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Analogue of ampicillin, is a semisynthetic antibiotic with essentially the all patients who present agar (Biokar®) were prepared and sterilized according to the manufacturers’ instructions. Another drug and may not reflect the rates.

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Mixing oral suspension: Tap bottle until all powder flows freely; add approximately one third of the total amount of water for reconstitution and shake vigorously to wet powder; add remainder of water and shake vigorously again.

After reconstitution, place required amount of suspension directly on child's tongue for swallowing; if taste is unacceptable, required amount of suspension can be added to formula, milk, fruit juice, water, ginger ale, or other cold drinks; preparation must be taken immediately. Shake suspension well before using; any unused portion must be discarded after 14

days

.

What Are Side Effects Associated with Using Amoxicillin? Common side effects of amoxicillin include: acuteallergic reaction anemia elevated liverenzymes persistent superficial infections of the skin diarrhea headache nausea vomiting rash antibiotic associated inflammation of the colon serum sickness-like reactions.

Post marketing side effects of Amoxicillin reported include: persistent superficial infections of the skin gastrointestinal black hairy tongue hemorrhagic/pseudomembranous colitis (may occur during or after treatment) Hypersensitivity reactions liver dysfunction cholestatic jaundice hepaticcholestasis acute cytolytic hepatitis Renal (crystalluria) Anemia hemolytic anemia Low platelet count (thrombocytopenia) thrombocytopenic purpura eosinophilia Low white blood cell count (leukopenia) agranulocytosis Central nervous system reactions reversible hyperactivity agitation anxiety insomnia confusion convulsions behavioral changes dizziness Tooth discoloration (brown, yellow or gray staining) This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. If your doctor has directed you to use this medication for diabetes, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.

Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of Amoxicillin include: Amoxicillin has moderate interactions with at least 27 different drugs.

Mild Interactions of Amoxicillin include: amiloride azithromycin aztreonam chloramphenicol clarithromycin erythromycin base erythromycin ethylsuccinate erythromycin lactobionate erythromycin stearate pyridoxine (antidote) This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Documented hypersensitivity to penicillins, cephalosporins, and imipenem.

Do not take Amoxil, Moxatag, or Trimox, if you are allergic to amoxicillin or any ingredients contained in this drug.

In case of overdose, get medical help or contact a Poison Control Center immediately. See "What Are Side Effects Associated with Using Amoxicillin?" Long-Term Effects. See "What Are Side Effects Associated with Using Amoxicillin?" Cautions.

Severe allergic reaction has been reported rarely but is more likely to occur following parenteral therapy with penicillins.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents; severity may range from mild diarrhea to fatal colitis; CDAD may occur over 2 months after discontinuation of therapy; if CDAD is suspected or confirmed, discontinue immediately and begin appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation.

Do not administer in patients with infectious mononucleosis or mono because of risk of development of red skin rash.

Do not administer to patients in the absence of a proven or suspected bacterial infection because of risk of development of drug-resistant bacteria. Superinfections with bacterial or fungal pathogens may occur during therapy; if suspected, discontinue immediately and begin appropriate treatment. Chewable tablets contain aspartame, which contains phenylalanine. Use caution in patients with allergy to cephalosporins, carbapenems. Endocarditis prophylaxis: use for only high-risk patients, as per recent AHA guidelines.

High doses may cause false urine glucose test by some methods.

Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

Amoxicillin is a penicillin antibiotic that is used to treat many different types of infection caused by bacteria, such as tonsillitis, bronchitis, pneumonia, and infections of the ear, nose, throat, skin, or urinary tract.

Amoxicillin is also sometimes used together with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination is sometimes used with a stomach acid reducer called lansoprazole (Prevacid).

Amoxicillin may also be used for purposes not listed in this medication guide. Bacterial Endocarditis Prophylaxis Helicobacter pylori Infection Lyme Disease -- Arthritis Lyme Disease -- Carditis Lyme Disease -- Erythema Chronicum Migrans Otitis Media Pneumonia Sinusitis Skin or Soft Tissue Infection Tonsillitis/Pharyngitis Urinary Tract Infection Skin and Structure Infection Bronchitis Chlamydia Infection Lyme Disease Tuberculosis - Urinary Tract Infection - Bacterial/Fungal/Protozoal/Viral Inhalation Bacillus anthracis Cutaneous Bacillus anthracis Anthrax Prophylaxis. What is the most important information I should know about amoxicillin ? You should not use this medicine if you are allergic to any penicillin antibiotic, such as ampicillin, dicloxacillin, oxacillin, penicillin, or ticarcillin.

Tell your doctor if you have ever had: kidney disease; mononucleosis (also called "mono"); diarrhea caused by taking antibiotics; or food or drug allergies (especially to a cephalosporin antibiotic such as Omnicef, Cefzil, Ceftin, Keflex, and others). It is not known whether this medicine will harm an

unborn

baby.

Tell your doctor if you are pregnant or plan to become pregnant. Amoxicillin can make birth control pills less effective.

Ask your doctor about using a non-hormonal birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy.

It may not be safe to breastfeed while using this medicine.

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following: Conditions: diarrhea from an infection with Clostridium difficile bacteria mononucleosis the kissing disease liver problems blockage of normal bile flow severe renal impairment.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise

and

judgment of healthcare professionals.

The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else.

A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

AMOXIL (amoxicillin) Capsules, Tablets, or Powder for Oral Suspension. 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,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.

It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.45.

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.

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.

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. Powder for Oral Suspension : Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125-mg reconstituted suspension contains 0.11 mEq (2.51 mg) of sodium.

Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium.

Each 5 mL of the 250-mg reconstituted suspension contains 0.15 mEq (3.36 mg) of sodium; each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. 3, flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus species.

(?-and ?-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae . AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis .

AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus spp.

(?-and ?-hemolytic isolates only), Staphylococcus spp., or E. AMOXIL® is indicated in the treatment of infections due to susceptible (ONLY ?-lactamase–negative) isolates of Streptococcus spp.

Triple Therapy for Helicobacter Pylori with Clarithromycin and 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 has been shown to reduce the risk of duodenal ulcer recurrence.

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 clarithromycin 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. 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 infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or amoxicillin for uti in pregnancy modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Dosing For Adult And Pediatric Patients > 3 Months Of Age. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus

pyogenes

to prevent the occurrence of acute rheumatic fever.

In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.

Table 1: Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age Infection Severity a Usual Adult Dose Usual Dose for Children > 3 Months b Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. b The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

Dosing In Neonates And Infants Aged ? 12 Weeks ( ? 3 Months) Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

It is recommended that there be at least 10 days' treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided every 12 hours.

There are currently no dosing recommendations for pediatric patients with impaired renal function. The recommended adult oral dose is 1 gram AMOXIL, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

The recommended adult oral dose is 1 gram AMOXIL and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.



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