3098-20 Continuous Epidural 18g Hustead
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Questions & Answers
Side Effects & Adverse Reactions
Initially, leuprolide acetate, like other LH-RH agonists, causes increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostate cancer, may occasionally develop during the first few weeks of leuprolide acetate treatment. A small number of patients may experience a temporary increase in bone pain, which can be managed symptomatically. As with other LH-RH agonists, isolated cases of ureteral obstruction and spinal cord compression have been observed, which may contribute to paralysis with or without fatal complications.
Safe use of leuprolide acetate in pregnancy has not been established clinically. Before starting treatment with leuprolide acetate, pregnancy must be excluded (see CONTRAINDICATIONS section).
Periodic monitoring of serum testosterone and prostate-specific antigen (PSA) levels is recommended, especially if the anticipated clinical or biochemical response to treatment has not been achieved. It should be noted that results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.
History
There is currently no drug history available for this drug.
Other Information
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 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:
Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing 5 mg/mL of leuprolide acetate, 6.3 mg/mL sodium chloride, USP for tonicity adjustment, 9 mg/mL of benzyl alcohol as a preservative and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF.
DESCRIPTIONLeuprolide 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 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:
Leuprolide acetate injection is a sterile, aqueous solution intended for daily subcutaneous injection.
It is available in a 2.8 mL multiple-dose vial containing 5 mg/mL of leuprolide acetate, 6.3 mg/mL sodium chloride, USP for tonicity adjustment, 9 mg/mL of benzyl alcohol as a preservative and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF.
Sources
3098-20 Continuous Epidural 18g Hustead Manufacturers
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Smiths Medical Asd, Inc.
![3098-20 Continuous Epidural 18g Hustead () Kit [Smiths Medical Asd, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
3098-20 Continuous Epidural 18g Hustead | Teva Parenteral Medicines, Inc.
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.
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