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Zoladex 10.8 mg

(goserelin acetate) implant


ZOLADEX® (goserelin acetate implant) is a GnRH agonist. Goserelin acetate is chemically described as an acetate salt of [D-Ser(But)6,Azgly10]. Its chemical structure is pyro-Glu-His-Trp-Ser-Tyr-DSer( But)-Leu-Arg-Pro-Azgly-NH2 acetate [C59H84N18O14·(C2H4O2) where x = 1 to 2.4]. Goserelin acetate is an off-white powder with a molecular weight of 1269 Daltons (free base). It is

freely soluble in glacial acetic acid. It is soluble in water, 0.1M hydrochloric acid, 0.1M sodium hydroxide, dimethylformamide and dimethyl sulfoxide. Goserelin acetate is practically insoluble in acetone, chloroform and ether.

ZOLADEX is supplied as a sterile, biodegradable product containing goserelin acetate equivalent to 3.6 mg of goserelin. ZOLADEX is designed for subcutaneous injection with continuous release over a 28-day period. Goserelin acetate is dispersed in a matrix of D,L-lactic and glycolic acids copolymer (13.3-14.3 mg/dose) containing less than 2.5% acetic acid and up to 12% goserelin-related substances and presented as a sterile, white to cream colored 1-mm diameter cylinder, preloaded in a special single use syringe with a 16-gauge x 36 +/- 0.5 mm siliconized needle with protective needle sleeve (SafeSystem™ Syringe) in a sealed, light- and moisture-proof, aluminum foil laminate pouch containing a desiccant capsule. Studies of the D,L-lactic and glycolic acids copolymer have indicated that it is completely biodegradable and has no demonstrable antigenic potential.

What are the possible side effects of goserelin (Zoladex)?

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

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

  • back pain, severe numbness or tingling in your legs or feet;
  • muscle weakness, problems with balance or coordination;
  • loss of bladder or bowel control;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • blood in your urine or stools;
  • feeling like you might pass...

Read All Potential Side Effects and See Pictures of Zoladex 10.8 mg »

What are the precautions when taking goserelin acetate implant (Zoladex 10.8 mg)?

Before using goserelin, tell your doctor or pharmacist if you are allergic to it; or to LHRH or LHRH-like hormones (e.g., triptorelin); 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: unexplained abnormal vaginal bleeding, diabetes, long-term alcohol use, smoking, personal or family history of bone loss (osteoporosis), heart disease (such as heart attack), high cholesterol/triglyceride levels, stroke, urinary blockage problem (in men), spinal cord problem (in men).

If you have diabetes, this drug may make it harder to control your blood sugar...

Read All Potential Precautions of Zoladex 10.8 mg »

Last reviewed on RxList: 7/27/2016
This monograph has been modified to include the generic and brand name in many instances.

Zoladex 10.8 mg - User Reviews

Zoladex 10.8 mg User Reviews

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