Carcinogenesis, Mutagenesis, and Impairment of Fertility
An 18-month oral dosing study with Panmicol in rats has not revealed any carcinogenic effect.
In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to Panmicol were examined for structural changes during the metaphase.
Prior to testing, the hamsters had received five oral Panmicol doses of 100 mg/kg body weight. The results of this study showed that Panmicol had no mutagenic effect.
How to use Panmicol-Betamethasone Lotion
Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
If you are using the lotion form of this medication, shake the bottle well before each use.
Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply a thin layer of the medication to the affected area and gently rub in, usually twice daily (in the morning and evening) or as directed by your doctor. Wash your hands after using unless you are using this medication to treat the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor. Wear loose-fitting clothes after applying the medication to the groin area.
Do not apply the medication in the eyes, nose, mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water.
The dosage and length of treatment depends on the type of infection being treated. Ringworm or jock itch is usually treated for 2 weeks, and athlete's foot is usually treated for 4 weeks. Do not use more than 45 grams of the cream or 45 milliliters of the lotion per week unless directed and closely monitored by your doctor.
Do not apply more often or use longer than prescribed. This may increase the risk of side effects.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.
Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.
Inform your doctor if your condition worsens or does not improve after 1 week of treatment for jock itch or ringworm or 2 weeks of treatment for athlete's foot.
Where can I find more information about Panmicol?
More information about Panmicol is available:
- Recommendations on the HIV-related uses of Panmicol, from the Gu >AIDSinfo database of ClinicalTrials.gov study summaries.
The above Patient Version drug summary is based on the following FDA label(s): Cream; Solution; Troche.
How should I take Panmicol?
Take Panmicol according to your health care provider’s instructions. Your health care provider will tell you how much Panmicol to take and when to take it. Before you start Panmicol and each time you get a refill, read any printed information that comes with your medicine.
How much Panmicol can you take?
Different types of products containing this active ingredient have different strengths. That’s why it is always important to read and follow the Drug Facts label. Most medicines warn against use of an active ingredient for longer than 7-10 days. Stop use and ask a doctor if symptoms persist.
Pregnancy Category C
There are no adequate and well-controlled studies with LOTRISONE cream in pregnant women. Therefore, LOTRISONE cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
There have been no teratogenic studies performed in animals or humans with the combination of Panmicol and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels.
Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) revealed no evidence of fetotoxicity due to Panmicol exposure.
No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) Panmicol doses up to 100 mg/kg/day during gestation Days 6 to 15. However, Panmicol dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. Panmicol dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg Panmicol was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks.
Oral Panmicol doses of 25, 50, 100, and 200 mg/kg/day (2-15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18-55 times the maximum human dose).
Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates.
Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.
Panmicol is an imidazole with broad-spectrum activity against Candida species and the dermatophytes T. tonsurans, Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.
What should I avoid while taking Panmicol?
There are no restrictions on foods, beverages, or activities during treatment with Panmicol unless your doctor directs otherwise.
Im > Panmicol is available as a 1% topical solution used for tinea versicolor or as a 10-mg troche used for oral thrush. The troches contain sugar and may promote caries if used in excess; otherwise they are nontoxic. They must be completely dissolved because any swallowed troche provides no benefit. The typical dosage for the treatment of oral candidiasis is four to five troches per day for 10 to 14 days. Miconazole is available as a 50-mg tablet for the treatment of oropharyngeal candidiasis. The tablet is taken once daily and should be placed into the buccal vestibule.
Ketoconazole is used for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. It is only available in the oral form in 200-mg tablets. These tablets are taken once daily (with a maximum daily dose of 800-mg in severe fungal disease). 4 The absorption of ketoconazole is affected by gastric ac > absorption. Ketoconazole poorly penetrates the cerebrospinal fluid (CSF), eye, urine, and saliva because of its high affinity and degree of protein binding. Common side effects include decreased libido and gynecomastia, particularly at higher doses. 3 Additionally, adrenal suppression has been reported. 5 Other side effects include fatigue, rash, and nausea. Hepatitis is a rare complication of ketoconazole use.
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Although Panmicol is available on prescription, you can also buy some preparations without a prescription at pharmacies and other retail outlets. It is available as a cream, as a spray and as a topical solution (a liquid which is applied directly on to the skin). The cream is most frequently used but, where large areas of skin are infected or where the area of the body which is being treated is quite hairy, a spray or topical solution may be more suitable. Sometimes Panmicol is combined in a cream with a mild corticosteroid called hydrocortisone (as in the brand called Canesten® HC). This cream is prescribed when the infection has caused the skin to become inflamed and sore.
Panmicol is a medicine which is also used to treat fungal infections on areas of the body other than the skin. For example, it is used to treat vaginal thrush and some ear infections. There is more information about the preparations used to treat these conditions in the separate medicine leaflets called Panmicol for vaginal thrush and Panmicol for ear infections.
Before using Panmicol for ear infections
To make sure this is the right treatment for you, before you start using Panmicol solution in your ear, make sure your doctor or pharmacist knows:
- If you are pregnant or breastfeeding. Although Panmicol is not known to be harmful to babies, you should only use medicines on the recommendation of a doctor while you are expecting or breastfeeding a baby.
- If you have ever had an allergic reaction to a medicine.
- If you are using any other drops or remedies in your ears.