Loprox

Burning, redness, or itching at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing at the application site.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Ciclopirox is a prescription medication used to treat fungal infections of the skin, nails, and scalp. Ciclopirox belongs to a group of drugs called antifungals, which work by stopping the growth of fungus.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

 

• Medicis Pharmaceutical Corp.

• Quality Care Products, LLC

• Valeant Pharmaceuticals North America LLC

Loprox is part of the drug classes:

• Other antifungals for topical use

• Other antiinfectives and antiseptics

Ciclopirox is an antifungal medicine that prevents fungus from growing on your skin.

Ciclopirox topical (for the skin) cream, gel, and lotion formulations are used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Ciclopirox shampoo is used to treat seborrheic dermatitis, an inflammatory skin condition of the scalp.

Ciclopirox nail lacquer is used to treat fungal infections of the toenails and fingernails.

Ciclopirox topical may also be used for purposes not listed in this medication guide.

Avoid contact with the eyes, nose, and inside of the mouth. If this does happen, rinse with water.

Avoid using other medications on the areas you treat with ciclopirox topical unless your doctor tells you to.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox nail lacquer.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

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.

Local Effects

If a reaction suggesting sensitivity or irritation occurs with the use of Loprox Shampoo, treatment should be discontinued and appropriate therapy instituted.

Contact of Loprox Shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water.

In patients with lighter hair color, hair discoloration has been reported.

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.

Table 1. Effective Treatment Rates at Week 4 in Trials 1 and 2

	Ciclopirox Shampoo	Vehicle
Study 1	220/380 (58%)	60/192 (31%)
Study 2	65/250 (26%)	32/249 (13%)

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

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:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA   By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada   U.S. Patent Numbers 7,981,909 and 8,227,490   Loprox is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.   ©Valeant Pharmaceuticals North America LLC   9505301 20001320B

Patient Information
Loprox® (loh-proks)
(ciclopirox)
Shampoo

Important: For use on the scalp only. Do not get Loprox Shampoo in your eyes, mouth, or vagina.

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:
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec, H7L 4A8, Canada

U.S. Patent Numbers 7,981,909; 8,227,490.

Loprox is a trademark of Valeant Pharmaceuticals International Inc. or its affiliates.
©Valeant Pharmaceuticals North America LLC

  9505301 20001320B

Rev. 06/2017

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

Loprox  ciclopirox shampoo

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-010 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ciclopirox (ciclopirox) ciclopirox 10 mg  in 0.96 mL

Inactive Ingredients Ingredient Name Strength disodium laureth sulfosuccinate   laureth-2   water   sodium chloride   sodium laureth-3 sulfate

Packaging # Item Code Package Description 1 NDC:99207-010-10 1 BOTTLE, PLASTIC in 1 CARTON 1 120 mL in 1 BOTTLE, PLASTIC 2 NDC:99207-010-01 6 BOTTLE, PLASTIC in 1 CARTON 2 10 mL in 1 BOTTLE, PLASTIC

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021159 03/20/2003

Labeler - Valeant Pharmaceuticals North America LLC (182837492)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceuticals Limited Canada		248761249	MANUFACTURE(99207-010)

Establishment
Name	Address	ID/FEI	Operations
Valeant Pharmaceuticals International, Inc		245141858	MANUFACTURE(99207-010), PACK(99207-010), LABEL(99207-010)

Revised: 06/2017   Valeant Pharmaceuticals North America LLC