COMPOSITION
Each gram of NEBACETIN contains:
- 5 mg of neomycin sulphate (equivalent to 2.244 IU of neomycin base),
- 250 UI of bacitracin.
PHARMACOLOGY
NEBACETIN is a combination between antibiotics-neomycin and bacitracin. Research and mechanism show that bacteria cells attacked/destroyed with 2 ways, bacitracin delaying the biosynthesis of cell's wall and neomycin destroy genetic code and synthesis sequel of protein and germ. Hence, NEBACETIN works synergistically.
Practical, NEBACETIN is not absorbed by skin neither mucous, so far topical use it is acceptable in high dose. Using NEBACETIN in high dose at the ulcer can prevent growth of resistant bacteria. Mechanism of NEBACETIN antibiotic can not be block by blood plasma, pus neither necrotic tissue.
Basically, NEBACETIN indicated for all local skin and ucus infection.
INDICATIONS
Nebacetin Powder:
Superficial bacterial infection of the skin, such as impetigo, varicose ulcers, pressures sores, tropic ulcers and burn.
DOSAGE AND ADMINISTRATION
Nebacetin Powder:
- Administration and dosage adults:
Before use, the area for application should be cleaned gently. Debris such as pus or crusts should be removed from the affected area. A thin film of the ointment / a light dusting of the powder should be applied to the affected area up to three times/day depending on the clinical condition. Treatment should not be continued for more 7 days without medical supervision.
The adults dose is suitable for use in older children, however in infants dosage should be reduced. A possibility of increased absorption exists in very young children, thus ointment/powder is not recommended for use in neonatus.
- Dosage in renal impairment:
Dosage should be reduced in patients with reduced renal function.
WARNINGS AND PRECAUTIONS
- Caution should be exercised so that the recommended dosage is not exceeded.
- Following significant systemic absorption, amynoglycoside such as neomycin can cause irreversible ototoxicity (and exacerbate existing partial nerve deafness); both neomycin sulphate and bacitracin have nephrotoxic potential.
- After a treatment course, administration should not be repeated for at least three months.
- In neonatus and infants, absorption by immature skin may be enhanced and renal function may be immature.
- In renal impairment the plasma clearance of neomycin is reduced, this is associated with an increased risk of ototoxicity, therefore, a reduction in dose should be made that relates to the degree of renal impairment.
- As with other antibacterial preparations, prolonged use may result in overgrowth by non-suspectable organism including fungi.
- Concurrent administration of other amynoglycosides is not recommended.
CONTRAINDICATIONS
- In patients who have demonstrated allergic hypersensitivity to the product or any of its constituents, or to cross-sensitising substances such as framycetin, kanamycin, gentamycin and other related antibiotics.
- Patients with any degree of nerve deafness in circumstances in which significant systemic absorption could occur.
ADVERSE EFFECTS
- The incidence of allergic hypersensitivity to neomycin sulphate in the general poopulation is low. However, there is an increased incidence of sensitivity to neomycin in certain selected groups of patients in dermatological practice particularly those with venous stasis eczema and ulceration.
- Allergic hypersensitivity to neomycin following topical application may manifest it self as a reddening and scaling of the effected skin, as an eczematous exacerbation of the lesion, or as a failure of the lesion to heal.
- Allergic hypersensitivity following application of bacitracin has been reported but is rare.
- Anaphylactic reactions following the topical administration of bacitracin have been reported but are rare.
DRUG INTERACTIONS
Following significant systemic absorption, neomycin sulphate can intensify and prolong the respiratory depressant effect of neuromuscular blocking agent.
PRESENTATION
NEBACETIN Powder
Bottle of 5 g
Registration No. DKL2140407324A1
ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER
Store below 30॰C
Manufactured by:
PT. Pharos Indonesia
Jakarta - Indonesia
For: PRIMA MEDIKA LABORATORIES, Tangerang - Indonesia
