ZEPHIRAN Sanofi Benzalkonium Chloride Topical Antiseptic Indications And Clinical Uses: Antisepsis of skin and mucous membranes

and as a disinfectant in surgery, obstetrics and gynecology, urology, ophthalmology, otorhinolaryngology and general practice. Also may be used as a disinfectant for hospital utensils and other environmental surfaces and for disinfection and storage of ampuls, thermometers, metal instruments and catheters. Contra-Indications: Incompatible with soap and anionic detergents. Use in occlusive dressings, casts and anal or vaginal packs is inadvisable, as they may produce irritation or chemical burns. Precautions: Sterile Water for Injection USP, should be used as a diluent in preparation for use in deep wounds or for irrigation of body cavities. Freshly distilled water is the appropriate diluent in all other indications. Cotton, wool, rayon products, gauze sponges and fibre pledgets should be stored separately from benzalkonium chloride aqueous solutions and immersed immediately prior to use. Antiseptics such as benzalkonium chloride aqueous solutions must not be relied upon to achieve complete sterilization, because they do not destroy all bacterial spores and certain viruses, including the etiologic agent of infectious hepatitis, and they may not destroy M. tuberculosis and other rare bacterial strains. Important: If benzalkonium chloride aqueous solution, in dilutions stronger than 1:3 000 enters the eyes, they should be immediately and repeatedly rinsed with water. Prompt medical attention is necessary. Concentrations greater than 1:5 000 should not be used on mucous membranes, with the exception of vaginal mucosa (see Dosage). Solutions that are used on inflamed or irritated tissues must be more dilute than those used on normal tissues. In preoperative antisepsis of the skin, benzalkonium chloride aqueous solutions should not be permitted to remain in prolonged contact with the patient's skin. Periorbital skin or head preparation should be carried out before anesthesia so that eye irritation can be reported immediately. Avoid pooling of the solution on the operating table. If benzalkonium chloride concentrate is spilled on the skin, wash immediately and copiously with soap and water. Adverse Reactions: Hypersensitivity may be exhibited rarely. Symptoms And Treatment Of Overdose: Symptoms: If solution is ingested, especially a concentrated solution, marked local irritation of the gastrointestinal tract may occur manifested by nausea and vomiting. Signs of systemic toxicity include restlessness, apprehension, weakness, confusion, dyspnea, cyanosis, collapse, convulsions and coma. Death occurs as a result of paralysis of the respiratory muscles. tag_Treatment Treatment: Administer several glasses of a mild soap solution, milk or egg whites beaten in water. Follow by gastric lavage with a mild soap solution. Avoid alcohol as it promotes absorption. To support respiration, maintain a clear airway and administer oxygen with artificial respiration if necessary. If convulsions occur, give a short-acting parenteral barbiturate with caution. If solutions containing Anti-Rust are ingested, the effects of sodium carbonate are manifested by gastric symptoms typical of locally irritant poisons. Nitrite poisoning may be serious and is manifested mainly by cardiovascular collapse, with rapid marked fall in blood pressure, tachycardia, muscular weakness, dyspnea, and slate colored mucous membranes. If very large doses are taken, methemoglobinemia occurs and results in anoxia. Sodium carbonate may be neutralized by large amounts of diluted acids in the form of diluted vinegar, lemon juice or orange juice. Fixed oils such as olive oil may be given in small amounts to protect irritated mucous membranes. For nitrite poisoning the patient is kept in shock position and comfortably warm. Oxygen should be administered (especially if methemoglobinemia is present). Methylene blue has also been used to treat methemoglobinemia. Dosage: For preoperative disinfection of skin or minor wounds, surgeon's hand and arm soak, Aqueous 1:750; denuded skin and mucous membranes, wet dressings, Aqueous 1:10 000 to 1:5 000; vaginal instillation and irrigation, oozing and open infections Aqueous 1:5 000 to 1:2 000; vesical and urethral irrigation, Aqueous 1:20 000 to 1:5 000; retention lavage, Aqueous 1:40 000 to 1:20 000; otorhinolaryngological irrigation, Aqueous 1:10 000 to 1:3 000; disinfection of bristle brushes, ampuls, wet towel drapes or rubber instruments, floors, walls, bathtubs, furniture and other surfaces, Aqueous 1:750. Disinfection of metallic instruments: Aqueous 1:750 (with Anti-Rust Tablets). Availability And Storage: Each mL of aqueous solution contains: benzalkonium chloride 1:750 in purified water. Alcohol-, bisulfite-, glucose-, gluten-, lactose-, parabens-, sodium-, starch-, sucrose- and tartrazine-free. Bottles of 3.75 L.

Hydrogen peroxide (H2O2) is a very pale blue liquid, slightly more viscous than water, that appears colorless in dilute solution. It is a weak acid, has strong oxidizing properties, and is a powerful bleaching agent. It is used as a disinfectant, antiseptic, oxidizer, and in rocketry as a propellant.[2] The oxidizing capacity of hydrogen peroxide is so strong that it is considered a highly reactive oxygen species. Hydrogen peroxide is naturally produced in organisms as a byproduct of oxygen metabolism. Nearly all living things (certainly all obligate and facultative aerobes) possess enzymes known as peroxidases, which harmlessly and catalytically decompose low concentrations of hydrogen peroxide to water and oxygen. Therapeutic use Hydrogen peroxide is generally recognized as safe (GRAS) as an antimicrobial agent, an oxidizing agent and for other purposes by the FDA.[28] Hydrogen peroxide has been used as an antiseptic and anti-bacterial agent for many years due to its oxidizing effect. While its use has decreased in recent years with the popularity of readily available over the counter products, it is still used by many hospitals, doctors and dentists.

Safety

Like many oxidative antiseptics, hydrogen peroxide causes mild damage to tissue in open wounds, but it also is effective at rapidly stopping capillary bleeding (slow blood oozing from small vessels in abrasions), and is sometimes used sparingly for this purpose, as well as cleaning. Hydrogen peroxide can be used as a toothpaste when mixed with correct quantities of baking soda and salt. [29] Hydrogen peroxide and benzoyl peroxide are sometimes used to treat acne.[30] Hydrogen peroxide is used as an emetic in veterinary practice.[31]

Regulations vary, but low concentrations, such as 3%, are widely available and legal to buy for medical use. Higher concentrations may be considered hazardous and are typically accompanied by a Material Safety Data Sheet (MSDS). In high concentrations, hydrogen peroxide is an aggressive oxidizer and will corrode many materials, including human skin. In the presence of a reducing agent, high concentrations of H2O2 will react violently. High-concentration hydrogen peroxide streams, typically above 40%, should be considered a D001 hazardous waste, due to concentrated hydrogen peroxide's meeting the definition of a DOT oxidizer, if released into the environment. The EPA Reportable Quantity (RQ) for D001 hazardous wastes is 100 pounds, or approximately ten gallons, of concentrated hydrogen peroxide. Hydrogen peroxide should be stored in a cool, dry, well-ventilated area and away from any flammable or combustible substances.[35] It should be stored in a container composed of non-reactive materials such as stainless steel or glass (other materials including some plastics and aluminium alloys may also be suitable).[36] Because it breaks down quickly when exposed to light, it should be stored in an opaque container, and pharmaceutical formulations typically come in brown bottles that filter out light.[37] Hydrogen peroxide, either in pure or diluted form, can pose several risks:

Explosive Vapors. Above roughly 70% concentrations, hydrogen peroxide can give off vapor that can detonate above 70 C (158 F) at normal atmospheric pressure.[citation needed] This can then cause a boiling liquid expanding vapor explosion (BLEVE) of the remaining liquid. Distillation of hydrogen peroxide at normal pressures is thus highly dangerous. Hazardous Reactions. Hydrogen peroxide vapors can form sensitive contact explosives with hydrocarbons such as greases. Hazardous reactions ranging from ignition to explosion have been reported with alcohols, ketones, carboxylic acids (particularly acetic acid), amines and phosphorus.[citation needed] Spontaneous Ignition. Concentrated hydrogen peroxide, if spilled on clothing (or other flammable materials), will preferentially evaporate water until the concentration reaches sufficient strength, at which point the material may spontaneously ignite.[38][39] Corrosive. Concentrated hydrogen peroxide (>50%) is corrosive, and even domestic-strength solutions can cause irritation to the eyes, mucous membranes and skin.[40] Swallowing hydrogen peroxide solutions is particularly dangerous, as decomposition in the stomach releases large quantities of gas (10 times the volume of a 3% solution) leading to internal bleeding. Inhaling over 10% can cause severe pulmonary irritation.[citation needed] Bleach Agent. Low concentrations of hydrogen peroxide, on the order of 3% or less, will chemically bleach many types of clothing to a pinkish hue. Caution should be exercised when using common products that may contain hydrogen peroxide, such as facial cleaner or contact lens solution, which easily splatter upon other surfaces.

Internal Ailments. Large oral doses of hydrogen peroxide at a 3% concentration may cause "irritation and blistering to the mouth, (which is known as Black hairy tongue) throat, and abdomen", as well as "abdominal pain, vomiting, and diarrhea".[41] Vapor Pressure. Hydrogen peroxide has a significant vapor pressure (1.2 kPa at 50 oC[CRC Handbook of Chemistry and Physics, 76th Ed, 1995-1996]) and exposure to the vapor is potentially hazardous. Hydrogen peroxide vapor is a primary irritant, primarily affecting the eyes and respiratory system and the NIOSH Immediately dangerous to life and health limit (IDLH) is only 75 ppm. Documentation for Immediately Dangerous to Life or Health Concentrations (IDLH): NIOSH [http://www.cdc.gov/NIOSH/National Institute for Occupational Safety and Health] Chemical Listing and Documentation of Revised IDLH Values (as of 3/1/95). Long term exposure to low ppm concentrations is also hazardous and can result in permanent lung damage and OSHAOccupational Safety and Health Administration has established a permissible exposure limit of 1.0 ppm calculated as an eight hour time weighted average (29 CFR 1910.1000, Table Z-1) and hydrogen peroxide has also been classified by the ACGIH American Conference of Industrial Hygienists (ACGIH) as a "known animal carcinogen, with unknown relevance on humans.[2008 Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices, ACGIH] In applications where high concentrations of hydrogen peroxide are used, suitable personal protective equipment should be worn and it is prudent in situations where the vapor is likely to be generated, such as hydrogen peroxide gas or vapor sterilization, to ensure that there is adequate ventilation and the vapor concentration monitored with a continuous gas monitor for hydrogen peroxide. Continuous gas monitors for hydrogen peroxide are available from several suppliers. Further information on the hazards of hydrogen peroxide is available from OSHA Occupational Safety and Health Guideline for Hydrogen Peroxide and from the ATSDR. Agency for Toxic Substances and Disease Registry Skin Disorders. Vitiligo is an acquired skin disorder with the loss of native skin pigment, which affects about 0.5-1% of the world population. Recent studies have discovered increased H2O2 levels in the epidermis and in blood are one of many hallmarks of this disease.[42]