1.BACTRIM DS HISTORY
(How was Bactrim DS discovered?)

Bactrim DS is a product of Roche Pharmaceuticals.

The US FDA approved Bactrim DS in July 2000.

The founder of Roche, Fritz Hoffmann-La Roche, was a pioneering entrepreneur who was convinced that the future belonged to branded pharmaceutical products. He was among the first to recognize that the industrial manufacture of standardized medicines would be a major advance in the fight against disease.

This led him to found F. Hoffmann-La Roche & Co. on October 1st 1896. From the very beginning, Fritz Hoffmann attached great importance to product information as the link between the pharmaceutical manufacturer and doctors, pharmacists and patients. Shortly after the foundation of the company, affiliates were opened in Germany, Italy, France, the US, Great Britain and Russia.

Since then, Roche has grown into one of the world's leading healthcare companies and one of the most important in Europe.

Note: World-drugs.net sells brand as well as generic version of Bactrim DS

2.BACTRIM DS FACTS

Bactrim DS contains trimethoprim and sulfamethoxazole, widely known as co-trimoxazole.

Co-trimoxazole exhibits a synergistic antibacterial effect when compared to each of its components administered singly. This is because trimethoprim and sulfamethoxazole inhibit successive steps in the folate synthesis pathway.

TETRAHYDROFOLATE SYNTHESIS PATHWAY

Sulfamethoxazole acts as a false-substrate inhibitor of dihydropteroate reductase. Sulfonamides such as sulfamethoxazole are analogues of p-aminobenzoic acid (PABA) and are competitive inhibitors of the enzyme; inhibiting the production of dihydropteroic acid.

Trimethoprim acts by interfering with the action of bacterial dihydrofolate reductase, inhibiting synthesis of tetrahydrofolic acid.

Folic acid is an essential precursor in the de novo synthesis of the DNA nucleosides thymidine and uridine. Bacteria are unable to take up folic acid from the environment (i.e. the infection host) thus are dependent on their own de novo synthesis - inhibition of the enzyme starves the bacteria of two bases necessary for DNA replication and transcription.

3.ABOUT BACTRIM DS MEDICATION

What are antibiotics?

An antibiotic is a drug that kills or slows the growth of bacteria. Antibiotics are one class of "antimicrobials", a larger group, which also includes anti-viral, anti-fungal, and anti-parasitic drugs. They are relatively harmless to the host, and therefore can be used to treat infections. The term originally described only those formulations derived from living organisms, in contradistinction to "chemotherapeutic agents", which were purely synthetic. Nowadays the term "antibiotic" is also applied also to synthetic antimicrobials, such as the sulfonamides.

Antibiotics are labeled as "magic bullets": drugs, which target disease without harming the host. Antibiotics are not effective in viral, fungal and other nonbacterial infections, and individual Antibiotics vary widely in their effectiveness on various types of bacteria. Some specific Antibiotics target either gram-negative or gram-positive bacteria, and others are more wide-spectrum Antibiotics.

The effectiveness of individual Antibiotics varies with the location of the infection, the ability of the antibiotic to reach the site of infection, and the ability of the bacteria to resist or inactivate the antibiotic. Some Antibiotics actually kill the bacteria (bactericidal), whereas others merely prevent the bacteria from multiplying (bacteriostatic) so that the host's immune system can overcome them.

Classes of Antibiotics?

There are many ways to classify Antibiotics.

One such classification is by chemical structure:

Aminoglycosides

• Amikacin
• Dibekacin
• Gentamicin
• Kanamycin
• Neomycin
• Netilmicin
• Paromomycin
• Sisomycin
• Streptomycin
• Tobramycin

Beta-lactam ring antibiotics

• Carbapenems
• Ertapenem
• Imipenem
• Meropenem
• Cephalosporins and cephamycins
• Cephalexin
• Cefazolin
• Cefuroxime
• Cefadroxil
• Ceftazidime
• Penicillins
• Amoxicillin

Monocyclic beta-lactams

Glycopeptide antibiotics

• Vancomycin
• Teicoplanin
• Ramoplanin
• Decaplanin

Oxazolidinones

• Linezolid
• Quinupristin/dalfopristin

Polyketides

Macrolides

• Erythromycin
• Azithromycin
• Clarithromycin
• Roxithromycin

Ketolides

• Telithromycin

Tetracyclines

• Doxycycline
• Oxytetracycline
• Chlortetracycline

Polymyxins

• Polymyxin B
• Colistin

Quinolones (fluoroquinolones)

• Nalidixic acid
• Ciprofloxacin (Cipro)
• Ofloxacin
• Norfloxacin (Norflox)
• Levofloxacin (Levaquin)
• Trovafloxacin (Trovan)

Streptogramins

Sulfonamides

• Prontosil

Other important antibiotics:

• Chloramphenicol
• Clindamycin
• Fusidic acid
• Trimethoprim

Another such classification is by their mechanism of action

Antibiotics, which interfere with cell-wall synthesis

Beta-lactams, including penicillins like Amoxicillin and cephalosporins; mono-lactams, such as Imipenem; vancomycin, bacitracin

Antibiotics that interfere with bacterial protein synthesis

Antibiotics that bind to the 50S ribosomal unit

Lincosamides/lincosides including clindamycin and lincomycin; chloramphenicol, macrolides

Antibiotics, which interfere the 30S ribosomal unit

Tetracyclines; aminoglycosides including gentamicin

Drugs that inhibit folate synthesis

Sulfonamides and trimethoprim

Drugs that interfere with DNA synthesis

Metronidazole, quinolones, novobiocin

Drugs that interfere with RNA synthesis

Rifampin (rifampicin)

Drugs that interfere with cell membrane function

Polymyxin B, gramicidin

Antibiotics can also be classified by the organisms against which they are effective, and by the type of infection in which they are useful, which depends on the sensitivities of the organisms that most commonly cause the infection and the concentration of antibiotic obtainable in the affected tissue.

Uses of Bactrim DS

Urinary Tract Infections

Bactrim DS is used for the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media

Otitis media is an inflammation and/or infection of the middle ear. Acute otitis media (acute ear infection) occurs when there is bacterial or viral infection of the fluid of the middle ear, which causes production of fluid or pus.

Bactrim DS is used for the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician.

Bactrim DS is not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults

For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, Bactrim DS offers some advantage over the use of a single antimicrobial agent.

Travelers' Diarrhea in Adults

Bactrim DS is used for the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic E.coli.

Shigellosis:

Bactrim DS is used for the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis Carinii Pneumonia

Pneumocystis is an infection of the lungs caused by the microorganism Pneumocystis carinii. Pneumocystis is almost exclusively seen in individuals whose immune systems have been compromised by AIDS or chemotherapy. Pneumocystis is usually a terminal event in AIDS patients.

Bactrim DS is used for the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.

4.BACTRIM DS EFFECTIVENESS
(When is Bactrim DS best taken?)

Bactrim DS is rapidly absorbed following oral administration. Both Bactrim DS exist in the blood as unbound, protein-bound, and metabolized forms; sulfamethoxazole also exists as the conjugated form. The metabolism of sulfamethoxazole occurs predominately 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 44% of trimethoprim and 70% of sulfamethoxazole 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 sul-famethoxazole.

Peak blood levels for the individual components occur 1 to 4 hours after oral administration. The mean serum half-lives of Bactrim DS 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. Detectable amounts of trimethoprim and sulfamethoxazole are present in the blood 24 hours after drug administration. During administration of 160 mg trimethoprim and 800 mg sulfamethoxazole b.i.d., the mean steady-state plasma concentration of trimethoprim was 1.72 mcg/mL. The steady-state minimal plasma levels of free and total sulfamethoxazole were 57.4 mcg/mL and 68.0 mcg/mL, respectively. These steady-state levels were achieved after 3 days of drug administration.

1 Excretion of Bactrim DS 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 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 N4-acetylated metabolite.2 When administered together as Bactrim DS, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other.

Both trimethoprim and sulfamethoxazole 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.

Sulfamethoxazole inhibits bacterial synthesis of dihy-drofolic acid by competing with para-aminobenzoic acid (PABA). Trimethoprim blocks the production of tetrahydrofolic acid from dihy-drofolic acid by binding to and reversibly inhibiting the required enzyme, dihydrofolate reductase. Thus, Bactrim DS blocks two consecutive steps in the biosynthesis of nucleic acids and proteins essential to many bacteria.

In vitro studies have shown that bacterial resistance develops more slowly with Bactrim DS than with either trimethoprim or sulfamethoxazole alone. In vitro serial dilution tests have shown that the spectrum of antibacterial activity of Bactrim DS includes the common urinary tract pathogens with the exception of Pseudomonas aeruginosa. The following organisms are usually susceptible: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and indole-positive Proteus species including Proteus vulgaris.

The usual spectrum of antimicrobial activity of Bactrim DS includes bacterial pathogens isolated from middle ear exudate and from bronchial secretions (Haemophilus influenzae, including ampicillin-resistant strains, and Streptococcus pneumoniae), and enterotoxigenic strains of Escherichia coli (ETEC) causing bacterial gastroenteritis. Shigella flexneri and Shigella sonnei are also usually susceptible.

5.BACTRIM DS EFFECTS ON SPECIAL POPULATION
(How do different people react to Bactrim DS?)

Pregnancy : Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose of Bactrim DS and have revealed no evidence of impaired fertility or harm to the fetus due to Bactrim DS. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Bactrim DS should be used during pregnancy only if clearly needed.

Labor and Delivery : It is not known whether use of dose of Bactrim DS in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of forceps delivery or other obstetrical intervention or resuscitation of the newborn.

Nursing Mothers : Penicillins has been shown to be excreted in human milk. Bactrim DS use by nursing mothers may lead to sensitization of infants. Caution should be exercised when Bactrim DS is administered to a nursing woman.

Pediatric Use : Because of incompletely developed renal function in neonates and young infants, the elimination of Bactrim DS may be delayed. Dosing of Bactrim DS should be modified in pediatric patients 12 weeks or younger (</=3 months).

6.BACTRIM DS EFFECTS ON MEDICAL CONDITIONS
(How does Bactrim DS affect your existing condition/ailment?)

Bactrim DS should not be used if you suffer from kidney or liver failure.

Bactrim DS should not be used if you suffer from life long inherited blood diseases, which can cause a variety of symptoms, including mental health problems (porphyrias).

7.OTHER/ALTERNATE USES OF BACTRIM DS
(What else does Bactrim DS treat?)

Bactrim DS may also be used for other infections as prescribed by your physician.

8.ADVERSE/SIDE EFFECTS of BACTRIM DS
(What are the side effects of Bactrim DS?)

The most common adverse effects are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria).

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, Other Blood Dyscrasias, And Hypersensitivity Of The Respiratory Tract.

Hematologic : Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia.

Allergic : Stevens-Johnson syndrome, toxic epidermal necrolysis, ana-phylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schönlein purpura, serum sickness-like syndrome, generalized allergic reactions, general-ized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, and rash. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported.

Gastrointestinal : Hepatitis, including cholestatic jaundice and hepatic necrosis, elevation of serum transaminase and bilirubin, pseudo-membranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia.

Genitourinary: Renal failure, interstitial nephritis, BUN and serum cre-atinine elevation, toxic nephrosis with oliguria and anuria, and crystalluria.

Metabolic : Hyperkalemia, hyponatremia.

Neurologic : Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache.

Psychiatric : Hallucinations, depression, apathy, nervousness.

Endocrine : 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.

Musculoskeletal : Arthralgia and myalgia.

Respiratory System : Cough, shortness of breath, and pulmonary infiltrates.

Miscellaneous : Weakness, fatigue, insomnia.

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