Sulfamethoxazole and Trimethoprim (Sulfamethoxazole and Trimethoprim)

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Trade Name: Sulfamethoxazole and Trimethoprim

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 800; 160 mg/1; mg/1

Storage and handling

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]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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

Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration.n n n n Sulfamethoxazole is n n n n -(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is Cn n n Hn n n Nn n n On n n S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:n nn
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is Cn n n Hn n n Nn n n On n n . It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:n nn
Inactive Ingredients:u00a0

Sulfamethoxazole and trimethoprim is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood as unbound, protein-bound and metabolized forms; sulfamethoxazole also exists as the conjugated form. Sulfamethoxazole is metabolized in humans to at least 5 metabolites: the Nn n n -acetyl-, Nn n n -hydroxy-, 5-methylhydroxy-, Nn n n -acetyl-5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of Nn n n -hydroxy metabolite is mediated n n n CYP2C9.n n n n Trimethoprim is metabolized n n n to 11 different metabolites, of which, five are glutathione adducts and six are oxidative metabolites, including the major metabolites, 1- and 3-oxides and the 3- and 4-hydroxy derivatives.n n n n The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.n n n n studies suggest that trimethoprim is a substrate of P-glycoprotein, OCT1 and OCT2, and that sulfamethoxazole is not a substrate of P-glycoprotein.n n n n Approximately 70% of sulfamethoxazole and 44% of trimethoprim are bound to plasma proteins. The presence of 10 mg percent sulfamethoxazole in plasma decreases the protein binding of trimethoprim by an insignificant degree; trimethoprim does not influence the protein binding of sulfamethoxazole.n n n n Peak blood levels for the individual components occur 1 to 4 hours after oral administration. The mean serum half-lives of sulfamethoxazole and trimethoprim are 10 and 8 to 10 hours, respectively. However, patients with severely impaired renal function exhibit an increase in the half-lives of both components, requiring dosage regimen adjustment (see n n n section). Detectable amounts of sulfamethoxazole and trimethoprim are present in the blood 24 hours after drug administration. During administration of 800 mg sulfamethoxazole and 160 mg trimethoprim b.i.d., the mean steady-state plasma concentration of trimethoprim was 1.72 mcg/mL. The steady-state mean plasma levels of free and total sulfamethoxazole were 57.4 mcg/mL and 68 mcg/mL, respectively. These steady-state levels were achieved after three days of drug administration.n n n Excretion of sulfamethoxazole and trimethoprim is primarily by the kidneys through both glomerular filtration and tubular secretion. Urine concentrations of both sulfamethoxazole and trimethoprim are considerably higher than are the concentrations in the blood. The average percentage of the dose recovered in urine from 0 to 72 hours after a single oral dose of sulfamethoxazole and trimethoprim is 84.5% u00a0for total sulfonamide and 66.8%u00a0for free trimethoprim. Thirty percent of the total sulfonamide is excreted as free sulfamethoxazole, with the remaining as Nn n n -acetylated metabolite.n n n When administered together as sulfamethoxazole and trimethoprim, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other.n n n n Both sulfamethoxazole and trimethoprim distribute to sputum, vaginal fluid and middle ear fluid; trimethoprim also distributes to bronchial secretion, and both pass the placental barrier and are excreted in human milk.n nn

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, 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 empiric selection of therapy.
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Sulfamethoxazole and trimethoprim tablets are contraindicated in patients with a known hypersensitivity to trimethoprim or sulfonamides, in patients with a history of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency.n n n n Sulfamethoxazole and trimethoprim tablets are contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole and trimethoprim tablets are also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.n nn

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The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). n n n n n n n n n Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.n n n n n n n Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.n n n n n n n Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.n n n n n Renal failure, interstitial nephritis, BUN and serum creatinine elevation, toxic nephrosis with oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine.n n n n n n Hyperkalemia, hyponatremian n n n n n n n Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.u00a0n n n Hallucinations, depression, apathy, nervousness.n n n n n n n The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides.n n n n n n n Arthralgia and myalgia. Isolated cases of rhabdomyolysis have been reported with sulfamethoxazole and trimethoprim, mainly in AIDS patients.n n n n n Cough, shortness of breath and pulmonary infiltrates (see n n n ).n n n n n n n Weakness, fatigue, insomnia.n n n n n n n The following adverse reactions have been identified during post-approval use of trimethoprim-sulfamethoxazole. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure:n nn

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Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg
Bottles of 10 NDC 66267-196-10
Bottles of 14 NDC 66267-196-14
Bottles of 20 NDC 66267-196-20
Bottles of 28 NDC 66267-196-28
Bottles of 30 NDC 66267-196-30
Bottles of 60 NDC 66267-196-60
Bottles of 90 NDC 66267-196-90n n 20u00ba to 25u00baC (68u00ba to 77u00baF); excursions permitted to 15u00ba to 30u00baC (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].n nDISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.n

Manufactured for:n n n n 2400 Route 130 Northn n n Dayton, NJ 08810n n n n Manufactured by:n n n n Hyderabad-500 072, Indian n n n Revised: 09/2013n nn

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Sulfamethoxazole and Trimethoprim (Sulfamethoxazole and Trimethoprim) which is also known as Sulfamethoxazole and Trimethoprim and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 800; 160 mg/1; mg/1.

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.