Description

Technical Parameters

Introduction

pill

product-1400-1400

Products Description

### Systematic explanation of STADA Anadrol tablets 50mg

#### 1. Drug overview

**STADA Anadrol (Oxandrol tablets 50mg)** is a synthetic steroid drug, the main ingredient of which is Oxymetholone, a 17α-alkylated androgen derivative. The drug was originally developed by Syntex, an American company, and later produced by pharmaceutical companies in many countries. As an internationally renowned generic drug company, STADA's Anadrol tablets are known for their high bioavailability and strict quality control, and are widely used to treat erythropoietic disorders such as aplastic anemia.

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#### 2. Indications and clinical applications

1. **Main indications**:

- **Aplastic anemia**: Promotes erythropoiesis by stimulating the differentiation of bone marrow stem cells.

- **Anemia after chemotherapy**: Assists in improving bone marrow suppression anemia caused by chemotherapy in cancer patients.

- **Myelodysplastic syndrome (MDS)**: Used to increase hemoglobin levels in some cases

- **Inherited anemia**: such as auxiliary treatment of Fanconi anemia.

2. **Off-label use**:

- Athletes or bodybuilders have abused its muscle-building effect (now banned by the International Anti-Doping Agency).

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#### 3. Physical and chemical properties

1. **Chemical structure**:

- **Molecular formula**: C₂₁H₃₂O₃

- **Chemical name**: 17β-hydroxy-2-hydroxymethylene-17α-methyl-5α-androstane-3-one

- **Molecular weight**: 332.48 g/mol

- **Stability**: Light-sensitive, need to be stored away from light; easily soluble in chloroform and ethanol, slightly soluble in water.

2. **Dosage form characteristics**:

- **Tablet hardness**: Passed the European Pharmacopoeia disintegration test (≤15 minutes).

- **Packaging**: Commonly used is aluminum-plastic blister packaging, 10 tablets per plate, shelf life 36 months.

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#### 4. Dosage form and appearance characteristics

1. **Appearance details**:

- **Color**: Classic white to milky white tablets, some batches may be light yellow (depending on the ratio of excipients).

- **Shape**: Round biconvex tablets, about 8-9mm in diameter, with chamfered edges for easy swallowing.

- **Notch**: Most versions have a center notch for easy dose adjustment (half tablet = 25mg).

- **Logo**: The word "STADA" and the dose mark "50" are printed on one side of the tablet, and the pharmaceutical company logo is on the other side.

2. **Excipient composition**:

- Microcrystalline cellulose, magnesium stearate, cross-linked sodium carboxymethyl cellulose, etc., to ensure that the drug solubility is greater than 85% (pH 6.8 medium).

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#### 5. Pharmacological advantages

1. **Highly effective erythropoiesis**:

- While stimulating the kidney to secrete erythropoietin (EPO), it directly activates bone marrow erythroid progenitor cells, a dual-pathway mechanism of action.

- Clinical trials show that 4-6 weeks of medication can increase hemoglobin by 2-4g/dL.

2. **Pharmacokinetic advantages**:

- **Bioavailability**: Oral absorption rate reaches 95%, and the first-pass effect is low.

- **Half-life**: 9-16 hours, supporting once-daily dosing.

- **Protein binding rate**: 98% binds to sex hormone binding globulin (SHBG), reducing free drug fluctuations.

3. **Dosage form design advantages**:

- 50mg high-dose specification reduces the number of tablets taken and improves compliance.

- Special coating technology masks bitterness and reduces gastrointestinal irritation.

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#### 6. Usage and dosage management

1. **Standard regimen**:

- The initial dose for adults is 1-2mg/kg/day (usually 50-100mg/day), and the maximum dose is 150mg/day.

- Children take 1-5mg/kg/day in divided doses, and bone age needs to be strictly monitored.

2. **Dose adjustment**:

- Efficacy evaluation: test reticulocyte count every 2 weeks, and evaluate hemoglobin response every 6 weeks.

- Intermittent therapy is recommended for long-term use (e.g., stop the drug for 1 month after 3 months of use).

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#### 7. Safety and precautions

1. **Common adverse reactions**:

- **Hepatotoxicity**: About 15% of patients experience elevated transaminases, and it is recommended to monitor liver function monthly.

- **Masculinization**: The incidence of hirsutism in female patients is >30%, and the voice is irreversible.

- **Metabolic effects**: LDL increases, HDL decreases, and cardiovascular risk increases by 2-3 times.

2. **Black box warning**:

- Risk of hepatocellular carcinoma (ultrasound screening is required for long-term use >12 months).

- Risk of premature epiphyseal closure in children (bone age monitoring every 6 months).

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#### 8. Contraindications and interactions

1. **Absolute contraindications**:

- Prostate cancer, breast cancer, pregnancy (teratogenic risk up to grade D).

- Severe liver dysfunction (Child-Pugh grade C).

2. **Drug interactions**:

- Enhances the anticoagulant effect of warfarin (requires a 30-50% reduction in warfarin dose).

- Combined use with cyclosporine aggravates nephrotoxicity.

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#### 9. Brand and market positioning

1. **STADA pharmaceutical advantages**:

- Passed EU GMP certification, bioequivalence test shows that the difference in AUC with the original drug A-50 (Oxymetholone) is less than 5%.

- Adopts fluidized bed granulation process to ensure content uniformity RSD <2%.

2. **Global market distribution**:

- Mainly sold in Central and Eastern Europe, Latin America and some Asian countries, the price is about 60-70% of the original drug.

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#### 10. Patient education points

1. **Medication guidance**:

- It is recommended to take it after meals in the morning to reduce gastrointestinal discomfort.

- If you miss a dose within 8 hours, you can take it again, otherwise skip it.

2. **Life management**:

- Avoid alcohol (increases the risk of hepatotoxicity).

- Regularly monitor blood pressure and blood sugar (may induce diabetes).

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#### Conclusion

STADA Anadrol 50mg is a classic erythroid stimulant. Its optimized dosage form design and strict production process balance efficacy and safety. However, in clinical applications, it is necessary to strictly grasp the indications and cooperate with multidisciplinary monitoring to maximize the benefits of treatment. In the future, with the development of gene therapy, its role may gradually shift to second-line treatment, but at this stage it is still an important choice for specific anemia population.