Luprodex

Luprodex

leuprorelin

Manufacturer:

Bharat

Distributor:

Sandoval

Marketer:

BSV Bioscience Phils
Concise Prescribing Info
Contents
Leuprorelin acetate
Indications/Uses
Endometriosis including pain relief & reduction of endometriosis lesions, as monotherapy for the symptomatic relief for women close to menopause who do not desire surgery, or adjunct to surgery. Pre-op hematologic improvement of patients w/ anemia caused by uterine leiomyomata (fibroids) concomitantly w/ Fe therapy. Advanced prostatic cancer. Alternative treatment of prostatic cancer when orchidectomy or estrogen administration are either not indicated or unacceptable to patient. Central precocious puberty in childn.
Dosage/Direction for Use
Endometriosis Initial dose should be given during the 1st 5 days of menstrual cycle. Duration: 6 mth as a single SC or IM inj or in combination w/ norethindrone acetate every mth. Retreatment w/ a 6-mth course of leuprorelin acetate mthly & norethindrone acetate daily if symptoms of endometriosis recur after a course of therapy. Uterine leiomyomata (fibroids) Initial dose should be given during the 1st 5 days of menstrual cycle. Duration: Up to 3 mth. Endometrial prep prior to intrauterine surgery 3.75 mg single dose may be given SC or IM inj 5-6 wk prior to surgery. Prostate cancer 3.75 mg depot as single IM inj administered mthly. Central precocious puberty Individualized dosage. Initially 0.3 mg/kg/4 wk (min 7.5 mg) administered as single IM or SC inj.
Contraindications
Hypersensitivity to GnRH, GnRH agonist analogs. Undiagnosed abnormal vag bleeding. Pregnancy & lactation.
Special Precautions
CV disease. Patients w/ history of or risk factors for QT prolongation & receiving concomitant medicinal products that might prolong QT interval. Transient testosterone flare. Decreased bone density. Pituitary apoplexy. Hyperglycemia & diabetes. Convulsions. Hepatic dysfunction & jaundice w/ elevated liver enzyme. Spinal fracture, paralysis & hypotension; increased risk of incident depression. Confirm diagnosis of fibroids & exclude ovarian mass, either visually by laparoscopy or by ultrasonography or other investigative technique before administration when considering pre-op treatment of fibroids. Severe bleeding. Increased uterine cervical resistance resulting to difficulty in dilating the cervix for intrauterine surgical procedure. Patients w/ urinary obstruction & metastatic vertebral lesions in men. Notify physician if regular menstruation persists in women. Precise diagnosis (if idiopathic &/or neurogenic) in girls w/ central precocious puberty prior treatment. Diagnostic tests of pituitary gonadotropic & gonadal functions. Consider assessment of CV risk factors prior to initiation of concurrent treatment w/ leuprorelin acetate & norethindrone acetate. Childn <18 yr.
Adverse Reactions
Hot flashes, nausea, malaise & fatigue & transient local irritation at the site of inj; inj site burning & paresthesia, ecchymoses, erythema. Nasopharyngitis, diarrhea, gastroenteritis/colitis, pruritus, night sweats, arthralgia, limb pain, myalgia, rigors, weakness, urinary infrequency, difficulty in micturation, dysuria, nocturia, oliguria, breast tenderness, testicular atrophy & pain, infertility, breast hypertrophy, erectile dysfunction, reduced penis size, inj site pain, bruising & stinging, increased blood creatinine phosphokinase, prolonged coagulation time, hematologic changes, anemia.
Drug Interactions
Prolonged QT interval w/ medicinal products known to prolong QT interval or medicinal products able to induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics.
MIMS Class
Trophic Hormones & Related Synthetic Drugs / Cancer Hormone Therapy
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Luprodex lyo powd for inj 3.75 mg
Packing/Price
(+ 2 mL amp diluent + 2 (22 G) needles + 3 mL syringe + 2 alcohol swabs) 1's
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