Alcohol as a preservative

Many of these reactions are related to the quantity of excipient found in a dosage form. Benzyl alcohol benzalkonium chloride, propylene glycol, lactose, and polysorbates are all associated with dose-related toxic reactions [52-54], Large-volume parenterals containing 1.5% benzyl alcohol as a preservative have caused metabolic acidosis, cardiovascular collapse, and death in low birth weight premature neonates and infants. The cumulative dose of benzyl alcohol ranged from 99 to 234 mg/kg per day in these patients [55,56], Dose-related adverse effects to excipients are of particular concern in the preterm, low birth weight infant because... 

Bacteriostatic sodium chloride Do not use in newborns. Benzyl alcohol as a preservative in bacteriostatic sodium chloride injection has been associated with toxicity in newborns. These solutions have not been reported to cause problems in older infants, children, and adults. 

Benzyl alcohol The multiple-dose vials of dalteparin, enoxaparin, and tinzaparin contain benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal gasping syndrome in premature infants. Because benzyl alcohol may cross the placenta, do not use LMWHs preserved with benzyl alcohol in pregnant women. Thromboembolic events If thromboembolic events occur despite LMWH prophylaxis, discontinue and initiate appropriate therapy. 

To be reconstituted with 5 mL bacteriostatic 0.9% sodium chloride for injection, USP, with normal 0.9% benzyl alcohol as a preservative saline (pH in the range of 7.0-9.0) Per vial 30 mg mannitol SC... 

Vials HSA containing formulation 0.25% albumin (human) sodium chloride sodium citrate citric acid 0.9% benzyl alcohol as a preservative water for injection... 

Several days later, Natividad Rosa brought us a whole basket of leaves, for which she was paid fifty pesos. The business seemed to have been discussed, for two other women brought us further quantities of leaves. As it was known that the expressed juice of the leaves is drunk in the ceremony, and this must therefore contain the active principle, the fresh leaves were crushed on a stone plate, squeezed out in a cloth, the juice diluted with alcohol as a preservative, and decanted into flasks in order to be studied later in the laboratory in Basel. I was assisted in this work by an Indian girl, who was accustomed to dealing with the stone plate, the metate, on which the Indians since ancient times have ground their corn by hand. 

Interferon alfa-2a formulations contain excipients sodium chloride, polysorbate, ammonium acetate, and benzyl alcohol as a preservative. Interferon alfa is also approved for use in the treatment of several other disorders. 

This ester-type anesthetic contains butacaine, with benzyl alcohol as a preservative. It is available as an ointment. The maximum dose is 5 ml of a 4% solution or 200 mg. 

Allergic contact dermatitis, characterized by erythema, palpable edema, and raised borders, was attributed to benzyl alcohol (2). In this case, the benzyl alcohol was present as a preservative in an injectable solution of sodium tetradecyl sulfate, a sclerosing agent used for the treatment of varicose veins. The author provided a hst of 151 injectable formulations (48 for subcutaneous administration) that contained benzyl alcohol as a preservative in the range 0.5-2.0%. The list included hormones and steroids, antihypertensive drugs (reserpine), vitamin formulations (vitamins B12 and Bg), ammonium sulfate, antihistamines, antibiotics, heparin (17 brands), tranquillizers, and sclerosing agents (sodium morrhuate and sodium tetradecyl sulfate). 

The fatal toxic syndrome in low-birth-weight neonates, which includes symptoms of metabolic acidosis and respiratory depression, was attributed to the use of benzyl alcohol as a preservative in solutions used to flush umbilical catheters. As a result of this, the FDA has recommended that benzyl alcohol should not be used in such flushing solutions and has advised against the use of medicines containing preservatives in the newborn. ... 

Each milliliter contains 3 MIL of interferon alpha-2a, recombinant, 7.21 mg of sodium chloride, 0.2 mg of polysorbate 80, 10 mg of benzyl alcohol as a preservative, and 0.77 mg of ammonium acetate. 

Vials HSA containing formulation 0.25% albumin (human) sodium chloride sodium citrate citric acid 0.9% benzyl alcohol as a preservative water for injection Pre filled syringe polysorbate-80 containing (HSA- free) formulation glycine polysorbate 80 sodium chloride sodium phosphate monobasic dihydrate sodium phosphate dibasic dihydrate water for injection... 

D. Rapid or large-volume IV administration may cause cardiotoxicity similar to that seen with phenytoin (see p 303) because of the diluent propylene glycol. Continuous infusions with this vehicle may result in a hyperlactatemia, increased osmolar gap, and renal dysfunction. Several products also contain up to 2% benzyl alcohol as a preservative. 

The solubility of 2,4-dichloro benzyl alcohol in water is poor in aqueous systems it tends to migrate into the organic phase. The use of 2,4-dichloro benzyl alcohol as a preservative therefore is very limited. Nevertheless it is listed in the EC positive list of preservatives for cosmetic products (maximum concentration for the applications 015%). Its main application, however, is in hand disinfectants. 

For example, the label of a prescription drug to be administered in the vein reads, testosterone propionate injection with benzyl alcohol as a preservative 10%, in sesame oil . Cocoa butter is a constituent of pro-menthazine hydrochloride used either orally or by suppositories for perennial and seasonal allergic rhinitis. It is manufactured by Wyeth Laboratories, Inc., Philadelphia, PA. Progesterone injection, USP, in sesame oil is used for intramuscular use only (manufactured by Steris Laboratories, Phoenix, AZ). 

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