Neomycin Sulphate/ Polymyxin B Sulphate/ Nystatin

Registered South African indications:

• Local treatment of vaginitis due to sensitive pathogens and treatment of non-specific vaginitis

Registered South African contraindications

• Hypersensitivity to neomycin, nystatin, polymyxin B sulphate, or any other components of this combination product 
• Allergy to peanut or soya, due to the presence of soybean oil in this combination product
• Use of a diaphragm and latex condoms with this combination product

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Hepatic impairment
• Elderly

Renal impairment

• Potential for systemic effects due to resorption of neomycin and polymyxin B by vaginal mucosa, especially in renal failure

Allergic reactions

• In case of local intolerance or allergic reaction, treatment must be interrupted

Antibiotic sensitisation

• Sensitisation to antibiotics by local route may affect later systemic use of the same or related antibiotics
• Limit treatment duration to mitigate risk of selecting resistant bacteria

Contains soybean oil

• Contains soybean oil and may cause hypersensitivity reactions (urticaria, anaphylactic shock)

Effects on ability to drive and use machines

• Not relevant

Forms avail. in SA and covered in this monograph: pvc

South African registered indications and dosages

Local treatment of vaginitis due to sensitive pathogens and treatment of non-specific vaginitis

Neomycin Sulphate/ Polymyxin B Sulphate/ Nystatin
35000/35000/100000 (iu)

• Vaginal (pvc): 1 cap, inserted deeply into the vagina in the evening (best achieved when lying back with legs slightly drawn up, preferably at night); Treatment duration: 12 days

Not to be taken orally

Do not stop the treatment during menstruation periods

Treatment should be associated with hygiene recommendations (wear cotton underwear, avoid vaginal douches, avoiding using an internal tampon during the treatment) and elimination of contributing factors, as much as possible

Treating the partner must be discussed on a case-by-case basis

Not established for use

South African recommendations

Pregnancy

• Caution; not recommended
• Due to the presence of an aminoglycoside, neomycin, which can cause an ototoxic risk, and the possibility of its systemic absorption, the use of this medicinal product is not recommended during pregnancy. Safety and/or efficacy has not been established

Breastfeeding

• Caution; not recommended
• Due to the digestive immaturity of the newborn and the pharmacokinetic properties of this medicinal product, its prescription is not recommended during lactation

Fertility

• No information available

South African recommendations

• Caution
  Due to the possible resorption of neomycin and polymyxin B by the vaginal mucosa, the risk of systemic effects, especially in the event of renal failure cannot be excluded

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

Immune System Disorders

• Local or systemic hypersensitivity reactions
• Allergic skin reaction
• Allergic oedema
• Contact allergic eczema (more frequent with long term use and may spread far from the treated areas)

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Pruritus
• Angioedema

Reproductive System and Breast Disorder

• Vulvovaginal pruritus
• Vulvovaginal burning sensation
• Vulvovaginal irritation

• Latex contraceptives (condoms and diaphragms)
• Spermicidal local contraception

None routine

Neomycin 
Neomycin is an aminoglycoside antibiotic. Neomycin is a bactericidal antibiotic that interferes with protein synthesis in susceptible microorganisms. Neomycin is a broad spectrum antibiotic. Gram-negative bacteria that are highly sensitive are E. Coli, Enterobacter aerogenes, Klebsiella pneumonia and Proteus vulgaris. Gram-positive microorganisms that are inhibited include S. Aureus and E.faecalis. M. Tuberculosis also is sensitive to Neomycin. Strains of P.euroginosa are resistant to neomycin.

Spectrum of activity: Aerobic Gram-positive bacteria such as Staphylococcus meti-S, Corynebacterium, Listeria monocytogenes. Aerobic Gram-negative bacteria such as Acinetobacter baumanii, Branhamella catarrhalis, Campylobacter, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Salmonella, Serratia, Shigella, Yersinia, and Pasteurella

Polymyxin B Sulphate
Polymyxin B is a polypeptide antibiotic. Polymyxins interact strongly with phospholipids and disrupt the structure of bacterial cell membranes. The permeability of the bacterial membrane changes immediately on contact with the drug. Sensitivity to polymyxin B apparently is related to the phospholipid content of the cell wall-membrane complex. The cell wall of certain resistant bacteria may prevent access of the drug to the cell membrane. Polymyxin B binds to the lipid A portion of endotoxin (the lipopolysaccharide of the outer membrane of gram-negative bacteria) and inactivates this molecule. The antimicrobial activities of Polymyxin B are restricted to gram-negative bacteria, including E. Coli, Klebsiella, Salmonella, Pasteurella, Bordetella and Shigella, which usually are sensitive to concentration of 0.05 to 2µg/ml. Most strains of P. Aeruginosa are inhibited by less than 8µg/ml in vitro. Proteus spp. are intrinsically resistant.

Spectrum of activity: Aerobic Gram-negative bacteria such as Acinetobacter, Aeromonas, Alcaligenes, Citrobacter freundii, Citrobacter koseri, Enterobacter, Escherichia coli, Klebsiella, Moraxella, Pseudomonas aeruginosa, Salmonella, Shigella, and Stenotrophomonas maltophilia.

Nystatin
Nystatin is a polyene antibiotic with antifungal (anticandida) activity. The mechanism of action of nystatin and other polyenes is based on the formation of insoluble complexes with the sterols of the cell membrane (ergosterol in fungi and cholesterol in mammals) which causes changes in the permeability that causes K and P efflux and alteration of the proton flux leading to cell death.

Spectrum of activity: Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeast and yeast like fungi, including Aspergillus fumigans, Candida albicans, Coccidiodes immitis, Cryptococcus neoformans and Histoplasma.

Neomycin/ Polymyxin B sulphate/ Nystatin

 Vaginal Capsule 35000 IU/35000 IU/100000 IU

• Polygynax (Bliss)