Amoxicillin/Clav Pot Oral Susp 400 mg/5mL

Amoxicillin/Clav Pot Oral Susp · POWDER, FOR SUSPENSION · Direct_Rx

No Recall History

Plain English

Amoxicillin/Clav Pot Oral Susp is a powder, for suspension containing amoxicillin/clav pot oral susp at 400 mg/5mL, taken oral. Manufactured by Direct_Rx.

Key Facts

Brand Name: Amoxicillin/Clav Pot Oral Susp
Generic Name: Amoxicillin/Clav Pot Oral Susp
NDC Code (Product): 72189-367
Manufacturer: Direct_Rx
Strength: 400 mg/5mL
Dosage Form: POWDER, FOR SUSPENSION
Route: ORAL
Marketing Status
Application #: ANDA201090
Marketing Start: 08/08/2022

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP 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 for oral suspension, USP is 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*: 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 o…

Dosage & Administration

Amoxicillin and clavulanate potassium for oral suspension may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal. 2.1 Adults The usual adult dose is one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 250 mg/125 mg tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one amoxicillin and clavulanate potassium 875 mg/125 mg tablet every 12 hours or one amoxicillin and clavulanate potassium 500 mg/125 mg tablet every 8 hours. Adults who have difficulty swallowing may be given the 125 mg/31.25 mg per 5 mL or 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. The 200 mg/28.5 mg per 5 mL suspension or the 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. Two amoxicillin and clavulanate potassium 250 mg/125 mg table…

Contraindications

4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension.

Drug Interactions

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see WARNINGS AND PRECAUTIONS (5.1)] Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS (5.2)] CDAD [see WARNINGS AND PRECAUTIONS (5.3)] 6.1 Clinical Trials Experience 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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassiu…

Adverse Reactions

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see WARNINGS AND PRECAUTIONS (5.1)] Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS (5.2)] CDAD [see WARNINGS AND PRECAUTIONS (5.3)] 6.1 Clinical Trials Experience 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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 U.S./Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassiu…

Frequently Asked Questions

What is Amoxicillin/Clav Pot Oral Susp used for?

Amoxicillin/Clav Pot Oral Susp contains Amoxicillin/Clav Pot Oral Susp. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is Amoxicillin/Clav Pot Oral Susp a controlled substance?

Amoxicillin/Clav Pot Oral Susp is not classified as a controlled substance by the DEA.

What is the generic name for Amoxicillin/Clav Pot Oral Susp?

The generic name for Amoxicillin/Clav Pot Oral Susp is Amoxicillin/Clav Pot Oral Susp. There are no other listed brand versions of Amoxicillin/Clav Pot Oral Susp.

What is the NDC code for Amoxicillin/Clav Pot Oral Susp 400 mg/5mL?

The NDC (National Drug Code) for Amoxicillin/Clav Pot Oral Susp 400 mg/5mL is 72189-367, listed by Direct_Rx.