Lorabid (Loracarbef) - Indications and Dosage

INDICATIONS AND USAGE

Lorabid 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. Lorabid'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 (see CLINICAL STUDIES section). For information on use in pediatric patients, see PRECAUTIONS—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. Lorabid is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of Lorabid 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 Lorabid in the treatment of cystitis, Lorabid'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 (see CLINICAL STUDIES section).

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

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

DOSAGE AND ADMINISTRATION

Lorabid 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 the following chart:

	DOSAGE	Duration
POPULATION/INFECTION	(mg)	(days)
ADULTS (13 years and older)
Lower Respiratory Tract
Secondary Bacterial Infection of Acute Bronchitis	200–400 q12h	7
Acute Bacterial Exacerbation of Chronic Bronchitis	400 q12h	7
Pneumonia	400 q12h	14
Upper Respiratory Tract
Pharyngitis/Tonsillitis	200 q12h	10a
Sinusitis	400 q12h	10
(See CLINICAL STUDIES and INDICATIONS AND USAGE for further information.)
Skin and Skin Structure
Uncomplicated Skin and Skin Structure Infections	200 q12h	7
Urinary Tract
Uncomplicated cystitis	200 q24h	7
(See CLINICAL STUDIES and INDICATIONS AND USAGE for further information.)
Uncomplicated pyelonephritis	400 q12h	14
PEDIATRIC PATIENTS (6 months to 12 years)
Upper Respiratory Tract
Acute Otitis Mediab	30 mg/kg/day in	10
	divided doses q12h
(See CLINICAL STUDIES and INDICATIONS AND USAGE for further information.)
Acute maxillary sinusitis	30 mg/kg/day in	10
	divided doses q12h
(See CLINICAL STUDIES and INDICATIONS AND USAGE for further information.)
Pharyngitis/Tonsillitis	15 mg/kg/day in	10a
	divided doses q12h
Skin and Skin Structure
Impetigo	15 mg/kg/day in	7
	divided doses q12h
a In the treatment of infections due to S. pyogenes, Lorabid should be administered for at least 10 days.
b Otitis media should be treated with the suspension. Clinical studies of otitis media were conducted with the suspension formulation only. The suspension is more rapidly absorbed than the capsules, resulting in higher peak plasma concentrations when administered at the same dose. Therefore, the capsule should not be substituted for the suspension in the treatment of otitis media (see CLINICAL PHARMACOLOGY).

PEDIATRIC DOSAGE CHART DAILY DOSE 15 mg/kg/day

		100 mg/5 mL Suspension		200 mg/5 mL Suspension
Weight		Dose given twice daily		Dose given twice daily
lb	kg	mL	tsp	mL	tsp
15	7	2.6	0.5	—	—
29	13	4.9	1.0	2.5	0.5
44	20	7.5	1.5	3.8	0.75
57	26	9.8	2.0	4.9	1.0

PEDIATRIC DOSAGE CHART DAILY DOSE 30 mg/kg/day

		100 mg/5 mL Suspension		200 mg/5 mL Suspension
Weight		Dose given twice daily		Dose given twice daily
lb	kg	mL	tsp	mL	tsp
15	7	5.2	1.0	2.6	0.5
29	13	9.8	2.0	4.9	1.0
44	20	—	—	7.5	1.5
57	26	—	—	9.8	2.0

Renal Impairment: Lorabid 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 (CLcr, mL/min). The equation assumes the patient's renal function is stable.

	(weight in kg) x (140 - age)
Males =	(72) x serum creatinine (mg/100 mL)
Females =	(0.85) x (above value)

Reconstitution Directions for Oral Suspension

Bottle Size	Reconstitution Direction
100 mL	Invert the bottle and tap to loosen powder. 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, 15–30°C (59–86°F), for 14 days without significant loss of potency. Keep tightly closed. Discard unused portion after 14 days.

HOW SUPPLIED

Pulvules:

•   200 mg, (blue and gray) (100s) NDC 61570-170-01.
•   400 mg, (blue and pink) (100s) NDC 61570-171-01.

Keep tightly closed. Store at 25°C (77°F); excursion permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from heat.

For Oral Suspension (strawberry bubble gum flavor):

•   100 mg/5 mL, (100-mL size) NDC 61570-135-10
•   200 mg/5 mL, (100-mL size) NDC 61570-136-10

Prior to mixing, store at 25°C (77°F); excursion permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].