Copaxone
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
COPAXONE is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
History
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Other Information
Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:
(Glu, Ala, Lys, Tyr)x●xCH3COOH
(C5H9NO4●C3H7NO2●C6H14N2O2●C9H11NO3)x●xC2H4O2
CAS - 147245-92-9
COPAXONE is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of COPAXONE solution contains 20 mg or 40 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7.0. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.
Sources
Copaxone Manufacturers
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Teva Neuroscience, Inc.
![Copaxone (Glatiramer Acetate) Injection, Solution [Teva Neuroscience, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Copaxone | Teva Neuroscience, Inc.
2.1 Recommended DoseCOPAXONE is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:
• COPAXONE 20 mg per mL: administer once per dayor
COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart
• COPAXONE 40 mg per mL: administer three times per week and at least 48 hours apart • COPAXONE 20 mg per mL and COPAXONE 40 mg per mL are not interchangeable. 2.2 Instructions for UseRemove one blister-packaged prefilled syringe from the refrigerated carton. Let the prefilled syringe stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Visually inspect the syringe for particulate matter and discoloration prior to administration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.
Areas for subcutaneous self-injection include arms, abdomen, hips, and thighs. The prefilled syringe is for single use only. Discard unused portions.
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