Prevention of Diazepam-Induced Thrombophlebitis With Cremophor as a Solvent

Mattila, Marco; Ruoppi, M.K.; Korhonen, Miika; Larni, HM; Valtonen, L.; Heikkinen, Helena

doi:10.1093/bja/51.9.891

Cited by 17 publications

(3 citation statements)

References 12 publications

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“…Incidences of thrombophlebitis have also been reported with other injections containing PG. Manila and his colleagues observed venous thrombosis following the use of diazepam containing PG 10 . Schou et al, studied the incidence of local reactions in hand and wrist veins following IV administration of diazepam in various solvents, including PG and lipid emulsion.…”

Section: Discussionmentioning

confidence: 99%

Untitled

2013

IJPSR

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Aim: To evaluate safety and efficacy of diclofenac 75 mg/1ml (Dynapar AQ) administered as IV bolus versus diclofenac 75mg/3ml administered as IV infusion in patients with postoperative pain. Methods: 350 postoperative adult patients were randomized to receive either treatment. Primary efficacy endpoints were time to onset of analgesia and postoperative pain intensity while secondary efficacy endpoints included degree of pain relief and global assessment by patient and investigator. The safety endpoints were pain intensity and grade of thrombophlebitis at injection site. Safety and efficacy endpoints were evaluated over 12 hour study period. Results: Both study drugs were safe and effective throughout study period. However, IV bolus route of Dynapar AQ produced significantly faster onset of analgesia, better improvement in postoperative pain intensity and pain relief upto 1 hour, lesser thrombophlebitis and lesser pain at administration site upto 8 hours. Also, global assessment by patient and investigator was significantly favorable towards Dynapar AQ. Conclusions: IV bolus route of Dynapar AQ is better alternative to IV infusion of diclofenac 75mg/3ml with rapid onset of analgesia and better tolerability at injection site.

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Section: Discussionmentioning

confidence: 99%

Untitled

2013

IJPSR

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“…Rapid intravenous administration of products containing propylene glycol has been associated with the development of hypotension and arrhythmias – a further reason why intravenous preparations of propylene glycol‐containing agents, especially phenytoin and digoxin, should be administered slowly. Products using propylene glycol as a vehicle are also liable to cause significant thrombophlebitis, which in some studies has had an incidence as high as 60% [7], often with serious consequences [8]. Such findings have led manufacturers to reformulate propylene glycol‐containing products such as diazepam into injections containing less irritant additives.…”

Section: Solventsmentioning

confidence: 99%

Pharmaceutics for the anaesthetist

Macpherson

2001

Anaesthesia

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Pharmaceutics is that branch of science concerned with the manufacture and formulation of pharmaceutical products, and is a subject almost exclusively in the domain of pharmacists and those concerned with pharmaceutical manufacture. However, there are some aspects of pharmaceutics that are of particular importance to the anaesthetist, such as the pharmacology of the various preservatives, antimicrobials and other additives found in anaesthetic products, and an understanding of basic processes such as emulsification and lyophylisation. This review aims to survey those areas.

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“…182,183 The high concentration of propylene glycol contained in certain drug products, such as phenytoin, diazepam, digoxin, and etomidate, may induce thrombophlebitis when administered intravenously. 184,185 In one study, 22% of patients experienced venous reactions to etomidate in propylene glycol, with no reactions to etomidate lipid emulsion.…”

Section: Propylene Glycolmentioning

confidence: 99%

“Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review)

1997

Pediatrics

141

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ABSTRACT. Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement 1 recommending that the Food and Drug Administration mandate labeling of over-thecounter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.ABBREVIATIONS. FDA, Food and Drug Administration; MDIs, metered-dose inhalers Pharmaceutical products often contain agents that have a variety of purposes, including improvement of the appearance, bioavailability, stability, and palatability of the product. Excipients (substances added to confer a suitable consistency or form to a drug, such as the vehicle, preservatives, or stabilizers) frequently make up the majority of the mass or volume of oral and parenteral drug products. These pharmaceutical adjuvants are usually considered to be inert and do not add to or affect the intended action of the therapeutically active ingredients.Some 773 chemical agents have been approved by the Food and Drug Administration (FDA) for use as inactive ingredients in drug products.2 Inasmuch as these compounds are classified as "inactive," no regulatory statutes require listing on product labeling. Pharmacopeial guidelines, enforceable under the Food, Drug, and Cosmetic Act, do require labeling of inactive ingredients for topical, ophthalmic, and parenteral preparations; orally administered products are currently exempt. Because of pressure from professional and consumer organizations asking the FDA to require complete disclosure of all ingredients, voluntary labeling was adopted by the two major pharmaceutical industry trade associations. These voluntary guidelines contain an exemption for "trade secret" components and do not require complete disclosure of all fragrance and flavoring ingredients.Current problems encountered with "inactive" ingredients include benzalkonium chloride-induced bronchospasm from antiasthmatic drugs, aspartameinduced headache and seizures, saccharin-induced cross-sensitivity reactions in children with sulfonamide allergy, benzyl alcohol toxicity in neonates receiving high-dose continuous infusion with preserved medications, dye-related cross-reactions in children with aspirin intolerance, lactose-induced diarrhea, and propylene glycol-induced hyperosmolality and lactic acidosis. Although many other excipients have been implicated in causing adverse reactions, these are the most significant in the pediatric population. ANTIASTHMATIC MEDICATIONSIt is readily appreciated that some percentage of asthmatic children will develop a "paradoxical" bronchospasm after they inhale their medication. Because many of these reactions were attributed to sulfite, which had been highly publicized ...

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Prevention of Diazepam-Induced Thrombophlebitis With Cremophor as a Solvent

Cited by 17 publications

References 12 publications

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Pharmaceutics for the anaesthetist

“Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review)

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