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| Product NDC Code | 61825-303 | ||||
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| Drug Name | Oravig |
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| Type | Brand | ||||
| Pharm Class | Azole Antifungal [EPC], Azoles [CS] |
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| Active Ingredients |
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| Route | BUCCAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 998548, 998550 |
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| Application Number | NDA022404 | ||||
| Labeler Name | Galt Pharmaceuticals, LLC | ||||
| Packages |
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Overdosage of Oravig
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Overdose with miconazole in humans has not been reported in the literature. Miconazole absorption and systemic exposure following application of ORAVIG are minimal [see Clinical Pharmacology (12.3)]. Symptomatic and supportive care is the basis for management.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC Marietta, GA 30067 at 1-833-757-0904 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical 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 ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 290 (%) Clotrimazole troches N = 287 (%) Patients with any adverse reaction during the study 158 (54.5) 146 (50.9) Gastrointestinal disorders Diarrhea Nausea Vomiting Dry mouth Abdominal pain upper 25.9 9.0 6.6 3.8 2.8 1.7 23.7 8.0 7.7 3.1 1.7 2.8 Infections and infestations Upper respiratory infection Gastroenteritis 15.9 2.1 1.4 17.1 2.4 2.8 Nervous system disorders Headache Ageusia 13.1 7.6 2.4 8.4 6.6 0.3 Blood and lymphatic disorders Anemia Lymphopenia Neutropenia 6.9 2.8 1.7 0.7 8.4 1.7 2.1 2.1 General disorders and administration site conditions Fatigue Pain 6.6 2.8 1.0 8.0 2.1 2.8 Respiratory/thoracic Cough Pharyngeal pain 5.2 2.8 0.7 7.7 1.7 2.4 Investigations Increased GGT 5.5 1.0 6.3 2.8 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 altered taste, 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) Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 147 (%) Miconazole gel N = 147 (%) Patients with at least one adverse reaction 30 (20.4) 32 (21.8) Gastrointestinal disorders Abdominal pain, upper Oral discomfort Nausea Vomiting Glossodynia 8.8 1.4 2.7 0.7 0.7 0 13.6 2.0 2.7 2.7 2.0 2.0 Nervous system disorders Dysgeusia 5.4 4.1 1.4 0 Skin and subcutaneous Pruritus 3.4 2.0 0.7 0.7 Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application 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 received miconazole 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 Adverse reaction (MedDRA v 9.1 System Organ Class and Preferred Term) ORAVIG N = 480 (%) Patients with at least one AE 209 (43.5) Gastrointestinal disorders Diarrhea Nausea Abdominal pain upper Vomiting 20.6 6.0 4.6 2.5 2.5 Infections and infestations 11.9 Nervous system disorders Headache Dysgeusia 10.6 5.0 2.9 Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.
| Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) | ORAVIG N = 290 (%) | Clotrimazole troches N = 287 (%) |
| Adverse Reaction (MedDRA v 9.1 System Organ Class and Preferred Term) | ORAVIG N = 147 (%) | Miconazole gel N = 147 (%) |
| Adverse reaction (MedDRA v 9.1 System Organ Class and Preferred Term) | ORAVIG N = 480 (%) |
| Patients with at least one AE | 209 (43.5) |
Oravig Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 DRUG INTERACTIONS Warfarin: Miconazole may enhance anticoagulant effect. Monitor prothrombin time, INR, and watch for bleeding (7.1). 7.1 Warfarin 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. 7.2 Drugs Metabolized Through CYP 2C9 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Miconazole is an antifungal drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours after application of the tablet. This provided an average saliva exposure to miconazole estimated from the AUC (0-24h) of 55.23 mcg·h/mL. The pharmacokinetic parameters of miconazole in the saliva of healthy volunteers are provided in Table 4. Table 4: Pharmacokinetic (PK) Parameters of Miconazole in Saliva Following Application of a Single ORAVIG 50 mg Tablet in Healthy Volunteers (N = 18) Salivary PK Parameters (N = 18) Mean ± SD (Min - Max) AUC 0-24h (mcg-h/mL) 55.2 ±35.1 (0.5 – 128.3) C max (mcg/mL) 15.1 ±16.2 (0.5 – 64.8) T max (hour) 7* (2.0 – 24.1) *Median In healthy volunteers, the duration of buccal adhesion was on average 15 hours following a single dose application of ORAVIG 50 mg. Plasma Plasma concentrations of miconazole were below the lower limit of quantification (0.4 mcg/mL) in 157/162 (97%) samples from healthy volunteers following single-dose application of ORAVIG 50 mg. Measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Plasma concentrations of miconazole evaluated after 7 days of treatment in 40 HIV-positive patients were all below the limit of quantification (0.1 mcg/mL). Metabolism and Excretion Most of the absorbed miconazole is metabolized by the liver with less than 1% of the administered dose found unchanged in urine. In healthy volunteers, the terminal half-life is 24 hours following systemic administration. There are no active metabolites of miconazole. Food Effect There was no formal food effect study conducted with ORAVIG; however, in clinical studies patients were allowed to eat and drink while taking ORAVIG. 12.4 Microbiology Mechanism of Action Miconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell. Antimicrobial Activity Miconazole is active against Candida albicans, C. parapsilosis and C. tropicalis. Correlation between minimum inhibitory concentration (MIC) results in vitro and clinical outcome has yet to be established. Resistance In vitro studies have shown that some Candida strains that demonstrate reduced susceptibility to one antifungal azole may also exhibit reduced susceptibility to other azoles suggesting cross-resistance. Clinically relevant resistance to systemically utilized triazoles may occur in Candida species. Resistance may occur by multiple mechanisms such as changes in amino acids and/or in the regulation of the target enzyme and of a variety of efflux pump proteins. Multiple mechanisms may co‑exist in the same isolate. Resistance breakpoints, correlating in vitro activity with clinical efficacy, have not been established for miconazole.
| 55.2 ±35.1 (0.5 – 128.3) | |
| 15.1 ±16.2 (0.5 – 64.8) | |
| 7* (2.0 – 24.1) |
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Miconazole is an antifungal drug [see Microbiology (12.4)].
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours after application of the tablet. This provided an average saliva exposure to miconazole estimated from the AUC (0-24h) of 55.23 mcg·h/mL. The pharmacokinetic parameters of miconazole in the saliva of healthy volunteers are provided in Table 4. Table 4: Pharmacokinetic (PK) Parameters of Miconazole in Saliva Following Application of a Single ORAVIG 50 mg Tablet in Healthy Volunteers (N = 18) Salivary PK Parameters (N = 18) Mean ± SD (Min - Max) AUC 0-24h (mcg-h/mL) 55.2 ±35.1 (0.5 – 128.3) C max (mcg/mL) 15.1 ±16.2 (0.5 – 64.8) T max (hour) 7* (2.0 – 24.1) *Median In healthy volunteers, the duration of buccal adhesion was on average 15 hours following a single dose application of ORAVIG 50 mg. Plasma Plasma concentrations of miconazole were below the lower limit of quantification (0.4 mcg/mL) in 157/162 (97%) samples from healthy volunteers following single-dose application of ORAVIG 50 mg. Measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Plasma concentrations of miconazole evaluated after 7 days of treatment in 40 HIV-positive patients were all below the limit of quantification (0.1 mcg/mL). Metabolism and Excretion Most of the absorbed miconazole is metabolized by the liver with less than 1% of the administered dose found unchanged in urine. In healthy volunteers, the terminal half-life is 24 hours following systemic administration. There are no active metabolites of miconazole. Food Effect There was no formal food effect study conducted with ORAVIG; however, in clinical studies patients were allowed to eat and drink while taking ORAVIG.
| 55.2 ±35.1 (0.5 – 128.3) | |
| 15.1 ±16.2 (0.5 – 64.8) | |
| 7* (2.0 – 24.1) |
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product. Known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] . Miconazole is an imidazole antifungal agent and is described chemically as 1-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole with an empirical formula of C 18 H 14 Cl 4 N 2 O and a molecular weight of 416.13. The structural formula is shown in Figure 1. Figure 1: Structural Formula of Miconazole Miconazole drug substance is a white to almost white powder. ORAVIG contains 50 mg of miconazole base, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; corn starch, NF; lactose monohydrate, NF; sodium lauryl sulfate, NF; magnesium stearate, NF; and talc, USP. oravig 01
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE & ADMINISTRATION Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days (2.1) . Instruct patients not to crush, chew, or swallow tablets (2.2) . 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) ].
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS & 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. 50 mg buccal tablets
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS & USAGE ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
Spl product data elements
Usually a list of ingredients in a drug product.Oravig Miconazole HYPROMELLOSE, UNSPECIFIED STARCH, CORN LACTOSE MONOHYDRATE SODIUM LAURYL SULFATE MAGNESIUM STEARATE TALC CASEIN MICONAZOLE MICONAZOLE Off-White rounded side / flat side marked with "L" L
Animal pharmacology and or toxicology
Information from studies of the drug in animals, if the data were not relevant to nor included in other parts of the labeling. Most labels do not contain this field.13.2 Animal Pharmacology & OR Toxicology Local tolerance studies (LLNA sensitization test and tolerance study on the jugal mucosa of hamster) did not reveal any toxicity.
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenicity studies with miconazole have not been conducted. Miconazole nitrate was not genotoxic when tested in vitro in a bacterial reverse mutation (Ames) assay or in an in vivo mouse bone marrow micronucleus test. Intraperitoneal injections of miconazole to mice induced chromosomal aberrations in spermatocytes and bone marrow cells, and morphologic abnormalities in sperm at doses similar to or below clinical doses. However, no impairment of fertility was observed in intravenous studies with miconazole at 40 mg/kg/day in rats or 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenicity studies with miconazole have not been conducted. Miconazole nitrate was not genotoxic when tested in vitro in a bacterial reverse mutation (Ames) assay or in an in vivo mouse bone marrow micronucleus test. Intraperitoneal injections of miconazole to mice induced chromosomal aberrations in spermatocytes and bone marrow cells, and morphologic abnormalities in sperm at doses similar to or below clinical doses. However, no impairment of fertility was observed in intravenous studies with miconazole at 40 mg/kg/day in rats or 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. 13.2 Animal Pharmacology & OR Toxicology Local tolerance studies (LLNA sensitization test and tolerance study on the jugal mucosa of hamster) did not reveal any toxicity.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 61825-303-14 once-daily ORAVIG® (miconazole) buccal tablets 50 mg 50 mg 14 Tablets Rx only oraviag06
Oravig: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Important Administration Instructions The tablet should be used immediately after removal from the bottle. • Instruct patients not to crush, chew, or swallow the tablet. • The rounded side of the tablet should be applied to the upper gum above the incisor tooth in the morning, after brushing the teeth. • The tablet should be held in place for 30 seconds with a slight pressure of the finger over the upper lip to make the tablet stick to the gum. • The tablet may be used if it sticks to the cheek, inside of the lip or the gum. • If the tablet does not adhere, it should be repositioned. • As the ORAVIG tablet absorbs moisture from the mouth, it will slowly dissolve over time and should be left in place – there is no need to remove the tablet. • Subsequent applications of ORAVIG should be made to alternate sides of the gum. • If ORAVIG does not stick or falls off within the first 6 hours , the same tablet should be repositioned immediately. If the tablet 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. Patients should avoid situations that could interfere with the sticking of the tablet including: • touching or pressing the tablet after placement • wearing upper denture • chewing gum • hitting tablet when brushing teeth • rinsing mouth too vigorously Hypersensitivity and Other Adverse Reactions Patients who develop hives, skin rash, or other symptoms of an allergic reaction, and patients who develop swelling or pain, at the tablet application site should stop ORAVIG and contact a healthcare provider. Patients may experience other adverse reactions including diarrhea, headache, nausea, and change in taste. Potential Embryo-fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)]. Manufactured By: Catalent Germany Schorndorf GmbH Steinbeisstraße 1-2 73614 Schorndorf Germany Distributed by: Galt Pharmaceuticals, LLC 1090 Northchase Pkwy., Suite 140 Marietta, GA 30067 Address medical inquires to: Galt Pharmaceuticals, LLC 1-833-757-0904 US patent numbers: 6,916,485; 7,651,698; 8,518,442. ©2021 Galt Pharmaceuticals, LLC INSTRUCTIONS FOR USE Oravig (OR-a-vig) (miconazole) buccal tablets Read this Instructions for Use before you start using ORAVIG and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use ORAVIG. How should I store ORAVIG? • Store ORAVIG at room temperature between 68°F to 77oF (20°C to 25oC). • Keep ORAVIG dry. Keep ORAVIG and all medicines out of the reach of children. How to use ORAVIG? Before applying the ORAVIG tablet Step 1. Locate the area on the upper gum, just above the left or the right incisor tooth. The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A). Step 2. With dry hands, take 1 ORAVIG tablet out of the bottle. ORAVIG is round on one side and flat on the other side (See Figure B). The tablet is marked with an “L” on the flat side. Applying the ORAVIG tablet Step 3. Place the flat side of the ORAVIG tablet on your dry fingertip. Gently push the round side of the tablet against your upper gum in the area shown in Figure C. Push the ORAVIG tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip. Step 4. Hold the ORAVIG tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds (See Figure D). This will make the tablet stick to your gum. Step 5. Leave the ORAVIG tablet in place until it dissolves. Do not remove the tablet. Step 6. Before applying your next dose, be sure to clear away any remaining ORAVIG tablet material on your gum. Manufactured By: Catalent Germany Schorndorf GmbH Steinbeisstraße 1-2 73614 Schorndorf Germany Distributed by: Galt Pharmaceuticals, LLC 1090 Northchase Pkwy., Suite 140, Marietta, GA 30067 Address medical inquires to: Galt Pharmaceuticals, LLC 1-833-757-0904 US patent numbers: 6,916,485; 7,651,698; 8,518,442. ©2021 Galt Pharmaceuticals, LLC This Instructions for Use has been approved by the U.S. Food and Drug Administration Approved: 06/2021 oravig-07 oravig-08 oravig 02 oravig 03 oravig 04 oravig 05
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.14 CLINICAL STUDIES Study in HIV Infected Patients The efficacy and safety of ORAVIG in the treatment of OPC was evaluated in a randomized, double-blind, double-dummy, multicenter trial comparing ORAVIG 50 mg once daily for 14 consecutive days (n = 290) with clotrimazole troches 10 mg 5 times per day for 14 days (n = 287) in HIV-positive patients with OPC. Seventy-five percent of patients were not receiving highly active antiretroviral treatment, 5% had CD4+ cell count < 50 cells/mm 3 , and 17% had a history of previous OPC. The mean viral load was 117,000 copies/mL. Patients were required to have symptoms and microbiological documentation of OPC for study entry. Most of the infections were caused by C. albicans (85%), followed by C. tropicalis (9%), and C. parapsilosis (3%). About 2% of the subjects were infected with more than one Candida species. Clinical cure [defined as a complete resolution of both signs and symptoms of OPC at the test of cure (TOC) visit (days 17-22)], and clinical relapse by days 35-38 (21-24 days after end of therapy) are presented in Table 5. Mycological cure [defined as eradication (i.e., no yeast isolates) of Candida species] at the TOC visit (days 17-22) is also reported in the table. Table 5: Clinical Cure and Mycological Cure at the TOC Visit and Relapse at Days 35-38 in HIV Infected Patients ORAVIG 50 mg N=290 a (%) Clotrimazole troches N=287 a (%) Clinical cure† 176 (60.7%) 187 (65.2%) Clinical relapse‡ Yes b 48 (27.3%) 52 (27.8%) No 124 (70.5%) 133 (71.1%) Missing 4 (2.3%) 2 (1.1%) Mycological cure 79 (27.2%) 71 (24.7%) a Analysis population includes all randomized patients who took at least 1 dose of study medication. One randomized subject excluded from the ORAVIG arm. b In those subjects who relapsed, the mean time to relapse was 15.3 days (SD 4.6) and 15.7 days (SD 6.6), in the ORAVIG and Clotrimazole treatment arms, respectively. † Difference in clinical cure rates (ORAVIG-clotrimazole troche) was -4.5%, with a 95% CI: (-12.4%, 3.4%). ‡ Percentage based on those who had clinical cure. Study in Head and Neck Cancer Patients The efficacy and safety of ORAVIG 50 mg was evaluated in an open-label, randomized, multicenter trial comparing ORAVIG 50 mg once daily for 14 days to miconazole oral gel 125 mg four times daily for 14 days in head and neck cancer patients who had received radiation therapy. Most of the infections were caused by C. albicans (71%), and C. tropicalis (8%). About 7% of the subjects were infected with more than one Candida species. Success rates of treatment at day 14 [defined as a complete (complete disappearance of candidiasis lesions) or partial response (improvement by at least 2 points of the score for extent of oral lesion compared with the score at day 1) based on a blind assessment] are shown in Table 6. Also reported in Table 6 are relapse rate at day 30, and mycologic cure assessed at day 14. Table 6: Clinical Success and Mycological Cure at Day 14, in Patients with Head and Neck Cancer who had Received Radiation Therapy ORAVIG 50 mg N=148 a (%) Miconazole oral gel N=146 a (%) Success rate (CR+PR) b 79 (53.4%) 69 (46.6%) CR † 74 (50.0%) 64 (43.8%) Clinical relapse‡ Yes c 14 (18.9%) 8 (12.5%) No 59 (79.7%) 56 (87.5%) Missing 1 (1.4%) 0 Mycological cure 66 (44.6%) 78 (53.4%) a Analysis population includes all subjects who received at least one dose of study medication. Reasons for not receiving treatment included negative mycological culture, informed consent withdrawn, or lost during screening. Six patients excluded per arm. b CR: complete response; PR: partial response c In those subjects who relapsed, the mean time to relapse was 18.8 days (SD 16.3) and 20.6 days (SD 13.5), in the ORAVIG and Miconazole oral gel group, respectively. †Difference in clinical complete response rates (ORAVIG-Miconazole oral gel) was 6.2%, with a 95% CI: (-5.2%, 17.6%). ‡Percentage based on those who had complete response.
| ORAVIG 50 mg N=290 a (%) | Clotrimazole troches N=287 a (%) | |
| Clinical cure† | 176 (60.7%) | 187 (65.2%) |
| Clinical relapse‡ | ||
| Yes b | 48 (27.3%) | 52 (27.8%) |
| No | 124 (70.5%) | 133 (71.1%) |
| Missing | 4 (2.3%) | 2 (1.1%) |
| Mycological cure | 79 (27.2%) | 71 (24.7%) |
| ORAVIG 50 mg N=148 a (%) | Miconazole oral gel N=146 a (%) | |
| Success rate (CR+PR) b | 79 (53.4%) | 69 (46.6%) |
| CR † | 74 (50.0%) | 64 (43.8%) |
| Clinical relapse‡ | ||
| Yes c | 14 (18.9%) | 8 (12.5%) |
| No | 59 (79.7%) | 56 (87.5%) |
| Missing | 1 (1.4%) | 0 |
| Mycological cure | 66 (44.6%) | 78 (53.4%) |
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.8.5 Geriatric Use Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Labor and delivery
Information about the drug’s use during labor or delivery, whether or not the use is stated in the indications section of the labeling, including the effect of the drug on the mother and fetus, on the duration of labor or delivery, on the possibility of delivery-related interventions, and the effect of the drug on the later growth, development, and functional maturation of the child.8.2 Lactation Risk Summary There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of ORAVIG. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ORAVIG and any potential adverse effects on the breastfed infant from ORAVIG or from the underlying maternal condition.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women. There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. (See Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicity was not reported in any animal study with miconazole.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1). Pediatric Use: Safety and efficacy not established in patients less than 16 years of age (8.4). See 12 for PATIENT COUNSELING INFORMATION and FDA-Approved Patient Labeling 8.1 Pregnancy Risk Summary Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women. There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. (See Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicity was not reported in any animal study with miconazole. 8.2 Lactation Risk Summary There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of ORAVIG. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ORAVIG and any potential adverse effects on the breastfed infant from ORAVIG or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking. 8.5 Geriatric Use Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 8.6 Hepatic Impairment Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution in patients with hepatic impairment. 8.7 Renal Impairment Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, no adjustment to therapy is necessary in patients with renal impairment.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED/STORAGE AND HANDLING ORAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of miconazole. ORAVIG tablets have a rounded side and a flat side. ORAVIG tablets are packaged in bottles of 14 tablets (NDC 61825-303-14). ORAVIG should be stored at 20 to 25 o C (68 to 77 o F) [see USP controlled room temperature]; excursions between 15 and 30 o C permitted at room temperature. Protect from moisture, and keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API