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Lupron Depot
Overview
What is Lupron Depot?
Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH or LH-RH), a GnRH agonist. The chemical name is 5- oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:
LUPRON DEPOT 11.25 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection.
The front chamber of LUPRON DEPOT 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (11.25 mg), polylactic acid (99.3 mg) and D-mannitol (19.45 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
During the manufacture of LUPRON DEPOT 11.25 mg for 3-month administration, acetic acid is lost, leaving the peptide.
What does Lupron Depot look like?
What are the available doses of Lupron Depot?
LUPRON DEPOT (leuprolide acetate for depot suspension) 11.25 mg for 3-month administration contains leuprolide acetate and is a lyophilized powder for reconstitution with supplied diluent in a prefilled dual chamber syringe.
What should I talk to my health care provider before I take Lupron Depot?
How should I use Lupron Depot?
LUPRON DEPOT 11.25 mg for 3-month administration is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Laparoscopic staging of endometriosis does not necessarily correlate with the severity of symptoms.
LUPRON DEPOT 11.25 mg in combination with a norethindrone acetate 5 mg tablet taken once daily as add-back therapy is also indicated for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
Use of norethindrone acetate in combination with LUPRON DEPOT 11.25 mg is referred to as add-back therapy, and is intended to reduce the loss of bone mineral density (BMD) and to reduce vasomotor symptoms associated with use of LUPRON DEPOT 11.25 mg. Decide between use of LUPRON DEPOT 11.25.mg alone or LUPRON DEPOT 11.25.mg plus norethindrone acetate add-back therapy for initial management of the symptoms and signs of endometriosis in consultation with the patient, considering the risks and benefits of adding norethindrone to LUPRON DEPOT 11.25 mg . For the safe and effective use of norethindrone acetate, refer to the norethindrone acetate prescribing information.
Limitation of use
[see Warnings and Precautions ]
[see Dosage and Administration ]
LUPRON DEPOT 11.25 mg given by a healthcare provider as a single intramuscular (IM) injection once every three months for up to two injections (6 months of therapy). LUPRON DEPOT may be administered alone or in combination with daily 5 mg tablet of norethindrone acetate (add-back).
If endometriosis symptoms recur after initial course of therapy, retreatment for no more than six months may be considered but with the addition of norethindrone acetate add-back therapy. Do not re-treat with LUPRON DEPOT 11.25 mg alone.
Assess bone density before retreatment begins. ,
What interacts with Lupron Depot?
Sorry No Records found
What are the warnings of Lupron Depot?
Sorry No Records found
What are the precautions of Lupron Depot?
Sorry No Records found
What are the side effects of Lupron Depot?
Sorry No records found
What should I look out for while using Lupron Depot?
LUPRON DEPOT 11.25 mg is contraindicated in women with the following:
When considering add-back therapy with norethindrone acetate, refer also to in the norethindrone acetate package insert.
What might happen if I take too much Lupron Depot?
Sorry No Records found
How should I store and handle Lupron Depot?
ArrayEach LUPRON DEPOT 11.25 mg kit (NDC 0074-3663-03) contains:Each syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of the diluent, LUPRON DEPOT 11.25 mg is administered as a single intramuscular injection.Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) .Each LUPRON DEPOT 11.25 mg kit (NDC 0074-3663-03) contains:Each syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of the diluent, LUPRON DEPOT 11.25 mg is administered as a single intramuscular injection.Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) .Each LUPRON DEPOT 11.25 mg kit (NDC 0074-3663-03) contains:Each syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable polymer of polylactic acid. When mixed with 1.5 mL of the diluent, LUPRON DEPOT 11.25 mg is administered as a single intramuscular injection.Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F) .
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Leuprolide acetate is a long-acting GnRH analog. A single injection of LUPRON DEPOT results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing at quarterly (LUPRON DEPOT 11.25 mg) intervals results in decreased secretion of gonadal steroids. Consequently, tissues and functions that depend on gonadal steroids for their maintenance become quiescent. This effect is reversible on discontinuation of drug therapy.
Leuprolide acetate is not active when given orally.
Non-Clinical Toxicology
LUPRON DEPOT 11.25 mg is contraindicated in women with the following:When considering add-back therapy with norethindrone acetate, refer also to in the norethindrone acetate package insert.
When considering add-back therapy with norethindrone acetate, refer also to in the norethindrone acetate package insert.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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