The following serious adverse drug reactions are discussed in detail in other sections oflabeling:

• Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactionrates observed in the clinical trials of a drug cannot be directly compared to rates in theclinical trials of another drug and may not reflect the rates observed in clinical practice.

The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects.

HIV Infected Patients

Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are pre­sented in Table 1.

Table 1 : Adverse Reactions (Treatment-Emergent) Occurring in a ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial

Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and alteredtaste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches.

Head and Neck Cancer Patients

In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used ORAVIG once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either arm are listed in Table 2.

Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial)

Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, andapplication site discomfort or pain, were experienced by 14 (9.5%) patients who used ORAVIG compared to 16 (10.9%) patients who used miconazole gel.

Overall ORAVIG Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who receivedmiconazole buccal tablet is listed in Table 3.

Table 3 : Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received ORAVIG in Clinical Trials

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

Read the Oravig (miconazole buccal tablets) Side Effects Center for a complete guide to possible side effects »

Warfarin

Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use ofwarfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor pro-thrombin time, International Normalized Ratio (INR), or other suitable anticoagulationtests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidenceof bleeding.

Drugs Metabolized Through CYP 2C9 and 3A4

No formal drug interaction studies have been performed with ORAVIG. Miconazole is aknown 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 interactionwith drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics,phenytoin, or ergot alkaloids cannot be ruled out.

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