Amoxicillin Capsule Amoxicillin For Suspension Amoxicillin
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Questions & Answers
Side Effects & Adverse Reactions
Anaphylactic Reactions
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. ALTHOUGH ANAPHYLAXIS IS MORE FREQUENT FOLLOWING PARENTERAL THERAPY, IT HAS OCCURRED IN PATIENTS ON ORAL PENICILLINS. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH AMOXICILLIN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXICILLIN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Clostridium difficile Associated Diarrhea
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, 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.
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due tosusceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below:
Infections of the Ear, Nose, and Throat
– due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
Infections of the Genitourinary Tract
– due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
Infections of the Skin and Skin Structure
– due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.
Infections of the Lower Respiratory Tract
– due to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Gonorrhea, Acute Uncomplicated (Ano-Genital and Urethral Infections in Males and Females)
– due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin is not recommended for empiric treatment of gonorrhea. Amoxicillin use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.
Triple Therapy for Helicobacter pyloriwith Clarithromycin and Lansoprazole
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
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. [See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION].
History
There is currently no drug history available for this drug.
Other Information
Amoxicillin is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2S,5R,6R)-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. The structural formula is:
C16H19N3O5S•3H2O M.W. 419.45
Amoxicillin Capsules, USP
Each capsule, for oral administration, provide amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin
Inactive Ingredients: CAPSULES-DRUG PRODUCT: Magnesium Stearate, Sodium Lauryl Sulfate.
CAPSULE SHELL AND PRINT CONSTITUENTS: Gelatin, Sodium Lauryl Sulfate, Titanium Dioxide, D&C Red No. 33; FD&C Blue No. 1; FD&C Red No. 40; FD&C Yellow No. 6. In addition, each 250 mg capsule contains up to 0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to 0.0052 mEq (0.119 mg) of sodium.
Amoxicillin for Oral Suspension, USP
Each 5 mL of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg or 250 mg of amoxicillin, when the dry powder is reconstituted according to directions.Inactive Ingredients: SUSPENSION: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide, Flavors, Microcrystalline Cellulose, Sodium Citrate, Sodium Propionate, Sucrose, FD&C Red No. 40, FD&C Yellow No. 6. In addition, each 5 mL of the 125 mg reconstituted suspension contains up to 0.209 mEq (4.80 mg) of sodium; each 5 mL of the 250 mg reconstituted suspension contains up to 0.417 mEq (9.60 mg) of sodium.
Amoxicillin Tablets, USP
Each tablet, for oral administration, provide amoxicillin trihydrate equivalent to 875 mg amoxicillin.
Inactive Ingredients: TABLETS: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Soy Lecithin, Talc, Titanium Dioxide. In addition, each tablet contains up to 0.032 mEq (0.74 mg) of Sodium.
Amoxicillin Tablets, USP (Chewable)
Each chewable tablet, for oral administration, contains amoxicillin trihydrate equivalent to 125 mg or 250 mg amoxicillin.Inactive Ingredients: CHEWABLE TABLETS: Aspartame*, Flavor, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, FD&C Red No. 40. THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY PHENYLKETONURICS: CONTAINS PHENYLALANINE. [*see PRECAUTIONS].
Sources
Amoxicillin Capsule Amoxicillin For Suspension Amoxicillin Manufacturers
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Dava Pharmaceuticals, Inc.
![Amoxicillin Capsule Amoxicillin For Suspension Amoxicillin Tablet Amoxicillin Tablet, Chewable [Dava Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Amoxicillin Capsule Amoxicillin For Suspension Amoxicillin | Dava Pharmaceuticals, Inc.
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 4. Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age
* Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
† 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.
Infection
Severity*
Usual Adult Dose
Usual Dose for Children > 3 Months†
Ear/Nose/Throat
Skin/Skin Structure
Genitourinary Tract
Mild/Moderate
500 mg every 12 hours
or250 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
or500 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
or500 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.
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 is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. NOTE: Chewable tablets (125 mg and 250 mg) contain aspartame and should not be used by phenylketonurics. [see PRECAUTIONS]
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.
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.Directions for Mixing Oral Suspension
Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/2 of the total amount of water for reconstitution (see Table 5) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. Each teaspoon (5 mL) will contain 125 mg or 250 mg of amoxicillin.
Table 5. Amount of Water for Mixing Oral Suspension
Strength
Bottle Size
Amount of Water
Required for Reconstitution
Oral Suspension 125 mg/5 mL
80 mL
69 mL
100 mL
86 mL
150 mL
128 mL
Oral Suspension 250 mg/5 mL
80 mL
56 mL
100 mL
70 mL
150 mL
104 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.
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