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DRUGS & SUPPLEMENTS
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Oceral
How is the drug helping you? |
Oceral uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- Clinical studies
- How supplied
INDICATIONS AND USAGE
Oceral® Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oceral® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.
Oceral® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which Oceral® Cream has been shown to be effective rarely occur in children below the age of 12.
CONTRAINDICATIONS
Oceral® Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.
WARNINGS
Oceral® (oxiconazole nitrate) Cream, 1% and Oceral® (oxiconazole nitrate) Lotion, 1% are not for ophthalmic or intravaginal use.
PRECAUTIONS
General: Oceral® Cream and Lotion are for external dermal use only. Avoid introduction of Oceral® Cream or Lotion into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of Oceral® Cream or Lotion, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.
Information for Patients: The patient should be instructed to:
- Use Oceral® as directed by the physician. The hands should be washed after applying the medication to the affected area(s). Avoid contact with the eyes, nose, mouth, and other mucous membranes. Oceral® is for external use only.
- Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens.
- Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing.
- Avoid the use of occlusive dressings unless otherwise directed by the physician.
- Do not use this medication for any disorder other than that for which it was prescribed.
Drug Interactions: Potential drug interactions between Oceral® and other drugs have not been systematically evaluated.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) or in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice).
Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 time the human dose based on mg/m2) and 15 mg/kg/day in males (4 times the human dose based on mg/m2). However, at doses above this level, the following effects were observed: a reduction in the fertility parameters of males and females, a reduction in the number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency.
Pregnancy:Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rabbits, rats, and mice at oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m2), respectively, and revealed no evidence of harm to the fetus due to Oceral. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Because oxiconazole is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.
Pediatric Use: Oceral® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which Oceral® Cream has been shown to be effective rarely occur in children below the age of 12.
Geriatric Use: A limited number of patients at or above 60 years of age (n ~ 396) have been treated with Oceral® Cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with Oceral® Lotion in US clinical trials. The number of patients is too small to permit separate analysis of efficacy and safety. No adverse events were reported with Oceral® Lotion in geriatric patients, and the adverse reactions reported with Oceral® Cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of Oceral® Cream and Lotion in geriatric patients is warranted.
ADVERSE REACTIONS
During clinical trials, of 955 patients treated with Oceral cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).
In a controlled, multicenter clinical trial of 269 patients treated with Oceral lotion, 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each).
OVERDOSAGE
When 5% oxiconazole cream (5 times the concentration of the marketed product) was applied at a rate of 1 g/kg to approximately 10% of body surface area of a group of 40 male and female rats for 35 days, 3 deaths and severe dermal inflammation were reported. No overdoses in humans have been reported with use of Oceral cream or lotion.
DOSAGE AND ADMINISTRATION
Oceral® Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oceral® Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.
Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
CLINICAL STUDIES
The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trials that form the basis for the approvals of Oceral® Lotion and Oceral® Cream.
Definitions:
- Mycological Cure: No evidence (culture and KOH preparation) of the baseline (original) pathogen in a specimen from the affected area taken at the 2-week post-treatment visit (for tinea [pityriasis] versicolor, mycological cure was limited to KOH only).
- Treatment Success: Both a global evaluation of 90% clinical improvement and a microbiologic eradication at the 2-week post-treatment visit.
Tinea Pedis: THERE ARE NO HEAD-TO-HEAD COMPARISON TRIALS OF THE Oceral® CREAM AND LOTION FORMULATIONS IN THE TREATMENT OF TINEA PEDIS.
Lotion Formulation: The clinical trial for the lotion formulation line extension involved 332 evaluable patients with clinically and microbiologically established tinea pedis. Of these evaluable patients, 64% were diagnosed with hyperkeratotic plantar tinea pedis and 28% with interdigital tinea pedis. Seventy-seven percent (77%) had disease secondary to infection with Trichophyton rubrum, 18% had disease secondary to infection with Trichophyton mentagrophytes, and 4% had disease secondary to infection with Epidermophyton floccosum.
The results of this clinical trial at the 2-week post-treatment follow-up visit are shown in the following table:
| Oceral® Lotion | |||
|---|---|---|---|
| Patient Outcome | b.i.d. | q.d. | Vehicle |
| Mycological cure | 67% | 64% | 28% |
| Treatment success | 41% | 34% | 10% |
In this study, the improvement and cure rates of the b.i.d.- and q.d.-treated groups did not differ significantly (95% confidence interval) from each other but were statistically (95% confidence interval) superior to the vehicle-treated group.
Cream Formulation: The two pivotal trials for the cream formulation involved 281 evaluable patients (total from both trials) with clinically and microbiologically established tinea pedis.
The combined results of these 2 clinical trials at the 2-week post-treatment follow-up visit are shown in the following table:
| Oceral® Cream | |||
|---|---|---|---|
| Patient Outcome | b.i.d. | q.d. | Vehicle |
| Mycological cure | 77% | 79% | 33% |
| Treatment success | 52% | 43% | 14% |
All the improvement and cure rates of the b.i.d.- and q.d.- treated groups did not differ significantly (95% confidence interval) from each other but were statistically (95% confidence interval) superior to the vehicle-treated group.
In addition, pediatric data (95 children ages 10 and under) available with the cream formulation indicate that it is safe and effective for use in children when used as directed. Adverse events were reported in 2 children; 1 child was reported to have reddening of the skin and 1 child was reported to have eczema-like skin alterations.
Tinea (pityriasis) Versicolor: Two pivotal clinical trials of Oceral® Cream in tinea (pityriasis) versicolor involved 219 evaluable patients in the q day Oceral® and vehicle arms of the trial with clinical and mycological evidence of tinea (pityriasis) versicolor. Patients were treated for 2 weeks with Oceral® Cream once daily, or with cream vehicle. The combined results of these clinical trials at the 2-week post-treatment follow-up visit are shown in the following table. These results are based on 207 patients (110 in the Oceral® group and 97 in the vehicle group) with efficacy evaluations at this visit.
| Oceral® Cream | ||
| Patient Outcome | q.d. | Vehicle |
| Mycological cure | 88% | 67% |
| Treatment success | 83% | 62% |
Only once a day was shown in both studies to be statistically superior to vehicle for all efficacy parameters at 2 weeks and follow-up.
HOW SUPPLIED
Oceral® (oxiconazole nitrate) Cream, 1% is supplied in:
- 30-g tubes (NDC 10337-358-30),
- 60-g tubes (NDC 10337-358-60), and
- 90-g tubes (NDC 10337-358-90).
Store between 15° and 30° C (59° and 86° F).
Oceral® (oxiconazole nitrate) Lotion, 1% is supplied in:
- 30-mL bottle (NDC 10337-359-30)
- 60-mL bottle (NDC 10337-359-60).
Store between 15° and 30° C (59° and 86° F).
Shake well before using.
PharmaDerm®
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747 USA
www.pharmaderm.com
I8358F/IF8358F
R01/12
#178
PharmaDerm®
NDC 10337-358-30
Oceral ® Cream, 1%*
(oxiconazole nitrate cream)
*Potency expressed as oxiconazole.
For Topical Dermatologic Use ONLY.
Not for Ophthalmic or Intravaginal Use.
Rx only
30 g
PharmaDerm®
NDC 10337-358-30
Oceral ® Cream, 1%*
(oxiconazole nitrate cream)
*Potency expressed as oxiconazole.
For Topical Dermatologic Use ONLY.
Not for Ophthalmic or Intravaginal Use.
Rx only
30 g
PharmaDerm® NDC 10337-359-30
Oceral ®
(oxiconazole
nitrate)
Lotion, 1%*
*Potency expressed as
oxiconazole.
For Topical
Dermatologic
Use ONLY.
Not for Ophthalmic
or Intravaginal Use.
Rx only 30 mL
Lotion 30mL Container
PharmaDerm® NDC 10337-359-30
Oceral ®
(oxiconazole
nitrate)
Lotion, 1%*
*Potency expressed as
oxiconazole.
For Topical
Dermatologic
Use ONLY.
Not for Ophthalmic
or Intravaginal Use.
Rx only 30 mL
30mL Lotion Carton
Oceral pharmaceutical active ingredients containing related brand and generic drugs:
Oceral available forms, composition, doses:
Oceral destination | category:
Oceral Anatomical Therapeutic Chemical codes:
Oceral pharmaceutical companies:
References
- Dailymed."OXISTAT (OXICONAZOLE NITRATE) CREAM OXISTAT (OXICONAZOLE NITRATE) LOTION [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
- Dailymed."OXICONAZOLE NITRATE: 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/dailym... (accessed August 28, 2018).
- "oxiconazole". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
Frequently asked Questions
Can i drive or operate heavy machine after consuming Oceral?Depending on the reaction of the Oceral after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Oceral not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Oceral addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Review
sdrugs.com conducted a study on Oceral, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Oceral consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.Visitor reports
Visitor reported useful
No survey data has been collected yetVisitor reported side effects
No survey data has been collected yetOne visitor reported price estimates
What is your opinion about drug cost? Did you feel the cost is apt, or did you feel it is expensive?The report given by the sdrugs.com website users shows the following figures about several people who felt the medicine Oceral is expensive, and the medicine is not expensive. The results are mixed. The perception of the cost of the medicine to be expensive or not depends on the brand name of the medicine, country, and place where it is sold, and the affordability of the patient. You can choose a generic drug in the place of the branded drug to save the cost. The efficiency of the medicine will not vary if it is generic or a branded one.
| Visitors | % | ||
|---|---|---|---|
| Expensive | 1 | 100.0% | |
One visitor reported frequency of use
How often in a day do you take the medicine?Are you taking the Oceral drug as prescribed by the doctor?
Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sdrugs.com website users about the frequency of taking the drug Oceral is mentioned below.
| Visitors | % | ||
|---|---|---|---|
| Twice in a day | 1 | 100.0% | |
Visitor reported doses
No survey data has been collected yetVisitor reported time for results
No survey data has been collected yetVisitor reported administration
No survey data has been collected yetOne visitor reported age
| Visitors | % | ||
|---|---|---|---|
| 30-45 | 1 | 100.0% | |
Visitor reviews
There are no reviews yet. Be the first to write one! |
The information was verified by Dr. Rachana Salvi, MD Pharmacology