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Indications / Uses : Treatment of commonly occurring bacterial infections eg, upper respiratory tract infections (eg, ear, nose and throat infections, otitis media); lower respiratory tract infections (eg, acute exacerbations of chronic bronchitis, lobar and bronchopneumonia); gastrointestinal tract infections (eg, typhoid and paratyphoid fever); genitourinary tract infections (eg, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, septic abortion, puerperal sepsis); other incfections including borreliosis (Lyme disease; Borrelia burgdorferi); skin and soft tissue infections; biliary tract infections; bone infections; pelvic infections; gonorrhea (nonpenicillinase-producing strains); septicemia; endocarditis; meningitis; peritonitis; dental abscess (as an adjunct to surgical management); Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer disease.
Infections eg, septicemia, endocarditis and meningitis due to susceptible organisms should be treated initially with high doses of a parenteral therapy and where appropriate, in combination with another antibiotic.
Prophylaxis of Endocarditis: Amoxil may be used for the prevention of bacteremia associated with procedures eg, dental extraction, in patients at risk of developing endocarditis (see Dosage & Administration).
Susceptibility to amoxicillin will vary with geography and time and local susceptibility data should be consulted where available and microbiological sampling and susceptibility testing where necessary (see Pharmacology: Microbiology under Actions).
Administration : May be taken with or without food: May be taken w/ meals for better absorption & to reduce GI discomfort.
Contraindications : Hypersensitivity to ?-lactam antibiotics (eg, penicillins, cephalosporins).
Special Precautions : Before initiating therapy with Amoxil/Amoxil Forte, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins or cephalosporins. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to ?-lactam antibiotics (see Contraindications). If an allergenic reaction occurs, Amoxil/Amoxil Forte should be discontinued and appropriate alternative therapy instituted. Serious anaphylactic reactions may require immediate emergency treatment with adrenaline. Oxygen, IV steroids and airway management, including intubation, may also be required.
Amoxicillin should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.
Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhea during or after antibiotic use. If prolonged or significant diarrhea occurs, or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Dosage should be adjusted in patients with renal impairment (see Dosage & Administration).
In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Overdosage).
Abnormal prolongation of prothrombin time [increased international normalized ratio (INR)] has been reported rarely in patients receiving Amoxil/Amoxil Forte and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Amoxil/Amoxil Forte Oral Suspension and Drops: Contain sodium benzoate which is a mild irritant to the skin, eyes and mucus membrane. It may increase the risk of jaundice in newborn babies. May contain aspartame which is a source of phenylalanine and should be used with caution in patients with phenylketonuria.
May contain sorbitol. If the patient have been told by the physician that the patient have an intolerance to some sugars, contact physician before taking Amoxil/Amoxil Forte.
Effects on the Ability to Drive or Operate Machinery: Adverse effects on the ability to drive or operate machinery have not been observed.
Use in pregnancy & lactation: The safety of Amoxil/Amoxil Forte for use in human pregnancy has not been established by well-controlled studies in pregnant women. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and these studies have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. Amoxil may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Amoxil may be given during lactation. With the exception of the risk of sensitization associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breastfed infant.