Natamycin

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.

No information provided.

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.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Natamycin falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Natamycin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Natamycin should be given to a pregnant woman only if clearly needed.

Ophthalmic Fungal Infections

Treatment of blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.a b

Efficacy not established for the treatment of deep fungal stromal keratitis or as a single agent for the treatment of fungal endophthalmitis.a b

Should not replace appropriate surgical procedures (e.g., conjunctival flap, penetrating keratoplasty) when indicated.a

May be used in combination with atropine preparations as indicated.a

Not effective for the treatment of intraocular scarring or loss of vision resulting from severe fungal corneal infections.a

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Pimaricin

Fungal keratitis: Ophthalmic: Instill 1 drop in conjunctival sac every 1 to 2 hours, after 3 to 4 days reduce to one drop 6 to 8 times daily; usual course of therapy is 2 to 3 weeks or until resolution of active fungal keratitis (may be useful to gradually reduce dosage at 4- to 7-day intervals to assure elimination of organism)

Fungal blepharitis or conjunctivitis: Ophthalmic: Instill 1 drop in conjunctival sac 4 to 6 times daily