Andolex - References for Content and Products

^#Cetylpyridinium chloride is active against certain types of bacteria and viruses

^& > 99.9 % reduction in viable bacteria after 30 seconds exposure in vitro.
^% The inhibitory effect on plaque formation lasts up to 14 hours in vitro.
*Certain mouth and gum infections

References

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1. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
2. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.
3. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
4. Kolliyavar B, Shettar L, Thakur S. Chlorhexidine: The Gold Standard Mouth Wash. J Pharm Biomed Sci. 2016;06(02):106-109.
5. IMS Total Private Market Value MAT, January 2024.
6. Impact Rx, January 2024.
7. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.
8. Quane PA, Graham GG, Ziegler JB. Pharmacology of benzydamine. Inflammopharmacology. 1998;6(2):95-107. doi: 10.1007/s10787-998-0026-0.
9. Valerio C, Di Loreto G, Salvatori E, Cattaneo A. Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial. Medicine (Baltimore). 2023;102(13):e33367. doi: 10.1097/MD.0000000000033367.
10. Farrer F. Review article: Sprays and lozenges for throat infections. S Afr Pharm J. 2012;54(2):120-122.
11. 10. Valerio C, Di Loreto G, Salvatori E, Cattaneo A. Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial. Medicine (Baltimore). 2023;102(13):e33367. doi: 10.1097/MD.0000000000033367.

SORE THROAT

1. Worrall G. Acute sore throat. Can Fam Physician. 2011;57(7):791-794.
2. Mayo Clinic Staff. Sore Throat. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/sore-throat/symptoms-causes/syc-20351635 [Cited December 2022].
3. Centers for Disease Control and Prevention. Sore Throat. [Online, reviewed 6 October 2021]. Available at: https://www.cdc.gov/antibiotic-use/sore-throat.html [Cited December 2022].
4. Van der Velden AW, Sessa A, Altiner A, Pignatari ACC, Shephard A. Patients with Sore Throat: A Survey of Self-Management and Healthcare-Seeking Behavior in 13 Countries Worldwide. Pragmat Obs Res. 2020 Sep 10;11:91-102. doi: 10.2147/POR.S255872.
5. Claasen, J. The Sore Throat. Continuing Medical Education, Vol 30, No 9 (2012)
6. Linder JA, Stafford RS. Antibiotic treatment of adults with sore throat by community primary care physicians: a national survey, 1989-1999. JAMA. 2001;286(10):1181-6. doi: 10.1001/jama.286.10.1181.
7. Stead W. Patient education: Sore throat in adults (Beyond the Basics). In: UpToDate, Aaronson MD (Ed), Bond S. Accessed 14 December 2022.
8. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.
9. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
10. Kolliyavar B, Shettar L, Thakur S. Chlorhexidine: The Gold Standard Mouth Wash. J Pharm Biomed Sci. 2016;06(02):106-109.
11. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
12. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.

SORE MOUTH

1. Cleveland Clinic. Mouth Sore. [Online 30 October 2021]. Available at: https://my.clevelandclinic.org/health/diseases/21754-mouth-sore [Cited December 2022].
2. Seymour T. Everything you need to know about stomatitis [Online 9 June 2017]. Available at: https://www.medicalnewstoday.com/articles/317839 [Cited December 2022].
3. Quane PA, Graham GG, Ziegler JB. Pharmacology of benzydamine. Inflammopharmacology. 1998;6(2):95-107. doi: 10.1007/s10787-998-0026-0.
4. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.
5. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
6. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.

HEALTHY MOUTH

1. Glick M, Monteiro da Silva O, Seeberger GK, Xu T, Pucca G, Williams DM, et al. . FDI Vision 2020: shaping the future of oral health. Int Dent J. 2012;62(6):278-91. doi: 10.1111/idj.12009.
2. Centers for Disease Control and Prevention. Oral Health Fast Facts. Available at: https://www.cdc.gov/oralhealth/fast-facts/index.html [Cited December 2022].
3. South African Government. National Oral Health Month. September 2022. Available at: https://www.gov.za/NationalOralHealthMonth2022 [Cited December 2022].
4. Cleveland Clinic. Oral Hygiene. [Online 12 May 2022].
5. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
6. Kolliyavar B, Shettar L, Thakur S. Chlorhexidine: The Gold Standard Mouth Wash. J Pharm Biomed Sci. 2016;06(02):106-109.
7. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
8. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.

DRY MOUTH

1. The Healthline Editorial Team, Nunez K. What to Know About Dry Mouth. [Updated 23 November 2021]. Available at: https://www.healthline.com/health/dry-mouth#takeaway [Cited December 2022].
2. Gurvits GE, Tan A. Burning mouth syndrome. World J Gastroenterol. 2013;19(5):665-72. doi: 10.3748/wjg.v19.i5.665.
3. Dodds MWJ, Roland S, Edgar M, Thornhill M. Saliva A review of its role in maintaining oral health and preventing dental disease. BDJ Team. 2015;2(1-8):15123. DOI: 10.1038/bdjteam.2015.123.
4. Southern Australian Dental Service. Information for people with dry mouth. Available at: https://www.sahealth.sa.gov.au/wps/wcm/connect/71b5e78040e84749993eddeeb39a63e9/RES-Dry-mouth-20401.pdf?MOD=AJPERES&CACHEID=ROOTWORKSPACE-71b5e78040e84749993eddeeb39a63e9-nwKH7R- [Cited December 2022].
5. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
6. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.

ANDOLEX ORAL SPRAY AND RINSE

1. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.
2. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.

ANDOLEX-C ORAL SPRAY AND RINSE

1. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.
2. Simard-Savoie S, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
3. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
4. Kolliyavar B, Shettar L, Thakur S. Chlorhexidine: The Gold Standard Mouth Wash. J Pharm Biomed Sci. 2016;06(02):106-109.

ANDOLEX-C ANTI-BACTERIAL MOUTHWASH

1. Kolliyavar B, Shettar L, Thakur S. Chlorhexidine: The Gold Standard Mouth Wash. J Pharm Biomed Sci. 2016;06(02):106-109.
2. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
3. Eden B. Prevention Strategies for Periodontal Diseases. Chapter 16:213-229.

ANDOLEX-C ORAL GEL

1. Quane PA, Graham GG, Ziegler JB. Pharmacology of benzydamine. Inflammopharmacology. 1998;6(2):95-107. doi: 10.1007/s10787-998-0026-0.
2. Turnbull RS. Benzydamine Hydrochloride (Tantum) in the management of oral inflammatory conditions. J Can Dent Assoc. 1995;61(2):127-34.

ANDOLEX-C LOZENGES

1. Wadesango L, Nxumalo N, Schellack N. An overview of throat lozenges and sprays in the management of pharyngitis at primary care level. S Afr Pharm J. 2019;86(2):17-20.
2. Steyer A , Maruši M, Kolenc M, Triglav T. A Throat Lozenge with Fixed Combination of Cetylpyridinium Chloride and Benzydamine Hydrochloride Has Direct Virucidal Effect on SARS-CoV-2. COVID. 2021;1:435–446. https://doi.org/10.3390/ covid1020037.
3. Almazan NA. Benzydamine HCl 0.15% for Oropharyngeal Diseases and Surgeries: A Review of Clinical Trials. Philippine Scientific J. 2009;42(1):38-42.

ANDOLEX THROAT LOLLIES

1. Farrer F. Review article: Sprays and lozenges for throat infections. S Afr Pharm J. 2012;54(2):120-122.
2. Data on File I.
3. Data on File II.

Andolex Throat Lollies Version Update IN4501/23

ANDOLEX SOOTHING LOZENGES

1. Sore throat. MayoClinic.org. [online, nd] [Cited December 2023]. Available at: https://www.mayoclinic.org/diseases-conditions/sore-throat/symptoms-causes/syc-20351635?p=1.
2. National Center for Biotechnology Information (2023). PubChem Compound Summary for CID 15684, 2,4-Dichlorobenzyl alcohol. [online] [Cited December 2023]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/2_4-Dichlorobenzyl-alcohol.

ANDOLEX ANALGESIC RANGE

1. Valerio C, Di Loreto G, Salvatori E, Cattaneo A. Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3% oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial. Medicine (Baltimore). 2023;102(13):e33367. doi: 10.1097/MD.0000000000033367.

Andolex Analgesic Version Update IN4655/24

Popup References

1. Sore throat. MayoClinic.org. [online, nd]. Available at: https://www.mayoclinic.org/diseases-conditions/sorethroat/ symptoms-causes/syc-20351635?p=1 [Cited December 2023].
2. Sore throat. MayoClinic.org. [online, nd]. Available at: https://www.mayoclinic.org/diseases-conditions/sore-throat/symptoms-causes/syc-20351635?p=1 [Cited October 2023].
3. Valerio C, Di Loreto G, Salvatori E, Cattaneo A. Comparative evaluation of rapidity of action of benzydamine hydrochloride 0.3 % oromucosal spray and benzydamine hydrochloride 3 mg lozenges in patients with acute sore throat: A phase IV randomized trial. Medicine (Baltimore). 2023;102(13):e33367. doi: 10.1097/MD.0000000000033367.

Digital References

1. Simard-Savoie, Forest D. Topical anaesthetic activity of benzydamine. Current Therapeutic Research. 1978;23(6):734-745.
2. IMS/TPM, data on file
3. Kumar SB. Chlorhexidine Mouthwash- A Review. J. Pharm. Sci. & Res. 2017; 9(9):1450-1452.
4. Wadesango L, Nxumalo N, Schellack N. An overview of throat lozenges and sprays in the management of pharyngitis at primary care level. S Afr Pharm J. 2019;86(2):17-20.
5. Steyer A , Maruši M, Kolenc M, Triglav T. A Throat Lozenge with Fixed Combination of Cetylpyridinium Chloride and Benzydamine Hydrochloride Has Direct Virucidal Effect on SARS-CoV-2. COVID. 2021;1:435–446. https://doi.org/10.3390/ covid1020037.
6. Difflam forte anti-inflammatory throat spray, product information September 2005
24. Impact Rx data on file

Scheduling status: S1 Proprietary name (and dosage form): ANDOLEX^®-C Oral Rinse. Composition: Each 15 ml contains: Benzydamine HCI 22.5 mg, Chlorhexidine gluconate 18 mg, Alcohol 9 % v/v. Indications: For the relief of minor infections and painful inflammatory conditions of the mouth and throat. Chlorhexidine in Andolex^®-C Oral Rinse helps to reduce the development of plaque. Registration number: 31/16.4/0143. Scheduling status: S1 Proprietary name (and dosage form): ANDOLEX^® Solution. Composition: Each 15 ml contains Benzydamine HCI 22.5 mg. Preservative: Methyl hydroxybenzoate 0.1 % m/v. Contains alcohol 10 % v/v. Dentistry: For use after dental operations. Registration number: Z/16/40. Scheduling status: S1 Proprietary name (and dosage form): ANDOLEX^®-C ORAL GEL. Composition: Benzydamine HCI 10 mg/g, Cetylpyridinium Chloride 1 mg/g. Indications: Temporarily relieves painful inflamed conditions of the mouth, including mouth and denture ulcers and sore gums. Registration number: 33/16.4/0285. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^®-C LOZENGES ORANGE. Composition: Each lozenge contains: Benzydamine HCI 3.00 mg, Cetylpyridinium chloride 1.33 mg. Registration number: 36/16.4/0195. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^®-C LOZENGES. Composition: Each lozenge contains: Benzydamine HCl 3.00 mg. Cetylpyridinium chloride 1.33 mg. Registration number: 31/16.4/0042. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^®-C LOZENGES HONEY/LEMON. Composition: Each lozenge contains: Benzydamine HCI 3.00 mg, Cetylpyridinium chloride 1.33 mg. Registration number: 35/16.4/0320. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^®-C LOZENGES STRAWBERRY. Composition: Each lozenge contains: Benzydamine HCl 3.00 mg. Cetylpyridinium chloride 1.33 mg. Registration number: 33/16.4/0374. Classification: Medical Device. Composition: Andolex^® Wildberry Pastilles. Each 1g pastille contains Ectoin^® 10 mg, (sugar) sorbitol 100 mg, maltitol 422 mg, (sweetener) acesulfame K 1 mg. Scheduling status: S0 Proprietary name and dosage form: ANDOLEX^® THROAT LOLLIES. Composition: Each Throat Lolly contains: Cetylpyridinium chloride 3 mg. Reference number: H1541 (Act 101/1965). Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^® BLACKCURRANT LOZENGES. Composition: Each lozenge contains: 2,4 Dichlorobenzyl Alcohol 1,2 mg; Amylmetacresol 0,6 mg. Contains sugar. Registration number: 50/16.4/2300. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^® HONEY LEMON LOZENGES. Composition: Each lozenge contains: 2,4 Dichlorobenzyl Alcohol 1,2 mg; Amylmetacresol 0,6 mg. Contains sugar. Registration number: 50/16.4/2330. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^® LEMON LOZENGES. Composition: Each lozenge contains: 2,4 Dichlorobenzyl Alcohol 1,2 mg; Amylmetacresol 0,6 mg. Contains sugar. Registration number: 50/16.4/2315. Scheduling status: S0 Proprietary name (and dosage form): ANDOLEX^® ORANGE LOZENGES. Composition: Each lozenge contains: 2,4 Dichlorobenzyl Alcohol 1,2 mg; Amylmetacresol 0,6 mg. Contains sugar. Registration number: 50/16.4/2310. Scheduling status: S1 Proprietary name (and dosage form): ANDOLEX^® ANALGESIC LOZENGES. Composition: Each lozenge contains: Benzydamine hydrochloride 3,00 mg. Registration number: 31/16/0239. Scheduling status: S1 Proprietary name (and dosage form): (and dosage form): ANDOLEX^® ANALGESIC SPRAY. Composition: Each lozenge contains: Benzydamine hydrochloride 45 mg/15 ml. Registration number: 51/16.5/0924

For full prescribing information, refer to the Professional Information as approved by the SAHPRA (South African Health Products Regulatory Authority) or the Instructions For Use available at www.inovapharma.co.za. Further information is avaliable on request from inovapharma. Name and business address of applicant: iNova Pharmaceuticals (Pty) Limited. Co. Reg. No. 1952/001640/07, 15E Riley Road, Bedfordview. Tel. No. 011 087 0000. www.inovapharma.co.za