Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment

Pronunciation: NEE-oh-MYE-sin/POL-ee-MIX-in B/BAS-i-TRAY-sin/HYE-droe-KOR-ti-sone
Generic Name: Neomycin/Polymyxin B/Bacitracin/Hydrocortisone
Brand Name: Generic only. No brands available.

Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is used for:

Treating eye inflammation and infection caused by certain bacteria.

Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is an antibiotic and corticosteroid combination. The antibiotics work by slowing the growth of, or killing, sensitive bacteria on the eye. The corticosteroid reduces inflammation.

Do NOT use Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment if:

• you are allergic to any ingredient in Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment


• you have a fungal (eg, ringworm), viral (eg, herpes simplex, chickenpox, vaccinia), or mycobacterial infection of the eye

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

Before using Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment:

Some medical conditions may interact with Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment. 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 (including kanamycin, paromomycin, streptomycin, and gentamicin)


• if you have diabetes, glaucoma, or thinning of the cornea or white of the eye


• if you have a wound at the application site


• if you have recently had cataract surgery or any other eye surgery

Some MEDICINES MAY INTERACT with Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment. Because little, if any, of Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment:

Use Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is only for the eye. Do not get it in your nose or mouth.


• Wash your hands well before and after using Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment.


• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment may be used around the eye or in the eye. To use Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.


• 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment. 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment, 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment.

Important safety information:

• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment may cause blurred vision. Use it with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly.


• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment only works against bacteria; it does not treat fungal or viral infections.


• Be sure to use Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment 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.


• Long-term use of Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment may cause an increase in the pressure in your eyes. Do NOT use more than the recommended dose or use for longer than 10 days without checking with your doctor.


• If your symptoms do not improve within 48 hours or if they become worse, check with your doctor.


• Tell your doctor or dentist that you take Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment before you receive any medical or dental care, emergency care, or surgery.


• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment while you are pregnant. It is not known if Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is found in breast milk after topical use. Do not breast-feed while using Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment.

Possible side effects of Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, stinging, or mild irritation when you put Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment in your eye.

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); eye pain or swelling; severe or persistent eye itching, burning, or redness; 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.

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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment:

Store Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment is 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 Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Ointment. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Neomycin/Polymyxin B/Bacitracin/Hydrocortisone resources

• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Dosage
• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Use in Pregnancy & Breastfeeding
• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Drug Interactions
• Neomycin/Polymyxin B/Bacitracin/Hydrocortisone Support Group
• 0 Reviews for Neomycin/Polymyxin B/Bacitracin/Hydrocortisone - Add your own review/rating

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• Conjunctivitis, Bacterial
• Uveitis

Phacobiotic

Phacobiotic may be available in the countries listed below.

Ingredient matches for Phacobiotic

Cefatrizine

Cefatrizine comp. with propylene glycole (a derivative of Cefatrizine) is reported as an ingredient of Phacobiotic in the following countries:

• Greece

International Drug Name Search

Dymadon

In the US, Dymadon is a member of the drug class miscellaneous analgesics and is used to treat Fever, Muscle Pain, Pain and Sciatica.

Ingredient matches for Dymadon

Paracetamol

Paracetamol is reported as an ingredient of Dymadon in the following countries:

• Australia

International Drug Name Search

Neo-Polycin Ointment

Dosage Form: ophthalmic ointment
NEO-POLYCIN

DESCRIPTION:

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is a sterile antimicrobial ointment for ophthalmic use.  Each gram contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units in a white petrolatum and mineral oil base.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae).  It has a potency equivalent of not less than 600 µg of neomycin standard per mg, calculated on an anhydrous basis.  The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).  It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis.  The structural formulae are:

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy.  It has a potency of not less than 40 bacitracin units per mg.  The structural formula is:

CLINICAL PHARMACOLOGY:

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms.  It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms.  It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms.  It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology:

Neomycin sulfate, polymyxin B sulfate, and bacitracin zinc together are considered active against the following microorganisms:  Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.  The product does not provide adequate coverage against Serratia marcescens.

INDICATIONS AND USAGE:

Neo-PolycinTM Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria.  Such infections encompass conjunctivitis, keratitis, and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

CONTRAINDICATIONS:

Neo-PolycinTM Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE.  Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye.  Ophthalmic ointments may retard corneal wound healing.  Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization.  A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.  The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid.  A sensitization reaction may manifest simply as a failure to heal.  During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed.  Symptoms usually subside quickly on withdrawing the medication.  Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

PRECAUTIONS:

General:

As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi.  If superinfection occurs, appropriate measures should be initiated.  Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may also develop.  If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.  There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).  Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections:  Kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface.  The use of this product by more than one person may spread infection.  Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections.  Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).  If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician.  Do not use this product if you are allergic to any of the listed ingredients.  Keep tightly closed when not in use.  Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin.  Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/mL) tested;  however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.  Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.  No adverse effects on male or female fertility, litter size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy:

Teratogenic Effects: Pregnancy Category C.

Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate or bacitracin.  It is also not known whether neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Neoymcin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS:

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment.  The exact incidence is not known.  Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS).  More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.  Local irritation on instillation has also been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

May be applied every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

HOW SUPPLIED:

Neo-PolycinTM Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip.

NDC 48102-006-35

Store at 20o-25oC (68o-77oF) [See USP Controlled room temperature].

Neo-Polycin is a Trademark of Fera Pharmaceuticals, LLC.

FERA

Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560

PF00635A

R0311

Principal Display Panel - Carton Label

FERA

NDC 48102-006-35

STERILE  Rx only

Neo-PolycinTM

neomycin and

polymyxin B

sulfates and

bacitracin zinc

Ophthalmic

Ointment USP

Net wt. 3.5 g (1/8 oz)

Principal Display Panel - Tube Label

FERA

NDC 48102-006-35

STERILE    Rx only

Neo-PolycinTM

neomycin and

polymyxin B sulfates

and bacitracin zinc

Ophthalmic

Ointment USP

Each gram contains:

neomycin sulfate equivalent

to 3.5 mg neomycin base,

polymyxin B sulfate equivalent

to 10,000 polymyxin B units,

bacitracin zinc equivalent to

400 bacitracin units in a

white petrolatum and mineral

oil base.

Net wt. 3.5 g (1/8 oz)

NEO-POLYCIN  neomycin and polymyxin b sulfates and bacitracin zinc  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 48102-006 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 U  in 1 g BACITRACIN ZINC (BACITRACIN) BACITRACIN 400 U  in 1 g

Inactive Ingredients Ingredient Name Strength MINERAL OIL   PETROLATUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 48102-006-35 1 TUBE In 1 CARTON contains a TUBE 1 3.5 g In 1 TUBE This package is contained within the CARTON (48102-006-35)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA060764	07/15/2011

Labeler - Fera Pharmaceuticals (831023713)

Registrant - Fera Pharmaceuticals (831023713)

Revised: 07/2011Fera Pharmaceuticals

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NeoBenz Micro

Generic Name: benzoyl peroxide topical (BEN zoyl per OX ide)

Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, Benziq, Benziq Wash, BPO Foaming Cloths, Brevoxyl, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-8, Loroxide, NeoBenz Micro, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Zaclir

What is NeoBenz Micro (benzoyl peroxide topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.

Benzoyl peroxide topical (for the skin) is used to treat acne.

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

What is the most important information I should know about NeoBenz Micro (benzoyl peroxide topical)?

There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

What should I discuss with my healthcare provider before using NeoBenz Micro (benzoyl peroxide topical)?

Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation. FDA pregnancy category C. It is not known whether benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzoyl peroxide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use NeoBenz Micro (benzoyl peroxide topical)?

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

Wash your hands before and after applying this medication. Shake the lotion well just before each use.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.

Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.

Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using NeoBenz Micro (benzoyl peroxide topical)?

Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.

NeoBenz Micro (benzoyl peroxide topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:

• 
  

  mild stinging or burning;

  
  


• 
  

  itching or tingly feeling;

  
  


• 
  

  skin dryness, peeling, or flaking; or

  
  


• 
  

  redness or other irritation.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect NeoBenz Micro (benzoyl peroxide topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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• NeoBenz Micro Side Effects (in more detail)
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• NeoBenz Micro Drug Interactions
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• Brevoxyl Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Brevoxyl Creamy Wash Prescribing Information (FDA)


• Desquam-X Wash Prescribing Information (FDA)


• Inova Pads MedFacts Consumer Leaflet (Wolters Kluwer)


• NeoBenz Micro Wash Plus Pack Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Neobenz Micro SD Prescribing Information (FDA)


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Compare NeoBenz Micro with other medications

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Where can I get more information?

• Your pharmacist can provide more information about benzoyl peroxide topical.

See also: NeoBenz Micro side effects (in more detail)

Neupogen

Generic Name: filgrastim (Injection route)

fil-GRA-stim

Commonly used brand name(s)

In the U.S.

• Neupogen

Available Dosage Forms:

• Solution


• Injectable

Therapeutic Class: Hematopoietic

Pharmacologic Class: Colony Stimulating Factor

Uses For Neupogen

Filgrastim is a synthetic (man-made) version of a substance that is naturally produced in your body called a colony stimulating factor. It helps the bone marrow to make new white blood cells.

When certain cancer medicines are used to fight cancer cells, they also affect the white blood cells that fight infections. Filgrastim is used to prevent or reduce the risk of infection while you are being treated with cancer medicines. This medicine is also used to help the bone marrow recover after a bone marrow transplantation, and for a process called peripheral blood progenitor cell collection in cancer patients.

This medicine is available only with your doctor's prescription.

Before Using Neupogen

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of filgrastim in children. However, safety and efficacy have not been established in patients with autoimmune neutropenia and babies younger than 1 month of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of filgrastim in the elderly. .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	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.

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 this medicine, 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 this medicine 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.

• Topotecan


• Vincristine


• Vincristine Liposome

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or


• Lung disease or breathing problems or


• Sickle cell disease (red blood cell disease) or


• Skin disorders (e.g., cutaneous vasculitis)—Use with caution. May make these conditions worse.

• Bone marrow problems (e.g., chronic myeloid leukemia [CML], myelodysplastic syndrome [MDS])—It is not known if filgrastim will work in patients with these conditions.

• Peripheral blood progenitor cell (PBPC) mobilization—Use of filgrastim is not recommended for PBPC mobilization in healthy donors.

Proper Use of Neupogen

A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin or into a vein.

You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions about:

• How to prepare the injection.


• The proper use of disposable syringes.


• How to give the injection.


• How long the injection can be stored at home.

If you have any questions about any of this, check with your doctor.

This medicine can be used for several different reasons, so there are different schedules for using it. Make sure you understand your personal schedule.

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 injectable dosage form:
  
  • To increase white blood cells:
    
    • Adults and children—Dose is based on body weight and must be determined by your doctor.
    
    
    • Newborn babies—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Neupogen

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away at the first sign of any infection such as fever, chills, cough, sore throat, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions that requires immediate medical attention. Tell your doctor right away if you or your child have a rash; itching skin; dizziness, lightheadedness, or fainting; swelling of the face, tongue, or throat; trouble with breathing; or chest pain after you receive the medicine.

Check with your doctor right away if you or your child are having a pain in the upper left part of your abdomen (stomach) or at the tip of the left shoulder. This could be a symptom of a serious side effect with the spleen.

Stop using this medicine and check with your doctor right away if you or your child develop fever, shortness of breath, chest pain or tightness, trouble with breathing, or wheezing. These could be symptoms of a serious lung condition called acute respiratory distress syndrome (ARDS).

This medicine may also cause bleeding in your lungs. Check with your doctor right away if you or your child cough up blood or if you have blood in your sputum (spit).

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause an allergic reaction in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

You or your child should not receive this medicine within 24 hours (1 day) before and after you receive cancer medicines or radiation treatments.

Neupogen 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

• Abdominal or stomach pain


• bleeding gums


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• blood in the urine or stools


• bloody nose


• cough


• coughing up blood


• decrease in height


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• dizziness


• facial swelling


• feeling of fullness


• fever or chills


• headache


• increased menstrual flow or vaginal bleeding


• lower back or side pain


• nausea or vomiting


• nosebleeds


• pain in the back, ribs, arms, or legs


• pain spreading to the left shoulder


• painful or difficult urination


• pale skin


• paralysis


• pinpoint red or purple spots on the skin


• prolonged bleeding from cuts


• red or black, tarry stools


• red or dark brown urine


• shortness of breath


• skin rash


• sore throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• tightness in the chest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Less common

• Blurred vision


• chest pain


• nervousness


• pounding in the ears


• slow or fast heartbeats

Incidence not known

• Blisters on the skin


• blue lips, fingernails, or skin


• difficult or fast breathing


• sores on the skin

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:

More common

• Bone, joint, or muscle pain


• hair loss or thinning of the hair


• loss of appetite


• weight loss

Less common

• Cracked lips


• difficulty having a bowel movement (stool)


• swelling or inflammation of the mouth

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: Neupogen 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.

More Neupogen resources

• Neupogen Side Effects (in more detail)
• Neupogen Use in Pregnancy & Breastfeeding
• Neupogen Drug Interactions
• Neupogen Support Group
• 0 Reviews for Neupogen - Add your own review/rating

• Neupogen Prescribing Information (FDA)


• Neupogen Monograph (AHFS DI)


• Neupogen MedFacts Consumer Leaflet (Wolters Kluwer)


• Neupogen Consumer Overview

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Neomycin,Polymyxin B,Gramicidin

Dosage Form: ophthalmic solution
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP (Sterile)

Rx only

DESCRIPTION:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is a sterile antimicrobial solution for ophthalmic use.

EACH mL CONTAINS: ACTIVES: Neomycin Sulfate, (equivalent to 1.75 mg neomycin base), Polymyxin B Sulfate equal to 10,000 Polymyxin B units, Gramicidin, 0.025 mg; INACTIVES: Sodium Chloride, Alcohol (0.5%), Poloxamer 188, Propylene Glycol, Purified Water. Hydrochloric Acid and/ or Ammonium Hydroxide may be added to adjust pH (4.7- 6.0).

PRESERVATIVE ADDED: Thimerosal 0.001%.

Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.

The structural formulae are:

Polymyxin B Sulfate is the sulfate salt of polymyxin Bl and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are:

Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillusbrevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are:

CLINICAL PHARMACOLOGY:

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.

Microbiology:

Neomycin sulfate, polymyxin B sulfate and gramicidin together are considered active against the following microorganisms: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

INDICATIONS AND USAGE:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

CONTRAINDICATIONS:

This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

WARNINGS:

NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.

The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter. (See PRECAUTIONS, General).

PRECAUTIONS:

General:

As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to this product may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or other allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or gramicidin. Treatment of cultured lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C. Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

DOSAGE AND ADMINISTRATION:

Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW

HOW SUPPLIED:

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP is supplied in a plastic squeeze bottle with a controlled drop tip in the following size:

10 mL – Prod. No. 03409

Storage:

Store between 15° – 30° C (59°– 86° F).

PROTECT FROM LIGHT.

KEEP OUT OF REACH OF CHILDREN.

Revised August 2007

Bausch & Lomb Incorporated

Tampa, FL 33637

©Bausch & Lomb Incorporated

9113400 (Folded)

9113500 (Flat)

PRINCIPAL DISPLAY PANEL

NDC 24208-790-62

Bausch & Lomb

Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP

(Sterile)

Rx only

[icon- eye] [icon- solution] [icon- 10 mL]

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN  neomycin sulfate, polymyxin b sulfate and gramicidin  solution/ drops

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24208-790 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 1.75 mg  in 1 mL POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP'U]  in 1 mL GRAMICIDIN (GRAMICIDIN) GRAMICIDIN 0.025 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-790-62 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-790-62)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064047	01/31/1996

Labeler - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Xellia Pharmaceuticals		305814345	ANALYSIS, MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Xellia Pharmaceuticals		401172630	ANALYSIS, MANUFACTURE

Revised: 03/2011Bausch & Lomb Incorporated

More Neomycin,Polymyxin B,Gramicidin resources

• Neomycin,Polymyxin B,Gramicidin Side Effects (in more detail)
• Neomycin,Polymyxin B,Gramicidin Use in Pregnancy & Breastfeeding
• Neomycin,Polymyxin B,Gramicidin Support Group
• 0 Reviews for Neomycin,Polymyxin B,Gramicidin - Add your own review/rating

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