Nandrolone Decanoate
Drug Related WarningNandrolone Decanoate
- Patients receiving androgenic anabolic steroid therapy have reported a condition known as Peliosis Hepatis, wherein liver and splenic tissue is replaced with blood-filled cysts. These cysts, at times associated with liver failure, may not be detected until life-threatening complications like intra-abdominal hemorrhage emerge. Discontinuation of the drug often leads to the complete disappearance of lesions.
- Liver cell tumors have also been documented, mostly benign and androgen-dependent; however, fatal malignant tumors linked with these medications have been reported. Withdrawal of the drug typically results in tumor regression or cessation of progression. Yet, hepatic tumors associated with androgens or anabolic steroids are highly vascular and might remain undetected until life-threatening intra-abdominal hemorrhage occurs.
- Patients treated with androgens and anabolic steroids often exhibit blood lipid alterations known to escalate the risk of atherosclerosis. These changes involve reduced high-density lipoprotein and sometimes increased low-density lipoprotein, potentially amplifying the risk of atherosclerosis and coronary artery disease.
Medicine Type :
Allopathy
Allopathy
Prescription Type:
Prescription Required
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Schedule H
Pharmacological Class:
Anabolic Androgenic Steroids (AAS), Therapy Class:
Anabolic steroid, Approved Countries
India, the United States, Canada, the United Kingdom, Italy, Australia, Germany, France, Japan and Spain.
Nandrolone Decanoate is an anabolic steroid belonging to the pharmacological class of class II anabolic androgenic steroids (AAS).
Nandrolone Decanoate is approved for use by the FDA for the treatment of anaemia and postmenopausal osteoporosis.
Nandrolone Decanoate is administered via intramuscular injection and slowly absorbed into the bloodstream. It undergoes hepatic metabolism and is eliminated primarily via urine as metabolites and unchanged forms.
Nandrolone Decanoate may have a few common side effects, such as oedema (swelling of legs, ankles, and feet), fluid retention, nausea, acne, and breast enlargement.
Nandrolone Decanoate is available in the form of an injection solution.
The molecule is available in India, the United States, Canada, the United Kingdom, Italy, Australia, Germany, France, Japan and Spain.
Nandrolone Decanoate is an anabolic steroid belonging to the pharmacological class of class II anabolic androgenic steroids (AAS).
It's believed that PDE7B hydrolyzes nandrolone decanoate to produce nandrolone itself. The androgen receptor gets activated by testosterone after it enters cells through receptor-mediated endocytosis. Following a conformational shift generated by binding, the androgen receptor dimerizes, reaches the nucleus, and can bind to DNA sequences to control transcription. Activation of ERK, Akt, and MAPK, as well as binding to and competitively inhibiting transcription factors, are two other ways that androgens control transcription.
The data duration of Nandrolone Decanoate action is approximately 2-3 weeks after administration.
The onset of Nandrolone Decanoate action typically occurs within a few days after its initial administration.
The Tmax and Cmax of Nandrolone Decanoate data have yet to be established.
Nandrolone Decanoate is available in the form of an injection solution.
Injection solution: Nandrolone Decanoate is administered via intramuscular injection, typically in the buttock area.
The dosage and frequency of injections are based on the condition being treated, as the physician recommends.
- Post Menopausal Osteoporosis (a disorder where bones weaken following the cessation of the menstrual cycle).
- Kidney issues cause anemia.
- For men with low testosterone levels, it's used in hormone replacement therapy.
- Breast cancer.
- Speedy recovery from severe illness, correcting protein metabolism post-surgery, burns, or significant illness.
Treatment of Postmenopausal osteoporosis
Nandrolone Decanoate reduces fracture risk, maintains bone density, and treats postmenopausal osteoporosis, which weakens bones. By preventing the breakdown of bone tissue and promoting the production of new bone, this medicine improves lean or low-muscle-mass women's bones. In postmenopausal women, in particular, nandrolone decanoate actively protects bone fragility and increases muscle mass. This helps prevent and cure osteoporosis, a prevalent disorder that increases bone fragility and fracture susceptibility, especially in women after menopause.
Nandrolone decanoate is indicated to manage anemia related to renal insufficiency, boosting hemoglobin and red cell mass. However, surgically induced a nephric patient have shown reduced responsiveness to this treatment.
Parenterally: Nandrolone Decanoate is usually administered parenterally. Inject Nandrolone Decanoate intramuscularly, typically into the gluteal muscle. Before administration, visually check parenteral drug products for particulates or discoloration if the container allows.
It is best to follow the physician's prescribed schedule for regular and evenly spaced intervals because the dose and duration of therapy are individualized per specific conditions to achieve the most effective and successful treatment outcome.
The dosage should be adjusted based on therapeutic response and weighing the benefit-to-risk ratio. The length of therapy depends on the condition response and side effects. Consider intermittent treatment.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Injection solutions: 100mg/ mL or 200mg/mL
Nandrolone Decanoate is available in the form of an injection solution.
Dose Adjustment in Adult Patients:
Anaemia of Renal Disease
For women: The recommended dose is 50 to 100 mg IM per week,
For men: The recommended dose is 100 to 200 mg weekly.
Post Menopausal Osteoporosis
Single dose: 100 mg IM every 3 - 4 weeks
If no hematologic improvement is observed within the initial six months of therapy, discontinue drug treatment.
Anabolic effects, particularly weight gain, are best elicited through periodic use. Administer Nandrolone Decanoate continuously for up to 12 weeks. If needed, after a four-week break, treatment may be resumed.
Maintain a diet consisting of foods high in calcium. The doctor may advise on vitamin D and calcium supplements. Vitamin D facilitates the absorption and retention of calcium, which fortifies bones. Postmenopausal women should limit their salt consumption to avoid losing too much bone mineral density. Acquire a sufficient amount of sleep and rest. It is advisable to quit drinking alcohol and smoking.
The dietary restriction should be individualized as per patient requirements.
Nandrolone Decanoate may be contraindicated in the following conditions:-
- Anyone who has previously experienced hypersensitivity to any of the product's constituents
- Kidney or liver problems
- Nephrosis
- Diabetes Type 1
- Heart Disease
- Pregnancy
- Migraine
- Prostate cancer, or porphyria (disorders that affect your body’s ability to make heme, a red pigment in your blood to which oxygen binds).
- Avoid using this medication for performance enhancement or muscle growth, especially by athletes or bodybuilders, due to severe potential adverse effects.
- Use caution in diabetic individuals, as it may reduce blood sugar levels. Regularly monitor glucose levels and adjust doses accordingly.
- Check for the composition of Arachis oil (derived from peanuts); avoid if allergic to peanuts or soya.
- Exercise caution due to the potential of Virilisation in females, leading to voice changes, excessive hair growth, irregular menstruation, etc.
- Anabolic steroids might heighten sensitivity to oral anticoagulants, necessitating a decrease in anticoagulant doses to maintain desired therapeutic levels.
- Monitor diabetic patients as anabolic steroids can affect glucose tolerance tests, necessitating adjustments in insulin or oral hypoglycemic dosages.
- Use cautiously in patients with benign prostatic hypertrophy.
- Anabolic steroid therapy can affect serum cholesterol levels; monitor and adjust treatment accordingly in patients with a history of heart conditions.
- Hormonal therapy may induce hypercalcemia in women with disseminated breast carcinoma; discontinue if it occurs.
Alcohol Warning
It is unsafe to consume Nandrolone Decanoate with alcohol.
Breast Feeding Warning
Avoid use during breastfeeding.
Pregnancy Warning
It is not recommended for use during pregnancy.
Food Warning
There are no specific food warnings.
The adverse reactions related to Nandrolone Decanoate can be categorized as
Common Adverse Effects: Acne, oily skin, increased hair growth, and fluid retention.
Less Common Adverse Effects: Mood swings, headache, or changes in sexual desire.
Rare Adverse Effects: Liver abnormalities, cardiovascular issues, or allergic reactions such as hives or swelling.
The clinically relevant drug interactions of Nandrolone Decanoate are briefly summarized here.
- Drug Interaction: Nandrolone Decanoate can potentially increase the effects of anticoagulants. Additionally, it might interfere with insulin, other oral diabetes treatments, and erythropoietin, a medicine used to treat anaemia.
- Drug-Food Interaction: No interactions found.
- Drug-Disease Interaction: Nandrolone Decanoate should not be used in cases of breast cancer in women who have hypercalcemia (high blood calcium levels), hyperlipoproteinemia, breast or prostate cancer in men who have been diagnosed with or are suspected of having it, kidney diseases, porphyria (a group of liver disorders), and bleeding disorders.
The most common side effects of Nandrolone Decanoate include:
Virilization is the term for the growth of masculine traits in women that can consist of changes in voice, hoarseness, increased facial or body hair, or acne.
Breast enlargement
Increased libido (sexual desire)
Nausea
Itching
Abnormal blood tests measure liver function, blood lipids (fats), and elevated haemoglobin levels.
Trouble sleeping
Chills
Impaired liver function
Edema (swelling of the ankles or feet or increased blood pressure)
Diarrhea
Elevated calcium levels in the blood
Hirsutism
- Pregnancy
Pregnancy Category X (FDA): The risks outweigh the potential benefits. Safer alternatives exist.
It is contraindicated for women who are pregnant or may become pregnant to use Nandrolone Decanoate tablets.
The use of anabolic steroids during pregnancy, especially in the first trimester, can lead to virilization of the external genitalia of the developing female fetus. In male patients, reversible oligospermia may develop following extended administration or an excessive dosage. There are no controlled studies on pregnancy in humans. It is considered inappropriate to use nandrolone while pregnant.
- Nursing Mothers
It is unknown if human milk contains any expelled anabolic steroids. Many medications are excreted in human milk, and because anabolic steroids can induce significant adverse responses in nursing infants, it is essential to consider the benefit of the drug to the mother when determining whether to stop breastfeeding or to stop taking it altogether.
- Pediatric Use
As per the FDA, safety and effectiveness in the pediatric population with metastatic breast cancer (rarely found) have not been established. It has not been verified.
Dosage Adjustment in Pediatric Patients:
Below two years: Not established.
2 to 13 years of age: The average dose is 25 to 50 mg every 3 to 4 weeks.
- Geriatric Use
The safety and efficacy of Nandrolone Decanoate in geriatric patients haven't been extensively studied. Caution is advised due to the potential risks of prostate hypertrophy, altered lipid profiles, and hepatic complications. Elderly patients should receive the lowest effective dose, with close monitoring for possible complications during treatment.
Dose Adjustment in Geriatric Patients:
Post Menopausal Osteoporosis
Single dose: 100 mg IM every 3 - 4 weeks.
Dose Adjustment in Kidney Impairment Patients:
Renal impairment: Should be used only if the benefits outweigh the risks; Caution.
Dose Adjustment in Hepatic Impairment Patients:
Patients with liver function disorders should take caution while administering Nandrolone Decanoate tablets because the drug is extensively metabolized in the liver.
Overdosage with Nandrolone Decanoate has not been reported. Very large single dosages do not produce severe adverse reactions. The potential of overdosage is practically eradicated with parenteral delivery.
Pharmacodynamics:
The alkylated anabolic steroid nandrolone decanoate can be utilized as a postmenopausal and geriatric osteoporosis adjuvant therapy as well as for the treatment of anaemia due to renal insufficiency. Given that it is administered every three to four weeks, it has a lengthy duration of action and a wide therapeutic window because acute overdoses are uncommon. The potential risks of administering this medication to individuals with hepatic, renal, or cardiac conditions should be explained to patients.
Pharmacokinetics:
Absorption
Nandrolone Decanoate, when injected intramuscularly, exhibits slow absorption after administration. It's characterized by a prolonged half-life due to its esterification with decanoic acid, causing delayed release into the bloodstream.
Nandrolone decanoate has an absorption half-life of 6 days and an elimination half-life of 4.3 hours.
Distribution
It is widely distributed in the body, accumulating in fatty tissues and muscles. Once in circulation, it binds strongly to plasma proteins, mainly albumin and sex hormone-binding globulin (SHBG), facilitating its distribution throughout the body. Its distribution is primarily in adipose tissue and muscles.
Metabolism
PDE7B may be responsible for the hydrolysis of nandrolone decanoate to nandrolone. The urine metabolites 19-norandrosterone, 19-noretiocholanolone, and 19-norepiandrosterone result from the continued metabolism of nandrolone. UGT2B7, UGT1A4, UGT2B4, UGT1A3, and UGT1A1 3-O-glucuronidate 19-norandrosterone.4 19-norretiocholanolone is 3-O-glucuronidated by UGT2B7, UGT2B4, UGT1A4, UGT1A10, UGT1A3, and UGT1A1.
Elimination
Although information about nandrolone decanoate elimination in the faeces is not easily accessible, it is removed as urine metabolites.
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- Busardò FP, Frati P, Sanzo MD, Napoletano S, Pinchi E, Zaami S, Fineschi V. The impact of nandrolone decanoate on the central nervous system. Curr Neuropharmacol. 2015 Jan;13(1):122-31. doi: 10.2174/1570159X13666141210225822. PMID: 26074747; PMCID: PMC4462037.
- Ali YH, Ali T. Nandrolone decanoate safely combats catabolism in burned patients: A new potential indication after recall. Burns. 2022 Feb;48(1):59-68. doi: 10.1016/j.burns.2021.04.011. Epub 2021 Apr 21. PMID: 34172326.
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- https://pdf.hres.ca/dpd_pm/00007111.PDF
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm
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Published on: 23 Nov 2023 8:24 AM GMT
