Amoxicillin Extended-Release

AMOXICILLIN EXTENDED-RELEASE- amoxicillin tablet, film coated, extended release
Fera Pharmaceuticals, LLC

1. INDICATIONS AND USAGE

Tonsillitis and/or Pharyngitis

Amoxicillin Extended-Release Tablets is a penicillin-class antibacterial indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes (S. pyogenes) in adults and pediatric patients 12 years and older.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin Extended-Release Tablets and other antibacterial drugs, Amoxicillin Extended-Release 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.

2. DOSAGE AND ADMINISTRATION

Tonsillitis and/or Pharyngitis

The recommended dose of Amoxicillin Extended-Release Tablets is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. The full 10-day course of therapy should be completed for effective treatment of tonsillitis and/or pharyngitis secondary to S. pyogenes.

Do not chew or crush tablet.

3. DOSAGE FORMS AND STRENGTHS

775 mg blue film-coated, oval-shaped tablets printed with “MB-111” on one side in black edible ink.

4. CONTRAINDICATIONS

Amoxicillin Extended-Release Tablets is contraindicated in patients with known serious hypersensitivity to amoxicillin or to other drugs in the same class or patients who have demonstrated anaphylactic reactions to beta-lactams.

5. WARNINGS AND PRECAUTIONS

5.1 Anaphylaxis and Hypersensitivity 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 Extended-Release Tablets, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Amoxicillin Extended-Release Tablets 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.

5.2 Clostridium difficile Associated Diarrhea (CDAD)

Clostridium difficile Associated Diarrhea (CDAD) has been reported with 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 antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two 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.

5.3 Superinfections

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, amoxicillin should be discontinued and appropriate therapy instituted.

5.4 Mononucleosis Rash

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

5.5 Development of Drug-Resistant Bacteria

Prescribing amoxicillin in the absence of proven or strongly suspected bacterial infection or treating prophylactically is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

5.6 False-Positive Urinary Glucose Tests

High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest® , Benedict’s Solution or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix®) be used.

6. ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.1 Clinical Study Experience

Tonsillitis and/or Pharyngitis

In a controlled Phase 3 trial, 302 adult and pediatric patients (≥12 years) were treated with Amoxicillin Extended-Release Tablets 775 mg once-daily for 10 days and 306 adult and pediatric patients (≥12 years) were treated with penicillin VK 250 mg QID for 10 days.

In this clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature with similar frequency reported in both treatment groups. Discontinuation due to drug-related treatment-emergent adverse reactions occurred in 1.3% of the Amoxicillin Extended-Release Tablets -treated patients and 3.3% of the penicillin VK-treated patients.

The most frequently reported adverse reactions (≥1%) which were suspected or probably drug-related are shown in Table 1.

Table 1. Drug-Related Treatment-Emergent Adverse Reactions by System Organ Class Experienced by ≥1% of Patients in Either Treatment Group – ITT/Safety Population

*Presented in decreasing order of frequency in the Amoxicillin Extended-Release Tablets column within each system organ class.

Number (%) of patients
System Organ Class/Preferred Term* Amoxicillin Extended-Release Tablets(N =302) Penicillin VK(N = 306 )
Patients with at least one drug-related treatment-emergent adverse event 32 (10.6) 45 (14.7)
Infections and infestations
Vulvovaginal mycotic infection 6 (2.0) 8 (2.6)
Gastrointestinal disorders
Diarrhea 5 (1.7) 6 (2.0)
Nausea 4 (1.3) 2 (0.7)
Vomiting 2 (0.7) 5 (1.6)
Abdominal pain 1 (0.3) 3 (1.0)
Nervous system disorders
Headache 3 (1.0) 3 (1.0)
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