Vancin-S

Vancomycin hydrochloride.

Vancin-S 125 mg: White to off-white granules in a white cap-white body hard capsule no. 2 with "
Click on icon to see table/diagram/image
" logo and "V125" in red color on the capsule shell.
Each capsule contains Vancomycin hydrochloride equivalent to Vancomycin 125 mg.

Pharmacology: Pharmacodynamics: Vancomycin, a tricyclic glycopeptide antibiotic, is bactericidal and appears to bind tightly to D-alanyl-D-alanine portion of cell wall precursor causing blockage of glycopeptide polymerization of cell wall biosynthesis. In addition, Vancomycin alters bacterial cell membrane permeability and RNA synthesis.
Pharmacokinetics: Vancin-S 125 mg: Absorption: Oral bioavailability usually is less than 5%. However, absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or with Clostridium difficile-induced pseudomembranous colitis. Serum Vancomycin concentrations are higher in patients with renal dysfunction than in those with normal renal function, and toxic serum concentrations may result.
Distribution: Vancomycin is widely distributed in body tissues and diffuses readily into pericardial, pleural, ascitic, and synovial fluid. Small amounts of the drug are distributed into bile. Vancomycin does not readily distribute into CSF in absence of inflammation unless serum concentrations are exceedingly high. Vancomycin is 30-60% bound to serum proteins. Protein binding may be lower (19-29%) in patients with hypoalbuminemia (e.g. burn patients, those with end stage renal disease). Vancomycin readily crosses the placenta and is distributed into cord blood. Vancomycin is distributed into milk.
Metabolism: No apparent metabolism.
Elimination: The serum elimination half-life of Vancomycin in adults with normal renal function has been reported to average 4-7 hours and the serum elimination half-life of Vancomycin is increased in patients with renal dysfunction. Vancomycin does not appear to be metabolized. Following oral administration, the drug is excreted mainly in feces. Vancomycin is only minimally removed by hemodialysis or peritoneal dialysis, including continuous ambulatory peritoneal dialysis. The drug is substantially removed by hemofiltration.

Vancin-S 125 mg: Antibiotic-associated pseudomembranous colitis caused by Clostridium difficile: The drug is used orally for the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile.
Staphylococcal enterocolitis: For treatment of enterocolitis caused by Staphylococcus aureus.
Therefore, Vancomycin must be given orally for these indications. Orally administered Vancomycin is not effective for other types of infections.
Vancin-S: Severe staphylococcal (including methicillin-resistant Staphylococcus aureus) infections eg, endocarditis, bone infection, septicemia, lower respiratory tract and skin infections. Severe staphylococcal infection in penicillin-allergic patient.

Vancin-S 125 mg: For oral use. The capsule should not be open and should be taken with plenty of water.
Adults: The recommended Vancomycin dose for the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile and staphylococcal enterocolitis, the usual oral dosage is 500 mg to 2 g daily given in 3 or 4 divided doses for 7 to 10 days.
Pediatric: For the treatment of antibiotic-associated pseudomembranous colitis caused by C. difficile and staphylococcal enterocolitis in children, the usual oral dosage of Vancomycin is 40 mg/kg daily given in 3 or 4 divided doses for 7-10 days. Dosage of oral Vancomycin in children should not exceed 2 g daily.
Vancomycin capsules are not appropriate for the treatment of children under the age of 12 years or for adolescents unable to swallow them. Below 12 years, age-appropriate formulation should be used.
Dosage in renal impairment: Due to the very low systemic absorption, dose adjustment is unlikely, unless substantial oral absorption may occur in case of inflammatory intestinal disorders or C. difficile-induced pseudomembranous colitis. Monitoring of serum Vancomycin concentrations of patients with inflammatory intestinal disorders should be performed.
Dosage in elderly: Elderly patients are at greater risk for nephrotoxicity during or after oral therapy, monitoring recommended with oral therapy.
Vancin-S: Severe infection caused by Staphylococcus species including methicillin-resistant Staphylococcus aureus and other vancomycin-susceptible organism: Adult: 500 mg every 6 hours or 1 g every 12 hours over IV for 60 minutes.
Children: 10 mg/kg every 6 hours or 20 mg/kg every 12 hours over 60 minutes.
Neonate/infant: Initially 15 mg/kg, followed by 10 mg/kg every 12 hours & every 12 hours for infant 1 week to 1 month.
Infection in neutropenic patients: 20 mg/kg every 8 hours.

Vancin-S 125 mg: Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Hemofiltration and hemoperfusion with amberlite resin XAD-4 have been reported to be of limited benefit.

Vancomycin is contraindicated in patients with known hypersensitivity to the drug.

Based on the Ministry of Public Health's Announcement: Vancomycin is contraindicated in individuals who are hypersensitive to the drug.
For pregnancy, Vancomycin may be harmful to fetal auditory nerve.

Vancin-S 125 mg: This preparation is for oral use only and is not systemically absorbed. Orally administered Vancomycin capsules are not effective for other types of infections.
Absorption may be enhanced in patients with inflammatory disorders of the intestinal mucosa or C. difficile-induced pseudomembranous colitis. These patients may be at risk for the development of adverse reactions, especially if there is a concomitant renal impairment. Monitoring of serum Vancomycin concentrations of patients with inflammatory disorders of the intestinal mucosa should be performed.
Serial monitoring of renal function should be performed when treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside or other nephrotoxic drugs.
Serial tests of auditory function may be helpful in order to minimize the risk of ototoxicity in patients with an underlying hearing loss, or who are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside.
Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.
Severe cutaneous adverse reactions (SCARS) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with Vancomycin treatment. Most of these reactions occurred within a few days and up to eight weeks after commencing treatment with Vancomycin.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Vancomycin should be withdrawn immediately and an alternative treatment considered. If the patient has developed a SCAR with the use of Vancomycin, treatment with Vancomycin must not be restarted at any time.
Prolonged use of Vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Vancin-S: Necrosis or severe pain in intramuscular administration.
Impaired renal or auditory function.
Infant and elderly especially in combination w/ aminoglycosides.

Pregnancy: Vancomycin crosses the placenta and can be detected in fetal serum amniotic fluid, and cord blood. Adverse fetal effects, including sensorineural, hearing loss or nephrotoxicity, have not been reported following maternal use during the second or third trimesters of pregnancy.
Lactation: Vancomycin is distributed into milk following IV administration. Vancomycin exhibits minimal oral absorption; therefore, the amount available to pass into the milk would be limited 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.

Neutropenia, renal failure, hearing loss/ototoxicity, redneck or red man syndrome.
Vancin-S 125 mg: Cardiovascular: Peripheral edema, vasculitis.
Central nervous system: Fatigue, headache.
Gastrointestinal: Abdominal pain, diarrhea, flatulence, nausea, vomiting.
Genitourinary: Urinary tract infection.
Neuromuscular & skeletal: Back pain.
Dermatologic and Sensitivity Reactions: Rashes (including exfoliative dermatitis), severe cutaneous adverse reaction (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP).
Renal: Increased serum creatinine, interstitial nephritis, renal insufficiency.
Otic: Tinnitus, dizziness, vertigo.
Hematologic: Agranulocytosis, eosinophilia, thrombocytopenia.
Miscellaneous: Fever, hypokalemia.
The absorption of Vancomycin from the gastrointestinal tract is negligible. However, in severe inflammation of the intestinal mucosa, especially in combination with renal insufficiency, side effects that occur when Vancomycin is administered parenterally may appear.
Vancin-S: Anaphylaxis. Inflammation at injection site following rapid administration.

Vancin-S 125 mg: Ototoxic and nephrotoxic drugs: Because of the possibility of additive toxicities, the concurrent or sequential systemic or topical use of other ototoxic and/or nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, bacitracin, cisplatin, colistin, polymyxin B, ciclosporin, and loop diuretics) and Vancomycin requires careful serial monitoring of renal and auditory function.
Bile acid sequestrants: May diminish the therapeutic effect of Vancomycin. Avoid concurrent administration of oral Vancomycin and bile acid sequestrants when possible. If use of both agents is necessary, consider separating doses by at least 2 hours to minimize the significance of the interaction.
Nonsteroidal anti-inflammatory drugs (NSAIDs): May increase the serum concentration of Vancomycin.
Colistimethate: Vancomycin may enhance the nephrotoxic effect of colistimethate.
Piperacillin: Piperacillin may enhance the nephrotoxic effect of Vancomycin.
Sodium picosulfate: Vancomycin may diminish the therapeutic effect of sodium picosulfate. Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using Vancomycin.
Neuromuscular-blocking agents: Vancomycin may enhance the neuromuscular-blocking effect of neuromuscular-blocking agents.
BCG (intravesical) and BCG vaccine (immunization): Vancomycin may diminish the therapeutic effect of BCG (intravesical)/BCG vaccine (immunization).
Typhoid vaccine: Vancomycin may diminish the therapeutic effect of typhoid vaccine. Only the live attenuated Ty21a strain is affected. Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with Vancomycin. Use of this vaccine should be postponed until at least 3 days after cessation of Vancomycin.
Vancin-S: Anesthesia. Concomitant use w/ aminoglycoside and other neurotoxic/nephrotoxic drugs may increase nephrotoxicity.

Vancin-S 125 mg: Store below 30°C.

Other Antibiotics

J01XA01 - vancomycin ; Belongs to the class of glycopeptide antibacterials. Used in the systemic treatment of infections.
A07AA09 - vancomycin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.

Cap: D; Powd for inj: S