ACETAZOLAMIDE MERCURY PHARMA

Posology i) Glaucoma (simple acute congestive and secondary):

Adults: 250 - 1,000mg (1-4 tablets) per 24 hours, usually in divided doses for amounts over 250mg daily. ii) Abnormal retention of fluid: Congestive heart failure, drug-induced oedema.

Adults:

For diuresis, the starting dose is usually 250 - 375mg (1-1½ tablets) once daily in the morning. If, after an initial response, the patient fails to continue to lose oedema fluid, do not increase the dose but allow for kidney recovery by omitting a day.

Best results are often obtained on a regime of 250 - 375mg (1-1½ tablets) daily for two days, rest a day, and repeat, or merely giving the DIAMOX tablets every other day. The use of DIAMOX tablets does not eliminate the need for other therapy, eg.

digitalis, bed rest and salt restriction in congestive heart failure and proper supplementation with elements such as potassium in drug-induced oedema. For cases of fluid retention associated with pre-menstrual tension, a daily dose (single) of 125 - 375mg is suggested.

iii) Epilepsy: Adults: 250 - 1,000mg daily in divided doses. Children: 8-30mg/kg in daily divided doses and not to exceed 750mg/day. The change from other medication to DIAMOX tablets should be gradual.

Elderly:

DIAMOX tablets should only be used with particular caution in elderly patients or those with potential obstruction in the urinary tract or with disorders rendering their electrolyte balance precarious or with liver dysfunction.

Method of administration:

Oral

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Not known: frequency cannot be estimated from the available data System organ class Frequency Adverse reactions Blood and lymphatic system disorders Not known Thrombocytopenia, Leukopenia, Aplastic anaemia, Bone marrow depression, Pancytopenia, Agranulocytosis**** Metabolism and nutrition disorder Not known Metabolic acidosis, electrolyte imbalance* and thirst** Psychiatric disorders Not known Depression, Irritability, reduced libido, Occasional instances of confusion Nervous system disorders Not known Paraesthesia, particularly a “tingling” feeling in the extremities, dizziness, Headache, Occasional instances of drowsiness, convulsions, Flaccid paralysis Eye disorders Not known Transient myopia*** Choroidal effusion, choroidal detachment Ear and labyrinth disorders Not known Impaired hearing and tinnitus Respiratory, thoracic and mediastinal disorders Not known Non-cardiogenic pulmonary oedema Gastrointestinal disorders Not known Melaena, Taste disturbance, Nausea, Vomiting Diarrhoea Hepatobiliary disorders Not known Fulminant hepatic necrosis****, Hepatitis or cholestatic jaundice Skin and subcutaneous tissue disorders Not known Urticaria, Rash (including Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis)****, Thrombocytic purpura, Photosensitivity, acute generalised exanthematous pustulosis (AGEP) Renal and urinary disorders Not known Haematuria, Crystalluria****, Renal and ureteral colic****, Renal lesions, Renal failure, Calculus formation****, Glycosuria, Polyuria General disorders and administration site conditions Not known Fever****, Fatigue, Anaphylaxis****, Flushing Investigations Not known Abnormal liver function *During long-term therapy, metabolic acidosis and electrolyte imbalance may occasionally occur.

This can usually be corrected by the administration of bicarbonate. **Adverse reactions during short-term therapy are usually non-serious. ***This condition invariably subsides upon diminution or withdrawal of the medication. ****Acetazolamide is a sulphonamide derivative and therefore some side- effects similar to those caused by sulphonamides have occasionally been reported.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Acetazolamide. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia.

Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure. When DIAMOX tablets is prescribed for long-term therapy, special precautions are advisable.

The patient should be cautioned to report any unusual skin rash. Periodic blood cell counts and electrolyte levels are recommended. Fatalities have occurred, although rarely, due to severe reactions to sulphonamides. A precipitous drop in formed blood cell elements or the appearance of toxic skin manifestations should call for immediate cessation of DIAMOX tablets therapy.

In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, DIAMOX tablets may aggravate acidosis and should be used with caution. In patients with a past history of renal calculi, benefit should be balanced against the risks of precipitating further calculi.

8). In case of AGEP diagnosis, acetazolamide should be discontinued and any subsequent administration of acetazolamide contraindicated. 8). Non- cardiogenic pulmonary oedema typically developed within minutes to hours after acetazolamide intake.

Symptoms included dyspnoea, hypoxia, and respiratory insufficiency. If non-cardiogenic pulmonary oedema is suspected, acetazolamide should be withdrawn, and supportive treatment should be given. Acetazolamide should not be administered to patients who previously experienced non-cardiogenic pulmonary oedema following acetazolamide intake.

Cases of choroidal effusion/detachment have been reported after the use of acetazolamide. Symptoms include acute onset of decreased visual acuity or ocular pain and can occur within hours after initiation of acetazolamide treatment.

If choroidal effusion/detachment is suspected, acetazolamide should be discontinued as rapidly as possible.

Information on Sodium Content:

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

1. Acetazolamide is contra-indicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked kidney and liver disease or dysfunction, suprarenal gland failure, and hyperchloremic acidosis. DIAMOX tablets should not be used in patients with hepatic cirrhosis as this may increase the risk of hepatic encephalopathy.

Long-term administration of DIAMOX tablets is contra-indicated in patients with chronic non-congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

DIAMOX tablets should not be used in patients hypersensitive to sulphonamides.