Curam 625mg Sandoz medicine for infections (2 blisters x 5 tablets)

Dosage form Box of 2 blisters x 5 tablets
Specifications Amoxicillin, clavulanic acid
Ingredient Lek Pharmaceuticals

Ingredient

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Composition information	Content
Amoxicillin	500mg
Clavulanic Acid	125mg

Uses

Indications

Curam 625mg drugs are indicated in the following cases:

Treatment of heavy respiratory infections: tonsillitis, sinusitis, otitis media have been treated with common antibiotics but does not help. Bronchial.

Treatment of bone and joint infections: osteomalitis This combination does not change the mechanism of the effect of amoxicillin (inhibit the synthesis of peptidoglycan bacterial cell membrane) but also has the effect of anti -bactericidal, expand the effect of Amoxicillin against many bacteria to produce beta - lactamase previously resistant to Amoxicillin alone, due to clavulanic acid has high force and attached to Beta - Laus processing.

Clavulanic acid obtained from the fermentation of Streptomyces Clavuligerus, with beta - lactam structure similar to penicillin nucleus, itself has very weak antibacterial effects and has the ability to inhibit beta - lactamase due to the majority of Gram -negative and Staphylococcus bacteria born, staphylococcus is resistant Methicillin/oxacillin must be considered as amoxicillin resistance and clavulanic acid. In vitro, clavulanic acid often inhibits staphylococcus penicillinase, beta - lactamase created by Bacteroides Fragilis, Moraxella Catatrhalis and beta - lactamase classified by Richmond and Sykes Type II, III, IV and V.

Clavulanic acid can inhibit several types of cephalosporinase generated by proteus vulgaris, bacteroides fragilis and burkholderia cepacia but often does not inhibit cephalosporinase transmitted via chromosomes Richmond - Sykes type I, therefore, many citrobacters, animobacter Morganella, SERRATIA spp. And Pseudomonas Aeruginosa is still resistant. Some beta - Lactamase broad spectrum transmitted via plasmid of Klebsiella Pneumoniae, some other Enterobacteriaceae and pseudomonas aeruginosa are also not inhibited by clavulanic acid.

Clavulanic acid can be absorbed through the bacterial cell wall, so it can inhibit the enzyme outside the cell and enzyme attached to the cell. How to vary depending on the inhibitor enzyme, but clavulanic acid often acts as a dispute and unfavorable inhibitor.

The bactericidal spectrum of the drug includes:

Gram -positive bacteria

Aerodic type: Streptococcus Faecalis, Streptococcus Pneumoniae, Streptococcus Pyogenes, Streptococcus Viridans, Staphylococcus aureus, Corynebacterium, Bacillus anthracis, Listeria monocytogenes.

Anaerobic type: Clostridium species, peptococcus, peptostreptococcus.

Gram -negative bacteria

Air -favorite type: Haemophilus Influenzae, Moraxella Catnrhalis, Escherichia Coli, Proteus Mirabilis, Proteus vulgaris, Klebsiella, Salmonella, Shigella, Bordetella, Neisseria Gonorrhoeea, Neisseria Meningitidis, Vibrio Cholerae, Pasteurella Multocida.

Anaerobic type: Baceroides including B. Fragilis. Thus, Amoxicillin and Potassium Clavulanate are acting for both types of bacteria to create and do not create beta - lactamase sensitive to drugs, but many clinicians believe that to treat bacteria not creating beta - lactamase should prioritize the use of alone amoxicillin, dedicated to combined drugs for sensitive beta -lactamase.

Because the drug is at risk of jaundice, it is not allowed to use the drug for more than 14 days. Before starting treatment with combined drugs, bacteria must be identified and antibiotics. While waiting for the results, for combination drug treatment if it is suspected of being beta - lactamase. If the test results show that drug resistance, it is necessary to stop immediately.

pharmacokinetic

absorption

Amoxicillin and potassium clavulanate are easily absorbed by oral and sustainable with the acid fluid of the stomach. The concentration of amoxicillin and clavulanic acid in the serum reaches maximum after 1 - 2.5 hours of taking single dose of regular tablets.

Potassium clavulanate does not affect the pharmacokinetics of amoxicillin, but amoxicillin can increase the absorption through the gastrointestinal tract and excretion through the urinary tract for potassium clavulanate compared to when using poisonous potassium clavulanate. After taking the tablet of 250mg amoxicillin and 125mg clavulanic acid, serum concentration reaches 3.7 - 4.8mcg/ml for amoxicillin and 2.2 - 3.5mcg/ml for clavulanic acid.

After taking the tablet of 500mg amoxicillin and 125mg Clavulanic acid, serum concentration reaches 6.5 - 9.7mcg/ml with amoxicillin and 2.1 - 3.9mcg/ml for clavulanic acid. With a single dose of oral solution containing 250mg of amoxicillin and 62.5mg of clavulanic acid, amoxicillin concentration reaches an average of 6.9mcg/ml and clavulanic acid reaches 1.6mcg/ml. After 1 hour oral 20mg/kg amoxicillin + 5mg/kg Clavulanic acid, there will be an average of 8.7mcg/ml of amoxicillin and 3.0mcg/ml of clavulanic acid in serum.

The absorption of the drug is not affected by food in a common form of preparation. However, prolonged liberation tablets for the best absorption when taking the drug right before meals. At the same time, the liberation tablet should not be taken with a high -fat meal due to Clavulanat absorption is reduced and should not take this type of medicine while hunger due to amoxicillin absorption is reduced.

Distribution

After drinking, both amoxicillin and clavulanic acid are distributed into the lungs, pleural fluid and peritoneal fluid, passing through the placenta. A small amount of pills found in sputum, saliva as well as in breast milk. When the meninges are not inflamed, the concentration of the medication in the cerebrospinal fluid is very low, but the larger amount is achieved when the meninges are inflamed. Amoxicillin binds to serum protein about 17-20% and clavulanic acid linked to protein about 22 - 30%.

The oral bioavailability of amoxicillin is 90% and of Clavulanic acid is 75%. Amoxicillin waste sale time is 1-2 hours and of Clavulanic Acid is about 1 hour.

Elimination

After taking single doses of amoxicillin and potassium clavulanate in adults with normal kidney function, 50 - 73% amoxicillin and 25 - 45% Clavulanic acid are discharged in urine in the form of unchanged within 6 to 8 hours. In people with kidney failure, the serum concentration of both amoxicillin and clavulanic acid is higher as well as half -life excreted also lasts longer.

In patients with 9ml creatinine clearance, half -life of amoxicillin and clavulanic acid are 7.5 and 4.3 hours respectively. Both amoxicillin and clavulanic acid are removed when hemolysis. When abdominal distances, clavulanic acid is also removed while only a very small amount of amoxicillin is removed.

Probenecid extends the excretion time of amoxicillin but does not affect the elimination of clavulanic acid.

Before taking Curam 625mg Sandoz medicine for infections (2 blisters x 5 tablets)

How to use

Oral drugs.

Do not take medicine for more than 14 days without checking the treatment.

Take medicine at the beginning of eating to minimize the phenomenon of non -tolerated drugs in the stomach - intestines.

Dosage

The dosage is usually calculated according to Amoxicillin dose in coordination.

Adult and children over 40kg

Use 1 tablet 12 hours/time.

For severe infections and respiratory infections

Use 1 tablet every 8 hours/time.

Elderly

No dose adjustments unless creatinine clearance

Children under 40kg of weight

Children under 40kg of weight are not used due to high doses of clavulanic acid.

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

Abdominal pain, vomiting and diarrhea. A few patients have rash, agitation or drowsiness.

Handling

Need to stop the drug immediately. Symptomatic treatment and support if needed. If an overdose occurs early and there is no contraindication, it may cause vomiting or gastric lavage. Overdose below 250mg/kg does not cause any special symptoms and does not need to clean the stomach. Interstitial nephritis leads to kidney failure that occurs in a few people with amoxicillin overdose. Primary crystals in some cases that lead to renal failure have been reported after the overdose of amoxicillin in adults and children. It is necessary to provide enough water and electrolytes to the body to maintain the urology and reduce the risk of crystal pee.

Kidney damage often recovers after stopping the drug. Hypertension can occur even in people with kidney function damaged by reducing the elimination of both amoxicillin and clavulanic acid. Hemotrogectomy can be used to remove both amoxicillin and clavulanic acid from circulation.

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 Curam 625mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: diarrhea, nausea, vomiting.

Skin: Outdoor, itching.

Uncommon, 1/1000

Blood: Eosin hypernagus.

liver: Hepatitis and jaundice, increased transaminase (may be heavy and last for several months). Other: Candida vaginitis, headache, fever, fatigue.

Rare, 1/10000

Systemic: Anaphylaxis reactions, edema Quincke.

Blood: A mitigation of platelets, leukopenia, hemolytic anemia. digestive: colitis has fake membranes. skin: Stevens - Johnson syndrome, diverse erythema, peeling dermatitis, poisoning epidermal necrosis. kidney: interstitial nephritis.

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

If the allergic reaction occurs such as erythema, edema, anaphylaxis, Stevens - Johnson syndrome, amoxicillin must be stopped and immediately treated emergency treatment with Adrenaline, oxygen breathing, intravenous corticoid therapy and ventilation, including intra -tracheal placement and never being treated with penicillin or cephalosporine.

Colitis has fake membranes: If mild, stop the drug. If severe (the possibility of clostridioides varesile), add water and electrolytes, use anti -Clostridioides antibiotics (metronidazole, vancomycin).

Warnings

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

Contraindicated

Curam 625mg contraindicated drug in the following cases:

allergies to the beta - lactam group (penicillin and cephalosporine). Pay attention to cross -allergies with beta -lactam antibiotics as cephalosporine.

Caution when using

Pay attention to the elderly, patients with a history of jaundice/liver dysfunction due to the use of amoxicillin and potassium clavulanate because of clavulanic acid causes increased cholestatic risk in the liver.

Signs and symptoms of cholestasis jaundice occur rarely when taking the drug but may be severe. However, these symptoms are often recovered and will end after 6 weeks of stopping treatment.

Before starting amoxicillin treatment, it is necessary to carefully investigate the history of allergies to penicillin, cephalosporin and other allergens.

Average or severe renal failure should pay attention to adjusting the dose.

Taking drugs for prolonged drugs sometimes develops resistant bacteria.

Periodically check the hematology, liver and kidney function during treatment. Distinguished diagnosis is needed to detect cases of diarrhea caused by C. different and colitis with fake membranes.

Patients with phenylketone urinary and patients need to control phenylalanine must be cautious when using chewing tablets or mixed powder containing aspartame converted by aspartame in the digestive tract into phenylalanine.

When high -dose intravenous injection, it is necessary to maintain the balance of import and export fluid to minimize ureteral stones. The bladder pipes must be checked regularly to avoid precipitation causing clogging when there is a high concentration of preparations in the urine at normal temperature.

The ability to drive and operate machinery

has not observed the unwanted effect on the ability to drive or operate machinery.

Be careful when used for driving objects and operating machinery.

Pregnancy

Classification of drugs for pregnant women according to the Australian Drug Administration (TGA): a.

Classification of drugs for pregnant women under the US Food and Drug Administration (FDA): b.

Experimental research on the reproductive process of mice has proved when using oral preparations and injected at a dose larger than 10 times the dose for humans does not cause deformities. However, because there is little experience in using preparations for pregnant women, it is necessary to avoid using drugs in pregnant women, especially in the first 3 months, except for the necessary case prescribed by the doctor.

Breastfeeding period

During breastfeeding can use preparations. The drug is not harmful to breastfed children unless there is a risk of sensitivity due to a very small amount of medicine in milk.

Medicinal interaction

The drug can cause prolonged bleeding time and blood clotting. Therefore, it is necessary to be careful for patients who are being treated with anticoagulants (Warfarin).

Like antibiotics with broad -effects, the drug can reduce the effectiveness of oral contraceptives, so it is necessary to notice to the patient in advance.

Nifedipine increases amoxicillin absorption.

Patients with hyperuricemia when using allopurinol along with amoxicillin will increase the ability of amoxicillin.

There may be antagonists between amoxicillin and bactericidal bacteria such as fusidic acid, chloramphenicol, tetracycline.

Amoxicillin reduces methotrexate secretion, increases toxicity on the gastrointestinal tract and hematopoietic system.

Probenecid when taken right before or simultaneously with amoxicillin reduces amoxicillin elimination, thereby increasing the concentration of amoxicillin in the blood. However, Probenecid does not affect the sale time, the maximum concentration of the drug in the blood (CMAX) and the area under the curve of drug concentration over time in the blood (AUC) of Clavulanic Acid.

Storage

Store in a dry place, temperature below 25 ° C.

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