Label: AMOXIL- amoxicillin powder, for suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 17, 2016

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  • INDICATIONS AND USAGE

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspension, USP 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.
    Amoxicillin for Oral Suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:
    1.1 Infections of the ear, nose, and throat
    - due to Streptococcus species.
    (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
    1.2 Infections of the genitourinary tract
    - due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
    1.3 Infections of the skin and skin structure
    - due to Streptococcus spp.
    (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.
    1.4 Infections of the lower respiratory tract
    - due to Streptococcus spp.
    (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
    1.5 Gonorrhea, acute uncomplicated (ano-genital and urethral infections in males and females)
    - due to Neisseria gonorrhoeae.
    Because of high rates of Amoxicillin resistance, Amoxicillin for Oral Suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for Oral Suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to Amoxicillin.
    1.6 Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole:
    Amoxicillin for Oral Suspension, USP, 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.
    1.7 Dual therapy for H. pylori with lansoprazole:
    Amoxicillin for Oral Suspension, USP, 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.

  • DOSAGE AND ADMINSTRATION

    2.1 Dosing for Adult and Pediatric Patients > 3 Months of Age

    Except for gonorrhea, 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 Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Monthsb
    Ear/Nose/Throat
    Skin/ Skin Structure
    Genitourinary Tract Mild/
    Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
    or
    20 mg/kg/day in divided doses every 8 hours
    Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
    or
    40 mg/kg/day in divided doses every 8 hours
    Lower Respiratory Tract
    Mild/
    Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
    or
    40 mg/kg/day in divided doses every 8 hours
    Gonorrhea
    Acute, uncomplicated ano-genital and urethral infections in males and females 3 grams as single oral dose Prepubertal children:
    50 mg/kg Amoxicillin, combined with 25 mg/kg probenecid as a single dose.
    Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.

    a Dosing for infections caused by bacteria that are intermediate in their susceptibility to Amoxicillin should follow the recommendations for severe infections.
    b The 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.

    2.2 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 Amoxicillin 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

    2.3 Dosing for H. pylori Infection

    Triple therapy: The recommended adult oral dose is 1 gram Amoxicillin, 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 Amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

    Please refer to clarithromycin and lansoprazole full prescribing information.

    2.4 Dosing in Renal Impairment

    Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
    Severely impaired patients with a glomerular filtration rate of < 30 mL/min. should not receive a 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.

    2.5 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 Strength Bottle Size Amount of Water
    Required for Reconstitution
    Oral Suspension 125 mg /5 mL 80 mL 66 mL
    100 mL 83 mL
    150 mL 125 mL
    Oral Suspension 200 mg /5 mL 50 mL 39 mL
    75 mL 59 mL
    100 mL 78 mL
    Oral Suspension 250 mg /5 mL 80 mL 59 mL
    100 mL 73 ml
    150 mL 110 mL
    Oral Suspension 400 mg /5 mL 50 mL 34 mL
    75 mL 51 mL
    100 mL 68 mL

    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.

  • DOSAGE FORMS AND STRENGTHS

    for Oral Suspension:125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted fruity flavored suspension contains 125 mg, 200 mg, 250 mg or 400 mg Amoxicillin as the trihydrate.

  • CONTRAINDICATIONS

    Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin or to other β-lactam antibiotics (e.g., penicillins and cephalosporins).

  • WANRINGS AND PRECAUTIONS

  • ADVERSE REACTIONS

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  • PRINCIPAL DISPLAY PANEL

    amoxicilling oral

  • INGREDIENTS AND APPEARANCE
    AMOXIL 
    amoxicillin powder, for suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-716(NDC:0143-9889)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS250 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTUTTI FRUTTI (TUTTI FRUTTI) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-716-335 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06532203/04/2016
    Labeler - Direct_Rx (079254320)
    Registrant - Direct_Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct_Rx079254320repack(61919-716)