"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophtha"...
Chronic open-angle glaucoma. Subacute or chronic angle-closure glaucoma after iridectomy or where surgery is refused or contraindicated. Certain non-uveitic secondary types of glaucoma, especially glaucoma following cataract surgery.
Concomitant esotropias with a significant accommodative component.
DOSAGE AND ADMINISTRATION
DIRECTIONS FOR PREPARING EYEDROPS
- Use aseptic technique.
- Tear off aluminum seals, and remove and discard rubber plugs from both drug and diluent containers.
- Pour diluent into drug container.
- Remove dropper assembly from its sterile wrapping. Holding dropper assembly by the screw cap and, WITHOUT COMPRESSING RUBBER BULB, insert into drug container and screw down tightly.
- Shake for several seconds to ensure mixing.
- Do not cover nor obliterate instructions to patient regarding storage of eyedrops.
Selection of Therapy – The medication prescribed should be that which will control the intraocular pressure around-the-clock with the least risk of side effects or adverse reactions. "Tonometric glaucoma" (ocular hypertension without other evidence of the disease) is frequently not treated with any medication, and echothiophate iodide for ophthalmic solution is certainly not recommended for this condition. In early chronic simple glaucoma with field loss or disc changes, pilocarpine is generally used for initial therapy and can be recommended so long as control is thereby maintained over the 24 hours of the day.
When this is not the case, echothiophate iodide for ophthalmic solution 0.03% may be effective and probably has no greater potential for side effects. If this dosage is inadequate, epinephrine and a carbonic anhydrase inhibitor may be added to the regimen. When still more effective medication is required, the higher strengths of echothiophate iodide for ophthalmic solution may be prescribed with the recognition that the control of the intraocular pressure should have priority regardless of potential side effects. In secondary glaucoma following cataract surgery, the higher strengths of the drug are frequently needed and are ordinarily very well tolerated.
The dosage regimen prescribed should call for the lowest concentration that will control the intraocular pressure around-the-clock. Where tonometry around-the-clock is not feasible, it is suggested that appointments for tension-taking be made at different times of the day so that inadequate control may be more readily detected. Two doses a day are preferred to one in order to maintain as smooth a diurnal tension curve as possible, although a single dose per day or every other day has been used with satisfactory results. Because of the long duration of action of the drug, it is never necessary or desirable to exceed a schedule of twice a day. The daily dose or one of the two daily doses should always be instilled just before retiring to avoid inconvenience due to the miosis.
Early Chronic Simple Glaucoma – Echothiophate iodide for ophthalmic solution 0.03% instilled twice a day, just before retiring and in the morning, may be prescribed advantageously for cases of early chronic simple glaucoma that are not controlled around-the-clock with other less potent agents. Because of prolonged action, control during the night and early morning hours may then sometimes be obtained. A change in therapy is indicated if, at any time, the tension fails to remain at an acceptable level on this regimen.
Advanced Chronic Simple Glaucoma and Glaucoma Secondary to Cataract Surgery – These cases may respond satisfactorily to echothiophate iodide for ophthalmic solution 0.03% twice a day as above. When the patient is being transferred to echothiophate iodide for ophthalmic solution because of unsatisfactory control with pilocarpine, carbachol, epinephrine, etc., one of the higher strengths, 0.06%, 0.125%, or 0.25% will usually be needed. In this case, a brief trial with the 0.03% eyedrops will be advantageous in that the higher strengths will then be more easily tolerated.
Concomitant Therapy – Echothiophate iodide for ophthalmic solution may be used concomitantly with epinephrine, a carbonic anhydrase inhibitor, or both.
Technique – Good technique in the administration of echothiophate iodide for ophthalmic solution requires that finger pressure at the inner canthus should be exerted for a minute or two following instillation of the eyedrops, to minimize drainage into the nose and throat. Excess solution around the eye should be removed with tissue and any medication on the hands should be rinsed off.
Accommodative Esotropia (Pediatric Use)
In Diagnosis – One drop of 0.125% may be instilled once a day in both eyes on retiring, for a period of two or three weeks. If the esotropia is accommodative, a favorable response will usually be noted which may begin within a few hours.
In Treatment – Echothiophate iodide for ophthalmic solution is prescribed at the lowest concentration and frequency which gives satisfactory results. After the initial period of treatment for diagnostic purposes, the schedule may be reduced to 0.125% every other day or 0.06% every day. These dosages can often be gradually lowered as treatment progresses. The 0.03% strength has proven to be effective in some cases. The maximum usually recommended dosage is 0.125% once a day, although more intensive therapy has been used for short periods.
Technique – (See "DOSAGE AND ADMINISTRATION, Glaucoma.")
Duration of Treatment – In diagnosis, only a short period is required and little time will be lost in instituting other procedures if the esotropia proves to be unresponsive. In therapy, there is no definite limit so long as the drug is well tolerated. However, if the eyedrops, with or without eyeglasses, are gradually withdrawn after about a year or two and deviation recurs, surgery should be considered. As with other miotics, tolerance may occasionally develop after prolonged use. In such cases, a rest period will restore the original activity of the drug.
Each package contains sterile echothiophate iodide for ophthalmic solution, sterile diluent, and dropper for dispensing 5 mL eyedrops of the strength indicated on the label. Four potencies are available:
NDC 0046-1062-05....................................1.5 mg package for 0.03%
White amorphous deposit on bottle walls. Aluminum crimp seal is blue.
NDC 0046-1064-05...................................3 mg package for 0.06%
White amorphous deposit on bottle walls. Aluminum crimp seal is red.
NDC 0046-1065-05...................................6.25 mg package for 0.125%
White amorphous deposit on bottle walls. Aluminum crimp seal is green.
NDC 0046-1066-05...................................12.5 mg package for 0.25%
White amorphous deposit on bottle walls. Aluminum crimp seal is yellow.
Handling and Storage
Prior to reconstitution: Store under refrigeration (2° to 8° C).
After reconstitution: Store at room temperature (approximately 25° C). Do not refrigerate. Discard any unused solution after 4 weeks.
This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. Manufactured for Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101 by Chesapeake Biological Laboratories, Inc. Baltimore, MD 21230. FDA Rev date: 3/9/2006
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Phospholine Iodide Information
- Phospholine Iodide Drug Interactions Center: echothiophate iodide opht
- Phospholine Iodide Side Effects Center
- Phospholine Iodide in detail including Side Effects and Drug Images
- Phospholine Iodide Overview including Precautions
- Phospholine Iodide FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.