Oravig

Oravig

INDICATIONS

ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.

DOSAGE AND ADMINISTRATION

Basic Dosing Information

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

Administration Instructions

ORAVIG should be applied in the morning, after brushing the teeth. The tablet should beapplied with dry hands. The rounded side surface of the tablet should be placed againsthe upper gum just above the incisor tooth (canine fossa) and held in place with slightpressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round onone 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).] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away anyremaining 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 gumshould 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 ofwater 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 INFORMATION].

HOW SUPPLIED

Dosage Forms And Strengths

ORAVIG is a buccal tablet containing 50 mg of miconazole. ORAVIG tablets are round,off-white tablets, with a rounded side and a flat side. The tablets are marked with an “L” on the flat side.

Storage And Handling

ORAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg ofmiconazole. ORAVIG tablets have a rounded side and a flat side. ORAVIG tablets are packaged in bottles of 14 tablets (NDC 43288-250-14).

ORAVIG should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature]; excursions between 15 and 30°C permitted at room temperature. Protect frommoisture, and keep out of reach of children.

Manufactured By: Catalent Germany Schorndorf GmbH Steinbeisstraße 2 73614 Schorndorf Germany. Manufactured For: Vestiq Pharmaceuticals, Inc.3000 Aerial Center Parkway, 160 Morrisville, NC 27560. Distributed By: Praelia Pharmaceuticals, Inc. 100 Tower View Court Cary, NC 27513. Revised: 08/2012

Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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