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 Malestrone solution:
Store Malestrone 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 Malestrone solution away, throw away the applicator and cap as well. Keep Malestrone solution out of the reach of children and away from pets.
Overdose of Malestrone in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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There is a single report of acute overdosage after parenteral administration of an approved Malestrone product in the literature. This subject had serum Malestrone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. There were no reports of overdosage in the Malestrone% clinical trial.
Treatment of overdosage would consist of discontinuation of Malestrone%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
What should I avoid while taking Malestrone?
Do not apply AndroGel or Malestrone Malestrone gel to your penis or your scrotum. Malestrone gel should also not be applied to your stomach area.
Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel Malestrone gel, or 2 hours after applying Malestrone Malestrone 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 Malestrone skin patch, avoid using an ointment form of the steroid.
Malestrone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
Malestrone warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer
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.
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 Malestrone
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 Malestrone 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 Malestrone product. Children and women should avoid contact with unwashed or unclothed application sites in men using Malestrone 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 Malestrone Gel should also be brought to the attention of a physician. Malestrone 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 Malestrone. 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 Malestrone products such as Malestrone 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 Malestrone 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 Malestrone 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 Malestrone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Malestrone replacement therapy in men.
Patients should be informed of this possible risk when deciding whether to use or to continue to use Malestrone Gel 1%.
Use in Women
Due to lack of controlled evaluations in women and potential virilizing effects, Malestrone Gel 1% is not indicated for use in women.
Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including Malestrone 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 Malestrone enanthate has produced multiple hepatic adenomas. Malestrone Gel 1% is not known to cause these adverse effects.
Edema
Androgens, including Malestrone 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 Malestrone Gel 1%, for hypogonadism.
Sleep Apnea
The treatment of hypogonadal men with Malestrone 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 Malestrone therapy.
Hypercalcemia
Androgens, including Malestrone 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 Malestrone 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 Malestrone Gel 1%, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Malestrone Gel 1% has dried.
What should I discuss with my healthcare provider before taking Malestrone?
Some medical conditions may interact with Malestrone 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 Malestrone 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 Malestrone patch
Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because side effects, including risk of bleeding, may be increased by Malestrone patch
Propranolol because its effectiveness may be decreased by Malestrone patch
This may not be a complete list of all interactions that may occur. Ask your health care provider if Malestrone 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.
Malestrone precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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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 Malestrone solution. Percutaneous creams leave as much as 90 mg residual Malestrone on the skin. The results from one study indicated that, after removal of a Malestrone (Malestrone (transdermal)) system, the potential for transfer of Malestrone to a sexual partner was 6 mc g, 1/45th the daily endogenous Malestrone production by the female body. Malestrone (Malestrone (transdermal)) TTS, unlikeMalestrone (Malestrone (transdermal)) andMalestrone (Malestrone (transdermal)) WITH ADHESIVE, has an occlusive backing that prevents the partner from coming in contact with the active material in the system. If aMalestrone (Malestrone (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 Malestrone (Malestrone (transdermal)) TTS is available. A separate instruction booklet is available for Malestrone (Malestrone (transdermal)) and Malestrone (Malestrone (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the Malestrone (Malestrone (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
Malestrone (Malestrone (transdermal)) TTS should not be applied to the scrotum.
Malestrone (Malestrone (transdermal)) and Malestrone (Malestrone (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only.
The Malestrone (Malestrone (transdermal)) products should be applied once daily to dry, clean skin. If the Malestrone (Malestrone (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 Malestrone concentrations may be measured.
Drug Interactions
Anticoagulants: C-17 substituted derivatives of Malestrone, 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 Malestrone product, administration of Malestrone cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Malestrone 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: Malestrone 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 Malestrone into some strains of female mice increases their susceptibility to hepatoma. Malestrone 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 Malestrone replacement therapy.
In men receiving Malestrone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Pregnancy Category X :
Teratogenic Effects: The Malestrone (Malestrone (transdermal)) products are not indicated for women and must not be used in women.
Nursing Mothers
The Malestrone (Malestrone (transdermal)) products are not indicated for women and must not be used in women.
Pediatric Use
Safety and efficacy of the Malestrone (Malestrone (transdermal)) products in pediatric patients has not been established.
What happens if I miss a dose of Malestrone?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Call your doctor for instructions if you miss an appointment for your Malestrone.
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).