Nafcillin (Nafcillin)

Trade Name : NAFCILLIN

Baxter Healthcare Corporation

INJECTION, SOLUTION

Strength 1 g/50mL

NAFCILLIN SODIUM Penicillin-class Antibacterial [EPC],Penicillins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nafcillin (Nafcillin) which is also known as NAFCILLIN and Manufactured by Baxter Healthcare Corporation. It is available in strength of 1 g/50mL per ml. Read more

Nafcillin (Nafcillin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Nafcillin Injection, USP is a sterile injectable product containing nafcillin which is added as Nafcillin Sodium, USP, a semisynthetic penicillin derived from the penicillin nucleus, 6-aminopenicillanic acid. The chemical name of nafcillin sodium is Monosodium (2,5,6)-6-(2-ethoxy-1-naphthamido)-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2-carboxylate monohydrate. It is resistant to inactivation by the enzyme penicillinase (beta-lactamase). The molecular formula of Nafcillin Sodium, USP is CHNNaOSu00b7HO. The molecular weight is 454.48. The structural formula of nafcillin sodium is as follows:
Nafcillin Injection, USP is a frozen, iso-osmotic, sterile, nonpyrogenic premixed 50 mL or 100 mL solution containing 1 g or 2 g of nafcillin, respectively, added as Nafcillin Sodium, USP. Dextrose, USP has been added to the above dosages to adjust osmolality (approximately 1.8 g and 3.6 g as dextrose hydrous to the 1 g and 2 g dosages, respectively). Sodium Citrate Hydrous, USP has been added as a buffer (approximately 90 mg and 180 mg to the 1 g and 2 g dosages, respectively). The pH has been adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. The pH is 6.5 (6.0 to 8.5). The solution is intended for intravenous use after thawing to room temperature.
This GALAXY container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

In a study of five healthy adults administered a single 500 mg dose of nafcillin by intravenous injection over seven minutes, the mean plasma concentration of the drug was approximately 30 mcg/mL at 5 minutes after injection. The mean area under the plasma concentration-versus-time curve (AUC) for nafcillin in this study was 18.06 mcgu00b7h/mL.
The serum half-life of nafcillin administered by the intravenous route ranged from 33 to 61 minutes as measured in three separate studies.
In contrast to the other penicillinase-resistant penicillins, only about 30% of nafcillin is excreted as unchanged drug in the urine of normal volunteers, and most within the first six hours. Nafcillin is primarily eliminated by nonrenal routes, namely hepatic inactivation and excretion in the bile.
Nafcillin binds to serum proteins, mainly albumin. The degree of protein binding reported for nafcillin is 89.9 u00b1 1.5%. Reported values vary with the method of study and the investigator.
The concurrent administration of probenecid with nafcillin increases and prolongs plasma concentrations of nafcillin. Probenecid significantly reduces the total body clearance of nafcillin with renal clearance being decreased to a greater extent than nonrenal clearance.
The penicillinase-resistant penicillins are widely distributed in various body fluids, including bile, pleural, amniotic and synovial fluids. With normal doses insignificant concentrations are found in the aqueous humor of the eye. High nafcillin CSF levels have been obtained in the presence of inflamed meninges.
Renal failure does not appreciably affect the serum half-life of nafcillin; therefore, no modification of the usual nafcillin dosage is necessary in renal failure with or without hemodialysis. Hemodialysis does not accelerate the rate of clearance of nafcillin from the blood.
A study which assessed the effects of cirrhosis and extrahepatic biliary obstruction in man demonstrated that the plasma clearance of nafcillin was significantly decreased in patients with hepatic dysfunction. In these patients with cirrhosis and extrahepatic obstruction, nafcillin excretion in the urine was significantly increased from about 30 to 50% of the administered dose, suggesting that renal disease superimposed on hepatic disease could further decrease nafcillin clearance.

Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see ).
Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant species, therapy with Nafcillin Injection, USP should be discontinued and alternative therapy provided.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin Injection, USP should be used only to treat or prevent 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.

A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Nafcillin, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue Nafcillin and institute appropriate therapy.
Clostridium difficilen- C. difficile
C. difficilen- C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

No data

No data

Neurotoxic reactions similar to those observed with penicillin G may arise with intravenous doses of nafcillin especially in patients with concomitant hepatic insufficiency and renal dysfunction (see ).
In the case of overdosage, discontinue nafcillin, treat symptomatically and institute supportive measures as required. Hemodialysis does not increase the rate of clearance of nafcillin from the blood.

Nafcillin Injection, USP supplied as a premixed frozen solution is to be administered as an intravenous infusion. The usual I.V. dosage for adults is 500 mg every 4 hours. For severe infections, 1 g every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.
With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not add supplementary medication to Nafcillin Injection, USP.
Store in a freezer capable of maintaining a temperature of -20u00b0C (-4u00b0F) or less.

Nafcillin Injection, USP in GALAXY container (PL 2040 Plastic) is for intravenous administration using sterile equipment.

Nafcillin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL and 100 mL single dose GALAXY containers (PL 2040 Plastic) as follows:
2G3540tNDC 0338-1017-41t1 gram nafcillin in 50 mLt2G3556tNDC 0338-1019-48t2 grams nafcillin in 100 mL
Store at or below -20u00b0C/-4u00b0F. See n
Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Baxter and Galaxy are registered trademarks of Baxter International Inc.
Baxter Healthcare Corporation
07-19-00-469Rev. September 2018

Container Label
Arrayn- Baxter Logo
1 g
Nafcillin Injection, USP
GALAXY Single DoseContainer
50 mL Iso-osmotic
NDC 0338-1017-41Code 2G3540Sterile Nonpyrogenic
Each 50 mL contains: Nafcillin Sodium, USP equivalent to 1 g Nafcillin with approx. 1.8 g Dextrose Hydrous, USP added to adjust osmolality and 90 mg Sodium Citrate Hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 6.5 (6.0 to 8.5).
Dosage: Intravenously as directed by a physician. See insert.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks and solution clarity. n
Store at or below -20u00b0C (-4u00b0F). Thaw at room temperature (25u00b0C/77u00b0F) or under refrigeration (5u00b0C/41u00b0F). Thawed solution is stable for 21 days under refrigeration (5u00b0C/41u00b0F) or 72 hours at room temperature (25u00b0C/77u00b0F).
Do not refreeze.
Baxter and Galaxy are registered trademarks of Baxter International Inc. n Deerfield, IL 60015 USA Made in USA
PL 2040 Plastic 07-34-63-877
Arrayn- Iso-osmotic Store at or below -20u00b0C/-4u00b0F. Do not refreeze.
1 g Baxter Healthcare Corporation n
Thaw at room temperature (25u00b0C/77u00b0F) or under refrigeration (5u00b0C/41u00b0F). Thawed solution is stable for 21 days under refrigeration (5u00b0C/41u00b0F) or 72 hours at room temperature (25u00b0C/77u00b0F). n
u00a0Handle frozen product containers with care. Product containers may be fragile in the frozen state.Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic07-04-65-185
NDC 0338-1071-41 Code 2G3540
FOR BAR CODE POSITION ONLY n
GALAXY
Each 50 mL contains: Nafcillin Sodium, USP equivalent to 1 g Nafcillin with approx. 1.8 g Dextrose Hydrous, USP added to adjust osmolality and 90 mg Sodium Citrate Hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 6.5 (6.0 to 8.5).
Dosage: Intravenously as directed by a physician. See insert.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. n
Arrayn- Baxter Logo
2 g
Nafcillin Injection, USP
GALAXY Single Dose Container
100 mL Iso-osmotic
NDC 0338-1019-48 Code 2G3556 Sterile Nonpyrogenic
Each 100 mL contains: Nafcillin Sodium, USP equivalent to 2 g Nafcillin with approx. 3.6 g Dextrose Hydrous, USP added to adjust osmolality and 180 mg Sodium Citrate Hydrous, USP added as a buffer. pH adjusted with hydrochloric acid and may have been adjusted with sodium hydroxide. pH 6.5 (6.0 to 8.5).
Dosage: Intravenously as directed by a physician. See insert.
Cautions: Do not add supplementary medication. Must not be used in seriesconnections. Check for minute leaks and solution clarity. n n
Store at or below -20u00b0C (-4u00b0F). Thaw at room temperature (25u00b0C/77u00b0F) or underrefrigeration (5u00b0C/41u00b0F). Thawed solution is stable for 21 days under refrigeration (5u00b0C/41u00b0F) or 72 hours at room temperature (25u00b0C/77u00b0F). n
Baxter and Galaxy are registered trademarks ofBaxter International Inc.n Deerfield, IL 60015 USA Made in USA
PL 2040 Plastic 07-34-63-878
Arrayn- Iso-osmoticStore at or below -20u00b0C/-4u00b0F. Do not refreeze.
2 g Baxter Healthcare Corporation n
Thaw at room temperature (25u00b0C/77u00b0F) or under refrigeration (5u00b0C/41u00b0F). Thawed solution is stable for 21 days under refrigeration (5u00b0C/41u00b0F) or 72 hours at room temperature (25u00b0C/77u00b0F). n
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter and Galaxy are registered trademarks of Baxter International Inc.
PL 2040 Plastic07-04-65-186
NDC 0338-1019-48 Code 2G3556 FOR BAR CODE POSITION ONLY n
GALAXY
Dosage: Intravenously as directed by a physician. See insert.
Cautions: Do not add supplementary medication. Must not be used in series connections. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear. n

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Nafcillin (Nafcillin)

Trade Name : NAFCILLIN

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Nafcillin (Nafcillin)

Trade Name : NAFCILLIN

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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