Medicinal Products

BACTRIM FORTE 800 mg / 160 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Sulfamethoxazole, Trimethoprim
laboratory: Roche

Compressed
Box of 50
All forms

Indication

They result from the antibacterial and antiparasitic activity of the product, the pharmacokinetic characteristics of sulfamethoxazole and trimethoprim, the risk of adverse effects (especially haematological and cutaneous) and must take into account, in a given country, the evolution of the sensitivity of the germs to the product and other available antibiotics. Depending on the indications and the organisms involved, the antibiotic with the best benefit / risk ratio should be used as a first-line treatment.
They are limited to adult infections caused by susceptible germs (see pharmacological properties).
Especially :
- Curative treatment :
. Pneumocystis carinii infections;
. urogenital infections of humans, including prostatitis.
- Prevention of Pneumocystis carinii infections in immunocompromised patients, including:
. in patients with HIV infection and at risk for pneumocystosis. In these cases, the incidence of cerebral toxoplasmosis also appears to be reduced in studies in patients receiving trimethoprim-sulfamethoxazole and tolerated for long periods;
. in case of bone marrow transplant or organ transplant.
On the other hand :
Taking into account the benefit / risk ratio compared to other products, the epidemiology and the bacterial resistance observed in these pathologies:
Treatment :
. high and low urinary tract infections in women including single-dose treatment of uncomplicated acute cystitis in women under 65;
. otitis and sinusitis, but only after bacteriological documentation,
. certain bronchopulmonary infections,
. digestive infections, and typhoid fever.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage BACTRIM FORTE 800 mg / 160 mg Tablet Box of 50

Dosage:
- normorénal adult subject:
The usual dosage is 1 tablet every 12 hours. It can reach 3 tablets a day in case of severe infections.
Special cases :
- single-dose treatment of uncomplicated acute cystitis in women under 65 : 3 single-dose tablets.
- Treatment of Pneumocystis carinii infections : 80 to 100 mg / kg / day of sulfamethoxazole and 16 to 20 mg / kg / day of trimethoprim in 3 to 4 doses.
- prevention of Pneumocystis carinii infections : in general, especially in HIV-infected persons, 1 tablet 3 times a week at 1 tablet per day.
. in bone marrow transplant patients : 1 tablet 2 times daily, 2 consecutive days per week for at least 6 months after transplantation.
. in organ transplant recipients : from 1 tablet a day to 1 tablet 3 times a week.
- Renal insufficiency adult subject:
. creatinine clearance> 30 ml / min : normal dosage,
. 15 ml / min <creatinine clearance <30 ml / min : half dose (same unit dosage, but once daily),
. creatinine clearance <15 ml / min : use only in case of hemodialysis. The usual dosage is then reduced by half, administered after dialysis; regular verification of plasma concentrations is recommended.
Administration mode :
The administration will be preferably during meals.

Against indications

CONTRAINDICATED:
This medicine MUST NEVER BE USED:
- in the event of a history of hypersensitivity to any of the components (in particular, hypersensitivity to sulphonamides),
- in premature babies and newborns because of the immaturity of their enzymatic systems,
- in case of G6PD deficiency, including in the breastfed child: risk of triggering hemolysis.
- in case of severe damage to the liver parenchyma,
- during breastfeeding if the newborn is less than one month old: the trimethoprim-sulfamethoxazole combination passes into breast milk. Breastfeeding is contraindicated if the mother or child has a G6PD deficiency, to prevent the occurrence of haemolysis. With sulfonamides with a long half-life, nuclear jaundices have been reported in neonates. As a result, breastfeeding is contraindicated when the newborn is less than one month old,
- in case of association with methotrexate (see interactions).
NOT RECOMMENDED :
- THIS MEDIA SHOULD NOT BE USED:
. during breastfeeding: beyond 1 month in the newborn, breastfeeding is not recommended,
. in combination with phenytoin, hyperkalemia [potassium salts, potassium diuretics, ACE inhibitors, angiotensin II inhibitors, nonsteroidal anti-inflammatory drugs, heparins (low molecular weight unfractionated), ciclosporin and tacrolimus, trimethoprim (see interactions).
- The use of trimethoprim-sulfamethoxazole is not recommended in patients with macrocytic anemia.
- Pregnancy: It is preferable, as a precautionary measure, not to use the combination sulfamethoxazole / trimethoprim during the first trimester of pregnancy. Studies in animals have shown a teratogenic effect. Clinical decline and published data on a still limited number of patients show no increase in the overall incidence of malformations or neonatal disorders. Two recent studies, however, mention the possibility of specific neural tube and heart damage in case of exposure during the three months following the last menstrual period. The mechanism of action involved would be that of interference with folates. These results must be confirmed and do not justify on their own to advise an abortion. Nevertheless, if the combination sulfamethoxazole-trimethoprim is used in early pregnancy folic acid supplementation may be proposed during the course of treatment, without evaluation to date its effectiveness in the prevention of abnormalities mentioned. In case of congenital G6PD deficiency, the occurrence of neonatal haemolysis is possible.

Bactrim Forte side effects

- General disorders:
Hypersensitivity reactions have been reported: hyperthermia, angioedema, anaphylactic shock, and anaphylactoid reactions.
Exceptional cases of interstitial lung disease have been reported.
The reported adverse effects, in order of decreasing frequency, are as follows:
- Skin manifestations:
Itchy rash, hives. These events are usually mild and rapidly reversible upon discontinuation of treatment.
Like other sulfonamide-containing drugs, trimethoprim-sulfamethoxazole has been associated with erythema multiforme skin manifestations, Stevens-Johnson syndrome, toxic epidermal necrosis (Lyell's syndrome) and fixed pigmented erythema.
- Digestive disorders :
Nausea, vomiting, epigastralgia, diarrhea.
Pseudomembranous colitis.
Cases of pancreatitis have been reported with trimethoprim-sulfamethoxazole; one-third of them in immunocompromised patients (transplant, HIV, AIDS).
- Hepatic disorders:
Hepatitis mainly cholestatic, increased transaminases and bilirubin.
- Hematological manifestations:
Cases of thrombocytopenia, leuconeutropenia, agranulocytosis, medullary aplasia, hemolytic anemia seem to be preferentially related to an immunoallergic mechanism. In subjects over 65 years of age and / or deficient in folate, these hematologic events, particularly cases of megaloblastic anemia and cytopenias, seem rather to be a toxic mechanism of dose and duration. Indeed, the product may interfere with folate metabolism.
- Urinary system disorders:
Cases of impaired renal function, interstitial nephropathy, isolated increases in serum creatinine, and crystalluria have been reported.
- Neurological manifestations:
Neuropathies (including peripheral neuropathy and paresthesia). Rare cases of aseptic meningitis, or pseudomeningeal symptoms, ataxia, convulsions, dizziness, and tremors have been reported.
Exceptional cases of uveitis have been described.
- Musculoskeletal system disorders:
Rare cases of arthralgia and myalgia, and isolated cases of rhabdomyolysis have been reported.
- Metabolic disorders:
Cases of hyperkalemia have been reported with trimethoprim-sulfamethoxazole:
. at the usual doses if there is an underlying disorder of potassium metabolism, kidney failure, or taking hyperkalaemic drugs. Close monitoring of serum potassium is then justified,
. in high doses, as used in the treatment of Pneumocystis carinii pneumonia .
In these cases, the increase in serum potassium was progressive and reversible upon discontinuation of treatment.
Cases of hyponatremia and metabolic acidosis have been reported.
Rare cases of hypoglycemia have been observed in non-diabetic patients. They usually appear after a few days of treatment.
- Manifestations in patients with HIV / AIDS infection:
The frequency of adverse effects, especially cutaneous, hyperthermia, leukopenia, increased transaminases and hyperkalemia at high dose, is more important.
Cases of pancreatitis and rhabdomyolysis have been reported in patients who are also receiving treatment that may result in such effects.

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