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Rx Item-Vancomycin 250Mg Cap 20 By Ani Pharma Gen Vancocin

Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120  UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207  MPN 039120Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120  UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207  MPN 039120Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Image 5 of Rx Item-Vancomycin 250Mg Cap 20 By Ani Pharma Gen Vancocin

Rx Item-Vancomycin 250Mg Cap 20 By Ani Pharma Gen Vancocin

$1154.32$76.99

Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120 UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207 MPN 039120 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. RX499436 Vancomycin 250mg Cap 20 by Akorn Pharma Item No. 499436 NDC No. 62559039120 UPC No. 6255903912

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Clinical Information
Gen. Code and Des.
9327 vancomycin HCl ORAL CAPSULE 250 MG
Strength
250 mg
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
8122816 GLYCOPEPTIDE ANTIBIOTICS
Active Ingredients
2791 vancomycin HCl 1404939
Inactive Ingredients
10138 blue dye
2549 gelatin 9000708

VANCOCIN- vancomycin hydrochloride capsule
ANI Pharmaceuticals, Inc.
VANCOCIN � (vancomycin hydrochloride USP) CAPSULES
1 INDICATIONS AND USAGE

VANCOCIN CAPSULES are indicated for the treatment of C. difficil e-associated diarrhea. VANCOCIN CAPSULES are also used for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains). Parenteral administration of vancomycin is not effective for the above infections; therefore, VANCOCIN CAPSULES must be given orally for these infections.

Orally administered VANCOCIN is not effective for other types of infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VANCOCIN CAPSULES and other antibacterial drugs, VANCOCIN CAPSULES should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Adults

VANCOCIN CAPSULES are used in treating C. difficile -associated diarrhea and staphylococcal enterocolitis.


C. difficile- associated diarrhea: The recommended dose is 125 mg administered orally 4 times daily for 10 days.

Staphylococcal enterocolitis: Total daily dosage is 500 mg to 2 g administered orally in 3 or 4 divided doses for 7 to 10 days.

2.2 Pediatric Patients

The usual daily dosage is 40 mg/kg in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.
3 DOSAGE FORMS AND STRENGTHS

VANCOCIN 125 mg* CAPSULES have an opaque blue cap and opaque brown body imprinted with "3125" on the cap and "VANCOCIN HCL 125 MG" on the body in white ink.

VANCOCIN 250 mg* CAPSULES have an opaque blue cap and opaque lavender body imprinted with "3126" on the cap and "VANCOCIN HCL 250 MG" on the body in white ink.

*Equivalent to vancomycin.
4 CONTRAINDICATIONS

VANCOCIN CAPSULES are contraindicated in patients with known hypersensitivity to vancomycin.
5 WARNINGS AND PRECAUTIONS
5.1 Oral Use Only

This preparation for the treatment of colitis is for oral use only and is not systemically absorbed. VANCOCIN CAPSULES must be given orally for treatment of staphylococcal enterocolitis and Clostridium difficile- associated diarrhea. Orally administered VANCOCIN CAPSULES are not effective for other types of infections.

Parenteral administration of vancomycin is not effective for treatment of staphylococcal enterocolitis and C. difficile -associated diarrhea. If parenteral vancomycin therapy is desired, use an intravenous preparation of vancomycin and consult the package insert accompanying that preparation.
DESCRIPTION

VANCOCIN CAPSULES for oral administration contain chromatographically purified vancomycin hydrochloride, a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis), which has the chemical formula C66 H75 Cl2 N9 O24 �HCl. The molecular weight of vancomycin hydrochloride is 1485.73; 500 mg of the base is equivalent to 0.34 mmol.

The capsules contain vancomycin hydrochloride equivalent to 125 mg (0.08 mmol) or 250 mg (0.17 mmol) vancomycin. The capsules also contain F D & C Blue No. 2, gelatin, iron oxide, polyethylene glycol, titanium dioxide, and other inactive ingredients.
Mechanism of Action

Vancomycin is an antibacterial drug (see CLINICAL PHARMACOLOGY
Microbiology

Mechanism of action

The bactericidal action of vancomycin against Staphylococcus aureus and the vegetative cells of Clostridium difficile results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis.

Mechanism of resistance

Staphylococcus aureus
S. aureus
isolates with vancomycin minimal inhibitory concentrations (MICs) as high as 1024 mcg/mL have been reported.
The exact mechanism of this resistance is not clear but is believed to be due to cell wall thickening and potentially the transfer of genetic material.
Clostridium difficile
Isolates of C. difficile generally have vancomycin MICs of <1 mcg/mL, however vancomycin MICs ranging from 4 mcg/mL to 16 mcg/mL have been reported. The mechanism which mediates C. difficile's decreased susceptibility to vancomycin has not been fully elucidated.

Vancomycin has been shown to be active against susceptible isolates of the following bacteria in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive bacteria

Staphylococcus aureus
(including methicillin-resistant isolates) associated with enterocolitis.

Anaerobic gram-positive bacteria

Clostridium difficile
isolates associated with C. difficile associated diarrhea.

Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120  UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207  MPN 039120
Vancomycin 250Mg Cap 20 By Ani
Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120 UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207 MPN 039120

Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120  UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207  MPN 039120
Vancomycin 250Mg Cap 20 By Ani Pharma
Item No.: RX499436 NDC No.62559-0391-20 62559-391-20 6255939120 62559039120 UPC/GTIN No. 0-36255-939120-7 036255-9391207 0362559391207 MPN 039120

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.