Hydroxyzine (Hydroxyzine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Amoxicillin and clavulanate potassium chewable tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower Respiratory Tract Infections – caused by ß-lactamase–producing strains of H. influenzae and M. catarrhalis.

Otitis Media – caused by ß-lactamase–producing strains of H. influenzae and M. catarrhalis.

Sinusitis – caused by ß-lactamase–producing strains of H. influenzae and M. catarrhalis.

Skin and Skin Structure Infections – caused by ß-lactamase–producing strains of S. aureus, E. coli, and Klebsiella spp.

Urinary Tract Infections – caused by ß-lactamase–producing strains of E. coli, Klebsiella spp. and Enterobacter spp.

While amoxicillin and clavulanate potassium chewable tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium chewable tablets due to their amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and ß-lactamase–producing organisms susceptible to amoxicillin and clavulanate potassium chewable tablets should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against S. pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin and clavulanate potassium chewable tablets (see Microbiology).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium chewable tablets and other antibacterial drugs, amoxicillin and clavulanate potassium chewable tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin and clavulanate potassium chewable tablets, should be performed together with any indicated surgical procedures.

DOSAGE AND ADMINISTRATION

Dosage

Pediatric Patients

Based on the amoxicillin component, amoxicillin and clavulanate potassium tablets USP, (chewable) should be dosed as follows:

Neonates and infants aged < 12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin and clavulanate potassium tablets USP, (chewable) is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/28.5 mg per 5 mL formulation in this age group is limited and, thus, use of the 125 mg/31.25 per 5 mL oral suspension is recommended.

Patients Aged 12 Weeks (3 Months) and Older

* The q12h regimen is recommended as it is associated with significantly less diarrhea (see CLINICAL STUDIES). However, the q12h formulations (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. † Each strength of amoxicillin and clavulanate potassium suspension is available as a chewable tablet for use by older children. ‡ Duration of therapy studied and recommended for acute otitis media is 10 days.
INFECTIONS	DOSING REGIMEN
	q12h *	q8h
	200 mg/5 mL or 400 mg/5 mL oral suspension†	125 mg/5 mL or 250 mg/5 mL oral suspension
Otitis media‡, sinusitis, lower respiratory tract infections, and more severe infections	45 mg/kg/day q12h	40 mg/kg/day q8h
Less severe infections	25 mg/kg/day q12h	20 mg/kg/day q8h

Pediatric Patients Weighing 40 kg and More: Should be dosed according to the following adult recommendations: The usual adult dose is one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 250 mg/125 mg every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium tablet, 875 mg/125 mg every 12 hours or one amoxicillin and clavulanate potassium tablet, 500 mg/125 mg every 8 hours. Among adults treated with 875 mg/125 mg tablets every 12 hours, significantly fewer experienced severe diarrhea or withdrawals with diarrhea versus adults treated with 500 mg/125 mg tablets every 8 hours. For detailed adult dosage recommendations, please see complete prescribing information for amoxicillin and clavulanate potassium tablets.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals (see WARNINGS).

Adults

Adults who have difficulty swallowing may be given the 125 mg/5 mL or 250 mg/5 mL suspension in place of the 500 mg tablet. The 200 mg/5 mL suspension or the 400 mg/5 mL suspension may be used in place of the 875 mg tablet. See dosage recommendations above for children weighing 40 kg or more.

The amoxicillin and clavulanate potassium 250 mg tablet and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The amoxicillin and clavulanate potassium 250 mg tablet contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. Therefore, the amoxicillin and clavulanate potassium 250 mg tablet and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable.

Due to the different amoxicillin to clavulanic acid ratios in the amoxicillin and clavulanate potassium 250 mg tablet (250/125) versus the amoxicillin and clavulanate potassium 250 mg chewable tablet (250/62.5), the amoxicillin and clavulanate potassium 250 mg tablet should not be used until the child weighs at least 40 kg and more.

Administration

Amoxicillin and clavulanate potassium tablets USP, (chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets USP, (chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets USP, (chewable) should be taken at the start of a meal.

HOW SUPPLIED

Amoxicillin and clavulanate potassium tablets USP, (chewable) are available as follows:

200 mg/28.5 mg - mottled pink, oval, biconvex tablets, debossed with “93” on one side and “2270” on the other side in bottles of 20 tablets.

400 mg/57 mg - mottled pink, oval, biconvex tablets, debossed with “93” on one side and “2272” on the other side in bottles of 20 tablets.

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).