Prescription Drugs

CLINICAL PHARMACOLOGY Cholera vaccine is used for active immunization against cholera. Field studies carried out in endemic cholera areas have shown cholera vaccines to be approximately 50% effective in reducing incidence of disease and for only 3 to 6 months. Use of cholera vaccine does not prevent transmission of infection.

DESCRIPTION Cholera Vaccine, USP is a sterile suspension of equal parts of Ogawa and Inaba serotypes of killed Vibrio cholerae (V. comma) in buffered sodium chloride injection. The Inaba and Ogawa strains of V. cholerae are grown on trypticase soy agar medium, removed from the medium with buffered sodium chloride injection and killed by the addition of 0.5 percent phenol. Phenol in a concentration of 0.5 percent is also used as the preservative in the finished vaccine. The vaccine contains 8 units of each serotype antigen (Ogawa and Inaba) per milliliter. Cholera vaccine may be injected intracutaneously (intradermally), subcutaneously or intramuscularly.

INDICATIONS Active immunization against cholera is indicated only for individuals traveling to or residing in countries where cholera is endemic or epidemic. DOSAGE AND ADMINISTRATIONShake vial vigorously before withdrawing each dose. Parenteral drug products should be inspected visually for presence of particulate matter and discoloration prior to use. The primary immunizing course consists of two doses administered one week to one month or more apart. The table below summarizes the recommended doses for both primary and booster immunizations by age, volume (mL), and route of administration. 3,5 The intracutaneous (intradermal) route is satisfactory for persons 5 years of age and older, but higher levels of antibody may be achieved in children less than 5 years old by the subcutaneous or intramuscular routes. Route & Age Dose number Intradermal Subcutaneous or Intramuscular 5 years and over 6 mos- 4 years 5-10 years Over 10 years 1 & 2 0.2 mL 0.2 mL 0.3 mL 0.5 mL Boosters 0.2 mL 0.2 mL 0.3 mL 0.5 mL In areas where cholera is epidemic or endemic, booster doses should be given every six months. The primary immunizing series need never be repeated for booster doses to be effective. Before injection, the rubber diaphragm of the vial and the skin over the site to be injected should be cleansed and prepared with a suitable germicide. HOW SUPPLIED Cholera Vaccine, USP, is supplied as 1.5 and 20 mL vials. STORAGE Keep between 2° and 8°C (35° and 46°F). Keep from freezing. REFERENCES Recommendation of the Immunization Practices Advisory Committee (ACIP). General recommendations on immunization. MMWR 32(1):1, 1983. Recommendations of the Immunization Practices Advisory Committee (ACIP). Yellow fever vaccine. MMWR 32(52):679, 1984. Recommendation of the Public Health Service Advisory Committee on Immunization Practices--Cholera Vaccine. MMWR 27(20):173, 1978. GANGAROSA, E. and FAICH, G.: Cholera: The risk to American travelers. Ann. Int. Med. 74:412, 1971. Report of the Committee on Infectious Diseases, American Academy of Pediatrics, 1982 (Red Book). Manufactured by: Wyeth Laboratories A Wyeth-Ayerst Company Marietta, PA 17547

PATIENT INFORMATION No Information Provided

OVERDOSE No Information Provided CONTRAINDICATIONS Use of cholera vaccine should be postponed in the presence of any acute illness. A history of severe systemic reaction or allergic response following a prior dose of cholera vaccine is a contraindication to further use.

SIDE EFFECTS Local reactions manifested by erythema, induration, pain, and tenderness at the site of injection occur in most recipients, and such local reactions may persist for a few days. Recipients frequently develop malaise, headache, and mild-to-moderate temperature elevations which may persist for 1 to 2 days. 1,4 DRUG INTERACTIONS Some data suggest that administration of cholera and yellow fever vaccines within three weeks of each other may result in decreased levels of antibody response to both vaccines as compared with administration at longer intervals. However, there is no evidence that protection to either disease is diminished following simultaneous administration. 1 It is currently recommended that, when feasible, cholera and yellow fever vaccines should be administered at a minimal interval of three weeks, unless time constraints preclude this. If the vaccines cannot be administered at least three weeks apart, they should be given simultaneously. 2

WARNINGS DO NOT INJECT INTRAVENOUSLY. Cholera vaccine should not be administered intramuscularly to persons with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. PRECAUTIONS GENERAL A separate, sterilized syringe and needle should be used for each patient to prevent transmission of hepatitis B virus and other infectious agents from one person to another. Before delivering the dose intramuscularly or subcutaneously, aspirate to help avoid inadvertent injection into a blood vessel. Before the injection of any biological, the physician should take all precautions known for prevention of allergic or other side reactions. This should include: a review of the patient's history regarding possible sensitivity; and a knowledge of the recent literature pertaining to the use of the biological concerned. Epinephrine (1:1000) should be available for immediate use when this product is injected. DRUG INTERACTIONS Some data suggest that administration of cholera and yellow fever vaccines within three weeks of each other may result in decreased levels of antibody response to both vaccines as compared with administration at longer intervals. However, there is no evidence that protection to either disease is diminished following simultaneous administration. 1 It is currently recommended that, when feasible, cholera and yellow fever vaccines should be administered at a minimal interval of three weeks, unless time constraints preclude this. If the vaccines cannot be administered at least three weeks apart, they should be given simultaneously. 2 PREGNANCY Pregnancy Category C Animal reproduction studies have not been conducted with cholera vaccine. It is also not known whether cholera vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. However, as with other inactivated bacterial vaccines, its use is not contraindicated during pregnancy unless the intended recipient has manifested significant systemic or allergic reaction following administration of prior doses. Use of cholera vaccine during pregnancy should be individualized to reflect actual need. 1,3