Drug Catalog - Product Detail
AMOXICILLIN/POT CLAV 250-125MG TAB 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 16714-0476-01 | NORTHSTAR RX | 30 | 250-125MG | TABLET |
PACKAGE FILES
Generic Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Substance Name
AMOXICILLIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA065063
Description
11 DESCRIPTION Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S, 5 R, 6 R )-6-[( R )-(-)-2-Amino-2-( p hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8 H 8 KNO 5 , and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z )( 2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: Inactive Ingredients Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. amoxicillin-chemical-structure clavulanate-potassium-chemical-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 76420-503-30 bottle of 30 Tablets (relabeled from NDC 16714-476-01) Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 76420-507-20 bottle of 20 Tablets (relabeled from NDC 16714-477-01) Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 76420-501-20 bottle of 20 Tablets (relabeled from NDC 16714-014-01) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container; advise patient to keep in closed container. KEEP OUT OF THE REACH OF CHILDREN.
Indications & Usage
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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. Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below: Amoxicillin and clavulanate potassium tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections ( 1.1 ) Acute bacterial otitis media ( 1.2 ) Sinusitis ( 1.3 ) Skin and skin structure infections ( 1.4 ) Urinary tract infections ( 1.5 ) 1.1 Lower Respiratory Tract Infections Caused by beta-lactamase producing isolates of Haemophilus influenzae and Moraxella catarrhalis . 1.2 Acute Bacterial Otitis Media Caused by beta-lactamase producing isolates of H.influenzae and M.catarrhalis . 1.3 Sinusitis Caused by beta-lactamase producing isolates of H.influenzae and M.catarrhalis . 1.4 Skin and Skin Structure Infections Caused by beta-lactamase producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. 1.5 Urinary Tract Infections Caused by beta-lactamase producing isolates of E.coli , Klebsiella species, and Enterobacter species. 1.6 Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal. Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours. ( 2.1 , 2.2 ) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.2 ) Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. ( 2.2 ) 2.1 Adults The usual adult dose is one 500 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet of amoxicillin and clavulanate potassium every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet of amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet of amoxicillin and clavulanate potassium every 8 hours. 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. Two 250 mg tablets of amoxicillin and clavulanate potassium should not be substituted for one 500 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet should not be substituted for each other, as they are not interchangeable. The 250 mg tablet of amoxicillin and clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid (as the potassium salt). The 250 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid, whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid. 2.2 Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged <12 weeks (<3 months) The recommended dose of Amoxicillin and clavulanate potassium is 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Experience with the 200 mg/5 mL formulation in this age group is limited, and thus, use of the 125 mg/5 mL oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older See dosing regimens provided in Table 1 . The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies ( 14.2 )] . However, the every 12 hour suspension (200 mg/5 mL and 400 mg/5 mL) and chewable tablets (200 mg and 400 mg) contain aspartame and should not be used by phenylketonurics. Table 1: Dosing in Patients Aged 12 weeks (3 months) and Older DOSING REGIMEN Every 12 hours Every 8 hours INFECTION 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 every 12 hours 40 mg/kg/day every 8 hours Less severe infections 25 mg/kg/day every 12 hours 20 mg/kg/day every 8 hours * Each strength of suspension of amoxicillin and clavulanate potassium is available as a chewable tablet for use by older children. † Duration of therapy studied and recommended for acute otitis media is 10 days. Patients Weighing 40 kg or More Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations. The 250 mg tablet of amoxicillin and clavulanate potassium should not be used until the child weighs at least 40 kg, due to the different amoxicillin to clavulanic acid ratios in the 250 mg tablet of amoxicillin and clavulanate potassium (250 mg/125 mg) versus the 250 mg chewable tablet of amoxicillin and clavulanate potassium (250 mg/62.5 mg). 2.3 Patients with Renal Impairment Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of <30 mL/min should not receive the 875 mg dose. Patients with a glomerular filtration rate of 10 to 30 mL/min should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a glomerular filtration rate less than 10 mL/min should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.