Active ingredients: Trimethoprim, Sulfamethoxazole
Bactrim 160 mg + 800 mg soluble tablets
Bactrim package inserts are available for pack sizes:- Bactrim 160 mg + 800 mg soluble tablets
- Bactrim 160 mg + 800 mg tablets, Bactrim 80 mg / 5 ml + 400 mg / 5 ml oral suspension
- Bactrim 80 mg + 400 mg tablets
Bactrim 40 mg / 5 ml + 200 mg / 5 ml oral suspension
Why is Bactrim used? What is it for?
Bactrim belongs to the therapeutic category of bactericidal chemotherapy drugs.
Indications
Respiratory tract infections: sinusitis, otitis media, acute bronchitis, pneumonia (also due to Pneumocystis carinii), exacerbations in chronic bronchitis or bronchiectasis.
Kidney and urinary tract infections: pyelitis, cystitis, prostatitis, urethritis, exacerbations in chronic urinary tract infections.
Infections of the genital system including gonococcal urethritis.
Infections of the digestive system: infections with Shigella, Salmonella typhi and paratyphi and other enteritis from sensitive germs
Contraindications When Bactrim should not be used
Known hypersensitivity to sulfonamides and / or trimethoprim, or to any of the excipients.
Severe renal failure with azotemia; severe lesions of the liver parenchyma; blood dyscrasias.
Children under two months of age.
During pregnancy and breastfeeding, in order to avoid the risk that failure to eliminate the drug from the mother's body and, respectively, the passage into milk, may cause neonatal jaundice.
Insufficiency of glucose-6-phosphate-dehydrogenase
Bactrim must not be administered in combination with dofetilide (see section "Interactions").
Precautions for use What you need to know before taking Bactrim
In the state of pregnancy, in very early childhood and in elderly patients, the product should be used only in case of real need and under the direct supervision of the doctor.
Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) DRESS (drug rash with eosinophilia and systemic symptoms), have been reported with the use of Bactrim; these initially appear as round red spots or circular patches that often occur they accompany blisters in the central part of the trunk.
Additional signs to note include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
These life-threatening rashes are often accompanied by flu-like symptoms. The rash may progress with the development of widespread blistering and peeling of the skin.
The highest risk of severe skin reactions occurs within the first few weeks of treatment.
If Stevens-Johnson syndrome or toxic epidermal necrolysis develops, Bactrim should no longer be used with the use of Bactrim.
If you develop a skin rash or these skin symptoms, stop taking Bactrim, consult a doctor urgently and tell them you are taking this drug.
Particular caution must be exercised in the treatment of patients with renal or hepatic dysfunction and in those with folate deficiency or with severe allergies.
During treatment, especially if prolonged, periodic checks of hepatic and renal function and blood counts are recommended.
The product should not be used in case of infections caused by ß-haemolytic streptococcus group A (pharyngitis and others)
Pregnancy and breastfeeding
Bactrim is contraindicated during pregnancy and while breastfeeding.
Interactions Which drugs or foods can modify the effect of Bactrim
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Prolongation of prothrombin time caused by Bactrim has been reported in patients receiving indirect anticoagulants. This interaction must therefore be kept in mind when Bactrim is prescribed to patients already on anticoagulant therapy; furthermore, the blood coagulation values must be checked again.
Toxic delirium has been reported following concomitant use of trimethoprim-sulfamethoxazole and amantadine.
There is evidence that trimethoprim, through inhibition of its renal transport system, may interact with dofetilide. Trimethoprim 160 mg in combination with sulfamethoxazole 800 mg administered twice daily concurrently with dofetilide 500 µg twice daily, for four days, resulted in a 103% increase in the area under the concentration-time curve (AUC) and a 93% increase in maximum concentration (Cmax). Dofetilide can cause serious ventricular arrhythmias associated with QT interval prolongation, including torsades de pointes, which are directly related to the plasma concentration of dofetilide. Concomitant administration of dofetilide and trimethoprim is contraindicated.
Warnings It is important to know that:
Should rashes appear, treatment with Bactrim should be stopped immediately.
Asymptomatic changes in relation to folate metabolism, however reversible with folinic acid, are possible although unlikely.
During prolonged treatment with Bactrim it is advisable to check the blood formula and urine regularly.
Dosage and method of use How to use Bactrim: Dosage
Adults and children over 12 years:
Normal dose: 1 soluble tablet 2 times a day, in the morning and in the evening after a meal.
Minimum dose and dose for prolonged treatments (more than 15 days): ½ soluble tablet 2 times a day.
Maximum dose (particularly severe cases): 1½ soluble tablet twice a day. In case of acute infections, Bactrim 160 mg + 800 mg soluble tablets should be administered for at least 5 days, or until the patient has been free from symptoms for 2 days.
In children aged between 2 months and 12 years, it is advisable to resort to the syrup, according to the dosage schedule indicated in the package leaflet included in the relative package.
How to use: The tablets dissolve, or more properly disperse rapidly in water or other aqueous liquids; in this way a drink with an acceptable flavor and easy to drink is obtained.
Overdose What to do if you have taken too much Bactrim
In theory, the following are possible: the appearance of crystals in the urine, oliguria or anuria; nausea, vomiting, diarrhea, headache, dizziness.
In case of intoxication, depending on the symptoms, it is necessary to foresee: gastric lavage, adequate fluid intake to accelerate renal elimination, hemodialysis, control of the blood formula and, in case of its alteration, administration of 6 - 12 mg of folinate of football.
In case of accidental intake of an excessive dose of the medicine, notify your doctor immediately or go to the nearest hospital
Side Effects What are the side effects of Bactrim
Like all medicines, this can cause side effects, although not everybody gets them.
The following standard categories of frequency are used: very common (≥ 1/10); common (≥ 1/100 e
Adverse events reported in the general population of patients treated with trimethoprim sulfamethoxazole
Infections and infestations
Very rare
Fungal infections such as candidiasis have been reported.
Disorders of the blood and lymphatic system
Rare
Many of the haematological changes observed were mild, asymptomatic and reversible on discontinuation of therapy. The most commonly observed changes were leukopenia, granulocytopenia and thrombocytopenia.
Very rare
Agranulocytosis, anemia (megaloblastic, haemolytic / autoimmune, aplastic), pancytopenia, methemoglobinemia, eosinophilia (associated with DRESS), hypoprothrombinemia, alterations in folate metabolism may occur.
Disorders of the immune system
Very rare
Hypersensitivity reactions have been reported.As with any other drug, allergic reactions, including cross reactions, may occur in patients hypersensitive to one of the components: for example, generalized skin and mucous reactions, urticaria, exfoliative dermatitis, fever, angioneurotic edema, anaphylactoid reactions, serum sickness, DRESS (drug rash with eosinophilia and systemic symptoms), interstitial pneumonia.
Cases of pulmonary infiltrates such as those occurring in eosinophilic or allergic alveolitis have been reported. These can manifest as symptoms such as coughing or difficulty breathing. Should such symptoms appear or worsen unexpectedly, the patient should be re-examined and discontinuation of Bactrim should be considered. In addition, cases of periarteritis nodosa and allergic myocarditis have been reported.
Metabolism and nutrition disorders
Very rare
Administration of TM in high doses, as in cases of Pneumocystis carinii pneumonia, results in a progressive, but reversible, increase in serum potassium concentrations in many patients. Even at recommended doses, TM can cause hyperkalaemia when administered to patients with a potassium metabolism disorder, renal insufficiency or who are being treated with drugs that cause hyperkalaemia. Monitoring of serum potassium is recommended in these patients.
Cases of hyponatraemia have been reported. Cases of hypoglycaemia have been reported in non-diabetic patients treated with TM-SMZ, usually after a few days of therapy. Patients with reduced kidney function, liver disease or malnutrition or who are treated with high doses of TM-SMZ are particularly at risk.
Psychiatric disorders
Very rare
Single cases of hallucinations have been described.
Nervous system disorders
Very rare
Neuropathy (which includes peripheral neuritis and paraesthesia), uveitis. Aseptic meningitis or meningeal-like symptoms, ataxia, convulsions, tinnitus, dizziness, headache, mental depression, insomnia and asthenia have been reported.
Gastrointestinal disorders
common
Nausea (with or without vomiting)
Rare
Stomatitis, glossitis, diarrhea
Very rare
Abdominal pain, pseudomembranous colitis. Cases of acute pancreatitis have been reported; many patients suffer from serious illnesses including AIDS.
Hepatobiliary disorders
Very rare
Elevated transaminase and bilirubin levels, hepatitis, cholestasis, hepatic necrosis, isolated cases of evanescent bile duct syndrome, jaundice have been described
Skin and subcutaneous tissue disorders
common
Multiple skin reactions have been described; these are generally mild and rapidly reversible after discontinuation of treatment.
Very rare
Like many other sulfonamide-containing drugs, Bactrim has been related to photosensitivity. Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), DRESS (drug rash with eosinophilia and systemic symptoms) have been reported (see section "Precautions for use"). Erythema multiforme, purpura and Henoch purpura -Schoenlein.
Musculoskeletal, connective tissue and bone disorders
Very rare
Cases of arthralgia and myalgia and isolated cases of rhabdomyolysis have been reported.
Renal and urinary tract disorders
Very rare
There have been reports of impaired renal function, interstitial nephritis, elevated blood urea nitrogen (BUN), albuminuria, haematuria, elevated creatinine and crystalluria. Sulfonamides, including Bactrim, may induce increased diuresis, particularly in patients with cardiac edema.
General disorders and administration site conditions
Bactrim perfusion intravenous infusion has occasionally resulted in local side effects in the form of mild to moderate venous pain and phlebitis.
Safety of TM-SMZ in HIV-positive patients
The HIV-positive patient population is similar to the general population in terms of the spectrum of side effects that can occur. In any case, some undesirable effects may occur with a higher frequency and with a different clinical picture.
These differences concern the following classes:
Disorders of the blood and lymphatic system
Very common
Leukopenia, granulocytopenia and thrombocytopenia.
Metabolism and nutrition disorders
Very common
Hyperkalemia. Uncommon Hyponatremia, hypoglycaemia.
Gastrointestinal disorders
Very common
Anorexia, nausea with or without vomiting, diarrhea. Hepatobiliary disorders Elevated transaminases.
Skin and subcutaneous tissue disorders
Very common
Maculopapular rash, usually accompanied by itching.
General disorders and administration site conditions
Very common
Fever, usually accompanied by maculopapular rashes.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package. The expiry date indicated refers to the product in intact packaging, correctly stored. Warning: do not use the medicine after the expiry date shown on the package
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition
Bactrim 160 mg + 800 mg soluble tablets: one soluble tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim.
Excipients: microcrystalline cellulose, sodium starch glycolate, sodium dioctyl sulfosuccinate, saccharin, magnesium stearate, corn starch.
Pharmaceutical form and packaging
Bactrim 160 mg + 800 mg soluble tablets: 16 soluble tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
BACTRIM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bactrim is an association between a sulfonamide derivative, sulfamethoxazole (SMZ) and a chemotherapeutic drug derived from diaminopyrimidines, trimethoprim (TM) in the ratio 5: 1.
Bactrim 80 mg + 400 mg tablets. One tablet contains: sulfamethoxazole 400 mg, trimethoprim 80 mg.
Bactrim 160 mg + 800 mg tablets. One tablet contains: sulfamethoxazole 800 mg, trimethoprim 160 mg.
Bactrim 160 mg + 800 mg soluble tablets. One tablet contains: sulfamethoxazole 800 mg, trimethoprim 160 mg.
Bactrim 40 mg / 5 ml + 200 mg / 5 ml oral suspension. 100 ml contain: sulfamethoxazole 4 g, trimethoprim 0,8 g. 5 ml of oral suspension (one scoop) contains 200 mg of SMZ and 40 mg of TM.
Bactrim 80 mg / 5 ml + 400 mg / 5 ml oral suspension. 100 ml contain: sulfamethoxazole 8 g, trimethoprim 1.6 g. 5 ml of oral suspension (one scoop) contains 400 mg of SMZ and 80 mg of TM.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Bactrim is available as tablets, soluble tablets and suspension for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Respiratory tract infections: sinusitis, otitis media, acute bronchitis, pneumonia (also due to Pneumocystis carinii), exacerbations in chronic bronchitis or bronchiectasis.
Kidney and urinary tract infections: pyelitis, cystitis, prostatitis, urethritis, exacerbations in chronic urinary tract infections.
Infections of the genital system including gonococcal urethritis.
Infections of the digestive system: infections with Shigella, Salmonella typhi and paratyphi and other enteritis from sensitive germs.
04.2 Posology and method of administration
In case of acute infections, Bactrim should be administered for at least 5 days or until the patient has been free from symptoms for 2 days.
• The pediatric dosage corresponds to approximately 6 mg of TM / kg / day.
• In severe infections, the dosage should be increased by 50%.
• In long-term maintenance therapies (over 15 days) it should be decreased by 50%.
How to use
Oral suspension: shake thoroughly before use.
Bactrim 160 mg + 800 mg soluble tablets dissolve, or more properly dissolve rapidly in water or other aqueous liquids; in this way a drink with an acceptable flavor and easy to drink is obtained.
04.3 Contraindications
Known hypersensitivity to sulfonamides and / or trimethoprim, or to any of the excipients. Severe renal failure with azotemia; severe lesions of the liver parenchyma; blood dyscrasias.
Children under two months of age.
During pregnancy and during breastfeeding, in order to avoid the risk that the failure to eliminate the drug from the mother's body and, respectively, the passage into the milk, may cause neonatal jaundice. Insufficiency of glucose-6-phosphate dehydrogenase.
Bactrim must not be administered in combination with dofetilide (see section 4.5).
04.4 Special warnings and appropriate precautions for use
In the state of pregnancy, in very early childhood and in elderly patients, the product should be used only in case of real need and under the direct supervision of the doctor.
The following life-threatening skin reactions have been reported with the use of Bactrim: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), DRESS (drug rash with eosinophilia and systemic symptoms). Patients should be informed. signs and symptoms and closely monitored for skin reactions The highest risk of developing SJS and TEN occurs in the first weeks of treatment.
If symptoms or signs of SJS and TEN occur (e.g. progressive skin rash often with blistering or mucosal lesions) Bactrim treatment should be discontinued.
The best results in the management of SJS and TEN are obtained with an early diagnosis and immediate discontinuation of therapy with any suspect drug. Early discontinuation is associated with a better prognosis.
If the patient has developed SJS and TEN with the use of Bactrim, Bactrim should no longer be used in this patient.
Particular caution must be exercised in the treatment of patients with renal or hepatic dysfunction and in those with folate deficiency or with severe allergies.
During treatment, especially if prolonged, periodic checks of hepatic and renal function and blood counts are recommended.
The product should not be used in case of infections caused by group A β-haemolytic streptococcus (pharyngitis and others).
Should rashes appear, treatment with Bactrim should be stopped immediately.
Asymptomatic changes in relation to folate metabolism, however reversible with folinic acid, are possible although unlikely.
During prolonged treatment with Bactrim it is advisable to check the blood formula and urine regularly.
The oral suspension contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Prolongation of prothrombin time caused by Bactrim has been reported in patients receiving indirect anticoagulants. This interaction must therefore be kept in mind when Bactrim is prescribed to patients already on anticoagulant therapy; furthermore, the blood coagulation values must be checked again.
Toxic delirium has been reported following concomitant use of TM-SMZ and amantadine.
There is evidence that TM, through inhibition of its renal transport system, may interact with dofetilide. Trimethoprim 160 mg in combination with sulfamethoxazole 800 mg administered twice daily concurrently with dofetilide 500 mg twice daily, for four days, resulted in a 103% increase in the area under the concentration-time curve (AUC) and a 93% increase in maximum concentration (Cmax). Dofetilide can cause serious ventricular arrhythmias associated with QT interval prolongation, including torsades de pointes, which are directly related to the plasma concentration of dofetilide. Concomitant administration of dofetilide and trimethoprim is contraindicated.
04.6 Pregnancy and lactation
Bactrim is contraindicated in pregnancy and during lactation.
04.7 Effects on ability to drive and use machines
No effects of the drug on these abilities have been reported or expected.
04.8 Undesirable effects
The following standard categories of frequency are used: very common (≥ 1/10); common (≥ 1/100 e
Adverse events reported in the general population of patients treated with TM-SMZ
Infections and infestations
Very rare: fungal infections such as candidiasis have been reported.
Disorders of the blood and lymphatic system
Rare: Many of the haematological changes observed were mild, asymptomatic and reversible on discontinuation of therapy. The most commonly observed changes were leukopenia, granulocytopenia and thrombocytopenia.
Very rare: agranulocytosis, anemia (megaloblastic, haemolytic / autoimmune, aplastic), pancytopenia, methemoglobinemia, eosinophilia (associated with DRESS), hypoprothrombinemia, alterations in folate metabolism may occur.
Disorders of the immune system
Very rare: hypersensitivity reactions have been reported. As with any other drug, allergic reactions, including cross reactions, may occur in patients who are hypersensitive to one of the components: for example, generalized skin and mucosal reactions, urticaria, exfoliative dermatitis, fever, angioneurotic edema, anaphylactoid reactions, serum sickness, DRESS (drug rash with eosinophilia and systemic symptoms), interstitial pneumonia.
Cases of pulmonary infiltrates such as those occurring in eosinophilic or allergic alveolitis have been reported. These can manifest as symptoms such as coughing or difficulty breathing. Should such symptoms appear or worsen unexpectedly, the patient should be re-examined and discontinuation of Bactrim should be considered.
In addition, cases of periarteritis nodosa and allergic myocarditis have been reported.
Metabolism and nutrition disorders
Very rare: Administration of TM at high doses, as in cases of Pneumocystis carinii pneumonia, results in a progressive, but reversible, increase in serum potassium concentrations in many patients. Even at recommended doses, TM can cause hyperkalaemia when administered to patients with a potassium metabolism disorder, renal insufficiency or who are being treated with drugs that cause hyperkalaemia. Monitoring of serum potassium is recommended in these patients.
Cases of hyponatraemia have been reported. Cases of hypoglycaemia have been reported in non-diabetic patients treated with TM-SMZ, usually after a few days of therapy. Patients with reduced kidney function, liver disease or malnutrition or who are treated with high doses of TM-SMZ are particularly at risk.
Psychiatric disorders
Very rare: single cases of hallucinations have been described.
Nervous system disorders
Very rare: neuropathy (including peripheral neuritis and paraesthesia), uveitis. Aseptic meningitis or meningeal-like symptoms, ataxia, convulsions, tinnitus, dizziness, headache, mental depression, insomnia and asthenia have been reported.
Gastrointestinal disorders
common: nausea (with or without vomiting)
Rare: stomatitis, glossitis, diarrhea.
Very rare: abdominal pain, pseudomembranous colitis.
Cases of acute pancreatitis have been reported; many patients suffer from serious illnesses including AIDS.
Hepatobiliary disorders
Very rare: elevated transaminase and bilirubin levels, hepatitis, cholestasis, hepatic necrosis, isolated cases of evanescent bile duct syndrome, jaundice have been described.
Skin and subcutaneous tissue disorders
common: multiple skin reactions have been described; these are generally mild and rapidly reversible after discontinuation of treatment.
Very rare: like many other sulfonamide-containing drugs, Bactrim has been related to photosensitivity.
Serious skin adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), DRESS (drug rash with eosinophilia and systemic symptoms), have been reported (see section 4.4).
Erythema multiforme, purpura and Henoch-Schoenlein purpura.
Musculoskeletal, connective tissue and bone disorders
Very rare: Cases of arthralgia and myalgia and isolated cases of rhabdomyolysis have been reported.
Renal and urinary tract disorders
Very rare: Cases of impaired renal function, interstitial nephritis, elevated blood urea nitrogen (BUN), albuminuria, haematuria, elevated creatinine and crystalluria have been reported. Sulfonamides, including Bactrim, may induce increased diuresis, particularly in patients with cardiac edema.
General disorders and administration site conditions
Bactrim perfusion intravenous infusion has occasionally resulted in local side effects in the form of mild to moderate venous pain and phlebitis.
Safety of TM-SMZ in HIV-positive patients
The HIV-positive patient population is similar to the general population in terms of the spectrum of side effects that can occur. In any case, some undesirable effects may occur with a higher frequency and with a different clinical picture.
These differences concern the following classes:
Disorders of the blood and lymphatic system
Very common: leukopenia, granulocytopenia and thrombocytopenia.
Metabolism and nutrition disorders
Very common: hyperkalaemia.
Uncommon: hyponatremia, hypoglycemia.
Gastrointestinal disorders
Very common: anorexia, nausea with or without vomiting, diarrhea.
Hepatobiliary disorders
Elevated transaminases.
Skin and subcutaneous tissue disorders
Very common: maculopapular rash, usually accompanied by pruritus.
General disorders and administration site conditions
Very common: fever, usually accompanied by maculopapular eruptions.
04.9 Overdose
In theory, the following are possible: the appearance of crystals in the urine, oliguria or anuria; nausea, vomiting, diarrhea, headache, dizziness.
In case of intoxication, depending on the symptoms, it is necessary to foresee: gastric lavage, adequate fluid intake to accelerate renal elimination, hemodialysis, control of the blood formula and, in case of its alteration, administration of 6 - 12 mg of folinate of football.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antibacterial for systemic use.
ATC code: J01EE01.
Bactrim represents an example of synergism with enhancement between two substances. The association leads to a higher pharmacological action than that exerted individually by the single components, since these act simultaneously on two consecutive points of the bacterial metabolism.
Like all substances with sulfonamide action, SMZ also competes with the uptake by bacteria of p-aminobenzoic acid, thus inhibiting the synthesis of folic acid; intervening in an exclusively bacterial process, it is not harmful to the human cell.
The TM acts on the next enzymatic step, blocking the bacterial dihydrofolic-reductase and thus enhancing the effect of the previous inhibition. The affinity of TM for this bacterial enzyme is at least 10,000 times higher than that for the human cell enzyme: its blocking action is therefore selective.
As a consequence of the double sequential block operated by the two substances, the result of their association is superadditive, with a bactericidal effect.
The spectrum of action of Bactrim is very broad and includes numerous Gram + and Gram- germs such as streptococci (in infections due to β-haemolytic streptococcus of group A the therapeutic activity is not always satisfactory), staphylococci, pneumococci, meningococci, gonococci, Bordetella, salmonellae, Klebsiella / Aerobacter, shigellae and cholera vibrio.
Bactrim also acts on certain germs that are difficult to attack: Haemophilus influenzae, Escherichia coli, Proteus mirabilis and Proteus vulgaris.
05.2 Pharmacokinetic properties
The two components of Bactrim exhibit satisfactorily overlapping absorption and blood kinetics. Both drugs are absorbed very quickly in the intestine and are distributed in the tissues, spreading in the "sputum, saliva, tracheobronchial secretions, in the" aqueous humor, in the cerebrospinal fluid, in the vaginal secretion, in the synovial fluid and in the prostate. .
Both trimethoprim and sulfamethoxazole have a plasma half-life of approximately 12 hours and are excreted in the urine in large quantities.
05.3 Preclinical safety data
The oral LD50 in mice is 4200 mg / kg.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Bactrim 80 mg + 400 mg tablets
povidone, sodium starch glycolate, magnesium stearate, sodium dioctyl sulfosuccinate.
Bactrim 160 mg + 800 mg tablets
povidone K30, magnesium stearate, docusate sodium, sodium starch glycolate.
Bactrim 160 mg + 800 mg soluble tablets
microcrystalline cellulose, sodium starch glycolate, sodium dioctyl sulfosuccinate, saccharin, magnesium stearate, corn starch.
Bactrim 40 mg / 5 ml + 200 mg / 5 ml oral suspension
70% non-crystallizable sorbitol, microcrystalline cellulose, sodium carboxymethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharin, polysorbate 80, ammonium glycyrrhizinate, caramel flavor, banana flavor, vanilla flavor, glycerol, alcohol, edetate sodium, purified water.
Bactrim 80 mg / 5 ml + 400 mg / 5 ml oral suspension
microcrystalline cellulose, sodium carboxymethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, 70% non-crystallizable sorbitol, saccharin, polysorbate 80, ammonium glycyrrhizinate, caramel flavor, banana flavor, vanilla flavor, alcohol, glycerol, edetate sodium, purified water.
06.2 Incompatibility
No specific incompatibilities are known to date.
06.3 Period of validity
Expiry of the unopened package correctly stored: 5 years.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Tablets
Blisters made of thermoformed plastic material, coupled with aluminum tape.
Soluble tablets, oral suspension
Bottles of dark glass (amber yellow), with screw cap of thermoplastic material.
The various containers are enclosed in their respective cardboard box together with the package leaflet (and the plastic measuring cup for the two oral suspension packs).
06.6 Instructions for use and handling
Oral suspension: shake thoroughly before use.
07.0 MARKETING AUTHORIZATION HOLDER
Roche S.p.A. - Piazza Durante 11 - 20131 Milan
08.0 MARKETING AUTHORIZATION NUMBER
"80 mg + 400 mg tablets" 20 tablets AIC n ° 021978010
"160 mg + 800 mg tablets" 16 tablets AIC n ° 021978046
"40 mg / 5 ml + 200 mg / 5 ml oral suspension" 1 bottle 100 ml AIC n ° 021978059
"80 mg / 5 ml + 400 mg / 5 ml oral suspension" 1 bottle 100 ml AIC n ° 021978061
"160 mg + 800 mg soluble tablets" 16 soluble tablets AIC n ° 021978097
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
June 2013