Drug information of Ciclopirox


Ciclopirox

Drug group:

Ciclopirox olamine  is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.

Mechanism of effect

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 are essential co-enzymes in 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.

Pharmacodynamic

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.

Pharmacokinetics

Half-Life: 1.7 hr

Protein Bound: 94-98%

Absorption: rapid but minimal

Metabolism: appears to be almost completely conjugated with glucuronic acid; 1-2% appears to be metabolized to N-desoxyciclopirox & an unidentified metabolite

Excretion: urine 1.3%

Drug indications

fungal infection

Dosage

Adult

Mild to Moderate Onychomycosis of Fingernails & Toenails

Nail lacquer topical solution: Apply evenly over entire nail plate qDay (preferably HS or 8 hours before washing) to all affected nails with applicator brush provided

Tinea Pedis or Tinea Corporis

Cream and suspension: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis

Gel: Apply BID; gently massage into affected areas and surrounding skin if no improvement after 4 weeks re-evaluate diagnosis

Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor

Cream and suspension: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis

Seborrheic Dermatitis of the Scalp

Gel: Apply BID; gently massage into affected areas; if no improvement after 4 weeks re-evaluate diagnosis

Shampoo: Apply 5 mL (1 teaspoonful) to wet hair; lather, and leave in place for approximately 3 minutes before rinsing; may use up to 10 mL for longer hair; repeat BID qWeek for 4 weeks; allow minimum of 3 days between applications

Pediatric

Tinea Pedis or Tinea Corporis

<10 years: Safety and efficacy not established

≥10 years: May use cream and suspension as in adults

≥16 years: May use Gel

Tinea Cruris, Cutaneous Candidiasis, Tinea Vesicolor

<10 years: Safety and efficacy not established

&ge:10 years: As in adults

Seborrheic Dermatitis of the Scalp

<16 years: Safety and efficacy not established

≥16 years: May use gel and shampoo as in adults

Mild to Moderate Onychomycosis of Fingernails & Toenails

<12 years: Safety and efficacy not established

≥12 years: May use laquer solution as in adults

Drug contraindications

Hypersensitivity

Side effects

Pain , Acne , itching , dry skin , stinging , redness , Rash

Interactions

Alerts

Onychomycosis: 6 months of therapy may be required for initial improvement in symptoms and they also should be notified that completely clear nail(s) may not be achieved with use of ciclopirox topical solution (nail lacquer)

Points of recommendation

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before and after using this medication, unless you are using ciclopirox to treat a hand condition.

To apply the cream, gel, or lotion:

  • Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks. Follow your doctor's instructions.
  • Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
  • If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

To use ciclopirox shampoo:

  • Wet the hair and apply approximately 1 teaspoon (5 mL) of the shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on the hair and scalp for 3 minutes. A timer may be used.
  • Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If no improvement is seen after 4 weeks of treatment, contact your doctor.

It may take up to 4 weeks before your symptoms improve after using ciclopirox topical cream, gel, lotion, or shampoo. Keep using the medicine as directed and tell your doctor if your symptoms do not improve, or if they get worse.

To use ciclopirox nail lacquer:

  • Use on the nails and immediately surrounding skin only. Avoid contact with other areas. Remove any loose nail or nail material using nail clippers or a nail file.
  • Apply ciclopirox nail lacquer once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, apply the nail lacquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower.
  • Apply ciclopirox nail lacquer daily over the previous coat. Once a week, remove the nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file.
  • To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use.

Treatment with ciclopirox nail lacquer may require several months before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine.

Store all forms of this medicine at room temperature away from moisture, heat, and light. Once a bottle of ciclopirox shampoo is opened, it should be used within 8 weeks.

Ciclopirox nail lacquer is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


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