Description

Technical Parameters

Introduction

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product-1400-1400

Products Description

### STADA brand Nolvadex tablets (20mg) systemic detailed explanation

#### 1. Drug Overview

**Generic Name**: Tamoxifen Citrate

**Trade Name**: Nolvadex (produced by STADA)

**Indications**:

- Adjuvant therapy for estrogen receptor-positive (ER+) breast cancer and metastatic breast cancer.

- Prevention of breast cancer in high-risk women (such as BRCA gene mutation carriers).

- Used for infertility treatment (regulating ovulation).

**Mechanism of Action**:

Tamoxifen is a selective estrogen receptor modulator (SERM) that inhibits the growth of estrogen-dependent tumors by competitively binding to estrogen receptors in breast tissue. It exhibits a partial agonist effect in bones and uterus.

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#### 2. Physical and chemical properties

1. **Chemical structure**:

- Molecular formula: C₃₂H₃₇NO₁₀ (citrate form)

- Molecular weight: 563.65 g/mol

- Chemical name: (Z)-2-[4-(1,2-diphenyl-1-butenyl)phenoxy]-N,N-dimethylethylamine citrate.

2. **Solubility and stability**:

- **Solubility**: Slightly soluble in water (about 0.5 mg/mL), easily soluble in organic solvents such as ethanol and chloroform.

- **Stability**: Need to be stored away from light, sensitive to moisture and heat, and may degrade if exposed to high temperature (＞30°C) for a long time.

3. **Formulation excipients**:

- Core ingredient: Tamoxifen citrate (equivalent to 20 mg tamoxifen base).

- Inactive ingredients: lactose, microcrystalline cellulose, magnesium stearate, hypromellose, etc., used to improve tablet molding and disintegration.

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#### 3. Tablet appearance and packaging

1. **Physical characteristics**:

- **Color**: 20mg Nolvadex produced by STADA is usually white to off-white round or oval tablets.

- **Logo**: "STADA" or "20" may be engraved on the surface of the tablet for easy identification.

- **Size**: Diameter is about 6-8mm, moderate thickness, easy to swallow.

2. **Packaging specifications**:

- Common packaging is aluminum-plastic blister board, 10 tablets per board, and 3 boards (30 tablets) per box.

- The packaging box is marked with batch number, expiration date and anti-counterfeiting mark, which meets EU GMP standards.

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#### 4. Core advantages

1. **High efficiency and selectivity**:

- For patients with ER+ breast cancer, 5 years of adjuvant treatment can reduce the risk of recurrence by 40%-50% (NSABP B-14 study).

- It has an estrogen-like protective effect on bones and reduces the risk of postmenopausal osteoporosis.

2. **Good tolerance**:

- Compared with chemotherapy, it has mild side effects and high patient compliance.

- Long-term use (5-10 years) has sufficient safety data, especially suitable for young patients.

3. **Economical**:

- As a non-patented drug, the price of generic drugs produced by STADA is 30%-50% lower than that of original drugs.

4. **Multi-scenario application**:

- It has dual effects of treatment and prevention, reducing the incidence of contralateral breast cancer by about 50%.

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#### 5. Pharmacokinetics

1. **Absorption and distribution**:

- **Oral bioavailability**: about 30%, eating does not affect absorption.

- **Peak time (Tmax)**: 4-7 hours, plasma protein binding rate> 98%.

2. **Metabolism and excretion**:

- **Metabolic pathway**: converted into active metabolites (4-hydroxytamoxifen, endoxifen) by liver CYP3A4/2C9 enzyme.

- **Half-life**: 5-7 days for the parent drug, up to 14 days for the active metabolite.

- **Excretion**: mainly excreted through feces (65%), a small amount through urine (9%).

3. **Adjustments for special populations**:

- Patients with impaired liver function need to reduce the dose, and those with severe renal damage do not need to adjust the dose.

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#### 6. Side effects and risk management

1. **Common adverse reactions**:

- Hot flashes (about 40% of patients), vaginal dryness, menstrual disorders.

- Gastrointestinal reactions (nausea, constipation), mild thrombocytopenia.

2. **Serious risks**:

- **Thromboembolism**: The risk of deep vein thrombosis increases 2-3 times (positively correlated with the duration of treatment).

- **Endometrial cancer**: Long-term use (>2 years) increases the risk by 2-4 times, and regular gynecological monitoring is required.

- **Retinopathy**: Rare but need to be alert to changes in vision.

3. **Contraindications**:

- Pregnancy (risk of teratogenicity), previous history of thrombosis, and allergy to excipients are contraindicated.

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#### 7. Dosage and administration regimen

- **Standard dose**: 20 mg/day, taken orally once or twice.

- **Course of treatment**: Adjuvant therapy usually lasts 5-10 years (according to NCCN guidelines).

- **Dose adjustment**: Patients with Child-Pugh B/C liver function should reduce the dose by half.

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#### 8. Storage and stability

- **Storage conditions**: Protect from light, below 25°C, relative humidity <60%.

- **Expiration period**: Usually 36 months in unopened state, moisture-proof after opening.

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#### 9. Manufacturer background: STADA

- **Founded**: 1895, headquartered in Bad Homburg, Germany.

- **Global status**: Leading generic drug company in Europe, with business covering 120 countries.

- **Quality control**: Follow EU EMA standards, and the production line is certified by FDA and MHRA.

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#### 10. Market positioning and patient education

- **Price range**: About €0.8-1.2/tablet (depending on regional medical insurance policies).

- **Patient tips**:

- Take the medicine at a fixed time every day, and make up for the missed dose within 12 hours.

- Avoid co-administration with strong CYP3A4 inducers (such as rifampicin) or inhibitors (such as ketoconazole).

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#### Conclusion

STADA's Nolvadex 20mg tablets have become one of the core drugs for comprehensive treatment of breast cancer due to its precise SERM mechanism, mature safety data and cost advantages. Patients need to weigh the efficacy and risks under the guidance of a doctor and cooperate with regular monitoring to achieve the best prognosis.