What is Orafungil?
Orafungil belongs to the group of medicines called antifungals. It is used to treat fungus infections of the body, feet, groin and thighs, scalp, skin, fingernails, and toenails. Orafungil may be taken alone or used along with medicines that are applied to the skin for fungus infections.
Use of Orafungil for prevention of fungus infection have not been established.
Orafungil is available only with your doctor's prescription.
Orafungil indications
Major indications for Orafungil (Orafungil microsize) are:
Tinea capitis (ringworm of the scalp)
Tinea corporis (ringworm of the body)
Tinea pedis (athlete's foot)
Tinea unguium (onychomycosis; ringworm of the nails)
Tinea cruris (ringworm of the thigh)
Tinea barbae (barber's itch)
Orafungil (Orafungil microsize) inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:
Trichophyton rubrum
Trichophyton tonsurans
Trichophyton mentagrophytes
Trichophyton interdigitalis
Trichophyton verrucosum
Trichophyton sulphureum
Trichophyton schoenleini
Microsporum audouini
Microsporum canis
Microsporum gypseum
Epidermophyton floccosum
Trichophyton megnini
Trichophyton gallinae
Trichophyton crateriform
Note: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical anti-fungal agents alone.
It is not effective in:
Bacterial infections
Candidiasism (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
Nocardiosis
How should I use Orafungil?
Use Orafungil ultramicrosize tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Orafungil ultramicrosize tablets by mouth with or without food.
- Swallow Orafungil ultramicrosize tablets whole.
- You may also crush Orafungil ultramicrosize tablets and sprinkle it onto 1 tablespoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away without chewing.
- To clear up your infection completely, take Orafungil ultramicrosize tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Orafungil ultramicrosize tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Orafungil ultramicrosize tablets.
Uses of Orafungil in details
Orafungil is used to treat infections caused by fungus such as ringworm, athlete's foot, jock itch, and fungal infections of the skin of scalp, fingernails, or toenails.
Orafungil description
Orafungil is a synthetic over-the-counter anti-fungal agent. It may come as a cream, powder, spray, or liquid aerosol, and is used to treat jock itch, athlete's foot and ringworm. It is sold under several brand names, most notably Tinactin (Schering-Plough Corporation) and Odor Eaters (Combe Incorporated). Other brands are Absorbine, Aftate, Desenex, Genaspor, NP 27, and Ting.
Orafungil dosage
Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.
Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium - depending on rate of growth - fingernails, at least 4 months; toenails, at least 6months.
General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis since in some forms of athlete's foot, yeasts and bacteria may be involved. Orafungil will not eradicate the bacterial or monilial infection.
Adults: A daily dose of 500 mg will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis.
For those fungus infections more difficult to eradicate such as tinea pedis and tinea unguium, a daily dose of 1.0 gram is recommended.
Children:Approximately 5 mg per pound of body weight per day is an effective dose for most children. On this basis the following dosage schedule for children is suggested:
Children weighing 30 to 50 pounds - 125 mg to 250 mg daily.
Children weighing over 50 pounds - 250mg to 500 mg daily.
How supplied
Orafungil (Orafungil microsize) 250 mg Tablets in bottles of 100 (NDC 0062-0211-60) (white, scored, imprinted "ORTHO 211").
Orafungil (Orafungil microsize) 500 mg Tablets in bottles of 100 (NDC 0062-0214-60) and 500 (NDC 0062-0214-70) (white, scored, imprinted "ORTHO 214").
Dispense Orafungil (Orafungil microsize) Tablets in a tight container as defined in the USP.
Orafungil (Orafungil microsize) Suspension 125 mg per 5 mL in bottles of 4 fl oz (120 mL) (NDC 0062-0206-04).
Dispense Orafungil (Orafungil microsize) Suspension in a tight, light-resistant container as defined in the USP.
STORE AT ROOM TEMPERATURE
DERMATOLOGICAL DIVISION, ORTHO PHARMACEUTICAL CORPORATION, Raritan, New Jersey 08869. Revised January 1997. FDA Rev date: n/a
Orafungil interactions
See also:
What other drugs will affect Orafungil?
Patients on warfarin-type anticoagulant therapy may require dosage adjustment of the anticoagulant during and after Orafungil therapy. Concomitant use of barbiturates usually depresses Orafungil activity and may necessitate raising the dosage.
The concomitant administration of Orafungil has been reported to reduce the efficacy of oral contraceptives and to increase the incidence of breakthrough bleeding.
Orafungil side effects
See also:
What are the possible side effects of Orafungil?
Applies to Orafungil: oral capsule, oral suspension, oral tablet
In addition to its needed effects, some unwanted effects may be caused by Orafungil (the active ingredient contained in Orafungil). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Orafungil:
More common:
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- fever
- itching
- joint or muscle pain
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness or weakness
- Confusion
- increased sensitivity of the skin to sunlight
- skin rash, hives, or itching
- soreness or irritation of the mouth or tongue
- Black, tarry stools
- chest pain
- cloudy urine
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness, tingling, pain, or weakness in the hands or feet
- painful or difficult urination
- shortness of breath
- swollen glands
- unusual bleeding or bruising
- yellow eyes or skin
- Abdominal or stomach pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- clay-colored stools
- dark urine
- dizziness
- headache
- loss of appetite
- nausea
- unpleasant breath odor
- vomiting of blood
Minor Side Effects
Some of the side effects that can occur with Orafungil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
More common:
- Hives or welts
- redness of the skin
- Trouble with sleeping
- Heartburn
- pain or discomfort in the chest, upper stomach, or throat
- sleeplessness
- unable to sleep
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
Orafungil contraindications
See also:
What is the most important information I should know about Orafungil?
Orafungil is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to Orafungil.
Orafungil may cause fetal harm when administered to a pregnant woman. Two published cases of conjoined twins have been reported in patients taking Orafungil during the first trimester of pregnancy, therefore, Orafungil is contraindicated in women who are or may become pregnant during treatment. Women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on Orafungil. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of Orafungil. Note: The Maximum Recommended Human Dose (MRHD) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. If higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. For example, if a 1000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2.
Orafungil has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4X the Maximum Recommended Human Dose (MRHD) based on Body Surface Area (BSA)]. Orafungil also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with Orafungil at doses of 500 to 1000 mg/week. There are reports of teratogenicity in a Golden Retriever when doses of 750 mg/day [1.2X the MRHD based on BSA] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9X the MRHD based on BSA] for intervals from one week up to the entire gestation period. Teratogenicity was also seen in mice when Orafungil was administered in doses equivalent to 5g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy.
Active ingredient matches for Orafungil:
Griseofulvin in Portugal.
List of Orafungil substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| NUFULVIN (India) | |
| Nufulvin 250 mg Tablet (Nulife Pharmaceuticals) | $ 0.02 |
| NUFULVIN 250MG TABLET 1 strip / 10 tablets each (Nulife Pharmaceuticals) | $ 0.24 |
| NUFULVIN tab 125 mg x 10's (Nulife Pharmaceuticals) | $ 0.11 |
| NUFULVIN tab 250 mg x 10's (Nulife Pharmaceuticals) | $ 0.18 |
| Nufulvin 125mg TAB / 10 (Nulife Pharmaceuticals) | $ 0.11 |
| Nufulvin 250mg TAB / 10 (Nulife Pharmaceuticals) | $ 0.18 |
| Nufulvin 250mg Tablet (Nulife Pharmaceuticals) | $ 0.02 |
| Opsovin (Bangladesh) | |
| Pharmaniaga Griseofulvin (Malaysia) | |
| Pharmaniaga Griseofulvin 500 mg x 50 x 10's | |
| Polygris (Germany) | |
| Poncyl | |
| Poncyl FP (Japan) | |
| Rexavin (Indonesia) | |
| Rexavin 125 mg x 10 x 10's (Ifars) | |
| Rexavin 500 mg x 10 x 10's (Ifars) | $ 27.01 |
| S-Fulvin | |
| SP-Grevin (Singapore) | |
| SP-Grevin 500 mg x 1's | |
| Spirofulvin | |
| Sporostatin (Brazil) | |
| Sporostatin Xan | |
| Sulvina (Spain) | |
| Syntofulvin (Cyprus) | |
| TINEAVIN | |
| TINEAVIN 250MG TABLET 1 strip / 10 tablets each (Spic Pharmaceuticals) | $ 0.23 |
| Trivanex (Thailand) | |
| Trivanex 125 mg x 1, 000's (Pharmasant) | |
| Trivanex 500 mg x 250's (Pharmasant) | |
| Ultrafulvin (Egypt) | |
| Ultragris | |
| Tablet; Oral; Griseofulvin Ultramicrocrystalline 165 mg | |
| Tablet; Oral; Griseofulvin Ultramicrocrystalline 330 mg | |
| Tablets; Oral; Griseofulvin Ultramicrocrystalline 165 mg | |
| Tablets; Oral; Griseofulvin Ultramicrocrystalline 330 mg | |
| Ultragriseofulvin | |
| Ultragriseofulvin Kahira (Egypt) | |
| Ulvin | |
| Ulvin 500mg Tablet (Seagull Pharmaceutical Pvt Ltd) | $ 0.14 |
| Walavin (India) | |
| Walavin 250mg TAB / 10 (Wallace Pharmaceuticals Ltd.) | $ 0.27 |
| 250 mg x 10's (Wallace Pharmaceuticals Ltd.) | $ 0.27 |
| Tablets; Oral; Griseofulvin 250 mg (Wallace Pharmaceuticals Ltd.) | |
| Walavin 250 mg Tablet (Wallace Pharmaceuticals Ltd.) | $ 0.03 |
| WALAVIN 250MG TABLET 1 strip / 10 tablets each (Wallace Pharmaceuticals Ltd.) | $ 0.18 |
| WALAVIN tab 250 mg x 10's (Wallace Pharmaceuticals Ltd.) | $ 0.27 |
| Walavin 250mg Tablet (Wallace Pharmaceuticals Ltd.) | $ 0.02 |
| WALAVIN-250 | |
| WALAVIN-250 Capsule/ Tablet / 250mg / 10 units (Wallace Pharmaceuticals) | $ 0.17 |
| Xuanjing | |
See 529 substitutes for Orafungil | |
References
- DailyMed. "GRISEOFULVIN, ULTRAMICROSIZE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "griseofulvin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "griseofulvin". http://www.drugbank.ca/drugs/DB00400 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Orafungil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Orafungil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
