Amoxicillin and Clavulanate Potassium

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Amoxicillin and clavulanate potassium for oral suspension does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium.
• Amoxicillin and clavulanate potassium for oral suspension contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL.
• Therefore, the 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL suspensions of amoxicillin and clavulanate potassium should not be substituted for amoxicillin and clavulanate potassium for oral suspension as they are not interchangeable.
• Dosage:
• Pediatric patients 3 months and older:
• Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below).
• This dose provides 6.4 mg/kg/day of the clavulanic acid component.
• Body Weight (kg) Volume of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension providing 90 mg/kg/day 8 3 mL twice daily 12 4.5 mL twice daily 16 6 mL twice daily 20 7.5 mL twice daily 24 9 mL twice daily 28 10.5 mL twice daily 32 12 mL twice daily 36 13.5 mL twice daily Pediatric patients weighing 40 kg and more:
• Experience with amoxicillin and clavulanate potassium for oral suspension in this group is not available.
• Adults:
• Experience with amoxicillin and clavulanate potassium for oral suspension in
• adults is not available and
• adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension in place of the 500 mg or 875 mg tablet of amoxicillin and clavulanate potassium.
• Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see WARNINGS and PRECAUTIONS (5) ].
• Directions for Mixing Oral Suspension:
• Prepare a suspension at time of dispensing as follows:
• Tap bottle until all the powder flows freely.
• Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder.
• Add remainder of the water and again shake vigorously.
• Amoxicillin and Clavulanate Potassium for Oral Suspension Bottle Size Amount of Water Required for Reconstitution 75 mL 71 mL 125 mL 112 mL 200 mL 176 mL Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.
• NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.
• Information for the Pharmacist:
• For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension.
• The resulting suspension is stable for 10 days under refrigeration.
• Stability of amoxicillin and clavulanate potassium for oral suspension when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the five flavors listed above.
• Administration:
• To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension should be taken at the start of a meal.
• Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension is administered at the start of a meal.
• Pediatric Patients less than 40 kg:
• 90 mg/kg/day divided every 12 hours, administered for 10 days.
• ( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension in infants younger than 3 months have not been established.
• Safety and efficacy of amoxicillin and clavulanate potassium for oral suspension have been demonstrated for treatment of acute otitis media in infants and
• children 3 months to 12 years [see Description of Clinical Studies (14) ].
• The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension have been established for the treatment of pediatric patients (3 months to 12 years) with acute bacterial sinusitis.
• This use is supported by evidence from adequate and well-controlled studies of amoxicillin and clavulanate potassium extended-release tablets in
• adults with acute bacterial sinusitis, studies of amoxicillin and clavulanate potassium for oral suspension in pediatric patients with acute otitis media, and by similar pharmacokinetics of amoxicillin and clavulanate in pediatric patients taking amoxicillin and clavulanate potassium for oral suspension [see CLINICAL PHARMACOLOGY (12) ] and
• adults taking amoxicillin and clavulanate potassium extended-release tablets.

Quoted from the official label, section “Pediatric Use”.

Side effects

• The most frequently reported adverse reactions were diaper rash (4%), diarrhea (3%), vomiting (2%), candidiasis (1%), and rash (1%).
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trial 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.
• Two clinical trials evaluated the safety of a 10 day treatment course of amoxicillin and clavulanate potassium for oral suspension 90/6.4 mg/kg/day, divided every 12 hours, in pediatric patients with acute otitis media [see Clinical Studies (14)] .
• The first trial involved 521 pediatric patients (3 months to 50 months) and the second trial involved 450 pediatric patients (3 months to 12 years).
• In the intent-to-treat population of the first trial of 521 patients, the most frequently reported adverse events were vomiting (7%), fever (6%), contact dermatitis (i.e., diaper rash) (6%), upper respiratory tract infection (4%), and diarrhea (4%).
• Protocol-defined diarrhea (i.e., 3 or more watery stools in one day or 2 watery stools per day for 2 consecutive days as recorded on diary cards) occurred in 13% of patients.
• The primary objective of the second study was to compare the safety of amoxicillin and clavulanate potassium for oral suspension (90/6.4 mg/kg/day, divided every 12 hours) to amoxicillin and clavulanate potassium (45/6.4 mg/kg/day, divided every 12 hours) for ten days.
• There was no statistically significant difference between treatments in the proportion of patients with 1 or more adverse events.
• The most frequently reported adverse reactions for amoxicillin and clavulanate potassium for oral suspension and the comparator of amoxicillin and clavulanate potassium were coughing (12% versus 7%), vomiting (7% versus 8%), contact dermatitis (i.e., diaper rash, 6% versus 5%), fever (6% versus 4%), and upper respiratory infection (3% versus 9%), respectively.
• The frequencies of protocol-defined diarrhea with amoxicillin and clavulanate potassium for oral suspension (11%) and amoxicillin and clavulanate potassium (9%) were not statistically different.
• Two patients in the group treated with amoxicillin and clavulanate potassium for oral suspension and one patient in the group treated with amoxicillin and clavulanate potassium were withdrawn due to diarrhea.
• 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium products, including amoxicillin and clavulanate potassium for oral suspension.
• Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
• These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium.
• Gastrointestinal :
• Nausea, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudo membranous colitis.
• Onset of pseudomembranous colitis symptoms may occur during or after antibacterial drug treatment.
• Hypersensitivity Reactions :
• Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see Warnings and Precautions (5.1) ].
• Liver :
• A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterial drugs.
• Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium or amoxicillin and clavulanate potassium for oral suspension.
• It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment.
• The histologic findings on liver biopsy have consisted of cholestatic, hepatocellular, or mixed cholestatic-hepatocellular changes.
• The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued.
• The hepatic dysfunction, which may be severe, is usually reversible.
• Deaths have been reported [see Contraindications (4.2) , Warnings and Precautions (5.2) ].
• Renal :
• Interstitial nephritis, hematuria, and crystalluria have been reported [see Overdosage (10) ] .
• Hemic and Lymphatic Systems :
• Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins.
• These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
• There have been reports of increased prothrombin time in patients receiving amoxicillin and clavulanate potassium and anticoagulant therapy concomitantly.
• Central Nervous System :
• Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity have been reported.
• Miscellaneous : Tooth discoloration (brown, yellow, or gray staining) has been reported.
• Most reports occurred in pediatric patients.
• Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Take amoxicillin and clavulanate potassium for oral suspension every 12 hours with a meal or snack to reduce the possibility of gastrointestinal upset.
• If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor.
• Counsel patients that antibacterial drugs, including amoxicillin and clavulanate potassium for oral suspension, should only be used to treat bacterial infections.
• Antibacterial drugs do not treat viral infections (e.g., the common cold).
• When amoxicillin and clavulanate potassium for oral suspension is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
• Skipping doses or not completing the full course of therapy may:
• (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin and clavulanate potassium for oral suspension or other antibacterial drugs in the future.
• Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued.
• Sometimes after starting treatment with antibacterial drugs, patient can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken the last dose of the antibacterial drug.
• If this occurs, patients should contact their physician as soon as possible.
• Keep suspension refrigerated.
• Shake well before using.
• When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium for oral suspension, use a dosing spoon or medicine dropper.
• Be sure to rinse the spoon or dropper after each use.
• Bottles of suspension of amoxicillin and clavulanate potassium for oral suspension may contain more liquid than required.
• Follow your doctor’s instructions about the amount to use and the days of treatment your child requires.
• Discard any unused medicine.
• Counsel patients that amoxicillin and clavulanate potassium for oral suspension contains a penicillin class drug product that can cause allergic reactions in some individuals.
• Counsel patients with phenylketonuria:
• Each 5 mL of the 600 mg/42.9 mg per 5 mL suspension of amoxicillin and clavulanate potassium for oral suspension contains 7.02 mg phenylalanine.
• The brands listed are trademarks of their respective owners and are not trademarks of the Aurobindo Pharma Limited.
• Manufactured for: Northstar Rx LLC Memphis, TN 38141.
• Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India.
• M.L.No.: 57/RR/AP/2003/F/R Revised: 12/2018

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Powder for Oral Suspension:
• 600 mg/42.9 mg per 5 mL:
• Strawberry-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg amoxicillin and 42.9 mg of clavulanic acid as the potassium salt). 600 mg/42.9 mg per 5 mL.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, strawberry flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt.
• NDC 68071-2355-5 BOTTLE OF 75mL Storage Store reconstituted suspension under refrigeration.
• Discard unused suspension after 10 days.
• Store dry powder for oral suspension at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
• Dispense in original container.

Quoted from the official label, section “How Supplied”.

What is in it

• Amoxicillin and clavulanate potassium for oral suspension, USP is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 0 5 S
• 3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S ,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 and may be represented structurally as:
• Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of beta - lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated beta-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C 8 H 8 KN0 5 and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z )-(2 R ,5 R )-3-(2-hydroxyethylidene) -7-oxo-4-oxa- 1-azabicyclo [3.2.0] - heptane-2­-carboxylate and may be represented structurally as:
• Amoxicillin and clavulanate potassium for oral suspension, USP is white to off-white granular powder and becomes white to pale yellow suspension with strawberry flavor after reconstitution. Inactive Ingredients:
• —Aspartame*, colloidal silicon dioxide, hypromellose, silicon dioxide, strawberry cream permaseal, succinic acid, and xanthan gum [see Warnings and Precautions (5.6) ]. Each 5 mL of reconstituted amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL contains 600 mg amoxicillin as the trihydrate and 42.9 mg clavulanic acid as the potassium salt (clavulanate potassium). The potassium content per 5 mL is 0.21 mEq. Amoxicillin chemical structure clavulanate potassium chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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