Penglobe (Bacampicillin HCl)

PENGLOBE®

Astra

Bacampicillin HCl

Antibiotic

Action And Clinical Pharmacology: Bacampicillin is a prodrug of ampicillin and is microbiologically inactive. During absorption from the gastrointestinal tract, bacampicillin is hydrolyzed by esterases present in the intestinal wall. It is microbiologically active as ampicillin, and exerts a bactericidal action through the inhibition of the biosynthesis of cell wall mucopeptides.

Indications And Clinical Uses: For infections at the following sites: upper and lower respiratory tract; skin and soft tissue; urinary tract and acute uncomplicated gonococcal urethritis, when due to sensitive strains of the following organisms:

Gram-positive: streptococci (including S. faecalis and S. pneumoniae) and nonpenicillinase-producing staphylococci.

Gram-negative: H. influenzae, N. gonorrhoeae, E. coli, P. mirabilis, Salmonellae and Shigellae.

As follow-up oral therapy for infections initially treated with parenteral ampicillin.

Bacampicillin is not indicated in the treatment of infections caused by b-lactamase-producing organisms.

In vitro studies should be performed to identify causative organisms and determine their susceptibility to ampicillin.

Disc Susceptibility Tests: Ampicillin, 10 µg discs, should be used to estimate the in vivo susceptibility of organisms to bacampicillin.

Contra-Indications: In patients with a history of hypersensitivity to any of the penicillins or cephalosporins.

Bacampicillin should not be used to treat infections associated with infectious mononucleosis because of the high frequency of exanthema associated with the use of aminopenicillins in these patients.

Manufacturers’ Warnings In Clinical States: Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients administered oral penicillins. These reactions are more apt to occur in individuals with a history of sensitivity to multiple allergens.

Before initiating therapy with bacampicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins and other allergens. If an allergic reaction occurs, the administration of bacampicillin should be discontinued and appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine, oxygen and i.v. steroids. Airway management, including intubation, should also be used as indicated.

Precautions: General: The possibility of superinfections with mycotic organisms or bacterial pathogens should be kept in mind during therapy with bacampicillin. Oxygen, epinephrine, i.v. fluids and i.v. steroids should be used to treat anaphylactic reactions. Emergency intubation may be necessary in some cases.

Special Disease Conditions: In patients with severely impaired renal function.

The passage of any penicillin from blood into the brain is facilitated by inflamed meninges and during cardiopulmonary bypass. In these circumstances and particularly in the presence of renal failure, when high serum concentrations can be attained, CNS adverse effects including myoclonia, convulsive seizures and depressed consciousness may occur. This has never been reported with oral ampicillin.

Laboratory Tests: Periodic assessment of organ system function, including renal, hepatic and hematopoietic evaluations should be made during prolonged therapy.

Patients with gonorrhea, who have a suspected lesion of syphilis, should have darkfield examinations before receiving bacampicillin and monthly serological tests for a minimum of 4 months.

Drug Interactions: Metabolism of bacampicillin produces low plasma concentrations of alcohol and acetaldehyde; although the risk of a disulfiram-alcohol interaction appears minimal, caution is recommended if concurrent use is unavoidable.

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. There are no data available on the incidence of rash in patients treated concurrently with bacampicillin and allopurinol.

Several reports have indicated that breakthrough bleeding and loss of contraceptive protection has occurred in women taking oral contraceptives and concurrently taking ampicillin. Although no reports have been received with regard to bacampicillin, it is recommended that an alternative contraceptive method be used during concurrent use of bacampicillin and oral contraceptive agents.

Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with bacampicillin may result in increased and prolonged blood levels of ampicillin.

Pregnancy: Ampicillin diffuses across the placental barrier into the fetal circulation. No harmful effects on the reproductive process have been reported in humans.

Lactation: The ampicillin from bacampicillin passes into the breast milk but any risk to the nursing infant seems unlikely when therapeutic doses are used. The potential for allergic sensitization should, however, be considered.

Adverse Reactions: The pattern of adverse reactions observed in patients treated with bacampicillin b.i.d. closely follows that of other aminopenicillins i.e. gastrointestinal symptoms and dermatological reactions dominate, although at a lower level. The lowest total incidence of adverse reactions was seen with bacampicillin 400 mg b.i.d.

More Common Reactions: Dermatological (400 mg b.i.d., 4.8%; 800 mg b.i.d., 4.3%): rash, urticaria, pruritus, increased sweating.

Note: Patients with mononucleosis infectiosa and with leukemia are at a higher risk of experiencing exanthema.

Upper Gastrointestinal (400 mg b.i.d., 3%; 800 mg b.i.d., 2%): nausea, vomiting, heartburn, dyspepsia, epigastric discomfort, glossitis, dry mouth, stomatitis.

Lower Gastrointestinal (400 mg b.i.d., 2.4%; 800 mg b.i.d., 4.3%): diarrhea, loose stool, abdominal pain, flatulence, constipation.

CNS (400 mg b.i.d., 0.6%; 800 mg b.i.d., 1.2%): dizziness, vertigo, headache, insomnia, somnolence.

Miscellaneous (400 mg b.i.d., 0.6%; 800 mg b.i.d., 1.6%): fatigue, myalgia, edema, vaginitis, dysuria, leukorrhea.

Less Common Reactions: Biochemical Abnormalities: Moderate rises in AST, ALT and alkaline phosphatase have been noted.

General: Serious hypersensitivity reactions such as anaphylaxis, angioedema, serum sickness, drug fever, vasculitis and Stevens-Johnson syndrome have been reported following use of penicillin class antibiotics. In addition, there have been 4 reports of Lyell’s syndrome/toxic epidermal necrolysis in patients treated with bacampicillin.

In rare cases, esophageal ulcerations have been reported in association with tablet intake without adequate liquid.

In rare cases, colitis, enterocolitis or pseudomembranous colitis in association with bacterial pathogens have been reported.

Other rare reactions which have been reported, regardless of causal relationship to bacampicillin, include stomatitis ulcerative, hepatitis, jaundice, circulatory failure, hypotension, oliguria, coma, chest pain and superinfection.

Hematological and Lymphatic: eosinophilia, hemolytic anemia, thrombocytopenia and leukopenia. These reactions are usually reversible upon discontinuation of therapy.

Symptoms And Treatment Of Overdose: Symptoms: The treatment of overdosage would likely be needed only in patients with severely impaired renal function since patients with normal kidneys excrete penicillins at a very fast rate. Following oral ingestion, symptoms that may occur include diarrhea, nausea, vomiting and abdominal pain. tag_Treatment

Treatment: The drug should be withdrawn, the stomach emptied and charcoal administered. Seizures caused by penicillins may be treated with anticonvulsive drugs. Hemodialysis lowers the serum level of penicillins.

Dosage And Administration: Chemically, 400 mg of bacampicillin HCl is equivalent to 278 mg of ampicillin on a molar basis. The absorption of bacampicillin is not significantly affected by food and therefore may be administered in association with meals.

Treatment should be continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. At least 10 days’ treatment is recommended for an infection caused by Group A b-hemolytic streptococci to prevent acute rheumatic fever or glomerulonephritis.

Urethritis due to N. gonorrhoeae: 1.6 g as a single dose with 1 g of probenecid. Bacampicillin is not recommended for the treatment of pharyngeal gonorrhea or secondary gonococcal infections (i.e. arthritis). There are inadequate clinical data to recommend an appropriate dosage regimen for the treatment of rectal gonorrhea.

Children: There are inadequate clinical data to recommend an appropriate dosage regimen.

Availability And Storage: 400 mg: Each white to yellowish-white, scored tablet, engraved ° on one side contains: bacampicillin HCl 400 mg. Nonmedicinal ingredients: Tablet Core: lactose, magnesium stearate and microcrystalline cellulose. Coating Layer: hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide. Energy: 0.42 kJ (0.1 kcal). Sodium- and tartrazine-free. Bottles of 100.

800 mg: Each white to yellowish-white, scored tablet, engraved ° contains: bacampicillin HCl 800 mg. Nonmedicinal ingredients: Tablet Core: lactose, magnesium stearate and microcrystalline cellulose. Coating Layer: hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide. Energy: 0.84 kJ (0.2 kcal). Sodium- and tartrazine-free. Bottles of 100.

Store at room temperature. Protect from moisture. (Shown in Product Recognition Section)

PENGLOBE® Astra Bacampicillin HCl Antibiotic

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