Mucus Relief Pe

Mucus Relief Pe Manufacturers

• Chain Drug Consortium
  

  ×

  Mucus Relief Pe | Chain Drug Consortium

  

  ---

  adults and children 12 years of age and older: take 1 tablet every 4 hours, with a full glass of water, while symptoms persist. Do not exceed 6 tablets in 24 hours. children under 12 years of age: do not use

  Close
  No Recall

  More Info
• Safeway
  

  ×

  Mucus Relief Pe | Teva Pharmaceuticals Usa Inc

  

  ---

  2.1 Schizophrenia

  Adults

  Dose Selection - Olanzapine orally disintegrating tablets should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine orally disintegrating tablets would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

  Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment. Olanzapine orally disintegrating tablets are not indicated for use in doses above 20 mg/day.

  Dosing in Special Populations - The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine orally disintegrating tablets (e.g., nonsmoking female patients ≥ 65 years of age), or who may be more pharmacodynamically sensitive to olanzapine orally disintegrating tablets [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)]. When indicated, dose escalation should be performed with caution in these patients.

  Maintenance Treatment - The effectiveness of olanzapine orally disintegrating tablets, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine orally disintegrating tablets for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies (14.1)]. The physician who elects to use olanzapine orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

  Adolescents

  Dose Selection - Olanzapine orally disintegrating tablets should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with schizophrenia was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 12.5 mg/day (mean dose of 11.1 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.1)].

  Maintenance Treatment - The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.2 Bipolar I Disorder (Manic or Mixed Episodes)

  Adults

  Dose Selection for Monotherapy - Olanzapine orally disintegrating tablets should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

  Short-term (3 to 4 weeks) antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials. The safety of doses above 20 mg/day has not been evaluated in clinical trials [see Clinical Studies (14.2)].

  Maintenance Monotherapy - The benefit of maintaining bipolar I patients on monotherapy with olanzapine orally disintegrating tablets at a dose of 5 to 20 mg/day, after achieving a responder status for an average duration of 2 weeks, was demonstrated in a controlled trial [see Clinical Studies (14.2)]. The physician who elects to use olanzapine orally disintegrating tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

  Dose Selection for Adjunctive Treatment - When administered as adjunctive treatment to lithium or valproate, olanzapine orally disintegrating tablet dosing should generally begin with 10 mg once-a-day without regard to meals.

  Antimanic efficacy was demonstrated in a dose range of 5 mg to 20 mg/day in clinical trials [see Clinical Studies (14.2)]. The safety of doses above 20 mg/day has not been evaluated in clinical trials.

  Adolescents

  Dose Selection - Olanzapine orally disintegrating tablets should be administered on a once-a-day schedule without regard to meals with a recommended starting dose of 2.5 or 5 mg, with a target dose of 10 mg/day. Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials, with a mean modal dose of 10.7 mg/day (mean dose of 8.9 mg/day). When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

  The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials [see Clinical Studies (14.2)].

  Maintenance Treatment - The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated; however, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. Thus, it is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

  2.3 Administration of Olanzapine Orally Disintegrating Tablets

  Remove the blister from the carton, peel back foil on blister. Do not push tablet through foil. Immediately upon opening the blister, using dry hands, remove tablet and place entire olanzapine orally disintegrating tablet in the mouth. Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without liquid.

  2.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder

  When using olanzapine and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax.

  Adults

  Olanzapine orally disintegrating tablets should be administered in combination with fluoxetine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Dosage adjustments, if indicated, can be made according to efficacy and tolerability within dose ranges of oral olanzapine 5 to 12.5 mg and fluoxetine 20 to 50 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination in adult patients with a dose range of olanzapine 6 to 12 mg and fluoxetine 25 to 50 mg. Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies.

  Children and Adolescents (10 to 17 years of age)

  Dosage and Administration information for pediatric patients (10 to 17 years) is approved for Eli Lilly and Company’s olanzapine tablets and olanzapine orally disintegrating tablets. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

  Safety and efficacy of olanzapine and fluoxetine in combination was determined in clinical trials supporting approval of Symbyax (fixed dose combination of olanzapine and fluoxetine). Symbyax is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of olanzapine and fluoxetine versus Symbyax. Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability.

  Table 1: Approximate Dose Correspondence Between Symbyax* and the Combination of Olanzapine and Fluoxetine * Symbyax (olanzapine/fluoxetine HCl) is a fixed-dose combination of olanzapine and fluoxetine.

  For
  Symbyax

  (mg/day)

  Use in Combination

  Olanzapine
  (mg/day)

  Fluoxetine
  (mg/day)

  3 mg olanzapine/25 mg fluoxetine
  6 mg olanzapine/25 mg fluoxetine
  12 mg olanzapine/25 mg fluoxetine
  6 mg olanzapine/50 mg fluoxetine
  12 mg olanzapine/50 mg fluoxetine

  2.5
  5
  10+2.5
  5
  10+2.5

  20
  20
  20
  40+10
  40+10

  While there is no body of evidence to answer the question of how long a patient treated with olanzapine and fluoxetine in combination should remain on it, it is generally accepted that bipolar I disorder, including the depressive episodes associated with bipolar I disorder, is a chronic illness requiring chronic treatment. The physician should periodically reexamine the need for continued pharmacotherapy.

  Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

  2.7 Olanzapine and Fluoxetine in Combination: Dosing in Special Populations

  The starting dose of oral olanzapine 2.5 to 5 mg with fluoxetine 20 mg should be used for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Dosing modification may be necessary in patients who exhibit a combination of factors that may slow metabolism. When indicated, dose escalation should be performed with caution in these patients. Olanzapine and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under 10 years of age [see Warnings and Precautions (5.12), Drug Interactions (7), and Clinical Pharmacology (12.3)].

  Close
  No Recall

  More Info
• Walgreen Co.
  

  ×

  Mucus Relief Pe | Ecolab Inc.

  

  ---

  wet hands with warm water apply soap to hands and scrub vigorously wash between fingers, around fingernails, and back of hands rinse hands thoroughly with warm water dry hands with clean towel or with mechanical dryer

  Close
  No Recall

  More Info