Unoprostone Ophthalmic

Name: Unoprostone Ophthalmic

What special precautions should I follow?

Before taking unoprostone,

  • tell your doctor and pharmacist if you are allergic to unoprostone, any other medications, or any of the ingredients in unoprostone solution. Ask your pharmacist for a list of the ingredients.
  • If unoprostone is used with other topical eye medications, allow at least 5 minutes between each medication.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any other eye medications.
  • tell your doctor if you have inflammation (swelling) of the eye, a torn or missing lens, or other eye conditions, and if you have or have ever had any other medical problems.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using unoprostone, call your doctor.
  • Tell your doctor if you wear soft contact lenses. Wait at least 15 minutes after using the medicine to put in soft contact lenses.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Dosing & Uses

Dosage Forms & Strengths

ophthalmic solution

  • 15%

Open-Angle Glaucoma

Indicated to lower IOP with open-angle glaucoma

1 gtt in affected eye(s) BID

Ocular Hypertension

Indicated to lower IOP with ocular hypertension

1 gtt in affected eye(s) BID

Administration

May use with other topical ophthalmic drugs to lower IOP; if 2 drugs are used, separate administration by at least 5 minutes

Contains benzalkonium chloride, which may be absorbed by soft contact lenses; remove contact lenses before administration and wait at least 15 minutes after administration before reinserting contact lenses

Avoid touching eyelids or surrounding areas with dropper bottle tip to minimize contaminating dropper tip and solution

Retinitis Pigmentosa (Orphan)

Orphan designation for treatment of retinitis pigmentosa

Orphan sponsor

  • Sucampo Pharma Americas, Inc. 4520 East-West Highway Bethesda, MD 20814

<18 years: Safety and efficacy not established

Warnings

Contraindications

Hypersensitivity

Cautions

Increased pigmentation may occur due to increased melanin content in iris, eyelid periorbital tissues, and eyelashes

May exacerbated active intraocular inflammation (eg, uveitis)

Macular edema, including cystoid macular edema reported; caution in aphakic patients or pseudophakic patients with torn posterior lens capsule

Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if distributed into human milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Uses For unoprostone

Unoprostone 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 (hypertension of the eye).

unoprostone is available only with your doctor's prescription.

For Healthcare Professionals

Applies to unoprostone ophthalmic: ophthalmic solution

Ocular

Unoprostone ophthalmic may change the eye color. This is caused by a gradual increase of the brown pigment in the iris. The change in iris color is slow and may not be noticeable for months.

When administered to animals for 12 months, one of ten animals exhibited increased pigmentation of the iris.

The manufacturer reports after 12 months of therapy an increased length in eyelashes (>= 1 mm) in approximately 10% to 14% of patients and a decreased length in eyelashes in 7% of patients.[Ref]

Very common (10% or more): Burning/stinging, dry eyes, itching, increased length of eyelashes
Common (1% to 10%): Abnormal vision, eyelid disorder, foreign body sensation, lacrimation disorder, blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, vitreous disorder
Uncommon (0.1% to 1%): Acute elevated intraocular pressure, color blindness, corneal deposits, corneal edema, corneal opacity, diplopia, hyperpigmentation of the eyelid, increased number of eyelashes, iris hyperpigmentation, iritis, optic atrophy, ptosis, retinal hemorrhage, visual field defect, decrease in the length of eyelashes
Postmarketing reports: Corneal erosion, chemosis[Ref]

Respiratory

Common (1% to 10%): Bronchitis, increased cough, pharyngitis, rhinitis, sinusitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus[Ref]

Cardiovascular

Common (1% to 10%): Hypertension
Postmarketing reports: Palpitations[Ref]

Gastrointestinal

Postmarketing reports: Dry mouth, nausea, vomiting[Ref]

Other

Common (1% to 10%): Accidental injury, pain[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reaction[Ref]

General

The most commonly reported side effects were burning/stinging, dry eyes, itching, and increased length of eyelashes.[Ref]

Immunologic

Common (1% to 10%): Flu-like syndrome[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Some side effects of unoprostone ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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