Micogloma 20 mg Eye drops solution

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.

Posology

• 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.

Special populations

Paediatric population

Currently available data are described in section 5.1.

Method of administration

For topical ophthalmic use

• 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.

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.

There is an increased potential for developing corneal oedema in patients with low endothelial cell counts. In addition, corneal oedemas and irreversible corneal decompensations have been reported in patients with pre-existing chronic corneal defects and/or a history of intra-ocular surgery while using topical dorzolamide. MICOGLOMA should be used with caution in such patients.

Choroidal detachment concomitant with ocular hypotony have been reported after filtration procedures with administration of aqueous suppressant therapies.

Use in the Elderly

In clinical studies conducted with dorzolamide as in MICOGLOMA, no overall differences in effectiveness or safety were observed in patients 65 years of age and older. However, greater sensitivity of some older individuals cannot be ruled out.

Paediatric Population

Dorzolamide has not been studied in patients less than 36 weeks gestational age and less than 1 week of age. Patients with significant renal tubular immaturity should only receive dorzolamide after careful consideration of the risk benefit balance because of the possible risk of metabolic acidosis.

Specific interaction studies have not been performed with MICOGLOMA. In clinical studies where an ophthalmic solution containing dorzolamide hydrochloride were used concomitantly with the following medicines, no adverse interactions were reported: Timolol ophthalmic solution, betaxolol ophthalmic solution and systemic medicines, including ACE-inhibitors, calcium channel blockers, diuretics, non-steroidal anti-inflammatory medicines (e.g. aspirin), and hormones (e.g. Oestrogen, insulin, thyroxine).

Association between MICOGLOMA and miotics and adrenergic agonists have not been fully evaluated during glaucoma therapy. MICOGLOMA is a carbonic anhydrase inhibitor and although administered topically, is absorbed systemically. Dorzolamide was not associated with acid-base disturbances. However, these disturbances have been reported with oral carbonic anhydrase inhibitors and have in some instances, resulted in interactions (e.g. toxicity associated with high dose salicylate therapy). Therefore, the potential for such interactions should be considered in patients receiving MICOGLOMA.

Fertility

Animal data do not suggest an effect of treatment with dorzolamide on male and female fertility. Human data are lacking.

Pregnancy

There are not adequate and well-controlled studies in pregnant women. Therefore, MICOGLOMA should not be used during pregnancy. In rabbits, dorzolamide produced teratogenic effects at maternotoxic doses.

Breastfeeding

It is not known whether dorzolamide or its metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of dorzolamide/metabolites in milk.

No studies on the effects on the ability to drive and use machines have been performed. Possible side effects such as dizziness and visual disturbances may affect the ability to drive and use machines.

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

Tabulated summary of adverse reactions

Dorzolamide hydrochloride

System Organ Class

Frequent

Less Frequent

Frequency

Unknown

Nervous system disorders

Headache

Dizziness, paraesthesia

-

Eye disorders

Burning and stinging eyes, superficial punctuate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision

Iridocyclitis, 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

-

Epistaxis

Dyspnoea

Gastrointestinal disorders

Nausea, bitter taste

Throat 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 conditions

Asthenia/fatigue

Signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions, including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm

-

Investigations

MICOGLOMA was not associated with clinically meaningful electrolyte disturbances.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

Only limited information is available with regard to human overdose by accidental or deliberate ingestion of dorzolamide hydrochloride. Treatment should be symptomatic and supportive. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.