XAVIER UNIVERSITY-ATENEO DE CAGAYAN

COLLEGE OF NURSING

A.Y. 2015-2016

“DRUG LABELLING”

SUBMITTED BY:Escala, Stephanie Joy A.Level 2 Nursing Student

SUBMITTED TO:MR. ERNST DALE UBAY-UBAY, RN, MN

Level 2 Clinical Instructor

DECEMBER 18, 2015

A. General UsesUpper Respiratory Tract Infections (including ENT): Sinusitis, otitis media, recurrent tonsillitis. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.Lower Respiratory Tract Infections: Acute exacerbations of chronic bronchitis, bronchopneumonia, UTIs often caused by Streptococcus pneumonia, Haemophilus influenzae and Moraxella catarrhalis.Genitourinary Tract and Abdominal Infections: In particular cystitis (especially when recurrent or complicated, but not prostatitis), septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis. These infections are often caused by Enterobacteriaceae (mainly Escherichia coli),Staphylococcus saprophyticus and Enterococcus sp.Skin and Soft Tissue Infections: In particular cellulitis, animal bites and severe dental abscess with spreading cellulites caused by Staphylococcus aureus, Streptococcus pyogenes and Bacteroides sp.

B. Actions and EffectsPharmacology: Pharmacokinetics: Absorption and Fate: Amoxicillin and clavulanate potassium are well-absorbed from the gastrointestinal tract after oral administration. Approximately 50-70% of the amoxicillin and approximately 25-40% of the clavulanic acid are excreted unchanged in urine during the first 6 hrs after administration of 10 mL of 250 mg/5 mL co-amoxiclav suspension.Neither component of co-amoxiclav is highly protein bound; clavulanic acid has been found to be approximately 25% bound to human serum and amoxicillin 18% bound.Amoxicillin diffuses readily into most body tissues and fluids with the exception of the brain and spinal fluid. The results of experiments involving the administration of clavulanic acid to animals suggest that this compound, like amoxicillin, is well distributed in body tissues.Side Effects: Transient hepatitis and cholestatic jaundice have been reported.Allergic reactions may occur, presenting as a pruritic skin rash, an erythematous skin reaction, urticaria, angioedema, anaphylaxis or eosinophilia. Coombs' test may become positive. In this event, withdrawal of co-amoxiclav and the administration of an antihistamine will suffice in most cases. Should a serious anaphylactic reaction occur, co-amoxiclav should be discontinued and the patient treated with the usual agents: Adrenaline, corticosteroids and antihistamines.Pseudomembranous colitis has been reported.Rarely, erythema multiforme and Stevens-Johnson syndrome have been reported.

C. ContraindicationHypersensitivity to any penicillin and those with a previous history of amoxicillin-potassium clavulanate-associated cholestatic jaundice/hepatic dysfunction.

D. PrecautionRenal function should be monitored in patients with moderate to severe renal impairment and co-amoxiclav dosage should be adjusted.Treatment with co-amoxiclav may give rise to a maculopapular rash during therapy or within a few days after completion. The incidence of maculopapular rash is especially high in patients suffering from infectious mononucleosis. The use of this antibiotic may lead to the selection of resistant strains of organisms and sensitivity testing should, therefore, be carried out whenever possible, to demonstrate the appropriateness of therapy. Monilial overgrowth eg, vaginitis and thrush have been reported.Treatment with co-amoxiclav can cause gastrointestinal symptoms eg, diarrhea, nausea and vomiting which are dose-related and can be minimized by administering the drug at the start of a meal. In addition, as these symptoms are especially related to the

potassium clavulanate component, where these gastrointestinal symptoms occur and a higher concentration of amoxicillin is required, consideration should be given to administering the additional amoxicillin separately.Changes in liver function tests have been observed in some patients receiving co-amoxiclav. The clinical significance of these changes is uncertain but co-amoxiclav should be used with caution in patients with evidence of hepatic dysfunction.Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may become apparent for several weeks after treatment has ceased.In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During 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. Amoxicillin has been reported to precipitate in bladder catheters after IV administration of large doses. A regular check of potency should be maintained.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 penicillin hypersensitivity.Erythematous rashes have been associated with glandular fever in patients receiving amoxicillin.Prolonged use may also occasionally result in overgrowth of nonsusceptible organisms.In patients with reduced urine output, crystalluria has been observed very rarely, Use in pregnancy: There are, however, no adequate studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Natravox should be used during pregnancy only if clearly needed.Reproduction studies in animals (mice and rats) with orally and parenterally administered co-amoxiclav have shown no teratogenic effects. In a single study in women with preterm, premature rupture of fetal membrane (pPROM), it was reported that prophylactic treatment with co-amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the 1st trimester, unless considered essential by the physician.Use in lactation: Co-amoxiclav may be administered during the period of lactation. With the exception of the risk of sensitization, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breastfed infants.Amoxicillin-class antibiotics are excreted in the milk; therefore, caution should be exercised when co-amoxiclav is administered to a nursing mother.

E. Drug-Drug InteractionsProbenecid decreases the renal tubular secretion of amoxicillin but does not affect clavulanic acid excretion. Concurrent use with co-amoxiclav may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.Co-amoxiclav may reduce the efficacy of oral contraceptives and patients should be warned accordingly.Penicillins eg, co-amoxiclav may decrease the removal of methotrexate from the body increasing the risk of toxicity.Antibiotics eg, co-amoxiclav may alter the effect of anticoagulants eg, warfarin.

F. Drug-Food InteractionsMay be taken with or without food: May be given w/o regard to meals.