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Trelstar

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Trelstar

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TRELSTAR®
(triptorelin pamoate) for Injectable Suspension Intramuscular Use.

DRUG DESCRIPTION

TRELSTAR (triptorelin pamoate for injectable suspension) is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR (triptorelin pamoate for injectable suspension) has a milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt). The empirical formula is C64H82N18O13 · C23H16O6 and the molecular weight is 1699.9. The structural formula is:

TRELSTAR (triptorelin pamoate) Structural Formula Illustration

The TRELSTAR (triptorelin pamoate for injectable suspension) products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials. Refer to Table 5 for the composition of each TRELSTAR (triptorelin pamoate for injectable suspension) product.

Table 5. TRELSTAR (triptorelin pamoate for injectable suspension) Composition

Ingredients TRELSTAR 3.75 mg TRELSTAR 11.25 mg TRELSTAR 22.5 mg
triptorelin pamoate (base units) 3.75 mg 11.25 mg 22.5 mg
poly-d,l-lactide-co-glycolide 136 mg 118 mg 182 mg
mannitol, USP 69 mg 76 mg 68 mg
carboxymethylcellulose sodium, USP 24 mg 27 mg 24 mg
polysorbate 80, NF 1.6 mg 1.8 mg 1.6 mg

When 2 mL sterile water is added to the vial containing TRELSTAR (triptorelin pamoate for injectable suspension) and mixed, a suspension is formed which is intended as an intramuscular injection. TRELSTAR (triptorelin pamoate for injectable suspension) is available in two packaging configurations: (a) TRELSTAR (triptorelin pamoate for injectable suspension) vial alone or (b) TRELSTAR (triptorelin pamoate for injectable suspension) vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.

What are the precautions when taking triptorelin pamoate for injectable suspension (Trelstar)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either olmesartan, amlodipine, or hydrochlorothiazide; or to other angiotensin receptor blockers (such as losartan); or to ACE inhibitors (such as lisinopril); or to other calcium channel blockers (such as nifedipine); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (such as renal artery stenosis, anuria), loss of too much body water (dehydration), liver disease, gout, lupus, untreated mineral imbalance (such as high/low potassium, low magnesium, high...

Read All Potential Precautions of Trelstar »

Last reviewed on RxList: 6/30/2011
This monograph has been modified to include the generic and brand name in many instances.

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