Patient Medication Information: uses, side effects, how to take - Blephamide S.O.P.
What is BLEPHAMIDE® S.O.P. used for?
BLEPHAMIDE® S.O.P. is used to treat inflammatory conditions of the eye where a bacterial infection also exists or where a bacterial infection could occur.
BLEPHAMIDE® S.O.P. is also used to treat injury to the eye from chemical, radiation or thermal burns.
BLEPHAMIDE® S.O.P. contains an antibacterial called sulfacetamide sodium, and it should be used exactly as directed by your healthcare professional.
How does BLEPHAMIDE® S.O.P. work?
BLEPHAMIDE® S.O.P. reduces inflammation and stops bacteria from growing in your eye.
What are the ingredients in BLEPHAMIDE® S.O.P.:
Medicinal ingredients: Sulfacetamide sodium and prednisolone acetate
Non-medicinal ingredients: Lanolin alcohol, mineral oil, petrolatum and white petrolatum
BLEPHAMIDE® S.O.P. comes in the following dosage forms:
As an ophthalmic ointment containing sulfacetamide sodium 10.0% w/v and prednisolone acetate 0.2% w/v
Do not use BLEPHAMIDE® S.O.P. if you:
- have a viral infection of the eye called herpes keratitis
- have other viral infections of the eye
- have eye infections with pus
- have tuberculosis infection of the eye
- have other mycobacterial infection of the eye
- have fungal infection of the eye
- are allergic to sulfacetamide sodium, prednisolone acetate or any other ingredient in BLEPHAMIDE® S.O.P.
- are allergic to antibiotics called sulfonamides
- are allergic to medicines called corticosteroids
To help avoid side effects and ensure proper use, talk to your healthcare professional before you use BLEPHAMIDE® S.O.P. Talk about any health conditions or problems you may have, including if you :
are pregnant or planning to become pregnant
- are breast-feeding or planning to breast-feed
- have an eye condition called glaucoma
- recently had cataract surgery
- have corneal or scleral tissue damage which is damage to the outside part of your eyeball
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for eye pressure.
Other warnings you should know about:
It is not known if BLEPHAMIDE® S.O.P. is safe and effective in children younger than 6 years of age.
Your vision may be temporarily blurry after using BLEPHAMIDE® S.O.P. Wait until your vision is clear before driving or using machines.
Potential Effects of Prolonged Use
Long term use may result in a new infection of your eye which does not respond to BLEPHAMIDE® S.O.P.
New Eye Infections
Using corticosteroids, like BLEPHAMIDE® S.O.P., especially for a long time, can affect how your body handles infections. Infections caused by bacteria, viruses or fungi can be hidden or can get worse when you use BLEPHAMIDE® S.O.P. Your body’s ability to fight infection may also be reduced. This can make you more likely to get new eye infections. If you notice any symptoms of an infection, such as eye swelling or redness that is not getting better, eye discharge, fever and chills, or you have extreme fatigue, talk to your healthcare professional immediately.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BLEPHAMIDE® S.O.P.:
- local anesthetics
- silver salts which are medicines used to treat eye infections
How to use BLEPHAMIDE® S.O.P.:
- If you wear contact lenses, you should not wear them while you are using BLEPHAMIDE® S.O.P.
- Use BLEPHAMIDE® S.O.P. as your doctor tells you to. Do not change the amount you use without consulting your doctor. If you stop treatment contact your doctor right away.
- Be careful not to touch your eye or any other surface with the tip of the tube. If you do, you may contaminate the medicine and this can infect your eyes later on.
- Although you may feel better early in treatment, BLEPHAMIDE® S.O.P. should be used exactly as directed.
- Misuse or overuse of BLEPHAMIDE® S.O.P. could lead to the growth of bacteria that will not be killed by sulfacetamide sodium (resistance). This means that BLEPHAMIDE® S.O.P. or other medicines that contain sulfacetamide sodium may not work for you in the future.
- Do not share your medicine.
- If your symptoms do not go away after two days of using BLEPHAMIDE® S.O.P., talk to your doctor. Your doctor will need to decide if you should keep using BLEPHAMIDE® S.O.P.
Usual dose:
Apply a small amount of BLEPHAMIDE® S.O.P. into the conjunctival sac, which is the space between the inside of your lower eyelid and your eyeball. Apply BLEPHAMIDE® S.O.P. between 3 and 6 times per day.
Overdose:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
What are possible side effects from using BLEPHAMIDE® S.O.P.?
These are not all the possible side effects you may feel when taking BLEPHAMIDE® S.O.P. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Altered sense of taste
- Blurred vision
- Drooping of the upper eyelid
- Eye inflammation
- Eye irritation
- Eye redness
- Feeling like there is something in your eye
- Headache
- Hypersensitivity
- Itchy eyes
- Large (dilated) pupils
- Rash, itching around the eye
Your doctor may perform tests on your eye while you are using BLEPHAMIDE® S.O.P.
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Allergic reaction: difficulty breathing, difficulty swallowing, fever, hives, itchy skin, rash, swelling of your tongue, throat or face. | √ | ||
| Cataracts (clouding of the lens of your eye): blurry vision, clouded vision, eye pain, fading or yellowing of colours, seeing halos and glare around lights, trouble seeing at night | √ | ||
| Eye infection, including corneal ulcers: itching, pain, redness, sensitivity to bright light, swelling, tearing, yellow discharge or crusts around the eye | √ | ||
| Glaucoma (serious eye disease where pressure in the eye is increased): blurred vision, eye redness, halos around lights, loss of vision, nausea, severe eye pain, vomiting | √ | ||
| Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (life-threatening skin conditions): blisters, rash, skin peeling, especially in mouth and eyes. | √ | ||
| Cushings Syndrome: abnormal weight gain, bruising, fatigue, high blood pressure | √ | ||
| Damage to a part of your eye called the optic nerve: vision loss | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Storage:
BLEPHAMIDE® S.O.P. should be stored at 15 to 25ºC. Protect from freezing and light. Store in an upright position.
Keep out of reach and sight of children.
If you want more information about BLEPHAMIDE® S.O.P.:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer's website www.allergan.ca, or by calling 1-800-668-6424.
Last revised: May 22, 2019
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© 2019 Allergan. All rights reserved.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.