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Lupron Depot 11.25

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Lupron Depot 11.25 mg

LUPRON DEPOT® -3 Month 11.25 mg
(leuprolide acetate for depot suspension) 3-MONTH FORMULATION

Lupron Depot 11.25 mg

DRUG DESCRIPTION

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5oxo-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®(leuprolide acetate) Structural Formula Illustration

LUPRON DEPOT–3 Month 11.25 mg 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 to be given ONCE EVERY THREE MONTHS.

The front chamber of LUPRON DEPOT–3 Month 11.25 mg prefilled dual-chamber syringe contains leuprolide acetate (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–3 Month 11.25 mg, acetic acid is lost, leaving the peptide.

What are the possible side effects of leuprolide (Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • pain, burning, stinging, bruising, or redness where the medication was injected;
  • feeling like you might pass out;
  • painful or difficult urination;
  • urinating more...

Read All Potential Side Effects and See Pictures of Lupron Depot 11.25 mg »

What are the precautions when taking leuprolide acetate for depot suspension (Lupron Depot 11.25 mg)?

Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fat levels (e.g., high cholesterol, high triglycerides), depression.

In adults, leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time because it reduces estrogen...

Read All Potential Precautions of Lupron Depot 11.25 mg »

Last reviewed on RxList: 4/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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Lupron Depot 11.25 mg - User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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