Vicometrim 960 Vidipha treatment and prevention of pneumonia (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Sulfamethoxazole, trimethoprim

Ingredient

Composition informationContent
Sulfamethoxazole800mg
Trimethoprim160mg

Uses

Indications

Vicometrim 960 drugs are indicated for the treatment of infections caused by the following sensitive bacteria:

  • Treatment and prevention of pneumes caused by Pneumocystis Jiroveci or "PJP" (formerly known as pneumocystis cannii or "PCP").
  • Treatment and prevention of Toxoplasma disease.
  • Treatment of nocardiosis.
  • The following infections can be treated with Vicometrim 960 when there is evidence that bacteria are sensitive to this antibiotic and give a better effect when using single antibiotics:

  • Uncomplicated urinary tract infection.
  • acute otitis media .
  • Exacerbivorce of chronic bronchitis.

    Pharmacy

    Mechanism of action

    sulfamethoxazol inhibits the use of para-aminobenzoic acid in the synthesis of dihydrofolate by bacterial cells, resulting in bacterial infections. Trimethoprim reverses the Reductase inhibiting Dihydrofolate bacteria (DHFR) A enzyme that operates in the metabolism of folat to convert dihydrofolate into tetrahydrofolate. Depending on the effects of effects may kill bacteria. Therefore trimethoprim and sulfamethoxazol blocked two consecutive steps during purin's biosynthesis and more nucleic acids needed for many bacteria. This impact creates in vitro efficiency between the two substances.

    Trimethoprim links to DHFR Plasmodial but less closer than the bacterial enzyme. Its affinity for DHFR mammals is 50,000 times lower than the corresponding bacterial enzyme.

    Medicine resistance mechanism

    In vitro studies have shown that bacterial resistance may grow slower with both sulfamethoxazol and trimethoprim in combination compared to Sulfamethoxazol or single trimethoprim.

    resistance to sulfamethoxazol can occur due to different mechanisms. Bacterial mutations increase PABA concentration and thus compete with sulfamethoxazol, resulting in reduced enzyme inhibitors dihydropteroat synthetase. Another anti -drug mechanism is plasmid intermediaries and the result of the production of synthetic enzymes dihydropteroat synthetase, with a reduced affinity for sulfamethoxazol compared to standard configuration enzymes.

    resistance to trimethoprim occurs through mutations via plasmid intermediaries, resulting in the production of an enzyme Reductase dihydrofolate that changes the affinity for trimethoprim compared to the standard configuration enzyme.

    Trimethoprim links to DHFR Plasmodial but less closer than the bacterial enzyme. Its affinity for DHFR mammals is 50,000 times lower than the corresponding bacterial enzyme. Many common pathogenic bacteria in vitro for trimethoprim and sulfamethoxazol are lower than concentrations in blood, tissue and urine after the recommended dose. However, as other antibiotics, in vitro activity does not necessarily show that the clinical effect has been proven and should be noted that sensitive tests are achieved only with the recommended vehicles that do not contain inhibitors, especially thymidin and thymin.

    Antibacterial spectrum: The drug resistance may vary in terms of geography and time with the selected bacteria strains and should pay attention to local information about resistance, especially when treating severe infections. When necessary, the consultant should search for local drug resistance information at least some types of infections. This information only gives a close guide and probability of whether microorganisms are sensitive to trimethoprim/sulfamethoxazol.

    The sensitivity of trimethoprim/sulfamethoxazol for some bacteria shown in the table below

    Common sensitive strains:

  • Aerobic Gram -positive bacteria: Staphylococcus aureus, Staphylococcus saprophyticus, Streptococcus pyogenes.

  • Aerobic Gram -negative bacteria: En
  • Some known resistance strains:

  • Aerobic gram -positive grams: Enterococcus Faecalis, Enterococcus Faecium, Nocardia spp., Staphylococcus Epidermidis, Streptococcus Pneumoniae.
  • Aerobic gram -negative bacteria: Citrobacter spp.
  • The anti -drug microorganisms:

  • Aerobic Gram -negative bacteria: Pseudomonas Aeruginosa, Shigella spp., Vibro Cholera.
  • Pharmacokinetic

    absorption

    After drinking, Trimethoprim and Sulfamethoxazol are quickly and almost completely absorbed. The presence of food does not seem to hinder the absorption. The peak concentration occurs from 1-4 hours after oral oral concentration and the concentration is related to the dose. Effective concentration exists in the blood for up to 24 hours after the treatment dose. Stable concentration in adults achieved after taking the drug for 2-3 days. No components in two components have a significant influence on the concentration of the blood of the rest.

    Distribution

    about 50% trimethoprim in plasma is connected to protein. The concentration of trimethoprim tissue is usually higher than the corresponding plasma concentration. The concentration in the lungs and kidneys is particularly high. Trimethoprim concentration in bile, prostate and tissue liquid, saliva, sputum and vaginal discharge beyond plasma concentrations. The concentration in aquatic, breast milk, cerebrospinal fluid, middle ear fluid, joint fluid and tissue (intestinal) is sufficient for antibacterial activity. Trimethoprim entered the amniotic fluid and the fetal tissue reaches the concentration of the mother's serum concentration.

    About 66% of sulfamethoxazol in plasma is connected to protein. The active ingredient concentration of sulfamethoxazol in amniotic fluid, aquatic fluid, bile, cerebrospinal fluid, middle ear fluid, sputum, joint fluid and tissue (interstitial) have a concentration of 20-50% of plasma concentrations.

    Biological Change

    sulfamethoxazol is eliminated through the unchanged kidney, accounting for 15-30% of the dose. This drug is metabolized more than trimethoprim, through acetylation, oxidation or glucuronidation. Over the period of 72 hours, about 85% of the dose can be found in urine in the form of unchanged drugs plus the main metabolite (N4-acetylated).

    Elimination

    Trimethoprim's waste time in people with normal kidney function is about 8.6 - 17 hours and an increase of 1.5 - 3.0 times when creatinine clearance is less than 10m/min. It seems that there is no significant difference in elderly patients compared to young patients. Trimethoprim is excreted mainly through the kidneys and about 50% of the dose is excreted in urine in 24 hours in unchanged form. Some metabolites have been determined in urine. The urinary trimethoprim level changes a lot.

    Sulfamethoxazol's waste time in humans with normal kidney function is about 9 - 11 hours.

    There is no change in the sale time of sulfamethoxazol with a reduced renal function but prolongs the sale time of the main metabolites, acetylated when creatinine clearance is less than 25ml/min.

    sulfamethoxazol is excreted mainly through the kidneys, between 15% and 30% of the recovery dose in urine in the form of activity.

    Pharmacokinetics in children with normal kidney function of both Vicometrim 960, TMP and SMZ components depend on age. TMP/SMZ elimination in infants, in the first two months of life, then both TMP and SMZ are higher with higher body clearance and shorter selling time. The difference is the most prominent in young children (> 1.7 months to 24 months) and gradually decreases with age, compared to young children (1 year to 3.6 years old), children (7.5 years old and

    Elderly patients

    Reducing kidney clearance of sulfamethoxazol.

    Special patient

    kidney failure

    Trimethoprim's semi -exhaust time increased by 1.5 - 3.0 times when creatinine clearance is less than 10ml/min. Vermoetrim 960 should be reduced when creatinine clearance decreases below 30m/minute (see the dose section).

    Hepatic failure

    Be careful when treating patients with severe liver parenchyma damage because there may be changes, absorption and biological transformation of trimethoprim and sulfamethoxazol.

    Elderly patients

    In elderly patients, there is a mitigation of the body's body clearance to sulfamethoxazol but not observed with Trimethoprim.

    Children

    See special dosage mode (see the dose section).

    Before taking Vicometrim 960 Vidipha treatment and prevention of pneumonia (10 blisters x 10 tablets)

    How to use

    oral medication, should take medicine with food or drink to minimize the likelihood of gastrointestinal disorders .

    Dosage

    Requested standard dose for acute bacterial infections

    Adults and children over 12 years old

  • The form of tablets is 1 tablet every 12 hours.
  • This dose is approximately 6mg of trimethoprim and 30mg of sulfamethoxazol/kg body weight for 24 hours.

  • should continue treatment until the patient has no symptoms for two days: most will be required to treat at least 5 days. If the clinical condition does not improve clearly after 7 days of treatment, the patient should be re -evaluated.
  • The replacement of the standard doses by short -term treatment lasts from 1-3 days for the uncomplicated urinary tract infection, which has been shown to be effective.

    Elderly patients

    See the "cautious use" section. Unless the dosage is applied.

    Liver function impairment

    There is no research data related to patient dosage liver function impairment .

    Special dose recommendations: (When applying other standard doses)

    The case of indicated dosage used "tablets" is a suitable tablet for adults, for example 80mg trimethoprim and 400mg sulfamethoxazol. The appropriate dose should be adjusted if used in other dosage formats.

    impaired renal function in adults and children over 12 years old (no information for patients under 12 years old):

  • Creatinin clearance> 30ml/minute: Normal dose.
  • Creatinine clearance 15 - 3 m/minute: ½ of the usual dose.
  • Creatinine clearance
  • recommend that sulfamethoxazol should be measured in plasma in about 2-3 days. In the samples obtained 12 hours after taking the drug. If the total concentration of sulfamethoxazol exceeds 150mcg/ml, it is necessary to stop treating until the measured value is below 120mcg/ml.
  • Pneumocystis Jiroveci (P.Carinii):

  • Treatment: Higher dosage is required, using 20mg of trimethoprim and 100mg of sulfamethoxazo/kg body weight divided into two or more doses for two weeks.
  • Preventive: Adults: Can use the following procedures:

  • 160mg trimethoprim/800mg sulfamethoxazol daily 7 days a week.
  • 160mg trimethoprim/800mg sulfamethoxazol three times a week, daily.
  • 320mg trimethoprim/1600mg sulfamethoxazol daily divided into twice, three times a week, day by day.
  • Nocardiosis

    There is no agreement on the most appropriate dosage. Adults take a dose of 6 to 8 capsules daily for 3 months.

    toxoplasmosis

    No consensus and the most appropriate dosage to treat or prevent this disease. The decision should be based on clinical experience. However, for preventive prophylaxis, Pneumocystis Jiroveci can be used.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose?

    Overdose:

  • Anorexia, nausea, vomiting, headache, unconsciousness.
  • Hematopoiia and jaundice are the late expression of overdose.
  • Bone inhibitors.
  • How to deal with overdose:

  • Causes vomiting, gastric lavage.
  • Acidification of urine to increase trimethoprim elimination.
  • If there are signs of marrow inhibition, patients need to use leucovocin (folinic acid) 5 -15mg/day until hematoma recovery.
  • What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using VicoMetrim 960 , you may experience unwanted effects (ADR).

    Very common, ADR

  • Metabolic and nutrient disorders: hyperkalemia.
  • Common, 1/100

  • Infection and infection: Candida growth.
  • nerve: headache.
  • digestive: Nausea, diarrhea .
  • Skin and subcutaneous tissues: rash.
  • Uncommon, 1/1000

  • Digestive: vomiting.
  • Very rare, ADR

  • Blood and lymphatic system: leukopenia, neutropenia, thrombocytopenia, granulocytopenia, huge red blood cell anemia, property anemia, methemoglobin leukemia, eosin, hemorrhage, hemolytic in patients with enamel G-6-PD.
  • The immune system: serum, hypersensitivity, allergic myocarditis, angioedema, fever caused by allergic vascular drugs like Henoch-Schoenlein bleeding, artery inflammation around the artery, body lupus erythematosus.

    Metabolic and nutrient disorders: hypoglycemia, hypoglycemia, anorexia, metabolic acidosis, renal tubular acidosis.

  • Mental disorders: depression, hallucinations.
  • Neurological: Aseptic meningitis, convulsions, peripheral neuritis, loss of air conditioning, dizziness, tinnitus, dizziness.

  • Ear: Grape vein inflammation.
  • Respiratory: cough, short breath, lung infiltration.
  • digestive: tongue inflammation, stomatitis, fake colitis, pancreatitis.
  • Liver: increased transaminase, increased blood bilirubin, cholest jaundice, liver necrosis.
  • Skin and subcutaneous tissues: light sensitive, flaky dermatitis, pink rash fixed in chromosomes, diverse roses, serious skin reactions (SCAR): Stevens-Johnson syndrome (SJS) and toxic cell necrosis (ten) have been reported (see caution when used).

  • Bone muscle and connective tissue: joint pain, muscle pain.
  • Urinary tract: impaired renal function (sometimes reported as kidney failure), interstitial nephritis.

    The effect on the treatment of Pneumocystis Jioveci (P.Cannii), pneumonia (PCP): Very rare hypersensitivity reaction, rash, fever, leukocytosis, thrombocytopenia, hyper enzyme, hyperkalemia, sodium hypoglycemia.

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    VicoMetrim 960 contraindicated in the following cases:

  • Patients are identified anemia giant red blood cells due to folic acid deficiency.
  • Sensitive to sulfonamid or with trimethoprim.

    Too hypersensitivity to any ingredients of the drug.

  • Patients with severe liver parenchyma damage.
  • Patients with severe renal impairment, can not perform repeated measurements in plasma.

  • Use drugs for children for the first 6 weeks of life.
  • Patients with a history of drug reduction due to drugs when using trimethoprim or sulphonamid.
  • Patients with acute metabolic disorders.
  • Precautions when used

    sulfamethoxazol and trimethoprim are combined in the formula due to the synergistic effect. However, this combination causes unwanted but serious effects such as Steven-Johnson syndrome and reduces all bloody hemoglobin, especially osteomomalia and granulocytes, especially common in the elderly.

    Avoid use for people with blood disorders (except for special monitoring), check the blood formula when treated for a long time, stop using immediately if blood disorders or foreign rash occurs.

    Patients are at risk of folat deficiency or hyperkalemia.

    Elderly.

    asthma.

    People deficiency G6PD.

    impaired liver function (avoid use if serious decline).

    Renal function decreases (avoid use if creatinine clearance is below 15m/minute).

    Monitor patients when using herbs containing excipients with castor oil can cause abdominal pain and diarrhea.

    The ability to drive and operate machinery

    There has been no research to survey the effect of the drug on driving or operating machinery. Moreover, it is impossible to predict adverse effects on such activities from the pharmacological properties of the drug. However, it should be noted that the clinical condition of the patient and the unwanted effects of the drug when considering the ability to operate the patient's machines.

    Pregnancy

    trimethoprim and sulfamethoxazol through the placenta and the safety of drugs in pregnant women have not been established. Tracking and monitoring studies have shown that there may be a link between exposure to folat and birth defects in humans.

    Trimethoprim is a folat antagonist and in animal studies, both agents have been shown to cause fetal abnormalities. Do not use drugs during pregnancy, especially in the first three months, unless necessary. Consider adding folat if using Vicometrim 960 during pregnancy.

    sulfamethoxazol competes with bilirubin to link with plasma albumin. Because the concentration of drugs from the mother continues to exist for a few days in newborns, there may be a risk of precipitation or exacerbating the newborn bilirubin bilirubin, with the theoretical risk of the brain skin, when Viometrim 960 is used for mothers near the time of birth. This theoretical risk is particularly related to newborn babies who are at high risk of increased blood bilirubin, such as premature babies and people with glucose-6-phosphate dehydrogenase deficiencies.

    Breastfeeding period

    The components of Vicometrim 960 (trimethoprim and sulfamethoxazol) are excreted in breast milk. Vicometrim 960 should be avoided at the end of pregnancy and in nursing mothers, which newborns or babies have or have the risk of developing, increasing blood bilirubin. In addition, Vermoetrim 960 should be avoided in children under 8 weeks according to the concept of newborn babies with hyperlirubin blood.

    Medicinal interaction

    With laboratory tests, Trimethoprim may interfere with plasma/serum creatinine when using alkaline picrat reactions. This can lead to plasma/serum creatinine evaluation. Creatinine clearance decreases: Creatinine secretion in renal tubules decreased from 23% to 9% while glomerular filtration remains unchanged.

    Zidovudin: In some cases, simultaneous treatment with zidovudin may increase the risk of unwanted and hematological effects of Vicometrim 960.

    cyclosporin: The impaired renal function has been observed in patients treated simultaneously with cyclosporin after kidney implant.

    Rifampicin: Concomitant use with rifampicin reduces the half -life of trimethoprim plasma after about a week. This has no clinical significance. When trimethoprim is simultaneously used with drugs forming cations in the physiological pH and is also partially excreted by the excretory activity of the kidney (e.g. Procanamid, Amantadin), the competition inhibitor ability of this process can increase the concentration of plasma of one or both drugs.

    Diuretics (thiazid): In elderly patients, simultaneously used with diuretics, mainly thiazid, there is a risk of thrombocytopenia with or without hemorrhage.

    pyrimethamine: Very few reports that patients taking pyrimethamine are higher than 25mg per week may have huge red blood cell anemia, so they are prescribed simultaneously with this combined antibiotic.

    Warfarin: The drug increases the anticoagulant activity of warfarin through the selective inhibition of stereoscopic of metabolism. Sulfamethoxazol can remove warfarin from the albumin protein bonds in vitro. Caution should be cautious about anticoagulants during treatment with Vicometrim 960.

    Phenytoin: The drug extends the selling time of phenytoin and if used simultaneously can lead to an increase in excessive phenytoin effect. Need to closely monitor patient condition and serum phenytoin concentration.

    Digoxin: Using trimethoprim simultaneously with digoxin has increased plasma digoxin concentrations in some elderly patients.

    Methotrexate: The drug may increase the concentration of free methotrexate in plasma. If you look at Vicometrim 960 as an appropriate treatment in patients with other anti -folat drugs such as methotrexate, it is advisable to consider adding folats (see carefully when used). Trimethoprim hinder plasma methotrexate quantification when using dihydrofolate reductase from lactobacillus casei in the test. There is no obstruction if measuring methotrexate by radioactive test.

    lamivudin: Use trimethoprim/sulfamethoxazol 160mg/800mg increases 40% in contact with lamivudin because of trimethoprim composition. Lamivudin does not affect the pharmacokinetics of trimethoprim or sulfamethoxazol.

    Interaction with sulphonylurea hypoglycemic drugs is not common but there has been a report on increased effects.

    Hemorrhage hyperpass: When taking medications for patients who are taking drugs that can cause hyperkalemia.

    Repaglinid: Trimethoprim may increase the contact of repaglinid, which can lead to hypoglycemia.

    Folinic Acid: Folinic acid supplements affect the antibacterial effect of trimethoprim-sulfamethoxazol. This has been observed in the prevention and treatment of pneumes caused by Pneumocystis Jiroveci.

    Birth control: Oral contraceptives are inactive because antibiotics have been reported. It is unclear this effect. Women treated with antibiotics should temporarily use other preventive methods other than oral contraceptives or choose other contraceptive methods.

    Storage

    In a dry place, the temperature does not exceed 30 ° C, avoiding light.

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