Ampicillin Sodium For Injection Bp 1g COMPOSITION: Each vial contains Ampicillin Sodium equivalent to Ampicillin 1g. Ampicillin Sodium is a semisynthetic penicillin which has broad antibacterial spectrum. It is markedly effective against Gram-negative bacteria as well as Gram-positive bacteria. Its action is bactericidal. Ampicillin Sodium is a sterile powder. It is almost odorless easily soluble in water and very stable in acid solution. INDICATIONS: Employed in the treatment of infections caused by Gram-negative bacteria a s well as Gram-positive bacteria Such as typhoid fever, septicemia, infections of the respiratory, urinary and biliary tracts. It is mainly indicated for the infections resistant to other drugs or at the appearances of severe toxic effects or in patients with renal-lesions. ADMINISTRATION AND DOSAGE: For intramuscular injection, it should be dissolved in 3ml of distilled water or normal sodium chloride solution and shake well before use. The dosage should be determined by the state and nature of the illness. For adults, the usual daily dose is 4g. (for individual dangerously-ill patient may be 6g), while for children, according to 100mg/kg of body weight in 4 divided doses a day is suggested. The dose may be reduced for patient with urinary tract infection to 2g a day for adults. Intravenous infusion 1-2g every time, it is compatible with the commonly used intravenous infusion fluids 100ml. Solutions should be changed within one hour, divided into 3-4 doses every four hours necessary. For children 50-100mg/kg/day. divided into doses. ADVERSE REACTIONS: As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of ampicillin: Gastrointestinal: Glossitis, stomatitis, black "hairy" tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. (These reactions are usually associated with oral dosage forms.) Hypersensitivity Reactions: Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form. CONTRAINDICATION:
A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication. CAUTION: 1.Skin test should be performed before use. The method and the dosage are the same as that of potassium penicillin G. 2.Slow and deep intramuscular injection is suggested. 3.Skin rash or other allergic reactions may occur during the course of therapy. Should it occur. use antihistamine or hormone and continue the therapy under close observation Stop the treatment if serious skin rash occurs. STORAGE: Ampicillin sodium should be kept in a well- closed container and stored at a temperature not exceeding 25ºC. PRESENTATION: 250mg, 500mg and 1000mg Ampicillin in vials.