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Tuesday, 27 September 2016

Acne Topical

Generic Name: benzoyl peroxide (Topical route)

BEN-zoe-il per-OX-ide

Commonly used brand name(s)

In the U.S.

Acne

Acne 10 Gel

Acne Wash

Benzac

Benzagel

Benzashave

BenzEFoam Ultra

Benziq

Binora

BPO 4% Gel

BPO 8% Gel

Brevoxyl

In Canada

10 Benzagel Acne Gel

2.5 Benzagel Acne Gel

2.5 Benzagel Acne Lotion

5 Benzagel Acne Gel

5 Benzagel Acne Lotion

5 Benzagel Acne Wash

Acetoxyl 10

Acetoxyl 2.5

Acetoxyl 20

Acetoxyl 5

Acnomel Bp 5

Alquam-X Acne Therapy Gel

Available Dosage Forms:

Soap

Lotion

Solution

Cream

Gel/Jelly

Liquid

Foam

Therapeutic Class: Antiacne Antibacterial

Uses For Acne

Benzoyl peroxide is used to treat acne.

It may also be used for other conditions as determined by your doctor.

Some of these preparations are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, benzoyl peroxide is used in certain patients with the following medical conditions:

Decubital ulcer (bed sores)

Stasis ulcer (a certain type of ulcer)

Before Using Acne

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

For children up to 12 years of age: Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of benzoyl peroxide with use in other age groups. For children 12 years of age and older: Although there is no specific information comparing use of benzoyl peroxide in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 12 years of age and older than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of benzoyl peroxide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of benzoyl peroxide

This section provides information on the proper use of a number of products that contain benzoyl peroxide. It may not be specific to Acne. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. To do so may cause irritation of the skin.

Do not use this medicine in or around the eyes or lips, or inside the nose, or on sensitive areas of the neck. Spread the medicine away from these areas when applying. If the medicine gets on these areas, wash with water at once.

Do not apply this medicine to windburned or sunburned skin or on open wounds, unless otherwise directed by your doctor.

This medicine usually comes with patient directions. Read them carefully before using the medicine.

To use the cream, gel, lotion, or stick form of benzoyl peroxide:

Before applying, wash the affected area with nonmedicated soap and water or with a mild cleanser and then gently pat dry with a towel.

Apply enough medicine to cover the affected areas, and rub in gently.

To use the shave cream form of benzoyl peroxide:

Wet the area to be shaved.

Apply a small amount of the shave cream and gently rub over entire area.

Shave.

Rinse the area and pat dry.

After-shave lotions or other drying face products should not be used without checking with your doctor first.

To use the cleansing bar, cleansing lotion, or soap form of benzoyl peroxide:

Use to wash the affected areas as directed.

To use the facial mask form of benzoyl peroxide:

Before applying, wash the affected area with a nonmedicated cleanser. Then rinse and pat dry.

Using a circular motion, apply a thin layer of the mask evenly over the affected area.

Allow the mask to dry for 15 to 25 minutes.

Then rinse thoroughly with warm water and pat dry.

After applying the medicine, wash your hands to remove any medicine that might remain on them.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For acne:
- For cleansing bar dosage form:
  - Adults and children 12 years of age and over—Use two or three times a day, or as directed by your doctor.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For cleansing lotion, cream, or gel dosage forms:
  - Adults and children 12 years of age and over—Use on the affected area(s) of the skin one or two times a day.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For lotion dosage form:
  - Adults and children 12 years of age and over—Use on the affected area(s) of the skin one to four times a day.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For facial mask dosage form:
  - Adults and children 12 years of age and over—Use one time a week or as directed by your doctor.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.
- For stick dosage form:
  - Adults and children 12 years of age and over—Use on the affected area(s) of the skin one to three times a day.
  - Children up to 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Acne

During the first 3 weeks you are using benzoyl peroxide, your skin may become irritated. Also, your acne may seem to get worse before it gets better. If your skin problem has not improved within 4 to 6 weeks, check with your health care professional.

You should not wash the areas of the skin treated with benzoyl peroxide for at least 1 hour after application.

Avoid using any other topical medicine on the same area within 1 hour before or after using benzoyl peroxide. Otherwise, benzoyl peroxide may not work properly.

Unless your doctor tells you otherwise, it is especially important to avoid using the following skin products on the same area as benzoyl peroxide:

Any other topical acne product or skin product containing a peeling agent (such as resorcinol, salicylic acid, sulfur, or tretinoin);

Hair products that are irritating, such as permanents or hair removal products;

Skin products that cause sensitivity to the sun, such as those containing lime or spices;

Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions; or

Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

Using these products along with benzoyl peroxide may cause mild to severe irritation of the skin. Although skin irritation can occur, some doctors sometimes allow benzoyl peroxide to be used with tretinoin to treat acne. Usually tretinoin is applied at night so that it doesn't cause a problem with any other topical products that you might use during the day. Check with your doctor before using any other topical medicines with benzoyl peroxide.

This medicine may bleach hair or colored fabrics.

Check with your doctor at any time your skin becomes too dry or irritated. Your health care professional can help you choose the right skin products for you to reduce skin dryness and irritation.

Acne Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Painful irritation of skin, including burning, blistering, crusting, itching, severe redness, or swelling

skin rash

Symptoms of overdose

Burning, itching, scaling, redness, or swelling of skin (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Dryness or peeling of skin (may occur after a few days)

feeling of warmth, mild stinging, and redness of skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Acne Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Compare Acne Topical with other medications

Acne
Perioral Dermatitis

Monday, 26 September 2016

Ketoconazole Foam

Dosage Form: aerosol, foam
FULL PRESCRIBING INFORMATION

Indications and Usage for Ketoconazole Foam

Ketoconazole Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Ketoconazole Foam, 2% for treatment of fungal infections have not been established.

Ketoconazole Foam Dosage and Administration

Ketoconazole Foam, 2% should be applied to the affected area(s) twice daily for four weeks. Hold the container upright, and dispense Ketoconazole Foam, 2% into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Ketoconazole Foam, 2% with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Ketoconazole Foam, 2% may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. Ketoconazole Foam, 2% is not for ophthalmic, oral or intravaginal use.

Dosage Forms and Strengths

Ketoconazole Foam, 2% contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers.

Contraindications

None

Warnings and Precautions

Contact Sensitization

Ketoconazole Foam, 2% may result in contact sensitization, including photoallergenicity. [See Adverse Reactions (6.2)]

Flammable Contents

The contents of Ketoconazole Foam, 2% include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Systemic Effects

Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH–induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.

Adverse Reactions

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates.

The safety data presented in Table 1 (below) reflect exposure to Ketoconazole Foam, 2% in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Ketoconazole Foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.

Application site reactions that were reported in ≤1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth.

Dermal Safety Studies

In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Ketoconazole Foam, 2%. Ketoconazole Foam, 2% may cause contact sensitization.

Drug Interactions

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects

Pregnancy Category C

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (4.8 times the maximum expected human topical dose based on a mg/m2 comparison, assuming 100% absorption from 8 g of foam). However, these effects may be partly related to maternal toxicity, which was also observed at this dose level. [See Pharmacokinetics (12.3)]

No reproductive studies in animals have been performed with Ketoconazole Foam, 2%.

There are no adequate and well-controlled studies of Ketoconazole Foam, 2% in pregnant women. Ketoconazole Foam, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Ketoconazole Foam, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Ketoconazole Foam, 2% is administered to women who are breastfeeding.

Pediatric Use

The safety and effectiveness of Ketoconazole Foam, 2% in pediatric patients less than 12 years of age have not been established.

Of the 672 subjects treated with Ketoconazole Foam, 2% in the clinical trials, 44 (7%) were from 12 to 17 years of age. [See Clinical Studies (14)]

Geriatric Use

Of the 672 subjects treated with Ketoconazole Foam, 2% in the clinical trials, 107 (16%) were 65 years and over.

Ketoconazole Foam Description

Ketoconazole Foam, 2% contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.

The chemical name for ketoconazole is piperazine, 1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H-imidazol-1-ylmethyl)-1, 3-dioxolan-4-yl]methoxy]phenyl]-, cis- with the molecular formula C26H28CI2N4O4 and a molecular weight of 531.43.

The following is the chemical structure:

Ketoconazole Foam, 2% contains 20 mg ketoconazole USP per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.

Ketoconazole Foam - Clinical Pharmacology

Mechanism of Action

The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is not known.

Pharmacodynamics

The pharmacodynamics of Ketoconazole Foam, 2% has not been established.

Pharmacokinetics

In a bioavailability study, 12 subjects with moderate to severe seborrheic dermatitis applied 3 g of Ketoconazole Foam, 2% twice daily for 4 weeks. Circulating plasma levels of ketoconazole were < 6 ng/mL for a majority of subjects (75%), with a maximum level of 11 ng/mL observed in one subject.

Microbiology

Ketoconazole is an antifungal agent which inhibits the in vitro synthesis of ergosterol, a key sterol in the cell membrane of Malassezia furfur. The clinical significance of antifungal activity in the treatment of seborrheic dermatitis is not known.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or photo-carcinogenic potential of Ketoconazole Foam, 2%.

In oral carcinogenicity studies in mice (18-months) and rats (24-months) at dose levels of 5, 20 and 80 mg/kg/day ketoconazole was not carcinogenic. The high dose in these studies was approximately 2.4 to 4.8 times the expected topical dose in humans based on a mg/m2 comparison. In a bacterial reverse mutation assay, ketoconazole did not express any mutagenic potential. In three in vivo assays (sister chromatid exchange in humans, dominant lethal and micronucleus tests in mice), ketoconazole did not exhibit any genotoxic potential.

At oral dose levels of 75 mg/kg/day (4.5 times the expected topical human dose in mg/m2), ketoconazole impaired reproductive performance and fertility when administered to male rats (increased abnormal sperm, decreased sperm mobility and decreased pregnancy in mated females).

Clinical Studies

The safety and efficacy of Ketoconazole Foam, 2% were evaluated in a randomized, double-blind, vehicle-controlled study in subjects 12 years and older with mild to severe seborrheic dermatitis. In the study, 427 subjects received Ketoconazole Foam, 2% and 420 subjects received vehicle foam. Subjects applied Ketoconazole Foam, 2% or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. The overall disease severity in terms of erythema, scaling, and induration was assessed at Baseline and week 4 on a 5-point Investigator’s Static Global Assessment (ISGA) scale.

Treatment success was defined as achieving a Week 4 (end of treatment) ISGA score of 0 (clear) or 1 (majority of lesions have individual scores for scaling, erythema, and induration that averages 1 [minimal or faint]) and at least two grades of improvement from baseline. The results are presented in Table 2. The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups.

How Supplied/Storage and Handling

Ketoconazole Foam, 2% is supplied in 50 g (NDC 45802-532-32) and 100 g (NDC 45802-532-33) aluminum containers.

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not store under refrigerated conditions.Do not expose containers to heat, and/or store at temperatures above 120°F (49°C). Do not store in direct sunlight.

Contents are flammable.

Contents under pressure. Do not puncture and/or incinerate container.

Keep out of reach of children.

Patient Counseling Information

See FDA-approved patient labeling. (17.3)

Instructions for Use

• Avoid fire, flame and/or smoking during and immediately following application.

• Do not apply Ketoconazole Foam, 2% directly to hands. Dispense onto a cool surface, and apply to the affected areas using the fingertips.

Local Reactions

• Ketoconazole Foam, 2% may cause skin irritation (application site burning and/or reactions)

• Ketoconazole Foam, 2% may cause contact sensitization.

• As with any topical medication, patients should wash their hands after application.

• Inform a physician if the area of application shows signs of increased irritation and report any signs of adverse reactions.

Patient Package Insert

- See below -

PATIENT INFORMATION

Ketoconazole Foam, 2%

IMPORTANT: For skin use only. Do not use in the eyes, mouth or vagina.

Read the Patient Information that comes with Ketoconazole Foam, 2% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Ketoconazole Foam, 2%?

Ketoconazole Foam, 2% is used on the skin (topical) to treat a skin condition called seborrheic dermatitis in patients 12 years and older. Seborrheic dermatitis can cause areas of flaky skin (scales) on the scalp, face, ears, chest or upper back.

Ketoconazole Foam, 2% has not been studied in children less than 12 years old.

What should I tell my doctor before using Ketoconazole Foam, 2%?

For female patients, tell your doctor if you:

• are pregnant or become pregnant. It is not known if Ketoconazole Foam, 2% can harm a fetus (unborn baby).

• breastfeeding. It is not known if Ketoconazole Foam, 2% passes into breast milk.

How should I use Ketoconazole Foam, 2%?

• Apply Ketoconazole Foam, 2% exactly as prescribed. Ketoconazole Foam, 2% is usually applied to the affected skin areas two times a day (once in the morning and once at night) for 4 weeks. Talk to your doctor if your skin does not improve after 4 weeks of treatment with Ketoconazole Foam, 2%.

• Keep the Ketoconazole Foam, 2% can away from and do not spray it near fire, open flame, or direct heat. Ketoconazole Foam, 2% is flammable. Never throw the Ketoconazole Foam, 2% can into a fire, even if the can is empty.

Instructions for applying Ketoconazole Foam, 2%

	1. Hold the can at an upright angle. 2. Push the button to spray Ketoconazole Foam, 2% directly into the cap of the can or other cool surface. Spray only the amount of Ketoconazole Foam, 2% that you will need to cover your affected skin. Do not spray Ketoconazole Foam, 2% directly onto your affected skin or your hands because the foam will begin to melt right away when it touches your skin. 3. If your fingers are warm, rinse them in cold water first. Be sure to dry them well before handling the Ketoconazole Foam, 2%. If the Ketoconazole Foam, 2% can seems warm or the foam seems runny, place the can under cool running water for a few minutes. 4. Using your fingertips, gently massage Ketoconazole Foam, 2% into the affected areas until the foam disappears. 5. If you are treating skin areas with hair such as your scalp, move any hair away so that the foam can be applied to the affected skin. 6. Do not get Ketoconazole Foam, 2% in your eyes, mouth or vagina. If any Ketoconazole Foam, 2% gets in your eyes, mouth or vagina, rinse areas well with water. 7. Wash your hands well after applying Ketoconazole Foam, 2%.

What are the possible side effects of Ketoconazole Foam, 2%?

The most common side effects of Ketoconazole Foam, 2% are reaction or burning on treated skin areas. Tell your doctor if you have any reaction on your treated skin such as redness, itching, or a rash. These are not all the side effects of Ketoconazole Foam, 2%. Ask your doctor or pharmacist for more information.

How should I store Ketoconazole Foam, 2%?

• Ketoconazole Foam, 2% is flammable.

• Do not spray Ketoconazole Foam, 2% near fire or direct heat. Never throw the can into a fire, even if the can is empty.

• Store the can of Ketoconazole Foam, 2% at room temperature, 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Do not place the Ketoconazole Foam, 2% can in the refrigerator or freezer.

• Keep the Ketoconazole Foam, 2% can away from all sources of fire and heat. Do not leave the Ketoconazole Foam, 2% can in direct sunlight.

• Do not smoke while holding the Ketoconazole Foam, 2% can or while spraying or applying the foam.

• Do not pierce or burn the Ketoconazole Foam, 2% can.

• Keep Ketoconazole Foam, 2% and all medicines out of the reach of children.

General information about Ketoconazole Foam, 2%

Medicines are sometimes prescribed for conditions that are not mentioned in Patient Information leaflets. Do not use Ketoconazole Foam, 2% for any other condition for which it was not prescribed. Do not give Ketoconazole Foam, 2% to other people, even if they have the same condition that you have. It may harm them.

This leaflet summarizes the most important information about Ketoconazole Foam, 2%. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ketoconazole Foam, 2% that is written for health professionals.

What are the ingredients in Ketoconazole Foam, 2%?

Active ingredient: ketoconazole, USP

Inactive Ingredients: cetyl alcohol NF, citric acid USP, ethanol (denatured with tert-butyl alcohol and brucine sulfate) 58%, polysorbate 60 NF, potassium citrate USP, propylene glycol USP, purified water USP, and stearyl alcohol NF pressurized with a hydrocarbon (propane/butane) propellant.

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

The Patient Information leaflet was last revised: August 2010

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

Rx Only

Made in Israel

Manufactured by Perrigo

Yeruham 80500, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev. 08/2010

5K200 RC J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CARTON

Rx Only

Ketoconazole Foam, 2%

For Topical Use Only.

Not For Ophthalmic, Oral, or Intravaginal Use.

Ketoconazole Foam, 2% Carton Image 1

Ketoconazole Foam, 2% Carton Image 2

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - label

Rx Only

Ketoconazole Foam, 2%

For Topical Use Only.

Not For Ophthalmic, Oral, or Intravaginal Use.

Ketoconazole Foam, 2% Label

KETOCONAZOLE
ketoconazole aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	45802-532
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (KETOCONAZOLE)	KETOCONAZOLE	2 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL
ANHYDROUS CITRIC ACID
TERT-BUTYL ALCOHOL
ALCOHOL
BRUCINE SULFATE
POLYSORBATE 60
POTASSIUM CITRATE
PROPYLENE GLYCOL
WATER
STEARYL ALCOHOL
BUTANE
PROPANE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	45802-532-32	1 CANISTER In 1 CARTON	contains a CANISTER
1		50 g In 1 CANISTER	This package is contained within the CARTON (45802-532-32)
2	45802-532-33	1 CANISTER In 1 CARTON	contains a CANISTER
2		100 g In 1 CANISTER	This package is contained within the CARTON (45802-532-33)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091550	08/30/2011

Labeler - Perrigo New York Inc (078846912)

Revised: 09/2011Perrigo New York Inc

More Ketoconazole Foam resources

Ketoconazole Foam Use in Pregnancy & Breastfeeding
Ketoconazole Foam Support Group
10 Reviews for Ketoconazole - Add your own review/rating

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Azasite Drops

Pronunciation: ay-ZITH-roe-MYE-sin
Generic Name: Azithromycin
Brand Name: Azasite

Azasite Drops are used for:

Treating eye infections caused by certain bacteria.

Azasite Drops are a macrolide antibiotic. It works by killing sensitive bacteria.

Do NOT use Azasite Drops if:

you are allergic to any ingredient in Azasite Drops

Contact your doctor or health care provider right away if any of these apply to you.

Before using Azasite Drops:

Some medical conditions may interact with Azasite Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have had an allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) to a macrolide antibiotic (eg, erythromycin, azithromycin)

Some MEDICINES MAY INTERACT with Azasite Drops. Because little, if any, of Azasite Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Azasite Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Azasite Drops:

Use Azasite Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Azasite Drops are for use in the eye only. Do not swallow it.

Wash your hands immediately before you use Azasite Drops.

Turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down.

To use Azasite Drops, tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.

To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

Do not wear contact lenses while you are using Azasite Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.

To clear up your infection completely, use Azasite Drops for the full course of treatment. Keep using it even if you feel better in a few days.

If you miss a dose of Azasite Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azasite Drops.

Important safety information:

Infrequently, Azasite Drops may cause blurred vision. Use Azasite Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Azasite Drops only works against bacteria; it does not treat viral infections.

Be sure to use Azasite Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Azasite Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Azasite Drops should be used with extreme caution in CHILDREN younger than 1 year; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Azasite Drops while you are pregnant. It is not known if Azasite Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use Azasite Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Azasite Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Azasite Drops. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); discharge from the eye; eye pain; red, swollen, blistered, or peeling skin; severe or persistent burning, stinging, or irritation of the eye; swelling around the eyes; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Azasite side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Azasite Drops:

Store unopened bottles of Azasite Drops in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Once the bottle is opened, it may be stored in the refrigerator or at room temperature below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused medicine after the bottle has been open for 14 days. Keep Azasite Drops out of the reach of children and away from pets.

General information:

If you have any questions about Azasite Drops, please talk with your doctor, pharmacist, or other health care provider.

Azasite Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Azasite Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Azasite resources

Azasite Side Effects (in more detail)
Azasite Use in Pregnancy & Breastfeeding
Azasite Support Group
1 Review for Azasite - Add your own review/rating

Compare Azasite with other medications

Conjunctivitis, Bacterial
Neonatal Conjunctivitis

Wednesday, 21 September 2016

ketorolac Oral, Intravenous, Injection, Intramuscular

kee-toe-ROLE-ak

Oral route(Tablet)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine .

Injection route(Solution)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, previously demonstrated hypersensitivity reactions, intrathecal or epidural administration, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine .

Commonly used brand name(s)

In the U.S.

Toradol

Toradol IV/IM

Available Dosage Forms:

Tablet

Solution

Injectable

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For ketorolac

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using ketorolac, you should discuss with your doctor the good that ketorolac can do as well as the risks of using it.

Ketorolac is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ketorolac is used in certain patients with the following medical conditions:

Pain after surgery in children

Before Using ketorolac

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ketorolac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketorolac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on ketorolac have been done only in adult patients, and there is no specific information comparing use of ketorolac in children up to 16 years of age with use in other age groups.

Geriatric

Stomach or intestinal problems, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ketorolac. Also, elderly people are more likely than younger adults to get very sick if the medicine causes stomach problems. Studies in older adults have shown that ketorolac stays in the body longer than it does in younger people. Your doctor will consider this when deciding on how much ketorolac should be given for each dose and how often it should be given.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ketorolac, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ketorolac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Aceclofenac

Acemetacin

Alclofenac

Apazone

Aspirin

Benoxaprofen

Bufexamac

Carprofen

Clometacin

Clonixin

Dexketoprofen

Diclofenac

Diflunisal

Dipyrone

Droxicam

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenoprofen

Fentiazac

Floctafenine

Flufenamic Acid

Flurbiprofen

Ibuprofen

Indomethacin

Indoprofen

Isoxicam

Ketoprofen

Lornoxicam

Meclofenamate

Mefenamic Acid

Meloxicam

Nabumetone

Naproxen

Niflumic Acid

Nimesulide

Oxaprozin

Oxyphenbutazone

Pentoxifylline

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Probenecid

Propyphenazone

Proquazone

Sulindac

Suprofen

Tenidap

Tenoxicam

Tiaprofenic Acid

Tolmetin

Zomepirac

Using ketorolac with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abciximab

Ardeparin

Argatroban

Beclamide

Beta Glucan

Bivalirudin

Caramiphen

Carbamazepine

Certoparin

Chlormethiazole

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desirudin

Diazepam

Dipyridamole

Enoxaparin

Escitalopram

Ethotoin

Felbamate

Femoxetine

Flesinoxan

Fluoxetine

Fluvoxamine

Fondaparinux

Fosphenytoin

Gabapentin

Ginkgo

Heparin

Lacosamide

Lepirudin

Levetiracetam

Mephenytoin

Mephobarbital

Methotrexate

Nadroparin

Nefazodone

Oxcarbazepine

Paraldehyde

Paramethadione

Parnaparin

Paroxetine

Pemetrexed

Phenacemide

Phenobarbital

Phenytoin

Piracetam

Pregabalin

Protein C

Reviparin

Rivaroxaban

Rufinamide

Sertraline

Sibutramine

Stiripentol

Tacrolimus

Tiagabine

Ticlopidine

Tinzaparin

Tirofiban

Topiramate

Trimethadione

Valproic Acid

Vigabatrin

Vilazodone

Zimeldine

Zonisamide

Using ketorolac with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Acetohexamide

Alacepril

Alprenolol

Amiloride

Arotinolol

Atenolol

Azilsartan Medoxomil

Azosemide

Befunolol

Bemetizide

Benazepril

Bendroflumethiazide

Benzthiazide

Betaxolol

Bevantolol

Bisoprolol

Bopindolol

Bucindolol

Bumetanide

Bupranolol

Buthiazide

Candesartan Cilexetil

Canrenoate

Captopril

Carteolol

Carvedilol

Celiprolol

Chlorothiazide

Chlorpropamide

Chlorthalidone

Cilazapril

Clopamide

Cyclopenthiazide

Cyclosporine

Delapril

Desvenlafaxine

Dilevalol

Duloxetine

Enalaprilat

Enalapril Maleate

Eprosartan

Esmolol

Ethacrynic Acid

Fosinopril

Furosemide

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydroflumethiazide

Imidapril

Indapamide

Irbesartan

Labetalol

Landiolol

Levobetaxolol

Levobunolol

Lisinopril

Lithium

Losartan

Mepindolol

Methyclothiazide

Metipranolol

Metolazone

Metoprolol

Milnacipran

Moexipril

Nadolol

Nebivolol

Nipradilol

Olmesartan Medoxomil

Oxprenolol

Penbutolol

Pentopril

Perindopril

Pindolol

Piretanide

Polythiazide

Propranolol

Quinapril

Ramipril

Sotalol

Spirapril

Spironolactone

Talinolol

Tasosartan

Telmisartan

Temocapril

Tertatolol

Timolol

Tolazamide

Tolbutamide

Torsemide

Trandolapril

Triamterene

Trichlormethiazide

Valsartan

Venlafaxine

Xipamide

Zofenopril

Interactions with Food/Tobacco/Alcohol

Proper Use of ketorolac

For patients taking ketorolac tablets:

To lessen stomach upset, ketorolac tablets should be taken with food (a meal or a snack) or with an antacid.

Take ketorolac with a full glass of water. Also, do not lie down for about 15 to 30 minutes after taking it. This helps to prevent irritation that may lead to trouble in swallowing.

For patients using ketorolac injection:

Medicines given by injection are sometimes used at home. If you will be using ketorolac at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving injections. Be certain that you understand exactly how the medicine is to be injected.

For safe and effective use of ketorolac, do not use more of it, do not use it more often, and do not use it for more than 5 days. Using too much of ketorolac increases the chance of unwanted effects, especially in elderly patients.

Ketorolac should be used only when it is ordered by your doctor for treating certain kinds of pain. Because of the risk of serious side effects, do not save any leftover ketorolac for use in the future, and do not share it with other people.

Dosing

The dose of ketorolac will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ketorolac. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (tablets):
- For pain:
  - Adults (patients 16 years of age and older)—One 10-milligram (mg) tablet four times a day, four to six hours apart. Some people may be directed to take two tablets for the first dose only.
  - Children up to 16 years of age—Use and dose must be determined by your doctor.

For injection dosage form:
- For pain:
  - Adults (patients 16 years of age and older)—15 or 30 mg, injected into a muscle or a vein four times a day, at least 6 hours apart. This amount of medicine may be contained in 1 mL or in one-half (0.5) mL of the injection, depending on the strength. Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle.
  - Children up to 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ketorolac, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ketorolac

Taking certain other medicines together with ketorolac may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. Therefore, do not take acetaminophen (e.g., Tylenol) together with ketorolac for more than a few days, unless otherwise directed by your medical doctor or dentist. Also, do not take any of the following medicines together with ketorolac, unless your medical doctor or dentist has directed you to do so and is following your progress:

Aspirin or other salicylates

Diclofenac (e.g., Voltaren®)

Diflunisal (e.g., Dolobid®)

Etodolac (e.g., Lodine®)

Fenoprofen (e.g., Nalfon®)

Floctafenine (e.g., Idarac®)

Flurbiprofen (e.g., Ansaid®)

Ibuprofen (e.g., Motrin®)

Indomethacin (e.g., Indocin®)

Ketoprofen (e.g., Orudis®)

Meclofenamate (e.g., Meclomen®)

Mefenamic acid (e.g., Ponstel®)

Nabumetone (e.g., Relafen®)

Naproxen (e.g., Naprosyn®)

Oxaprozin (e.g., Daypro®)

Phenylbutazone (e.g., Butazolidin®)

Piroxicam (e.g., Feldene®)

Sulindac (e.g., Clinoril®)

Tenoxicam (e.g., Mobiflex®)

Tiaprofenic acid (e.g., Surgam®)

Tolmetin (e.g., Tolectin®)

Zomepirac (e.g., Zomax®)

Ketorolac may cause some people to become dizzy or drowsy. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Serious side effects can occur during treatment with ketorolac. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking ketorolac and check with your doctor immediately if you notice any of these warning signs.

ketorolac Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Swelling of face, fingers, lower legs, ankles, and/or feet

weight gain (unusual)

Less common

Bruising (not at place of injection)

high blood pressure

skin rash or itching

small, red spots on skin

sores, ulcers, or white spots on lips or in mouth

Rare

Abdominal or stomach pain, cramping, or burning that is severe

bleeding from the rectum or bloody or black, tarry stools

bloody or cloudy urine

blue lips and fingernails

blurred vision of other vision change

burning, red, tender, thick, scaly, or peeling skin

chest pain

convulsions

cough or hoarseness

dark urine

decrease in amount of urine that is sudden

fainting

fast, irregular, noisy, or troubled breathing

fever with severe headache, drowsiness, confusion, and stiff neck or back

fever with or without chills or sore throat

hallucinations (seeing, hearing, or feeling things that are not there)

hearing loss

hives

increase in amount of urine or urinating often

light-colored stools

loss of appetite

low blood pressure

mood changes or unusual behavior

muscle cramps or pain

nausea, heartburn, or indigestion that is severe and continues

nosebleeds

pain in lower back and/or side

pain, tenderness, or swelling in the upper stomach area

painful or difficult urination

pale skin

puffiness or swelling of the eyelids or eyes

ringing or buzzing in ears

runny nose

severe restlessness

shortness of breath

swollen or painful glands

swollen tongue

thirst that continues

tightness in the chest with or without wheezing

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

More common

Abdominal or stomach pain (mild or moderate)

bruising at place of injection

diarrhea

dizziness

drowsiness

headache

indigestion

nausea

Less common or rare

Bloating or gas

burning or pain at place of injection

constipation

feeling of fullness in abdominal or stomach area

increased sweating

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

More ketorolac Oral, Intravenous, Injection, Intramuscular resources

Ketorolac Oral, Intravenous, Injection, Intramuscular Use in Pregnancy & Breastfeeding
Drug Images
Ketorolac Oral, Intravenous, Injection, Intramuscular Drug Interactions
Ketorolac Oral, Intravenous, Injection, Intramuscular Support Group
74 Reviews for Ketorolac Oral, Intravenous, Injection, Intramuscular - Add your own review/rating

Compare ketorolac Oral, Intravenous, Injection, Intramuscular with other medications

Pain
Postoperative Pain

Ketoconazole Shampoo

Dosage Form: shampoo
Ketoconazole Shampoo, 2%

For topical application only.

Rx only

DESCRIPTION

Ketoconazole Shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole, USP in a concentration of 2% in an aqueous suspension. It also contains: sodium laureth sulfate, disodium laureth sulfosuccinate, cocamide diethanolamide, hydrochloric acid, NF, PEG-120 methyl glucose dioleate, imidurea, NF, sodium chloride, USP, sodium hydroxide, NF, fragrance, FD&C red No. 40, and purified water, USP.

Ketoconazole is cis - 1 - acetyl - 4 - [4 - [[2 - (2,4 - dichlorophenyl) - 2 - (1H - imidazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl]piperazine and has the following structural formula:

CLINICAL PHARMACOLOGY

Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.

Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months, or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months).

An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of Ketoconazole Shampoo, 2%, was significantly less than that of 2.5% selenium sulfide shampoo.

A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to Ketoconazole Shampoo, 2%.

Mode of Action: Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum ovale. Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebo controlled study in patients who had moderately severe tinea (pityriasis) versicolor. Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of Ketoconazole Shampoo, 2%, were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%). There had been mycological confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84% and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen. While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference between the two active regimens was not.

Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur). Development of resistance by these microorganisms to ketoconazole has not been reported.

INDICATIONS AND USAGE

Ketoconazole Shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

CONTRAINDICATIONS

Ketoconazole Shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

PRECAUTIONS

Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of Ketoconazole Shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Information for Patients

Patients should be advised of the following:

Ketoconazole Shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided.

The following have been reported with the use of Ketoconazole Shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions.

Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, or shortness of breath should discontinue Ketoconazole Shampoo, 2% and contact their physician immediately.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to assess the carcinogenic potential of Ketoconazole Shampoo, 2% have not been conducted. A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg were not genotoxic. The Ames Salmonella microsomal activator assay was also negative.

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp.

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (a dose 10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.

Nursing Mothers

There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Caution should be exercised when Ketoconazole Shampoo, 2%, is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

ADVERSE REACTIONS

In 11 double-blind trials in 264 patients using Ketoconazole Shampoo, 2%, for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of Ketoconazole Shampoo, 2%, (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

In worldwide experience with Ketoconazole Shampoo, 2% there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

OVERDOSAGE

Ketoconazole Shampoo, 2%, is intended for external use only. In the event of accidental ingestion, supportive measures should be employed. Induced emesis and gastric lavage should usually be avoided.

DOSAGE AND ADMINISTRATION

Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water.

One application of the shampoo should be sufficient.

HOW SUPPLIED

Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 0781-7090-04).

Storage conditions: Store at a temperature not above 25°C (77°F). Protect from light.

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

Manufactured by

TOLMAR Inc., Fort Collins, CO 80526 for

Sandoz Inc., Princeton, NJ 08540

04456 Rev. 5 05/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KETOCONAZOLE
ketoconazole shampoo, suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0781-7090
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (KETOCONAZOLE)	KETOCONAZOLE	20.5 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURETH SULFATE
DISODIUM LAURETH SULFOSUCCINATE
HYDROCHLORIC ACID
IMIDUREA
SODIUM CHLORIDE
SODIUM HYDROXIDE
COCO DIETHANOLAMIDE
PEG-120 METHYL GLUCOSE DIOLEATE
WATER
FD&C RED NO. 40

Product Characteristics
Color	RED (orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0781-7090-04	118.28 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076942	11/04/2005

Labeler - Sandoz Inc. (110342024)

Establishment
Name	Address	ID/FEI	Operations
TOLMAR Inc.		791156578	MANUFACTURE, ANALYSIS

Revised: 06/2011Sandoz Inc.

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Cutaneous Candidiasis
Dandruff
Seborrheic Dermatitis
Tinea Corporis
Tinea Cruris
Tinea Pedis
Tinea Versicolor

Tuesday, 27 September 2016

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