Lanam SC 200 mg/28.5mg Imexpharm powder treated infections, acute sinusitis, otitis media (12 packs x 0.8g)

ATC code: J01CR02.

Mechanism of operation: Amoxicillin is a semi -synthetic antibiotic belonging to the penicillin group (betalactam antibiotic). Amoxicilin has bactericidal effects that attach to one or more protein of bacterial penicillin (Pbps) to inhibit peptidoglycan biosynthesis, which is a component of bacterial cell walls. Finally, the bacteria decompose by the enzymes to destroy the bacterial cell wall. Amoxicillin is easily destroyed by beta lactamase enzymes and therefore the antibacterial spectrum of the monounsaturated amoxicillin does not include bacteria that produce these enzymes. Clavulanic acid is a beta-lactam, structurally related to penicillin. Clavulanic acid has the ability to inhibit beta lactamase enzymes and therefore, prevent inactivity to amoxicillin. Clavulanic acid monomers do not have clinical antibacterial effects.

Lanam SC 200 mg/28.5 mg is a combination of amoxicillin and clavulanic acid. This coordination does not change the mechanism of the effect of amoxicillin but has the effect of anti-bactericidal, expanding the effect of amoxicillin against many bacteria that produce beta lactamase previously resistant to Amoxicilin monon treatment, due to clavulanic acid with high affinity and attached to beta-lactamase of bacteria to inhibit.

Hematology/ pharmacokinetic association: The time of antibiotic concentration is higher than the minimum inhibitory concentration (T> MIC) is the main parameter that shows the effect of amoxicillin.

Resistance mechanism: The two main mechanisms of resistance bacteria for amoxicillin/ clavulanic acid combination are:

For children weighing

Treatment time should be considered depending on the response of the patient. Some bacterial infections (such as osteomyelitis) require longer treatment time. Do not extend the treatment time more than 14 days without re -assessing the patient's condition.

Adults and children from 40 kg should use other products with amoxicillin/ macid Clavulanic content more suitable for adults.

Children weighs

Recommended dose:

There is no clinical data on the use of amoxicillin/ clavulanic acid in 7/1 ratio for children under 2 months old. Therefore, the proposal for these subjects has not been implemented.

Elderly:

There is no need to adjust the dose.

Patients with renal failure:

Be cautious about dosage when using and periodically check liver function during drug use.

What to do when overdose?

overdose:

Symptoms on the gastrointestinal tract and water balance disorders, electrolytes may be an expression of overdose. Observed the urinary amoxicillin crystal, in some cases, the kidney failure.

Seism can occur in patients with renal failure or high doses.The crystal of amoxicillin has also been found in the bladder tubes, especially after using high doses through the injection. Therefore, it is necessary to periodically check the status of the bladder tubes.

How to handle:

Stop using drugs, treat symptoms on the gastrointestinal tract and monitor water and electrolyte balance.

It is possible to remove amoxicilin/ clavulanic acid from circulation by hemolysis method.

What to do when forgetting a dose?

Use the next dose after at least 4 hours. Do not use double dose to compensate for missed dose.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Before starting treatment with Lanam SC 200mg/28.5mg, the patient's allergic history should be carefully investigated with penicillin, cephalosporin or other betalactam drugs.

Severe hypersensitivity reactions and sometimes fatal (such as anaphylaxis and serious side effects) have been recorded in patients treated with penicillin drugs. These reactions often occur in patients with a history of allergies to penicillin and other allergens. If the allergic reaction occurs, it is necessary to stop using amoxicillin/ clavulanic acid and other treatments for other appropriate treatment.

During treatment with Lanam SC 200mg/28.5mg, if the bacteria have been identified as sensitive to amoxicillin, it is possible to switch to single amoxicillin.

This drug is not suitable for treating bacterial infections caused by bacteria that have been resistant to beta-lactam antibiotics under the intermediary mechanism of beta-lactamase enzymes inhibited by clavulanic acid. Do not use this medication to treat bacterial infections caused by s.pneumonia resistant to penicillin.

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

Avoid using amoxicillin/ acid Clavulanic acid for patients suspected of having a mononulocytic hypertension because these patients are at risk of measles rash when using amoxicillin.

Using alopurinol while being treated with amoxicillin may increase the risk of skin allergies.

Take the drug that sometimes causes excessive growth of bacteria that are not sensitive to the drug.

The appearance of a whole body erythema with pustules at the beginning of the treatment may be a manifestation of acute all -body pustules syndrome (AGEP).

If these manifestations appear, the patient should stop the drug and contraindes to any preparation containing amoxicillin.

Be cautious when used in combination with amoxicillin/ clavulanic acid for patients with impaired liver function.

The side effects of the drug in the liver mainly occur in male patients, the elderly and the patient must be treated for a long time, rarely occurs in children. Typically, signs and symptoms usually occur during the process or after a short time of treatment, but in some cases, it may not be clear until several weeks after stopping treatment. These symptoms can often recover on their own. However, there are still cases of serious, even death, but very rare, mainly in patients with serious illness or use in combination with drugs that are at risk of affecting the liver.

Colitis associated with antibiotics has been reported with almost all antibacterial agents including amoxicillin and can fluctuate in a level from mild to life -threatening. Therefore, it is necessary to diagnose this disease in patients with diarrhea during or after medication. If the fake colitis is caused by antibiotics, it is necessary to stop using amoxicillin/ clavulanic acid immediately and conduct appropriate treatments. The anti -peristalgic inhibitors in these cases.

Periodically check the function of organs such as kidney and liver function, hematology index during long -term treatment. Prothrombin time has been reported in patients treated with mamoxicilin/ clavulanic acid, but it rarely occurs. The patient's condition should be monitored when used simultaneously with anticoagulants. It is possible to adjust the oral anticoagulant dose if necessary to maintain the concentration of anticoagulants as desired.

Dosage for patients with renal impairment should be adjusted depending on the degree of renal failure (see the dose - Usage section).

Very rare cases of urinary crystal observation in patients who reduce urine secretion, mainly in patients taking drugs in the form of injection.

Patients should maintain sufficient amount of oral fluid in the urine to reduce the ability to cause crystal amoxicilinurin, especially when taking the drug in high doses.

In patients with urine pipes, regular testing of urine tubes should be checked.

During the treatment of amoxicillin, the glucose oxidase enzyme should be used when the glucose test is needed in the urine because of the non -enzyme methods that can give false positive results.

Clavulanic acid in the drug can cause nonsense cohesion of IgG and albumin on the membrane of red blood cells, resulting in a false positive result of the Coombs solution.

The drug can cause false positive testing Bio-Rad Laboratories Platelia Aspergillus EIA due to cross-reactions with polysaccharids and polyfuranose are not Aspergillus. Therefore, for patients who are taking amoxicilin and clavulanic acid, cautious if there is a positive result when testing by this method and should be further determined by other diagnostic methods.

Information related to the excipients of the drug:

Each package of oral powder Powder Lanam SC 200mg/28.5mg contains the corresponding 5 mg Aspartam (E951). After drinking, the Aspartam's excipient ingredient is hydrolyzed in the gastrointestinal tract. One of the hydrolysis products is phenylalanin, which can be harmful to patients with phenylketon (PKU).

There is no clinical and non -clinical information evaluating the use of aspartam for children under 12 weeks of age.

The excipients Manitol (E421) in the drug can cause mild laxative in patients.

The effect of drugs on driving and operating machinery

There are no studies on the effects of the drug on the ability to drive and operate machinery. However, some unwanted effects of the drug such as allergic reactions, dizziness, convulsions ... can reduce the ability to focus and react of the patient. Therefore, caution when using the drug for these objects. If the patient has the above unwanted effects, it is not advisable to drive or operate machinery.

Using drugs for women during pregnancy and lactation

Using drugs for pregnant women:

Animal studies show that the drug is not directly or indirectly harmful to pregnancy, embryo/ fetal development, birth or development after birth.

Data on the use of amoxicillin/ clavulanic acid in pregnant women also shows that it does not increase the risk of birth defects in children, however, these research data are still limited. A single study in premature women due to early rupture of amniotic fluid reported prophylactic treatment with amoxicillin/ clavulanic acid may increase the risk of necrotizing bowel infections in infants.

Therefore, patients should avoid taking the drug during pregnancy, unless the doctor is prescribed.

Use medicine for breastfeeding women:

Amoxicilin and clavulanic acid are both breast milk (no information about the effect of clavulanic acid on breastfed babies). This can lead to diarrhea or fungal infection on mucous membranes in breastfed babies, thus stop breastfeeding to ensure safety for babies. Children's sensitivity to drugs should be considered.

Amoxicilin/ Clavulanic Acid is only used during breastfeeding after being evaluated by a doctor between the benefits and potential risks.

Drug interaction

Interaction of drugs:

Oral anticoagulant drugs:

Oral anticoagulants and penicillin antibiotics have been widely used in reality without noting any interactions. However, in the literature, it refers to increasing international normalization index (INR) in patients using acenocoumarol or warfarin simultaneously with amoxicillin. If it is necessary to use simultaneously, it is advisable to carefully monitor prothrombin or INR time when starting or stopping using Lanam SC 200 mg/ 28.5 mg. Can adjust anticoagulant dose if needed.

methotrexate:

Penicillin antibiotics reduce methotrexate secretion, thus increasing the toxicity of methotrexate.

Probenecid:

Avoid simultaneously with Probenecid. Probenecid reduces amoxicillin secretion in the renal tubules thus increasing and prolonging the concentration of amoxicillin in the blood but does not affect clavulanic acid.

mycophenolat mofetil:

In patients who are taking Mycophenolat Mofetil, there has been reports on a 50% reduction in metabolites with the remaining mycophenolic acidic activity (MPA) after starting treatment with amoxicillin/ clavulanic acid combination. The change of this concentration may not accurately show changes in the overall MPa exposure level.

Therefore, it is not necessary to adjust the dose of mycophenolat mofetil without clinical evidence of grafting dysfunction. However, clinical monitoring should be closely monitored during the use of the drug and a short time after stopping treatment with antibiotics.

Oral contraceptive pills:

Like antibiotics with broad effects, the drug can reduce the effectiveness of oral contraceptives.

nifedipin:

Increase amoxicillin absorption.

Bacterial pliers:

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

alopurinol:

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

Diagnostic tests: