ACETIC ACID: 81 Adverse Event Reports & Safety Profile

DESCRIPTION Each 100 mL contains: Glacial Acetic Acid USP 0.25 g Water for Injection USP qs pH: 3.1 (2.8-3.4)

Calculated

Osmolarity: 42 mOsmol/liter The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Glacial Acetic Acid USP CH 3 COOH 60.05 0.25% Acetic Acid Irrigation USP is a prediluted, sterile, nonpyrogenic aqueous solution suitable for urologic irrigation. It contains no preservatives or added buffers. The solution is hypotonic. The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber latex, PVC or DEHP.

INDICATIONS AND USAGE 0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.

DOSAGE AND ADMINISTRATION As required for urologic irrigation. 0.25% Acetic Acid Irrigation USP may be administered by gravity drip via an administration set connected to an indwelling urethral catheter designed for continuous or intermittent two-way flow. For continuous or intermittent irrigation, the rate of administration will correspond roughly to the rate of urine flow and should be adjusted to maintain a urinary effluent pH of 4.5 to 5.0. Nitrazine or other pH paper may be used to monitor pH, preferably at least four times daily. Drip rate should be adjusted as necessary to maintain desired pH; increasing flow rate reduces pH value and vice versa. With continuous or intermittent irrigation, each patient will require a volume of approximately 500 to 1500 mL per 24 hours. Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

CONTRAINDICATIONS Hypersensitivity to hydrocortisone and acetic acid otic solution or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

ADVERSE REACTIONS Systemic acidosis, pain, and hematuria have been reported in patients receiving urinary bladder irrigation with 0.25% acetic acid solution. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination, if deemed necessary.

WARNINGS If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Ask a doctor before use if you have never had migraines diagnosed by a health professional, you have a headache that is different from your usual migraines, you have the worst headache of your life, you have fever and stiff neck, you have a migraine so severe as to require bed rest. Do not use if known sensitivity to BHI Migraine or any of its ingredients exists.

PRECAUTIONS General Use aseptic technique when preparing and administering sterile irrigation solutions. Use only if solution is clear and container and seal are intact. If pain or hematuria should occur during irrigation, it should be discontinued and the patient reevaluated. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with 0.25% Acetic Acid Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy Teratogenic Effects

Animal reproduction studies have not been conducted with 0.25% Acetic Acid Irrigation USP. It is also not known whether 0.25% Acetic Acid Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.25% Acetic Acid Irrigation USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 0.25% Acetic Acid Irrigation USP is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of 0.25% Acetic Acid Irrigation USP have not been performed to determine whether patients over 65 years of age respond differently from younger subjects. Although systemic absorption of the product is unlikely, greater sensitivity of some older individuals cannot be ruled out.

ACTIVE INGREDIENTS: Triticum Aestivum MT, Berberis Vulgaris 3X, Glycyrrhiza Glabra 3X, Lappa Major 3X, Rhamnus Frangula 3X, Rhamnus Purshiana 3X, Stillingia Sylvatica 3X, Trifolium Pratense 3X, Xanthoxylum Fraxineum 3X, Phytolacca Decandra 4X, Glandula Suprarenalis Suis 8X, Hepar Suis 8X, Lymph (Suis) 8X, Thyroidinum (Suis) 8X, Belladonna 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphoricum Acidum 12X, Phosphorus 12X, Salicylicum Acidum 30X, 60X, 200X, Cortisone Aceticum 30X, 60X, 200X, Eugenol 30X, 60X, 200X, Stearyl Alcohol 30X, 60X, 200X, Xylitol 30X, 60X, 200X, Folliculinum 30X, 60X, 200X, Benzoicum Acidum 30X, 60X, 200X, Chlorinum 30X, 60X, 200X, Potassium Sorbate 30X, 60X, 200X, Sorbitol 30X, 60X, 200X, Resorcinum 30X, 60X, 200X, Benzyl Alcohol 30X, 60X, 200X, Lacticum Acidum 30X, 60X, 200X, Isopropyl Palmitate 30X, 60X, 200X, Boricum Acidum 30X, 60X, 200X, Aceticum Acidum 30X, 60X, 200X, Phenyl Butazone 30X, 60X, 200X, Petroleum Jelly 30X, 60X, 200X, Plumbum Metallicum 30X, 60X, 200X, Adrenocorticotrophin 15C.

​Inactive Ingredients: ​Ethanol Alcohol 15% (Non-GMA, Kosher Certified, Corn Free, Gluten Free, Allergen Free), Glycerin 15%, Purified Water.