VANCOMYCIN HCL (vancomycin hcl)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Pregnancy

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Hearing loss
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Systemic mastocytosis

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Neutropenic disorder

There are 31 severe adverse reactions.

More Frequent	Less Frequent
None.	Hearing loss Kidney disease with reduction in glomerular filtration rate (GFr) Nephrotoxicity Neutropenic disorder

Rare/Very Rare

Acute generalized exanthematous pustulosis Acute renal failure Agranulocytosis Anaphylaxis Cardiac arrest Clostridioides difficile infection DRESS syndrome Dyspnea Erythema Exfoliative dermatitis Hypersensitivity angiitis Hypersensitivity drug reaction Hypotension Interstitial nephritis Kounis syndrome Leukopenia Linear immunoglobulin A bullous dermatosis Maculopapular rash Ototoxicity Pancytopenia Shock Stevens-johnson syndrome Thrombocytopenic disorder Thrombophlebitis Tinnitus Toxic epidermal necrolysis Urticaria

There are 17 less severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anticholinergic toxicity Chest pain Chills Diarrhea Dizziness Drug fever Eosinophilia Fever Flushing Injection site sequelae Myalgia Nausea Phlebitis after infusion Pruritus of skin Skin rash Vertigo Wheezing

There was no evidence of teratogenicity when vancomycin was administered IV to rats in dosages up to 200 mg/kg daily (1180 mg/m2 or equivalent to the recommended maximum human dosage based on mg/m2) or to rabbits in dosages up to 120 mg/kg daily (1320 mg/m2 or 1.1 times the recommended maximum human dosage based on mg/m2). There were no effects on fetal weight or development in rats at the highest dosage tested or in rabbits given 80 mg/kg daily (880 mg/m2 or 0.74 times the maximum recommended human dosage based on mg/m2). In one study, no sensorineural hearing loss or nephrotoxicity was reported in neonates born to women who received IV vancomycin for severe staphylococcal infections associated with injection drug abuse- during pregnancy.

In one infant whose mother received IV vancomycin in the third trimester of pregnancy, conductive hearing loss was reported; however, a causal relationship to vancomycin has not been established. Because the number of pregnant women in this study was limited and vancomycin was only administered during the second and third trimester of pregnancy, it is not known whether the drug can cause fetal harm when administered to pregnant women. In a prospective study, no major adverse effects were observed in mothers or their newborns when IV vancomycin was administered at the time of delivery.

This study included 55 pregnant women with positive group B Streptococcus culture with resistance to clindamycin or unknown sensitivity and a high-risk penicillin allergy. Vancomycin dosage ranged from 1 g every 12 hours to 20 mg/kg (maximum individual dose 2 g) every 8 hours. None of the newborns had sensorineural hearing loss; although renal function of the neonates was not assessed, all neonates were discharged in good condition. Vancomycin should be used during pregnancy only when clearly needed.

Vancomycin is distributed into milk following IV administration. Systemic absorption of oral vancomycin is very low and it is not known whether the drug distributes into human milk following oral administration. However, IV and oral vancomycin should be used with caution in nursing women. Because of the potential for serious adverse reactions from the drug in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of vancomycin to the woman.

In clinical studies of oral vancomycin, 54% of patients were >65 years of age; of these, 40% were >65-75 years of age and 60% were >75 years of age. In these studies, geriatric patients treated with oral vancomycin capsules for diarrhea associated with CDI were more likely to develop nephrotoxicity during or after completion of therapy. Renal function should be monitored during and after treatment with oral vancomycin in all geriatric patients, including those with normal renal function.

Geriatric patients >65 years of age may take longer to respond to oral vancomycin therapy compared with younger patients. Clinicians should be aware of the appropriate duration of oral vancomycin treatment in geriatric patients and therapy should not be prematurely discontinued or prematurely switched to an alternate therapy. IV vancomycin dosage in geriatric patients should be adjusted based on the degree of renal impairment. Because geriatric patients may have decreasing glomerular filtration with increasing age, increased serum vancomycin concentrations may occur if dosage is not adjusted in these patients.