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OXITOLAND 50mg tablets

OXITOLAND
OXYMETHOLONE
Oral Tablets

FORMULA

Each tablet contains:
Oxymetholone ……………………………………………………………………… 50 mg
Excipients q.s. ……………………………………………………………………. 1 tablet

CHARACTERISTICS

Oxitoland contains oxymetholone, a potent androgenic anabolic drug. It is indicated in the treatment of anemias caused by a deficient red blood cell production. Oxymetholone enhances erythropoietin production in pacients with anemia due to the deficiency in the bone marrow, and frequently, stimulates erythropoiesis in anemia caused by a deficiency in the production of erythrocytes.

INDICATIONS

Oxymetholone (50 mg) is indicated in the treatment of anemia caused by a deficient production of erythrocytes. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and anemia caused by the administration of myelotoxic substances, frequently respond to treatment. Administration of oxymetholone (50 mg) must not exclude other support measures, such as blood transfusions, iron correction, folic acid, vitamin B12 and pyridoxine, antibacterial therapy and the appropriate use of corticosteroids.

CONTRAINDICATIONS

Before implementing the therapy, the physician must analiyze if the risks outweight the potential benefits for the patient. Anabolic agents are generally contraindicated in the following situations:
1- Prostate carcinoma or breast carcinoma in male patients.
2- Breast carcinoma in female patients with hypercalcemia; androgenic anabolic steroids can stimulate osteolytic bone resorption.
3- Pregnancy: oxymetholone can be harmful to the fetus. If a patient becomes pregnant during treatment with this drug, she must be informed about the potential hazard to the fetus.
4- Nephrosis
5- Hypersensitivity to the drug.
6- Severe hepatic failure.
7- Breastfeeding: It is not known whether anabolic steroids are excreted in human milk. Because of a potential risk of adverse reactions in infants with breast milk that contains anabolic steroids, women who take oxymetholone should not breastfeed.

PRECAUTIONS AND WARNINGS

1- Hepatotoxicity: jaundice is common at prescribed doses. Clinic jaundice may be painless. It can also be associated to an acute hepatic enlargement and pain in the right upper quadrant, what can lead to the misleading assumption of an acute obstruction of the bile duct (which requires surgery). Drug induced jaundice is usually reversible once the medication is discontinued. A continuous therapy may be associated to hepatic coma and death. Due to hepatotoxicity associated with the administration of oxymetholone, periodic monitoring of the hepatic function is recommended. Hepatocellular carcinoma and hepatic peliosis (a rare condition of poorly defined ethiology) have been observed in patients with congenital and acquired aplastic anemia, treated with oxymetholone and other androgens for a long term. In some cases, with the withdrawal of the drug, a regression was observed in liver lesions.
2- Virilization: There can be virilization in women. Amenorrhea usually appears in adult women, even with thrombocytopenia. Concomitant administration of high doses of progestin agents for the control of amenorrhea is not recommended.
3- Iron deficiency: Development of anemia manifested by low iron in serum and a percentage decrease of saturation of transferrin has been observed in pacientes treated with oxymetholone. A periodic iron serum determination, and iron conjugation thermal capacity are recommended.
If iron deficiency is determined, this must be adequately treated with iron supplements.
4- Leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role of oxymetholone is not clear, since malignant transformation has been observed in blood dyscrasias and leukemia in patients with aplastic anemia not treated with oxymetholone.
5- This drug has to be used with caution in pacients with heart, kidney or liver dysfunctions. Oedema, with or without congestive heart failure can occur occasionally. Concomitant administration of corticosteroids or ACTM can contribute to oedema: this is generally controlable, with and appropriate diuretic therapy and/or digitalis.
6- Hypercalcemia can be developed, spontaneously as well as a result of hormonal therapy, in women with carcinoma disseminated in breast, due to stimulation of osteolysis. If this occurs during use of this drug, withdraw use of the drug.
7- Anabolic steroids might increase sensitivity to anticoagulants. The reduction of anticoagulant doses may be necessary in order to keep prothrombin on the desired level.
8- It has been observed that anabolic steroids can interfere with the glucose tolerance tests. Diabetic patients must be closely monitored and insulin or oral hypoglucemics doses should be adjusted.
9- Anabolic steroids must be used with caution in patients with benign prostate hypertrophy. In geriatric male patients treated with androgenic anabolic steroids there can be an increase in the incidence of prostate hypertrophy and prostate carcinoma.
10- Blood lipid changes, that are known to be associated with an increase in the risk of arterosclerosis, have been observed in patients treated with androgenic anabolic steroids. These changes include the decrease of high density lipoprotein and sometimes the increase of high density lipoprotein. Changes can be more notable and have a serious impact on the risk of arterosclerosis and coronary artery disease
11- Anabolic/androgenic steroids should be used with caution in children. Anabolic agents may accelerate epiphyseal maturation faster than the lineal growth in children and the effect can persist for 6 months after the withdrawal of the drug. Therefore, therapy must be monitored through radiographic studies at 6 months intervals, in order to avoid the risk of compromising adult height.
12- Because of serious side effects, anabolic steroids must not be used to promote athletic conditions.

ADVERSE REACTIONS

1- Hepatotoxicity is one of the adverse reactions frequently associated with an anabolic steroids therapy. The reversible increase in bromosulfatein can occur on an early stage and seems to be dose-related. An increase in serum bilirubin with or without increase of transaminases alkaline phosphatase (GOT and PGT), indicate a greater excretory dysfunction. The histological frame is that of intrahepatic cholestasis with little or no cellular damage.
2- Virilization is the most common undesirable side effect, associated with the use of anabolic steroids. Acne can appear frequently. In prepubertal individuals common side effects are penis enlargement and increased erections, hirsutism and increase in skin pigmentation can also occur. In young postpuberal men, testicular function is inhibited with oligospermia, seminal volume diminishes, there are changes in libido and impotence. Testicular atrophy can occur. Chronic priaprism, masculine patterns of hair loss, epididymitis and bladder irritability have been reported. In women there can be hirsutism, deepening of the voice, clitoral enlargement (that can be irreversible even after withdrawal of medication), changes in libido and menstrual irregularities. The use of estrogen combined with androgens does not prevent virilization in women.
3- Other adverse reactions associated to an anabolic-androgen therapy include: nausea, agitation, insomnia, shivers, premature closure of epiphysis in children, vomit and diarrhea.

4- There are alterations in thyroid function tests: a decrease of GPD, in the ability to conjugate tyroxine to fix radioiodine and there can be an increase of T3 fixation because of the erythrocytes. Free thyroxine is normal. Alterations in the test persist for 2 or 3 weeks, generally, after withdrawal of the drug. The excretion of 17-ketosteroids is reduced.

DOSAGE

Recommended doses in children and adults are 1 to 5 mg/kg of body weight/day. The effective dose is 1 to 2 mg/kg/day, but higher doses may be necessary and dosage must be individualized. Response is not always inmediate and a minimum therapeutic test must be done at 3 to 6 months. After remission, patients can be maintained without the use of drugs and others can be maintained with lower daily doses. A continuos therapy is generally necessary for patients with congenital aplastic anemia.

RESTRICTIONS IN USE

Hypersensitivity to the drug. Patients with aplastic anemia. Pregnancy. Breastfeeding. Hepatic failure.

OVERDOSE

Acute toxicity in animals is very low and there are no overdose reports in humans. But if you experience any symptom withdraw immediately medication and go to the Medical Emergency Center (Dr. Luis María Argaña, Toxicology Department – Gral. Santos and Teodoro S. Mongelós – Phone 220 418.

PACKAGING

Box with 20 tablets

Keep at a temperature below 25º C in a dry place.
Keep out of reach of children.

Sale only with Prescription.
Made in Paraguay