Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets)

1. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) © The Swiss Pharmacy

2. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) are used for the treatment of various herpes virus infections. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and Cold sores (caused by herpes labialis). Valacyclovir is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, this medication is used to reduce the number of future episodes. © The Swiss Pharmacy

3. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Valcivir Tablets are manufactured by Cipla Limited, India in the strengths of 500 mg and 1000 mg. © The Swiss Pharmacy

4. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) The active ingredient contained in Valcivir tablets is Valacyclovir Hydrochloride. Each film-coated Valcivir tablet contains Valacyclovir Hydrochloride equivalent to 500 mg or 1000 mg of Valacyclovir. © The Swiss Pharmacy

6. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Uses of Valcivir 500 mg and 1000 mg Tablets: Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) belong to a group of medicines called antivirals. They are used for the treatment of genital herpes, shingles (herpes zoster), ophthalmic zoster (shingles affecting the eye region) and cold sores (herpes labialis). It is also used to treat chickenpox and cold sores in children. Valacyclovir is also used to prevent cytomegalovirus (CMV) infection and disease following solid organ transplantation. CMV is another type of herpes virus that can cause symptoms similar to glandular fever (high temperature, sore throat and swollen glands). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

7. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Uses of Valcivir 500 mg and 1000 mg Tablets: Valcivir tablets work by stopping the multiplication of the virus which causes herpes, shingles and cold sores. It can reduce the length and severity of an outbreak and duration of pain, and shorten the healing time of crusts, associated with herpes, shingles and cold sores. In your body, Valacyclovir becomes the anti-herpes medicine, Acyclovir. Although Valacyclovir will not cure shingles or genital herpes, it does help relieve the pain and discomfort and helps the sores heal faster. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

8. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Recommended Adult Dosage Valcivir Tablets may be given with or without food. The dose of Valcivir Tablets Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) for various indications in adult patients is given below: Cold Sores (Herpes Labialis): Cold Sores (Herpes Labialis): The recommended dosage of Valacyclovir for the treatment of cold sores is 2 gm twice daily for 1 day, taken about 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching, or burning). Genital Herpes Initial Episodes: Genital Herpes Initial Episodes: The recommended dosage of Valacyclovir for treatment of initial genital herpes is 1 gm twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

9. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Recommended Adult Dosage The dose of Valcivir Tablets for various indications in adult patients is given below: Genital Herpes Recurrent Episodes: Genital Herpes Recurrent Episodes: The recommended dosage of Valacyclovir for the treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode. Genital Herpes Suppressive Therapy: Genital Herpes Suppressive Therapy: The recommended dosage of Valacyclovir for chronic suppressive therapy of recurrent genital herpes is 1 gm once daily in patients with normal immune function. In patients with a history of nine or fewer recurrences per year, an alternative dose is 500 mg once daily. In HIV-infected patients with CD4+ cell count greater than 100 cells/mm3, the recommended dosage of Valacyclovir for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

10. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Recommended Adult Dosage The dose of Valcivir Tablets for various indications in adult patients is given below: Reduction of Transmission: Reduction of Transmission: The recommended dosage of Valacyclovir for reduction of the transmission of genital herpes in patients with a history of nine or fewer recurrences per year is 500 mg once daily for the source partner. Herpes Zoster: Herpes Zoster: The recommended dosage of Valacyclovir for the treatment of herpes zoster is 1 gm orally, three times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of the herpes zoster rash. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

11. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Recommended Adult Dosage Cold Sores (Herpes Labialis): Cold Sores (Herpes Labialis): The recommended dosage of Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) for the treatment of cold sores in patients, 12 years of age and older, is 2 gm twice daily for 1 day, taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g. tingling, itching or burning). Chickenpox: Chickenpox: The recommended dosage of Valacyclovir for treatment of chickenpox in immunocompetent patients aged 2 to below 18 years is 20 mg/kg, administered three times daily for 5 days. The total dose should not exceed 1 gm three times daily. Treatment should be started at the earliest sign or symptom. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

12. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Contraindications ➔Valcivir Tablets are contraindicated in patients with a known hypersensitivity to Valacyclovir Hydrochloride, Acyclovir, or any component of the tablet. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

13. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Storage Instructions Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

14. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Warnings Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of Valacyclovir tablets (Valcivir tablets) in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher than recommended doses of Valcivir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

15. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Warnings Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in elderly patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher than recommended doses of Valcivir tablets for their level of renal function. Use with caution in elderly patients and reduce dosage in patients with renal impairment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

16. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Possible Side Effects The serious side effects reported with Valacyclovir Hydrochloride (Valcivir tablets) are as follows: TTP/HUS, acute renal failure and central nervous system effects. The most common side effects reported in at least one indication by greater than 10% of adult patients treated with Valacyclovir and observed more frequently with Valacyclovir compared to placebo are headache, nausea, and abdominal pain. The only side effect reported in greater than 10% of paediatric patients aged less than 18 years was headache. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

17. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Valcivir Tablets Overdosage Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased consciousness and coma, have been reported in patients receiving overdoses of Valacyclovir Hydrochloride (Valcivir tablets). Nausea and vomiting may also occur. Caution is required to prevent inadvertent overdosing. Many of the reported cases involved renally impaired and elderly patients receiving repeated overdoses, due to lack of appropriate dosage reduction. Patients should be observed closely for signs of toxicity. Haemodialysis significantly enhances the removal of Acyclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

18. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Valcivir Tablets During Pregnancy Valacyclovir Hydrochloride (Valcivir tablets) has been classified by the US FDA as Pregnancy Category B. There are no adequate and well-controlled studies of Valacyclovir or Acyclovir in pregnant women. Based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to Acyclovir in-utero appears similar to the rate for infants in the general population. Valcivir tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies performed at oral doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, respectively, revealed no evidence of teratogenicity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy

19. Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) Valcivir Tablets Valcivir Tablets (Generic Valacyclovir Hydrochloride Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9618_Valacyclovir-Tablets.html © The Swiss Pharmacy