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Sulfamethoxazole And Trimethoprim (Sulfamethoxazole And Trimethoprim)

Trade Name : Sulfamethoxazole and Trimethoprim

Sun Pharmaceutical Industries, Inc.

TABLET

Strength 40080 mg/1mg/1

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 Sun Pharmaceutical Industries, Inc.. It is available in strength of 400; 80 mg/1; mg/1 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx only
  • 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.
  • Sulfamethoxazole is n -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is CHNOS. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:
  • Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is CHNO. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:
  • Inactive ingredients:
  • 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 N-acetyl-, N-hydroxy-, 5-methylhydroxy-, N-acetyl- 5-methylhydroxy- sulfamethoxazole metabolites, and an N-glucuronide conjugate. The formulation of N-hydroxy metabolite is mediated CYP2C9.
  • Trimethoprim is metabolized 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.
  • The free forms of sulfamethoxazole and trimethoprim are considered to be the therapeutically active forms.
  • In vitro
  • 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.
  • 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 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 u00b5g/mL. The steady-state mean plasma levels of free and total sulfamethoxazole were 57.4 u00b5g/mL and 68.0 u00b5g/mL, respectively. These steady-state levels were achieved after three days of drug administration. 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% for total sulfonamide and 66.8% for free trimethoprim. Thirty percent of the total sulfonamide is excreted as free sulfamethoxazole, with the remaining as N-acetylated metabolite. When administered together as sulfamethoxazole and trimethoprim, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other.
  • 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.
  • 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 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.
  • 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.
  • 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.
  • No data
  • No data
  • The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). n
  • Hematologic:
  • Allergic Reactions:
  • Gastrointestinal:
  • Genitourinary:
  • Metabolic and Nutritional: n- Array
  • Neurologic:
  • Psychiatric:
  • Endocrine:
  • Musculoskeletal:
  • Respiratory: n- Array
  • Miscellaneous:
  • 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:
  • Acute:
  • Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression.
  • General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and 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 sulfamethoxazole and trimethoprim.
  • Chronic:
  • Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age.
  • Sulfamethoxazole and trimethoprim tablets, USP are supplied as follows:
  • Sulfamethoxazole 400 mg and trimethoprim 80 mg tablets, white, round, scored, debossed MP 81
  • Sulfamethoxazole 800 mg and trimethoprim 160 mg tablets, double strength, white, oval shaped, scored, debossed MP 85
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).
  • [See USP Controlled Room Temperature]
  • DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
  • No data
  • Distributed by: Sun Pharmaceutical Industries, Inc.
  • Cranbury, NJ 08512
  • Rev 08, August 2020
  • No data
  • No data
  • No data
  • No data

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Validated Cold Chain Shipment

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