INTRODUCTION

SETUVIR 5% contains Acyclovir which belongs to the group of medicines called antiviral agents. It is used for the topical treatment of cold sores and genital infections in adults and in adolescents aged above 12 years. Cold sores are viral infection caused by herpes simplex virus around the border of the lips. It is characterized by clustered, small, fluid-filled, painful blisters around the oral cavity. Genital herpes is a sexually transmitted viral infection caused by herpes simplex virus which is characterized by genital pain, sores, ulcers and scabs.

Acyclovir works by killing or stopping the growth and multiplication of virus that cause cold sores or genital herpes. Apply a thin layer of this medicine to the affected area 5 times daily. It should not be applied in the mouth, eyes or the vagina. If the affected area has still not healed even after treated for specified duration, stop using this medicine and contact your doctor.

This medicine may cause temporary burning or stinging sensation at application site or mild drying or flaking of skin. Consult your doctor if they bother you. SETUVIR 5% is considered safe for use during pregnancy and breastfeeding. However, consult your doctor before application. This medicine should not be used to treat cold sores in the mouth or if you have frequent episodes of cold sores (more than 4 times a year). It is strictly not recommended for use in children aged below 12 years. Consult your doctor before taking.

USES OF SETUVIR 5%

• Treats cold sores and genital infections topically

HOW SETUVIR 5% WORKS

Following topical application, acyclovir penetrates deeply within the skin and stops the growth and multiplication of virus particles that causes cold sores and genital infections in human cells. It gets incorporated into the viral DNA and competitively inhibits the viral DNA polymerase enzyme which stops lengthening of viral DNA strand, prevents further multiplication of new viral cells and clears up your infection.

DIRECTIONS FOR USE

Wash your hands before application. Apply a thin layer of this medicine to the affected area five times a day or as directed by your physician. Space each application with four hours interval (such as 7am, 11am, 3pm, 7pm and 11pm). It is for external use only. It should not be used in the mouth, eyes or the vagina. Wash your hands thoroughly after each application. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and type of infection. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF SETUVIR 5%

HOW TO MANAGE SIDE EFFECTS

Skin rash or redness:

Avoid hot showers because hot water can irritate the skin. Do not rub or scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use moisturizers to soothe and hydrate the affected area. If it does not get better, speak to a doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Tell your doctor about all the medicines you use, including non-prescription and prescription medicines, and herbal supplements.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store below 25°C
• Do not store in a refrigerator
• Do not use this medicine after 1 month since you first opened the tube

FAQs ABOUT SETUVIR 5%

Can SETUVIR 5% be used to treat genital herpes?

Yes. It is used for the topical treatment of cold sores and genital infections in adults and in adolescents aged above 12 years.

What should I do if I forgot to apply SETUVIR 5%?

If you forget to apply this medicine, simply apply it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not apply a double dose to make up for a missed dose.

How to use SETUVIR 5%?

Apply a thin layer of this medicine to the affected area five times a day or as directed by your physician. Space each application with four hours interval (such as 7am, 11am, 3pm, 7pm and 11pm). It is for external use only. It should not be used in the mouth, eyes or the vagina. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and type of infection. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

REFERENCES

1. KD. Tripathi. Antiviral Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 799-800.

2. Edward P. Acosta and Charles Flexner. Antiviral agents (non-retroviral). Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1594-1600.

3. Gerald G. Briggs and Roger K. Freeman. A. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 77-83.

4. GlaxoSmithKline. Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on August 2018] [Accessed 15th December 2020] https://clinicaltrials.gov/ct2/show/NCT00711776

5. Spotswood L. Spruance, Robert Nett, Thomas Marbury, Ray Wolff, James Johnson, Theodore Spaulding and The Acyclovir Cream Study Group. Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials. NCBI; PMC US National Library of Medicine, National Institute of Health. July 2002. [Accessed 15th December 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC127288/

6. Spotswood L Spruance , Robert Nett, Thomas Marbury, Ray Wolff, James Johnson, Theodore Spaulding. Acyclovir cream for treatment of herpes simplex labialis: results of two randomized, double-blind, vehicle-controlled, multicenter clinical trials. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised on July 2002] [Accessed 15th December 2020] https://pubmed.ncbi.nlm.nih.gov/12069980/

7. Glaxo Operations UK Limited. Electronic Medicines Compendium (EMC). [Revised on March 2020] [Accessed 15th December 2020] https://www.medicines.org.uk/emc/files/pil.5468.pdf

8. GlaxoSmithKline Mississauga. U.S. Food & Drug Administration. [Revised on April 2014] [Accessed 15th December 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021478s007lbl.pdf

9. Salutas Pharma GmbH and Rowa Pharmaceuticals Ltd. Health Products Regulatory Authority (HPRA). [Revised on June 2015] [Accessed 15th December 2020] https://www.hpra.ie/img/uploaded/swedocuments/2163616.PA0711_017_001.bf7379c0-78a4-4656-8481-a974954b0dca.000001Acic%20Cream%20PIL.150929.pdf

USEFUL DIAGNOSTIC TESTS

• Herpes Simplex Virus 1 DNA PCR
• Herpes Simplex Virus 1 IgG