DrugBuyers.Com: Amoxicillin

AMOXILâ

(capsules, tablets, chewable tablets, and powder for oral suspension)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial drugs, AMOXIL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Formulations of AMOXIL contain amoxicillin, 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 amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45.

Capsules, tablets, and powder for oral suspension of AMOXIL are intended for oral administration.

Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500-mg capsule are imprinted with AMOXIL and 500. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients: Colloidal silicon dioxide, crospovidone, FD&C Red No. 30 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.

Chewable Tablets: Each cherry-banana-peppermint-flavored tablet contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 200-mg chewable tablet contains 0.0005 mEq (0.0107 mg) of sodium; the 400-mg chewable tablet contains 0.0009 mEq (0.0215 mg) of sodium. The 200-mg and 400-mg pale pink round tablets are imprinted with the product name AMOXIL and 200 or 400 along the edge of 1 side. Inactive ingredients: Aspartame*, crospovidone NF, FD&C Red No. 40 aluminum lake, flavorings, magnesium stearate, and mannitol.

AMOXIL (amoxicillin) is indicated in the treatment of infections due to susceptible (ONLY b-lactamase-negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat due to Streptococcus spp. (a- and b-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Infections of the genitourinary tract due to E. coli, P. mirabilis, or E. faecalis.

Infections of the skin and skin structure due to Streptococcus spp. (a- and b -hemolytic strains only), Staphylococcus spp., or E. coli. Infections of the lower respiratory tract due to Streptococcus spp. (a- and b -hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae. Gonorrhea, acute uncomplicated (ano-genital and urethral infections) due to N. gonorrhoeae (males and females).

H. pylori eradication to reduce the risk of duodenal ulcer recurrence Triple therapy: AMOXIL/clarithromycin/lansoprazole

AMOXIL, 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. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Dual therapy: AMOXIL/lansoprazole AMOXIL, 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 clar-ithromycin 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.

AMOXIL may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed. Patients should be counseled that antibacterial drugs, including AMOXIL, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When AMOXIL is prescribed to treat a bacterial infection, patients should be told 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 AMOXIL (amoxicillin) or other antibacterial drugs in the future.

WARNINGS
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 AMOXIL, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, AMOXIL 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.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate-to-severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.

PRECAUTIONS
General: 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.

Prescribing AMOXIL in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Phenylketonurics: Each 200-mg chewable tablet of AMOXIL contains 1.82 mg phenylalanine; each 400-mg chewable tablet contains 3.64 mg phenylalanine. The suspensions of AMOXIL (amoxicillin) do not contain phenylalanine and can be used by phenylketonurics.

Laboratory Tests: As with any potent drug, periodic assessment of renal, hepatic, and hematopoietic function should be made during prolonged therapy.

All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with amoxicillin should have a follow-up serologic test for syphilis after 3 months.

INFORMATION FOR PATIENTS

AMOXIL may be taken every 8 hours or every 12 hours, depending on the strength of the product prescribed. Patients should be counseled that antibacterial drugs, including AMOXIL, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When AMOXIL is prescribed to treat a bacterial infection, patients should be told 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 AMOXIL (amoxicillin) or other antibacterial drugs in the future.

--------------------
Tip: Try our Database to find out who has the best deals...