Praelia Pharmaceuticals Inc

Praelia Pharmaceuticals Inc Drugs

• Oravig
  

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  Oravig

  

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  2.1 Basic Dosing Information

  The recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

  2.2 Administration Instructions

  ORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum.

  Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3)] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition,

  ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still does not adhere, a new tablet should be placed. If ORAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once. If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose. [See Patient Counseling Information (17)].

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• Zuplenz
  

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  Zuplenz

  

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  2.1 Prevention of Nausea and Vomiting Associated with Highly Emetogenic Cancer Chemotherapy

  Adults The recommended adult oral dosage of ZUPLENZ (ondansetron) oral soluble film is 24 mg given successively as three 8 mg films administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥50 mg/m2. Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Dosage and Administration (2.6)]. Multiday, single-dose administration of a 24 mg dosage has not been studied.

  Pediatrics Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.2 Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Cancer Chemotherapy

  Adults The recommended adult oral dosage is one 8 mg ZUPLENZ oral soluble film given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8 mg ZUPLENZ oral soluble film should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].

  Pediatrics For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4 mg ZUPLENZ oral soluble film given three times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4 mg ZUPLENZ oral soluble film should be administered three times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy [see Dosage and Administration (2.6)].

  2.3 Prevention of Nausea and Vomiting Associated with Radiotherapy

  Adults The recommended adult oral dosage of ZUPLENZ oral soluble film is one 8 mg film given three times a day [see Dosage and Administration (2.6)].

  For total body irradiation, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.

  For single high-dose fraction radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.

  For daily fractionated radiotherapy to the abdomen, one 8 mg ZUPLENZ oral soluble film should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.

  Pediatrics Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.4 Prevention of Postoperative Nausea and/or Vomiting

  Adults The recommended adult oral dosage of ZUPLENZ oral soluble film is 16 mg given successively as two 8 mg films 1 hour before induction of anesthesia. Each ZUPLENZ oral soluble film should be allowed to dissolve completely before administering the next film [see Dosage and Administration (2.6)].

  Pediatrics Safety and effectiveness of ZUPLENZ in pediatric patients have not been established for this indication.

  2.5 Dosage Adjustment for Patients with Impaired Hepatic Function

  In patients with severe hepatic impairment (Child-Pugh score of 10 or greater)2, clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see Clinical Pharmacology (12.3)]. In such patients, a total daily dose of 8 mg should not be exceeded.

  2.6 Important Administration Instructions

  With dry hands, fold the pouch along the dotted line to expose the tear notch. While still folded, tear the pouch carefully along the edge and remove the ZUPLENZ oral soluble film from the pouch. Immediately place the film on top of the tongue where it dissolves in 4 to 20 seconds. Once the ZUPLENZ oral soluble film is dissolved, swallow with or without liquid [see Clinical Pharmacology (12.3)]. Wash hands after taking ZUPLENZ.

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