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.