Ampiclox 500 Capsule

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting of modifying antimicrobial therapy, in the absence of such data, local epidemiology and susceptibility patterns contribute to the empiric selection of therapy. …

• Adults and children weighing over 20 kg: For genitourinary or gastrointestinal tract infections other than gonorrhea in men and women, the usual dose is 500 mg qid in equally spaced doses; severe or chronic infections may require larger doses
• For the treatment of gonorrhea in both men and women, a single oral dose of 3.5 grams of ampicillin administered simultaneously with 1 gram of probenecid is recommended
• Physicians are cautioned to use no less than the above recommended dosage
• For the treatment of gonorrhea
• Follow-up cultures should be obtained from the original site(s) of infection 7 to 14 days after therapy
• In women, it is also desirable to obtain culture test-of-cure from both the endocervical and anal canals
• Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis
• For respiratory tract infections , the usual dose is 250 mg qid in equally spaced doses
• Pediatric patients weighing 20 kg or less: For genitourinary or gastrointestinal tract infections , the usual dose is 100 mg/kg/day total, qid in equally divided and spaced doses
• For respiratory tract infections, the usual dose is 50 mg/kg/day total, in equally divided and spaced doses three to four times daily
• Doses for children should not exceed doses recommended for
• Adults
• All Patients, Irrespective of Age and Weight : Larger doses may be required for severe or chronic infections
• Although ampicillin is resistant to degradation by gastric acid, it should be administered at least one-half hour before or two hours after meals for maximal absorption. …

• Penicillins are excreted primarily unchanged by the kidney; therefore, the incompletely developed renal function in
• Neonates and young
• Infants will delay the excretion of penicillin
• Administration to
• Neonates and young
• Infants should be limited to the lowest dosage compatible with an effective therapeutic regimen (see DOSAGE AND ADMINISTRATION )

• Information for the Patient 1
• The patient should inform the physician of any history of sensitivity to allergens, including previous hypersensitivity reactions to penicillins and cephalosporins (see WARNINGS ). 2
• Advise patients about the signs and symptoms of serious skin manifestations
• Instruct patients to stop taking ampicillin immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see WARNINGS ]. 3
• Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. …

• The use of Ampicillin is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin or to other beta-lactam antibacterial drugs
• Ampicillin is also contraindicated in infections caused by penicillinase-producing organisms
• Ampicillin is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with ampicillin

When administered concurrently, the following drugs may interact with ampicillin. Allopurinol : Substantially increased incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. Bacteriostatic Antibiotics : Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented. …

SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE THERAPY WITH ANY PENICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS OR OTHER ALLERGENS. …

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 penicillin 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: Infections and Infestations: Clostridioides difficile -associated diarrhea (see WARNINGS section). Gastrointestinal : glossitis, stomatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs. …

Pregnancy Teratogenic Effects Reproduction studies in animals have revealed no evidence of impaired fertility or harm to the fetus due to penicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed. (See PRECAUTIONS-Drug/Laboratory Test Interactions .)

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required. In patients with renal function impairment, ampicillin-class antibiotics can be removed by hemodialysis but not by peritoneal dialysis.

Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Clinitest ® is a registered trademark of Miles, Inc. Clinistix ® is a registered trademark of Bayer Corporation. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.