Klamentin 500/125 DHG Pharma Treatment of sinusitis, otitis media, bronchitis (3 blisters x 4 tablets)

Dosage form Box of 3 blisters x 4 tablets
Specifications Amoxicillin, clavulanic acid

Ingredient

Composition information	Content
Amoxicillin	500mg
Clavulanic Acid	125mg

Uses

indicated

klamentin is indicated for treatment in adults and children in the following cases of infection:

Acute sinusitis (full diagnosis);

Acute otitis media;

Exacerbats of chronic bronchitis (full diagnosis);

Having pneumonia in the community;

cystitis;

Pyelonephritis;

Skin infections and soft tissue especially tissue tissue, insect bites, burnt abscess;

Bone and joint infections, especially osteomyelitis.

Pharmacological

Amoxicillin is a semi -synthetic antibiotic belonging to the Beta - Lactam family with broad bactericidal spectrum for many Gram -positive and gram -negative bacteria due to the synthetic inhibition of bacterial cells. But because amoxicillin is easily destroyed by beta - lactamase, so amoxicillin does not work for bacterial strains that produce these enzymes.

Clavulanic acid has a beta -lactam structure similar to penicillin, capable of inhibiting beta - lactamase due to the majority of Gram -negative bacteria and staphylococcus. In particular, clavulanic acid has a strong inhibition effect of beta - lactamase transmitted via plasmid that resists penicillins and cephalosporins.

The combination of clavulanic acid and amoxicillin in klamentin helps amoxicilin not be destroyed by beta - lactamase, while expanding the antibacterial spectrum of amoxicillin (effectively for many common bacteria that have been resistant to amoxicillin, resistant to other penicilins and cephalosporins.

The bactericidal spectrum of the drug includes:

Gram -positive bacteria:

Aerobic 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:

Aerobic type: Haemophilus Influenzae, Escherichia Coli, Proteus Mirabilis, Proteus vulgaris, Klebsiella, Salmonella, Shigella, Borderella, Neisseria Gonorrhoeae, Neisseria meningitidis, Vibrio Cholerae, Pasteura Multocida.

Anaerobic type: Baceroides including B. Fragilis.

pharmacokinetics

absorption:

Amoxicillin and clavulanic acid are easily absorbed by oral. Maximum serum concentration after 1-2 hours.

The absorption of the drug is not affected by food and it is best to take it right before meals. The oral bioavailability of amoxicillin is 90% and of Clavulanic acid is 75%.

Distribution:

After taking the tablet dose of 500 mg amoxicillin and 125 mg of clavulanic acid, serum concentration reaches 37 - 4.8 micrograms/ml for amoxicillin and 21 - 3.9 micrograms/ml for clavulanic acid.

both amoxicillin and clavulanic acid are distributed into the lungs, pleural fluid and peritoneal fluid, passing through the placenta. Amoxicillin is excreted in milk, without data showing that Clavulanic acid in the milk of mothers who are nursing.

Metabolism:

Amoxicillin is metabolized very little in the body into a corresponding penicilloic acid. Clavulanic acid is partially metabolized into low molecular weight metabolites.

Era:

Amoxicillin's waste time in serum is 1-2 hours and of Clavulanic Acid is about 1 hour. 55 - 73% amoxicillin and 25 - 45% Clavulanic acid are discharged through urine in the form of activity. Amoxicillin and clavulanic acid are excreted mainly through the kidneys.

In people with kidney failure, the serum concentration of both amoxicillin and clavulanic acid is higher as well as the resilience time is longer. In patients with 9 -ml creatinine clearance, the semi -waste time of amoxicillin and clavulanic acid is 7.5 and 4.3 hours respectively.

both amoxicillin and clavulanic acid are removed when hemolysis. When the peritoneal fertilizer, 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 Klamentin 500/125 DHG Pharma Treatment of sinusitis, otitis media, bronchitis (3 blisters x 4 tablets)

How to use

should swallow both klamentin tablets and not chewed. If necessary, can break the pill and swallow and not chew.

Use within 30 days after opening aluminum bags.

Dosage

Dosage depends on the expected pathogens and the ability to be sensitive to antibacterial agents, severity and position of infection, age, weight and kidney function of the patient. The higher use of amoxicillin doses and/ or other ratios of clavulanic amoxicillin acid should be considered when necessary.

For adults and children ≥ 40 kg:

The dose of 500 mg/ 125 mg x 3 times/ day.

For children

From 20 mg/ 5 mg/ day to 60 mg/ 15 mg/ kg/ day, divided into 3 times.

There is no recommended dose for children

Renal failure : Adjust the dosage based on the maximum level proposed by Amoxicillin. No need to adjust the dose in patients with creatinine clearance> 30 ml.

Adults and children ≥ 40 kg:

Creatinine clearance from 10 to 30 ml/ minute dose 500 mg/ 125 mg x 2 times/ day. Amoxicillin and clavulanic in serum decreases).

Children

Creatinine clearance from 10 to 30 ml/ minute dose 15 mg/ 3.75 mg/ kg x 2 times/ day (maximum 500 mg/ 125 mg x 2 times/ day). Time/ day.

Hepatic failure:

Use carefully and periodically monitor liver function. Not enough data to give recommended dose. Take medicine right before meals to minimize the phenomenon of non -intolerance of the gastrointestinal tract and optimize the absorption of amoxicillin, clavulanic acid.

can start treatment with infusion and follow oral continuation. Or as directed by the physician.

Duration of treatment should be determined depending on the level of patient response. Some cases of bacterial infections (such as osteomyelitis) need longer treatment time. Treatment should not exceed 14 days without examination.

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 of Klamentin 500/125? Observed the amoxicillin crystal, in some cases leading to renal failure. Convulsions can occur in patients with weakened renal function or high doses.

Treatment: can be treated with symptoms on the gastrointestinal tract and pay attention to water and electrolyte balance. Can use the method of hemolysis so that the drug is 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 Klamentin 500/125, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Skin: Candida infection on the skin.

Digestive: diarrhea, nausea, vomiting.

Uncommon, 1/1000

Digestive: indigestion.

Skin: skin rash, itching, urticaria.

Liver: slightly increase AST and/ or ALT.

Rare, 1/10000

Systemic: Anaphylaxis, Stevens-Johnson syndrome.

digestive: fake colitis.

Instructions on how to handle ADR

If allergic reactions occur such as erythema, iron, anaphylaxis, Stevens-Johnson syndrome, amoxicillin must be stopped and immediately emergency treatment with adrenalin, oxygen breathing, intravenous corticoid therapy and ventilation, including internal trachea and never being treated with penicillin or cephalosporin.

Palmitis: If mild, stop the drug. If severe (possibly due to Clostridium difficile), rehydration and electrolyte, anti -Clostridium antibiotics (metronidazol, vancomycin).

Warnings

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

contraindicated

Klamentin 500/125 contraindications in the following cases:

Patients with a history of hypersensitivity to beta - lactam, for example penicilin, cephalosporin or any ingredients of the drug.

Patients with a history of jaundice with liver dysfunction related to amoxicilin/ clavulanic acid.

Be cautious when using

should carefully ask the history of hypersensitivity reactions and penicillin, cephalosporin or other allergens before starting treatment with amoxicillin/ clavulanic acid.

In case of infection, it has been shown to be caused by sensitive bacteria and amoxicillin, it should be considered from amoxicillin / clavulanic acid to amoxicillin according to the official instructions.

Klamentin is not suitable for use in case of risk of reducing sensitivity or resistance to beta - lactam due to beta -lactamase is easily inhibited by clavulanic acid. Do not be used to treat S. Pneumoniae bacteria resistant to penicillin.

Convulsions can occur in patients with impaired renal function or in patients with high doses.

Avoid using amoxicillin / clavulanic acid if suspected of mononucleosis of the infection due to the appearance of measles rash related to this condition after using amoxicillin.

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

Prolonged treatment can cause superinfection due to over -developing bacteria that are not sensitive. Stop using Klamentin and Amoxicillin later if the symptoms of the erythematosus appear.

Be careful when using amoxicillin/ clavulanic acid in patients with signs of liver function impairment.

Antibiotic -related colitis that has been reported may have a mild to life -threatening severity.

In patients with renal failure, the dose should be adjusted according to the degree of renal failure. You should drink enough water to maintain the amount of urine excreted during the high doses of amoxicillin use to reduce the possibility of the occurrence of amoxicillin crystals.

While treating amoxicillin, the glucose oxidase enzyme should be used for testing in the urine because fake positive results may occur with non -enzyme methods. There has been a fake positive test result with the Bio-Rad Laboratories Platelia Aspergillus Eia in patients using amoxicilin/ acid Clavulanic.

The ability to drive and operate machinery

The drug can cause dizziness, headache should be cautious when operating machinery, driving train, people working on high and other cases.

Pregnancy

data on the use of amoxicillin/clavulanic acid during pregnancy in humans does not show increased risk of birth defects.

In a single study in premature women due to early amniotic fluid breakage, there was a report on preventive treatment with amoxicillin/ clavulanic acid that may be associated with increased risk of necrotizing bowelitis in newborns. Pregnancy should be avoided, unless the doctor thinks it is necessary.

The period of breastfeeding

The drug is excreted into breast milk. Therefore, in newborn babies, diarrhea and fungal infections can occur when breastfed.

Amoxicilin/ Clavulanic Acid should only be used during breastfeeding after the doctor assesses the risk.

Interactive drug

There are cases of Inr increasing in patients using acenocoumarol or warfarin and has specified an amoxicillin batch. If it is necessary to use simultaneously, carefully monitor prothrombin or INR time with the use or stopping amoxicillin.

Need to adjust the anticoagulant dose of oral methotrexate: increases the toxicity of methotrexate's theory of methotrexate due to penicillin antibiotics inhibiting excretion through the renal tubules.

Probenecid: reduces the secretion of amoxicillin in the renal tubules, thus increasing the concentration of amoxicillin in the blood.

Mycophenolate Mofetil: In patients who are taking MyCophenolate Mofetil, there has been a report on the decrease in the dose of metabolic metabolites with mycophenolic acid activity about 50% after starting oral amoxicillin combined with clavulanic acid. Clinical monitoring should be closely monitored during the use of this drug with antibiotics.

Storage

In a dry place, the temperature does not exceed 300C, avoiding light.

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