Amoxicillin 250/500 Capsules

Product Description

DESCRIPTION

Formulations of  MEDCLAVE  contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negativemicroorganisms. Chemically, it is (2S,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. It may be represented structurally as:

The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45.

Capsules: Each capsule of  MEDCLAVE (amoxicillin) , with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name  MEDCLAVE (amoxicillin)  and 250; the cap and body of the 500-mg capsule are imprinted with  MEDCLAVE (amoxicillin) and 500. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with  MEDCLAVE (amoxicillin)  centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Powder for Oral Suspension: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg  MEDCLAVE (amoxicillin)  as the trihydrate. Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: FD&C Red No. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

INDICATIONS

Infections Of The Ear, Nose, And Throat

 MEDCLAVE (amoxicillin)  is indicated in the treatment of infections due to susceptible (ONLY “negative) isolates of Streptococcus species.-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Infections Of The Genitourinary Tract

 MEDCLAVE (amoxicillin)  is indicated in the treatment of infections due to susceptible (ONLY -lactamase“negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Infections Of The Skin And Skin Structure

 MEDCLAVE (amoxicillin)  is indicated in the treatment of infections due to susceptible (ONLY negative) isolates of Streptococcus spp. (²-hemolytic isolates only), Staphylococcus spp., or E. coli.

Infections Of The Lower Respiratory Tract

 MEDCLAVE (amoxicillin) is indicated in the treatment of infections due to susceptible (ONLY “negative) isolates of Streptococcus spp. -hemolytic isolates only), S. pneumoniae, Staphylococcus spp., orH. influenzae.

Helicobacter Pylori Infection

Triple Therapy for Helicobacter Pylori with Clarithromycin and Lansoprazole

 MEDCLAVE (amoxicillin) , in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual Therapy for H. Pylori with Lansoprazole

 MEDCLAVE (amoxicillin) , in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, Microbiology.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of MEDCLAVE (amoxicillin) and other antibacterial drugs,  MEDCLAVE (amoxicillin) should be used only to treat infections that are proven or strongly suspected to be caused by 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.

DOSAGE AND ADMINISTRATION

Dosing For Adult And Pediatric Patients > 3 Months Of Age

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Table 1: Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

A Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. 
bThe children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

Dosing In Neonates And Infants Aged 12 Weeks (  3 Months)

Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of MEDCLAVE is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

Dosing For H. Pylori Infection

Triple therapy

The recommended adult oral dose is 1 gram MEDCLAVE, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy

The recommended adult oral dose is 1 gram MEDCLAVE and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information.

Dosing In Renal Impairment

Directions For Mixing Oral Suspension

Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension

After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

HOW SUPPLIED

Dosage Forms And Strengths

Capsules

250 mg, 500 mg. Each capsule of amoxicillin, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name amoxicillin and 250; the cap and body of the 500 mg capsule are imprinted with amoxicillin and 500.

Tablets

500 mg, 875 mg. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with amoxicillin centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side.

Powder for Oral Suspension

125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gumflavored suspension contains 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.