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VALTREX is a brand name for Valacyclovir (also known as Valaciclovir). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Varicella zoster virus (VZV) infections – herpes zoster Valtrex is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4). Valtrex is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section…
Verbatim from this product's MHRA label. Tap a section to expand.
Patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster. There are no data on treatment started more than 72 hours after onset of the zoster rash. Immunocompetent Adults The dose in immunocompetent patients is 1000 mg three times daily for seven days (3000 mg total daily dose).
This dose should be reduced according to creatinine clearance (see Renal impairment below). Immunocompromised Adults The dose in immunocompromised patients is 1000 mg three times daily for at least seven days (3000 mg total daily dose) and for 2 days following crusting of lesions.
This dose should be reduced according to creatinine clearance (see Renal impairment below). In immunocompromised patients, antiviral treatment is suggested for patients presenting within one week of vesicle formation or at any time before full crusting of lesions.
Treatment of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years) Immunocompetent Adults and Adolescents (≥12 years) The dose is 500 mg of Valtrex to be taken twice daily (1000 mg total daily dose). This dose should be reduced according to creatinine clearance (see Renal impairment below).
For recurrent episodes, treatment should be for three to five days. For initial episodes, which can be more severe, treatment may have to be extended to ten days. Dosing should begin as early as possible. For recurrent episodes of herpes simplex, this should ideally be during the prodromal period or immediately upon appearance of the first signs or symptoms.
Valtrex can prevent lesion development when taken at the first signs and symptoms of an HSV recurrence. Herpes labialis For herpes labialis (cold sores), valaciclovir 2000 mg twice daily for one day is effective treatment in adults and adolescents.
The second dose should be taken about 12 h (no sooner than 6 h) after the first dose. This dose should be reduced according to creatinine clearance (see Renal impairment below). When using this dosing regimen, treatment should not exceed one day, since this has been shown not to provide additional clinical benefit.
g. tingling, itching or burning). Immunocompromised Adults For the treatment of HSV in immunocompromised adults, the dosage is 1000 mg twice daily for at least 5 days, following assessment of the severity of the clinical condition and immunological status of the patient.
The most common adverse reactions (ARs) reported in at least one indication by patients treated with Valtrex in clinical trials were headache and nausea. 4) are discussed in greater detail in other sections of the label. Undesirable effects are listed below by body system organ class and by frequency.
The following frequency categories are used for classification of adverse effects:
Very common ≥ 1/10, Common ≥1/100 to < 1/10, Uncommon ≥ 1/1,000 to < 1/100, Rare ≥ 1/10,000 to < 1/1000, Very rare Not known < 1/10,000 (Cannot be estimated from the available data) Clinical trial data have been used to assign frequency categories to ARs if, in the trials, there was evidence of an association with valaciclovir.
For ARs identified from post marketing experience, but not observed in clinical trials, the most conservative value of point estimate (“rule of three”) has been used to assign the AR frequency category. For ARs identified as associated with valaciclovir from post-marketing experience, and observed in clinical trials, study incidence has been used to assign the AR frequency category.
The clinical trial safety database is based on 5855 subjects exposed to valaciclovir in clinical trials covering multiple indications (treatment of herpes zoster, treatment/suppression of genital herpes & treatment of cold sores).
Clinical Trial Data Nervous system disorders Very common:
Headache Gastrointestinal disorders Common: Nausea Post Marketing Data Blood and lymphatic system disorders Uncommon: Leucopenia, thrombocytopenia Leucopenia is mainly reported in immunocompromised patients.
Immune system disorders Rare:
Anaphylaxis Psychiatric and nervous system disorders Common: Dizziness Uncommon: Confusion, hallucinations, decreased consciousness, tremor, agitation Rare: Ataxia, dysarthria, convulsions, encephalopathy, coma, psychotic symptoms, delirium.
4.
Table 1:
DOSAGE ADJUSTMENT FOR RENAL IMPAIRMENT Therapeutic Indication Creatinine Clearance (mL/min) Valaciclovir Dosage a Varicella-Zoster Virus (VZV) Infections Treatment of herpes zoster (shingles) in immunocompetent and immunocompromised adults ≥ 50 30 to 49 10 to 29 10 1000 mg three times daily 1000 mg twice daily 1000 mg once daily 500 mg once daily Herpes Simplex Virus (HSV) Infections Treatment of HSV infections - immunocompetent adults and adolescents ≥ 30 < 30 500 mg twice daily 500 mg once daily - immunocompromised adults ≥ 30 < 30 1000 mg twice daily 1000 mg once daily Treatment of herpes labialis (cold sores) in immunocompetent adults and adolescents (alternative 1-day regimen) ≥50 30 to 49 10 to 29 <10 2000mg twice in one day 1000 mg twice in one day 500 mg twice in one day 500 mg single dose Suppression of HSV infections - immunocompetent adults and adolescents ≥ 30 < 30 500 mg once daily b 250 mg once daily - immunocompromised adults ≥ 30 < 30 500 mg twice daily 500 mg once daily Cytomegalovirus (CMV) Infections CMV prophylaxis in solid organ transplant recipients in adults and adolescents ≥75 50 to <75 25 to <50 10 to <25 <10 or on dialysis 2000 mg four times daily 1500 mg four times daily 1500 mg three times daily 1500 mg twice daily 1500 mg once daily a For patients on intermittent haemodialysis, the dose should be given after dialysis on dialysis days.
bFor HSV suppression in immunocompetent subjects with a history of ≥10 recurrences/year, better results may be obtained with 250 mg twice daily. 1. 4 Special warnings and precautions for use Drug reaction with eosinophilia and systemic symptoms (DRESS) DRESS, which can be life-threatening or fatal, has been reported in associate with valaciclovir treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of DRESS appear, valaciclovir should be withdrawn immediately and an alternative treatment considered (as appropriate).
1. 1)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For initial episodes, which can be more severe, treatment may have to be extended to ten days. Dosing should begin as early as possible. This dose should be reduced according to creatinine clearance (see Renal impairment below). For maximum clinical benefit, the treatment should be started within 48 hours.
A strict monitoring of the evolution of lesions is advised. Suppression of recurrences of herpes simplex virus (HSV) infections in adults and adolescents (≥12 years) Immunocompetent Adults and Adolescents (≥12 years) The dose is 500 mg of Valtrex to be taken once daily.
Some patients with very frequent recurrences (≥ 10/year in absence of therapy) may gain additional benefit from the daily dose of 500 mg being taken as a divided dose (250 mg twice daily). Treatment should be re-evaluated after 6 to 12 months of therapy.
Immunocompromised Adults The dose is 500 mg of Valtrex twice daily. This dose should be reduced according to creatinine clearance (see Renal impairment below). Treatment should be re-evaluated after 6 to 12 months of therapy. Prophylaxis of cytomegalovirus (CMV) infection and disease in adults and adolescents (≥12 years) The dosage of Valtrex is 2000 mg four times a day, to be initiated as early as possible post-transplant.
This dose should be reduced according to creatinine clearance (see Renal impairment below). The duration of treatment will usually be 90 days, but may need to be extended in high-risk patients. Special populations Children The safety and efficacy of Valtrex in children below the age of 12 years has not been established.
Elderly The possibility of renal impairment in the elderly must be considered and the dose should be adjusted accordingly (see Renal impairment below). Adequate hydration should be maintained. Renal impairment Caution is advised when administering Valtrex to patients with impaired renal function.
Adequate hydration should be maintained. The dose of Valtrex should be reduced in patients with impaired renal function as shown in Table 1 below. In patients on intermittent haemodialysis, the Valtrex dose should be administered after the haemodialysis has been performed.
g. immediately after renal transplantation or engraftment. The Valtrex dosage should be adjusted accordingly. Hepatic impairment Studies with a 1000 mg dose of valaciclovir in adult patients show that dose modification is not required in patients with mild or moderate cirrhosis (hepatic synthetic function maintained).
Pharmacokinetic data in adult patients with advanced cirrhosis (impaired hepatic synthetic function and evidence of portal-systemic shunting) do not indicate the need for dose adjustment; however, clinical experience is limited. For higher doses (4000 mg or more per day), see section
Neurological disorders, sometimes severe, may be linked to encephalopathy and include confusion, agitation, convulsions, hallucinations, coma. 4). In organ transplant patients receiving high doses (8000 mg daily) of Valtrex for CMV prophylaxis, neurological reactions occurred more frequently compared with lower doses used for other indications.
g. bilirubin, liver enzymes). 4) Renal and urinary disorders Uncommon: Renal pain, haematuria (often associated with other renal events).
Rare:
Renal impairment, acute renal failure (especially in elderly patients or in patients with renal impairment receiving higher than the recommended doses).
Not known:
Tubulointerstitial nephritis. Renal pain may be associated with renal failure. Intratubular precipitation of aciclovir crystals in the kidney has also been reported. 4). Additional information on special populations There have been reports of renal insufficiency, microangiopathic haemolytic anaemia and thrombocytopenia (sometimes in combination) in severely immunocompromised adult patients, particularly those with advanced HIV disease, receiving high doses (8000 mg daily) of valaciclovir for prolonged periods in clinical trials.
These findings have also been observed in patients not treated with valaciclovir who have the same underlying or concurrent conditions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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If the patient has developed DRESS with the use of valaciclovir, treatment with valaciclovir must not be restarted in this patient at any time. Hydration status Care should be taken to ensure adequate fluid intake in patients who are at risk of dehydration, particularly the elderly.
2). Elderly patients are likely to have reduced renal function and therefore the need for dose reduction must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side-effects and should be closely monitored for evidence of these effects.
8). Use of higher doses of valaciclovir in hepatic impairment and liver transplantation There are no data available on the use of higher doses of valaciclovir (4000 mg or more per day) in patients with liver disease. Specific studies of valaciclovir have not been conducted in liver transplantation, and hence caution should be exercised when administering daily doses greater than 4000 mg to these patients.
Use for zoster treatment Clinical response should be closely monitored, particularly in immunocompromised patients. Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.
e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy. Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.
Transmission of genital herpes Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated. During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced.
However, the risk of transmission is still possible. Therefore, in addition to therapy with valaciclovir, it is recommended that patients use safer sex practices. Use in ocular HSV infections Clinical response should be closely monitored in these patients.
Consideration should be given to intravenous antiviral therapy when response to oral therapy is unlikely to be sufficient. g. donor CMV-positive/recipient CMV negative or use of anti- thymocyte globulin induction therapy) indicate that valaciclovir should only be used in these patients when safety concerns preclude the use of valganciclovir or ganciclovir.
8). 2).