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Leuprosun 22.5mg - Leuprolide Acetate Injection

Leuprosun 22.5mg is a long-acting depot injection containing Leuprolide Acetate, used for hormone-sensitive cancers and gynecological conditions. A single dose offers up to 6 months of hormonal suppression, making it ideal for long-term management.

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General Information:
Generic Name: Leuprolide Acetate
Brand Name: Leuprosun 22.5mg
Packing: Single-dose vial with sterile diluent
Strength: 22.5 mg
Manufacturer: Sun Pharmaceutical Industries Ltd.
Form: Injectable (Depot Injection)
Category: GnRH (Gonadotropin-Releasing Hormone) Agonist / Antineoplastic / Hormonal Therapy
Product Introduction:
Leuprosun 22.5mg is a sustained-release hormonal injection used to suppress sex hormones like testosterone and estrogen. It is widely indicated in the treatment of advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. This formulation delivers Leuprolide over a 6-month period, reducing the need for frequent dosing.

Uses:
Leuprosun 22.5mg is prescribed for:
  1. Advanced Prostate Cancer – to lower testosterone and slow tumor growth
  2. Endometriosis – reduces estrogen and controls symptoms
  3. Uterine Fibroids – pre-surgical shrinkage and symptom management
  4. Central Precocious Puberty (CPP) – to delay premature puberty in children
  5. Breast Cancer – in premenopausal hormone-receptor positive cases (off-label use)
  6. Assisted Reproductive Technology (ART) – hormonal regulation in IVF cycles

Storage Instructions:
  1. Store below 25°C (77°F)
  2. Do not freeze
  3. Protect from moisture and light
  4. Use the reconstituted solution immediately
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Leuprolide Acetate is a GnRH agonist that initially stimulates the release of LH and FSH from the pituitary gland. This leads to a temporary rise in sex hormone levels, followed by downregulation of GnRH receptors and inhibition of LH/FSH secretion, ultimately reducing testosterone in men and estrogen in women—slowing the progression of hormone-sensitive diseases.

Side Effects:
Common side effects include:
  1. Hot flashes
  2. Injection site discomfort
  3. Fatigue
  4. Decreased libido
  5. Sweating
  6. Vaginal dryness (in females)
Serious side effects may include:
  1. Osteoporosis (bone thinning)
  2. Mood disorders (anxiety, depression)
  3. Hyperglycemia or diabetes
  4. QT interval prolongation
  5. Tumor flare (worsening of symptoms during initial phase)
  6. Severe allergic reactions (rash, difficulty breathing, facial swelling)

Dosage (Typical Recommended Dose):
  1. 22.5 mg intramuscular injection once every 6 months (24 weeks)
  2. The dose may vary based on disease and patient profile
  3. Administered by trained medical personnel only

Method of Administration:
  1. Intramuscular (IM) injection in the gluteal region
  2. Requires reconstitution with provided sterile diluent before injection
  3. Deep IM route ensures extended release
  4. Not to be self-administered

Precautions:
  1. Not for use during pregnancy or lactation
  2. Use non-hormonal birth control during treatment
  3. Monitor bone density, glucose levels, and mood changes during long-term use
  4. Watch for signs of tumor flare in the first weeks of treatment
  5. Caution in patients with heart disease, psychiatric illness, or osteopenia/osteoporosis

Drug Interactions:
May interact with:
  1. QT-prolonging drugs (e.g., certain antibiotics, antidepressants)
  2. Diabetes medications (can affect blood sugar control)
  3. Corticosteroids
  4. Other hormonal therapies or chemotherapeutic agents
  5. Always disclose current medications and supplements to your doctor

Allergies:
  1. Contraindicated in patients with known hypersensitivity to Leuprolide Acetate, GnRH analogs, or any excipients in the product
  2. Signs of an allergic reaction include rash, itching, swelling, dizziness, and trouble breathing

Overdose Information:
  1. Overdose is rare due to controlled administration
  2. Symptoms may include hormonal imbalance, fatigue, or mood disturbances
  3. Supportive care is the main approach; no specific antidote exists

Missed Dose Instructions:
  1. If a scheduled dose is missed, contact your healthcare provider immediately
  2. Delays may cause hormonal rebound and worsening of disease
  3. Never attempt to self-administer the dose

Additional Notes:
  1. Regular clinical monitoring is necessary during treatment
  2. May require calcium and vitamin D supplementation to protect bone health
  3. Periodic PSA (Prostate-Specific Antigen) testing for prostate cancer patients is essential
  4. Carry a treatment alert card indicating use of Leuprolide therapy
  5. Inform your doctor of any planned surgeries or dental procedures

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