Stability and visual compatibility of bretylium tosylate with selected large-volume parenterals and additives. 1983

G P Perentesis, and G W Piltz, and H L Kirshcenbaum, and P Navalakha, and W Aronoff, and A J Cutie

The stability of bretylium tosylate when mixed with large-volume parenteral (LVP) solutions was assessed over a four-week period, and the compatibility of bretylium tosylate when mixed with eight frequently used drugs was evaluated. Bretylium tosylate admixtures of approximately 1 mg/ml were prepared in both polyvinyl chloride (PVC) bags and glass bottles of 5% dextrose injection, 0.9% sodium chloride injection, and lactated Ringer's injection. The admixtures were examined visually and stored for four weeks at 25 +/- 0.5 degree C under fluorescent light. The concentrations of bretylium tosylate were determined spectrophotometrically at times 0.25, 0.5, 1, 3, 8, 24, and 48 hours and twice weekly thereafter for four weeks. Spectrophotometric assays were confirmed with high-pressure liquid chromatography. Admixtures of bretylium tosylate were prepared with aminophylline, calcium gluconate, digoxin, regular insulin, lidocaine hydrochloride, phenytoin sodium, procainamide hydrochloride, and quinidine gluconate in 5% dextrose injection and 0.9% sodium chloride injection. The admixtures were examined visually for 48 hours. The concentration of bretylium tosylate did not change appreciably during the four-week study period. There were no signs of haze, precipitation, color change, or evolution of gas. There were no apparent differences in stability when comparing the glass with the PVC containers. Bretylium tosylate was also found to be compatible with all the additives tested except phenytoin sodium; a precipitate formed immediately when the latter drug was added to the bretylium tosylate solution. Bretylium tosylate was stable for four weeks in the LVP solutions studied in both glass and PVC containers. The admixtures of bretylium sodium with the other drugs were all visually compatible except those containing phenytoin sodium.

UI MeSH Term Description Entries
D007263 Infusions, Parenteral The administration of liquid medication, nutrient, or other fluid through some other route than the alimentary canal, usually over minutes or hours, either by gravity flow or often by infusion pumping. Intra-Abdominal Infusions,Intraperitoneal Infusions,Parenteral Infusions,Peritoneal Infusions,Infusion, Intra-Abdominal,Infusion, Intraperitoneal,Infusion, Parenteral,Infusion, Peritoneal,Infusions, Intra-Abdominal,Infusions, Intraperitoneal,Infusions, Peritoneal,Intra Abdominal Infusions,Intra-Abdominal Infusion,Intraperitoneal Infusion,Parenteral Infusion,Peritoneal Infusion
D011143 Polyvinyl Chloride A polyvinyl resin used extensively in the manufacture of plastics, including medical devices, tubing, and other packaging. It is also used as a rubber substitute. Chloroethylene Polymer,Polychloroethylene,Vinyl Chloride Polymer,Chloroethylene Homopolymer,Geon,PVC,Ultron,Viaflex,Vinylite,Chloride, Polyvinyl,Homopolymer, Chloroethylene,Polymer, Chloroethylene,Polymer, Vinyl Chloride
D001949 Bretylium Compounds Benzylammonium compounds with the formula Br-phenyl-CN+R3 that include BRETYLIUM TOSYLATE. Compounds, Bretylium
D001950 Bretylium Tosylate An agent that blocks the release of adrenergic transmitters and may have other actions. It was formerly used as an antihypertensive agent, but is now proposed as an anti-arrhythmic. Bretylate,Bretylium Tosilate,Bretylol,Ornid
D004344 Drug Incompatibility The quality of not being miscible with another given substance without a chemical change. One drug is not of suitable composition to be combined or mixed with another agent or substance. The incompatibility usually results in an undesirable reaction, including chemical alteration or destruction. (Dorland, 27th ed; Stedman, 25th ed) Drug Incompatibilities,Incompatibilities, Drug,Incompatibility, Drug
D004349 Drug Packaging Containers, packaging, and packaging materials for drugs and BIOLOGICAL PRODUCTS. These include those in ampule, capsule, tablet, solution or other forms. Packaging includes immediate-containers, secondary-containers, and cartons. In the United States, such packaging is controlled under the Federal Food, Drug, and Cosmetic Act which also stipulates requirements for tamper-resistance and child-resistance. Similar laws govern use elsewhere. (From Code of Federal Regulations, 21 CFR 1 Section 210, 1993) DRUG LABELING is also available. Drug Containers and Closures,Packaging, Drug,Drug Containers,Container, Drug,Containers, Drug,Drug Container,Drug Packagings,Packagings, Drug
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D005079 Excipients Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc. Excipient,Stabilizing Agent,Stabilizing Agents,Suspending Agent,Suspending Agents,Agent, Stabilizing,Agent, Suspending,Agents, Stabilizing,Agents, Suspending
D005898 Glass Hard, amorphous, brittle, inorganic, usually transparent, polymerous silicate of basic oxides, usually potassium or sodium. It is used in the form of hard sheets, vessels, tubing, fibers, ceramics, beads, etc.
D012996 Solutions The homogeneous mixtures formed by the mixing of a solid, liquid, or gaseous substance (solute) with a liquid (the solvent), from which the dissolved substances can be recovered by physical processes. (From Grant & Hackh's Chemical Dictionary, 5th ed) Solution

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