Nandrolone decanoate is a parenteral anabolic steroid. It is primarily used to treat anemia, chronic renal failure, osteoporosis and AIDS-associated wasting syndrome. This agent is known to increase hemoglobin and red cell mass. With the development of recombinant human erythropoietin, nandrolone decanoate use in anemia associated with chronic renal failure has declined. It has also been the subject of drug misuse and abuse, often producing adverse effects such as changes in libido, hepatotoxicity, increased risk of cardiovascular disease, and antisocial behavior. Some of the masculinizing effects in women can be irreversible. Nandrolone decanoate was approved by the FDA in 1983 and became a controlled substance in 1991.
Mechanism of Action: Nandrolone decanoate shares the actions of endogenous androgens such as testosterone. Exogenous androgens such as nandrolone decanoate promote protein anabolism and stimulate appetite which results in a reversal of catabolic processes and negative nitrogen balance. Increases in lean body mass in patients with cachexia (e.g., malnourished dialysis patients) and decreased bone resorption and increased bone density in patients with osteoporosis are often noted. Blood glucose, erythrocyte production, and the balance of calcium are also affected by androgens. Increased erythrocyte production is apparently due to enhanced production of erythropoietic stimulating factor. Patients with anemia associated with renal disease will have increases in red blood cell volume and hemoglobin after receiving nandrolone decanoate.
Since nandrolone decanoate has actions similar to endogenous androgens, administration of nandrolone decanoate has the possibility of causing serious disturbances of growth and sexual development if given to young children and causing unwanted adverse effects in women. Exogenous androgens suppress gonadotropin-releasing hormone, thereby reducing the gonadotropic function of the pituitary through a negative-feedback mechanism. This results in a reduction of endogenous testosterone, luteinizing hormone, and follicle-stimulating hormone. Exogenous androgens may also have a direct effect on the testes. Reversible increases in low-density lipoproteins (LDL) and decreases in high-density lipoproteins (HDL) also occur.
Pharmacokinetics: Nandrolone decanoate is administered intramuscularly. In the systemic circulation, nandrolone decanoate is rapidly hydrolyzed to free nandrolone by plasma esterases. Nandrolone has high lipid solubility and can rapidly diffuse into cells. Nandrolone is subsequently metabolized in the liver via reduction and oxidation which is similar to the metabolism of testosterone. Data on the excretion of the parent compound and metabolites are lacking. The plasma clearance of nandrolone is approximately 1.6 L/hour/kg and the elimination half-life of the parent compound is 6 to 8 days.
Route-Specific Pharmacokinetics: Intramuscular Route: Following intramuscular injection, nandrolone decanoate is slowly released from the intramuscular depot at a relatively constant rate over approximately 4 days. A 100-mg dose produces peak serum concentrations in 3—6 days.
Indications: Nandrolone Decanoate is used in the treatment of anemia resultant of renal insufficiency, as well as off-label for cachexia, osteoporosis, and wasting syndrome.
Contraindications and Precautions: Your health care provider needs to know if you have any of these conditions: breast cancer; diabetes; heart disease; kidney disease; liver disease; prostate trouble; an unusual or allergic reaction to nandrolone, other medicines, foods, dyes, or preservatives; pregnant or trying to get pregnant; breast-feeding. You will need to have blood work done while you are taking this medicine. This drug may affect blood sugar in patients with diabetes.
Nandrolone decanoate injections are administered intramuscularly only. Do not inject via intravenous administration. Nandrolone decanoate contains benzyl alcohol. Do not use this formulation in patients with benzyl alcohol hypersensitivity.
Androgen therapy (such as nandrolone) can result in loss of diabetic control and should be used with caution in patients with diabetes mellitus. Close monitoring of blood glucose is recommended.
Nandrolone decanoate is absolutely contraindicated during pregnancy because of probable adverse effects on the fetus (FDA pregnancy category X). Androgenic anabolic steroids are known to cause embryotoxicity, fetotoxicity, and masculinization of female animal offspring. Nandrolone decanoate is contraindicated in females who are or may become pregnant. If nandrolone decanoate is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus.
It is not known if anabolic steroids are excreted in human milk. Nandrolone is not indicated in females of childbearing potential; use during breast-feeding should be avoided because of the potential for serious adverse reactions in nursing infants. Alternative methods to breast-feeding are recommended.
Use of androgens (such as nandrolone) in children should be undertaken only with extreme caution. Androgens may accelerate bone maturation without stimulating compensatory linear growth, sometimes resulting in compromised adult stature. Radiographic examinations of the hand and wrist should be performed every 6 months to assess the rate of bone maturation and the effect of the drug on epiphyseal centers. Once the epiphyses have closed, growth is terminated. Even after discontinuation of treatment, epiphyseal closure can be enhanced for several months.
Nandrolone decanoate can stimulate the growth of cancerous tissue and should not be used in male patients with prostate cancer or breast cancer. Patients with prostatic hypertrophy should be treated with caution because of the possible development of malignancy.
Androgens (such as nandrolone) can induce osteolysis and should be used with caution in patients with hypercalcemia. Androgen-induced hypercalcemia occurs especially in immobile patients and those with metastatic breast cancer.
Alterations in the serum lipid profile consisting of decreased HDL and increased LDL occur with anabolic steroids including nandrolone. The drug should be used cautiously in patients with hypercholesterolemia and in those with cardiac disease especially in those with arteriosclerosis, coronary artery disease, and myocardial infarction. Monitoring of lipoprotein concentrations is recommended. During treatment with androgens, edema can occur because of sodium retention. Thus, this another reason to use nandrolone cautiously in patients with heart failure, peripheral edema, or severe cardiac disease.
During treatment with androgens, edema occurs because of fluid retention in association with sodium retention. Nandrolone decanoate is therefore contraindicated in patients withsevere hepatic disease and should be avoided in patients with severe renal disease because of possible exacerbation of these conditions. In addition, patients with nephrosis or nephrotic phase of nephritis should be treated with caution. Because androgenic anabolic steroids have been associated the development of peliosis hepatis and benign and malignant liver tumors (e.g., hepatocellular cancer), further cautions are warranted for patients with hepatic disease. Patients with hepatic disease or hepatic dysfunction also can be at risk of drug accumulation because of reduced clearance.
This list may not include all possible contraindications.
Pregnancy: Nandrolone decanoate is absolutely contraindicated during pregnancy because of probable adverse effects on the fetus (FDA pregnancy category X). Androgenic anabolic steroids are known to cause embryotoxicity, fetotoxicity, and masculinization of female animal offspring. Nandrolone decanoate is contraindicated in females who are or may become pregnant. If nandrolone decanoate is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus.
Breast-feeding: It is not known if anabolic steroids are excreted in human milk. Nandrolone is not indicated in females of childbearing potential; use during breast-feeding should be avoided because of the potential for serious adverse reactions in nursing infants. Alternative methods to breast-feeding are recommended.
Interactions: Possible interactions include: goserelin; leuprolide; medicines for diabetes; medicines for the prostate like dutasteride, finasteride, saw palmetto; warfarin. This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Some items may interact with your medicine.
Androgens can enhance the effects of anticoagulants.1 Dosage of the anticoagulant may have to be decreased in order to maintain prothrombin time at the desired therapeutic level. When anabolic steroid or androgen therapy is started or stopped in patients on anticoagulant therapy, close monitoring is required. Additionally, nandrolone decanoate may generate a pharmacodynamic interaction with warfarin by independently affecting the activity of circulating coagulation proteins. Androgens reduce the amount or activity of circulating coagulant proteins thereby enhancing the anticoagulant effect of warfarin.
The actions of androgens could be antagonized by 5-alpha reductase inhibitors (i.e., dutasteride, finasteride).23 Avoid concurrent use of androgens with 5-alpha-reductase inhibitors.
Drug interactions with Saw palmetto, Serenoa repens have not been specifically studied or reported. Saw palmetto extracts appear to have antiandrogenic effects.45 The antiandrogenic effects of Saw palmetto, Serenoa repens would be expected to antagonize the actions of androgens; it would seem illogical for patients taking androgens to use this herbal supplement.
Exogenously administered androgens (testosterone derivatives or anabolic steroids) have variable effects on blood glucose control in patients with diabetes mellitus. In general, low testosterone concentrations are associated with insulin resistance. Further, when hypogonadal men (with or without diabetes) are administered exogenous androgens, glycemic control typically improves as indicated by significant reductions in fasting plasma glucose concentrations and HbA1c. In one study in men with diabetes, testosterone undecenoate 120 mg PO/day for 3 months decreased HbA1c concentrations from a baseline of 10.4% to 8.6% (P<0.05); fasting plasma glucose concentrations decreased from 8 mmol/l at baseline to 6 mmol/l (P<0.05). Significant reductions in HbA1c and fasting plasma glucose concentrations did not occur in patients taking placebo.6 Similar results have been demonstrated with intramuscular testosterone 200 mg administered every 2 weeks for 3 months in hypogonadal men with diabetes.7 In healthy men, testosterone enanthate 300 mg IM/week for 6 weeks or nandrolone 300 mg/week IM for 6 weeks did not adversely affect glycemic control; however, nandrolone improved non-insulin mediated glucose disposal.8 It should be noted that some studies have shown that testosterone supplementation in hypogonadal men has no effect on glycemic control.910Conversely, the administration of large doses of anabolic steroids in power lifters decreased glucose tolerance, possibly through inducing insulin resistance.10 While data are conflicting, it would be prudent to monitor all patients with type 2 diabetes on antidiabetic agents receiving androgens for changes in glycemic control, regardless of endogenous testosterone concentrations. Hypoglycemia or hyperglycemia can occur; dosage adjustments of the antidiabetic agent may be necessary.
Based on case reports with methyltestosterone and danazol, androgens may increase plasma concentrations of cyclosporine, leading to a greater risk of nephrotoxicity.11121314
Increased fluid retention may occur with concomitant nandrolone decanoate and corticosteroid use. Corticosteroids with greater mineralocorticoid activity such as fludrocortisone are more likely to cause edema.15
Androgens may be necessary to assist in the growth response to human growth hormone, but excessive doses of androgens in prepubescent males can accelerate epiphyseal maturation.16
Goserelin17 and leuprolide18 inhibit steroidogenesis. Concomitant use of nandrolone decanoate with goserelin or leuprolide is relatively contraindicated and would defeat the purpose of goserelin or leuprolide therapy.
Androgens are known to stimulate erythropoiesis.18 Despite the fact that endogenous generation of erythropoietin is depressed in patients with chronic renal failure, other tissues besides the kidney can synthesize erythropoietin, albeit in small amounts. Concurrent administration of androgens can increase the patient’s response to epoetin alfa, reducing the amount required to treat anemia. Because adverse reactions to epoetin alfa have been associated with an abrupt increase in blood viscosity, this drug combination should be avoided, if possible. Further evaluation of this combination needs to be made.
In vitro, both genistein and daidzein inhibit 5 alpha-reductase isoenzyme II, resulting in decreased conversion of testosterone to the potent androgen 5-alpha-dihydrotestosterone (DHT) and a subsequent reduction in testosterone-dependent tissue proliferation.19 The action is similar to that of finasteride, but is thought to be less potent. Theoretically, because the soy isoflavones appear to inhibit type II 5-alpha-reductase, the soy isoflavones may counteract the activity of the androgens.
This list may not include all possible drug interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
Adverse Reactions/Side Effects: Change in sex drive or performance; diarrhea; hair loss; headache; trouble sleeping. This list may not describe all possible side effects. Call your health care provider immediately if you are experiencing any signs of an allergic reaction: allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue; breast lump; breathing problems; changes in mood, especially anger, depression, or rage; change in voice; dark urine; increase in facial hair; irregular menstrual periods; acne, nausea, vomiting; stomach pain; swelling in ankles or legs; trouble passing urine or change in the amount of urine; yellowing of the eyes or skin.
Menstrual irregularity can occur with nandrolone decanoate therapy in females. Disruption of the regular menstrual cycle secondary to nandrolone decanoate-induced suppression of gonadotropin secretion can lead to amenorrhea or oligomenorrhea.
When androgens (such as nandrolone) are given to women, virilization, manifested by acne, hirsutism, clitoromegaly, male pattern baldness, reduced breast size, and deepening of the voice or hoarseness, can occur. If treatment is discontinued when these symptoms first appear, they usually subside. Prolonged treatment can lead to irreversible masculinity, so the benefit of treatment should be measured against the risk.
Androgens can cause teratogenesis. Androgens are classified as pregnancy category X, and are absolutely contraindicated during pregnancy because of probable adverse effects on the fetus. Androgenic anabolic steroids such as nandrolone decanoate are known to cause embryotoxicity, fetotoxicity, and masculinization of female animal offspring. Nandrolone decanoate is contraindicated in women who are or may become pregnant.
Male patients can experience feminization during prolonged therapy with nandrolone decanoate, which is believed to result from inhibition of gonadotropin secretion and conversion of androgens to estrogens. These effects are more pronounced in patients with concurrent hepatic disease and include mastalgia and gynecomastia. Feminizing effects are generally reversible. Inhibition of testicular function, testicular atrophy, impotence (erectile dysfunction), epididymitis, and bladder irritation can also occur.
Priapism and excessive sexual stimulation, more common in geriatric males, are generally the effect of excessive nandrolone decanoate dosage. Oligospermia and decreased ejaculate volume may occur in patients receiving long-term therapy or excessive doses. Alopecia resembling male pattern baldness has also occurred.
Prostate cancer as a secondary malignancy or prostatic hypertrophy can develop during prolonged therapy with nandrolone decanoate and are more likely to occur in elderly males. Signs of acute epididymitis (e.g., fever, chills, pain in the inguinal region) and/or urinary urgency should prompt withdrawal of the drug and reevaluation of dosage.
In prepubescent males
When androgens (such as nandrolone) are used in the treatment of immature males, early virilism can be a disadvantage because it is accompanied by premature epiphyseal closure. Monitoring of skeletal maturation should be undertaken at about 6-month intervals. Once the epiphyses have closed, growth is terminated. Even after discontinuation of treatment, epiphyseal closure can be enhanced for several months. Penile enlargement and an increased frequency of erections can also occur.
In males and females
Peripheral edema can occur with nandrolone use as the result of increased fluid retention (in association with sodium retention) and is manifested by weight gain. In the treatment of patients with impaired renal function or congestive heart failure, the fluid retention is of greater significance. Other serum electrolytes (i.e., calcium, chloride, phosphate, and potassium) are also retained.
Androgen therapy (such as nandrolone) is related to growth and secretion of the sebaceous glands, which can cause an acneiform rash indistinguishable from acne vulgaris.
Hepatic dysfunction can occur from use of androgenic anabolic steroids (such as nandrolone) and have been shown to be more significant with administration of the oral 17-alpha-alkylandrogens (e.g., methyltestosterone). Cholestatic jaundice with, rarely, hepatic necrosis and death have been reported. Elevated hepatic enzymes are more common than overt jaundice. The drug should be discontinued if cholestatic jaundice or hepatitis occurs. Peliosis hepatis, a condition characterized by splenic tissue being replaced by blood filled cysts, has occurred in patients receiving androgenic anabolic steroids. The cysts are sometimes present with minimal hepatic dysfunction, but may be associated with hepatic failure. They are often not noticeable until life-threatening hepatic failure or intra-abdominal hemorrhage develops. Discontinuation of steroid therapy usually results in complete disappearance of cysts. Hepatoma also occurs rarely and is usually benign and androgen-dependent; life-threatening malignant hepatoma has been reported. Withdrawal of drug often results in regression or cessation of progression of the tumors. However, hepatomas associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be undetected until life-threatening intra-abdominal hemorrhage develops.
Androgen therapy (such as nandrolone) has induced osteolysis and can exacerbate hypercalcemia. Androgen-induced hypercalcemia occurs especially in immobile patients and those with metastatic carcinoma of the breast.
Observational studies in post-menopausal women, bodybuilders, and weightlifters using anabolic steroids have revealed ‘pro-atherogenic’ changes in lipid profiles, including decreases in HDL concentrations and increases in LDL concentrations. Synthetic androgens may produce a greater lowering of the HDL-C:LDL-C ratio than does testosterone. Oral anabolic steroids (e.g., stanozolol) may produce greater changes than parenteral ones. Although the implications of androgen-induced (such as nandrolone) hypercholesterolemia are unclear, caution should be exercised, particularly in patients predisposed to dyslipidemias or atherosclerosis.
Androgen therapy (such as nandrolone) can produce libido decrease or libido increase. Geriatric males have been found to be more likely to experience excessive sexual stimulation.
Miscellaneous adverse reactions to nandrolone decanoate therapy have included decreased glucose tolerance, diarrhea, edema, excitability, habituation, increased CPK and creatinine, insomnia, mental depression, nausea and vomiting.
Intramuscular administration of anabolic steroids (such as nandrolone) can cause inflammation, urticaria, postinjection induration and furunculosis. Patients should be observed for any signs of an injection site reaction.
Anabolic steroids (such as nandrolone) may cause suppression of clotting factors II, V, VII, and X. Prolonged bleeding time may occur.
This list may not include all possible adverse reactions or side effects. Call your health care provider immediately if you are experiencing any signs of an allergic reaction: skin rash, itching or hives, swelling of the face, lips, or tongue, blue tint to skin, chest tightness, pain, difficulty breathing, wheezing, dizziness, red, a swollen painful area/areas on the leg.
How is this medication best taken? Nandrolone Decanoate is typically administered via an injection into muscle. It is usually given by a healthcare provider in a hospital or clinic setting. If you get this medicine at home, you will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals and do not take your medicine more often than directed. It is important that you put your used needles and syringes in a special sharps container: do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
What do I do if I miss a dose? If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.
Storage: Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the expiration date. Do not flush unused medications or pour down a sink or drain.
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