Teva Neuroscience, Inc.

Teva Neuroscience, Inc. Drugs

• Azilect
  

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  Azilect

  

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  2.1 General Dosing Recommendations

  When AZILECT is prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start AZILECT at the recommended dose of 1 mg administered orally once daily.

  In patients taking levodopa, with or without other PD drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of AZILECT is 0.5 mg once daily. If the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily. When AZILECT is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response.

  The recommended doses of AZILECT should not be exceeded because of risk of hypertension [see Warnings and Precautions (5.1)].

  2.2 Patients Taking Ciprofloxacin or Other CYP1A2 Inhibitors

  Patients taking concomitant ciprofloxacin or other CYP1A2 inhibitors should not exceed a dose of AZILECT 0.5 mg once daily [see Warnings and Precautions (5.4), Drug Interactions (7.6), and Clinical Pharmacology (12.3)].

  2.3 Patients with Hepatic Impairment

  Patients with mild hepatic impairment should not exceed a dose of AZILECT 0.5 mg once daily. AZILECT should not be used in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

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• Copaxone
  

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  Copaxone

  

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  2.1 Recommended Dose

  COPAXONE 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 day

  or

  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 Use

  Remove 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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