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Lupron Depot-ped Generic Name & Formulations
Legal Class
Rx
General Description
Leuprolide acetate 7.5mg, 11.25mg or 15mg; per kit; depot susp for IM inj; preservative-free.
Pharmacological Class
GnRH analogue.
See Also
How Supplied
Depot-PED kit—1 (prefilled dual-chamber syringe w. diluent, supplies); Depot-PED 3 Month kit—1 (prefilled dual-chamber syringe w. diluent, supplies)
Manufacturer
Lupron Depot-ped Indications
Indications
Central precocious puberty.
Lupron Depot-ped Dosage and Administration
Adult
Not applicable.
Children
<1yr: not established. ≥1yrs: Individualize. Give by single IM inj once a month into the gluteal area, anterior thigh, or shoulder; rotate inj sites. ≤25kg: 7.5mg; 25–37.5kg: 11.25mg; >37.5kg: 15mg; if inadequate response with starting dose, may increase to next available higher dose. Also, dose may be adjusted with changes in body weight.
Lupron Depot-ped Contraindications
Contraindications
Pregnancy.
Lupron Depot-ped Boxed Warnings
Not Applicable
Lupron Depot-ped Warnings/Precautions
Warnings/Precautions
Must be administered by a healthcare professional. Initial transient rise in gonadotropins and sex steroids may result in increased signs/symptoms of puberty. Monitor LH and sex steroid levels at 1–2 months after treatment initiation, with dose changes, and as clinically indicated; for Depot 3-Month: monitor at months 2–3, month 6 and as needed thereafter. Measure height and bone age velocity every 6–12 months. Monitor for pseudotumor cerebri or psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Exclude pregnancy prior to initiation. Advise females of reproductive potential to use non-hormonal method of contraception during treatment. Nursing mothers.
Lupron Depot-ped Pharmacokinetics
See Literature
Lupron Depot-ped Interactions
Interactions
Caution with concomitant drugs that are associated with convulsions (eg, bupropion, SSRIs).
Lupron Depot-ped Adverse Reactions
Adverse Reactions
Transient exacerbation of symptoms, inj site reactions, pain, headache, emotional lability, acne/seborrhea, rash, vaginitis, vaginal discharge, syncope, GI upset, gynecomastia, weight increased, mood altered.
Lupron Depot-ped Clinical Trials
See Literature
Lupron Depot-ped Note
Not Applicable
Lupron Depot-ped Patient Counseling
See Literature
