OXYLAB – Tablets

Oxymetholone 50 mg

Oral tablets

FORMULA

Oxymetholone 50 mg

Oral tablets

FEATURES

Oxylab contains oxymetholone, a potent androgenic anabolic drug. It is indicated in the treatment of anemia caused by poor red blood cell production.Oxymetholone increases erythropoietin production in patients with anemia due to bone marrow deficiency, and often 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 deficiency in the 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) should not exclude other supportive measures, such as blood transfusions, correction of iron, folic acid, vitamin B12 and pyridoxine, antibacterial therapy and the appropriate use of corticosteroids.

CONTRAINDICATIONS

Before applying therapy, the clinician should aim to analyze whether the risks outweigh the potential benefits to the patient. Anabolic agents are generally contraindicated in the following situations:

breast carcinoma or carcinoma 1- prostate in male patients.

2- Breast carcinoma in women with hypercalcemia; anabolic androgenic steroids can stimulate osteolytic bone resorption.

3- Pregnancy: oxymetholone can be harmful to the fetus. If a patient becomes pregnant during treatment with this medicine, she should be informed of the potential risk to the fetus.

4- Nephrosis

5- Hypersensitivity to the drug.

6- severe liver failure.

7- Lactation: It is not known whether anabolic steroids are excreted in human milk. Due to the potential risk of adverse reactions in infants with breast milk containing anabolic steroids, women taking oxymetholone should not breastfeed.

PRECAUTIONS AND WARNINGS

1- Hepatotoxicity: jaundice is common at prescribed doses. Clinical jaundice can be painless. It can also be associated with acute liver enlargement and right upper quadrant pain, which can lead to the mistaken assumption of acute bile duct obstruction (requiring surgery). Drug-induced jaundice is usually reversible once the drug is discontinued. Continuous therapy can be associated with liver coma and death. Due to the hepatotoxicity associated with the administration of oxymetholone, periodic monitoring of liver function is recommended. Hepatocellular carcinoma and peliosis hepatis (a rare disease of poorly defined etiology) 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 in liver lesions was observed.

2- Virilization: There can be no virilization in women. Amenorrhea usually appears in adult women, even with thrombocytopenia. Concomitant administration of high-dose progestin agents for the control of amenorrhea is not recommended.

3- iron deficiency: Development of anemia is manifested by a low level of iron in the serum and a percentage of decrease in transferrin saturation has been observed in patients treated with oxymetholone. A periodic determination of serum iron, iron, and conjugation heat capacity is recommended.

If iron deficiency is determined, this must be treated appropriately with iron supplements.

4- leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role of oxymetholone is unclear, since malignant transformation has been observed in blood dyscrasias and leukemia in patients with aplastic anemia not treated with oxymetholone.

5- This medicine should be used with caution in patients with heart, kidney or liver dysfunctions. Edema, with or without congestive heart failure can occur from time to time. Concomitant administration of corticosteroids or ACTM may contribute to edema: this is generally controllable, with and appropriate diuretic therapy and / or digitalis.

6- Hypercalcemia can develop spontaneously, as well as a result of hormonal therapy, in women with disseminated breast carcinoma, due to the stimulation of osteolysis. If this occurs while using this medicine, discontinue use of the medicine.

7- Anabolic steroids can increase sensitivity to anticoagulants. Reduction of anticoagulant doses may be necessary in order to maintain prothrombin at the desired level.

8- It has been observed that anabolic steroids can interfere with glucose tolerance tests. Diabetic patients should be monitored and doses of insulin or oral hypoglucemics should be adjusted.

9- Anabolic steroids should be used with caution in patients with benign hypertrophy of the prostate. In geriatric male patients treated with anabolic androgenic steroids there can be an increased incidence of prostate hypertrophy and prostate carcinoma.

10- blood lipid changes, which are known to be associated with an increased risk of atherosclerosis, have been observed in patients treated with anabolic androgenic steroids. These changes include the decrease in high-density lipoprotein and sometimes the increase in high-density lipoprotein. The changes can be more noticeable and have a serious impact on the risk of arteriosclerosis and coronary artery disease.

11- Anabolic / androgenic steroids should be used with caution in children. Anabolic agents can accelerate epiphyseal maturation faster than linear growth in children, and the effect may persist for 6 months after drug withdrawal. Therefore, therapy should be supervised through radiographic studies at 6-month intervals, in order to avoid the risk of compromising adult height.

12- Due to serious side effects, anabolic steroids should not be used to promote athletic conditions.

ADVERSE REACTIONS

1- Hepatotoxicity is one of the adverse reactions frequently associated with anabolic steroid therapy. The reversible increase in bromosulfatein can occur at an early stage and appears to be dose related. An increase in serum bilirubin, with or without an increase in alkaline phosphatase transaminases (GOT and PGT), indicates greater excretory dysfunction. The histological setting 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 increased skin pigmentation can also occur. In young postpubertal men, testicular function is inhibited with oligospermia, seminal volume decreases, there are changes in libido and impotence. Testicular atrophy may occur. Chronic priapism, male patterns of hair loss, epididymitis, and bladder irritability have been reported. In women there can be hirsutism, deepening of the voice, enlargement of the clitoris (which may be irreversible, even after withdrawal of the medication), changes in libido and menstrual irregularities. The use of estrogens in combination with androgens does not prevent virilization in women.

3- Other adverse reactions associated with anabolic-androgen therapy include: nausea, agitation, insomnia, tremors, premature closure of the epiphyses in children, vomiting and diarrhea.

4- there are alterations in thyroid function tests: a decrease in GPD, in the ability to conjugate thyroxine to fix radioactive iodine and there can be no increase in T3 fixation due to erythrocytes. Free thyroxine is normal. Test abnormalities persist for 2 to 3 weeks, usually after drug withdrawal. 17-CS excretion is reduced.

DOSAGE

The 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 the dose must be individualized. The response is not always immediate and a minimal therapeutic trial should be done in 3 to 6 months. After remission, patients can be maintained without the use of drugs and others can be maintained with lower daily doses. Continuous therapy is generally necessary for patients with congenital aplastic anemia.

Use restrictions

Hypersensitivity to the drug. Patients with aplastic anemia. The pregnancy. Breast-feeding. Liver failure

OVERDOSE

Acute toxicity in animals is very low and there are no reports of overdose in humans. But if you experience any symptoms immediately remove the medication and go to the Emergency Medical Center.

PACKAGING

Box with 100 tablets

Store at a temperature below 25 ° C in a dry place.

Keep out of the reach of children.

The sale only with the prescription.