Anzemet

Anzemet Manufacturers

• Sanofi-aventis U.s. Llc
  

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  Anzemet | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.

  

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  2.1 Recommended Dosing Schedule

  PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.

  Table 1: Recommended Dosing Schedule for PROTONIX Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. † Controlled studies did not extend beyond 12 months ‡ 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. 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‡ 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* * Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed. Delayed-Release Tablets Oral Swallowed whole, with or without food For Delayed-Release Oral Suspension Oral Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal For Delayed-Release Oral Suspension Nasogastric tube See instructions below

  PROTONIX Delayed-Release Tablets

  PROTONIX 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 PROTONIX Delayed-Release Tablets.

  PROTONIX For Delayed-Release Oral Suspension

  PROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.

  Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.

  PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce

  Open packet. Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES. Take within 10 minutes of preparation. Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary.

  PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice

  Open packet. Empty granules into a small cup or teaspoon containing one teaspoon of apple juice. Stir for 5 seconds (granules will not dissolve) and swallow immediately. To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately.

  PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube Administration

  For patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed-Release Oral Suspension can be given as follows:

  Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger. Connect the catheter tip of the syringe to a 16 French (or larger) tube. Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing. Empty the contents of the packet into the barrel of the syringe. Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe.

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• Sanofi-aventis U.s. Llc
  

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  Anzemet | Sanofi-aventis U.s. Llc

  

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  The recommended doses of ANZEMET Tablets should not be exceeded.

  Adults

  The recommended oral dosage of ANZEMET (dolasetron mesylate) is 100 mg given within one hour before chemotherapy.

  Pediatric Patients

  The recommended oral dosage in pediatric patients 2 to 16 years of age is 1.8 mg/kg given within one hour before chemotherapy, up to a maximum of 100 mg. Safety and effectiveness in pediatric patients under 2 years of age have not been established.

  In children for whom the 100 mg tablet is not appropriate based on their weight or ability to swallow tablets, the ANZEMET Injection solution may be mixed into apple or apple-grape juice for oral dosing in pediatric patients. The diluted product may be kept up to 2 hours at room temperature before use. However, ANZEMET Injection solution when administered intravenously is contraindicated in adult and pediatric patients for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy due to dose dependent QT prolongation.

  Use in the Elderly, Renal Failure Patients, or Hepatically Impaired Patients

  No dosage adjustment is recommended, however; ECG monitoring is recommended for elderly and renally impaired patients (see WARNINGS and CLINICAL PHARMACOLOGY, Pharmacokinetics in Humans).

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