Littmox

Littmox

amoxicillin

Manufacturer:

Lloyd

Distributor:

Littman
Full Prescribing Info
Contents
Amoxicillin trihydrate.
Description
Each capsule contains: Amoxicillin (as trihydrate), USP 500 mg.
Amoxicillin trihydrate (Littmox) are scarlet (cap) and ivory (body) capsules encapsulating a white or almost white, crystalline or semi-granular powder.
Action
Pharmacology: Pharmacodynamics and Pharmacokinetics: Amoxicillin exerts its bactericidal activity by interfering with the bacterial cell wall synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking when the terminal glycine residue of the pentaglycine bridge is linked to the fourth residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by penicillins. As a result, the bacterial cell wall is weakened, the cell swells, and then ruptures. Amoxicillin is readily hydrolyzed by the staphylococcal penicillinase.
Amoxicillin is a broad spectrum aminopenicillin antibiotic that is structurally related to ampicillin. It is rapidly bactericidal against susceptible organisms during the stage of active multiplication. It is ineffective in most staphylococcal infections since it is destroyed by β-lactamase.
Amoxicillin is active in vitro and in clinical infections against most strains of the following microorganisms: See Table 1.

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Amoxicillin is a semi-synthetic penicillin and a close chemical and pharmacological relative to Ampicillin. The drug is stable in acid and is designed for oral use. The antimicrobial spectrum of amoxicillin is essentially identical to that of Ampicillin with the important exception that Amoxicillin appears to be less effective than Ampicillin for shigellosis. Amoxicillin is more rapidly and completely absorbed from the gastrointestinal tract than ampicillin which is the major difference between the two. Peak concentration in plasma are two and one-half times greater for amoxicillin than ampicillin after oral administration of the same doses. Food does not interfere with absorption, perhaps because of more complete absorption of this congener.
Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. Amoxicillin diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid, except when meninges are inflamed. The half-life of amoxicillin is 61.3 minutes. Most of the amoxicillin is excreted unchanged in the urine; its excretion can be delayed by concurrent administration of probenecid. In blood serum, amoxicillin is approximately 20% protein-bound. Orally administered doses of 250-mg and 500-mg amoxicillin capsules result in average peak blood levels 1 to 2 hours after administration in the range of 3.5 mcg/mL to 5.0 mcg/mL and 5.5 mcg/mL to 7.5 mcg/mL, respectively.
Indications/Uses
For the treatment of infections caused by susceptible Gram-positive and Gram-negative organisms as respiratory, gastrointestinal and genitourinary tracts, skin and soft tissues infections.
Dosage/Direction for Use
Amoxicillin may be given orally without regard to meals. (See Table 2.)

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Special Population: Patients with Renal Impairment: See Table 3.

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Neonates and infants ≤3 months: 20 to 30 mg/kg/day in divided doses every 12 hours.
Usual Duration of Treatment: For most infections: 5 to 14 days, depending on the type and severity of infection. Continue treatment for at least 48 to 72 hours after the patient becomes asymptomatic or after evidence of bacterial eradication has been continued.
For β-hemolytic streptococcal infections: At least 10 days to prevent rheumatic fever or glomerulonephritis.
For Lyme Disease: At least 12 days.
*
Frequent bacteriologic and clinical appraisal is necessary during treatment of chronic urinary tract infections and maybe required for several months after therapy has been completed.
Overdosage
In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying. Adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Amoxicillin may be removed from circulation by hemodialysis.
Contraindications
Known hypersensitivity to penicillins or cephalosporins, or any component of the product.
Special Precautions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be given.
Serious anaphylactic reactions require immediate emergency treatment with Epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated.
Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including Amoxicillin, 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.
Use In Pregnancy & Lactation
Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers:
Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Adverse Reactions
As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins: Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Nausea, vomiting, diarrhea, black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions: Serum sickness−like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Renal: Crystalluria has also been reported.
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.
Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Drug Interactions
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
As with other antibiotics, Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Presentation/Packing
Cap 500 mg x 100's.
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