Source: Health Products Regulatory Authority (ZA) Revision Year: 2013 Publisher: LITHA PHARMA (PTY) LTD, 106 16th Road, Midrand, 1685, South Africa
ZELITREX is indicated for the treatment of herpes zoster (shingles). ZELITREX reduces the duration of zoster-associated pain, which includes acute and postherpetic neuralgia, thus accelerating resolution of pain. ZELITREX also reduces the proportion of patients with zoster-associated pain.
ZELITREX is indicated for the episodic treatment of recurrent genital herpes in immunocompetent adult patients.
ZELITREX is indicated for the prevention (suppression) of recurrent herpes simplex infection of the skin and mucous membrane of the ano-genital area.
ZELITREX is indicated for the prophylaxis of cytomegalovirus (CMV) infection, CMV disease and other herpes virus infections following organ transplantation, where a special risk exists.
For treatment of herpes zoster: 1000 mg of ZELITREX to be taken three times per day for seven days.
Recurrent genital herpes: The recommended dosage for the treatment of recurrent genital herpes is 500 mg twice daily for 5 days. Dosing should begin as early as possible. For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately the first signs or symptoms appear. There are no data on the effectiveness of ZELITREX when initiated more than 24 hours after the onset of signs and symptoms.
Immunocompetent patients: 500 mg to be taken once daily. Some patients with very frequent recurrences (e.g. 10 or more per year) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily).
Immunocompromised patients: 500 mg twice daily.
Adults and adolescents (from 12 years of age): 2000 mg to be taken four times a day. Dosing should be initiated as early as possible post-transplant. This dose should be reduced according to creatinine clearance (see Dosage in renal impairment). The duration of treatment will usually be 90 days, but may need to be extended in high risk patients.
No data are available.
The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see renal impairment below). Adequate hydration should be maintained.
Caution is advised when administering ZELITREX to patients with impaired renal function. Adequate hydration should be maintained.
The dose of ZELITREX should be modified as follows in patients with significantly impaired renal function:
| Therapeutic indication | Creatinine Clearance | ZELITREX Dose |
|---|---|---|
| Herpes zoster | 15-30 ml/min | 1000 mg twice a day |
| <15 ml/min | 1000 mg once a day | |
| Recurrent genital herpes | >15 ml/min | 500 mg twice daily |
| 0-15 ml/min | 500 mg once daily | |
| Prevention of recurrences Immunocompetent | 15-30 ml/min | No dosage adjustment |
| <15 ml/min | 250 mg once daily | |
| Immunocompromised | 15-30 ml/min | No dosage adjustment |
| <15 ml/min | 500 mg once daily |
In patients on haemodialysis the ZELITREX dose recommended for patients with a creatinine clearance of less than 15 ml/min should be used, but the dose should be administered after the haemodialysis has been performed.
The dosage of ZELITREX should be adjusted in patients with impaired renal function as shown in the table below:
| Creatinine Clearance | ZELITREX Dose |
|---|---|
| ≥75 ml/min | 2000 mg four times daily |
| 50 to <75 ml/min | 1500 mg four times daily |
| 25 to <50 ml/min | 1500 mg three times daily |
| 10 to <25 ml/min | 1500 mg twice daily |
| <10 ml/min or dialysis** | 1500 mg once daily |
** In patients on haemodialysis, the ZELITREX dosage should be administered after the haemodialysis has been performed.
The creatinine clearance should be monitored frequently, especially during periods when renal function is changing rapidly e.g. immediately after transplantation or engraftment. The ZELITREX dosage should be adjusted accordingly.
Dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained). Pharmacokinetic data in patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dosage adjustment; however, clinical experience is limited. For higher doses (4 g or more) see SIDE EFFECTS.
Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of ZELITREX. Nausea and vomiting may also occur. Caution is required to prevent inadvertent overdosing. Many of these reported cases involved renally impaired and elderly patients receiving repeated overdoses, due to lack of appropriate dosage reduction.
In the event of a symptomatic ZELITREX overdose occurring, acyclovir is removable by haemodialysis.
Keep out of reach of children.
Store at or below 30°C.
Protect from light. Keep dry.
ZELITREX 250: Blister pack of 60 tablets.
ZELITREX 500: Blister packs of 42 tablets.
Blister packs of 30 tablets.
Blister packs of 10 tablets.
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