Drugs Details

Drugs Info of Natacyn
Drugs Details
  • Drugs Type  : FDA
  • Date : 23rd Feb 2015 04:34 am
  • Brand Name : Natacyn
  • Generic Name : natamycin ophthalmic (Pronunciation: NA ta MYE sin off THAL mik)
Descriptions

NATACYN® (natamycin ophthalmic suspension) 5% is a sterile, antifungal drug for topical ophthalmic administration. Each mL of the suspension contains: Active: natamycin 5% (50mg). 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

Chemical Structure

Molecular Formula: C33H47NO13
Molecular Weight: 665.73

Chemical name: Stereoisomer of 22-[(3-amino-3,6-dideoxy- β-D-mannopyranosyl)oxy]-1,3,26­trihydroxy-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.

What are the possible side effects of natamycin ophthalmic (Natacyn)?

Serious side effects are not expected with this medication.

Commonly, mild irritation (redness, stinging, or burning) may occur.

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...

Read All Potential Side Effects and See Pictures of Natacyn »

This monograph has been modified to include the generic and brand name in many instances.

Indications

NATACYN® (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.

Dosage Administration

SHAKE WELL BEFORE USING. The preferred initial dosage in fungal keratitis is one drop of NATACYN® (natamycin ophthalmic suspension) 5% instilled in the conjunctival sac at hourly or two-hourly intervals. The frequency of application can usually be reduced to one drop 6 to 8 times daily after the first 3 to 4 days. Therapy should generally be continued for 14 to 21 days or until there is resolution of active fungal keratitis. In many cases, it may be helpful to reduce the dosage gradually at 4 to 7 day intervals to assure that the replicating organism has been eliminated. Less frequent initial dosage (4 to 6 daily applications) may be sufficient in fungal blepharitis and conjunctivitis.

How Supplied

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

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following events have been identified during post-marketing use of NATACYN® (natamycin) in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to their seriousness, frequency of reporting, possible causal connection to NATACYN® (natamycin) , or a combination of these factors include: allergic reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, paresthesia, and tearing.

Read the Natacyn (natamycin) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

No information provided.

Precautions

General

FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION. Failure of improvement of keratitis following 7-10 days of administration of the drug suggests that the infection may be caused by a microorganism not susceptible to natamycin.

Continuation of therapy should be based on clinical re-evaluation and additional laboratory studies.

Adherence of the suspension to areas of epithelial ulceration or retention of the suspension in the fornices occurs regularly.

Use only if the container is undamaged.

Carcinogenesis, Mutagenesis, Impairment of Fertility: There have been no long term studies done using natamycin in animals to evaluate carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with natamycin. It is also not known whether natamycin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. NATACYN® (natamycin ophthalmic suspension) 5% should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when natamycin 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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

NATACYN® (natamycin ophthalmic susp ension) 5% is contraindicated in individuals with a history of hypersensitivity to any of its components.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Natamycin is a tetraene polyene antibiotic derived from Streptomyces natalensis. It possesses in vitro activity against a variety of yeast and filamentous fungi, including Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. The mechanism of action appears to be through binding of the molecule to the sterol moiety of the fungal cell membrane. The polyenesterol complex alters the permeability of the membrane to produce depletion of essential cellular constituents. Although the activity against fungi is dose-related, natamycin is predominantly fungicidal.* Natamycin is not effective in vitro against gram-positive or gram-negative bacteria. Topical administration appears to produce effective concentrations of natamycin within the corneal stroma but not in intraocular fluid. Systemic absorption should not be expected following topical administration of NATACYN® (natamycin ophthalm ic suspension) 5%. As with other polyene antibiotics, absorption from the gastrointestinal tract is very poor. Studies in rabbits receiving topical natamycin revealed no measurable compound in the aqueous humor or sera, but the sensitivity of the measurement was no greater than 2 mg/mL.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Natacyn

Generic Name: natamycin ophthalmic (Pronunciation: NA ta MYE sin off THAL mik)

  • What is natamycin ophthalmic (Natacyn)?
  • What are the possible side effects of natamycin ophthalmic (Natacyn)?
  • What is the most important information I should know about natamycin ophthalmic (Natacyn)?
  • Who should not use natamycin ophthalmic (Natacyn)?
  • How should I use natamycin ophthalmic (Natacyn)?
  • What happens if I miss a dose (Natacyn)?
  • What happens if I overdose (Natacyn)?
  • What should I avoid while using natamycin ophthalmic (Natacyn)?
  • What other drugs will affect natamycin ophthalmic (Natacyn)?
  • Where can I get more information?

What is natamycin ophthalmic (Natacyn)?

Natamycin is an antifungal medication.

The ophthalmic form of natamycin is used to treat fungal infections of the eyes.

Natamycin ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of natamycin ophthalmic (Natacyn)?

Serious side effects are not expected with this medication.

Commonly, mild irritation (redness, stinging, or burning) may occur.

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.

Read the Natacyn (natamycin) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about natamycin ophthalmic (Natacyn)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Side Effects Centers
  • Natacyn

Patient Detailed How Take

Who should not use natamycin ophthalmic (Natacyn)?

Do not use natamycin ophthalmic if you have a bacterial or viral infection in your eye. It is used to treat infections caused by fungi only.

It is not known whether natamycin ophthalmic will harm an unborn baby. Do not use natamycin ophthalmic without first talking to your doctor if you are pregnant.

It is also not known whether natamycin passes into breast milk. Do not use natamycin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use natamycin ophthalmic (Natacyn)?

Use natamycin ophthalmic eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops.

To apply the eyedrops:

  • Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Do not use any eyedrop that is discolored or has particles in it.

Store natamycin ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.

Side Effects Centers
  • Natacyn

Patient Detailed Avoid Taking

What happens if I miss a dose (Natacyn)?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose (Natacyn)?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using natamycin ophthalmic (Natacyn)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Natamycin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

What other drugs will affect natamycin ophthalmic (Natacyn)?

Avoid other eye medications unless they are approved by your doctor.

Drugs other than those listed here may also interact with natamycin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

Your pharmacist has additional information about natamycin ophthalmic written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.03. Revision date: 12/15/2010.

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