Healthcare Professionals


Clinical Overview

Oral Thrush

References: 1. Vazquez JA, Patton LL, Epstein JB, et al; SMiLES Study Group. Randomized, comparative, double-blind, double-dummy, multicenter trial of miconazole buccal tablet and clotrimazole troches for the treatment of oropharyngeal candidiasis: study of miconazole Lauriad® efficacy and safety (SMiLES). HIV Clin Trials. 2010;11(4):186-196. 2. Data on file, Midatech Pharma US Inc.



Oral Thrush

References: 1. Bensadoun R-J, Daoud J, El Gueddari B, et al. Comparison of the efficacy and safety of miconazole 50-mg mucoadhesive buccal tablets with miconazole 500-mg gel in the treatment of oropharyngeal candidiasis: a prospective, randomized, single-blind, multicenter, comparative, phase III trial in patients treated with radiotherapy for head and neck cancer. Cancer. 2008;112:204-211. 2. Data on file, Midatech Pharma US Inc


Important Safety Information


Safety & Tolerability

Contraindications

Oravig® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.


Warnings, Precautions and Adverse Reactions

Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including Oravig®. Discontinue Oravig® immediately at the first sign of hypersensitivity.

There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.


Drug Interactions

Wafarin

Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if Oravig® is administered concomitantly with warfarin. Also monitor for evidence of bleeding.

Drugs Metabolized Through CYP2C9 and 3A4

No formal drug interaction studies have been performed with Oravig®. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following Oravig® administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.

Adverse Reactions

Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received Oravig® in Clinical Trials.


(MedDRA v 9.1 System Organ Class and Preferred Term) N = 480 (%)
Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
   Diarrhea 6.0
   Nausea 4.6
   Abdominal pain upper 2.5
   Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
   Headache 5.0
   Dysgeusia 2.9

Discontinuation of Oravig® due to adverse drug reactions occurred in 0.6% overall.


Dosing & Administration

Dosing

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. 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.

Instructions on Usage

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. 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,


Important Safety Information for Oravig® (Miconazole) ▲ expand

Indication

  • Oravig® is indicated for the local treatment of oral thrush in adults.

Important Safety Information

Read the Patient Information that comes with Oravig® before you start taking it and each time you get a refill. There may be new information. This brochure does not take the place of talking with your doctor or about your medical condition or your treatment.

Do not use Oravig® if you:

  • are allergic to miconazole (M-Zole, Monistat, Vusion).
  • are allergic to milk protein concentrate.
  • are allergic to any of the ingredients in Oravig®. See Prescribing Information for a complete list of ingredients in Oravig®.

Before taking Oravig®, tell your doctor if you:

  • have liver problems.
  • have any other medical conditions.
  • are pregnant or plan to become pregnant. It is not known if Oravig® will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. It is not known if Oravig® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Oravig®.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Oravig® may affect the way other medicines work, and other medicines may affect how Oravig® works.

Especially tell your doctor if you take:

  • a diabetes medicine.
  • phenytoin (Dilantin, Phenytek).
  • an ergot medicine. Ask your doctor or pharmacist if you are not sure if your medicine is an ergot medicine.
  • the blood thinner medicine warfarin sodium (Coumadin, Jantoven).

Allergic reactions. Tell your doctor or get emergency medical help right away if you have any of the symptoms below:

  • skin rash or hives.
  • swelling of your face, eyes, lips, tongue or throat.
  • trouble swallowing or breathing.

The most common side effects of Oravig® include diarrhea, change in taste, headache, upper stomach (abdominal) pain, nausea and vomiting. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oravig®. For more information, ask your doctor or pharmacist.

Healthcare professionals and patients should report any adverse events associated with Tolectin to the FDA's MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional information about Oravig®, please refer to the Full Prescribing Info.



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