Loracarbef

Loracarbef is indicated in the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (As recommended dosages, durations of therapy, and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific recommendations.)

Lower Respiratory Tract

Secondary Bacterial Infection of Acute Bronchitis caused by S. pneumoniae, H. influenzae (includingβ-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).

Acute Bacterial Exacerbations of Chronic Bronchitis caused by S. pneumoniae, H. influenzae (includingβ-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).

Pneumonia caused by S. pneumoniae or H. influenzae (non-β-lactamase-producing strains only). Data are insufficient at this time to establish efficacy in patients with pneumonia caused by β-lactamase-producing strains of H. influenzae.

Upper Respiratory Tract

Otitis Media † caused by S. pneumonia, H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes.

Acute Maxillary Sinusitis† caused by S. pneumoniae, H. influenzae (non-β-lactamase-producing strains only), or M. catarrhalis (includingβ-lactamase-producing strains). Data are insufficient at this time to establish efficacy in patients with acute maxillary sinusitis caused by β-lactamase-producing strains of H. influenzae.

† NOTE: In a patient population with significant numbers of β-lactamase-producing organisms, Loracarbef's clinical cure and bacteriological eradication rates were somewhat less than those observed with a product containing a β-lactamase inhibtor. Loracarbef's decreased potential for toxicity compared to products containing β-lactamase inhibitors along with the susceptibility patterns of the common microbes in a given geographic area should be taken into account when considering the use of an antimicrobial. For information on use in pediatric patients, seePRECAUTIONS—Pediatric Use.

Pharyngitis and Tonsillitis caused by S. pyogenes. (The usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin administered by the intramuscular route. Loracarbef is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Loracarbef in the subsequent prevention of rheumatic fever are not available at present.)

Skin and Skin Structure

Uncomplicated Skin and Skin Structure Infections caused by S. aureus (including penicillinase-producing strains) or S. pyogenes. Abscesses should be surgically drained as clinically indicated.

Urinary Tract

Uncomplicated Urinary Tract Infections (cystitis) caused by E.coli or S. saprophyticus*.

NOTE: In considering the use of Loracarbef in the treatment of cystitis, Loracarbef's lower bacterial eradication rates and lower potential for toxicity should be weighed against the increased eradication rates and increased potential for toxicity demonstrated by some other classes of approved agents.

Uncomplicated Pyelonephritis caused by E. coli.

*Although treatment of infections due to this organism in this organ system demonstrated a clinically acceptable overall outcome, efficacy was studied in fewer than 10 infections.

Culture and susceptibility testing should be performed when appropriate to determine the causative organism and its susceptibility to Loracarbef. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

CONTRAINDICATION

Loracarbef is contraindicated in patients with known allergy to Loracarbef or cephalosporin-class antibiotics.

Loracarbef is used to treat bacterial infections in many different parts of the body. It works by killing bacteria or preventing their growth. Loracarbef will not work for colds, flu, or other virus infections.

Loracarbef is available only with your doctor's prescription.

Loracarbef is administered orally either at least 1 hour prior to eating or at least 2 hours after eating. The recommended dosages, durations of treatment, and applicable patient populations are described in TABLE 13.

Renal Impairment: Loracarbef may be administered to patients with impaired renal function. The usual dose and schedule may be employed in patients with creatinine clearance levels of 50 ml/min or greater. Patients with creatinine clearance between 10 and 49 ml/min may be given half of the recommended dose at the usual dosage interval, or the normal recommended dose at twice the usual dosage interval. Patients with creatinine clearance levels less than 10 ml/min may be treated with the recommended dose given every 3 to 5 days; patients on hemodialysis should receive another dose following dialysis.

When only the serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance (CL, ml/min). The equation assumes the patient's renal function is stable.

• 50 ml: Add 30 ml of water in 2 portion to the dry mixture in the bottle. Shake well after each addition.
• 75 ml: Add 45 ml of water in 2 portions to the dry mixture in the bottle. Shake well after each addition.
• 100 ml: Add 60 ml of water in 2 portions to the dry mixture in the bottle. Shake well after each addition.

After mixing, the suspension may be kept at room temperature, 59° to 86°F (15° to 30°C), for 14 days without significant loss of potency. Keep tightly closed. Discard unused portion after 14 days.

How supplied

Loracarbef (Loracarbef) Pulvules: 200 mg, is blue and gray with 3170.

Loracarbef (Loracarbef) Pulvules: 400 mg, is blue and pink with 3171.

Keep tightly closed. Store at controlled room temperature, 59° to 86°F (15° to 30°C). Protect from heat.

Pulves oral suspension is strawberry bubble gum flavor.

PRODUCT LISTING

REFERENCES

1. National Committee for Clinical Laboratory Standards, M2-A4 performance standards for antimicrobial disk susceptibility tests. ed 4, Villanova, PA, April, 1990.

2. National Committee for Clinical Laboratory Standards, M7-A2 methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically, ed 2, Villanova, PA, April, 1990.

See also:
What is the most important information I should know about Loracarbef?

Loracarbef is contraindicated in patients with known allergy to Loracarbef or cephalosporin-class antibiotics.

Use Loracarbef suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Loracarbef suspension on an empty stomach at least 1 hour before or 2 hours after eating.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• To clear up your infection completely, continue using Loracarbef suspension for the full course of treatment even if you feel better in a few days.
• If you miss a dose of Loracarbef suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Loracarbef suspension.

See also:
What other drugs will affect Loracarbef?

Probenecid: As with other b-lactam antibiotics, renal excretion of Loracarbef is inhibited by probenecid and resulted in an approximate 80% increase in the AUC for Loracarbef.

See also:
What are the possible side effects of Loracarbef?

The nature of adverse reactions to Loracarbef are similar to those observed with orally administered β-lactam antimicrobials. The majority of adverse reactions observed in clinical trials were of a mild and transient nature; 1.5% of patients discontinued therapy because of drug-related adverse reactions. No one reaction requiring discontinuation accounted for >0.03% of the total patient population; however, of those reactions resulting in discontinuation, gastrointestinal events (diarrhea and abdominal pain) and skin rashes predominated.

All Patients

The following adverse events, irrespective of relationship to drug, have been reported following the use of Loracarbef in clinical trials. Incidence rates (combined for all dosing regimens and dosage forms) were less than 1% for the total patient population, except as otherwise noted:

Gastrointestinal: The most commonly observed adverse reactions were related to the gastrointestinal system. The incidence of gastrointestinal adverse reactions increased in patients treated with higher doses. Individual event rates included diarrhea, 4.1%; nausea, 1.9%; vomiting, 1.4%; abdominal pain, 1.4%; and anorexia.

Hypersensitivity:Hypersensitivity reactions including, skin rashes (1.2%), urticaria, pruritus, and erythema multiforme.

Central Nervous System: Headache (2.9%), somnolence, nervousness, insomnia, and dizziness.

Hemic and Lymphatic Systems: Transient thrombocytopenia, leukopenia, and eosinophilia.

Hepatic: Transient elevations in AST (SGOT), ALT (SGPT), and alkaline phosphatase.

Renal:Transient elevations in BUN and creatinine.

Cardiovascular System: Vasodilatation.

Genitourinary: Vaginitis (1.3%), vaginal moniliasis (1.1%).

As with other β-lactam antibiotics, the following potentially severe adverse experiences have been reported rarely with Loracarbef in worldwide post-marketing surveillance: anaphylaxis, hepatic dysfunction including cholestasis (with or without jaundice), prolongation of the prothrombin time with clinical bleeding in patients taking anticoagulants, and Stevens-Johnson syndrome.

Pediatric Patients

The incidences of several adverse events, irrespective of relationship to drug, following treatment with Loracarbef were significantly different in the pediatric population and the adult population as follows:

β-Lactam Antimicrobial Class Labeling:

The following adverse reactions and altered laboratory test results have been reported in patients treated with β-lactam antibiotics:

Adverse Reactions—Allergic reactions, aplastic anemia, hemolytic anemia, hemorrhage, agranulocytosis, toxic epidermal necrolysis, renal dysfunction, and toxic nephropathy. As with other β-lactam antibiotics, serum sickness-like reactions have been reported rarely with Loracarbef.

Several β-lactam antibiotics have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy should occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Altered Laboratory Tests—Increased prothrombin time, positive direct Coombs' test, elevated LDH, pancytopenia, and neutropenia.

Loracarbef is a carbacephem antibiotic sometimes grouped together with the second-generation cephalosporin antibiotics. It is marketed under the trade name Loracarbef.