Daliresp

Daliresp Manufacturers

• Astrazeneca Pharmaceuticals Lp
  

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  Daliresp | Astrazeneca Pharmaceuticals Lp

  

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  The recommended dose of DALIRESP is one 500 microgram (mcg) tablet per day, with or without food.

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• Cardinal Health
  

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  Daliresp | Cardinal Health

  

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  Savella is given orally with or without food.

  Taking Savella with food may improve the tolerability of the drug.

  2.1 Recommended Dosing

  The recommended dose of Savella is 100 mg/day (50 mg twice daily).

  Based on efficacy and tolerability dosing may be titrated according to the following schedule:

  Day 1: 12.5 mg once

  Days 2-3: 25 mg/day (12.5 mg twice daily)

  Days 4-7: 50 mg/day (25 mg twice daily)

  After Day 7: 100 mg/day (50 mg twice daily)

  Based on individual patient response, the dose may be increased to 200 mg/day (100 mg twice daily).

  Doses above 200 mg/day have not been studied.

  Savella should be tapered and not abruptly discontinued after extended use [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].

  2.2 Patients with Renal Insufficiency

  No dosage adjustment is necessary in patients with mild renal impairment.

  Savella should be used with caution in patients with moderate renal impairment.

  For patients with severe renal impairment (indicated by an estimated creatinine clearance of 5-29 mL/min), the maintenance dose should be reduced by 50% to 50 mg/day (25 mg twice daily).

  Based on individual patient response, the dose may be increased to 100 mg/day (50 mg twice daily).

  Savella is not recommended for patients with end-stage renal disease.

  2.3 Patients with Hepatic Insufficiency

  No dosage adjustment is necessary for patients with hepatic impairment.

  As with any drug, caution should be exercised in patients with severe hepatic impairment.

  2.4 Discontinuing Savella

  Withdrawal symptoms have been observed in clinical trials following discontinuation of milnacipran, as with other serotonin and norepinephrine re-uptake inhibitors (SNRIs) and selective serotonin re-uptake inhibitors (SSRIs). Patients should be monitored for these symptoms when discontinuing treatment. Savella should be tapered and not abruptly discontinued after extended use [see Warnings and Precautions (5.7)].

  2.5 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with Savella. Conversely, at least 5 days should be allowed after stopping Savella before starting a MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].

  2.6 Use of Savella with other MAOIs such as Linezolid or Methylene Blue

  Do not start Savella in a patient being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

  In some cases, a patient already receiving Savella therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Savella should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Savella may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

  The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Savella is unclear. The clinician should nevertheless be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

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• Forest Laboratories, Inc.
  

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  Daliresp | Ranbaxy Pharmaceuticals Inc.

  

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  2.1 Recommended Dosing Schedule

  Pantoprazole sodium is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

  Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets

  Indication

  Dose

  Frequency

  Short-Term Treatment of Erosive Esophagitis Associated With GERD

  Adults

  40 mg

  Once daily for up to 8 weeks*

  Children (5 years and older)

  ≥ 15 kg to < 40 kg

  20 mg

  Once daily for up to 8 weeks

  ≥ 40 kg

  40 mg

  Maintenance of Healing of Erosive Esophagitis

  Adults

  40 mg

  Once daily***

  Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

  Adults

  40 mg

  Twice daily**

  * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.

  ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

  ***Controlled studies did not extend beyond 12 months

  2.2 Administration Instructions

  Directions for method of administration for each dosage form are presented in Table 2.

  Table 2: Administration Instructions

  Formulation

  Route

  Instructions*

  Delayed-Release Tablets

  Oral

  Swallowed whole, with or without food

  * Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed.

  Pantoprazole sodium delayed-release tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.

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