Foodin 1000mg Elpen medicine for respiratory infections (12 packs)

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

Ingredient

Composition information	Content
Amoxicillin	875mg
Clavulanic Acid	125mg

Uses

Indications

Amoxicillin + Clavulanate preparations used for treatment in a short time (less than 14 days) Cases of infections caused by the beta-lactamase strains are not responded to treatment with aminopenicilin alone:

Severe upper respiratory infections: tonsillitis, sinusitis, otitis media have been treated with common antibiotics but does not help.

Lower respiratory infections by H. Influenzae and Moraxella Catest (previous names: Branhamella Catatrbalis) producing Beta - Lactamase: Acute and chronic bronchitis, pneumonia - Bronchial.

Urinary - genital heavy bacterial infections by E.coli strains, Klebsiella and Enerobacter produce beta - sensitive lactamase: cystitis, urethritis, pyelonephritis (female genital tract infections).

Skin and soft tissue infections: pimples, insects, abscess, wound infections, cellular inflammation.

Bone and joint infections: Bone inflammation.

Dental infections: to alveolar abscess.

Other bacterial infections: infections caused by sensitive bacteria, obstetric infections (infections caused by abortion, obstetric blood infections, infections caused by miscarriage), bacterial infections in the abdomen (intravenous injection in blood infections, peritonitis, prevent bacterial infections during stomach - intestinal, head and neck surgery, heart, kidney, joint replacement and bile ducts).

Pharmacokology

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic), which inhibits one or more enzymes (often called proteins associated with penicillin, PBPS) involved in the peptidoglycan biosynthesis is an essential component of the bridge that creates a bacterium's cell wall wall. Inhibiting the peptidoglycan biosynthesis makes the cell wall weaker, then often leads to the cell that is separated and died.

Amoxicillin is easily destroyed by beta-lactamase created by anti-drug bacteria strains and therefore these bacteria strains are not sensitive to amoxicillin when only used for amoxicillin.

Clavulanic acid is a beta lactam related to the structure with penicillin, which is active in which some beta-lactamase enzymes, thus preventing amoxicillin inactiveness. When only used, clavulanic acid has no effect to kill bacteria on clinical.

Two main anti -drug mechanisms with amoxicillin/clavulanic acid are:

Inactivated by some bacterial beta-lactamase inhibited bacterial acid, including groups B, C and D. Bacterial medicine, especially in Gram -negative bacteria.

Sensitive bacteria:

Aerobic gram -positive bacteria:

Enterococcus Faecalis.

Gardnerella Vaginalis.

Staphylococcus aureus (methicillin sensitive).

Streptococcus Agalactiae.

Aerobic gram -negative bacteria:

capnocytophaga spp.

Eikenella Corrodens.

bacteroides fragilis.

fusobacterium nucleatum.

Aerobic gram -positive bacteria:

Enterococcus Faecium.

Escherichia coli.

Aerobic gram -negative bacteria:

acinetobacter sp. sp.

Serratia sp.

chlamydophila phosphoniae.

chlamydophila psittaci.

Amoxicillin and clavulanic acid are completely dissolved in a liquid solution in physiological pH. Both ingredients are well absorbed and fast when used orally. Amoxicilin/Clavulanic acid is best absorbed if used right before meals. After oral use, the bioavailability of amoxicillin and clavulanic acid is about 70%. The plasma characteristics of amoxicillin and clavulanic acid are similar and the time to obtain the peak concentration in the plasma of amoxicillin and clavulanic acid (max) about 1 hour.

When using a combination of amoxicillin/clavulanic acid, the concentration of amoxicillin and clavulanic acid obtained in the serum is similar to when taking orally amoxicillin or separate clavulanic acid.

Distribution:

About 25% of the total amount of clavulanic acid and 18% of the total amount of amoxicillin in plasma is attached to protein. Amoxicillin's distribution volume is about 0.3 - 0.4 l/kg and about 0.2 l/kg for clavulanic acid.

Like most penicillin, amoxicillin is also found in breast milk. It has also been discovered the form of clavulanic acid in breast milk. Both amoxicilin and clavulanic acid have passed through the placenta fence.

Metabolism:

Amoxicilin is partly excreted in the urine in the form of peniciloic acid without active, equivalent to 10-25% of the original dose. Clavulanic acid is strongly metabolized in humans, eliminated through urine, feces and breathing in the form of carbon dioxide.

Era:

The main excretion path of amoxicillin is through the kidneys, while clavulanic acid is eliminated by both the kidneys and the mechanism without the kidneys.

Many studies have shown about 50 - 85% amoxicillin and about 27-60% of Clavulanic acid are eliminated in urine after 24 hours. For clavulanic acid, the drug is most deducted in the first 2 hours after taking the drug.

Concentrated with probenecid slows down amoxicillin but does not affect the elimination of clavulanic acid through the kidney.

Before taking Foodin 1000mg Elpen medicine for respiratory infections (12 packs)

How to use

oral medication. Take the drug right before eating to minimize the risk of non -intolerance in the stomach - intestines and optimize the absorption of the drug.

Mix the amount of flour in each pack with a little water, stir and drink immediately.

There is no special requirement on drug treatment after use.

Dosage

When choosing the dose of amoxicillin/clavulanic acid to treat infections in each patient must pay attention to:

Predict the disease and their sensitivity level with antibiotics.

For adults and children> 40 kg using Foodin phase powder will provide a total daily dose of 1750 mg of amoxicillin/250 mg Clavulanic acid when using 2 packages daily and 2625 mg of amoxicillin/375 mg Clavulanic acid when taking 3 packages daily as recommended below.

For children The treatment time depends on the response of the patient. With some infections requires longer treatment time (eg bone inflammation). Do not take the drug for more than 14 days without checking the treatment.

Adults and children> 40 kg

Recommended dose:

Standard dose (for all indications): 1 pack/time x 2 times/day.

Recommended dose:

25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day divided into 2 times daily. Clavulanic 7: 1 with a dose greater than 45 mg/6.4 mg/kg/day in young children under 2 years old.

There is no clinical data when using amoxicillin/ clavulanic acid 7: 1 for children under 2 months of age, so it is not possible to set the recommendations for this child.

Older people

No need to adjust the dose in the elderly.

Patients with renal failure

No need to adjust the dose in patients with creatinine clearance> 30 ml/min.

It is not recommended to use amoxicillin/clavulanic acid 7: 1 in patients with creatinine clearance

Patients with liver failure

Precautions when using drugs for patients with liver failure and must monitor liver function periodically.

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 250 mg/kg does not cause special symptoms and does not need to clean the stomach. Interstitial nephritis leads to kidney failure that occurs in a small number of patients using amoxicillin overdose. Disclaimer crystal in some cases leading to kidney failure has been reported after amoxicillin overdose in adults and children. Need to provide enough water and electrolytes to the body to maintain the urinary and reduce the risk of urination.

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. You can use the method of hemolysis to remove both amoxicillin and clavulanic acid from circulation.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

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 Foodin drugs, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Infection and parasitic infection: Candida infection on the skin and mucosa.

Nervous system: dizziness, headache.

Digestive system: indigestion.

Blood and lymphatic system: Reducing leukemia, platelet reduction.

Infection and parasitic infection: Excessive development of non -sensitive bacteria. Convulsions, sterile meningitis Urine: interstitial nephritis, crystal urinary.

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Contraindicated Foodin drugs in the following cases:

Hypersensitivity to the active ingredient, any penicillin or any ingredient in the drug. Amoxicilin/Clavulanic acid.

Be cautious when using

must carefully ask the history of hypersensitivity reactions to penicillin, cephalosporin or other beta-lactam antibiotics before starting treatment with amoxicillin/clavulanic acid.

There have been reports on severe hypersensitivity reactions and sometimes fatal (anaphylaxis) in patients treated with penicillin. These reactions are more common in patients with a history of hypersensitivity to penicillin and a history of allergies. If these allergic reactions appear, it is necessary to stop treating with amoxicillin/clavulanic and switch to other appropriate alternative therapy.

In case of infection, it is shown that bacteria are sensitive to amoxicilin, so consider transferring treatment from amoxicillin/clavulanic acid to amoxicillin according to official treatment instructions.

This form of preparation of amoxicillin/clavulanic acid mixture is inappropriate if it is suspected that there is a high risk of patients infected with bacterial strains that have been sensitive or resistant to antibiotics of the beta-lactam group and not through sensitive intermediaries with beta lactamase, leading to inhibition effects of clavulanic acid. Do not use drugs to treat diseases caused by pneumococcal resistance to penicillin.

Convulsions may occur in patients with renal failure or taking drugs in high doses.

Avoid treating amoxicillin/clavulanic acid in the case of suspected single and mononulocytosis due to the appearance of measles rash associated with this condition after using amoxicilin.

Simultaneous use of allopurinol when treated with amoxicillin may increase the likelihood of skin allergic reactions.

Extending the time of using the drug can sometimes lead to overworked growth of non -drug -sensitive bacteria.

The appearance of the whole body and fever accompanied by pustules at the beginning of treatment may be a symptom of the acute all -body pustules syndrome (AGEP), and then it is imperative to stop treatment with amoxicillin/ clavulanic acid and control amoxicillin later.

Be cautious when using amoxicillin/acid clavulanic in patients with liver failure.

Liver events are often reported in women and the elderly and may be involved in prolonging the drug use time. These events are rarely reported in children. In all patients, signs and symptoms often appear in or immediately after treatment but in some cases, it is not until several weeks after stopping treatment to be clearly manifested. These events often recover. Liver events may be serious and very rare for deaths. These events often appear mainly in patients with serious or useed diseases simultaneously with known drugs at risk of liver.

Antibiotic -related colitis has been reported when using almost all antibiotics, including amoxicillin with mild to life -threatening severity. Therefore, this diagnostic consideration is often important in patients with diarrhea during or after taking any antibiotics. If colitis occurs against antibiotics, it is necessary to stop treating with amoxicilin/clavulanic acid immediately, consult a doctor and switch to appropriate treatment therapy. Contraindications for drugs that reduce peristalsis in this case.

Recommended recommendations for organs, including liver, kidney function and hematopoietic function during prolonged treatment.

There has been a report of patients who have prolonged prothrombin but rarely treated with amoxicillin/clavulanic acid. Appropriate monitoring must be monitored when the patient is prescribed simultaneously with anticoagulants. The dose can be adjusted for oral anticoagulants if necessary to maintain the desired anticoagulant level.

In patients with liver failure, the dose must be adjusted according to the degree of liver failure.

There has been a report on crystal, but very rare in patients with urinary disorders, mainly injected. When using high doses of amoxicilin, it is recommended that patients should drink enough water and maintain the amount of excreted urine to reduce the risk of the occurrence of amoxicillin crystals. In patients using urinary catheter, they must regularly check to make sure the catheter is not clogged.

During the treatment with amoxicillin, the glucose oxidase enzyme must be used if you want to test for a glucose in the urine because the methods of not using the enzyme can give a positive result.

Because Clavulanic acid has an irregular IgG and albumin to the red blood cell membrane, which leads to a Coombs test for misconceptions.

There have been reports on positive test results when using the Platelia Aspergillus EIA test of Bio-Rad Laboratories in patients treated with amoxicilin/acid Clavulanic, although these patients are eventually identified as no Aspergilius infection. There have been reports on the cross-reaction between polysaccharid of non-Aspergilius species and polyfuranose in the testing reagent of Bio-Rad Laboratories Platelia Aspergilius EIA. Therefore, the positive test results in patients being treated with amoxicillin/clavulanic acid should be careful and must be affirmed based on other diagnostic tests.

Foodin phase powder contains 12.5 mg of aspartam, which is a source of phenylalanin, so be careful when used for patients with phenylceton.

The effect of the drug on the ability to drive and operate machinery

The drug can cause dizziness, headache, so it is necessary to be cautious when taking the drug for people who are driving and operating machinery.

Use drugs for women during pregnancy and lactation

pregnancy

Animal studies when using amoxicillin/clavulanic acid does not show direct or indirect effects on pregnancy, embryo/fetal development, before or postpartum development. There are very few data on the use of amoxicillin/clavulanic acid during human pregnancy, and these data also does not show that the drug increases the risk of birth defects. In a single study in premature women due to early rupture of amniotic fluid, there was a report on preventive treatment with amoxicillin/clavulanic acid that may be associated with increased risk of necrotizing bowelitis in infants. Avoid using drugs during pregnancy, unless the doctor thinks it is necessary.

Breastfeeding period

Both active ingredients in the drug are excreted in breast milk (unknown about the effect of clavulanic acid on breastfeeding children). The consequences can cause breastfed babies to be infected with fungal mucosa and diarrhea, so they may have to stop breastfeeding. Also pay attention to the risk of children sensitive to the drug. Only used with amoxicilin/clavulanic acid during the breastfeeding phase after being considered for benefits/risk by a specialist.

Interactive drug

Oral anticoagulant drugs

Oral anticoagulants and penicillin antibiotics have been widely used without seeing reports on drug interactions. However, there have been a number of cases of increased internationalization rate (INR) in patients using acenocoumarol or warfarin and prescribed with amoxicillin. If this coordination is necessary, closely monitor prothrombin time or internationalization rate when increasing the dose or stopping amoxicillin. However, it may be necessary to adjust the dose of oral anticoagulants.

methotrexate

Penicilin reduces methotrexate excretion thus increasing the risk of toxicity.

Probenecid

Do not recommend using the drug simultaneously with Probenecid. Probenecid reduces elimination in the renal tubules of amoxicillin. Simultaneous use with probenecid may increase and prolong the concentration of amoxicillin in the blood but do not affect clavulanic acid.

mycophenolatmofetil

In patients who are being treated with Mycophenolate Mofetil, there has been a report on the decrease in the dosage of metabolites with mycophenolic acid activity (MPA) about 50% after oral amoxicillin in combination with clavulanic acid. The change of concentration before the dose may not accurately show changes in the overall MPa exposure level. Therefore, the change of mycophenolate mofetil dose is unnecessary when there is no clinical evidence that the dysfunction after transplantation. However, it is necessary to closely monitor clinically and immediately after coordination of antibiotic treatment.

Storage

Temperature does not exceed 30 ° C.

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