PediPak
PediPak Uses, Dosage, Side Effects, Food Interaction and all others data.
Ciclopirox Olamine is a synthetic, broad-spectrum, antifungal agent. The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.
Ciclopirox is a broad-spectrum antifungal medication that also has antibacterial and anti-inflammatory properties. Its main mode of action is thought to be its high affinity for trivalent cations, which inhibit essential co-factors in enzymes. Ciclopirox exhibits either fungistatic or fungicidal activity in vitro against a broad spectrum of fungal organisms, such as dermatophytes, yeasts, dimorphic fungi, eumycetes, and actinomycetes. In addition to its broad spectrum of action, ciclopirox also exerts antibacterial activity against many Gram-positive and Gram-negative bacteria. Furthermore, the anti-inflammatory effects of ciclopirox have been demonstrated in human polymorphonuclear cells, where ciclopirox has inhibited the synthesis of prostaglandin and leukotriene. Ciclopirox can also exhibit its anti-inflammatory effects by inhibiting the formation of 5-lipoxygenase and cyclooxygenase.
Urea is an osmotic diuretic similar to mannitol but more irritant. It induces diuresis by increasing osmotic pressure of the glomerular filtrate and increasing excretion of sodium, potassium and chloride ions. Its osmotic effect also draws water from cells e.g. brain, CSF and anterior chamber of the eye, thereby decreasing intracranial or intraocular pressure. Unlike mannitol, urea penetrates the eye and causes a rebound increase in intraocular pressure if the plasma concentration of the drug is less than that in the vitreous humour. Applied topically, urea promotes hydration of keratin and mild keratolysis in dry skin. It increases water uptake by the stratum corneum and has an antipruritic effect.
As a humectant, urea draws water into the striatum corneum.
| Trade Name | PediPak |
| Generic | Ciclopirox + urea |
| Type | Kit |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Ciclopirox cream is used for the topical treatment of the following dermal infections:Tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis Candidiasis moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Urea 25% cream is used for the treatment of dry, cracked skin and hyperkeratosis on the soles of the feet including the heels. Suitable for general and diabetic foot care.
PediPak is also used to associated treatment for these conditions: Fungal skin infection, Pityriasis versicolor, Seborrheic dermatitis of the scalp, Tinea Corporis, Tinea Cruris, Tinea Pedis, Vulvovaginal Candidiasis, Cutaneous candidiasis, Mild Onychomycosis, Moderate OnychomycosisDermatitis, Dermatitis, Contact, Dermatitis, Eczematous, Dry Eyes, Dry Skin, Dry Skin; Eczema, Eczema, Dyshidrotic, Eye pruritus, Helicobacter Pylori Infection, Insect Bites, Lichen Planus (LP), Neurodermatitis, Nummular Dermatitis, Psoriasis, Seborrheic Dermatitis, Sunburn, Allergic skin manifestations, Anal eczema, Calluses, Moisturizing
How PediPak works
Unlike antifungals such as itraconazole and terbinafine, which affect sterol synthesis, ciclopirox is thought to act through the chelation of polyvalent metal cations, such as Fe3+ and Al3+. These cations inhibit many enzymes, including cytochromes, thus disrupting cellular activities such as mitochondrial electron transport processes and energy production. Ciclopirox also appears to modify the plasma membrane of fungi, resulting in the disorganization of internal structures. The anti-inflammatory action of ciclopirox is most likely due to inhibition of 5-lipoxygenase and cyclooxygenase. ciclopirox may exert its effect by disrupting DNA repair, cell division signals and structures (mitotic spindles) as well as some elements of intracellular transport.
Dosage
PediPak dosage
Gently massage Ciclopirox cream into the affected and surrounding skin areas twice daily, in the morning and evening for four weeks. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.
Apply a small amount twice daily to the skin after washing or bathing.
In extreme cases, before bed you may choose to cover the feet with plastic wrap and then put socks over the plastic wrap to increase the hydration rate.
Recommended for use on adults and children over 12 years.
After use, wear sandals or slippers to avoid staining carpets.
Ciclopirox cream is not for ophthalmic use.
Side Effects
Ciclopirox Olamine cream is well tolerated with a low incidence of side effects. The most frequently reported events are itching, redness, burning, dryness, or irritation of treated skin.
May irritate inflamed skin or exudative lesions. Transient stinging may occur in deep cracks. Discontinue use if local irritation or rash occurs during use.
Toxicity
Oral LD50 in rat is >10 ml/kg. Symptoms of overexposure include drowsiness and headache.
Precaution
If a reaction suggesting sensitivity or chemical irritation occurs with the use of Ciclopirox Cream, treatment should be discontinued and appropriate therapy instituted.
Interaction
There are no known drug interactions and none well documented.
Elimination Route
Rapidly absorbed after oral administration. Mean absorption of ciclopirox after application to nails of all twenty digits and adjacent 5 millimeters of skin once daily for 6 months in patients with dermatophytic onychomycoses was less than 5% of the applied dose. Ciclopirox olamine also penetrates into hair and through the epidermis and hair follicles into sebaceous glands and dermis.
Half Life
1.7 hours for 1% topical solution.
Elimination Route
Most of the compound is excreted either unchanged or as glucuronide. After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides.
Pregnancy & Breastfeeding use
Pregnancy Category B. There are no adequate or well-controlled studies in pregnant women. Therefore, Ciclopirox cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ciclopirox cream is administered to nursing women.
Urea cream can be used during pregnancy and lactation.
Contraindication
Ciclopirox Olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
For use only on the soles of the feet and heels unless otherwise directed by the prescriber. Pregnant women should consult their Healthcare Professional before use. For External Use Only. Avoid contact with eyes. Keep out of reach of children. Always replace cap after use. Do not use if tube seal is broken or appears tampered with.
Storage Condition
Store in a cool and dry place protected from light. Keep out of the reach of children.
Store between 10° – 30° C in a dry place. Keep lid tightly closed.
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