Monograph Details
|
|
Endocrine System
> Pituitary disorders
|
|
LUPRON DEPOT-PED |
| Manufacturer |
|
TAP Pharmaceutical Products, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
GnRH analogue. |
| Generic Name |
|
Leuprolide acetate 7.5 mg, 11.25 mg or 15 mg/kit; depot susp for IM inj. |
| Also |
|
• LUPRON
|
| Indications |
|
Central precocious puberty. |
| Children |
|
Initially 0.3 mg/kg (minimum 7.5 mg) every 4 weeks as single IM inj, may increase in increments of 3.75 mg every 4 weeks. |
| Adults |
|
Not applicable. |
| Contraindications |
|
Pregnancy (Cat.X). |
| Precautions |
|
Confirm diagnosis. Monitor hormonal effects within first 4–8 weeks, growth velocity and bone age velocity every 6–12 months. Apprise patient and/or guardian of long-term effects and importance of compliance. Exclude pregnancy before treatment. Nursing mothers: not recommended. |
| Adverse Reactions |
|
Transient exacerbation of symptoms, pain, acne, rash, syncope, GI upset, emotional lability, gynecomastia, vaginitis, vaginal discharge, local reactions. |
| How Supplied |
Multidose vial (2.8 mL)—1 (w. syringes)
Depot-PED kit—1 (syringe w. diluent) |
|
|
|
|
