Is this medication very expensive?
What happens if I overdose Cidoteston?
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 Cidoteston solution:
Store Cidoteston 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 Cidoteston solution away, throw away the applicator and cap as well. Keep Cidoteston solution out of the reach of children and away from pets.
Overdose of Cidoteston in details
There is one report of acute overdosage with Cidoteston enanthate injection: Cidoteston levels of up to 11,400 ng/dL were implicated in a cerebrovascular accident.
Oral ingestion of Cidoteston is not expected to result in clinically significant serum Cidoteston concentrations due to extensive first-pass (hepatic) metabolism.
Treatment of overdosage would consist of discontinuation of Cidoteston together with appropriate symptomatic and supportive care.
What should I avoid while taking Cidoteston?
Do not apply AndroGel or Cidoteston Cidoteston gel to your penis or your scrotum. Cidoteston gel should also not be applied to your stomach area.
Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel Cidoteston gel, or 2 hours after applying Cidoteston Cidoteston 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 Cidoteston skin patch, avoid using an ointment form of the steroid.
Cidoteston gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
5.1 Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer
- Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
- Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating treatment. It is appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices.
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of Cidoteston. Check hematocrit prior to initiating Cidoteston treatment. It is appropriate to re-evaluate the hematocrit 3 to 6 months after starting Cidoteston treatment, and then monitor annually. Discontinue Cidoteston therapy if the hematocrit becomes elevated. Cidoteston therapy may be restarted when the hematocrit decreases to an acceptable level. An increase in red blood cell mass may increase the risk of thromboembolic events.
5.3 Venous Thromboembolism
There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using Cidoteston products such as Cidoteston. 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 Cidoteston and initiate appropriate workup and management.
5.4 Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of Cidoteston 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 Cidoteston compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of Cidoteston replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use Cidoteston.
5.5 Use in Women and Children
Women and children should not use Cidoteston. Use in women and children has not been studied with Cidoteston.
Due to lack of controlled studies in women and potential virilizing effects, Cidoteston is not indicated for use in women and children.
5.6 Potential for Adverse Effects on Spermatogenesis
At large doses of exogenous androgens, including Cidoteston, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) that could lead to adverse effects on semen parameters including reduction of sperm count.
5.7 Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (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 Cidoteston enanthate has produced multiple hepatic adenomas. Cidoteston is not known to cause these adverse effects.
Androgens, including Cidoteston, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
Gynecomastia may develop and persist in patients being treated with androgens, including Cidoteston, for hypogonadism.
5.10 Sleep Apnea
The treatment of hypogonadal men with Cidoteston may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease.
Changes in serum lipid profile may require dose adjustment or discontinuation of Cidoteston therapy.
Androgens, including Cidoteston, 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.
5.13 Decreased Thyroxine-Binding Globulin
Androgens, including Cidoteston, may decrease concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remains unchanged and there is no clinical evidence of thyroid dysfunction.
5.14 Magnetic Resonance Imaging (MRI)
Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because Cidoteston contains aluminum, it is recommended to remove the system before undergoing an MRI.
What should I discuss with my healthcare provider before taking Cidoteston?
Do not use Cidoteston buccal system if you have cancer of the breast or prostate. Cidoteston may worsen some cancers of these types.
Before using Cidoteston buccal system, tell your doctor if you have
had a previous allergic reaction to Cidoteston;
sleep apnea (brief periods of not breathing during sleep) or if you have risk factors for sleep apnea (e.g., obesity, chronic lung disease);
difficulty with urination due to enlargement of the prostate;
heart disease; or
liver disease or kidney disease.
You may not be able to use Cidoteston buccal system, or you may need a dosage adjustment or special monitoring if you have any of the conditions listed above.
Cidoteston buccal system is not approved for use by women and must not be used by women. Cidoteston buccal system is in the FDA pregnancy category X. This means that Cidoteston is known to cause birth defects in an unborn baby. Do not use Cidoteston buccal system if you are pregnant or could become pregnant during treatment.
Cidoteston buccal system is not approved for use by women and must not be used by women. It is not known whether Cidoteston from the buccal system will pass into breast milk. Do not use Cidoteston buccal system if you are breast-feeding a baby.
Men over 65 years of age that use Cidoteston buccal system may be at increased risk for the development of prostatic enlargement or cancer. You may not be able to use buccal system Cidoteston, or you may require a lower dose or special monitoring.
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 Cidoteston solution. Percutaneous creams leave as much as 90 mg residual Cidoteston on the skin. The results from one study indicated that, after removal of a Cidoteston (Cidoteston (transdermal)) system, the potential for transfer of Cidoteston to a sexual partner was 6 mc g, 1/45th the daily endogenous Cidoteston production by the female body. Cidoteston (Cidoteston (transdermal)) TTS, unlike Cidoteston (Cidoteston (transdermal)) and Cidoteston (Cidoteston (transdermal)) WITH ADHESIVE, has an occlusive backing that prevents the partner from coming in contact with the active material in the system. If a Cidoteston (Cidoteston (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 Cidoteston (Cidoteston (transdermal)) TTS is available. A separate instruction booklet is available for Cidoteston (Cidoteston (transdermal)) and Cidoteston (Cidoteston (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the Cidoteston (Cidoteston (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
- Cidoteston (Cidoteston (transdermal)) TTS should not be applied to the scrotum.
- Cidoteston (Cidoteston (transdermal)) and Cidoteston (Cidoteston (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only.
- The Cidoteston (Cidoteston (transdermal)) products should be applied once daily to dry, clean skin. If the Cidoteston (Cidoteston (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.
- 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 Cidoteston concentrations may be measured.
Anticoagulants: C-17 substituted derivatives of Cidoteston, 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 Cidoteston product, administration of Cidoteston cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Cidoteston 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: Cidoteston 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 Cidoteston into some strains of female mice increases their susceptibility to hepatoma. Cidoteston 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 Cidoteston replacement therapy.
In men receiving Cidoteston replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Pregnancy Category X :
Teratogenic Effects: The Cidoteston (Cidoteston (transdermal)) products are not indicated for women and must not be used in women.
The Cidoteston (Cidoteston (transdermal)) products are not indicated for women and must not be used in women.
Safety and efficacy of the Cidoteston (Cidoteston (transdermal)) products in pediatric patients has not been established.
What happens if I miss a dose of Cidoteston?
Call your doctor for instructions if you miss an appointment for your Cidoteston injection.
- 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