuo Shi replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of Nuo Shi compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Nuo Shi replacement therapy in men.
Patients should be informed of this possible risk when deciding whether to use or to continue to use Nuo Shi Gel 1%.
Use in Women
Due to lack of controlled evaluations in women and potential virilizing effects, Nuo Shi Gel 1% is not indicated for use in women.
Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including Nuo Shi Gel 1%, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.
Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular Nuo Shi enanthate has produced multiple hepatic adenomas. Nuo Shi Gel 1% is not known to cause these adverse effects.
Edema
Androgens, including Nuo Shi Gel 1%, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.
Gynecomastia
Gynecomastia may develop and persist in patients being treated with androgens, including Nuo Shi Gel 1%, for hypogonadism.
Sleep Apnea
The treatment of hypogonadal men with Nuo Shi may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
Lipids
Changes in serum lipid profile may require dose adjustment or discontinuation of Nuo Shi therapy.
Hypercalcemia
Androgens, including Nuo Shi Gel 1%, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
Decreased Thyroxine-binding Globulin
Androgens, including Nuo Shi Gel 1%, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Flammability
Alcohol based products, including Nuo Shi Gel 1%, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Nuo Shi Gel 1% has dried.
What should I discuss with my healthcare provider before taking Nuo Shi?
Some medical conditions may interact with Nuo Shi patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)
- if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity
- if you have a history of blood clots
Some MEDICINES MAY INTERACT with Nuo Shi patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by Nuo Shi patch
- Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because side effects, including risk of bleeding, may be increased by Nuo Shi patch
- Propranolol because its effectiveness may be decreased by Nuo Shi patch
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nuo Shi patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Nuo Shi precautions
General
The physician should instruct patients to report any of the following:
- Too frequent or persistent erections of the penis.
- Any nausea, vomiting, changes in skin color, or ankle swelling.
- Breathing disturbances, including those associated with sleep.
Virilization of female partners has been reported with use of a topical Nuo Shi solution. Percutaneous creams leave as much as 90 mg residual Nuo Shi on the skin. The results from one study indicated that, after removal of a Nuo Shi (Nuo Shi (transdermal)) system, the potential for transfer of Nuo Shi to a sexual partner was 6 mc g, 1/45th the daily endogenous Nuo Shi production by the female body. Nuo Shi (Nuo Shi (transdermal)) TTS, unlike Nuo Shi (Nuo Shi (transdermal)) and Nuo Shi (Nuo Shi (transdermal)) WITH ADHESIVE, has an occlusive backing that prevents the partner from coming in contact with the active material in the system. If a Nuo Shi (Nuo Shi (transdermal)) TTS system is inadvertently transferred to a female partner, it should be removed immediately and the contacted skin washed. Changes in body hair distribution or significant increase in acne of the female partner should be brought to the attention of a physician.
Information for Patients
An information brochure containing instructions for the use of Nuo Shi (Nuo Shi (transdermal)) TTS is available. A separate instruction booklet is available for Nuo Shi (Nuo Shi (transdermal)) and Nuo Shi (Nuo Shi (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the Nuo Shi (Nuo Shi (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
- Nuo Shi (Nuo Shi (transdermal)) TTS should not be applied to the scrotum.
- Nuo Shi (Nuo Shi (transdermal)) and Nuo Shi (Nuo Shi (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only.
- The Nuo Shi (Nuo Shi (transdermal)) products should be applied once daily to dry, clean skin. If the Nuo Shi (Nuo Shi (transdermal)) product has come off after it has been worn for more than 12 hours and it cannot be reapplied, the patient may wait until the next routine application time to apply a new system.
Laboratory Tests
- Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
- Liver function, prostatic specific antigen, cholesterol, and high-density lipoprotein should be checked periodically.
- To ensure proper dosing, serum Nuo Shi concentrations may be measured.
Drug Interactions
Anticoagulants: C-17 substituted derivatives of Nuo Shi, 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 Nuo Shi product, administration of Nuo Shi cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Nuo Shi 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal Data: Nuo Shi has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, which metastasized in some cases. There is suggestive evidence that injection of Nuo Shi into some strains of female mice increases their susceptibility to hepatoma. Nuo Shi is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Human Data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.
Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma.
Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of prostate cancer prior to initiation of Nuo Shi replacement therapy.
In men receiving Nuo Shi replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Pregnancy Category X :
Teratogenic Effects: The Nuo Shi (Nuo Shi (transdermal)) products are not indicated for women and must not be used in women.
Nursing Mothers
The Nuo Shi (Nuo Shi (transdermal)) products are not indicated for women and must not be used in women.
Pediatric Use
Safety and efficacy of the Nuo Shi (Nuo Shi (transdermal)) products in pediatric patients has not been established.
What happens if I miss a dose of Nuo Shi?
Call your doctor for instructions if you miss an appointment for your Nuo Shi.
References
- 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).
- DrugBank. "testosterone". http://www.drugbank.ca/drugs/DB00624 (accessed September 17, 2018).
- MeSH. "Androgens". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
