Loprox Information
Loprox (Ciclopirox) Description
Loprox (Ciclopirox) Shampoo 1% contains the synthetic antifungal agent, ciclopirox.
Each gram (equivalent to 0.96 mL) of Loprox (Ciclopirox) Shampoo contains 10 mg ciclopirox in a shampoo base consisting of Purified Water USP, Sodium Laureth Sulfate, Disodium Laureth Sulfosuccinate, Sodium Chloride USP, and Laureth-2.
Loprox (Ciclopirox) Shampoo is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:
Loprox (Ciclopirox) Clinical Studies
In two randomized, double-blind clinical trials, patients 16 years and older with seborrheic dermatitis of the scalp applied Loprox (Ciclopirox) Shampoo or its vehicle two times per week for 4 weeks. Patients who were immunocompromised, those with psoriasis or atopic dermatitis, women of childbearing potential not using adequate contraception, and pregnant or lactating women were excluded from the clinical studies. An evaluation of the overall status of the seborrheic dermatitis, and the presence and severity of erythema or inflammation, and scaling, was made at week 4, using a scale of 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = pronounced, and 5 = severe. Effective treatment was defined as achieving a score of 0 (or a score of 1 if the baseline score was ≥3) simultaneously for status of the seborrheic dermatitis, erythema or inflammation, and scaling at Week 4. Ciclopirox shampoo was shown to be statistically significantly more effective than vehicle in both studies. Efficacy results for the two studies are presented in the following table.
Efficacy for black patients was not demonstrated, although only 53 black patients were enrolled in the two pivotal studies.
Loprox (Ciclopirox) Indications And Usage
Loprox (Ciclopirox) Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
Loprox (Ciclopirox) Contraindications
Loprox (Ciclopirox) Shampoo is contraindicated in individuals who have shown hypersensitivity to any of its components.
Loprox (Ciclopirox) Warnings
Loprox (Ciclopirox) Shampoo is not for ophthalmic, oral, or intravaginal use.
Loprox (Ciclopirox) Precautions
If a reaction suggesting sensitivity or irritation should occur with the use of Loprox (Ciclopirox) Shampoo, treatment should be discontinued and appropriate therapy instituted.
Contact of Loprox (Ciclopirox) Shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water.
Seborrheic dermatitis may appear at puberty, however, no clinical studies have been done in patients younger than 16 years.
In patients with lighter hair color, hair discoloration has been rarely reported.
There is no relevant clinical experience with patients who have a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, recent or recurring herpes zoster, or persistent herpes simplex), who are immunocompromised (e.g., HIV-infected patients and transplant patients), or who have a diabetic neuropathy.
Long-term animal studies have not been performed to evaluate the carcinogenic potential of Loprox (Ciclopirox) Shampoo or ciclopirox.
The following genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in the Ames and assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells, with and without metabolic activation (positive); chromosome aberration assays in V79 Chinese hamster lung fibroblast cells in the presence of supplemental Fe, with and without metabolic activation (negative); gene mutation assays in the HGPRT-test with V79 Chinese hamster lung fibroblast cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA synthesis assay in A549 human cells) (negative). An cell transformation assay in BALB/c 3T3 cells was negative for cell transformation. In an Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at a dosage of 5000 mg/kg body weight.
A combined oral fertility and embryofetal developmental study was conducted in rats with ciclopirox olamine. No effect on fertility or reproductive performance was noted at the highest dose tested of 3.85 mg/kg/day ciclopirox (approximately 1.3 times the maximum recommended human dose based on body surface area comparisons).
Loprox (Ciclopirox) Adverse Reactions
In 626 patients treated with Loprox (Ciclopirox) Shampoo twice weekly in the two pivotal clinical studies, the most frequent adverse events were increased itching in 1% of patients, and application site reactions, such as burning, erythema, and itching, also in 1% of patients. Other adverse events occurred in individual patients only.
Adverse events that led to early study medication termination in clinical trials occurred in 1.5% (26/1738) of patients treated with Loprox (Ciclopirox) Shampoo and 2.0% (12/661) of patients treated with shampoo vehicle. The most common adverse events leading to termination of study medication in either group was seborrhea. In the Loprox (Ciclopirox) Shampoo group, other adverse events included rash, pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash.
Loprox (Ciclopirox) Dosage And Administration
Wet hair and apply approximately 1 teaspoon (5 mL) of Loprox (Ciclopirox) Shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications.
If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with Loprox (Ciclopirox) Shampoo, the diagnosis should be reviewed.
Loprox (Ciclopirox)
Loprox (Ciclopirox) Principal Display Panel - Ml Carton
NDC 99207-010-10
FOR TOPICAL USE ONLY.NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.KEEP OUT OF REACH OF CHILDREN.
120 mL
Rx Only
