Source: Web Search Revision Year: 2021 Publisher: Merck Sharp & Dohme (Israel-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170, Israel
ATC Code: D07CC01
Diprogenta combines the antibacterial action of gentamicin (an aminoglycoside antibiotic) with the anti-inflammatory, antipruritic and vasoconstrictive properties of betamethasone dipropionate (a highly potent, class III corticosteroid).
Gentamicin interferes with the growth of sensitive bacteria by inhibiting protein synthesis. Its action against pathogenic, Gram-negative and Gram-positive bacteria is bactericidal, and is based on the ability of the antibiotic to bind to bacterial 30S ribosomal subunits.
In the table below, bacteria are categorised according to their susceptibility to gentamicin:
| Bacteria | In vitro (µg/mL) | ||
|---|---|---|---|
| MIC50 | MIC90 | Sensitivity % | |
| Staphylococcus (Coagulase-negative) | 50 | 100 | 18 |
| Enterobacter sp. | 0.4 | 0.8 | 100 |
| Serratia | 0.8 | 3.12 | 100 |
| Klebsiella sp. | 0.8 | 3.12 | 95 |
| Proteus mirabilis | 3.12 | 6.25 | 70 |
| Escherichia coli | 0.8 | 3.12 | 94 |
| Pseudomonas aeruginosa | 0.8 | 12.5 | 79 |
| Staphylococcus | 0.2 | 25 | 78 |
| Proteus (indole-positive) | 1.56 | 100 | 71 |
The following bacteria are usually resistant to aminoglycosides: meningococci, Streptococcus pneumoniae, most types of streptococci (notably Group D), Mycoplasma sp., Chlamydia sp. and anaerobes such as Bacteroides sp. and Clostridium sp.
Inflamed skin diseases due to secondary bacterial infections can be treated with Diprogenta, bringing relief from subjective complaints such as pruritus.
The ointment is particularly suitable for use on dry and chapped skin.
The cream is a cooling, non-oily, water-permeable oil-in-water emulsion, which is indicated for acute and weeping stages of disease.
No penetration or absorption studies have been performed on this galenic formulation. Under normal circumstances, only a fraction of the locally applied amount of corticosteroid is systemically available. Penetration and permeation rates depend on the body site, skin condition, the galenic formulation being used, patient age and method of application.
Gentamicin absorption need hardly be considered when used on intact skin. However, increased percutaneous absorption should be taken into account in cases of keratin layer loss, inflammation and occlusive/ extensive application. When used topically, absorption may be greater with the cream formulation when compared with the ointment.
Corticosteroid studies using animal models have shown that bethamethasone is toxic to reproduction (cleft palate, skeletal malformations).
In reproduction toxicity studies on rats, prolonged gestation, prolonged labour and dystocia were recorded. Furthermore, a reduction in offspring survival was observed, as well as decreased body weight and a reduction in weight gain. There was no evidence of impaired fertility.
Mutagenicity and carcinogenicity have not been studied.
Toxicity studies on animals and humans have not yielded any evidence of skin irritation, following local application of twice-daily gentamicin over three days at concentrations several times higher than those in formulations for therapeutic use.
Results from epicutaneous Draize patch tests (conducted on 100 patients) have demonstrated that gentamicin is not a primary skin irritant. Furthermore, gentamicin has a low skin sensitisation index.
Mutagenicity and carcinogenicity have not been studied.
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