Curam Siro 250mg/5ml Sandoz to treat infections

Dosage form Box x 5ml
Specifications Amoxicillin, clavulanic acid
Ingredient Sandoz

Ingredient

Composition information	Content
Amoxicillin	250mg
Clavulanic Acid	62.5mg

Uses

Indications

Curam is indicated in the following cases:

Curam is an antibiotic that has a bactericidal effect that is the cause of bacterial infection. The drug consists of two different active ingredients, amoxicillin and clavulanic acid.

Curam is used for adults and children to treat the following infections:

Acute sinusitis (diagnosed).

Acute otitis media.

Exacection of chronic bronchitis (diagnosed).

Pneumonia has a community.

cystitis.

Pyelonephritis - pyelonephritis.

Skin infections and soft tissue, especially cellular inflammation, bite animal traces, severe tooth abscess with spreading tissue inflammation.

Bone and joint infections, especially osteomyelitis.

The use should be considered according to the official instructions on the appropriate use of antibiotics.

Pharmacokological

Therapy group: Coordination of penicillin group, including beta - lactamase inhibitors.

Mechanism of impact

Amoxicillin is a semi -synthetic penicillin (Lacta - Lactam antibiotic group) inhibits one or more enzymes (often called penicillin -mounted proteins, Pbps) in the peptidoglycan biosynthesis of bacteria, is an indispensable structural component of bactericidal cell walls. Peptidoglycan synthesis inhibits cell wall walls, then a cup and cell death.

Amoxicillin is easily decomposed by the beta - lactamase enzyme produced by resistance bacteria and therefore the effect of amoxicillin alone does not include these enzyme -producing bacteria. Clavulanic acid is a beta - lactam -related drug with penicillin. Clavulanic acid is inactivated some beta - lactamase enzymes thus preventing the inactivity of amoxicillin. Clavulanic acid simply does not cause any useful antibacterial effect on clinically.

Common sensitive strains

Gram-Duong aerobic bacteria:

Enterococcus Faecalis.

Gardnerella Vaginalis.

staphylococcus aureus (methicillin sensitivity). Streptococcus Agalactiae. streptococcus pneumoniae.

streptococcus pyogenes and other beta hemolytic streptococcus.

Streptococcus Viridans.

Gram-nam aerobic bacteria:

capnocytophaga spp.

Eikenella Corrodens.

Haemophilus Influenzae.

Moraxella Catnrhalis.

Pasteurella Multocida.

Anaerobic bacteria:

bacteroides fragilis.

fusobacterium nucleatum.

Prevotella spp.

Anti -drug species

Gram-Duong aerobic bacteria:

Enterococcus Faecium.

Gram-nam aerobic bacteria:

Escherichia Coli.

klebsiella oxytoca.

klebsiella pneumoniae.

Proteus Mirabilis.

proteus vulgaris.

endogenous anti -drug bacteria

Gram-noodle aerobic bacteria:

acinetobacter sp.

citrobacter Freundii.

Enerobacter sp.

Legionella Pneumophila.

Morganella Morganii.

Providantia spp.

pseudomonas sp.

Serratia sp.

stenotrophomonas maltophilia.

Other bacteria:

chlamydophila pneumoniae.

chlamydophila psittaci.

Coxiella Burnetti.

mycoplasma pneumoniae.

Pharmacokinetic

absorption

amoxicillin and clavulanic acid are completely dissociated in water solutions in physiological pH. Both components are absorbed quickly and well by oral. After oral use, amoxicillin and clavulanic acid are about 70%. The plasma data of two components is similar and the time to reach the peak concentration in plasma (TMAX) is about 1 hour.

Distribution

about 25% clavulanic acid and 18% amoxicillin in plasma are linked to protein. The apparent distribution volume is about 0.3 - 0.4L/kg for amoxicillin and about 0.2/kg for clavulanic acid. After intravenous infusion, both amoxicillin and clavulanic acid are found in the gallbladder, abdominal tissue, skin, fat, muscle tissue, episodes and peritoneal fluid, bile and latex. Amoxicillin does not distribute well into cerebrospinal fluid.

From animal studies, there is no evidence that the metabolites of each drug component are removed significantly in tissue. Amoxicillin, like most penicillin, can be found in breast milk. A small amount of clavulanic acid can also be detected in breast milk (see the use of drugs for pregnant and lactating women). Both amoxicillin and clavulanic acid have been shown to be able to pass the placenta fence (see the use of drugs for pregnant and lactating women).

Metabolism

Amoxicillin excreted in part in the urine in the form of penicilloic acid that is not active in about 10-25% of the initial dose. Most Clavulanic acid is metabolized in humans, eliminated in urine and feces and in the form of carbon dioxid gases in exhaled gas.

Elimination

Amoxicillin is excreted the main kidney, while clavulanic acid is eliminated through the kidneys and even without the kidneys. The average selling time of amoxicillin/clavulanic acid is about an hour and the average total total clearance is approximately 25L/hour in healthy people. About 60 - 70% Amoxicillin and 40 - 65% Clavulanic acid are excreted in urine in the form of unchanged in the first 6 hours after using single doses of amoxicillin/clavulanic acid 250mg/125mg or 500mg/125mg.

Many studies show that the amount of excretion in urine is about 50 - 85% for amoxicillin and 27 - 60% for clavulanic acid for a 24 -hour period. In the case of clavulanic acid, a large amount of drugs are excreted for the first 2 hours after taking the drug. Simultaneous use with probenecid slowly excreting amoxicillin but does not slow down the excretion of clavulanic acid through the kidneys.

Age

Amoxicillin's waste time is similar to children from 3 months to 2 years old, older children and adults. For very young children (including premature babies) in the first week of birth, the dose distance must not exceed 2 times/day due to the incomplete renal elimination. Because kidney function can decrease in the elderly, be careful in choosing the dose and should monitor the kidney function.

Gender

After taking orally amoxicillin/acid clavulanic in men and healthy women, gender does not have a significant impact on pharmacokinetics of both amoxicillin and clavulanic acid.

kidney failure

The total serum clearance of amoxicillin/clavulanic acid decreases proportional to the degree of renal function. Amoxicillin's clearance is significantly reduced than clavulanic acid because amoxicillin is excreted through the kidney at a higher rate. Dosage in case of renal failure must be adjusted to prevent excessive accumulation of amoxicillin while maintaining sufficient amount of clavulanic acid.

Hepatic failure

Be cautious when prescribing patients with liver failure and need to monitor liver function periodically.

Before taking Curam Siro 250mg/5ml Sandoz to treat infections

How to use

oral drugs.

The drug is used with meals to minimize the ability to intolerine the gastrointestinal tract.

The treatment can be started with a summary of the product characteristics of the intravenous intravenous formula and continued with oral preparations.

Shake the bottle to make the dough, add water to the jar as instructed, reverse the jar and shake well.

Always shake the bottle carefully before use.

Dosage

The dose is shown through amoxicillin/clavulanic acid except for the case of the dose indicated as a single component.

Curam doses 250mg/5ml to treat a separate case of infection to take into account

Possible pathogens and their sensitivity to antibacterial drugs.

Severe and infection position.

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

The use of other forms of amoxicillin/clavulanic acid (for example, higher amoxicillin doses or different ratios between amoxicillin and clavulanic acid) should be considered when necessary.

For adults and children weighing over 40kg

Dosage 500mg/125mg, taken 3 times/day.

Curam formula 250mg/5ml offers a total dose of 1,500mg amoxicillin/375mg Clavulanic acid daily, when used as recommended.

For children weighing under 40kg, this formula provides a maximum dose of 2,400mg of amoxicillin/600mg Clavulanic acid daily, when used as recommended below. If it is found to use a higher daily daily amoxicillin, it is recommended to choose another preparation to avoid high doses of clavulanic acid daily.

Duration of treatment should be determined according to the patient's response. Some cases of bacterial infections (eg bone inflammation) need longer treatment time. The treatment process should not last more than 14 days without review.

Children weighing under 40kg

Dosage 20mg/5mg/kg/day to 60mg/15mg/kg/day, divided 3 times a day.

Children can be treated with amoxicillin/clavulanic acid tablets, chewing or packaging for children.

Children 6 years of age or less or weighing under 25kg should be treated with amoxicillin/clavulanic acid in the form of oral fluid or a package for children.

There is no clinical data available for amoxicillin/clavulanic acid (formula 4: 1) taller than 40mg/10mg/kg/day for children under 2 years old.

Elderly

No dose adjustment.

kidney failure

Maximum amoxicillin dose adjustment is recommended. No dose adjustment in patients with creatinine clearance (CLCR) greater than 30ml/min.

Adults and children ≥ 40kg

East clearance

Dosage

Clcr: 10 - 30ml/minute

500mg/125mg, 2 times/day CLCR 500mg/125mg, 1 time/day

dialysis 500mg/125mg every 24 hours, plus 500mg/125mg during dialysis, repeated at the end of the dialysis (because the blood concentration of both amoxicillin and clavulanic acid drops. 40kg

East clearance

Dosage CLCR: 10 - 30ml/min 15mg/3.75mg/kg, 2 times/day (maximum 500mg/2mg, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2, 2 Time/day).

To recover drug concentration during circulation, 15mg/3.75mg/kg should be used after dialysis.

Be cautious about dosage and monitor liver function evenly.

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 and signs of overdose

Expressions of overdose may be symptoms in the gastrointestinal tract and water and electrolyte disorders. The amoxicillin crystal has been observed, in some cases that can lead to renal failure (see the warning and caution when taking the drug).

Convulsions may occur in patients with renal failure or in cases of high doses.

There has been a report on Amoxicillin precipitating in the bladder catheter, mainly after high -dose intravenous infusion. Should maintain regular inspection of catheter (see the warning and caution when taking the drug).

How to handle

Symptoms of gastrointestinal tract can be treated as symptoms, should pay attention to water/electrolyte balance. Amoxicillin/Clavulanic acid can be removed from dialysis.

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 250mg/5ml, you may experience unwanted effects (ADR).

Unwanted effects are often reported as diarrhea, nausea and vomiting.

Unwanted effects are collected from clinical studies and reports after circulation of amoxicillin/clavulanic acid, arranged by MEDDRA's organs and listed below.

Infections and parasites

Common: Candida infection in the mucosa.

Unknown: The bacteria are not too sensitive to grow too much.

Blood disorders and lymphatic systems

Rare: Reducing white blood cells (including neutropenia), thrombocytopenia.

unknown: recovering leukocytes, hemolytic anemia, prolonged bleeding time and prothrombin time.

immune system disorders

Unknown: Neurological angio, anaphylaxis, serum disease syndrome, hypersensitivity vasculitis.

Nervous system disorders

Less: dizziness, headache.

Unknown: hyperactivity with recovery, convulsions, sterile meningitis.

Gastrointestinal disorders

Common: diarrhea, nausea, vomiting.

Uncommon: indigestion.

unknown: antibiotic colitis, black tongue, enamel color change.

Liver disorder

Uncommon: increase AST or ALT.

unknown: hepatitis, jaundice.

Skin disorders and subcutaneous tissues

Uncommon: skin rash, itching, urticaria.

rare: Diverse roses. Unknown: Stevens-Johnson syndrome, poisoned epidermal necrosis, flaking dermatitis, pustules syndrome (AGEP) and drug reactions with acidic hypernages and systemic symptoms (Dress).

Kidney and urinary disorders

Unknown: interstitial nephritis, urinary crystals.

Instructions on how to handle ADR

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

Curam medicine 250mg/5ml contraindicated in the following cases:

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

There is a history of severe hypersensitivity reaction (such as anaphylactic reaction) with any beta - lactam antibiotic (such as cephalosporin, carbapenem or monobactam).

There is a history of jaundice/liver failure due to amoxicillin/acid clavulanic.

Prisable when using

Before starting treatment with Curam 250mg/5ml, careful survey should be conducted with previous hypersensitivity reactions with peniclillin, cephalosporin or other beta -lactam antibiotics.

There have been reports on serious and sometimes fatal hypersensitivity cases (including anaphylactic reactions and serious harmful reactions on the skin) in patients treated with penicillin. These reactions often occur in patients with a history of hypersensitivity to penicillin and have allergies. If any allergic reaction occurs, CRAM 250mg/5ml must be stopped immediately and applied appropriate alternative treatments.

In the case of infection, it is shown that bacteria are sensitive to amoxicillin, the transfer from Curam 250mg/5ml to amoxicillin uses should be considered according to the official instructions. The presentation of Curam 250mg/5ml is not suitable for use when there is a high risk that the hypothetical pathogens have reduced sensitivity or resistance to the beta - lactam group without intermediaries Beta - Lactamase are inhibited by clavulanic acid. This form of presentation should not be used to treat pneumonia caused by S. Pneumoniae resistant to penicillin. Convulsions can occur in patients with renal failure or in patients with high doses.

Avoid using Curam 250mg/5ml if suspected of mononucleosis of the bacterial infection due to the appearance of measles rash after using amoxicillin.

Simultaneous use of allopurinol during treatment with amoxicillin may increase the risk of allergic reactions in the skin. Used for a long time can cause excessive growth of non -sensitive bacteria. The appearance of the whole body erythema combined with pustules at the beginning of treatment may be a symptom of the external pustules syndrome (AGEP).

If this reaction occurs, it is necessary to stop treating with Curam 250mg/5ml immediately and contraindicated with the use of amoxicillin. Curam 250mg/5ml should be used carefully in patients with evidence of liver function impairment.

The liver problems have been reported mainly in men and the elderly and may be related to prolonged treatment. These issues are rarely reported in children. In all groups, liver signs and symptoms usually occur during or immediately after treatment but in some cases it may appear several weeks after the end of treatment. They often recover themselves. Liver problems may also be heavy and in some rare deaths that have been reported. These cases mostly occur in patients with serious illness or use simultaneously known drugs that are at risk of liver toxicity.

Antibiotic -related colitis has been reported to most antibacterial drugs including amoxicillin and can be classified from mild to threatening. Therefore, it is important to consider this diagnosis in patients with diarrhea during or after antibiotic treatment. If colitis occurs related to antibiotics, stop Curam 250mg/5ml immediately, consult a doctor and start an appropriate therapy. Contraindicated drugs reduce bowel motility in this case.

The ability to drive and operate machinery

No research has been conducted on the effect of the drug on the ability to drive and operate machinery. However, unwanted reactions may occur (such as allergic reactions, dizziness, convulsions) and may affect the ability to drive and operate machinery.

Pregnancy

Animal research does not show direct or indirect effects on pregnancy, embryo/fetal development, childbirth or postpartum development. Restricted data in 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, there was a report that early treatment for rupture with amoxicillin/clavulanic acid may be associated with an increase in the risk of necrotizing bowelitis in infants. The use of drugs should be avoided during pregnancy, unless considered as necessary by the physician.

Breastfeeding period

Both substances are excreted through breast milk (the effect of clavulanic acid on infants who are breastfed are not known).

Therefore, diarrhea and fungal infections in the mucosa can occur in breastfeeding, may have to stop breastfeeding.

Sensitivity should be taken into account.

Amoxicillin/Clavulanic acid should only be used during breastfeeding after being considered the risk/benefit by the physician.

Medicinal interaction

Anticoagulant drugs for oral form

Penicillin antibiotics and antibiotics have been widely used in practice and there is no report on interaction. However, in the literature, there are international standardized ratios (INR) in patients maintaining the use of acenocoumarol or warfarin and are added amoxicillin. If simultaneous use is necessary, carefully monitor prothrombin or INR time when extra or stop using amoxicillin. In addition, adjusting the oral anticoagulant dose may be necessary.

methotrexate

Penicillin may reduce methotrexate secretion, which increases the risk of toxicity.

Probenecid

Do not recommend simultaneous use with Probenecid. Probenecid reduces amoxicillin secretion in the renal tubules. Simultaneous use with probenecid can cause increased and prolonged the concentration of amoxicillin in the blood but does not affect the level of clavulanic acid.

mycophenolat mofetil

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

Storage

Do not store drug bottles (powdered form for mixing mixture) above 30ºC. Store in the original packaging to avoid moisture.

Pre -phased phase mixed form must be stored in the refrigerator (2 ° - 8 ° C) and must be used within 7 days. After that, it is necessary to remove the leftover leftover.

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