Arsenicum Album 200c

Arsenicum Album 200c Manufacturers

• Paramesh Banerji Life Sciences Llc
  

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  Arsenicum Album 200c | Sandoz Inc

  

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  2.4 Olanzapine for Injection: Agitation Associated with Schizophrenia and Bipolar I Mania

  Dose Selection for Agitated Adult Patients with Schizophrenia and Bipolar I Mania

  The efficacy of intramuscular olanzapine for injection in controlling agitation in these disorders was demonstrated in a dose range of 2.5 mg to 10 mg. The recommended dose in these patients is 10 mg. A lower dose of 5 or 7.5 mg may be considered when clinical factors warrant [see CLINICAL STUDIES (14.3)]. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. However, the efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been systematically evaluated in controlled clinical trials. Also, the safety of total daily doses greater than 30 mg, or 10 mg injections given more frequently than 2 hours after the initial dose, and 4 hours after the second dose have not been evaluated in clinical trials. Maximal dosing of intramuscular olanzapine (e.g., 3 doses of 10 mg administered 2 to 4 hours apart) may be associated with a substantial occurrence of significant orthostatic hypotension [see WARNINGS AND PRECAUTIONS (5.6)]. Thus, it is recommended that patients requiring subsequent intramuscular injections be assessed for orthostatic hypotension prior to the administration of any subsequent doses of intramuscular olanzapine for injection. The administration of an additional dose to a patient with a clinically significant postural change in systolic blood pressure is not recommended.

  If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg/day as soon as clinically appropriate.

  Intramuscular Dosing in Special Populations

  A dose of 5 mg/injection should be considered for geriatric patients or when other clinical factors warrant. A lower dose of 2.5 mg/injection should be considered for patients who otherwise might be debilitated, be predisposed to hypotensive reactions, or be more pharmacodynamically sensitive to olanzapine [see WARNINGS AND PRECAUTIONS (5.12), DRUG INTERACTIONS (7), and CLINICAL PHARMACOLOGY (12.3)].

  Administration of Olanzapine for Injection

  Olanzapine for injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  Directions for Preparation of Olanzapine for Injection with Sterile Water for Injection

  Dissolve the contents of the vial using 2.1 mL of Sterile Water for Injection to provide a solution containing approximately 5 mg/mL of olanzapine. The resulting solution should appear clear and yellow. Olanzapine for injection reconstituted with Sterile Water for Injection should be used immediately (within 1 hour) after reconstitution. Discard any unused portion.

  The following table provides injection volumes for delivering various doses of intramuscular olanzapine for injection reconstituted with Sterile Water for Injection.

  Dose, mg Olanzapine

  Volume of Injection, mL

  10

  Withdraw total contents of vial

  7.5

  1.5

  5

  1

  2.5

  0.5

  Physical Incompatibility Information

  Olanzapine for injection should be reconstituted only with Sterile Water for Injection. Olanzapine for injection should not be combined in a syringe with diazepam injection because precipitation occurs when these products are mixed. Lorazepam injection should not be used to reconstitute olanzapine for injection as this combination results in a delayed reconstitution time. Olanzapine for injection should not be combined in a syringe with haloperidol injection because the resulting low pH has been shown to degrade olanzapine over time.

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