Unisom Sleeptabs

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• Chattem, Inc.
  

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  Unisom Sleeptabs | Actavis Pharma, Inc.

  

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  2.1 Recommended Dose

  In Combination with Cisplatin 100 mg/m2

  The recommended dose of vinorelbine is 25 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes on days 1, 8, 15 and 21 of a 28 day cycle in combination with cisplatin 100 mg/m2 on day 1 only of each 28 day cycle.

  In Combination with Cisplatin 120 mg/m2

  The recommended dose of vinorelbine is 30 mg/m2 administered as an intravenous injection or infusion over 6 to 10 minutes once a week in combination with cisplatin 120 mg/m2 on days 1 and 29, then every 6 weeks.

  Single-Agent

  The recommended dose of vinorelbine is 30 mg/m2 administered intravenously over 6 to 10 minutes once a week. 2.2 Dose Modifications

  Hematologic Toxicity

  [see Warnings and Precautions (5.1)]

  Hold or decrease the dose of vinorelbine in patients with decreased neutrophil counts using the following schema.

   Neutrophils on Day of Treatment (Cells/mm3)  Percentage of Starting Dose of Vinorelbine  ≥ 1,500  100%  1,000 to 1,499  50%  < 1,000  Do not administer vinorelbine. Repeat neutrophil count in one week. If three consecutive weekly doses are held because Neutrophil count is < 1,000 cells/mm3, discontinue vinorelbine  Note : For patients who experience fever and/or sepsis while neutrophil count is < 1,500 or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of vinorelbine should be:  > 1,500  75%  1,000 to 1,499  37.5%  < 1,000  Do not administer vinorelbine.    Repeat neutrophil count in one week.

  Hepatic Impairment/Toxicity

  [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)]

  Reduce vinorelbine dose in patients with elevated serum total bilirubin concentration according to the following schema:

   Serum total bilirubin concentration (mg/dl)  Percentage of Starting Dose of Vinorelbine  ≤ 2.0  100%  2.1 to 3.0  50%  > 3.0  25%

  Concurrent Hematologic Toxicity and Hepatic Impairment

  In patients with both hematologic toxicity and hepatic impairment, administer the lower of the doses based on the corresponding starting dose of vinorelbine determined from the above schemas.

  Neurologic Toxicity

  [see Warnings and Precautions (5.5)]

  Discontinue vinorelbine for NCI CTCAE Grade 2 or higher peripheral neuropathy or autonomic neuropathy causing constipation.

  2.3 Preparation and Administration

  Preparation of Vinorelbine Injection, USP

  Dilute Vinorelbine Injection, USP in either a syringe or intravenous bag using one of the recommended solutions.

  Syringe

  Dilute to a concentration between 1.5 and 3 mg/mL. The following solutions may be used for dilution:

  5% Dextrose Injection, USP 0.9% Sodium Chloride Injection, USP

  Intravenous Bag

  Dilute to a concentration between 0.5 and 2 mg/mL. The following solutions may be used for dilution:

  5% Dextrose Injection, USP 0.9% Sodium Chloride Injection, USP 0.45% Sodium Chloride Injection, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP Ringer's Injection, USP Lactated Ringer's Injection, USP

  Stability

  Diluted Vinorelbine Injection, USP may be used for up to 24 hours under normal room light when stored in polypropylene syringes or polyvinyl chloride bags at 5° to 30°C (41° to 86°F).

  Administration

  Administer diluted Vinorelbine Injection, USP over 6 to 10 minutes into the side port of a free-flowing intravenous line followed by flushing with at least 75 to 125 mL of one of the solutions.

  Vinorelbine Injection, USP must only be administered intravenously. It is extremely important that the intravenous needle or catheter be properly positioned before any vinorelbine is injected.

  Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. If particulate matter is seen, Vinorelbine Injection, USP should not be administered.

  Management of Suspected Extravasation

  If vinorelbine leakage into surrounding tissue occurs or is suspected, immediately stop administration of vinorelbine and initiate appropriate management measures in accordance with institutional policies. [see Warnings and Precautions (5.4).] 2.4 Procedures for Proper Handling and Disposal

  Handle and dispose Vinorelbine Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs1.

  Exercise caution in handling and preparing the solution of Vinorelbine Injection, USP. The use of gloves is recommended. If the solution of Vinorelbine Injection, USP contacts the skin or mucosa, immediately wash the skin or mucosa thoroughly with soap and water.

  Avoid contamination of the eye with Vinorelbine Injection, USP. If exposure occurs, flush the eyes with water immediately and thoroughly.

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