Abbreviated Prescribing Information: Zonisamide Rosemont 20mg/ml Oral Suspension.
Consult Summary of Product Characteristics before prescribing.
Presentation: White to off-white suspension, each 1 ml of suspension contains 20 mg of Zonisamide. Therapeutic Indications: Zonisamide Oral Suspension is indicated as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy and adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Posology and Method of Administration: Zonisamide oral suspension can be taken with or without food, but it must be shaken thoroughly and vigorously for 10 seconds before use. A feeding tube can be used to administer this product. In the adult population, zonisamide may be taken as monotherapy or added to existing therapy. Generally, depending on the diagnosis status, patient condition, and treatment regimen (monotherapy vs. Adjunctive therapy with or without CYP3A4-inducing agents), the dosage ranges from 50 mg/day initially up to a maximum daily dosage of 300 to 500 mg per day. Dose may increase at weekly intervals up to 100 mg (5 ml) with adjuvant therapy with CYP3A4-inducing agents, while for patients with hepatic or renal impairment and/or without CYP3A4-inducing agents, the dose may increase at two-weekly intervals.
Paediatric population: Zonisamide must be added to existing therapy for paediatric patients aged 6 years and above. Physicians should draw the attention of paediatric patients and their parents/carers to the Patient Alert Box (in the package leaflet) on preventing heatstroke. In generally, the dosage ranges from 1 mg/kg/day initially up to a maximum daily dosage of 300 – 500 mg/day depending on patient’s weight. Dose may increase at weekly intervals up to 1 mg/kg with adjuvant therapy with CYP3A4-inducing agents, while for patients without CYP3A4-inducing agents, the dose may increase at two-weekly intervals. There are limited data from clinical studies in patients with a body weight of less than 20 kg. Therefore, children aged 6 years and above and with a body weight less than 20 kg should be treated with caution. The safety and efficacy of zonisamide in children aged below 6 years have not yet been established. In elderly and renal impairment patients, caution should be exercised as there is limited information on the use of zonisamide in these patients. Use in patients with severe hepatic impairment is not recommended. Caution must be exercised in treating patients with mild to moderate hepatic impairment. When zonisamide treatment is to be discontinued, it should be withdrawn gradually.
Contra-indications: Hypersensitivity to the active substance, to any of the excipients, or to sulphonamides.
Special Warnings and Precautions for use: Consideration must be given to discontinuing zonisamide in patients who develop an otherwise unexplained rash. In order to minimize the risk of seizures during withdrawal, patients with epilepsy should gradually reduce their dosage of zonisamide. Caution should be exercised for immune based adverse reactions associated with zonisamide due to the presence of the sulphonamide group. Cases of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide. Consideration must be given to discontinue zonisamide and appropriate measures to be implemented to reduce intraocular pressure. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. There have been reports of renal stone formation risk and related symptoms like flank pain, renal colic, or renal pain, particularly in people who are predisposed to nephrolithiasis. Consideration must be given to the possibility of metabolic acidosis brought on by zonisamide. Consider lowering the dosage or stopping zonisamide (by gradually stopping or lowering a therapeutic dose) if metabolic acidosis appears and lasts because osteopenia may result. Given the possibility of an interaction, zonisamide should be used cautiously in adult patients receiving treatment concurrently with carbonic anhydrase inhibitors like topiramate or acetazolamide. Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients. If the child is not treated this can lead to brain damage and death. Patients receiving treatment concurrently with carbonic anhydrase inhibitors such as topiramate or acetazolamide should use zonisamide with caution due to the potential risk of heat-related disorders. Discontinuation of zonisamide be considered If pancreatitis is evident, in the absence of another obvious cause. Caution should be exercised with rhabdomyolysis, and zonisamide discontinuation should be considered if required. Effective contraception must be used by women who are of childbearing age both during and for one month following zonisamide treatment. Women who are capable of becoming pregnant should seek professional advice about the potential effects of zonisamide on the fetus. Before beginning treatment, the patient should be informed of these risks and their relative importance to the benefits. Caution should be exercised with weight loss, potentially more serious in children and cognition.
Any warning from the MC, CHM CSM or MHRA: No.
Black Triangle notice: N/A.
Legal Category: POM.
List of very common, common and serious reported adverse reactions (refer to the SPC for full details): Ecchymosis, hypersensitivity, anorexia, agitation, irritability, confusional state, depression, affect lability, anxiety, insomnia, psychotic disorder, ataxia, dizziness, memory impairment, somnolence, bradyphrenia, disturbance in attention, nystagmus, paraesthesia, speech disorder, tremor, diplopia, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, rash, pruritus, alopecia, nephrolithiasis, fatigue, influenza-like illness, pyrexia, oedema peripheral, decreased bicarbonate, weight decreased, decreased appetite, mood swings, vomiting, blood creatinine phosphokinase increased, alanine aminotransferase increased, pneumonia, agranulocytosis, aplastic anaemia, metabolic acidosis, grand mal seizure, neuroleptic malignant syndrome, pancreatitis, liver toxicity, cholecystitis, Stevens Johnson syndrome, toxic epidermal necrolysis, rhabdomyolysis, renal failure and aspartate aminotransferase increased.
Pack Size and NHS Price: 150 mL-20mg/ml- £109.14.
Marketing Authorisation Number: PL 00427/0257.
Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
Date of Preparation: Oct-2024