Drug Details
Drug Name(s) OPTICROM
FDA Application No. (NDA) 018155
Active Ingredient(s) CROMOLYN SODIUM
Company ALLERGAN
Original Approval or Tentative Approval Date October 3, 1984
Chemical Type 3 New dosage form
Review Classification S Standard review drug
O Orphan drug
Drug Name(s) OPTICROM
FDA Application No. (NDA) 018155
Active Ingredient(s) CROMOLYN SODIUM
Company ALLERGAN
Original Approval or Tentative Approval Date October 3, 1984
Chemical Type 3 New dosage form
Review Classification S Standard review drug
O Orphan drug
Uses
This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used to treat other eye conditions (such as allergic conjunctivitis, giant papillary conjunctivitis).
How to use Opticrom ophthalmic
Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.
It is best to avoid wearing contact lenses while using this medication.
This medication is used in the affected eye(s), usually 4 times daily or as directed by your doctor. Treatment may be continued for as long as 3 months.
Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over the eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. This will prevent the medication from draining away from the eye. Try not to blink and do not rub the eye. Repeat these steps if your dose is for more than 1 drop and for the other eye if so directed.
Do not rinse the dropper. Replace the dropper cap tightly after each use.
If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed.
It may take up to several days of continued use to see a relief in symptoms and up to 6 weeks for full benefit. If immediate relief of symptoms (itching) is needed, use other quick-relief medication (such as eye drops containing antihistamines, decongestants, or nonsteroidal anti-inflammatory drugs-NSAIDs) along with cromolyn as directed by your doctor. Tell your doctor if your condition persists or worsens.
Side Effects
Burning or stinging of the eye may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before using cromolyn, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.