Natacyn

NATACYN® (natamycin ophthalmic suspension 5%) is a 15mL fill packaged in a 15 mL amber glass bottle with a black phenolic closure. A flint glass dropper with a red plastic closure and a black rubber bulb are packaged separately in a clear plastic blister with Tyvek backing.

NDC 0065-0645-15

STORAGE: Store between 2-24°C (36-75°F).Do not freeze. Avoid exposure to light and excessive heat.

Revised: May 2008. ALCON LABORATORIES, INC., Fort Worth, Texas 76134, USA. FDA revision date: 07/18/08

• Alcon Laboratories, Inc.

• Alcon Laboratories, Ophthalmic Div.

Antifungal antibiotic; polyene macrolide produced by Streptomyces natalensis.a b

Specific Drugs

Absorption

Bioavailability

Following topical application to eye, effective concentrations obtained in corneal stroma but not in intraocular fluid.b

Not systemically absorbed following topical application to eye.a b

Not significantly absorbed from mucous membranes or intact or denuded skin.a

Onset

Epithelial fungal infections may show response to treatment within 2 days and heal completely in 2–4 weeks.a

Distribution

Extent

Following topical application to the eye, adheres to the cornea in areas of epithelial ulceration and is retained in the conjunctival fornices.a b

Not known whether natamycin is distributed into milk.b (See Bioavailability under Pharmacokinetics.)

• Predominately fungicidal.a b

• Binds to sterols in the fungal cell membrane.a b Affects permeability of the selective membrane barrier, depleting potassium and other essential cellular constituents.a b

• Mechanism of action appears similar to that of amphotericin B and nystatin.a

• Active in vitro against Aspergillus, Blastomyces dermatitidis, Candida, Cephalosporium, Coccidioides immitis, Cryptococcus neoformans, Curvularia, Epidermophyton, Fusarium, Histoplasma capsulatum, Microsporum, Penicillium, and Sporothrix schenckii.a b

• Has some activity in vitro and in vivo against Trichomonas vaginalis.a

• Inactive against gram-positive and gram-negative bacteria and viruses.a b

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of natamycin in children with use in other age groups.

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 natamycin 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.

Pregnancy

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. 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.

• If you have an allergy to natamycin or any other part of Natacyn (natamycin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Natacyn® (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of the suspension contains: Active: natamycin 5% (50 mg). Preservative: benzalkonium chloride 0.02%. Inactive: sodium hydroxide and/or hydrochloric acid (neutralized to adjust the pH), purified water.

The active ingredient is represented by the chemical structure:

Established name: Natamycin

Molecular Formula: C33H47NO13

Molecular Weight: 665.73

Chemical name: Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26- trihydroxy-12- methyl-10-oxo-6,11,28- trioxatricyclo[22.3.1.05,7] octacosa-8,14,16,18,20-pentaene-25- carboxylic acid.

Other: Pimaricin

The pH range is 5.0 - 7.5.

Do not touch dropper tip to any surface, as this may contaminate the suspension. Patients should be advised not to wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis.

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