Bactrim SUSP 200mg 40mg 5ml, Sulfamethoxazole Trimetoprim
THIS IS A BRAND MEDICATION
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 .
DOSAGE AND ADMINISTRATION:
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 .