Babytrim - New Pharbaco powder for infection treatment (10 packs x 1.5g)

Dosage form Box of 10 packs x 1.5g
Specifications Sulfamethoxazole, trimethoprim
Ingredient Middle otitis, sinusitis, prostatitis, cystitis, pyelonephritis, dysentery, shigella infection, chronic bronchitis

Ingredient

Composition informationContent
Sulfamethoxazole200mg
Trimethoprim40mg

Uses

indicated

Babytrim - New powder is indicated in the following cases:

Treatment of infections caused by bacteria sensitive to cotrimoxazol:

Gastrointestinal tract infections in children: diarrhea caused by E. coli, shigella dysentery, secondary drug in typhoid or typhoid.

Treatment of upper and lower respiratory tract infections in children: pharyngitis infection, otitis media, acute pneumonia, exacerbation of chronic bronchitis, pneumocystis carinii pneumonia.

Lower urinary tract infections and genital tract in children are uncomplicated, prostatitis.

Treatment of Brucella, plague, toxoplasma disease.

Pharmacokic

cotrimoxazol is a mixture of sulfamethoxazol (5 parts) and trimethoprim (1 part). Cotrimoxazol is an anti -bacterial drug with broad bactericidal spectroscopy, mushrooms and protozoa. Cotrimoxazol's treatment effect is based on mutual mutual effects of two components:

  • Sulfamethoxazol is a sulfamid, inhibiting competition in bacterial folic acid synthesis.
  • trimethoprim is a derivative of pyrimidin inhibits the specific enzyme dihydrofolat reductase of bacteria. Cotrimoxazol coordination of sulfamethoxazol and trimethoprim inhibits two consecutive stages of folic acid metabolism, thus effectively inhibiting the synthesis of purin, thymin and final DNA of bacteria. The growth of anti -drug bacteria and causes the drug to work even when bacteria resist each component of the drug.
  • cotrimoxazol works with drugs that are sensitive to drugs such as E.coli, Klebsiella Sp, Entobacter SP, S.Pneumonie, Pneumocystis Carinii (PCP), Shigella, H.influenzae, P.Vulgaris (including ampiciline resistance strains).

    Pharmacokinetics

    absorption

    Cotrimoxazole absorbs fast and good in the digestive tract. After taking 1 - 4 hours a single dose of cotrimoxazol contains 160 mg of trimethoprim and 800 mg of sulfamethoxazol, the peak concentration of trimethoprim serum is 1 - 2 micrograms/ml and of sulfamethoxazol not attached to serum protein of 40 - 60 micrograms/ml.

    After taking multiple doses, the concentration of peaks in serum in a stable state is usually greater than 50% of concentrations when taking a single dose. After taking cotrimoxazol, the ratio of serum concentration of trimethoprim on the concentration of sulfamethoxazol in a stable state is usually 1:20.

    Distribution

    Both drugs are widely distributed into tissues and fluids in the body, including cerebrospinal fluid. The distribution voltage of trimethoprim (100 - 120 liters) is greater than the distribution volume of sulfamethoxazol (12 - 18 liters). In patients with meninges without inflammation, the concentration of trimethoprim in cerebrospinal fluid is equal to 50% and of sulfamethoxazol in cerebrospinal fluid is 40% compared to serum concentration.

    about 44% trimethoprim and about 70% sulfamethoxazol attached to plasma proteins. Both trimethoprim and sulfamethoxazole are through the placenta and in the amniotic fluid, the concentration of trimethoprim is 80% and the concentration of sulfamethoxazol is equal to 50% compared to the serum concentration in serum. Both drugs are in milk, the concentration of trimethoprim is about 125% and of sulfamethoxazol is 10% compared to the corresponding drug concentration in serum.

    Elimination

    In people with normal kidney function, half -life in Trimethoprim's serum is 8 - 11 hours, and of sulfamethoxazol is 10 - 13 hours. In adults, there is a creatinine clearance coefficient of 10 - 30 ml/min, half a lifetime in the serum of trimethoprim can increase up to 15 hours. In people with chronic kidney failure, the half -life of sulfamethoxazol can be 3 times higher than people with normal kidney function.

    In children under 1 year old, half a lifetime in Trimethoprim's serum is about 7.7 hours, children from 1 to 10 years old about 5.5 hours. Both medications metabolize in the liver. Both eliminate quickly through the kidneys. In adults, normal kidney function, about 50 - 60% trimethoprim and 45 - 70% sulfamethoxazole oral dosage excreted into the urine for 24 hours.

    About 80% of trimethoprim and 20% of sulfamethoxazole are found in unchanged urine. Only a small amount of trimethoprim excreted into the feces. Hematalo fertilizer only removes a part of trimethoprim and sulfamethoxazol activity.

    Before taking Babytrim - New Pharbaco powder for infection treatment (10 packs x 1.5g)

    How to use

    Cut the packet of drugs and pour the powder into the cup. Pour water into the drug pack, then pour water from the package into the cup. Stir and drink now.

    Dosage

    Cotrimoxazol dose is calculated in trimethoprim in fixed combination containing sulfamethoxazol 5 mg and trimethoprim 1 mg.

    acute otitis media

    Children 2 months and older: The usual dose of cotrimoxazol is 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times 12 hours apart. The normal treatment time is 10 days.

    Urinary tract infections

    Due to sensitive bacteria E.coli, Proteus, Klebsiella, Morganella Morganii or Entobacter.

  • Inhabited urinary tract infections: 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times 12 hours apart, for 3 days or for 7 to 10 days.
  • Chronic or recurrent urinary tract infections: Children 2 months and older: The usual dose of cotrimoxazol is 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times apart 12 hours, for 10-14 days.

    Experience of chronic bronchitis

    Children 2 months and older: The usual dose of cotrimoxazol is 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times 12 hours apart. The normal treatment time is 10 days.

    Gastrointestinal tract infections

    Bacillary dysentery (S.Flexneri or S. Sonnei): Children: 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times 12 hours apart, for 5 days.

    Brucella disease

    Children dose 10 mg/kg/day trimethoprim (in combination of cotrimoxazol) divided into 2 times, for 4-6 weeks.

    Cholera

    Children dose 4 - 5 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times 12 hours apart, drink for 3 days. Coordinate with infusion and electrolytes.

    Plague

    Preventive for people who come into contact with people with pulmonary plague. Children at least 2 months and older: The dose of 8 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 2 times equal, drink 12 hours apart, for 7 days.

    pneumocystis carinii pneumonia (Pneumocystis Jiroveci)

    Children take 15 - 20 mg trimethoprim (in combination of cotrimoxazol)/kg/day divided into 3 or 4 small doses equal. The usual treatment time is 14 - 21 days.

    Priority or secondary backup

    Backup in children, including HIV -infected children: Trimethoprim dosage disruption regimen (in combination of cotrimoxazol) is 150 mg/day divided into 2 small doses, drink for 3 days a week.

    Toxoplasma disease

    Backup in children with HIV infected: Trimethoprim dose (in combination of cotrimoxazol) is 150 mg/m2/day divided into 2 small doses.

    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?

    Symptoms

    Anorexia, nausea, vomiting, headache, unconscious. Hematopoietic disorders and jaundice are late manifestations of overdose, inhibitors.

    Handling

    Causes vomiting, gastric lavage. Acidification of urine to increase trimethoprim elimination. If there are signs of marrow inhibition, patients need to use leucovorin (folinic acid) 5 - 15 mg/day until hematoma recovery. Hematalo fertilizer only removes a small amount of medicine. The abdominal division is ineffective.

    What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

    Side Effects

    When using Babytrim - New powder, you may experience unwanted effects (ADR).

    Common, ADR> 1/100

  • Body: Fever.
  • digestive: Nausea, vomiting, diarrhea, tongue inflammation.

    Skin: itching, foreigner.

    Uncommon, 1/1000

  • Blood: Eosin leukemia, leukopenia, neutropenia, hemorrhage.
  • Skin: urticaria.

    Rare, ADR

  • Body: Anaphylaxis, serum disease.
  • blood: huge red blood cell anemia, hemolytic anemia, thrombocytopenia, granulocytopenia and all bloody hemoglobin. nerve: Aseptic meningitis.

    Skin: Poisoned epidermal necrosis (Lyell syndrome), Stevens - Johnson syndrome, diverse erythema, angioedema, light sensitivity.

  • Liver: jaundice, cholestasis in the liver, liver necrosis.
  • Metabolism: hyperkalemia, hypoglycemia.
  • Mental: Illusion.
  • genital - urinary: kidney failure, interstitial nephritis, kidney stones.

    ears: tinnitus.

    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

    Babytrim - New contraindicated powder in the following cases:

  • Children under 2 months of age, premature babies.
  • Sensitive to any ingredients of the drug.
  • Severe renal failure without monitoring the concentration of drugs in plasma.

  • Liver and hemorrhage damage.
  • Be cautious when using

    death, although very rarely occurred due to severe reactions including: liver necrosis, leukopenia, hyperplasmic anemia, hematuria disorders and hypersensitivity of the respiratory tract. The life -threatening skin reaction of Stevens - Johnson (SJS) syndrome and poisoned epidermal necrosis (Ten) has been reported with the use of cotrimoxazols.

    Patients must be notified of signs and symptoms and closely monitor skin reactions. The highest risk appears SJS and Ten are in the first weeks of treatment. If the symptoms or signs of SJS or ten (for example, the skin rash progresses regularly with blisters or mucosal lesions), it should be discontinued with cotrimoxazol.

    The best result in controlling SJS and Ten is early diagnosis and immediately stop any suspected drug. The early stop will give better prognosis. If the patient has been sjs or ten when using cotrimoxazol, do not re -use cotrimoxazol for this patient at any time.

    Special care is always encouraged when treating older patients because they are more sensitive to harmful reactions and are susceptible to serious effects, as a special result when there exists complicated conditions, such as renal failure and/or impaired liver function and/or simultaneous use of other drugs.

    Despite the sulfonamid crystal in the urine of patients treated with cotrimoxazol, the evidence of vivo crystal crystals is very rare. Therefore, it is necessary to monitor the patient's urine. Especially patients with malnutrition, this risk is higher.

    regularly check the monthly blood count in patients with cotrimoxazol for a long time, or patients with folat or elderly; Because there is the possibility of changing without symptoms of hematology due to lack of folat. These changes can be overcome when using folic acid (5 - 10 mg/day) without affecting the antibacterial activity of the drug.

    The drug can cause hemolytic anemia in people with G6DP deficiency. Precautions when taking drugs for patients with serious allergies or bronchial asthma. Cotrimoxazol should not be used in the treatment of sore throat due to streptococcal beta soluble group A; Because the treatment of pharyngeal infections is less effective than penicillin.

    Trimethoprim has been recorded reducing phenylalanin metabolism but does not make sense in patients with diet phenylketon with strict diet. Cotrimoxazol should not be indicated for patients to know or doubt Porphyrin metabolism disorders. Both trimethoprim and sulfonamid (although it is not specifically sulfamethoxazol), is more serious than this disorder.

    Strict monitoring of blood potassium in patients at risk of hyperkalemia. Except for careful supervision, cotrimoxazole should not be used for patients with serious hematological disorders. Cotrimoxazol is used for patients treated toxic toxicity with little or no effect on the bone marrow or peripheral blood. The combination of antibiotics in cotrimoxazol should only be used when, according to doctors, the benefits of treatment are greater than any possible risks; It is necessary to consider the use of the most effective antibacterial.

    The ability to drive and operate machinery

    There is still no studies to investigate the effects of cotrimoxazol on driving or operating machinery. Moreover, the adverse effects on these activities cannot be predicted from the effects of the drug. However, it should be noted for the clinical condition of the patient and the unwanted effects of cotrimoxazol when used for patients with the ability to drive and operate machinery.

    Pregnancy

    Sulfonamid can cause jaundice in children during the period of birth due to pushing bilirubin from albumin. Because trimethoprim and sulfamethoxazol can hinder folic acid metabolism, the drug is only used during pregnancy when necessary. If you need to take the drug during pregnancy, it is important to use folic acid.

    The period of breastfeeding

    The drug excreted through breast milk, so women during breastfeeding are not allowed to take the drug. Babies are very sensitive to the toxic effect of the drug.

    Drug interaction

    trimethoprim may affect plasma/serum creatinine when using Picrat alkaline reaction to evaluate. This can lead to increased plasma/serum creatinine levels to 10%. Creatinine clearance is decreased: The excretion in the renal tubules of creatinine decreased from 23% to 9% while glomerular filtration remains unchanged.

    In some cases, simultaneous treatment of cotrimoxazol with zidovudine may increase the risk of side hematology. If treated at the same time is necessary, it is necessary to consider to monitor hematology parameters.

    The recovery impairment has been observed in patients treated with cotrimoxazol and cyclosporin after kidney transplantation.

    Simultaneous use of rifampicin and cotrimoxazols shorten trimethoprim's disposal time after about a week. This is not considered clinical significance. When using Trimethoprim simultaneously with cation drugs in the physiological pH and partially eliminated through the kidneys (for example, Procainamid, Amantadin), the competitive inhibitor will lead to an increase in plasma concentration of one or both drugs.

    In older patients who use simultaneously with diuretics, mainly thiazid, which may increase the risk of thrombocytopenia with or without hemorrhage. There are reports showing patients using pyrimethamine at the dose exceeding 25 mg per week can worsen huge red blood cell anemia if used simultaneously with cotrimoxazol.

    cotrimoxazol has been shown to increase Warfarin's anticoagulant activities through the selective inhibition of stereopetic selection of its transformation. Sulfamethoxazol can replace warfarin sites with plasma albumin protein in vitro. It is necessary to strictly control anticoagulants while using cotrimoxazol.

    cotrimoxazole extends phenytoin's disposal time and if combined treatment can lead to excessive phenytoin effect. It is necessary to closely monitor the condition of the patient and the level of phenytoin in serum.

    Simultaneous use of trimethoprim with digoxin increases the concentration of digoxin in plasma in some elderly patients.

    cotrimoxazol may increase the free concentration of methotrexate in plasma. Trimethoprim affects methotrexate quantitative tests in serum when using Dihydrofolate Reductase from lactobacillus casei in tests. There is no effect if methotrexate is quantified by radioactive immunity.

    Use trimethoprim/sulfamethoxazol 160 mg/800 mg (cotrimoxazol) increases 40% lamivudine concentration (due to trimethoprim). Lamivudin does not affect the pharmacokinetics of trimethoprim or sulfamethoxazol.

    Interaction with sulfonylurea hypoglycemic drugs is not common but this ability has been reported. Be careful in patients who are taking drugs that cause hyperkalemia. If cotrimoxazol is considered an appropriate therapy in patients who are taking other folat drugs such as methotrexate, adding folat.

    Storage

    Where dry, less than 30 ° C.

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