Bleph 10

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Sulfacetamide sodium monohydrate 100 mg/mL
Available from:
Allergan New Zealand Ltd
INN (International Name):
Sulfacetamide sodium monohydrate 100 mg/mL
Dosage:
10 %
Pharmaceutical form:
Eye drops, solution
Composition:
Active: Sulfacetamide sodium monohydrate 100 mg/mL Excipient: Benzalkonium chloride Dibasic sodium phosphate heptahydrate Hydrochloric acid Monobasic sodium phosphate monohydrate Polysorbate 80 Polyvinyl alcohol Purified water Sodium edetate Sodium hydroxide Sodium thiosulfate pentahydrate
Units in package:
Bottle, dropper, 15 mL
Class:
Restricted
Prescription type:
Restricted
Manufactured by:
Katwijk Chemie BV
Product summary:
Package - Contents - Shelf Life: Bottle, dropper, - 15 mL - 18 months from date of manufacture stored at or below 25°C protect from light 4 weeks opened stored at or below 25°C protect from light
Authorization number:
TT50-0657
Authorization date:
1969-12-31

BLEPH-10 ® sulfacetamide sodium Datasheet Version 2.0

DATA SHEET

NAME OF MEDICINE

BLEPH ®

-10 EyeDrops

Sulfacetamide sodium 100mg/mL ophthalmic solution

PRESENTATION

Eyedrops: 10% with 1.4%polyvinyl alcohol(LIQUIFILM ®

), 0.005% benzalkonium chloride,

polysorbate80, sodium thiosulfate disodiumedetate, dibasicsodium phosphate anhydrous,

monobasicsodium phosphateheptahydrate, hydrochloricacidorsodium hydroxide to pH 7.4 and

purified water.

USES

Actions:Thesulfonamidesare bacteriostatic agentsand thespectrum of activity is similar for all.

Sulfonamides inhibit bacterial synthesisof dihydrofolicacid by preventingthe condensation of the

pteridine withaminobenzoicacid through competitiveinhibition of the enzyme dihydropteroate

synthetase.Resistantstrains have altered dihydropteroate synthetase with reduced affinity for

sulfonamidesor produce increased quantities of aminobenzoicacid.

Topically applied sulfonamides are consideredactiveagainst susceptible strains of the following

common bacterial eye pathogens:Escherichia coli, Staphylococcusaureus, Streptococcus

pneumoniae, Streptococcus(viridans group),Haemophilus influenzae,Klebsiellaspeciesand

Enterobacterspecies.

Topically applied sulfonamidesdo notprovideadequate coverageagainstNeisseriaspecies,

SerratiamarcescensandPseudomonas aeruginosa.A significantpercentageof staphylococcal

isolatesare completely resistant to sulfadrugs.

INDICATIONS

Treatment ofconjunctivitis, cornealulcer,and other superficialocularinfectionsfromsusceptible

micro-organisms and asanadjunct to systemicsulphonamide therapy of trachoma.

DOSAGE AND ADMINISTRATION

Conjunctivitis, corneal ulcer andsuperficial ocular infections:

One ortwodrops into lower conjunctival sac oftheaffected eye(s) every 2 or3 hoursduring the

day, less often at night.

Trachoma:2drops in the affected eye(s) every twohours: concomitant systemic sulphonamide

therapy is indicated.

CONTRAINDICATIONS

Hypersensitivity to sulphonamidepreparations. Contact lensesshould notbe worn inthe

presence of ocularinfection or throughout treatment with BLEPH ® -10 eye drops.

BLEPH-10 ® sulfacetamide sodium Datasheet Version 2.0

WARNINGS AND PRECAUTIONS

The solutions are incompatible with silver preparations. Non-susceptableorganisms,including

fungi, may proliferate withthe use ofthis preparation. Sulfonamidesare inactivated bythe

aminobenzoicacidpresentin purulent exudates.

Instructionsto Patient:Note.If significant improvement of symptoms hasnot been achieved

after 2 to 3 days of treatment, please consult your physician.

Pregnancy:Sulfonamides may causekernicterusin babiesduring the firstmonth of life by

displacing bilirubin from plasmaalbumin. Sulfonamidesshould beavoided when possible inthe

last month ofpregnancy.

Nursing Mothers:Systemically administered sulfonamidesare capable of producing kernicterus

in infantsof lactatingwomen. Because of the potential for thedevelopment of kernicterus in

neonates, a decision should be madewhether todiscontinue nursing or discontinue the drug,

taking into account the importance of thedrug to themother.

Use inChildren:Safety andeffectivenessinchildrenbelowtheageoftwomonthshavenotbeen

established.

ADVERSEEFFECTS

Local Effects:Themost common adversereactions areconjunctival irritation, burning,and

stinging. While the irritation may be transient, occasionally useof the medicationhas to be

discontinued.

Although sensitivity reactions to sulfacetamide sodiumare rare, an isolated incident of Stevens-

Johnson syndromewas reported in a patientwhohad experienced a previous blisteringdrug

reaction to an orally administered sulphonamide,and a single instance oflocal hypersensitivity

was reportedwhich progressed to a fatal syndrome resembling systemic lupus erythmatosus.

OVERDOSAGE

Flush excessmedication from the skin with water ornormalsaline.

PHARMACEUTICAL PRECAUTIONS

Dropper bottles (15 mL). Protect fromlight and excessive heat.

Do not use if solutionis discoloured dark brown.

Store below25 o

C.

MEDICINECLASSIFICATION

RestrictedMedicine.

PACKAGEQUANTITIES

Eye Drops, 10%, 15mL.

BLEPH-10 ® sulfacetamide sodium Datasheet Version 2.0

FURTHER INFORMATION

BLEPH ® -10 eye drops contains sulfacetamide sodium, polyvinyl alcohol (LIQUIFILM ® ),

polysorbate80, sodium thiosulfate, disodiumedetate, dibasicsodium phosphate anhydrous,

monobasicsodium phosphate heptahydrate and benzalkoniumchlorideasa preservative. The pH

is maintainedat 6.8to 7.5. Sulfacetamide sodiumis N-Sulfanilylacetamidemonosodiumsalt

monohydrate.Sulfacetamide sodium is soluble 1 in2.5 of water; sparingly soluble in alcohol;

practically insoluble inchloroformand ether.

NAME AND ADDRESS

AllerganNew Zealand Limited.

Cornerof Manu TapuDrive and

JosephHammond Place

Auckland International Airport Mangere

AUCKLAND

Toll free telephone: 0800 659 912

DATE OF PREPERATION

14 August, 2008

® RegisteredTrademark ofAllergan Inc.

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