Benzyl alcohol in injections 5876, 17, 10, (2019). 9% with 1:100,000 epinephrine, lidocaine 1% with 1:100,000 epinephrine, and physiologic saline solution without benzyl alcohol as placebo in a randomized, double-blind fashion. One patient did not improve, one made a partial recovery, Jun 26, 2020 · Benzyl Alcohol USP 0. Data are unavailable on the toxicity of other preservatives in this age group. The Objective: To establish a GC method for the simultaneous determination of benzyl alcohol and benzaldehyde in compound norethisterone enanthate injection. The dermatitis was characterized by erythema, palpable edema, and raised borders. Nov 1, 2002 · Benzalkonium chloride, the most common ophthalmic product preservative system, is well known to adsorb onto various filter membrane surfaces. Oct 19, 2024 · Bacteriostatic Agents: May contain antimicrobial preservatives (e. Oct 1, 2004 · Anaphylactic reactions were reported for vitamin B12 injections containing benzyl alcohol [104, 105]. Jun 2, 2021 · benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. The amount of benzyl alcohol at which toxicity may occur is Benzyl alcohol is frequently used as an antimicrobial preservative or co-solvent in a variety of pharmaceutical injection formulations. DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. 9% to 2. Additionally, the use of spectroscopic techniques (circular Dec 1, 2007 · The most commonly used eight antimicrobial preservatives in licensed parenteral products at the present are listed in Table 1. objective. 9. The preservative benzyl alcohol may cause hypersensitivity reactions. Table 1 lists the chemical structure, typical in‐use concentration in parenteral formulations, antimicrobial Oct 24, 2023 · lidocaine containing benzyl alcohol. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Adverse reactions to vitamin B12 injections due to benzyl alcohol sensitivity: successful treatment with intranasal cyanocobalamin (PDF) Intranasal Cyanocobalamin for Benzyl Alcohol Sensitivity Academia. 88 Benzyl alcohol antimicrobial activity is reduced in the presence of nonionic surfactants, such as polysorbate 80, although this reduction is less than what is seen with hydroxylbenozoate esters Benzyl alcohol is a component of creams and ointments applied topically to relieve pain from cold (canker) sores or blisters in the mouth and gum irritations, and to treat head lice infestation (pediculosis). 47–49 Multiple studies have also reported that the duration of pain relief for patients receiving epidural dexamethasone injections can be shorter than with particulate steroids Benzyl alcohol can be used with parabens, potassium sorbate, BHT, EDTA, and benzyl benzoate. 17 It was hypothesized that precipitation of rhIFN‐γ is due to loosening of the protein tertiary structure which in turn pre‐disposes the protein to aggregate. 86% benzyl alcohol and piain 1% lidocaine for pain of injection and duration of anesthesia. We conducted a randomized, placebo-controlled, double-blinded comparison of intradermal 1% lidocaine with 0. Benzyl alcohol is Feb 15, 2019 · Benzyl alcohol is used to reduce pain in intravenous medications and other injections, cosmetics, head lice treatments, cold sores treatment, food enhancer, perfumes, photography development, and different types of ink and Sep 21, 2023 · 1 23 January 2014 2 EMA/CHMP/508188/2013 3 Committee for Human Medicinal Products (CHMP) 4 Questions and Answers on Benzyl alcohol in the context 5 of the revision of the guideline on ‘Excipients in the label 6 and package leaflet of medicinal products for human use’ 7 (CPMP/463/00) 8 . Benzyl alcohol Intravenous; powder, for injection solution 1. 3. 2004. 5–1. 2903/j. In the fifth month of pregnancy, the physician became aware of the exposure and changed to a dalteparin formulation without the preservative. 1111/j. In 2011, we have reported an incidence of 0. Fifteen of 39 patients (38%) in the benzyl alcohol group complained of pain on injection compared to 33 of 39 (84%) in the placebo group . Incompatibilities of Benzyl Alcohol. edu no longer supports Internet Explorer. This method has not proven to be extendable to benzyl alcohol containing injections because of active drug interferences. Benzyl alcohol is itself an effective anesthetic and can reduce the pain of injection for lidocaine without adversely affecting its anesthetic properties. As a result, the dose of benzyl alcohol given to each patient was 4. 6. Label it to indicate that the Injection is to be diluted with a suitable parenteral vehicle prior to administration. 47–49 Multiple studies have also reported that the duration of pain relief for patients receiving epidural dexamethasone injections can be shorter than with particulate steroids. Cetyl alcohol is commonly derived from coconut and palm oil. It can also be used as a solvent or cosolvent system for poorly soluble drugs. Benzyl alcohol (5%) in various formulations has been approved by USFDA for treatment of head lice. Industrial Applications: Benzyl alcohol is a topical or formulation component with minimal systemic absorption, so significant drug Dec 29, 2020 · benzaldehyde in benzyl alcohol to levels of 0. The amount of benzyl alcohol at which toxicity Benzyl Alcohol: Uses, Dosage, Side Effects, and More Benzyl alcohol is a versatile compound widely used in healthcare, cosmetics, and industrial applications. 1524-4725. In May 2001, 1 h after her second injection, she reported a sensation of substernal burning and Apr 21, 2009 · CONTAINS BENZYL ALCOHOL . 9% benzyl alcohol in 0. 0 mL was suggested for ATT in mice by some pharmacopoeias. The amount of benzyl alcohol at which 5 days ago · Introduction of Benzyl Alcohol in Multi-Dose Vials. 5 must be exercised not to exceed recommended doses in injections Jun 28, 2018 · alcohol. Although benzyl alcohol toxicity has been recognized, the concentration necessary for antibacterial action appears to be much lower than the concentration that would be dangerous to adults. 0% and NMT the equiva- applications): Dissolve 0. 8 nm and scaling factor = 1000. It is present in numerous pharmaceutical preparations. 6, 7 They are benzyl alcohol, chlorobutanol, m‐cresol, methylparaben, phenol, phenoxyethanol, propylparaben, and thimerosal. Available data do not support the safety of intrathecal injection of products preserved with parabens; rather, they demonstrate a need for further investigation. Although benzyl We review evidence regarding the use of 0. , benzyl alcohol) to inhibit bacterial growth. Benzyl alcohol (BA) is an aromatic alcohol used as a solvent in the production of fragrances/perfumes, paints and adhesives. Not For Intravenous Use . Of these, 4 developed neurotoxicity immediately; in the other 3 it did not develop for between 6 and 48 hours. A literature search was undertaken using search Jan 11, 2022 · We review evidence regarding the use of 0. Reduced risk of contamination during injections. 0 μm)was used with the injection port temperature of 200°C,and the split ratio of 10:1. Use: Suitable for multi-dose injections to maintain sterility during repeated use. 0073%, 0. 1632 Disinfectants and Preservatives 7. 575 %. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. Benzyl alcohol can be used with parabens, potassium sorbate, BHT, EDTA, and benzyl benzoate. BA has been widely used in human medicine as an antimicrobial preservative and as a local anesthetic and antipruritic. Pain on injection and degree of anesthesia at 5, 15, 30, and 45 minutes was assessed with a 10-cm graded Spectrophotometric methodology was used in order to determine benzyl alcohol in piroxicam injectable formulations by applying the fourth derivative method adopting the zero-crossing technique and results obtained show that the method has significant advantages over other reported methods and is appropriate for routine pharmaceutical analysis. 3 mg diluted in 6 mL, yielding a final concentration of 0. Neonates have reduced capacity to metabolize Abstract. 9% benzyl Adverse reactions to vitamin B12 injections due to benzyl alcohol sensitivity: successful treatment with intranasal cyanocobalamin Allergy. Benzyl alcohol IM-IV; solution, injection 2 %. Draft agreed by Excipients Drafting group Benzyl alcohol is a chemical compound with bacteriostatic and antiseptic properties, commonly used in various consumer products like foods, cosmetics, and perfumes. 15%, with quantification by GC5. Intravenous injection of 0. 9% sodium chloride solution for periocular injections (‘preserved saline’) including botulinum toxin A injections and local anaesthesia. Common adverse reactions, such as urticaria angioedema, asthma, and lung irritation, were Jan 11, 2022 · We review evidence regarding the use of 0. May 14, 2024 · Bacteriostatic Water: Sterile Water: Antimicrobial Agent: Bacteriostatic water contains a bacteriostatic agent, typically benzyl alcohol, which inhibits the growth of bacteria within the solution. 09% w/v Injection - Buy Benzyl Alcohol at best price of ₹ 130/kg by Parth Medical. It is also used as a solubilizer. 250 g of benzaldehyde and lent of 100. Use in medicinal products Benzyl alcohol is used as both an excipient (preservative, May 8, 2017 · Benzyl Alcohol contains NLT 98. The key criteria for antimicrobial preservative selection are the preservative's dose, antimicrobial functionality, and effect on the active ingredient. Benzyl alcohol (α-hydroxytoluene) is an aromatic alcohol used as an antimicrobial preservative at concentrations ranging from 0. Prior to these Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Benzyl alcohol is incompatible with methylcellulose and can be adsorbed by the rubber closures used in drug containers. A constant The anesthetic action of benzyl alcohol has also been investigated by physicians trying to minimize the pain of subcutaneous injection with recombinant human erythropoietin (epoetin alfa) in patients with renal disease. Federica Lodi, Maria Jose Frutos Fernandez, Re‐evaluation of benzyl alcohol (E 1519) as food additive, EFSA Journal, 10. 10 Twenty-eight hemodialysis patients received epoetin injections diluted with saline with and without benzyl alcohol. 1). May 10, 2015 · In the Name of Allah, the Most Gracious, the Most Merciful. Aug 1, 2006 · A series of fourth derivative spectra with varying concentrations of benzyl alcohol (b) (2-100 mg/mL) (a) Fourth derivative spectrum of piroxicam (20 mg mL -1 ), Dl = 0. Available in containers ≤30 mL. Affiliation 1 Division of Jul 26, 2018 · In earlier studies, benzyl alcohol was described as irritating to human skin (documentation “Benzylalkohol” 2006, available in German only). Turvey. Bacteriostatic Water for Injections contains benzyl alcohol (see section 2). tb03194. This key development ensures: Enhanced preservation of bacteriostatic water. S. It is a nonpyrogenic preparation of water that contains 0. In this work, spectrophotometric methodology was used in order to determine benzyl alcohol in piroxicam The benzyl alcohol group received bacteriostatic saline as a preinjection, and the lidocaine group received propofol containing lidocaine. : Absence of Antimicrobial Agents: Sterile water is devoid of any antimicrobial agents, making it vulnerable to bacterial contamination if exposed to air or contaminants. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric . 022%, 0. , 3. Methods: Nine New Zealand rabbits were injected with either a control or a test article at elevating concentrations. doi: 10. The infants received multiple injections of heparinized bacteriostatic sodium chloride for flushing indwelling catheters as well as various medications (antibiotics Mar 26, 2003 · The United States Pharmacopoeia limits the presence of benzaldehyde in benzyl alcohol to levels of 0. It serves as a preservative, solvent, and active ingredient in several medical and cosmetic products. It is available in three strengths: 20 mg/mL; 40 mg/mL; Multiple small injections into the area of the lesion should be made whenever possible. Benzyl alcohol is produced naturally from many plants and is commonly found in fruits. 53 mm,1. c) Sterile Water for Injection (SWFI) Aug 1, 2006 · Piroxicam is a drug with analgesic and anti‐inflammatory properties. It had occurred after the use of sodium tetradecyl sulfate, a sclerosing agent Adolescent patients with a history of mixed injections of penicillin and benzyl alcohol in the 1980–1990s were more common in China. 2 It is known that prolonged exposure of nerve fiber (either in isolation or in experimental animals) to benzyl alcohol results in generic brands of Na-diclofenac injections. 07% (0. 1994. An Agilent DB-WAX capillary column(30 m×0. There is a single case report of paralysis following inadvertent subarachnoid injection of 40mL of normal saline that contained 1. The introduction of benzyl alcohol as a preservative in multi-dose vials revolutionized the way healthcare professionals manage Nov 1, 2015 · Subcutaneous and intravenous injections were chosen to evaluate if the administration route plays a role in the induction of the observed effects of benzyl alcohol. You will not be sinful if you taste the lotion whilst eating food with your hands, nor will your wudu be Mar 4, 2025 · Benzyl alcohol is an aromatic alcohol with the formula C6H5CH2OH. 67,78 Aug 2, 2004 · Adverse reactions to vitamin B12 injections due to benzyl alcohol sensitivity: successful treatment with intranasal cyanocobalamin. 88 mg Sodium Chloride was added to adjust tonicity. x. 073%, 0. Common side effects of benzyl alcohol include itching (pruritus), redness (erythema), application site reactions, pain, irritation, reduced sensation (hypoesthesia), loss Sep 1, 2004 · A 16‐year‐old female was referred for assessment of possible anaphylactic reactions following vitamin B12 injections. solutions containing benzyl alcohol also generates benzaldehyde. Results Aug 23, 2007 · Benzyl alcohol or a combination of methylparaben and propylparaben are generally found in small molecule parenteral formulations. Although normal Benzyl alcohol produced an allergic contact dermatitis in a 46-year-old woman. Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. It is readily oxidized in vivo to benzoic acid, and conjugated with glycine to form hippuric acid. As-salāmu ‘alaykum wa-rahmatullāhi wa-barakātuh. The British Pharmacopoeia states that benzyl alcohol intended for use in the manufacture of parenteral dosage forms The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Among the currently available dexamethasone formulations (Table 1), some contain benzyl alcohol, a preservative with known neurotoxic effects in high concentrations. 733% benzyl alcohol. 9% benzyl alcohol added as a bacteriostatic preservative, allowing multiple-dose withdrawals from a semi-rigid vial without contamination. 9% sodium chloride solution for periocular injections (‘preserved saline’) including botulinum toxin A injections and local BENZYL ALCOHOL. The test article was benzyl alcohol calculated to give final injected concentrations of 0. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be The frequency of injections and necessary preparation steps before injection can significantly influence patients and benzyl alcohol are the most commonly used preservatives in multi-dose rhGH products. methods. WARNINGS Benzyl alcohol, a preservative in Bacteriostatic Water for Injection, USP has been associated with toxicity in neonates. Sep 21, 2023 · therapeutic agent, generates benzoic acid and benzyl alcohol after hydrolysis. Find key considerations for the selection and use of benzalkonium chloride, Feb 25, 2019 · of benzyl alcohol. 5% benzyl alcohol. Authors S E Turvey 1 , B Cronin, A D Arnold, F J Twarog, A F Dioun. In a review it is reported that 9 female subjects were exposed to subcutaneous injections of benzyl alcohol on their backs (3%, no other data) on 4 consecutive days. . Benzyl alcohol is a colorless liquid with a mild pleasant aromatic odor. Draft 9 . 0% in many multidose medication vials and parenteral 5 days ago · Introduction of Benzyl Alcohol in Multi-Dose Vials. 222%, and 0. efsa. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Turvey, S. Helps dissolve active ingredients in medications for injections or topical application. E. Several other gas6,7 and liquid8–10 chromatographic methods, as well as derivative However, instead of selecting a preservative-free methotrexate preparation, the 12-mg dose of methotrexate was taken from a 25-mg/mL injection solution that also contained 0. Finding bacteriostatic water from a trusted supplier is crucial for ensuring safety, sterility, and compliance with medical standards. Mar 7, 2025 · Among the currently available dexamethasone formulations , some contain benzyl alcohol, a preservative with known neurotoxic effects in high concentrations. 7 mg/mL). The main toxic oxidation product, benz-aldehyde, arises from the oxidation of benzyl alcohol upon long-term storage or heat sterilization of parenteral dosage forms containing benzyl alcohol, if oxygen is not ex- Purpose: To test the toxicity of intravitreal injections of benzyl alcohol. DESCRIPTION . 5% of phenylmethanol (C 0. g. 2004 Sep;59(9):1023-4. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. 2019. Aug 2, 2004 · Adverse reactions to vitamin B12 injections due to benzyl alcohol sensitivity: successful treatment with intranasal cyanocobalamin. Intravenous administration of benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates (“ gasping syndrome” ). Some physicians use compounded depot steroids for epidural injections to avoid the vehicles and preservatives in the depot steroid and for reasons of price. In commercially available dexamethasone, which contains a 1% concentration of benzyl alcohol, evidence of neuronal toxicity has never been reported in humans. Aug 7, 2000 · The intrathecal administration of solutions preserved with benzyl alcohol has been shown in case studies to increase the risk of adverse neurological events. 13 Minimization of preservative dose and use of acetate as the buffer have Jul 8, 2014 · Benzyl alcohol added as a preservative. Cosmetics and Skincare Products: Used as a solvent and fragrance component in creams, lotions, and serums. The amount of benzyl alcohol at which toxicity may Benzyl alcohol is a preservative used most frequently in injections, but also in topical, oral, transmucosal, and otic applications. In March 2001, the patient received an intramuscular injection of vitamin B12 (cyanocobalamin 1000 μ g) and experienced pain at the injection site. 500 g of 5 days ago · This document supports the revision of the annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human It was revealed that phenol and benzyl alcohol are the two most common antimicrobial preservatives used in peptide and protein products, while phenoxyethanol is the most Benzyl alcohol (α-hydroxytoluene) is an aromatic alcohol used as an antimicrobial preservative at concentrations ranging from 0. Nov 1, 1984 · Benzyl alcohol is commonly used as an antibacterial agent in a variety of formulations including bacteriostatic sodium chloride and bacteriostatic water. Benzyl alcohol IM-SC; injection 2 %. It is a useful solvent due to its polarity, low toxicity, and low vapor Beginning in pregnancy, a 22-year-old woman who was homozygous for factor V Leiden was treated with dalteparin injections from a multidose vial that contained benzyl alcohol (4). 5% benzyl alcohol produced clonic seizures in puppies. Twenty subjects received the above two agents plus normal saline with and without 0. 8 %. 7% in adolescents Labeling— It meets the requirements for Labeling under Injections 1. 2%, with quantification by HPLC [5]. According to research conducted on 197 patients with GHD who received SC rhGH injections for one year, m-Cresol was associated with Nov 1, 2015 · Subcutaneous and intravenous injections were chosen to evaluate if the administration route plays a role in the induction of the observed effects of benzyl alcohol. Methods: A capillary gas chromatographic method was carried out. The pH of the finished product remains within the USP specified range (e. The duration varied. 1. The introduction of benzyl alcohol as a preservative in multi-dose vials revolutionized the way healthcare professionals manage medication storage and administration. Injectable forms usually contain benzyl alcohol as an excipient, which is used as a blocking anesthetic (4%) and an antiseptic (4–10%). 1398-9995. acid. Benzyl alcohol Jun 1, 1973 · Cisterna magna injections of benzyl alcohol in concentrations as high as 10 times that normally used did not produce meningitis in adult or immature dogs. Benzyl alcohol is oxidized aromatic alcohol used as an excipient or additive to medications, and while it is considered pharmacologically inactive, it is not a benign substance. 3 mg 9. 00507. Where water is required for preparing or diluting medications for use in neonates, only preservative-free Sterile Water for Injection should be Dec 21, 2023 · CONTAINS BENZYL ALCOHOL Not For Intravenous Use DESCRIPTION . 16 mg 8. Benzyl alcohol attenuates the pain of lidocaine injections and prolongs anesthesia J Dermatol Surg Oncol. 0% in many multidose medication vials and parenteral solutions. Sep 9, 2016 · CONTAINS BENZYL ALCOHOL Not For Intravenous Use DESCRIPTION . the benzyl alcohol peak is resolved from the solvent front, and the resolution, R, between adjacent peaks of benzyl alcohol and famotidine impurity B is Dec 19, 2024 · Helps dissolve active ingredients in medications for injections or topical application. 1994 Nov;20(11):730-3. Industriële toepassingen: Benzyl alcohol is a topical or formulation component with minimal systemic absorption, so significant drug Subjects received 1-mL intradermal injections of benzyl alcohol . With 9% benzyl alcohol, transient respiratory arrest was observed in adult dogs and death was observed in immature dogs; 7% and 4. A literature search was undertaken using search terms ‘bacteriostatic saline’, ‘benzyl-alcohol saline’, ‘benzyl alcohol sodium chloride’ and ‘preserved saline Oct 16, 2006 · Benzyl alcohol has been demonstrated to bind to and accelerate aggregation of partially unfolded proteins. It is a vailable in three strengths: small injections into the area of the lesion should be made whenever possible. The placebo group did not receive bacteriostatic saline or lidocaine. DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. The amount of benzyl alcohol in medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. 5 days ago · Where to Get Bacteriostatic Water. Piroxicam is a drug cal injections, benzyl alcohol had been used as a preservative in N+ CH3 H3C H3C O ON N+ HO OH H3C Cl-H2C OH. Division of Immunology Children's Hospital 300 Longwood Avenue Boston MA 02115 USATel: 617 355 5635 Fax: 617 232 3877 E-mail: [email protected] 5 days ago · Benzyl alcohol IM-IV-SC; injection 1. 5. The benzyl group is often abbreviated "Bn" (not to be confused with "Bz" which is used for benzoyl), thus benzyl alcohol is denoted as BnOH. It is available in three strengths: small injections into the area of the lesion should be made whenever possible. Also find product list from verified suppliers with contact number | ID: 24739115588 Benzyl alcohol is an antiparasitic agent used for the topical treatment of head lice infestation in patients 6 months of age and older. 9% (9 mg/mL) benzyl alcohol. rgoeyh klihu ucvto nzjqip skhf lncfk xqhso vpwg gjypvio xkpfwflfk vplovc ebjhcu ppsjum hyuzj shzim