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SANDOZ POLYTRIMETHOPRIM is a brand name for Trimethoprim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
The most frequent adverse reaction to Sandoz Polytrimethoprim is local irritation consisting of transient burning or stinging, itching or increased redness upon instillation. These reactions occur in less than 4 of 100 patients treated.
Sandoz Polytrimethoprim has a low incidence of hypersensitivity reactions (less than 2 of 100 patients treated) consisting of lid edema, itching, increased redness, tearing and/or circumocular rash. SYMPTOMS AND TREATMENT OF OVERDOSAGE Poisoning is unlikely to occur from the ingestion of Sandoz Polytrimethoprim.
If poisoning does occur, remove the agent from the stomach by lavage and/or emesis. If renal function is normal, force fluids orally or parenterally to promote excretion. In extreme overdosage in patients with impaired renal function, consideration should be given to dialysis as a means of both eliminating the drug from the blood and in reducing the risk of uremia.
m. for 5 to 7 days) is an effective antidote for adverse effects in the hemopoietic system caused by trimethoprim.
DOSAGE AND ADMINISTRATION Adults:
In mild to moderate infections, instill 1 or 2 drops in the affected eye every 3 hours (maximum of 6 doses per day) for a period of 7-10 days. More severe infections may require instillation of 1 or 2 drops every hour until improvement is observed and then reduced to 1 or 2 drops every 3 hours.
Children:
Children over two months of age are treated in the same manner as adults. 36 Structural formula: Physicochemical properties: Trimethoprim sulfate is a white, odourless, crystalline powder with a melting range of 239 - 242°C. 05% (w/v) aqueous solution is between 4 and 5.
Sandoz Polytrimethoprim Page 6 of 9 Drug Substance - Polymyxin B Proper name:
Polymyxin B sulfate Chemical name: Polymyxin B sulfate Molecular formula and molecular mass: C56H98N16O13 / C55H96N16O13 1202 / 1188 Structural formula: DAB = α,y-diaminobutyric acid (all linked through the α-group except where shown); Leu = leucine; Phe = phenylalanine; Thr - threonine Solubility: Fully soluble in water (20 mg/mL) and slightly soluble in alcohol.
Physical Characteristics:
Polymyxin B sulfate is a white to buff coloured powder which may have a faint sour-like odour. Polymyxin is a generic term for antibiotics derived from the fermentations of various media by the strain of Bacillus polymyxa. 5. 004% Nonmedicinal ingredients: Sodium chloride, sodium hydroxide or sulfuric acid (to adjust pH) and purified water.
STABILITY AND STORAGE RECOMMENDATIONS Store at room temperature (15 - 30°C). Protect from light. AVAILABILITY OF DOSAGE FORMS Sandoz Polytrimethoprim is available in plastic DROP-TAINER™ dispensers of 10 mL. MICROBIOLOGY The in vitro spectrum of action of trimethoprim sulfate and polymyxin B sulfate encompasses most bacterial pathogens that cause external infections of the eye.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 Polymyxin B is proven bactericidal against Pseudomonas aeruginosa as well as other Gram-negative bacteria. 2- 6 PHARMACOLOGY When used topically, trimethoprim and polymyxin B are rarely sensitizing and absorption through intact skin and mucous membrane is insignificant.
Blood samples were obtained from eleven human volunteers at 20 minutes, one hour and three hours following instillation of two drops of a solution continuing 1 mg trimethoprim and 10 000 units of polymyxin B per mL. On the nine previous days, each patient received two drops of solution four times per day.
03 mg trimethoprim per mL of serum and 1 unit polymyxin B per mL of serum. Sandoz Polytrimethoprim Page 8 of 9 TOXICOLOGY A study was undertaken to determine the effects of trimethoprim and polymyxin B (TP) on the eyes of normal human volunteers.
In a double-blind comparative study, TP eye drops were administered to one eye and a saline control preparation to the other in each of 20 healthy volunteers. Dosage administered was one drop, four times daily for a period of ten days.
The eyes were examined on days 3,5,8 and 11. Volunteers were questioned regarding possible side effects at the time of their visits. 05) more stinging, gritty sensations and circumocular itching than the control drops. These three actions were always transient and almost invariably mild.
A transient and minimal degree of redness was occasionally observed (8 occasions in 6 volunteers) in TP treated eyes. The mean scores of the redness were not significantly different to those of the control preparation. A second study was done in normal human volunteers with TSP sterile ophthalmic solution.
TSP contained trimethoprim (1 mg/mL), sulfacetamide (5 mg/mL) and polymyxin B (10 000 units/mL). The study was conducted in a double-blind, placebo-controlled fashion with each volunteer receiving TSP and vehicle into separate eyes.
The dosage was two drops into each eye, four times a day for ten days. Ophthalmic evaluations were conducted before and after each instillation of the drops. Forty-eight completed the study. Conjunctival erythema was observed after instillation of active drug with a frequency of 65%.
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