Tap Pharmaceutical Products Inc.

Tap Pharmaceutical Products Inc. Drugs

• Lupron
  

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  Lupron

  

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  The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, sodium chloride for tonicity adjustment, 1.8 mg of benzyl alcohol as preservative and water for injection. The pH may have been adjusted with sodium hydroxide and/or acetic acid.

  Follow the pictorial directions on the reverse side of this package insert for administration.

  NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.

  LUPRON INJECTION can be administered by a patient/parent or health care professional.

  The dose of LUPRON INJECTION must be individualized for each child. The dose is based on a mg/kg ratio of drug to body weight. Younger children require higher doses on a mg/kg ratio.

  After 1-2 months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, sex steroids, and Tanner staging to confirm downregulation. Measurements of bone age for advancement should be monitored every 6-12 months. The dose should be titrated upward until no progression of the condition is noted either clinically and/or by laboratory parameters.

  The first dose found to result in adequate downregulation can probably be maintained for the duration of therapy in most children. However, there are insufficient data to guide dosage adjustment as patients move into higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate downregulation be verified in such patients whose weight has increased significantly while on therapy.

  As with other drugs administered by injection, the injection site should be varied periodically.

  Discontinuation of LUPRON INJECTION should be considered before age 11 for females and age 12 for males.

  The recommended starting dose is 50 mcg/kg/day administered as a single subcutaneous injection. If total downregulation is not achieved, the dose should be titrated upward by 10 mcg/kg/day. This dose will be considered the maintenance dose.

  Follow the pictorial directions on the reverse side of this package insert for administration.

  NOTE: As with other parenteral products, inspect the solution for discoloration and particulate matter before each use.

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