Sodium Sulfacetamide - Plus (Ovace)

Trade Name : OVACE

Mission Pharmacal Company

LIQUID

Strength 100 mg/mL

SULFACETAMIDE SODIUM Sulfonamide Antibacterial [EPC],Sulfonamides [CS]

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Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sodium Sulfacetamide - Plus (Ovace) which is also known as OVACE and Manufactured by Mission Pharmacal Company. It is available in strength of 100 mg/mL per ml. Read more

Sodium Sulfacetamide - Plus (Ovace) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: citric acid, disodium EDTA, fragrance, methylparaben, PEG-150 pentaerythrityl tetrastearate (and) aqua (and) PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, propylene glycol, propylparaben, purified water, sodium chloride, and sodium laureth sulfate (and) cocamide DEA (and) cocamidopropyl betaine (and) glycol stearate.
  • Sodium sulfacetamide is a sulfonamide with antibacterial activity. Sodium sulfacetamide is Cn Hn Nn NaOn Su00b7Hn O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:n
  • Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
  • Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.
  • The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
  • This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
  • This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.
  • Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.n n n
  • FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
  • General:
  • Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.
  • Information for Patients:
  • Drug Interactions:
  • Carcinogenesis, Mutagenesis and Impairment of Fertility:
  • Pregnancy:n- Category C.
  • Nursing Mothers:
  • Pediatric Use:
  • Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
  • The oral LDn of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately.n
  • Manifestations:
  • Seborrheic dermatitis including seborrhea sicca -
  • Secondary cutaneous bacterial infections -
  • Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F), excursions permitted between 15u00b0C and 30u00b0C (between 59u00b0F and 86u00b0F). Brief exposure to temperatures up to 40u00b0C (104u00b0F) may be tolerated provided the mean kinetic temperature does not exceed 25u00b0C (77u00b0F); however, such exposure should be minimized.
  • NOTICE:
  • Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.
  • This product is supplied in the following size(s):n n16 fl. oz. (473 mL) bottles, n 0178-0630-16n
  • To report
  • Manufactured for:n nMISSION PHARMACAL COMPANYn nSan Antonio, TX 78230 1355n
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