Amoxicillin formulations

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    Amoxicillin formulations


    It inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Amoxicillin: Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus 6-aminopenicillanic acid. pneumoniae with reduced susceptibility to penicillin Amoxy-Clav is an oral antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the β-lactamase inhibitor clavulanate potassium (the potassium salt of clavulanic acid). Treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase−producing pathogens and S. Clavulanic Acid: It is a β-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of β-lactamases by blocking the active sites of these enzymes. Phone : 079-4903 0903/50 Fax : 079-4903 0915 Email : [email protected]: It inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Amoxicillin inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. The aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil®) and the other one with the generic tablet Amoxicare®, with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC0-8, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. Cmax and AUC0-∞ were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of Cmax and AUC0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable.

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    Amoxicillin Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus 6-aminopenicillanic acid. It inhibits cross-linkage between the linear peptidoglycan polymer chains that make up a major component of the cell walls of both Gram-positive and Gram-negative bacteria. Generic Name and Formulations Amoxicillin as trihydrate 125mg/5mL, 250mg/5mL; raspberry-strawberry flavor. Company Various generic manufacturers. AMOXIL amoxicillin Capsules, Tablets, or Powder for Oral Suspension. DESCRIPTION. 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.

    Some clinicians select amoxicillin over penicillin VK to treat odontogenic infection because of a more convenient dosing regimen e.g., 2-3 doses daily for amoxicillin versus 4 doses daily for penicillin VK. Except for coverage of Haemophilus influenzae in acute sinus and otitis media infections, amoxicillin is not any more effective than penicillin VK for the treatment of odontogenic infections. It is less effective than penicillin VK against aerobic gram-positive cocci and similar in efficacy against anaerobes. Thus penicillin VK is the drug of choice for treating odontogenic infections. Contraindications: Hypersensitivity to amoxicillin, penicillin or any component of the formulation. Warnings/Precautions: Use with caution in patients with severe renal impairment (modify dosage); low incidence of cross-allergy with other beta-lactams and cephalosporins exists. The usual daily oral dose for treating odontogenic infections in children is: Children under 12 years: 20-40 mg/kg divided in 2-3 doses daily for 10 days. The invention is directed to a pediatric oral suspension composition containing amoxicillin and clavulanate potassium where the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 m L, and a method of treating bacterial infections by providing between about one to about fourteen dosage days of the composition. A liquid composition for treating pediatric otitis media comprising amoxicillin and clavulanate potassium in a ratio of greater than 28:1, wherein the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 m L. The liquid composition of claim 1 wherein the ratio is between about 28:1 to about 56:1 and the amount of clavulanate potassium is present in an amount of about 5 mg/5 m L to about 21.5 mg/5 m L. The liquid composition of claim 1 wherein the ratio is about 35:1 and the amount of clavulanate potassium is present in an amount of about 17 mg/5 m L. The liquid composition of claim 1 wherein the amoxicillin is present in an amount of about 200 mg/5 m L to about 600 mg/5 m L and the clavulanate potassium is present in an amount of about 0.1 mg/5 m L to about 21.5 mg/5 m L. The liquid composition of claim 1 which is an oral suspension. A pediatric oral suspension comprising amoxicillin and clavulanate potassium wherein the amoxicillin is present in an amount of about 600 mg/5 m L and the clavulanate potassium is present in an amount of about 21.5 mg/5 m L, with the ratio of amoxicillin to clavulanate potassium is about 28:1. The composition of claim 6 wherein the amoxicillin is present in an amount of about 90 mg/kg per day per pediatric patient and the clavulanate potassium is present in an amount of about 3.2 mg/kg per day. A method of treating pediatric otitis media in patients under 24 months of age which comprises providing two or more dosages of an oral suspension containing amoxicillin combined with clavulanate potassium at a ratio of about 28:1 wherein the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 m L. The method of claim 8 wherein the initial dosage has more clavulanate potassium than subsequent dosages. The method of claim 8 wherein the dosages are given for up to fourteen days. The method of claim 8 wherein the amount of amoxicillin in each dosage is from about 200 to about 600 mg/5 m L of suspension and the amount of clavulanate potassium in the first dosage is from about 0.1 to about 21.5 mg/5 m L of suspension. The method of claim 8 wherein the amount of amoxicillin in each dosage is about 90 mg/kg per day per pediatric patient and the clavulanate potassium is present in an amount of about 3.2 mg/kg per day. The method of claim 8 further comprising adding a pain reduction medication to the oral suspension. The method of claim 13 wherein the medication is chosen from acetaminophen, non-steroidal anti-inflammatory medication, or antipyretic medication. A method of treating pediatric patients under 24 months of age for a drug resistant bacteria infection which comprises providing two or more dosages of an oral suspension containing amoxicillin combined with clavulanate potassium at a ratio of about 28:1 wherein the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 m L. The method of claim 15 wherein the initial dosage has more clavulanate potassium than subsequent dosages. The method of claim 15 wherein the dosages are given for up to fourteen days. The method of claim 15 wherein the amount of amoxicillin in each dosage is from about 200 to about 600 mg/5 m L of suspension and the amount of clavulanate potassium in the first dosage is from about 0.1 to about 21.5 mg/5 m L of suspension. The method of claim 15 wherein the amount of amoxicillin in each dosage is about 90 mg/kg per day per pediatric patient and the clavulanate potassium is present in an amount of about 3.2 mg/kg per day. The method of claim 15 further comprising adding a pain reduction medication to the oral suspension. The method of claim 20 wherein the medication is chosen from acetaminophen, non-steroidal anti-inflammatory medication, or antipyretic medication. The method of claim 15 wherein the antimicrobial resistant bacterial infection is selected from streptococcus pneumoniae, haemophilus influenzae, and Moraxella catarrhalis. A method of treating beta-lactamase producing haemophilus influenzae and Moraxella catarrhalis in pediatric patients under 24 months of age which comprises providing two or more dosages of an oral suspension containing amoxicillin combined with clavulanate potassium at a ratio of about 28:1 wherein the clavulanate potassium is present in an amount equal to or less than about 21.5 mg/5 m L. The method of claim 23 wherein the initial dosage has more clavulanate potassium than subsequent dosages. The method of claim 23 wherein the dosages are given for up to fourteen days. The method of claim 23 wherein the amount of amoxicillin in each dosage is from about 200 to about 600 mg/5 m L of suspension and the amount of clavulanate potassium in the first dosage is from about 0.1 to about 21.5 mg/5 m L of suspension. The method of claim 23 wherein the amount of amoxicillin in each dosage is about 90 mg/kg per day per pediatric patient and the clavulanate potassium is present in an amount of about 3.2 mg/kg per day. The method of claim 23 further comprising adding a pain reduction medication to the oral suspension. The method of claim 28 wherein the medication is chosen from acetaminophen, non-steroidal anti-inflammatory medication, or antipyretic medication. The invention is for a pediatric oral suspension composition comprised of amoxicillin and clavulanate potassium. For pediatric administration of supplements and pharmaceuticals it is well recognized by those of skill in the art that solutions or liquid suspensions are highly preferable dosage forms. Tablets and capsules are difficult for children to swallow and the amount of drug delivered is not as flexible as is often required for pediatric drugs. With liquid dosage forms, by contrast, the amount of drug delivered to the patient can be varied over a wide range merely by regulating the volume of dose of known concentrations. From the perspectives of ease of use, accuracy of dose, and bioavailability, oral liquid dosage forms are generally preferred to be in the form of a solution. From the perspective of taste, oral liquid dosage forms are generally preferred to be in the form of a suspension which tends to mask the taste of the drug.

    Amoxicillin formulations

    Amoxicillin Capsules, for Oral Suspension, and Tablets Chewable., Amoxicillin Suspension Dosage & Rx Info Uses, Side Effects

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    Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers Mario Del Tacca, 1, 2 Giuseppe Pasqualetti, 1, 2 Antonello Di Paolo, 2 Agostino Virdis, 3 Gabriele Massimetti, 4 Giovanni Gori, 2 Daniele Versari, 3 Stefano Taddei, 1, 3 and Corrado Blandizzi. Formulations of AMOXIL contain amoxicillin, a semisynthetic antibiotic, an analog. Amoxicillin trihydrate for oral suspension 200 mg/5 mL, 250 mg/5 mL or 50. This note provides a product profile for Amoxicillin Dispersible Tablets DT, describes its availability and. Figure 3 Different Amoxicillin Product Formulations.

     
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