Curam 1000mg Sandoz medicine for infections (10 blisters x 8 tablets)
Dosage form Box of 10 blisters x 8 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Lek Pharmaceuticals
Ingredient
| Composition information | Content |
| Amoxicillin | 875mg |
| Clavulanic Acid | 125mg |
Uses
indications
Curam drugs are indicated in cases of treatment of the following infections in adults and children:
ATC code: J01Cr02.
Mechanism of action
Amoxicillin is a semi -synthetic penicillin (Lacta - Lactam antibiotic group) inhibits one or more enzymes (often called penicillin, Pbps) in the peptidoglycan biosynthesis of bacteria, is an indispensable structural component of peptic cell walls, peptidoglycan synthetic inhibitors leads to weakening cells and after -enlightenment, after -which are weakened and then weakened cells cell death.
Amoxicillin is easily decomposed by the Beta - lactamase enzyme produced by resistance bacteria and therefore the effect of amoxicillin alone does not include these enzyme -producing bacteria.
Clavulanic acid is a beta - lactam -related drug with a penicillin group. Clavulanic acid is inactivated some beta - lactamase enzymes thus preventing the inactivity of amoxicillin. Clavulanic acid simply does not cause any useful antibacterial effect on clinical.
Pharmacokinetic - Pharmacy relationship
Time on minimum inhibitory concentration (T> MIC) is considered as an effective determinant of Amoxicillin.
resistance mechanism
The two main mechanisms of resistance to amoxicillin/clavulanic acid are:
The minimum inhibitory threshold concentration of amoxicillin/clavulanic acid is tested by the European Commission's test of antibacterial sensitivity (EUCAST).
bacteria 1 The recorded values are for amoxicillin levels, for the purpose of testing sensitivity, Clavulanic acid levels are fixed at 2 mg/l. 2 The recorded values are for agricultural oxacillin. 3 The value of the threshold in the table is based on the value of the threshold of ampicillin. 4 concentrations of resistance threshold r> 8 mg/l ensure that all strains areolated with anti -drug mechanisms reported resistance. 5 The thresholds in the table are based on the level of threshold of benzylpenicillin. Common sensitive strains Gram -positive aerobic bacteria Gram -positive aerobic bacteria Enterococcus fast $. Gram -negative aerobic bacteria Gram -negative aerobic bacteria * All staphylococci anti -methicillin staphicillin is resistant to amoxicillin/clavulanic acid. 1 Streptococcus pneumoniae has been resistant to penicillin should not be treated with this product. 2 sensitive reduced strains have been reported in some EU countries with frequency over 10%. absorption amoxicillin and clavulanic acid are completely dissociated in water solutions in physiological pH. Both components are absorbed quickly and well by oral. After oral use, amoxicillin and clavulanic acid are about 70%. Plasma data of two similar components and time to reach the peak concentration in plasma (TMAX) is about 1 hour. The results of pharmacokinetics research, in which amoxicillin/clavulanic acid (tablet 875mg/125mg used 2 times/day) is used at hunger for healthy volunteers presented below. amx/shift 875mg/125 mg 875mg/125mg * Median value (interval) distribution about 25% clavulanic acid and 18% amoxicillin in plasma are linked to protein. The apparent distribution volume is about 0.3 - 0.4 liters/kg for amoxicillin and about 0.2 liters/kg for clavulanic acid. After intravenous infusion, both amoxicillin and clavulanic acid are found in gallbladder, abdominal tissue, skin, fat, muscle tissue, epidemiologist and peritoneal fluid, bile and latex. Amoxicillin does not distribute well into cerebrospinal fluid. From animal studies, there is no evidence that the metabolites of each drug component are significantly retained in tissue. Amoxicillin, like most penicillin, can be found in breast milk. A small amount of clavulanic acid can also be detected in breast milk (see the use of drugs for pregnant and lactating women). both amoxicillin and clavulanic acid have been shown to be able to pass the placenta fence. transformation Amoxicillin excreted in part in the urine in the form of penicilloic acid that is not active in about 10-25% of the initial dose. Most Clavulanic acid is metabolized in humans, eliminated in urine and feces and in the form of carbon dioxid in exhaled gas. Elimination Amoxicillin is excreted by the kidneys, while clavulanic acid is eliminated through the kidneys and even without the kidneys. The average selling time of amoxicillin/clavulanic acid is about an hour and the average total total clearance is approximately 25 liters/hour in healthy people. About 60 - 70% amoxicillin and 40 - 65% Clavulanic acid are excreted in urine in the form of unchanged in the first 6 hours after using single doses of amoxicillin/clavulanic acid 250mg/125mg or 500mg/125mg. Many studies show that the amount of excretion in urine is about 50 - 85% for amoxicillin and 27 - 60% for clavulanic acid for a 24 -hour period. In the case of clavulanic acid, a large amount of drugs are excreted for the first 2 hours after taking the drug. Simultaneously used with probenecid slowly excreting amoxicillin but does not slow down the excretion of clavulanic acid through the kidney. Age Amoxicillin's waste time is similar to children from 3 months to 2 years old, older children and adults. For very young children (including premature babies) in the first week of birth, the dose distance must not exceed 2 times/day due to the incomplete renal elimination. Because kidney function can decrease in the elderly, be careful in choosing the dose and should monitor the kidney function. Sex After taking orally amoxicillin/acid Clavulanic in men and healthy women, gender does not have a significant impact on the pharmacokinetics of both amoxicillin and clavulanic acid. kidney failure The total serum clearance of amoxicillin/clavulanic acid decreases proportional to the degree of renal function. Amoxicillin's clearance is significantly reduced than clavulanic acid because amoxicillin is excreted through the kidney at a higher rate. The dosage in case of renal failure must be adjusted to prevent excessive accumulation of amoxicillin while maintaining sufficient amount of clavulanic acid. liver failure Be cautious when prescribing patients with liver failure and need to monitor liver function periodically. Dynamic pharmacokinetics
Before taking Curam 1000mg Sandoz medicine for infections (10 blisters x 8 tablets)
How to use
oral medication.
The drug is used with meals to minimize the ability to intolerine the gastrointestinal tract.
Can start treatment with a summary of the product characteristics of the intravenous formula and continue with oral preparations.
Dosage
Dosage is shown in the content of amoxicillin/clavulanic acid except where the dose is indicated in the form of a single component.
Curam dose to treat a separate case of infection to be taken into account:
The use of other types of presentation of amoxicillin/clavulanic acid (for example, higher forms of amoxicillin doses and/or different ratios between amoxicillin and clavulanic acid) should be considered as needed.
For adults and children weighing over 40kg, this formula provides a total dose of 1,750 mg amoxicillin/250mg clavulanic acid when used 2 times/day and 2,625mg amoxicillin/375mg clavulanic acid when used 3 times/day, when used as recommended below.
For children weighing under 40kg, this Curam formula offers a maximum dose of 1,000 - 2,800mg of amoxicillin/143 - 400mg Clavulanic acid daily, when used as recommended below. If it is found to use a higher daily daily amoxicillin, it is recommended to choose another preparation to avoid high doses of clavulanic acid daily.
Duration of treatment should be determined according to the patient's response. Some cases of bacterial infections (eg bone inflammation) need longer treatment time. The treatment process should not last more than 14 days without review.
adults and children weighing 40kg or more
Recommended dose:
Children can be treated with Curam tablets, chaos or packaging for children.
Recommended dose:
25mg/3.6mg/kg/day to 45mg/6.4mg/kg/day, divided into 2 times/day.
Dosage up to 70mg/10mg/kg/day, divided into 2 times/day can be considered for some infections (such as otitis media, sinusitis and lower respiratory tract infections). The table below presented the recognized dose (mg/kg of weight) on children weighing from 25kg to 40kg when using a tablet 875mg/125mg:
3,1
There is currently no clinical data on the dose of amoxicillin/clavulanic acid (formula 7: 1) higher than 45mg/6.4 mg/kg/day for children under 2 years old.
There is no clinical data on amoxicillin/clavulanic acid 7: 1 in patients under 2 months old. Therefore, there is no recommendation about the dose on this object.
Elderly: No dose adjustment.
kidney failure
No dose adjustment in patients with creatinine clearance (CLCR) is greater than 30 ml/min.
On patients with creatinine clearance below 30 ml/min, do not recommend the use of amoxicillin/clavulanic acid ratio 7: 1 because there is no recommendations on dose adjustment.
liver failure
Need to be cautious about dosage and monitoring liver function regularly
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 and signs of overdose
Expressions of overdose may be symptoms in the gastrointestinal tract and water and electrolyte disorders. Observed the amoxicillin crystal, in some cases can lead to renal failure.
Convulsions may occur in patients with renal failure or in cases of high doses.
There has been a report on Amoxicillin precipitating in the bladder catheter, mainly after high -dose intravenous lines. Should maintain regular checkpoints.
How to handle
Symptoms of the gastrointestinal tract may be treated as symptoms, should pay attention to water/electrolyte balance.
Amoxicillin/Clavulanic acid can be removed from dialysis.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
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 Curam drugs you may experience unwanted effects (ADR). Unwanted effects are often reported as diarrhea, nausea and vomiting.
Unwanted effects are collected from clinical studies and reports after circulation of amoxicillin/clavulanic acid, arranged by MEDDRA's organs and listed below.
The following words are used to classify the appearance of unwanted effects:
Very common (≥1/10).
Common (≥1/100 to
Less (≥1/1,000 to
Rare (≥1/10,000 to
Very rare (
Unknown (not evaluated based on existing data).
Surrated syndrome unknown
Meetheadache rarely Knowing
diarrhea Pepper
antibiotic colitis ALT
itching
Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Curam drugs against in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
Before starting treatment with amoxicillin/clavulanic acid, careful survey should be conducted with previous hypersensitivity reactions with penicillin, cephalosporin or other beta-lactam antibiotics.
There have been reports on serious and sometimes fatal hypersensitivity cases (including anaphylactic reactions and serious harmful reactions on the skin) in patients treated with penicillin. These reactions often occur in patients with a history of hypersensitivity to penicillin and have allergies. If any allergic reaction occurs, it is necessary to stop treating with amoxicillin/clavulanic acid immediately and apply appropriate alternative treatments.
In the case of infection, it is shown that bacteria are sensitive to amoxicillin, which should be considered to switch from amoxicillin/clavulanic acid to amoxicillin based on official instructions.
This type of Curam presentation is not suitable for use when there is a high risk of pathogens that reduce sensitivity or resistance to the beta-lactam group without via beta-lactamase sensitive intermediaries-inhibited by clavulanic acid. Do not use this form to treat S. Pneumoniae resistance penicillin.Seism can occur in patients with renal impairment or in patients with high doses.
Should avoid using amoxicillin/clavulanic acid if suspected of mononulocytosis due to the appearance of measles rash after using amoxicillin.
Concomitant use of Allopurinol during treatment with amoxicillin may increase the risk of allergic reactions in the skin.
Using drugs for a long time can cause excessive growth of non -sensitive bacteria.
The appearance of a whole body erythema combined with pustules at the beginning of treatment may be a symptom of the acute pustules syndrome (AGEP). If this reaction occurs, it is necessary to stop treating with Curam and contraindicated with the use of amoxicillin.
Be careful when using amoxicillin/acid clavulanic in patients with evidence of liver function impairment.
Liver problems have been reported mainly in men and the elderly, which may be related to prolonged treatment. Very rarely reports on these issues in children. In all object groups, liver signs and symptoms usually occur during or immediately after treatment, but in some cases it may appear several weeks after the end of treatment. They often recover themselves. Liver problems may also be heavy and in some rare cases, there have been deaths. These cases mostly occur in patients with serious illnesses or simultaneously used with drugs that are known to be at risk of liver toxicity.
Antibiotic -related colitis has been reported to most antibacterial drugs including amoxicillin and can classify from mild to life -threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea during or after antibiotic treatment. If colitis occurs related to antibiotics, stop Curam immediately, consult a doctor and start an appropriate therapy. Contraindicated drugs reduce bowel motility in this case.
Recommended recommendations for functional assessments of organs, including kidneys, liver and hematopoietic organs during prolonged treatment.
Prothrombin time has been reported in a rare number of cases in patients using amoxicillin/clavulanic acid. Appropriate monitoring when using anticoagulant drugs simultaneously. The dose of oral anticoagulant may be needed to maintain the desired concentration of anticoagulants.
In patients with renal failure, the dose adjustments need to be suitable for the degree of renal failure.
In patients with a decrease in urine, it rarely observes the urinary crystal, often occurs in patients taking injection drugs. While using high -dose amoxicillin, it is recommended to maintain enough drinking water and urine to minimize the risk of amoxicillin crystals. In patients with bladder catheter, should be maintained in regular checks.
During the treatment with amoxicillin, the glucose oxidase enzyme should be used when checking in the urine because the fake positive results may occur with the non -enzyme method.
The presence of clavulanic acid in the Curam can cause nonspecific connection between IgG and albumin by red blood cell membrane leads to false positive results in the COOMBS test.
There has been a positive test results when using the Bio-Rad Laboratories Platelia Aspergillus EIA in patients with amoxicillin/clavulanic acid, who have been confirmed as nonpergillus infection. Cross-reactions between non-Apergillus polysaccharids and polyfuranose with the Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore, positive results in patients using amoxicillin/clavulanic acid should be carefully interpreted and affirmed by other diagnostic methods.
important information about some components of Curam 1000mg: Curam 1000mg contains 0.63 mmol (24.5mg) of potassium per capsules. It is necessary to consider this if there are kidney problems or in a potassium -controlled diet.
The effect of the drug on driving and operating machinery
There has been no research on the effect of the drug on the ability to drive and operate machinery. However, unwanted effects may occur (for example, allergic reactions, dizziness, convulsions), can affect the ability to drive and operate machinery.
Use drugs for women during pregnancy and lactation
Pregnant women
Animal studies do not show directly or indirectly harmful effects on pregnancy, embryo/fetal development, childbirth or postpartum development. Restricted data in the use of amoxicillin/clavulanic acid during pregnancy does not show an increase in the risk of birth defects. In a single study in premature, premature rupture of women, there was a report that the prophylactic treatment with amoxicillin/clavulanic acid may be associated with increased risk of necrotizing intestinal inflammation in infants. Should avoid using drugs during pregnancy, unless considered as necessary by the physician.
breastfeeding women
Both substances are excreted through breast milk (unknown effects of clavulanic acid on infants who are breastfed). Therefore, diarrhea and fungal infection in the mucosa can occur in breastfeeding, may have to stop breastfeeding. Sensitivity should be taken into account. Amoxicillin/Clavulanic acid should only be used during breastfeeding after being considered the benefits/risk by the physician.
Interactive drug
Oral anticoagulants and penicillin antibiotics have been widely used in practice and there is no report on interaction. However, in the literature there are cases of international standardization ratios (INR) in patients maintaining the use of acenocoumarol or warfarin and are added amoxicillin. If the simultaneous use is necessary, should carefully monitor Prothrombin or INR time when using or stop using amoxicillin. In addition, may need to adjust the oral anticoagulant dose.
methotrexate
penicillin may reduce methotrexate secretion, increasing the risk of toxicity.
Probenecid
Do not recommend simultaneous use with Probenecid. Probenecid reduces amoxicillin secretion in the renal tubules. Simultaneous use with probenecid may cause increased and prolonged the concentration of amoxicillin in the blood but does not affect the level of clavulanic acid.
mycophenolat mofetil
In patients using Mycophenolat Mofetil, there has been a report on the reduction of the concentration of the active metabolites as mycophenolic acid (MPA) is approximately 50% when using amoxicillin and oral clavulanic acid. The change in the starting level may not accurately represent the overall change of MPA exposure. Therefore, the change of doses of mycophenolat mofetil is not necessary in the absence of clinical evidence in implant dysfunction. However, closely monitoring should be performed during simultaneous use of drugs and a short time after the end of antibiotic treatment.
Storage
To be out of reach and vision of children.
Expiry date: 24 months from the date of manufacture.
Do not use the drug after the expiry date stated on the packaging.
Do not store more than 25 ° C.
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