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Bactrim SUSP 200mg 40mg 5ml, Sulfamethoxazole Trimetoprim

Bactrim SUSP 200mg 40mg 5ml, Sulfamethoxazole Trimetoprim
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Bactrim SUSP 200mg 40mg 5ml, Sulfamethoxazole Trimetoprim


INDICATIONS: BACTRIM COMPOSITUM ® is a bactericidal broad-spectrum antimicrobial and expectorant fluxing action.

It is indicated in the treatment of respiratory tract infections . It is effective for acute exacerbations of chronic bronchitis , acute lung diseases such as pneumonia, bronchopneumonia , lung abscess , in all cases caused by gram-negative bacilli such as Haemophilus influenzae especially Klebsiella pneumoniae and Staphylococcus aureus. COMPOSITUM BACTRIM ® can also be used as a prophylactic during the winter of acute exacerbations in severe chronic bronchitis.

It is also indicated in tracheobronchitis and empyema . Also in infections of the upper respiratory tract where the germ is sensitive to cotrimoxazole .

• Infections of the upper respiratory tract : tonsillitis, pharyngitis, laryngitis and laryngotracheitis .

• Infections of respiratory tract exacerbations of chronic bronchitis , otitis media and pneumonia in children Pneumocysitis carini in children and adults .

• Infections of the ear, nose and throat otitis media , labyrinthitis and sinusitis.

Pharmacokinetics HUMAN :

Pharmacodynamics COMPOSITUM BACTRIM ® is cotrimoxazole ( trimethoprim + sulfamethoxazole ) plus guaifenesin . A bactericidal association with flow-and expectorant action.

• Its formula is specific for respiratory tract infections .

• Empowerment Synergy between the two substances.

• Suitable for the healing and symptomatic treatment of acute and chronic bronchopulmonary infections bactericides .

Pharmacokinetics After oral administration trimethoprim is absorbed faster than sulfamethoxazole . Peak blood concentrations are achieved trimethoprim in 2 hours while sulfamethoxazole is at 4 hours . The half-lives of sulfamethoxazole and trimethoprim are about 11 to 10 hours, respectively .

Trimethoprim is rapidly distributed and concentrated in the tissues and about 40 % bound to plasma proteins in the presence of sulfamethoxazole. The volume of distribution of trimethoprim is 9 times greater than the sulfamethoxazole . The drug penetrates readily into the cerebrospinal fluid and sputum . Also in the bile. Almost 65 % of sulfamethoxazole are bound to plasma proteins.

About 60 % of the administered trimethoprim and 25 to 50 % of sulfamethoxazole are excreted within 24 hours in the urine. Metabolites of trimethoprim are also excreted .

Mechanism of action: The antimicrobial activity of cotrimoxazole results of their actions on 2-step enzymatic pathway for the synthesis of tetrahydrofolic acid. Sulfamethoxazole PABA inhibits the incorporation of folic acid and trimethoprim prevents reducing dihydrofolate to tetrahydrofolate .

CONTRAINDICATIONS : In severe conditions of the liver parenchyma , blood dyscrasias and severe renal impairment , when you can not determine the plasma concentration regularly .

It should not be administered to patients with known hypersensitivity to sulfonamides or trimethoprim .

PRECAUTIONS: You should immediately be discontinued at the first appearance of skin rash or any other serious adverse reactions .

COMPOSITUM BACTRIM ® should be administered with caution to patients with a history of severe allergies and asthma .

There is an increased risk of adverse effects in elderly patients or when other complications such as liver function and / or decreased renal , or concomitant use of other drugs (in which case the risk may be related to the dose and duration of treatment ) . In rare cases have been reported in connection with fatal adverse reactions such as blood dyscrasias, exudative erythema multiforme major ( Stevens -Johnson syndrome ) , toxic epidermal necrolysis (Lyell's syndrome ) and fulminant hepatic necrosis.

To minimize the risk of adverse reactions , duration of treatment COMPOSITUM ® BACTRIM should be as short as possible, especially in elderly patients. In renal insufficiency, the dose should be adjusted according to the special administration instructions .

If BACTRIM COMPOSITUM ® is administered for prolonged periods , it requires prolonged blood counts . If a significant reduction was detected in the count of any formed blood element , it should be discontinued . Unless it is a rare event , it should not give this drug to patients with serious haematological disorders.

There have been reports of pancytopenia in patients treated with a combination of trimethoprim and methotrexate .

In elderly patients , or in patients with preexisting folic acid deficiency or kidney failure, may present indicative of folic acid deficiency hematological changes . These changes are reversible by folinic acid therapy .

They should be performed urinalysis and renal function regularly in patients on prolonged treatment with BACTRIM compositum ® (especially in presenting renal failure). During treatment , you must ensure adequate fluid intake and urine output normal to prevent crystalluria .

Because of the possibility of hemolysis, BACTRIM should not be administered to patients with COMPOSITUM ® G6PD deficiency unless it is absolutely essential , and then only in small doses .

It has been determined that the trimethoprim decreases metabolism of phenylalanine but this is not significant in PKU patients with adequate dietary restriction .

As with all drugs containing sulfonamides, caution is advised in patients with porphyria or thyroid dysfunction.

Patients who are " slow acetylators " may be more prone to idiosyncratic reactions to sulfonamides .

RESTRICTIONS OF USE DURING PREGNANCY AND BREAST-FEEDING : Do not use during pregnancy and lactation, even in premature infants under 6 months of age.

ADVERSE REACTIONS : Following the recommended dose is well tolerated , but as with all sulfonamides, may be presented nausea , vomiting , rash , Stevens- Johnson syndrome, granulocytopenia , thrombocytopenia , leucopenia and Lyell syndrome. These reactions are more common in elderly patients with renal insufficiency and concomitant use of other drugs ( thiazides, pyrimethamine , etc.). Allergic myocarditis, Henoch- Schoenlein purpura , jaundice , arthralgia , myalgia , ataxia , seizures , vertigo may occur .

It has come to observe transient mild jaundice , as well as headaches , depression , and hallucinations.

DRUG INTERACTIONS AND OTHER GENDER : In elderly patients may occur a rise in blood levels of digoxin.

You can increase the effect of anticoagulants hipotrombótico warfarínicos .

Potentiates the effect of oral hypoglycemics .

It has been reported a single case in the literature of toxic Delirium with concomitant BACTRIM COMPOSITUM ® and amantadine .

COMPOSITUM BACTRIM ® inhibits the hepatic metabolism of phenytoin.

COMPOSITUM BACTRIM ® may decrease the effectiveness of tricyclic antidepressants.

Sulfamethoxazole competes with protein binding of methotrexate .

Indomethacin can elevate serum SMZ .

BACTRIM COMPOSITUM ® may interfere with the analysis of the reaction of alkaline picrate Jaffé .

Vitamin C to acidify the urine, may facilitate precipitation of sulfa crystals and acetylated derivatives ( crystalluria ) .

CHANGES IN RESULTS OF LABORATORY TESTS may occur bilirubin and transaminase elevation and elevated serum creatinine and urea nitrogen.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis , Impairment of Fertility: these effects are not known to date. By interfering with folic acid COMPOSITUM ® BACTRIM justification must be assessed potential effect against risk pregnant .


Children 6 months : Take 1 /2 teaspoon (2.5 ml ) every 12 hours.

Children 6 months to 5 years: Take 1 teaspoon (5.0 ml ) every 12 hours.

Children 6-12 years: Take 1 tablespoon (10 ml ) every 12 hours.

Adults : Take 2 tablespoons (10 ml ) every 12 hours.

Treatment duration: 10 to 14 days .

Larger amounts can be given in special circumstances to patients with serious or life-threatening .

The dose for patients with renal impairment should be reduced , and should not be given if creatinine clearance is less than 15 ml per minute.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION : Symptoms of overdose are: nausea, vomiting , diarrhea, headache and dizziness.

Adequate ventilation, gastric lavage and basic drugs used in emergency : In case of overdose general supportive measures are recommended.


Bottle with 120 ml including metering measure.

RECOMMENDED STORAGE: Keep the bottle tightly closed at room temperature not exceeding 30 ° C. Protect from light .

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