Pharmaceutical form | Oxandrolone 10 mg Tablets. There are 25 tablets in a blister. 4 blisters are packed in a cardboard box together with an enclosed leaflet. |
Active ingredient | Oxandrolone 10 mg |
Pharmacotherapeutic group | Anabolic / androgenic steroids. |
This drug promotes weight gain during weight loss after surgery, chronic infections, injuries, and for patients who have certain health conditions that prevent weight gain. It is also used to compensate for protein catabolism from long-term corticosteroid use and to relieve bone pain caused by osteoporosis. Prescribed to counteract the catabolic effects of radiation therapy and corticosteroids. When treating children with impaired childhood development, immaturity. Can be used during rehabilitation therapy for pathologies accompanied by impaired protein synthesis, cachexia of various origins, after infectious and radiation diseases |
Package leaflet (information for patients)
Tradename
Oxandrolone
Dosage form
Tablets 10 mg.
Description
Round, flat, beveled to the edge white tablets with an imprint in the form of the brand name "V" on one side.
Composition
Active ingredient: Oxandrolone 10 mg.
Excipients: microcrystalline cellulose 102, calcium stearate, aerosil ® 200 (hydrophilic pyrogenic silicon dioxide).
Pharmacotherapeutic group
Anabolic / androgenic steroids.
Pharmacological properties
Anabolic steroids both reverse corticosteroid catabolism and reverse the deep negative nitrogen balance that occurs with corticosteroid therapy. Mechanism of action: in debilitated patients, anabolic steroids stimulate cellular protein synthesis. (If the nitrogen balance is positive, then anabolism occurs.) They also induce feelings of well-being in debilitated patients, encouraging them to eat more and gain weight. Improves calcium balance and reduces bone resorption.
Indications for use
This drug promotes weight gain during weight loss after surgery, chronic infections, injuries, and for patients who have certain health conditions that prevent weight gain. It is also used to compensate for protein catabolism from long-term corticosteroid use and to relieve bone pain caused by osteoporosis. Prescribed to counteract the catabolic effects of radiation therapy and corticosteroids. When treating children with impaired childhood development, immaturity.
Can be used during rehabilitation therapy for pathologies accompanied by impaired protein synthesis, cachexia of various origins, after infectious and radiation diseases
Method of administration and dosage
Film-coated tablets should be swallowed whole with plenty of water. The drug should not be taken on an empty stomach.
The duration of treatment will depend on the patient's response and whether there are any adverse reactions. Therapy should be administered using an interval, non-constant schedule. The average daily dose for adults is 2.5 to 20 mg, divided into 2-4 doses. The normal course of treatment is 4 to 6 weeks and can be repeated as indicated. In children and elderly patients, the total daily dose is <0.1 mg per kilogram of body weight. Anabolic effect in severe wasting: Adults: 10-20 mg orally per day.
Side Effects
As with any type of medication, there are several types of side effects. The following list includes the most common side effects:
- For people with chronic obstructive pulmonary disease (COPD) or patients who do not respond to bronchodilators, close monitoring is necessary because the patient may have exacerbation of COPD and fluid retention.
- For people with liver disease, side effects may include jaundice, liver necrosis (death of living cells and tissues), hepatocellular neoplasm (new growth of abnormal tissue).
Side effects in men:
- Prepubertal period (before puberty): Steroid therapy can lead to an enlarged penis or a persistent erection.
- Postpubertal (after puberty): Steroid treatment can impair testicular function, testicular atrophy (wasting muscle tissue), oligospermia (low sperm count), impotence (inability to maintain an erection of the penis), chronic priapism, epididymitis (inflammation of the scrotum), and irritability bubble.
Female side effects:
- Enlarged clitoris and menstrual irregularities
Other side effects that can occur in either sex:
- Effects on the central nervous system: agitation, insomnia (sleep disturbance), depression.
- Hematological effects: bleeding in patients taking anticoagulant therapy.
- Breast: development of gynecomastia (male breast enlargement).
- Larynx: Women may experience a decrease in voice.
- Hair: Hirsutism (excessive hair growth) and male pattern baldness in women.
- Skin: acne, especially in prepubertal men and women.
- Skeletal: Premature closure of the epiphyses (rounded end of the long bone) in children.
- Fluids and electrolytes: edema (fluid retention), retention of serum electrolytes (potassium, sodium chloride, phosphate and calcium).
- Metabolic and endocrine system: decreased glucose tolerance, increased excretion of creatinine, increased serum creatinine phosphokinase, fetal masculinization and suppression of gondatropin secretion.
Contraindication
Anabolic steroid therapy may increase the sensitivity of patients to oral anticoagulants. The dose of anticoagulant may need to be reduced if sensitivity occurs to control the desired clotting time. Patients receiving anticoagulant medications need close monitoring, especially when steroid treatment is started or stopped.
Overdose
Symptoms: hepatotoxicity and intoxication. During intoxication, sweating, nausea, and vomiting may occur. These symptoms can be eliminated by reducing the dose.
Treatment: in case of signs of poisoning, induce vomiting or gastric lavage, prescribe activated charcoal and a laxative, and consult a doctor.
Intoxication and hepatotoxicity b olee likely in older patients, and especially in young children (therapeutic overdose or accidental poisoning can be very dangerous for them).
Precautions
- Pregnancy: May cause virilization in female fetuses.
- Breastfeeding: It is not known how anabolic steroids are excreted in breast milk. In accordance with the adverse reactions that may occur in infants, it is necessary to decide whether to stop breastfeeding or stop taking the drug.
- Pediatrics: The use of anabolic steroids can have serious consequences, the benefits of which should be assessed before starting therapy. Anabolic steroids can accelerate the maturation of the pineal gland in children faster than linear growth, and the effect can last up to 6 months after the drug is stopped. In any case, therapy should be monitored by X-ray studies at intervals of 3 to 6 months, and the drug should be discontinued before bone age reaches the norm for chronological age, in order to avoid the risk of deterioration in adult growth.
Interaction with other medicinal products
Anabolic steroids can enhance the effect of oral anticoagulants: the dosage can be reduced to maintain prothrombin time. In diabetics, taking anabolic steroids may increase the need for insulin and oral hypoglycemic agents. Adrenocorticoids or ACTH can increase edema when used in combination with anabolic steroids. Methandienone lowers fasting blood glucose levels in both normal people and people with diabetes.
Special instructions
Peliosis of hepatitis can occur in patients receiving anabolic steroids. These cysts can be present with minimal liver dysfunction, but they are associated with a liver defect. Symptoms are often not recognized until a life-threatening liver problem or intra-abdominal bleeding develops. Discontinuation of anabolic steroid treatment usually results in complete resolution of the lesions. Tumors in liver cells have also been reported. Many of these tumors are benign and estrogen-dependent, but fatal malignant tumors have also been reported; discontinuation of the drug may lead to regression or cessation of tumor development. Even though androgen-related or anabolic steroid-associated liver tumors, they are much more vascular than other liver tumors and may not manifest until life-threatening intra-abdominal hemorrhage develops. Changes in blood lipids associated with an increased risk of arteriosclerosis in patients taking androgens and anabolic steroids. These changes include a decrease in high density lipoprotein changes and sometimes an increase in low density lipoprotein. The changes can be very noticeable and should seriously affect the risk of changes in blood lipids associated with an increased risk of arteriosclerosis in patients taking androgens and anabolic steroids
Pregnancy and elbowing
This drug should not be used during pregnancy and lactation.
During pregnancy, the drug can cause virilization in female fetuses.
During breastfeeding, it is not known how anabolic steroids are excreted in breast milk. In accordance with the adverse reactions that may occur in infants, it is necessary to decide whether to stop breastfeeding or stop taking the drug.
Influence on the ability to drive vehicles and work with mechanisms
Does not affect
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 °C, the reach of children.
Shelf life
3 years. Do not use after the expiration date printed on the package.
Vacation conditions
On prescription.
Packaging
Oxandrolone 10 Tablets. There are 25 tablets in a blister. 4 blisters are packed in a cardboard box together with an enclosed leaflet.