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.
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
Oravig® is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product.
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.
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.
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 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.
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.
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,
Indication
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:
Before taking Oravig®, tell your doctor if you:
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:
Allergic reactions. Tell your doctor or get emergency medical help right away if you have any of the symptoms below:
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.