Medication info
Donggu Cephalexin Hydrate Capsule

Donggu Cephalexin Hydrate Capsule

Prescription medicationHard capsule경구
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
(주)동구바이오제약
Appearance
A hard capsule with purple upper and white lower parts containing a pale yellow powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 200401463 · Notified 2004.01.20 · Insurance code 657300660

Summary

Main use
Treatment of otitis media, respiratory infections (such as pneumonia and pharyngitis), and urinary tract infections (such as pyelonephritis and cystitis).
Who takes it
Adults · Children
Adult dose
As cephalexin hydrate, administer 250mg (potency) every 8 hours orally. For severe infections (such as pneumonia) and infections with low susceptibility, the dosage may be doubled. In cases of acute gonococcal urethritis, administer 3g of this drug combined with 1g of probenecid as a single dose. In patients with kidney impairment, the dosage can be administered without changes. Treatment of beta-hemolytic streptococcus infections should be continued for at least 10 days.
Child dose
Administer 20mg (potency) per Kg of body weight divided every 8 hours. In cases of severe infections, otitis media, and infections with low susceptibility, 40mg (potency) per Kg can be administered with a maximum dose of 1.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment of otitis media, respiratory infections (such as pneumonia and pharyngitis), and urinary tract infections (such as pyelonephritis and cystitis).

  • Otitis media
  • pneumonia
  • pharyngitis
  • tonsillitis
  • bronchitis
  • pyelonephritis
  • cystitis
  • gonococcal urethritis
  • abscesses
  • furuncles
  • folliculitis
  • soft tissue infections
View approved original text

This medication is effective against various bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, and Escherichia coli. It is particularly used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis. It is also effective against urogenital infections such as pyelonephritis, cystitis, and gonococcal urethritis. Additionally, it is used for the treatment of skin abscesses, furuncles, folliculitis, soft tissue infections, infectious necrosis, subcutaneous abscesses, bite wounds, and wound infections. It is widely used for the treatment of various types of infectious diseases.

How to take

Adult dose

As cephalexin hydrate, administer 250mg (potency) every 8 hours orally. For severe infections (such as pneumonia) and infections with low susceptibility, the dosage may be doubled. In cases of acute gonococcal urethritis, administer 3g of this drug combined with 1g of probenecid as a single dose. In patients with kidney impairment, the dosage can be administered without changes. Treatment of beta-hemolytic streptococcus infections should be continued for at least 10 days.

Child dose

Administer 20mg (potency) per Kg of body weight divided every 8 hours. In cases of severe infections, otitis media, and infections with low susceptibility, 40mg (potency) per Kg can be administered with a maximum dose of 1.

Precautions

This drug works by binding to certain proteins, disrupting the synthesis of the bacterial cell wall, and killing bacteria. This medication should not be used in patients who have experienced severe allergic reactions or shock from this drug or similar classes of antibiotics in the past. Patients who are allergic to penicillin antibiotics or those with a predisposition to allergic reactions such as bronchial asthma, skin rashes, or hives should be administered with caution. In patients with severely impaired kidney function, those who have difficulty taking this medication orally, elderly patients, or those in poor overall health, vitamin K deficiency symptoms may appear, and their condition should be closely monitored. Patients with a history of gastrointestinal diseases, especially colitis, also need to be cautious. During the administration of this drug, serious allergic reactions such as shock or anaphylaxis can occur rarely; if symptoms arise, the administration should be stopped immediately, and appropriate treatment should be sought. Skin reactions such as severe rashes, blistering, or mucosal damage leading to Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so unusual symptoms should be monitored closely. Blood tests may indicate agranulocytosis, anemia, thrombocytopenia, or other hematological abnormalities, necessitating regular checks, and should the abnormalities be discovered, administration must cease. Liver function abnormalities or renal function declines may occur; therefore, liver and kidney statuses should be periodically assessed, and the use of the drug discontinued if abnormalities arise. Severe colitis may occur rarely in the gastrointestinal tract; if abdominal pain or diarrhea worsens, the drug should be discontinued immediately. In the respiratory system, rare interstitial pneumonia or pulmonary infiltration may occur; if symptoms of dyspnea arise, treatment should be stopped and appropriate medical care obtained. In the central nervous system, symptoms such as anxiety, insomnia, confusion, dizziness, or hallucinations may occur occasionally, warranting caution. Signs of dysbiosis, such as stomatitis or candidiasis, may occur rarely. Vitamin K and B vitamin deficiencies may develop; therefore, nutritional status should be properly managed during long-term use. To prevent resistance, it is advisable to conduct susceptibility testing and only administer for the necessary duration. Interactions may occur when used with other medications, particularly nephrotoxic drugs, anticoagulants, or oral contraceptives, thus requiring caution. Women who are pregnant or breastfeeding should use this drug only with caution, as its safety has not been fully established. In newborns, particularly in infants under 1 month old, the safety and efficacy of this drug have not been sufficiently demonstrated, so its use should be avoided. Elderly patients may experience adverse reactions more easily due to diminished bodily functions, thus dosage and intervals should be adjusted carefully. Care should be taken as this drug may affect certain urine tests or blood tests.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • dyspnea
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • shock
  • anaphylaxis
  • interstitial pneumonia
  • eosinophilic pulmonary infiltration
  • jaundice
Show 4 more
  • acute renal failure
  • severe colitis
  • thunderclap headache
  • seizure.

Mild side effects

  • Generalized flushing
  • angioedema
  • paresthesia
  • syncope
  • hypertension
  • vasodilation
  • rash
  • erythema
  • pruritus
  • fever
Show 20 more
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reactions
  • agranulocytosis
  • granulocytopenia
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytopenia
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • temporary hepatitis
  • and elevated AST
  • ALT
  • ALP
  • BUN
  • serum creatinine.

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

Storage

This drug may be sensitive to air and moisture and should be stored in a tightly closed container. Maintaining a storage temperature between 1 and 30 degrees Celsius is recommended. This way, the effectiveness of the medication can be safely preserved.

Appearance and packaging

Appearance

A hard capsule with purple upper and white lower parts containing a pale yellow powder.

Package unit

30 capsules/bottle, 300 capsules/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.

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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.