Sulfamethoxazole And Trimethoprim (Sulfatrim)

Trade Name : SULFATRIM

Pharmaceutical Associates, Inc.

SUSPENSION

Strength 20040 mg/5mLmg/5mL

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 (Sulfatrim) which is also known as SULFATRIM and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 200; 40 mg/5mL; mg/5mL per ml. Read more

Sulfamethoxazole And Trimethoprim (Sulfatrim) 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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Pharmaceutical Associates, Inc.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 containing 200 mg sulfamethoxazole and 40 mg trimethoprim per 5 mL for oral administration.
Sulfamethoxazole is n n n n n n n -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is Cn n n n n n Hn n n n n n Nn n n n n n On n n n n n S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula is:n nn n nn
Trimethoprim is 2,4-diamino-5-(3,4,5- trimethoxybenzyl) pyrimidine; the molecular formula is Cn n n n n n Hn n n n n n Nn n n n n n On n n n n n . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and. It has the following structural formula is:n nn n nn

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. The metabolism of sulfamethoxazole occurs predominantly by N4-acetylation, although the glucuronide conjugate has been identified. The principal metabolites of trimethoprim are the 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. 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 n n n 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 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.n n n 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% for total sulfonamide and 66.8% for free trimethoprim. Thirty percent of the total sulfonamide is excreted as free sulfamethoxazole, with the remaining as Nn n n n n n -acetylated metabolite.n n n n n n When administered together as sulfamethoxazole and trimethoprim, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other.n nn n nn
Both sulfamethoxazole and trimethoprim distribute to sputum, vaginal fluid and middle ear fluid; trimethoprim also distributes to bronchial secretions, 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 oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 is 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 is also contraindicated in pregnant patients and nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus. Sulfamethoxazole and trimethoprim oral suspension is contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole and trimethoprim is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS.
SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS SULFAMETHOXAZOLE/ TRIMETHOPRIM, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION.n- Array
Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.
Sulfamethoxazole/trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole/trimethoprim.
The sulfonamides should not be used for the treatment of group A u03b2-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.
Clostridium difficile
C. difficile
C. difficile
C. difficile
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against n n n n n n may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of n n n n n n , and surgical evaluation should be instituted as clinically indicated.n nn n nn

No data

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

No data

Not recommended for use in pediatric patients less than 2 months of age.

Sulfamethoxazole and Trimethoprim Oral Suspension USP, containing 200 mg sulfamethoxazole and 40 mg trimethoprim per teaspoonful (5 mL), is a cherry flavored suspension available in:
NDC 0121-0854-16: 16 fl oz (473 mL) bottle
Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP Controlled Room Temperature]. Protect from light.
SHAKE WELL BEFORE USING.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
To report SUSPECTED ADVERSE REACTIONS, contact Pharmaceutical Associates, Inc. at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Rx only

1. Kremers P, Duvivier J, Heusghem C. Pharmacokinetic Studies of Co-Trimoxazole in Man after Single and Repeated Doses. n n n n n n . Feb-Mar 1974; 14:112u2013117.n nn n nn
2. Kaplan SA, et al. Pharmacokinetic Profile of Trimethoprim-Sulfamethoxazole in Man. n n n n n n . Nov 1973; 128 (Suppl): S547u2013 S555.n nn n nn
3. Varoquaux O, et al. Pharmacokinetics of the trimethoprim-sulfamethoxazole combination in the elderly. n n n n n n . 1985;20:575u2013581.n nn n nn
4. Rudoy RC, Nelson JD, Haltalin KC. n n n n n n . May 1974;5:439u2013443.n nn n nn
5. National Committee for Clinical Laboratory Standards. n n n n n n ; Approved Standard u2013 Fourth Edition. NCCLS Document M7u2013A4, Vol.17, No. 2, NCCLS, Wayne, PA, January, 1997.n nn n nn
6. Hardy DW, et al. A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of n n n n n n pneumonia in patients with the acquired immunodeficiency syndrome. n n n n n n . 1992; 327: 1842u20131848.n nn n nn
7. Marinella Mark A. 1999. Trimethoprim-induced hyperkalemia: An analysis of reported cases. n n n n n n . 45:209u2013212.n nn n nn
8. Margassery, S. and B. Bastani. 2002. Life threatening hyperkalemia and acidosis secondary to trimethoprim-sulfamethoxazole treatment. n n n n n n . 14:410u2013414.n nn n nn
9. Brumfitt W, Pursell R. Trimethoprim/Sulfamethoxazole in the Treatment of Bacteriuria in Women. n n n n n n . Nov 1973; 128 (Suppl):S657u2013S663.n nn n nn
10. Masur H. Prevention and treatment of n n n n n n pneumonia. n n n n n n . 1992; 327: 1853u20131880.n nn n nn
11. Recommendations for prophylaxis against n n n n n n pneumonia for adults and adolescents infected with human immunodeficiency virus. n n n n n n 1992; 41(RR-4):1u201311.n nn n nn
12. CDC Guidelines for prophylaxis against n n n n n n pneumonia for children infected with human immunodeficiency virus. n n n n n n . 1991; 40(RR-2):1u201313.n nn n nn

Manufactured for:n n n n n n Pharmaceutical Associates, Inc.n n n n n n Greenville, SC 29605n n n n n n R02/18n nn n nn

NDCn- 0854
SULFATRIMu2122n n n n n n PEDIATRICn n n n n n SUSPENSIONn n n n n n (sulfamethoxazole andn n n n n n trimethoprimn n n n n n oral suspension USP)n n n n n n
CHERRY FLAVOR
Each 5 mL (teaspoonful) contains:
Sulfamethoxazole, USP 200 mgn n n n n n Trimethoprim, USP 40 mgn n n n n n Alcohol NMT 0.5%n nn n nn
Rx Only
16 FL OZ (473 mL)
Arrayn- Pharmaceuticaln n n n n n Associates, Inc.n n n n n n n- Array

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Sulfamethoxazole And Trimethoprim (Sulfatrim)

Trade Name : SULFATRIM

SUSPENSION

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 (Sulfatrim)

Trade Name : SULFATRIM

SUSPENSION

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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