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MAXITROL is a brand name for Dexamethasone, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
The following uncommon (≥1/1 000 to <1/100) adverse reactions have been observed with MAXITROL ointment and suspension in clinical studies: Immune system disorders: hypersensitivity Eye disorders: keratitis, intraocular pressure increased, vision blurred, photophobia, mydriasis, eyelid ptosis, eye pain, eye swelling, eye pruritus, ocular discomfort, foreign body sensation in eyes, eye irritation, ocular hyperaemia and lacrimation increased Post-Market Adverse Drug Reactions Additional adverse reactions identified from post-marketing surveillance include the following.
Frequencies cannot be estimated from the available data. Eye disorders: ulcerative keratitis Nervous system disorders: headache Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome DRUG INTERACTIONS No drug interaction studies have been performed with MAXITROL.
Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems (see WARNINGS AND PRECAUTIONS, General). CYP3A4 inhibitors including ritonavir and cobicistat may increase systemic exposure resulting in increased risk of adrenal suppression/Cushing’s syndrome.
(see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid effects.
No drug-food, drug-herb, drug-laboratory interactions or drug-lifestyle interactions are known. DOSAGE AND ADMINISTRATION MAXITROL Ointment Apply a thin coating to the conjunctival sacs of the affected eye(s) topically three to four times daily.
Frequency of application may be reduced gradually to once a day application for several days after 3 to 4 days when a satisfactory response has been obtained. MAXITROL® Prescribing Information Page 8 of 15 MAXITROL Suspension SHAKE WELL BEFORE USE.
Instill one to two drops topically in the conjunctival sac of the affected eye(s) four to six times daily. Dosage may be reduced after 3 to 4 days when a satisfactory response has been obtained. Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.
This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions. Missed dose If more than 1 topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dexamethasone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ointments should be administered last. OVERDOSAGE Due to the characteristics of this preparation, no additional toxic effects are expected with an acute ocular overdose of MAXITROL ointment or suspension, nor in the event of accidental ingestion of the contents of a tube/bottle.
For management of a suspected drug overdose, contact your regional Poison Control Centre. STORAGE AND STABILITY Do not store above 25oC. Do not refrigerate. Keep out of reach and sight of children. 5 mg/g (as Neomycin Sulfate) and Polymyxin B Sulfate 6000 IU/g.
01% w/w.
Non-medicinal Ingredients:
White Petrolatum and Anhydrous Liquid Lanolin. 5 g tube dispensers with ophthalmic tip. 5 mg/mL (as Neomycin Sulfate) and Polymyxin B Sulfate 6000 IU/mL. 004% w/v.
MAXITROL® Prescribing Information Page 9 of 15 Non-medicinal Ingredients:
Purified Water, Sodium Chloride, Hydroxypropyl Methylcellulose, Polysorbate 20, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH). MAXITROL suspension is supplied in 5 mL sterile DROP-TAINER® dispensers. Tamper evidence is provided by a closure with an extended skirt that locks to the bottle finish on application and breaks away from the closure on opening.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
IMPORTANT:
PLEASE READ MAXITROL® Prescribing Information Page 10 of 15 CONSUMER INFORMATION Pr MAXITROL® Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP This leaflet is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about MAXITROL® ointment.
Contact your doctor or pharmacist if you have any questions about MAXITROL ointment.
ABOUT THIS MEDICATION What the medication is used for:
MAXITROL ointment is used to treat inflammation of the eye caused by microorganisms.
What it does:
MAXITROL ointment contains a steroid, dexamethasone, and two antibiotics, neomycin sulfate and polymyxin B sulfate. The antibiotics, neomycin and polymyxin B sulfates, work by reducing infection while dexamethasone helps to reduce inflammation.
MAXITROL ointment contains antibacterial drugs. Antibacterial drugs treat only bacterial infections. They do not treat viral infections.
When it should not be used:
Do not use MAXITROL ointment if you: Are allergic to dexamethasone, neomycin sulfate, polymyxin B sulfate or any of the other ingredients in MAXITROL ointment (see What the important nonmedicinal ingredients are). Have herpes simplex keratitis (inflamed cornea of the eye caused by Herpes simplex), smallpox, chickenpox or any other viral infection of the eye.
Have a fungal infection of the eye or an untreated parasitic eye infection. Have a mycobacterial infection of the eye, including tuberculosis. 5 mg/g (as neomycin sulfate) Polymyxin B sulfate, 6000 IU/g What the important nonmedicinal ingredients are: Preservatives: methylparaben, propylparaben Others: liquid lanolin, […]