Vancocin


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Related to Vancocin: gentamicin, vancomycin

vancomycin hydrochloride

PMS-Vancomycin, Vancocin

Pharmacologic class: Tricyclic glycopeptide

Therapeutic class: Anti-infective

Pregnancy risk category C (with parenteral use); B (with oral use)

Action

Binds to bacterial cell wall, inhibiting cell-wall synthesis and causing secondary damage to bacterial membrane

Availability

Capsules: 125 mg, 250 mg

Powder for injection: 500-mg vial, 1-g vial, 5-g vial, 10 g-vial

Indications and dosages

Severe, life-threatening infections caused by susceptible strains of methicillin-resistant staphylococci, Staphylococcus epidermidis, Streptococcus viridans or Streptococcus bovis (alone or combined with an aminoglycoside), or Enterococcus faecalis (combined with an aminoglycoside)

Adults: 500 mg I.V. q 6 hours or 1 g I.V. q 12 hours

Children: 10 mg/kg I.V. q 6 hours

Infants and neonates: Initially, 15 mg/kg I.V., followed by 10 mg/kg I.V. q 8 hours in infants 8 days to 1 month old, or 10 mg/kg I.V. q 12 hours in infants less than 8 days old

Endocarditis prophylaxis in penicillin-allergic patients at moderate risk who are scheduled for dental and other invasive procedures

Adults: 1 g I.V. slowly over 1 to 2 hours, with infusion completed 30 minutes before invasive procedure begins

Children: 20 mg/kg I.V. over 1 to 2 hours, with infusion completed 30 minutes before invasive procedure begins

Enterocolitis caused by Staphylococcus aureus

Adults: 500 mg to 2 g P.O. daily in three or four divided doses for 7 to 10 days

Children: 40 mg/kg P.O. daily in three or four divided doses for 7 to 10 days; total daily dose shouldn't exceed 2 g.

Clostridium difficile-associated diarrhea

Adults: 125 mg P.O. q.i.d. for 10 days

Children: 40 mg/kg P. O. in three or four divided doses for 7 to 10 days; total daily dose shouldn't exceed 2 g.

Dosage adjustment

• Renal impairment
• Elderly patients

Off-label uses

• Peritonitis
• Meningitis
• Intraocular infections
• Febrile neutropenia

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• renal impairment, preexisting hearing loss
• concurrent use of anesthetics, immunosuppressants, or nephrotoxic or ototoxic drugs
• elderly patients
• pregnant or breastfeeding patients
• neonates.

Administration

Know that I.V. therapy is ineffective against enterocolitis and pseudomembranous diarrhea.
• For intermittent I.V. infusion, dilute by adding 10 or 20 ml of sterile water for injection to vial containing 500 mg or 1 g of drug, respectively, to yield a concentration of 50 mg/ml. Dilute further by adding at least 100 ml or 200 ml, respectively, of dextrose 5% in water or normal saline solution; infuse over at least 1 hour.
• Don't give by I.M. route.
• Be aware that capsules aren't systemically absorbed; therefore, oral therapy is ineffective in infections other than C. difficile-associated diarrhea and enterocolitis caused by S. aureus.

Keep emergency equipment and epinephrine on hand in case of anaphylaxis.

Adverse reactions

CV: hypotension, cardiac arrest, vascular collapse

EENT: permanent hearing loss, ototoxicity, tinnitus

GI: nausea, vomiting, abdominal pain, pseudomembranous colitis

GU: nephrotoxicity, severe uremia

Hematologic: eosinophilia, leukopenia, neutropenia

Metabolic: hypokalemia

Respiratory: wheezing, dyspnea

Skin: "red man" syndrome (nonallergic histamine reaction with rapid I.V. infusion), rash, urticaria, pruritus, necrosis

Other: chills, fever, thrombophlebitis at injection site, anaphylaxis

Interactions

Drug-drug.Aminoglycosides, amphotericin B, bacitracin, cephalosporins, cisplatin, colistin, nondepolarizing neuromuscular blockers, pentamidine (with parenteral use): increased risk of nephrotoxicity and ototoxicity

Anesthetic agents (with parenteral use): erythema and histamine-like flushing

Drug-diagnostic tests.Albumin, blood urea nitrogen (BUN), creatinine: increased levels

Eosinophils, neutrophils: decreased counts

Potassium: decreased level

Patient monitoring

Monitor closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis.
• Check drug blood level weekly. Therapeutic peak ranges from 30 to 40 g/L; therapeutic trough, 5 to 10 mg/L.
• Assess BUN and creatinine levels every 2 days, or daily in patients with unstable renal function.
• Monitor urine output daily. Weigh patient at least weekly.
• Assess hearing before and during therapy; stay alert for hearing loss. Patient may require baseline and weekly audiograms.
• Check I.V. site often for phlebitis.
• Watch for "red-man" syndrome, which can result from rapid infusion. Signs and symptoms include hypotension, pruritus, and maculopapular rash on face, neck, trunk, and limbs.
• Monitor CBC. Watch for signs and symptoms of blood dyscrasias.
• Closely monitor respiratory status. Stay alert for wheezing and dyspnea.

Monitor vital signs and cardiovascular status, especially for vascular collapse and other signs of impending cardiac arrest.

Patient teaching

• Tell patient he may take with or without food.
• Instruct patient to take oral drug exactly as prescribed for as long as prescribed, even if symptoms improve.
• Explain importance of prophylactic I.V. therapy to patients at risk for endocarditis who are scheduled for invasive procedures.

Advise patient to promptly report rash, hearing loss, breathing problems, and signs and symptoms of "red-man" syndrome, nephrotoxicity, and blood dyscrasias.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

vancomycin

(van-koe-mye-sin) ,

Vancocin

(trade name)

Classification

Therapeutic: anti infectives
Pregnancy Category: C

Indications

Intravenous: Treatment of potentially life-threatening infections when less toxic anti-infectives are contraindicated. Particularly useful in staphylococcal infections, including:
  • Endocarditis,
  • Meningitis,
  • Osteomyelitis,
  • Pneumonia,
  • Septicemia,
  • Soft-tissue infections in patients who have allergies to penicillin or its derivatives or when sensitivity testing demonstrates resistance to methicillin.
Oral: Treatment of staphylococcal enterocolitis or diarrhea due to Clostridium difficile. Intravenous: Part of endocarditis prophylaxis in high-risk patients who are allergic to penicillin.

Action

Binds to bacterial cell wall, resulting in cell death.

Therapeutic effects

Bactericidal action against susceptible organisms.
Active against gram-positive pathogens, including:
  • Staphylococci (including methicillin-resistant strains of Staphylococcus aureus),
  • Group A beta-hemolytic streptococci,
  • Streptococcus pneumoniae,
  • Corynebacterium,
  • Clostridium difficile,
  • Enterococcus faecalis,
  • Enterococcus faecium.

Pharmacokinetics

Absorption: Poorly absorbed from the GI tract.
Distribution: Widely distributed. Some penetration (20–30%) of CSF; crosses placenta.
Metabolism and Excretion: Oral doses excreted primarily in the feces; IV vancomycin eliminated almost entirely by the kidneys.
Half-life: Neonates: 6–10 hr; Children 3 mo–3 yr: 4 hr; Children >3 yr: 2–2.3 hr; Adults: 5–8 hr (↑ in renal impairment).

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IVrapidend of infusion12–24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity.
Use Cautiously in: Renal impairment (dosage reduction required if CCr ≤80 mL/min);Hearing impairment;Intestinal obstruction or inflammation (↑ systemic absorption when given orally); Obstetric / Lactation: Safety not established.

Adverse Reactions/Side Effects

Ear, Eye, Nose, Throat

  • ototoxicity

Cardiovascular

  • hypotension

Gastrointestinal

  • nausea
  • vomiting

Genitourinary

  • nephrotoxicity (most frequent)

Dermatologic

  • rashes

Hematologic

  • eosinophilia
  • leukopenia

Local

  • phlebitis (most frequent)

Musculoskeletal

  • back and neck pain

Miscellaneous

  • hypersensitivity reactions including anaphylaxis (life-threatening)
  • chills
  • fever
  • "red man" syndrome (with rapid infusion)
  • superinfection

Interactions

Drug-Drug interaction

May cause additive ototoxicity and nephrotoxicity with other ototoxic and nephrotoxic drugs (aspirin, aminoglycosides, cyclosporine, cisplatin, loopdiuretics ).May enhance neuromuscular blockade from nondepolarizing neuromuscular blocking agents.↑ risk of histamine flush when used with generalanesthetics in children.

Route/Dosage

Serious Systemic Infections

Intravenous (Adults) 500 mg q 6 hr or 1 g q 12 hr (up to 4 g/day).
Intravenous (Children >1 mo) 40 mg/kg/day divided q 6–8 hr Staphylococcal CNS infection—60 mg/kg/day divided q 6 hr, maximum dose: 1 g/dose.
Intravenous (Neonates 1 wk–1 mo) <1200 g: 15 mg/kg/day q 24 hr. 1200–2000 g: 10–15 mg/kg/dose q 8–12 hr. >2000 g: 15–20 mg/kg/dose q 8 hr.
Intravenous (Neonates <1 wk) <1200 g: 15 mg/kg/day q 24 hr. 1200–2000 g: 10–15 mg/kg/dose q 12–18 hr. >2000 g: 10–15 mg/kg/dose q 8–12 hr.
Intrathecal (Adults) 20 mg/day.
Intrathecal (Children) 5–20 mg/day.
Intrathecal (Neonates) 5–10 mg/day.

Endocarditis Prophylaxis in Penicillin-Allergic Patients

Intravenous (Adults and Adolescents) 1-g single dose 1-hr preprocedure.
Intravenous (Children) 20-mg/kg single dose 1-hr preprocedure.

Diarrhea Due to C. difficile

Oral (Adults) 125 mg q 6 hr for 10 days.
Oral (Children) 40 mg/kg/day divided into 3 or 4 doses for 7–10 days (not to exceed 2 g/day).

Staphylococcal Enterocolitis

Oral (Adults) 500–2000 mg/day in 3–4 divided doses for 7–10 days.
Oral (Children) 40 mg/kg/day in 3–4 divided doses for 7–10 days (not to exceed 2 g/day).

Renal Impairment

Intravenous (Adults) An initial loading dose of 750 mg–1 g (not less than 15 mg/kg); serum level monitoring is optimal for choosing maintenance dose in patients with renal impairment; these guidelines may be helpful. CCr 50–80 mL/min—1 g q 1–3 days; CCr 10–50 mL/min—1 g q 3–7 days; CCr <10 mL/min—1 g q 7–14 days.

Availability (generic available)

Capsules: 125 mg, 250 mg
Injection: 500-mg, 750-mg, 1-, 5-, 10-g vials

Nursing implications

Nursing assessment

  • Assess patient for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and throughout therapy.
  • Obtain specimens for culture and sensitivity prior to initiating therapy. First dose may be given before receiving results.
  • Monitor IV site closely. Vancomycin is irritating to tissues and causes necrosis and severe pain with extravasation. Rotate infusion site.
  • Monitor BP throughout IV infusion.
  • Evaluate eighth cranial nerve function by audiometry and serum vancomycin levels prior to and throughout therapy in patients with borderline renal function or those >60 yr of age. Prompt recognition and intervention are essential in preventing permanent damage.
  • Monitor intake and output ratios and daily weight. Cloudy or pink urine may be a sign of nephrotoxicity.
  • Assess patient for signs of superinfection (black, furry overgrowth on tongue; vaginal itching or discharge; loose or foul-smelling stools). Report occurrence.
  • Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue drug and notify health care professional immediately if these problems occur. Keep epinephrine, an antihistamine, and resuscitation equipment close by in case of an anaphylactic reaction.
  • Pseudomembranous Colitis: Assess bowel status (bowel sounds, frequency and consistency of stools, presence of blood in stools) throughout therapy.
  • Lab Test Considerations: Monitor for casts, albumin, or cells in the urine or decreased specific gravity, CBC, and renal function periodically during therapy.
    • May cause increased BUN levels.
  • Trough concentrations should not exceed 10 mcg/mL (mild-moderate infections) or 15–20 mcg/mL (for severe infections).

Potential Nursing Diagnoses

Risk for infection (Indications)
Disturbed sensory perception(auditory) (Side Effects)

Implementation

  • Vancomicin must be given orally for treatment of staphylococcal enterocolitis and C. difficile-associated diarrhea. Orally administered vancomycin is not effective for other types of infections.
  • Oral: Use calibrated measuring device for liquid preparations. IV dose form may be diluted in 30 mL of water for oral or nasogastric tube administration. Resulting solution has bitter, unpleasant taste. May mix with a flavoring syrup to mask taste. Stable for 14 days if refrigerated.
  • Intravenous Administration
  • pH: 2.5–5.0.
  • Intermittent Infusion: Diluent: To reconstitute, add 10 mL of sterile water for injection to 500-mg vial or 20 mL of sterile water for injection to 1-g vial for a concentration of 50 mg/mL. Dilute further with at least 100 mL of 0.9% NaCl, D5W, D5/0.9% NaCl, or LR for every 500 mg of vancomycin being administered. Reconstituted vials stable for 14 days if refrigerated. Infusion is stable for 96 hr if refrigerated.Concentration: ≤5 mg/mL.
  • Rate: Infuse over at least 60 min (90 min for doses >1 g). Do not administer rapidly or as a bolus, to minimize risk of thrombophlebitis, hypotension, and "red-man (neck)" syndrome (sudden, severe hypotension; flushing and/or maculopapular rash of face, neck, chest, and upper extremities). May need to slow infusion further to 1.5–2 hr if red-man syndrome occurs.
  • Intrathecal: Diluent: Dilute with preservative-free NS.Concentration: 1–5 mg/mL.
  • Rate: Directly instill into ventricular cerebrospinal fluid.
  • Y-Site Compatibility: acetylcysteine, acyclovir, aldesleukin, alemtuzumab, alfentanil, allopurinol, alprostadil, amifostine, amikacin, amiodarone, amsacrine, anidulafungin, argatroban, ascorbic acid, atracurium, atropine, azithromycin, benztropine, bleomycin, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, carboplatin, carmustine, caspofungin, chlorpromazine, ciprofloxacin, cisatracurium, cisplatin, clindamycin, cyanocobalamin, cyclophosphamide, cyclosporine, cytarabine, dactinomycin, dexamethasone, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dolasetron, dopamine, doripenem, doxacurium, doxapram, doxorubicin hydrochloride, doxorubicin liposome, doxycycline, enalaprilat, ephedrine, epinephrine, epirubicin, eptifibatide, ertapenem, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, filgrastim, fluconazole, fludarabine, folic acid, gemcitabine, gentamicin, glycopyrrolate, granisetron, hetastarch, hydromorphone, ifosfamide, insulin, irinotecan, isoproterenol, ketamine, labetalol, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, meropenem, metaraminol, methyldopate, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitoxantrone, morphine, multivitamins, mycophenolate, nalbuphine, naloxone, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, ondansetron, oxacillin, oxaliplatin, oxytocin, paclitaxel, palonosetron, pamidronate, pancuronium, papaverine, pemetrexed, penicillin G, pentamidine, pentazocine, pentobarbital, perphenazine, phenobarbital, phentolamine, phenylephrine, phytonadione, potassium acetate, potassium chloride, procainamide, prochlorperazine, promethazine, propranolol, protamine, pyridoxime, ranitidine, remifentanil, rifampin, sodium acetate, sodium bicarbonate, sodium citrate, succinylcholine, sufentanil, tacrolimus, teniposide, thiamine, thiotepa, tigecycline, tirofiban, tobramycin, tolazoline, trastuzumab, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, voriconazole, zidovudine, zolendronic acid
  • Y-Site Incompatibility: albumin, aminophylline, amphotericin B cholesteryl, amphotericin B colloidal, amphotericin lipid complex, amphotericin B liposome, azathioprine, bivalirudin, cefoperazone, chloramphenicol, dantrolene, daptomycin, diazepam, diazoxide, epoetin alfa, fluorouracil, furosemide, ganciclovir, heparin, ibuprofen, idarubicin, indomethacin, ketorolac, leucovorin calcium, methylprednisolone, mitomycin, moxifloxacin, phenytoin, rituximab, streptokinase, trimethoprim/sulfamethoxazole, valproate sodium

Patient/Family Teaching

  • Advise patients on oral vancomycin to take as directed. Take missed doses as soon as remembered unless almost time for next dose; do not double dose.
  • Instruct patient to report signs of hypersensitivity, tinnitus, vertigo, or hearing loss.
  • Advise patient to notify health care professional if no improvement is seen in a few days.
  • Patients with a history of rheumatic heart disease or valve replacement need to be taught importance of using antimicrobial prophylaxis prior to invasive dental or medical procedures.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

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

Vancocin

(văn′kō-sĭn)
A trademark for the hydrochloride form of the drug vancomycin.

Vancocin

A brand name for the antibiotic VANCOMYCIN.
References in periodicals archive ?
In the second quarter, ANI's authorized generic partner for Vancocin adjusted its estimates for chargebacks, rebates, and other deductions from gross sales for the last five months of 2014, which resulted in a non-recurring $1.
7 million, as a direct result of raw materials acquired for key products, and inventories related to EEMT, Lithobid and Vancocin.
Cost of sales decreased as a percentage of net revenues to 20% from 33%, primarily due to price increases for the Company's existing products, as well as higher margin sales of the newly acquired Lithobid and Vancocin branded products.
Cost of sales decreased as a percentage of net revenues to 22% from 37%, primarily due to price increases for the Company's existing products, as well as higher margin sales of the newly acquired Lithobid and Vancocin branded products.
Vancocin net sales during the three months were $4 million compared to $66 million for the same period in 2012.
However, on April 10, 2012, ViroPharma issued a press release announcing that the FDA had informed the Company that the sNDA approved for Vancocin on December 14, 2011 would not qualify for three additional years of exclusivity.
changes in prescribing or procedural practices of physicians, including off-label prescribing of products competitive with Vancocin, Cinryze, Buccolam and Plenadren;
On April 10, 2012 before the market opening, the company filed a 8-K with the SEC attaching a press release which stated among other things that the FDA informed Viropharma that the recent supplemental new drug application (sNDA) for Vancocin approved on December 14, 2011 would not qualify for three additional years of exclusivity based on the agency's assertion that in order for an sNDA for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it must be a significant new use or indication.
The Complaint alleged that defendants' representations about market exclusivity in the December 14 press release and similar representations concerning market exclusivity during the Class Period were materially misleading due to the fact that defendants' failure to disclose the fact that to obtain market exclusivity Vancocin would need to meet a statutory standard applicable only to "old" antibiotics (those approved before 1997) which the label changes had little or no prospect of compliance.
Achieved $136 million in quarterly net product sales, including $68 million in worldwide net sales of Cinryze (C1 esterase inhibitor[human]), and $66 million in net sales of Vancocin (Vancomycin Hydrochloride Capsules, USP);
In the 199 patients in the modified intent-to treat (MITT) group (patients that received study drug and had a confirmed diagnosis of CDAD), the clinical cure rate was 92 percent and 87 percent for the CB-183,315 125mg and CB-183,315 250mg arms, respectively, compared to 89 percent in the Vancocin arm.
difficile infections will now have access to a generic formulation of Vancocin that is identical to the brand, and proven through decades of use to be a high quality treatment for this potentially deadly disease.