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USP DI Vol. II - UNOPROSTONE (Ophthalmic)

UNOPROSTONE (Ophthalmic)


Some commonly used brand names are:

In the U.S.?

  • Rescula

Category

  • Antiglaucoma agent,ophthalmic
  • antihypertensive, ocular

Description

Unoprostone (yoo-noh-PROST-ohn)is used to treat increased pressure in the eye caused by open-angle glaucoma.It is also used to treat a condition called ocular hypertension (hypertensionof the eye).

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

    Ophthalmic
  • Ophthalmic solution (eye drops) (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For unoprostone, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to unoprostone. Also tell your health care professionalif you are allergic to any other substances, such as benzalkonium chloride.

Pregnancy?Unoprostone has not been studied in pregnant women. However,studies in animals have shown that unoprostone given by injection causes increasesin the number of miscarriages. Before using this medicine, make sure yourdoctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?It is not known whether unoprostone passes into human breastmilk. However, it has been shown to pass into the milk of nursing animals.

Children?Studies on this medicine have been done only inadult patients and there is no specific information comparing use of ophthalmicunoprostone in children with use in other age groups.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.


Proper Use of This Medicine

To use the eye drops:

  • First, wash your hands. Tilt the head back and, pressing your fingergently on the skin just beneath the lower eyelid, pull the lower eyelid awayfrom the eye to make a space. Drop the medicine into this space. Let go ofthe eyelid and gently close the eyes. Do not blink. Keep the eyes closed andapply pressure to the inner corner of the eye with your finger for 1 or 2minutes to allow the medicine to be absorbed by the eye.
  • To keep this medicine as germ-free as possible, do not touch theapplicator tip to any surface (including the eye). Also, keep the containertightly closed.

Use this medicine only as directed. Do not usemore of it and do not use it more often than your doctor ordered. To do somay increase the chance of too much medicine being absorbed into the bodyand the chance of side effects.

If you wear contact lenses: These eye drops contain a preservative thatcould be absorbed by the contact lenses. Wait at least15 minutes after putting these drops in before you put in your contact lenses.

If your doctor ordered two different eye drops to be used together, waitat least 5 minutes between the times you apply the medicines.

Dosing?The doseof unoprostone will be different for different patients. Follow your doctor's orders or the directions on the label. The followinginformation includes only the average doses of unoprostone. If your dose is different, do not change it unless your doctor tellsyou to do so.

  • For ophthalmic dosage form (eye drops):
    • For glaucoma or hypertension of the eye:
      • Adults?Use one drop in the affected eye or eyes two times aday.
      • Children?Use and dose must be determined by your doctor.

Missed dose? If you miss a dose of this medicine, use itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing. Do not refrigerate.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that yourdoctor check your progress at regular visits to make sure that thismedicine is working and to check for unwanted effects.

Contact your doctor immediately if you are having eye surgery, you experiencetrauma to your eye, or you develop an eye infection to determine if you shouldcontinue to use your present container of eye drops.

This medicine may cause some people to have blurred vision for a shorttime. Make sure you know how you react to this medicinebefore you drive, use machines, or do anything else that could be dangerousif you cannot see properly.

Ophthalmic unoprostone may cause your eyes to become more sensitive tolight than they are normally. Wearing sunglasses and avoiding too much exposureto bright light may help lessen the discomfort.


Side Effects of This Medicine

Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

    Check with your doctor as soon as possibleif any of the following side effects occur:

      Less common

        Blood in the whites of the eyes; blurredvision or eye pain; eye irritation or redness

      Rare

        Blindness; color blindness; decreased vision or other changes in vision

    Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

      More common

        Abnormal tearing of eyes; burning orstinging of eyes; chills; cough; diarrhea; doublevision; dry eyes; fever; general feeling of discomfort or illness; headache; itching of eyes; joint pain; loss of appetite; muscle aches and pains; nausea; runny nose; shivering; sore throat; sweating; trouble sleeping; unusual tirednessor weakness; vomiting

      Less common or rare

        Discharge from eye; inflammation ofthe eye; redness, pain, swelling of eye, eyelid,or inner lining of eyelid; sensitivity to light

    Otherside effects may occur that usually do not need medical attention. These sideeffects may go away during treatment as your body adjusts to the medicine.Also, your health care professional may be able to tell you about ways toprevent or reduce some of these side effects. Check with your health careprofessional if any of the following side effects continue or are bothersomeor if you have any questions about them:

      More common

        Feeling of having something in the eye; increased or decreased length of eyelashes

      Less common or rare

        Change in the color of the iris or eyelid; increase in number of eyelashes; difficulty seeingat night; increased sensitivity of eyes to sunlight

Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your doctor.


Developed: 10/10/2000