Augmentin


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amoxicillin and clavulanate potassium

Apo-Amoxi-Clav (CA), Augmentin, Augmentin-Duo (UK), Augmentin XR, Clavulin (CA), Novo-Clavamoxin (CA)

Pharmacologic class: Aminopenicillin

Therapeutic class: Anti-infective

Pregnancy risk category B

Action

Amoxicillin inhibits transpeptidase, preventing cross-linking of bacterial cell wall and leading to cell death. Addition of clavulanate (a beta-lactam) increases drug's resistance to beta-lactamase (an enzyme produced by bacteria that may inactivate amoxicillin).

Availability

Oral suspension: 125 mg amoxicillin with 31.25 mg clavulanic acid/5 ml, 200 mg amoxicillin with 28.5 mg clavulanic acid/5 ml, 250 mg amoxicillin with 62.5 mg clavulanic acid/5 ml, 400 mg amoxicillin with 57 mg clavulanic acid/5 ml, 600 mg amoxicillin with 42.9 mg clavulanic acid/5 ml

Tablets (chewable): 200 mg amoxicillin with 28.5 mg clavulanate, 400 mg amoxicillin with 57 mg clavulanate

Tablets (extended-release): 1,000 mg amoxicillin with 62.5 mg clavulanate

Tablets (film-coated): 250 mg amoxicillin with 125 mg clavulanate, 500 mg amoxicillin with 125 mg clavulanate, 875 mg amoxicillin with 125 mg clavulanate

Indications and dosages

Lower respiratory tract infections, otitis media, sinusitis, skin and skin-structure infections, and urinary tract infections (UTIs) caused by susceptible strains of gram-negative and gram-positive organisms

Adults and children weighing more than 40 kg (88 lb): 500 mg q 12 hours or 250 mg P.O. q 8 hours (based on amoxicillin component). For severe infections, 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours.

Serious infections and community-acquired pneumonia

Adults and children weighing more than 40 kg (88 lb): 875 mg P.O. q 12 hours or 500 mg P.O. q 8 hours

Infants and children ages 3 months and older weighing less than 40 kg (88 lb): 20 to 45 mg/kg/day P.O. in divided doses q 12 hours or 20 or 25 to 40 mg/kg/day in divided doses q 8 hours, based on severity of infection and amoxicillin component (125 mg/5 ml or 250 mg/5 ml suspension)

Infants younger than 3 months: 30 mg/kg/day P.O. (based on amoxicillin component) divided q 12 hours. (125 mg/5 ml oral suspension is recommended.)

Recurrent or persistent acute otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis in children ages 2 and younger and in children who have received antibiotic therapy within last 3 months

Children ages 3 months to 12 years: 90 mg/kg/day of Augmentin ES-600 P.O. q 12 hours for 10 days

Dosage adjustment

• Severe renal impairment
• Hemodialysis
• Infants ages 3 months and younger

Contraindications

• Hypersensitivity to drug or any penicillin
• Phenylketonuria (some products)
• History of cholestatic jaundice or hepatic dysfunction associated with this drug

Precautions

Use cautiously in:
• severe renal insufficiency, infectious mononucleosis
• pregnant patients.

Administration

Ask about history of penicillin allergy before giving.
• Give with or without food.
• Know that maximum dosage for infants ages 3 months and younger is 30 mg/kg/day divided q 12 hours.
• Be aware that 12-hour dosing is recommended to reduce diarrhea.

Adverse reactions

CNS: lethargy, hallucinations, anxiety, confusion, agitation, depression, dizziness, fatigue, hyperactivity, insomnia, behavioral changes, seizures (with high doses)

GI: nausea, vomiting, diarrhea, abdominal pain, stomatitis, glossitis, gastritis, black "hairy" tongue, furry tongue, enterocolitis, pseudomembranous colitis

GU: vaginitis, nephropathy, interstitial nephritis

Hematologic: anemia, thrombocytopenia, thrombocytopenic purpura, leukopenia, hemolytic anemia, agranulocytosis, bone narrow depression, eosinophilia

Hepatic: cholestatic hepatitis

Respiratory: wheezing

Skin: rash

Other: superinfections (oral and rectal candidiasis), fever, anaphylaxis

Interactions

Drug-drug.Any food: enhanced clavulanate absorption

Chloramphenicol, macrolides, sulfonamides, tetracycline: decreased amoxicillin efficacy

Hormonal contraceptives: decreased contraceptive efficacy

Probenecid: decreased renal excretion and increased blood level of amoxicillin

Drug-food.Any food: enhanced clavulanate absorption

Drug-herbs.Khat: decreased antimicrobial effect

Patient monitoring

• Monitor patient carefully for signs and symptoms of hypersensitivity reaction.

Monitor for seizures when giving high doses.
• Check patient's temperature and watch for other signs and symptoms of superinfection, especially oral or rectal candidiasis.

Patient teaching

Instruct patient to immediately report signs or symptoms of hypersensitivity reaction, such as rash, fever, or chills.
• Tell patient he may take drug with or without food.
• Inform patient that drug lowers resistance to some types of infections. Instruct him to report new signs or symptoms of infection (especially of mouth or rectum).
• Advise patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Tell patient taking hormonal contraceptives that drug may reduce contraceptive efficacy. Suggest she use alternative birth control method.
• Inform parents that they may give liquid form of drug directly to child or may mix it with foods or beverages.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and herbs mentioned above.

amoxicillin/clavulanate

(a-mox-i-sill-in/klav-yoo-lan -ate) ,

Augmentin

(trade name),

Augmentin ES

(trade name),

Augmentin XR

(trade name),

Clavulin

(trade name)

Classification

Therapeutic: anti infectives
Pharmacologic: aminopenicillins beta lactamase inhibitors
Pregnancy Category: B

Indications

Treatment of a variety of infections including:
  • Skin and skin structure infections,
  • Otitis media,
  • Sinusitis,
  • Respiratory tract infections,
  • Genitourinary tract infections.

Action

Binds to bacterial cell wall, causing cell death; spectrum of amoxicillin is broader than penicillin. Clavulanate resists action of beta-lactamase, an enzyme produced by bacteria that is capable of inactivating some penicillins.

Therapeutic effects

Bactericidal action against susceptible bacteria.
Active against:
  • Streptococci,
  • Pneumococci,
  • Enterococci,
  • Haemophilus influenzae,
  • Escherichia coli,
  • Proteus mirabilis,
  • Neisseria meningitidis,
  • N. gonorrhoeae,
  • Staphylococcus aureus,
  • Klebsiella pneumoniae,
  • Shigella,
  • Salmonella,
  • Moraxella catarrhalis.

Pharmacokinetics

Absorption: Well absorbed from the duodenum (75–90%). More resistant to acid inactivation than other penicillins.
Distribution: Diffuses readily into most body tissues and fluids. Does not readily enter brain/CSF; CSF penetration is ↑ in the presence of inflamed meninges. Crosses the placenta and enters breast milk in small amounts.
Metabolism and Excretion: 70% excreted unchanged in the urine; 30% metabolized by the liver.
Half-life: 1–1.3 hr.

Time/action profile (peak blood levels)

ROUTEONSETPEAKDURATION
PO30 min1–2 hr8–12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity to penicillins or clavulanate;Suspension and chewable tablets contain aspartame and should be avoided in phenylketonurics;History of amoxicillin/clavulanate-associated cholestatic jaundice.
Use Cautiously in: Severe renal insufficiency (dose ↓ necessary);Infectious mononucleosis (↑ risk of rash);Hepatic impairment (dose cautiously, monitor liver function).

Adverse Reactions/Side Effects

Central nervous system

  • seizures (high doses) (life-threatening)

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • diarrhea (most frequent)
  • hepatic dysfunction
  • nausea
  • vomiting

Genitourinary

  • vaginal candidiasis

Dermatologic

  • rash (most frequent)
  • urticaria

Hematologic

  • blood dyscrasias

Miscellaneous

  • allergic reactions including anaphylaxis and serum sickness (life-threatening)
  • superinfection

Interactions

Drug-Drug interaction

Probenecid ↓ renal excretion and ↑ blood levels of amoxicillin—therapy may be combined for this purpose.May ↑ the effect of warfarin.Concurrent allopurinol therapy ↑ risk of rash.May ↓ the effectiveness of hormonal contraceptives.Clavulanate absorption is ↓ by a high fat meal.

Route/Dosage

Most Infections (Dosing based on amoxicillin component)
Oral (Adults and Children >40 kg) 250 mg q 8 hr or 500 mg q 12 hr.
Serious Infections and Respiratory Tract Infections
Oral (Adults and Children >40 kg) 875 mg q 12 hr or 500 mg q 8 hr; Acute bacterial sinusitis—2000 mg q 12 hr for 10 days as extended release (XR) product; Community-acquired pneumonia—2000 mg every 12 hr for 7–10 days as extended release (XR) product.
Recurrent/persistent acute otitis media due to Multidrug-resistant Streptococcus pneumonia, H. influenzae, or M. catarrhalis
Oral (Children <40 kg) 80–90 mg/kg/day in divided doses q 12 hr for 10 days (as ES formulation only).

Renal Impairment

Oral (Adults) CCr 10–30 mL/min—250–500 mg q 12 hr (do not use 875 mg tablet); CCr <10 mL/min—250–500 mg q 24 hr.
Otitis Media, Sinusitis, Lower Respiratory Tract Infections, Serious Infections
Oral (Children ≥3 mo) 200 mg/5 mL or 400 mg/5 mL suspension—45 mg/kg/day divided q 12 hr; 125 mg/5 mL or 250 mg/5 mL suspension—40 mg/kg/day divided q 8 hr.
Less Serious Infections
Oral (Children ≥3 mo) 200 mg/5 mL or 400 mg/5 mL suspension—25 mg/kg/day divided q 12 hr or 20 mg/kg/day divided q 8 hr (as 125 mg/5 mL or 250 mg/5 mL suspension).
Oral (Children <3 mo) 15 mg/kg q 12 hr (125 mg/mL suspension recommended).

Availability (generic available)

Tablets: 250 mg amoxicillin with 125 mg clavulanate, 500 mg amoxicillin with 125 mg clavulanate, 875 mg amoxicillin with 125 mg clavulanate Cost: Generic — 500 mg $18.98 / 20, 875 mg $23.46 / 30
Chewable tabletscherry-banana flavor: 200 mg amoxicillin with 28.5 mg clavulanate, 400 mg amoxicillin with 57 mg clavulanate Cost: Generic — 200 mg $36.17 / 20, 400 mg $68.93 / 20
Extended-release tablets (scored): 1000 mg amoxicillin with 62.5 mg clavulanate Cost: Generic — $108.62 / 28
Powder for oral suspension 125 mg/5 mL is banana flavor; 200 mg/5ml is fruit flavor; 250 mg/5 mL is orange flavor; 400 mg/5 mL is fruit flavor; 600 mg/5 mL is orange or strawberry-creme flavor: 125 mg amoxicillin with 31.25 mg clavulanate/5 mL, 200 mg amoxicillin with 28.5 mg clavulanate/5 mL, 250 mg amoxicillin with 62.5 mg clavulanate/5 mL, 400 mg amoxicillin with 57 mg clavulanate/5 mL, 600 mg amoxicillin with 42.9 mg clavulanate/5 mL (ES formulation) Cost: Generic — 200 mg $36.17 / 100 mL, 250 mg $86.43 / 100 mL, 400 mg $68.93 / 100 mL, 600 mg $83.03 / 125 mL

Nursing implications

Nursing assessment

  • Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
  • Obtain a history before initiating therapy to determine previous use of and reactions to penicillins or cephalosporins. Persons with a negative history of penicillin sensitivity may still have an allergic response.
  • Observe for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Notify health care professional immediately if these occur.
  • Obtain specimens for culture and sensitivity prior to therapy. First dose may be given before receiving results.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis. May begin up to several weeks following cessation of therapy.
  • Lab Test Considerations: May cause ↑ serum alkaline phosphatase, LDH, AST, and ALT concentrations. Elderly men and patients receiving prolonged treatment are at ↑ risk for hepatic dysfunction.
    • May cause false-positive direct Coombs’ test result.

Potential Nursing Diagnoses

Risk for infection (Indications,  Side Effects)
Noncompliance (Patient/Family Teaching)

Implementation

  • Oral: Administer around the clock. Administer at the start of a meal to enhance absorption and to decrease GI side effects. Do not administer with high fat meals; clavulanate absorption is decreased. XR tablet is scored and can be broken for ease of administration. Capsule contents may be emptied and swallowed with liquids. Chewable tablets should be crushed or chewed before swallowing with liquids. Shake oral suspension before administering. Refrigerated reconstituted suspension should be discarded after 10 days.
    • Two 250-mg tablets are not bioequivalent to one 500-mg tablet; 250-mg tablets and 250-mg chewable tablets are also not interchangeable. Two 500-mg tablets are not interchangeable with one 1000-mg XR tablet; amounts of clavulanic acid and durations of action are different. Augmentin ES 600 (600 mg/5 mL) does not contain the same amount of clavulanic acid as any of the other Augmentin suspensions. Suspensions are not interchangeable.
    • Pediatric: Do not administer 250-mg chewable tablets to children <40 kg due to clavulanate content. Children <3 mo should receive the 125-mg/5 mL oral solution.

Patient/Family Teaching

  • Instruct patients to take medication around the clock and to finish the drug completely as directed, even if feeling better. Advise patients that sharing of this medication may be dangerous.
  • Pediatric: Teach parents or caregivers to calculate and measure doses accurately. Reinforce importance of using measuring device supplied by pharmacy or with product, not household items.
  • Advise patient to report the signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
  • Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools occur and not to treat with antidiarrheals without consulting health care professionals.
  • Instruct the patient to notify health care professional if symptoms do not improve or if nausea or diarrhea persists when drug is administered with food.
  • Instruct female patients taking oral contraceptives to use an alternate or additional method of contraception during therapy and until next menstrual period; may decrease effectiveness of hormonal contraceptives.

Evaluation/Desired Outcomes

  • Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

Augmentin

(ôg-mĕn′tĭn)
A trademark for a preparation of amoxicillin and clavulanic acid.

Augmentin®

Infectious disease A combination antibiotic containing amoxicillin and clavulinic acid Indications Ampicillin-resistant S aureus, B fragilis, β-lactam-producing Enterobacteriaceae
References in periodicals archive ?
Augmentin (Amoxycillin and Clavulanic Acid) syrup is used to treat a wide range of infections caused by bacteria and such infections may affect the chest (bronchitis or pneumonia), bladder (cystitis), sinuses (sinusitis), the ears (otitis media) or the skin.
Augmentin is commonly used to treat a variety of bacterial infections.
In a statement issued on Wednesday, Dr Amin Hussein Al Amiri, Assistant Undersecretary for Medical Practices and Licensing at the ministry, assured that the Augmentin Antibiotic Syrup 165mg, manufactured by Glaxo Smith Kline (GSK) is safe and does not cause any side effects.
Omar Al-Sayed Omar told KUNA that the imported Augmentin to Kuwait was
The only medication that I have taken, is an antibiotic called Augmentin, the strongest ones I have taken when I had a bad cold two years ago," he said according to the CNN transcript of excerpts from the interview.
It also sells popular drugs such as Calpol paracetamol tablets, Augmentin antibiotics and Neosporin eye drops.
Three years later, Mankind launched Moxikind-CV625, "There were brands like Augmentin from GSK, Clavam from Alkem and Mox-Clav from Ranbaxy, among others .
But there are other extended-release formulations, such as Augmentin XR, typically taken twice a day.
In July, GlaxoSmithKline agreed to pay $29 million to settle charges that it used illegal tactics to maintain its patent on Augmentin, a popular antibiotic used in the treatment of a variety of common infections.