Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim)

Trade Name : Sulfamethoxazole and Trimethoprim

Mylan Institutional LLC

INJECTION

Strength 8016 mg/mLmg/mL

SULFAMETHOXAZOLE; TRIMETHOPRIM Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]

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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 Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) which is also known as Sulfamethoxazole and Trimethoprim and Manufactured by Mylan Institutional LLC. It is available in strength of 80; 16 mg/mL; mg/mL per ml. Read more

Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim) 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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No data

Indications and Usage () 7/2020

Sulfamethoxazole and trimethoprim injection is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial, indicated in adults and pediatric patients two months of age and older for treatment of infections caused by designated, susceptible bacteria.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim injection and other antibacterial drugs, sulfamethoxazole and trimethoprim injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ()

Pneumocystis jirovecii

No data

Sulfamethoxazole and trimethoprim injection, USP is available as an injection containing 80 mg/mL of sulfamethoxazole and 16 mg/mL of trimethoprim in 5 mL single-dose and 30 mL multiple-dose vials.
Injection: 80 mg/mL sulfamethoxazole and 16 mg/mL trimethoprim in 5 mL single-dose and 30 mL multiple-dose vials. ()

Sulfamethoxazole and trimethoprim is contraindicated in the following:

No data

Clostridioides difficile
Pneumocystis jirovecii

The following serious adverse reactions are described elsewhere in the labeling:
The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, and anorexia) and allergic skin reactions (such as rash and urticaria). ()
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or n

Potential for Sulfamethoxazole and Trimethoprim to Affect Other Drugs
Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of sulfamethoxazole and trimethoprim with drugs that are substrates of CYP2C8 and 2C9 or OCT2
Table 4: Drug Interactions with Sulfamethoxazole and Trimethoprim Injection
Sulfamethoxazole and trimethoprim, specifically the trimethoprim component, can interfere with a serum methotrexate assay as determined by the competitive binding protein technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA).
The presence of sulfamethoxazole and trimethoprim may also interfere with the Jaffu00e9 alkaline picrate reaction assay for creatinine, resulting in overestimations of about 10% in the range of normal values.

No data

Acute
Since there has been no extensive experience in humans with single doses of sulfamethoxazole and trimethoprim in excess of 25 mL (400 mg trimethoprim and 2000 mg sulfamethoxazole), the maximum tolerated dose in humans is unknown.
Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.
Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression.
General principles of treatment include the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating trimethoprim and sulfamethoxazole.
Chronic
Use of sulfamethoxazole and trimethoprim at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.

Sulfamethoxazole and trimethoprim injection USP, a sterile, clear, colorless or slightly yellow solution for intravenous infusion only, is a combination of sulfamethoxazole, a sulfonamide antimicrobial, and trimethoprim, a dihydrofolate reductase inhibitor antibacterial. Each mL contains 16 mg trimethoprim, USP and 80 mg sulfamethoxazole, USP compounded with propylene glycol 400 mg (38.6% v/v and 40.0% w/v); dehydrated alcohol 100 mg (12.3% v/v and 10.0% w/v); diethanolamine 3 mg (0.3% v/v and 0.3% w/v); benzyl alcohol 10 mg (1.0% v/v and 1.0% w/v) as a preservative; sodium metabisulfite 1 mg (0.1% w/v) as an antioxidant; water for injection q.s.; air replaced with nitrogen; pH adjusted with sodium hydroxide and/or hydrochloric acid if necessary. pH 9.5 to 10.5.
Trimethoprim, USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:
CHNO M.W. 290.3
Sulfamethoxazole, USP is -(5-methyl-3-isoxazolyl) sulfanilamide. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:
CHNOS M.W. 253.28

No data

Carcinogenesis
Sulfamethoxazole was not carcinogenic when assessed in a 26-week tumorigenic mouse (Tg-rasH2) study at doses up to 400 mg/kg/day sulfamethoxazole; equivalent to 2-fold the human systemic exposure (at a daily dose of 800 mg sulfamethoxazole .
Mutagenesis
In vitro
in vitro
in vitro
in vivo
In vivo
Sulfamethoxazole alone was positive in an reverse mutation bacterial assay and in micronucleus assays using cultured human lymphocytes.
Trimethoprim alone was negative in reverse mutation bacterial assays and in chromosomal aberration assays with Chinese Hamster ovary or lung cells with or without S9 activation. In Comet, micronucleus and chromosomal damage assays using cultured human lymphocytes, trimethoprim was positive. In mice following oral administration of trimethoprim, no DNA damage in Comet assays of liver, kidney, lung, spleen, or bone marrow was recorded.
Impairment of Fertility
No adverse effects on fertility or general reproductive performance were observed in rats given oral dosages as high as 350 mg/kg/day sulfamethoxazole plus 70 mg/kg/day trimethoprim, doses roughly two times the recommended human daily dose on a body surface area basis.

No data

Sulfamethoxazole and trimethoprim injection, USP is supplied as follows:
5 mL Single-Dose Vialscontaining 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.
30 mL Multiple-Dose Vialseach 5 mL containing 80 mg trimethoprim (16 mg/mL) and 400 mg sulfamethoxazole (80 mg/mL) for infusion with 5% dextrose in water.
After initial entry into vial, the remaining contents must be used within 48 hours.
Store at 20u00b0 to 25u00b0C [68u00b0 to 77u00b0F]. [See USP Controlled Room Temperature]. n- DO NOT REFRIGERATE.

Arrayn- Embryou2013fetal Toxicity
Advise female patients of reproductive potential that sulfamethoxazole and trimethoprim can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy .
Arrayn- Lactation
Advise nursing women to avoid breastfeeding during treatment with sulfamethoxazole and trimethoprim.
Arrayn- Antibacterial Resistance
Counsel patients that antibacterial drugs including sulfamethoxazole and trimethoprim should only be used to treat bacterial infections. It does not treat viral infections (e.g., the common cold).
Instruct patients to maintain an adequate fluid intake in order to prevent crystalluria and stone formation.
Arrayn- Diarrhea
Advise patients that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Bangalore, India
DECEMBER 2020

NDC 67457-778-05
Sulfamethoxazole and Trimethoprim Injection, USP
Sulfamethoxazole 400 mg/5mL (80 mg/mL)
Trimethoprim 80 mg/5 mL (16 mg/mL)
For Intravenous Infusion Only
Must be diluted with 5% dextrose injection prior to administration
Sterile
Mylan
Rx only
10 x 5 mL Single-Dose Vials

NDC 67457-779-30
Sulfamethoxazole and Trimethoprim Injection, USP
Sulfamethoxazole 400 mg/5mL (80 mg/mL)
Trimethoprim 80 mg/5 mL (16 mg/mL)
For Intravenous Infusion Only
Must be diluted with 5% dextrose injection prior to administration
Sterile
Mylan
Rx only
30 mL Multiple-Dose Vials

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Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim)

Trade Name : Sulfamethoxazole and Trimethoprim

INJECTION

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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Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim)

Trade Name : Sulfamethoxazole and Trimethoprim

INJECTION

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)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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CONTACT US

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