Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: Pharma Dynamics (Pty) Ltd, 1<sup>st</sup> Floor, Grapevine House, Steenberg Office Park, Silverwood Close, Westlake, Cape Town, 7945, South Africa
TEXAMER is indicated for the relief of symptoms associated with the following allergic conditions:
Safety and efficacy have not been demonstrated beyond six weeks.
The daily recommended dose is one 5 mg tablet.
The dosing intervals must be individualised according to renal function. Use the table below to adjust the dosage intervals as indicated.
The patient’s creatinine clearance (CLcr) can be estimated from the serum creatinine determination using the modified formula of Cockroft and Gault:
CLcr (ml/min) = (140 – age in years) x weight in kg / Serum creatinine (µmol/l)
x (0,85 for women)
Dosage in patients with renal impairment:
| Renal status | Creatinine clearance (CLcr) | Dose |
|---|---|---|
| Normal | ≥80 ml/min | 5 mg once daily |
| Mild impairment | 50-79 ml/min | 5 mg once daily |
| Moderate impairment | 30 to 49 ml/min | 5 mg every second day |
| Severe impairment | <30 ml/min | 5 mg every third day |
| End stage renal disease/ receiving dialysis | <10 ml/min | Contraindicated |
No dosage adjustment is needed in patients with hepatic impairment.
In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Adults with renal impairment above).
Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (refer to Patients with renal impairment above).
Children 6–12 years:
The recommended daily dose is 5 mg once daily.
Children 2–6 years: TEXAMER film-coated tablets should not be used in children aged 2 – 6 years, as no adjusted dosage is possible with the film-coated tablet formulation (see section 4.3 and 4.4).
Children aged less than 2 years:
TEXAMER film-coated tablets is contraindicated in children aged less than 2 years (see section 4.3 and 4.4).
In paediatric patients suffering from renal impairment:
The dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his/her body weight. There are no specific data for children with renal impairment.
Intermittent allergic rhinitis (symptoms <4 days/week or during less than 4 weeks) has to be treated according to the disease and its history; therapy can be halted upon disappearance of symptoms and restarted again when symptoms reappear. In case of persistent allergic rhinitis (symptoms >4 days/week or during more than 4 weeks), continuous therapy can be proposed to the patient during the period of exposure to allergens. Clinical experience is currently available for a 6-month treatment period.
The film-coated tablet must be taken orally, swallowed with liquid and may be taken with or without food. It is recommended to take the daily dose in one single intake.
Doctors should advise patients who forget to take TEXAMER to take a dose as soon as possible and then continue with the normal dose. Patients should not take a double dose to compensate for the missed dose.
Symptoms of overdose may include drowsiness in adults.
Overdosage in children may produce agitation and restlessness followed by drowsiness.
There is no known specific antidote to TEXAMER. Should overdose occur, symptomatic and supportive treatment is recommended. Levocetirizine is not effectively removed by haemodialysis.
3 years.
Store at or below 30°C.
Protect from moisture.
Keep blister strip in outer carton until required for use.
TEXAMER is packed into two different blister strips:
Not all pack sizes and pack types are marketed.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
