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Sulfacetamide and Prednisolone (Sulfacetamide Sodium / Prednisolone Sodium Phosphate Ophthalmic) - Summary

 
 



SUMMARY

Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is a sterile topical ophthalmic solution combining an antibacterial and a corticosteroid. Each mL Contains: Actives: sulfacetamide sodium (as the monohydrate) 100 mg, prednisolone sodium phosphate 2.5 mg (equivalent to prednisolone phosphate 2.3 mg). Preservative: thimerosal 0.1 mg. Inactives: edetate disodium, poloxamer 407, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. pH range is 6.5 to 7.5.

Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where a superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular antibacterial drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

The product does not provide adequate coverage against: Neisseria species, Pseudomonas species, Serratia marcescens.

A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.


See all Sulfacetamide and Prednisolone indications & dosage >>

NEWS HIGHLIGHTS

Clinical Trials Related to Sulfacetamide and Prednisolone (Sulfacetamide / Prednisolone Ophthalmic)

Effects of Brain Stimulation on Learning and Reasoning [Completed]
Imaging studies of the brain have revealed the different areas involved in the processes of learning and reasoning. However, the specific role these regions play in these processes, or if stimulating these areas can improve these processes is unknown. Researchers would like to use repetitive transcranial stimulation (rTMS) to better understand the roles of individual brain regions on the processes of learning and reasoning. Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp, and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses. The purpose of this study is to use rTMS to help determine the roles of different brain regions in the development of implicit learning of motor sequences and analogic reasoning. In addition, researchers hope to evaluate if stimulation of these regions speeds up the process of learning or analogic reasoning.

SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture. [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of risedronate sodium (Actonel®) after a wrist fracture in postmenopausal women.

Efficacy and Safety of Dihydroartemisinin/Piperaquine (Artekin®) for the Treatment of Uncomplicated Malaria in Peru [Completed]
In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P. falciparum malaria in the Amazonian Region, and has proved its efficacy against multi-resistant P. falciparum parasites, but several side effects have been reported. Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT, increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out, between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and 260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32. 0 hours and 35. 5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of patients whose cleared parasitaemia were 67. 2% in the DHA-PPQ group, and 58. 1% in the MAS3 group (RR 1. 25, [95% CI 1. 03−1. 52], p = 0. 017). All patients were able to clear parasites within 72 hours after the first dose. The mean time for fever clearance was 28. 0 and 29. 5 hours in DHA-PPQ and MAS3 group respectively. (P= 0. 69). Twenty-four hours after the first dose, 85. 5% and 83. 1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively (p>0. 05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97. 7% and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0. 99, 95% CI [0. 86−1. 13], P = 0. 88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group, according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3 group, two Late Treatment Failures was reported. The frequency of adverse events was significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.

DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú.

BURULICO Drug Trial Study Protocol: RCT SR8/SR4+CR4, GHANA [Active, not recruiting]
The standard for treatment Buruli ulcer disease (BUD) used to be surgery but the WHO now advises streptomycin (S, 15 mg/kg daily, intramuscularly) and rifampicin (R,10 mg/kg daily) along with surgery. This preliminary advice was based on observations in 21 patients with pre-ulcerative lesions of BUD, who were given daily SR treatment for varying periods of time. In patients treated with SR for at least 4 weeks, M. ulcerans could no longer be cultured from excised lesions. SR has been introduced without a formal evaluation or comparison with other treatments have been conducted or published, but the impression is that this treatment is beneficial and may cure BUD without additional surgical management.

This study protocol evaluates the hypothesis that early, limited lesions of BUD(pre-ulcerative or ulcerated lesions, ≤ 10 cm maximum diameter), can be healed without recurrence using antimycobacterial drug therapy, without the need for debridement surgery.

In endemic regions in Ghana, patients will be actively recruited and followed if ≥ 5 years of age, and with early (i. e., onset < 6 months) BUD.

- consent by patients and / or care givers / legal representatives

- clinical evaluation, and by

- analysis of three 0. 3 cm punch biopsies under local anaesthesia.

- disease confirmation: dry reagent-based polymerase chain reaction (DRB-PCR IS2404)

- randomization: either SR for 8 weeks, or 4 weeks of SR followed by R and clarithromycin

(C)

- stratification: ulcerative or pre-ulcerative lesions.

Biopsies will be processed for histopathology, DRB-PCR-, microscopy, culture, genomic, and sensitivity tests. Lesions will be assessed regularly for progression or healing during treatment. Drug toxicity monitoring includes blood cell counts, liver enzymes and renal tests; and ECG and audiographic tests.

Primary endpoint: healing without recurrence at 12 months follow-up after start of treatment Secondary endpoint: reduction in lesion surface area and/or clinically assessed improvement on completion of treatment, averting the need for debridement surgery.

Recurrences will be biopsied for confirmation, using PCR, histopathology, and culture. Sample size: 200 patients, with 2x74 evaluable patients to be randomized; 80% power to detect a difference of 20 % in recurrence-free cure 12 months after start of treatment between the two groups (60 versus 80%). A Data Safety and Monitoring Board will make interim analyses.

Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury [Recruiting]
We hypothesize that bone mineral content is diminished in children aged 4-18 following burn injury. This is based on data in burned children in other regional hospitals as well as findings in our own population of marginal growth delay following burn injury. Our objectives are two-fold. The first goal is to establish that diminished bone mineral density is a long-term problem among children admitted to this regional burn hospital as compared to healthy children in the region. This is important particularly since bone health may be region specific, or may even relate to modes of care that vary from hospital to hospital during the acute and convalescent phases of injury. There is no data on bone mineral density in burned children in regions outside of the Southwestern portion of the USA. Also, comparisons to healthy children living in this region using the same scanning machine are needed.

The second purpose of this study is to test the effects of calcium and vitamin D supplementation in burned children on bone accrual in burned children. In this 2-year study, children aged 4-18 who have been previously burned will take either a calcium supplement with vitamin D or a placebo for one year. We will evaluate patients every 6 months for 2 years (patients will be measured 6 months and 1 year after the 1 year treatment to find out if the supplement group maintained any increase in bone formation that occurred during the 1-year treatment.

more trials >>


Page last updated: 2008-07-28

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