Complete information including dosage, side effects, interactions and pregnancy & breast feeding warnings for patient and professional use
Overview and uses
Sulfacetamide sodium is used topically for ocular infections due to susceptible bacteria and Chlamydia, including ophtalmia neonatorum caused by Ch. oculogenitalis.
- For the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
- Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
Pharmacological classification: topical sulfonamide anti bacterial
Brand names: Bleph – 10
- Available as 10%, 20% and 30% eye drops and as 6% eye ointment.
Mechanism of action:
Sulfonamides inhibit the formation of bacterial folic acid by inhibiting folate synthase enzyme. Since sulfonamides are structurally similar to PABA, they inhibit the union of PABA with pteridine residue to form dihydropteroic acid which conjugates with glutamic acid to produce dihydrofolic acid. Also, being structurally similar to PABA, sulfonamides may get directly incorporated into the bacterial cell to form an altered folate which is metabolically injurious.
- For conjunctivitis and other superficial ocular infections
- Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.
- For trachoma
- Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.
Safety and effectiveness of Sulfacetamide sodium usage in infants less than 2 months of age is not established.
Side effects or adverse effects
Note that adverse effects that include systemic effects and hypersensitivity can occur irrespective of the route of administration.
- Hypersensitivity reaction including urticarial rash (most common), allergic myocarditis, arthralgia, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens – Johnson syndrome, urticaria, serum sickness, photo sensitization and generalized skin eruptions.
- Consult your doctor as soon as possible if you observe skin rash, red or purple colored skin rash, facial swelling, swelling of the tongue, hives on the skin, joint pain, a painful red area on the skin that spreads quickly, peeling of the skin without blistering, fever, shortness of breath during exercise at first and then at night time while lying down, abnormal heart beat, light headedness, sharp or stabbing chest pain and fatigue are some of the symptoms. This may require immediate medical attention and discontinuation of the therapy.
- For eye drops and eye ointments, symptoms of hypersensitivity are purulent discharge or aggravation of inflammation or pain.
- Gastrointestinal side effects include nausea, vomiting, abdominal pain, diarrhea, anorexia, pancreatitis and stomatitis.
- Ask your pharmacist to recommend a suitable medicine and consult your doctor.
- Occurrence of hepatitis and jaundice, though rare cannot be ruled out.
- Nausea, stomach pain, dark colored urine, yellowing of the skin and whites of the eye, light or clay colored stools, fever and unusual tiredness are some of the symptoms. Consult your doctor as soon as possible. This may require discontinuation of the treatment with sulfonamides.
- Aplastic anemia, hemolytic anemia, hypoprothrombinemia, leucopenia, purpura and agranulocytosis.
- Purple colored spots under skin, sudden fever, chills, sore throat, weakness in limbs, mouth ulcers, bleeding gums, easy bruising and prolonged bleeding are some of the symptoms of the above mentioned condition. Consult your doctor as soon as possible as some of the above mentioned conditions are serious and life threatening.
- Tremulousness, delirium and disorientation have been frequently reported
- Shaking of a body part or even full body, anxiety, fear, hallucinations, irritability, rapid and unpredictable mood swings, difficulty in reading, writing, recalling or speaking of words are some of the symptoms of the above mentioned condition. Consult your doctor as soon as possible.
- Occurrence of frank psychosis is rare.
- Ataxia, convulsions, hallucinations, headache, insomnia, mental depression, peripheral neuritis, tinnitus and vertigo have also been reported.
- Crystalluria, lupus periarteritis nodosa, toxic nephrosis with oliguria and anuria have also been reported.
- Occurrence of hypoglycemia has also been reported with Sulfonamides use.
- Kernicterus may be precipitated in new born, commonly observed with premature born babies.
- Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.
- Bacterial resistance to sulfonamides may also develop.
- The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.
- Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur
Pregnancy & breast feeding warnings
Pregnancy: Category C, which means animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
- Sulfonamides use is contraindicated in a mother nursing a G6PD deficient breast feeding infant.
- Sulfonamides use in mothers nursing a premature baby or a baby with jaundice should be avoided as safety profile for Sulfonamides use in such cases is not established.
- Sulfonamides can be used in a mother nursing a healthy and full term baby.
Drug – drug interactions
- Sulfacetamide preparations are not compatible with silver preparations.
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“Product information. Bleph – 10 (Sulfacetamide sodium ophthalmic solution 10%).” Allergan, Inc., Irvine, CA, USA.
Note: The sole purpose of every information shared on this article is to bring awareness. Do not use this information as a medical advice or prescription advice or as a tool for the treatment, diagnosis or prevention of the disease.