Micogloma 20 mg Solution

    Micogloma 20 mg Solution

    S3


    1. What MICOGLOMA is and what it is used for.

    MICOGLOMA is indicated in the treatment of elevated intraocular pressure (IOP) in patients with:

    • ocular hypertension;
    • open-angle glaucoma;
    • pseudoexfoliative glaucoma or other secondary open-angle glaucomas; and
    • short term treatment of paediatric glaucomas as adjunctive therapy to beta-blockers and for monotherapy.

    2. What you need to know before you take/use MICOGLOMA.

    Contraindications

    • MICOGLOMA is contraindicated in patients with hypersensitivity to dorzolamide or any of the excipients listed in section 6.1.
    • Dorzolamide has not been studied in patients with moderate progressing to severe renal impairment (CrCI < 30 mL/min) or with hyperchloraemic acidosis. Dorzolamide and its metabolites are excreted predominantly by the kidney. MICOGLOMA is therefore contra-indicated in such patients.

    Special warnings and precautions for use

    MICOGLOMA has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. MICOGLOMA has not been studied in patients with acute angle-closure glaucoma.

    MICOGLOMA contains a sulphonamide group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulphonamides may occur with MICOGLOMA, including severe reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, and other blood dyscrasias. Sensitisation may recur when a sulphonamide is re-administered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of MICOGLOMA.

    Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi. Although no acid-base disturbances have been observed with dorzolamide, urolithiasis has been reported infrequently. MICOGLOMA is a topical carbonic anhydrase inhibitor that is absorbed systemically, therefore patients with a prior history of renal calculi may be at increased risk of urolithiasis. There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and dorzolamide. The concomitant administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended.

    Local ocular adverse effects, primarily conjunctivitis and lid reactions, have been reported with chronic administration of MICOGLOMA. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of therapy. If such reactions are observed, treatment with MICOGLOMA should be discontinued and the patient evaluated before considering restarting the medicine.

    3. How to take/use MICOGLOMA.

    When used as monotherapy, the dose is one drop of MICOGLOMA in the affected eye(s) 3 times daily.

    When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of MICOGLOMA in the affected eye(s) 2 times per day. When substituting MICOGLOMA for another ophthalmic anti-glaucoma medicine, discontinue the other medicine after proper dosing in one day, and start MICOGLOMA on the next day. If more than one topical ophthalmic medicine is being used, the medicines should be administered at least 10 minutes apart.

    4. Possible side effects.

    The following adverse reactions have been reported with dorzolamide hydrochloride ophthalmic solution (as MICOGLOMA):

    Tabulated summary of adverse reactions

    System Organ ClassFrequentLess FrequentFrequency Unknown
    Nervous system disordersHeadacheDizziness, paraesthesia-
    Eye disordersBurning and stinging eyes, superficial punctuate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred visionIridocyclitis, irritation including redness, pain, eyelid crusting, transient myopia (which resolves upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment (following filtration surgery)Foreign body sensation in eye
    Cardiac disorders--Palpitations
    Respiratory, thoracic, and mediastinal disorders-EpistaxisDyspnoea
    Gastrointestinal disordersNausea, bitter tasteThroat irritation, dry mouth-
    Skin and subcutaneous tissue disorders-Contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis-
    Renal and urinary disorders-Urolithiasis-
    General disorders and administration site conditionsAsthenia/fatigueSigns and symptoms of local reactions (palpebral reactions) and systemic allergic reactions, including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm-

    5. How to store MICOGLOMA.

    Store at or below 25 °C. MICOGLOMA should not be used more than 28 days after opening.

    Important Disclaimer

    The Micogloma 20 mg Solution professional information leaflet below is the property of Adcock Ingram and is provided on Somayeza exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Somayeza serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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