Medication info

Amocra Dry Syrup (Amoxicillin and Clavulanate Potassium (7:1))

Prescription medicationSyrup경구
Ingredient · strength
Amoxicillin Hydrate›36.326g / 100gDilute Potassium Clavulanate›10.352g / 100g
Manufacturer / importer
건일바이오팜주식회사
Appearance
A white or slightly yellow powder that is dissolved to make a syrup.
Packaging
50mL (5.5057g) / bottle
Approval status
Active

MFDS item code 201802108 · Notified 2018.05.18 · Insurance code 073000301

Summary

Main use
(Respiratory, Urinary) Treatment of infections
Who takes it
Adults · Children
Adult dose
In the case of recurrent tonsillitis and other upper respiratory infections, lower respiratory infections, urinary tract infections, and mild to moderate skin and soft tissue infections, the dosage is 25 mg of amoxicillin and 3.6 mg of clavulanate potassium per kg of body weight, divided into two doses per day. For severe infections such as otitis media, sinusitis, and bronchopneumonia, the dosage is 45 mg of amoxicillin and 6.4 mg of clavulanate potassium per kg of body weight.
Child dose
The 7:1 syrup is not suitable for children under 2 months of age. The 7:1 syrup is also not suitable for pediatric patients with renal failure.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

(Respiratory, Urinary) Treatment of infections

  • Acute and chronic bronchitis
  • lobar pneumonia and bronchopneumonia
  • empyema
  • lung abscess
  • tonsillitis
  • sinusitis
  • otitis media
  • cystitis
  • urethritis
  • pyelonephritis
  • pelvic infections
  • gonorrhea
View approved original text

This medication is used to treat various types of bacterial infections. It is primarily effective against respiratory infections such as acute and chronic bronchitis, pneumonia, tonsillitis, sinusitis, and otitis media. It can also be used to treat urinary tract infections like cystitis, urethritis, and pyelonephritis. It is suitable for treating pelvic infections, sexually transmitted diseases such as gonorrhea, as well as abscesses, pyogenic infections, soft tissue infections, and wound infections. Moreover, it is used for osteomyelitis and dental infections, thereby improving various tissue infections. This medicine exerts a broad antimicrobial effect against diverse bacteria, aiding in the treatment of infections.

How to take

Adult dose

In the case of recurrent tonsillitis and other upper respiratory infections, lower respiratory infections, urinary tract infections, and mild to moderate skin and soft tissue infections, the dosage is 25 mg of amoxicillin and 3.6 mg of clavulanate potassium per kg of body weight, divided into two doses per day. For severe infections such as otitis media, sinusitis, and bronchopneumonia, the dosage is 45 mg of amoxicillin and 6.4 mg of clavulanate potassium per kg of body weight.

Child dose

The 7:1 syrup is not suitable for children under 2 months of age. The 7:1 syrup is also not suitable for pediatric patients with renal failure.

Precautions

This medication is a beta-lactam antibiotic, and should not be used by patients with a history of allergic reactions or hypersensitivity to penicillins or cephalosporins. In particular, in patients with viral infections such as infectious mononucleosis or lymphocytic leukemia, the risk of rash is increased and administration should be avoided. Patients who have previously experienced jaundice or liver dysfunction due to this medication or penicillin should not use it due to the risk of recurrence. It contains lactose, so patients with genetic metabolic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid taking this medication. Patients with impaired liver function should use it cautiously as there is a risk of liver function deterioration, and those with moderate to severe renal impairment may have elevated plasma drug levels and may need dosage adjustments. Those with a history of allergies, patients on parenteral nutrition, elderly individuals, and those with poor overall health should exercise caution as well. Gastrointestinal symptoms such as diarrhea, vomiting, and abdominal pain may occur, and in severe cases, serious conditions like colitis may arise, so if any unusual symptoms occur, drug discontinuation is necessary. Liver dysfunction has also been reported, and symptoms of hepatitis or jaundice may occur, hence regular liver function tests are advisable. Skin rashes, itching, and rarely severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if a rash develops, use should be discontinued immediately. Blood tests may reveal leukopenia, thrombocytopenia, or hemolytic anemia, thus periodic blood testing is required. Symptoms of central nervous system disturbances such as restlessness, anxiety, drowsiness, and seizures may occur rarely; consult healthcare professionals if these symptoms appear. This medication may affect the intestinal flora, potentially reducing the effectiveness of oral contraceptives, so women who are using contraception should be cautious. It should be avoided during the first trimester of pregnancy, and women who are pregnant or breastfeeding should consult a doctor before taking it. Safety in children, especially in newborns under two months or premature infants, has not been established, so caution is needed. Elderly individuals may experience adverse reactions more easily due to decreased bodily functions; thus, dosage and administration intervals should be adjusted and monitored. This medication should be stored in a dry place below 25 degrees Celsius and refrigerated after preparation, to be used within 7 days. In case of overdose, gastrointestinal symptoms, kidney damage, convulsions, etc. may occur, so immediate medical attention is needed. Before using this medication, it is essential to confirm any history of allergy to penicillin or cephalosporin drugs, and during use, it is necessary to closely monitor for any adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe allergic reactions, high fever with severe rash, blisters, skin peeling, pain in the mouth/eye mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, hepatic abnormalities (jaundice), sudden and very severe reactions.

Mild side effects

Diarrhea, colitis, indigestion, stomatitis, gastritis, glossitis, black hairy tongue, nausea, vomiting, loss of appetite, abdominal pain, bloating, constipation, colonic pain, hyperacidity, loose stools, dry mouth, acute pancreatitis, candidiasis, antibiotic-induced colitis, hepatitis, elevation of AST, ALT, ALP, LDH, serum bilirubin, skin itching, erythema multiforme, angioedema, serum sickness-like syndrome, hypersensitivity vasculitis, acute generalized exanthematous pustulosis.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to store it in a cool, dry place below 25 degrees Celsius.

Appearance and packaging

Appearance

A white or slightly yellow powder that is dissolved to make a syrup.

Package unit

50mL (5.5057g) / bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.