Loprox

LOPROX^® (ciclopirox) Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.

LOPROX Shampoo is not for ophthalmic, oral, or intravaginal use.

Wet hair and apply approximately 1 teaspoon (5 mL) of LOPROX 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 Shampoo, the diagnosis should be reviewed.

LOPROX is a shampoo containing 1% ciclopirox.

Each gram (equivalent to 0.96 mL) of LOPROX Shampoo contains 10 mg ciclopirox in a colorless and translucent shampoo base.

None.

LOPROX (ciclopirox) Shampoo, 1% contains the synthetic antifungal agent ciclopirox for topical use.

Each gram (equivalent to 0.96 mL) of LOPROX Shampoo contains 10 mg ciclopirox in a shampoo base consisting of disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate.

LOPROX Shampoo is a colorless, translucent solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-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:

In two randomized, double-blind clinical trials, subjects 16 years and older with seborrheic dermatitis of the scalp applied LOPROX Shampoo or its vehicle twice weekly for 4 weeks. Subjects 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 trials. An evaluation of the overall status of the seborrheic dermatitis, 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 trials. Efficacy results for the two trials are presented in Table 1 below.

Efficacy for African American subjects was not demonstrated, although only 53 African American subjects were enrolled in the two pivotal trials.

LOPROX (ciclopirox) Shampoo, 1% is colorless and translucent, and supplied in 120 mL plastic bottles
(NDC 99207-010-10).

Discard unused product after initial treatment duration.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

The patient should be instructed to:

• Use LOPROX Shampoo as directed by the physician. Avoid contact with the eyes. If contact occurs, rinse thoroughly with water. LOPROX Shampoo is for external use on the scalp only. Do not swallow.
• Use LOPROX Shampoo for seborrheic dermatitis for the full treatment time even though symptoms may have improved. Notify the physician if there is no improvement after 4 weeks.
• Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).
  

Manufactured for:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada

LOPROX is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2019 Bausch Health Companies Inc. or its affiliates

9505303

Patient Information
LOPROX^® (loh-proks)
(ciclopirox)
Shampoo

What is LOPROX Shampoo?

LOPROX Shampoo is a prescription medicine used on the scalp to treat adults with a skin condition called seborrheic dermatitis.

It is not known if LOPROX Shampoo is safe and effective in children under 16 years of age.

What should I tell my doctor before using LOPROX Shampoo?

Before using LOPROX Shampoo, tell your doctor if you:

• have any other medical conditions.
• are pregnant or plan to become pregnant. It is not known if LOPROX Shampoo will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if LOPROX Shampoo passes into your breast milk.
• are taking prescription and nonprescription medicines, vitamins, and herbal supplements.
  
  Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use LOPROX Shampoo?

• Use LOPROX Shampoo exactly as your doctor tells you to use it.
• Wash your hair using LOPROX Shampoo 2 times each week for 4 weeks. There should be at least 3 days between each time you use LOPROX Shampoo.
• Use LOPROX Shampoo for 4 weeks even if your skin condition improves.
• Tell your doctor if your scalp condition is not getting better after you have used LOPROX Shampoo for 4 weeks.
• Do not swallow LOPROX Shampoo.
• Avoid getting LOPROX Shampoo in your eyes. If LOPROX Shampoo gets into your eyes, rinse them well with water.

How should I apply LOPROX Shampoo?

• Wet your hair and apply approximately 1 teaspoon of LOPROX Shampoo to your scalp. You may use up to 2 teaspoons of LOPROX Shampoo if you have long hair. Lather and leave LOPROX Shampoo on your hair and scalp for 3 minutes. You may use a timer.
• After 3 minutes have passed, rinse your hair and scalp.

What are the possible side effects of LOPROX Shampoo?

The most common side effects of LOPROX Shampoo include: itching, burning, and redness of the scalp. Tell your doctor if you get any of these symptoms and they become worse or do not go away, or if you get blistering, swelling, or oozing in your scalp.

These are not all the possible side effects of LOPROX Shampoo. For more information, ask your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LOPROX Shampoo?

• Store LOPROX Shampoo at room temperature, between 59° to 86°F (15° to 30°C).
• Safely throw away any unused LOPROX Shampoo after you finish your treatment.

Keep LOPROX Shampoo and all medicines out of reach of children.

General information about LOPROX Shampoo

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LOPROX Shampoo for a condition for which it was not prescribed. Do not give LOPROX Shampoo to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about LOPROX Shampoo that is written for health professionals.

For more information about LOPROX Shampoo, call 1-800-321-4576.

What are the ingredients in LOPROX Shampoo?

Active ingredient: ciclopirox

Inactive ingredients: disodium laureth sulfosuccinate, laureth-2, purified water, sodium chloride, and sodium laureth sulfate.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada

LOPROX is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2019 Bausch Health Companies Inc. or its affiliates

9505303

Rev. 05/2019

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 99207-010-10

Rx only

LOPROX^®
SHAMPOO
(ciclopirox) 1%

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE
KEEP OUT OF REACH OF CHILDREN

120 mL

Ortho Dermatologics