Zephiran (Benzalkonium Chloride)



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.

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.

ZEPHIRAN® Sanofi Benzalkonium Chloride Topical Antiseptic

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