Curam 625mg Sandoz medicine for infections (5 blisters x 4 tablets)

Dosage form Box of 5 blisters x 4 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Other labels

Ingredient

Composition information	Content
Amoxicillin	500mg
Clavulanic Acid	125mg

Uses

Indications

are indicated to treat the following bacterial infections caused by bacteria sensitive to Curam in adults and children (see the dose and usage parts, special caution cases when using and pharmacological properties):

Sinusitis caused by acute bacteria (diagnosed).

Acute otitis media.

Exacection of chronic bronchitis (diagnosed).

Pneumonia is suffering from the community. cystitis.

Pyelonephritis.

Skin and soft tissue infections, especially cellular inflammation, bite of animals, heavy tooth abscess with spreading tissue tissue.

Bone and joint infections, especially osteomyelitis.

Should consider the official guide on the use of appropriate antibacterial drugs.

Pharmacokology

Pharmacological therapy group: Penicillin antibiotic combined with beta - lactamase inhibitors.

ATC code: J01CR02.

Mechanism of action

Amoxicillin is a semi -synthetic penicillin (Lacta - Lactam antibiotic), inhibiting one or more enzymes (often called penicillin - PBP) in bacterial peptidoglycan biosynthesis - an indispensable structural component of bacterial cell walls. The synthesis of peptidoglycan leads to cellular weaknesses, which is often followed by cellularization and cell death.

Amoxicillin is easily degenerated by beta - lactamase created by resistance bacteria, so the activity spectrum of solitary amoxicillin does not include organisms that produce these enzymes.

Clavulanic acid is a beta - lactam related to structure with penicillin. It is inactivated some beta - lactamase enzymes thus preventing Amoxicillin inactivity. Slone clavulanic acid does not produce clinical useful antibacterial effects.

Mobile pharmacokinetic/pharmacokinetic relationship (PK/PD)

Time on minimum inhibitory concentration (T> MIC) is thought to be the main decisive factor of the efficiency of amoxicillin.

resistance mechanism

The two main mechanisms of resistance for amoxicillin/clavulanic acid are:

Inactivity caused by bacterial beta - lactamase that they themselves are not inhibited by clavulanic acid, including groups B, C and D.

Change of penicillin -mounted protein (PBP) reduces the affection of antibacterial drugs on targets.

The non -absorbing properties of bacteria or the pumping mechanism can lead to or contribute to the resistance of bacteria, especially for gram -negative bacteria.

Breakpoint:

Mic fractures for amoxicillin/acid Clavulanic are values under the European Commission on antibacterial sensitivity test (EUCAST).

Biology

Sensitible fractures (µg/ml)

Intermediate

resistance

≤ 1

≤ 2

coagulase2

≤ 0.25

0.25

Enterococcus1

≤ 4

≤ 0.25

0.25

streptococcus pneumoniae3

≤ 0.5

1 - 2

≤ 8

≤ 4

Gram -positive anaerobic bacteria

≤ 4

≤ 2

4 - 8

For testing purposes of sensitivity, Clavulanic acid levels are fixed to 2mg/l.

2 reported values are the concentration of oxacillin.

3 Broken points in the board based on fractures for ampicillin.

4 fractures on resistance R> 8mg/l ensure that all the isolated strains with resistance mechanisms are reported as resistance.

5 Broken points in the table based on a broken point for benzylpenicillin.

When necessary, expert advice should be found in case the local resistance rate is so large that the benefits of the drug in at least some types of infections are still unclear.

Common sensitive species

Glass bacteria

Enterococcus Faecalis

Gardnerella Vaginalis

Staphylococcus aureus (sensitive to methicillin) £

Staphylococci has no coagulase (sensitive to methicillin)

streptococcus agalact

streptococcus pneumoniae1

Streptococcus Pyogenes and other beta -solted streptococcus streptococcus

Streptococcus Viridans group

Gram -negative bacteria

capnocytophaga spp.

Eikenella Corrodens

haemophilus infuenzae2

Pasteurella Multocida

Anaerobic bacteria

bacteroides fragilis

fusobacterium nucleatum

Prevotella spp.

Glass bacteria

Enterococcus fast $

Air -negative gram bacteria

Escherichia Coli

klebsiella oxytoca

klebsiella pneumoniae

Proteus sarcasm

proteus vulgaris

acinetobacter sp.

citrobacter Freundii

Enerobacter sp.

Legionella Pneumophila

Morganella Morganii

Providencia spp.

pseudomonas sp.

Serratia sp.

stenotrophomonas maltops

Other microorganisms

chlamydophila pneumoniae

chlamydopha psittac

COXLLA BURNETT

mycoplasma pneumoniae

£ All Staphylococcus resistance to methicillin is resistant to amoxicillin/clavulanic acid.

A form of amoxicillin/acid Clavulanic acid may not be suitable for treating streptococcus pneumoniae resistant to penicillin (see the dosage and use, warning and caution especially when used).

2 has reported on sensitive reduction strains in some countries in the European Union (EU) with a higher frequency of 10%.

Amoxicillin and clavulanic acid dissociate completely in water solution in physiological pH. Both of these ingredients are absorbed quickly and well by oral. Amoxicillin/clavulanic acid is optimally absorbed when taken at the beginning of the meal. After oral use, Amoxicillin and Clavulanic acid have a bioavailability of about 70%. Plasma data of both components is similar and the time reaches the peak concentration in plasma (TMAX) in each case of about 1 hour.

Dynamic pharmacokinetic results for a study in which amoxicillin/clavulanic acid (tablets 500mg/125mg, 2 times/day) are used for hunger for healthy volunteers presented below.

Average dynamic pharmacokinetic parameters (± standard deviation, sd)

dose

cmax

tmax*

AUC (0-24 hours)

t 1/2

(μg/ml)

(hours)

(μg.

(hours)

500/125 mg

500

7.19

± 2.26

15 (1,0-2,5)

53.5 ± 8.87

1.15 ± 0.20

500 mg/125 mg

125

2.40

± 0.83

1.5 (1.0-2,0)

15.72 ± 3.86

0.98 ± 0.12

* Average (scope)

Distribution

About 25% of the total amount of plasma clavulanic acid and 18% of the total amount of amoxicillin in plasma is associated with 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 using intravenous sugar, both amoxicillin and clavulanic acid are found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, fluid fluid, abdominal fluid, bile and latex. Amoxicillin does not properly distribute into the cerebrospinal fluid.

Animal studies show that there is no evidence of retention in the derivative tissue from drugs that are statistically significant for each ingredient. Amoxicillin, like most penicillin, can be found in breast milk. The amount of clavulanic acid can also be detected in breast milk (see the part of pregnant and lactating women).

both amoxicillin and clavulanic acid have been shown to be able to pass the placenta fence (see the part of pregnant and nursing women).

Biological variables

Amoxicillin is partially eliminated through urine in the form of inactivated penicilloic acid in the same amount equivalent to 10-25% of the original dose. Clavulanic acid is strongly metabolized in humans and is eliminated in urine and feces in the form of carbon dioxide in exhaled air.

Elimination

The main excretion line for amoxicillin is through the kidneys, while clavulanic acid is excreted by the mechanisms through the kidney and no kidneys.

Amoxicillin/Clavulanic acid has an average time for sale about an hour and the average total total clearance of about 25 liters/hour in healthy people. About 60 - 70% of amoxicillin and 40 - 65% of clavulanic acid excreted in the form of unchanged urine in the first 6 hours after taking a single dose of single tablets amoxicilllin/clavulanic acid 250mg/125mg or 500mg/125mg. Different studies have recorded the excretion in urine is 50 - 85% for amoxicillin and about 27-60% for clavulanic acid after a 24 -hour period. In the case of clavulanic acid, the largest amount of medicine is excreted in the first 2 hours after taking the drug.

Simultaneously used with probenecid slows the secretion of amoxicillin but does not slow down the excretion of clavulanic acid through the kidney (see the interaction with other drugs).

Age

Amoxicillin's waste time is the same for children about 3 months to 2 years old, older children and adults. For very young children (including premature babies) in the first week of life, the distance of drug use should not exceed 2 times/day due to the excretion of the kidneys. Because older patients are more likely to be impaired renal function, need to be cautious when choosing the dose and monitoring of kidney function can be helpful.

gender

After using amoxicillin/clavulanic acid orally for healthy men and women, gender does not affect statistically significant about the pharmacokinetic parameters of amoxicillin or clavulanic acid.

kidney failure

Amoxicillin/acid clearance Clavulanic acid in serum decreases proportional to renal function. The decrease in the clearance of the drug is more pronounced for amoxicillin than clavulanic acid, as the higher amoxicillin ratio is excreted through the kidney. Therefore, the dosage in renal failure must prevent excessive amoxicillin accumulation while maintaining the full clavulanic acid level (see the dose and usage).

Hepatic failure

Patients with liver failure should be cautious about dosage and monitor liver function at regular distances.

Before taking Curam 625mg Sandoz medicine for infections (5 blisters x 4 tablets)

How to use

Curam tablets are taken orally.

Use the drug at the beginning of the meal to minimize the intolerance of the gastrointestinal tract and optimize the absorption of amoxicillin/clavulanic acid.

Can start treatment with a summary of the product characteristics of intravenously and continue with oral preparations.

Dosage

Doses are completely mentioned as the content of amoxicillin/acid clavulanic.

Curam dose is chosen to treat a separate case of infection that needs to be taken into account:

Possible pathogens and their sensitivity to antibacterial drugs (see the warning and caution especially when used)

Severe and infection site

Age, weight and kidney function of the patient as shown below.

The use of other types of presentation of amoxicillin/clavulanic acid combination (for example, higher types of amoxicillin doses and/or different ratios between amoxicillin and clavulanic acid) should be considered when necessary (see warning and prudent parts especially when used and energy -powered properties).

For adults and children ≥ 40kg this Curam formula offers a total dose of 1,500mg of amoxicillin/375mg Clavulanic acid daily, when used as recommended below. If found to use a higher daily daily amoxicillin, it is recommended to choose another Curam preparation to avoid high doses of daily clavulanic acid (see the warning and caution especially when used and pharmacological properties).

Duration of treatment should be determined according to the patient's response. Some cases of infections (for example, osteoarthritis) takes longer treatment. The treatment process should not last more than 14 days without reconsideration (see the warning section and caution especially when used for prolonged treatment).

Adults and children ≥ 40kg

Use a tablet (dose 500mg/125mg), 3 times/day.

Children can be treated with Curam tablets or other pharmaceutical formulas of the form of amoxicillin/clavulanic acid combination such as chaos or children's packages. Children 6 years of age or less should be treated with amoxicillin/clavulanic acid in the form of a chaotic or package for children.

There is no clinical data on Curam's dosage (formula 4: 1) taller than 40mg/10mg/kg/day for children under 2 years old.

Elderly

No need to consider adjusting the dose.

kidney failure

Maximum amoxicillin dose adjustment is recommended.

No dose adjustment in patients with creatinine clearance (CrCl) is greater than 30ml/min.

Adults and children ≥ 40 kg

Creatinine clearance (CrCl): 10 - 30ml/minute

500mg/125mg, 2 times/day

500mg/125mg, 1 time/day

500mg/125 mg every 24 hours, plus 500mg/125 mg while the fertilizer is repeated at the end of the fertilizer session (when the concentrations of both amoxicillin and clavulanic acid decrease).

Need to be cautious about dosage and monitor liver function at regular distances (see the parts contraindicated and warning and prudent especially when used)

What to do when overdose? In some cases, the amoxicillin crystal has been observed leading to renal failure (see the part of caution when taking the drug).

Convulsions can occur in patients with renal function or in high -dose users.

There has been an amoxicillin report that causes precipitation in the bladder catheter, mainly after intravenous injection at large doses. Should maintain regular checkups (see the parts of caution when taking the drug).

How to handle

Symptoms of the gastrointestinal tract can be treated as symptoms, note the water/electrolyte balance. Amoxicilin/Clavulanic acid can be excluded from circulation due to hemolysis.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

The most commonly reported side effects (ADR) are diarrhea, nausea and vomiting.

The side effects of the drug from clinical studies and after -sales monitoring have been classified by Meddra by the organic group listed below.

The following terms are used to classify the appearance of unwanted effects:

Very common (≥ 1/10);

Common (≥ 1/100 to

Common

Unknown

Rare

Unknown

immune system disorders

Unknown

dizzy

Less

headache

Less

Unknown

diarrhea

Very common

Nausea 3

Common

Less

Unknown

Less

Hepatitis 6

Unknown

Less

Rare

Unknown

2 See parts of caution when taking the drug.

3 more common nausea, associated with higher doses. If there is a clear gastrointestinal reaction, it can reduce these reactions by taking Curam at the beginning of the meal.

4 includes fake colitis and bleeding colitis (see the parts of caution when taking the drug).

5 has recorded an average increase in AST and/or ALT in patients treated with beta -lactam antibiotics, but it is unclear the meaning of these findings.

6 of these reactions have been recorded with other penicillins and cephalosporin (see the parts of caution when taking the drug).

7 If any hypersensitivity dermatitis is occurring, it is necessary to stop treatment (see the part of caution cases when taking the drug).

8 See the overdose and management.

9 See the parts of caution when taking the drug.

10 See the contraindications and caution cases when taking the drug.

Warnings

Contraindicated

Hypersensitivity to active ingredients, with any drugs of the penicillin group or any excipients of the drug.

History of severe hypersensitivity reactions (for example, anaphylaxis) for another drug belonging to the beta - lactam group (for example, cephalosporin, carbapenem or monobactam).

History of jaundice/liver failure due to amoxicillin/clavulanic acid (see the unwanted effect)

Be cautious when taking drugs

Before starting treatment with amoxicillin/clavulanic acid, should carefully investigate the previous hypersensitivity reactions with penicillin, cephalosporin or other drugs belonging to the beta - lactam group (see the anti -contrapeination sections and undesirable effects).

There have been reports on serious hypersensitivity reactions and sometimes fatal (anaphylactic form) in patients being treated with penicillin. These reactions are more likely to occur in people with a history of hypersensitivity to penicillin and people with allergies. If an allergic reaction occurs, amoxicillin/clavulanic acid must be discontinued and appropriate alternative treatment sets. In case of proving infection is caused by amoxicillin -sensitive organisms, it is advisable to consider to switch from amoxicillin/clavulanic acid to amoxicillin according to the official instructions.

This type of Curam presentation is not suitable for use when there is a high risk of anti -anticipation agents with beta -lactam drugs without intermediaries of beta - lactamase sensitive to masters inhibition due to clavulanic acid. Do not use this form to treat S. Pneumoniae resistance penicillin.

Convulsions can occur in patients with renal function or in people who are taking high doses (see the unwanted effect).

Avoid using amoxicillin/clavulanic acid if suspected to have a single -blood leukemia due to the appearance of measles rash that has been related to this condition after using amoxicillin.

Concentrated with allopurinol during treatment with amoxicillin may increase the likelihood of skin allergic reactions.

Using long -term drugs can sometimes lead to excessive growth of anti -drug bacteria.

The appearance of a whole body with a fever at the beginning of treatment in combination with pustules may be a symptom of the acute all -body pustules (AGEP) (see the unwanted effect). This reaction requires stop use of Curam and contraindicated to use any form of amoxicillin later.

Be careful when using amoxicillin/clavulanic acid in patients with evidence of hepatic failure (see the dose parts, usage, contraindications and unwanted effects).

There has been a report on side effects on the liver, mainly in men and the elderly, which may be associated with prolonged treatment. It is rare for reports on these side effects in children. In all research groups, signs and symptoms often occur during treatment or a short time after treatment, but some cases occur unclear until several weeks after stopping treatment. These symptoms are usually recovered. The side effects of the liver may be severe and in some extremely rare cases, there have been deaths. These cases are almost always occurring in patients with serious illnesses before or are taking simultaneously with known drugs that can cause side effects on the liver (see the unwanted effect). Colitis associated with antibiotics has been reported with almost all antibacterial drugs and the severity of mild to life -threatening range (see the unwanted effect). Therefore, it is important to consider this diagnosis in patients with diarrhea during or after using any antibiotic. If colitis is associated with antibiotics, it is necessary to stop Curam immediately, consult a doctor and start an appropriate therapy. Contraindications for drugs that reduce bowel motility in this condition.

It is necessary to periodically assess the functional system function functions, including kidney, liver and hematopathy during prolonged treatment. There has been a rare report on prolifers in patients using amoxicillin/clavulanic acid. Appropriate monitoring when anticoagulants are prescribed simultaneously. It may be necessary to adjust the dose of oral anticoagulants to maintain the desired anticoagulant concentration (see the interactive parts of the drug with other drugs and other types of interactions and unwanted effects).

In patients with renal impairment, the dose should be adjusted according to the degree of renal failure (see the dose and usage).

In patients with decreased urine, in very rare cases, the urinary crystal, mainly when treated with injection. While using high -dose amoxicillin, it is recommended to maintain the full amount of fluid and the amount of urine discharged to reduce the possibility of the occurrence of urinary amoxicillin crystals, in patients with bladder catheter, should maintain regular testing (see overdose and treatment).

During the treatment of amoxicillin, the glucose oxidase enzyme should be used whenever the presence of glucose is required in the urine because of a false positive result that may occur with non -enzyme method.

The presence of clavulanic acid in the Curam can cause an inferior IgG and albumin cohesion by red blood cell membrane that leads to a fake positive Coombs test.

There have been reports on positive test results, using Bio - rad Laboratories Platelia Aspergillus EIA in patients who are taking amoxicilin/clavulanic acid as those who are later noticed without Aspergillus. Cross reactions with non -Aspergillus and polyfuranose polysaccharids with the BIO test - Rad Laboratories Platelia Aspergillus EIA have been reported. Therefore, you should carefully consider positive test results in patients using amoxcillin/clavulanic acid and should be confirmed by other diagnostic methods.

The ability to drive and operate machinery

has not recorded a adverse reaction report or no research on the effect of the drug on the ability to operate machinery, train drivers, higher people working and other cases. However, unwanted effects may (for example, allergic reactions, dizziness, convulsions), can affect the ability to drive and operate machinery, people working on high and other cases (see unwanted effects).

Pregnancy and lactation

Pregnancy

Animal studies do not show direct or indirect effects on pregnancy, embryo/fetal development, birth and postpartum development. The data is limited in the use of amoxicillin/clavulanic acid during pregnancy in humans does not show an increase in the risk of birth defects. In a single study on women breaking vegetable membranes early before birth, a report was a preventive treatment for moxicillin/clavulanic acid that may be associated with increased risk of necrotizing bowelitis in infants. The drug should be avoided in pregnancy, unless the doctor is necessary.

Breastfeeding period

Both substances are excreted through breast milk (unclear effects of clavulanic acid on babies are breastfed). Therefore, diarrhea and mucous fungal infection may be breastfed, so you may have to stop breastfeeding. Amoxicilin/Clavulanic acid should only be used during breastfeeding after being treated by the doctor to assess benefits compared to the risk.

Other special subjects

have not been recorded.

Medicinal interaction

Anticoagulant drugs for oral form

In practice, oral anticoagulants and penicillin antibiotics have been widely used without any reports on drug interactions. However, in the literature, there are cases of increased international standardization ratio in patients treated with acenocoumarol or warfarin and prescribed an amoxicillin course. If needed simultaneously, prothrombin should be carefully monitored or internationalized ratio with additional or amoxicillin stops. In addition, it may be necessary to adjust the oral anticoagulant dose (see the parts of caution when taking the drug and the unwanted effect)

methotrexate

penicillin can reduce methotrexate secretion, which is capable of increasing toxicity.

Probenecid

Do not recommend simultaneous use with Probenecid. Probenecid reduces the secretion of amoxicillin in the renal tubules. Simultaneous use with probenecid can lead to prolonged increase in blood amoxicillin levels, not clavulanic acid levels.

mycophenolat mofetil

In patients using Mycophenolat Mofetil, there has been a report on the reduction of the starting dose concentration of metabolites with mycophenolic acid activity (MPA) approximately 50% when using amoxicillin and oral clavulanic acid. The change in the starting level of the dose may not represent the exact change for the overall MPa exposure change. Therefore, the change of doses of mycophenolat mofetil is not necessary in the absence of clinical evidence of grafting dysfunction. However, closely monitoring should be performed during the simultaneous use of drugs and short time after the end of antibiotic treatment.

Storage

Store less than 30 ° C, in a dry place. Stay out of reach of children.

Expiry date: 2 years from the date of production.

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Curam 625mg Sandoz medicine for infections (5 blisters x 4 tablets)

Ingredient

Uses

Indications

Pharmacokology

Before taking Curam 625mg Sandoz medicine for infections (5 blisters x 4 tablets)

How to use

Dosage

What to do when overdose? In some cases, the amoxicillin crystal has been observed leading to renal failure (see the part of caution when taking the drug).

Side Effects

Warnings

Contraindicated

Be cautious when taking drugs

The ability to drive and operate machinery

Pregnancy and lactation

Other special subjects

Medicinal interaction

Storage

Other drugs

Disclaimer

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