Emend

Emend Manufacturers

• Physicians Total Care, Inc.
  

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  Emend | Physicians Total Care, Inc.

  

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  2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

  Capsules of EMEND (aprepitant) are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of EMEND is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.

  EMEND may be taken with or without food.

  EMEND (fosaprepitant dimeglumine) for Injection (115 mg) is a prodrug of aprepitant and may be substituted for oral EMEND (125 mg), 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an intravenous infusion administered over 15 minutes.

  In clinical studies with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3 Day 4 EMEND 125 mg orally 80 mg orally 80 mg orally none Dexamethasone 12 mg orally 8 mg orally 8 mg orally 8 mg orally Ondansetron 32 mg I.V. none none none

  In a clinical study with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3 EMEND 125 mg orally 80 mg orally 80 mg orally Dexamethasone 12 mg orally none none Ondansetron 2 x 8 mg orally none none 2.2 Prevention of Postoperative Nausea and Vomiting (PONV)

  The recommended oral dosage of EMEND is 40 mg within 3 hours prior to induction of anesthesia.

  EMEND may be taken with or without food.

  2.3 Geriatric Patients

  No dosage adjustment is necessary for the elderly.

  2.4 Patients with Renal Impairment

  No dosage adjustment is necessary for patients with renal impairment or for patients with end stage renal disease (ESRD) undergoing hemodialysis.

  2.5 Patients with Hepatic Impairment

  No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic impairment (Child-Pugh score >9).

  2.6 Coadministration with Other Drugs

  For additional information on dose adjustment for corticosteroids when coadministered with EMEND, see Drug Interactions (7.1).

  Refer to the full prescribing information for coadministered antiemetic agents.

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• Rebel Distributors Corp
  

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  Emend | Rebel Distributors Corp

  

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  2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

  Capsules of EMEND (aprepitant) are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of EMEND is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.

  EMEND may be taken with or without food.

  EMEND (fosaprepitant dimeglumine) for Injection (115 mg) is a prodrug of aprepitant and may be substituted for oral EMEND (125 mg), 30 minutes prior to chemotherapy, on Day 1 only of the CINV regimen as an intravenous infusion administered over 15 minutes.

  In clinical studies with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3 Day 4 * EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. † Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone was chosen to account for drug interactions. ‡ Ondansetron was administered 30 minutes prior to chemotherapy treatment on Day 1. EMEND* 125 mg orally 80 mg orally 80 mg orally none Dexamethasone† 12 mg orally 8 mg orally 8 mg orally 8 mg orally Ondansetron‡ 32 mg I.V. none none none

  In a clinical study with EMEND, the following regimen was used for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy:

  Day 1 Day 2 Day 3 * EMEND was administered orally 1 hour prior to chemotherapy treatment on Day 1 and in the morning on Days 2 and 3. † Dexamethasone was administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone was chosen to account for drug interactions. ‡ Ondansetron 8-mg capsule was administered 30 to 60 minutes prior to chemotherapy treatment and one 8-mg capsule was administered 8 hours after the first dose on Day 1. EMEND* 125 mg orally 80 mg orally 80 mg orally Dexamethasone† 12 mg orally none none Ondansetron‡ 2 x 8 mg orally none none 2.2 Prevention of Postoperative Nausea and Vomiting (PONV)

  The recommended oral dosage of EMEND is 40 mg within 3 hours prior to induction of anesthesia.

  EMEND may be taken with or without food.

  2.3 Geriatric Patients

  No dosage adjustment is necessary for the elderly.

  2.4 Patients with Renal Impairment

  No dosage adjustment is necessary for patients with renal impairment or for patients with end stage renal disease (ESRD) undergoing hemodialysis.

  2.5 Patients with Hepatic Impairment

  No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic impairment (Child-Pugh score >9).

  2.6 Coadministration with Other Drugs

  For additional information on dose adjustment for corticosteroids when coadministered with EMEND, see Drug Interactions (7.1).

  Refer to the full prescribing information for coadministered antiemetic agents.

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• Merck Sharp & Dohme Corp.
  

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  Emend | Lake Erie Medical Dba Quality Care Products Llc

  

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  Initial Treatment

  Citalopram hydrobromide  should be administered at an initial dose of 20 mg once daily, generally with an increase to a dose of 40 mg/day. Dose increases should usually occur in increments of 20 mg at intervals of no less than one week. Although certain patients may require a dose of 60 mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose; doses above 40 mg are therefore not ordinarily recommended.

  Citalopram hydrobromide should be administered once daily, in the morning or evening, with or without food.

  Special Populations

  20 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment, with titration to 40 mg/day only for nonresponding patients.

  No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram hydrobromide should be used with caution in patients with severe renal impairment.

  Treatment of Pregnant Women During the Third Trimester

  Neonates exposed to citalopram hydrobromide and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram hydrobromide during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering citalopram hydrobromide in the third trimester.

  Maintenance Treatment

  It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram hydrobromide in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram hydrobromide (20 to 60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram hydrobromide 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

  Discontinuation of Treatment with Citalopram Hydrobromide

  Symptoms associated with discontinuation of citalopram hydrobromide and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

  Switching Patients To or From a Monoamine Oxidase Inhibitor

  At least 14 days should elapse between discontinuation of an MAOI and initiation of citalopram hydrobromide therapy. Similarly, at least 14 days should be allowed after stopping citalopram hydrobromide before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

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• Merck Sharp & Dohme Corp.
  

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  Emend | Merck Sharp & Dohme Corp.

  

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  2.1 Prevention of Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy (HEC)

  EMEND for Injection 150 mg (Single Dose Regimen of EMEND):

  EMEND for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. No capsules of EMEND are administered on Days 2 and 3. EMEND for Injection should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 1. The recommended dosage of dexamethasone with EMEND for Injection 150 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 115 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

  Table 1: Recommended dosing (Single Dose Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy Day 1 Day 2 Day 3 Day 4 * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions. EMEND 150 mg intravenous none none none Dexamethasone* 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none

  EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

  EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 2. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

  Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

  Table 2: Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy Day 1 Day 2 Day 3 Day 4 * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions. EMEND 115 mg intravenous 80 mg orally 80 mg orally none Dexamethasone* 12 mg orally 8 mg orally 8 mg orally once daily 8 mg orally once daily 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none 2.2 Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy (MEC)

  EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

  EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 3. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

  Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.

  Table 3: Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions. Day 1 Day 2 Day 3 EMEND 115 mg intravenous 80 mg orally 80 mg orally Dexamethasone* 12 mg orally none none 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none 2.3 Preparation of EMEND for Injection Table 4: Preparation Instructions for EMEND for Injection (115 mg and 150 mg) 115 mg 150 mg Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. Step 2 Aseptically prepare an infusion bag filled with 110 mL of normal saline. Aseptically prepare an infusion bag filled with 145 mL of normal saline. Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 110 mL of normal saline to yield a total volume of 115 mL and a final concentration of 1 mg/1 mL. Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of normal saline to yield a total volume of 150 mL and a final concentration of 1 mg/1 mL. Step 4 Gently invert the bag 2-3 times. Gently invert the bag 2-3 times. Note: The differences in preparation for each dose are displayed as bolded text.

  The reconstituted final drug solution is stable for 24 hours at ambient room temperature (at or below 25°C).

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

  Caution: EMEND for Injection should not be mixed or reconstituted with solutions for which physical and chemical compatibility have not been established. EMEND for Injection is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Lactated Ringer's Solution and Hartmann's Solution.

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