Amoxicillin and Clavulanate Potassium (Page 2 of 8)

2.4 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 2 below) and shake vigorously to suspend 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 for Reconstitution

Contents of Each Teaspoonful (5 mL)

200 mg/28.5 mg per 5 mL

100 mL

92 mL

200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt

400 mg/57 mg per 5 mL

100 mL

87 mL

400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt

Note: Shake oral suspension well before using. Reconstituted suspension must be stored under refrigeration and discarded after 10 days.

3 DOSAGE FORMS AND STRENGTHS

Tablets

500 mg/125 mg Tablets: White, oblong-shaped, biconvex, film-coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

875 mg/125 mg Tablets: White, capsule-shaped, biconvex, film-coated, scored tablets, debossed 93 on one side and 22 scoreline 75 (22 │ 75) on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Powder for Oral Suspension

200 mg/28.5 mg per 5 mL: White to off-white, orange-raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).

400 mg/57 mg per 5 mL: White to off-white, orange -raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt).

Chewable Tablets

200 mg/28.5 mg Chewable Tablets: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other.

400 mg/57 mg Chewable Tablets: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other.

The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg tablet should not be used in children weighing less than 40 kg. The 250 mg tablet of amoxicillin/clavulanate potassium and the 250 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg tablet of amoxicillin/clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg chewable tablet contains 62.5 mg of clavulanic acid.

Two 250 mg tablets of amoxicillin/clavulanate potassium should NOT be substituted for one 500 mg tablet of amoxicillin/clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin/clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of amoxicillin/clavulanate potassium are not equivalent to one 500 mg tablet of amoxicillin/clavulanate potassium.

4 CONTRAINDICATIONS

4.1 Serious Hypersensitivity Reactions

Amoxicillin/clavulanate potassium 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/clavulanate potassium is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin/clavulanate potassium. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin/clavulanate potassium, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.

5.2 Hepatic Dysfunction

Hepatic dysfunction, including hepatitis and cholestatic jaundice has been associated with the use of amoxicillin/clavulanate potassium. Hepatic toxicity is usually reversible; however, deaths have been reported. Hepatic function should be monitored at regular intervals in patients with hepatic impairment.

5.3 Clostridium Difficile Associated Diarrhea (CDAD)

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin/clavulanate potassium, 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

5.4 Skin Rash in Patients With Mononucleosis

A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin/clavulanate potassium should not be administered to patients with mononucleosis.

5.5 Potential for Microbial Overgrowth

The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. If superinfection occurs, amoxicillin/clavulanate potassium should be discontinued and appropriate therapy instituted.

5.6 Phenylketonurics

Amoxicillin/clavulanate potassium chewable tablets and amoxicillin/clavulanate potassium powder for oral suspension contain aspartame which contains phenylalanine. Each 200 mg chewable tablet of amoxicillin/clavulanate potassium contains 3.4 mg phenylalanine. Each 400 mg chewable tablet contains 6.7 mg phenylalanine. Each 5 mL of the 200 mg/28.5 mg per 5 mL oral suspension contains 0.67 mg phenylalanine. Each 5 mL of the 400 mg/57 mg per 5 mL oral suspension contains 1.12 mg phenylalanine. The other formulations of amoxicillin/clavulanate potassium do not contain phenylalanine.

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