Medication info
Sephae Capsule (Cephalexin Hydrate)

Sephae Capsule (Cephalexin Hydrate)

Prescription medicationHard capsuleApproval withdrawn
Ingredient · strength
Cefaclor Hydrate›250mg / 1 capsule
Manufacturer / importer
풍림무약(주)
Appearance
A hard capsule with a blue opaque upper part and a white opaque lower part filled with a light yellow powder.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201603693 · Approved 2016.06.21

This product's status changed to Approval withdrawn on 2025.12.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of otitis media, respiratory infections (pneumonia, pharyngitis, etc.), and urinary tract infections (pyelonephritis, cystitis, etc.)
Who uses it
Adults · Children
Adult dosage
Administer 250 mg (potency) of Cephalexin Hydrate orally every 8 hours. In cases of severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, this drug 3 g and probenecid 1 g should be administered together as a single dose.
Children's dosage
Administer 20 mg/kg (potency) divided every 8 hours per day. For severe infections, otitis media, and infections with low susceptibility, 40 mg/kg (potency) can be administered per day, with a maximum dose of

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

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

  • Otitis media
  • pneumonia
  • pharyngitis
  • tonsillitis
  • bronchitis
  • pyelonephritis
  • cystitis
  • gonococcal urethritis
  • boils
  • abscesses
  • folliculitis
  • cellulitis
View approved original text

This medication is effective against various bacteria such as Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella, and Neisseria gonorrhoeae. It is used for respiratory infections such as otitis media, pneumonia, pharyngitis, tonsillitis, and bronchitis, as well as urinary tract infections such as pyelonephritis, cystitis, and gonococcal urethritis. Additionally, it is effective for treating skin and soft tissue infections such as boils, abscesses, folliculitis, cellulitis, infectious gangrene, subcutaneous abscesses, infected wounds, and wound infections. It is utilized in the treatment of various bacterial infections and is used to improve infection symptoms and support quick recovery.

Dosage and Administration

Adult dosage

Administer 250 mg (potency) of Cephalexin Hydrate orally every 8 hours. In cases of severe infections (such as pneumonia) and infections with low susceptibility, the dose may be doubled. For acute gonococcal urethritis, this drug 3 g and probenecid 1 g should be administered together as a single dose.

Children's dosage

Administer 20 mg/kg (potency) divided every 8 hours per day. For severe infections, otitis media, and infections with low susceptibility, 40 mg/kg (potency) can be administered per day, with a maximum dose of

Precautions

This drug is an antibiotic that kills bacteria by binding to certain proteins and interfering with bacterial cell wall synthesis. This drug should not be given to patients who have experienced a shock reaction from previous use of this drug or who are allergic to this drug or cephalosporin antibiotics. It also contains lactose, so it should not be used in patients with lactose intolerance or galactose metabolism disorders. Caution should be exercised in patients with known allergies to penicillin antibiotics or those who frequently exhibit allergic symptoms such as asthma, rashes, or hives. Patients with severely impaired kidney function, those who cannot take orally, elderly patients, or patients in poor overall condition may show symptoms of vitamin K deficiency and should be closely monitored. Patients with a past history of gastrointestinal disease, especially colitis, should also take caution. Rarely, severe allergic reactions such as shock or anaphylaxis may occur with this drug, so symptoms should be carefully monitored and the drug should be discontinued immediately if any abnormalities are observed. There may be serious skin reactions such as severe rashes or toxic epidermal necrolysis, so caution is warranted. Various abnormal reactions such as changes in blood cell counts, liver dysfunction, and kidney dysfunction may occur, necessitating regular testing. Severe intestinal symptoms like pseudomembranous colitis may also arise, so abdominal pain or diarrhea should be reported immediately. Respiratory symptoms or central nervous system abnormalities may rarely occur and should be carefully observed. Fungal infections such as stomatitis or candidiasis can occur with this drug's use. Symptoms of vitamin K and B deficiencies may rarely arise, so patients should be alert to symptoms. To prevent the development of resistant bacteria, it is important to administer this drug only for the minimum duration necessary. Interaction may occur if used with other antibiotics, so consultation with a physician or pharmacist is recommended. The safety of this drug during pregnancy has not been established, so it should only be used when necessary; nursing mothers should use it cautiously as it may affect the infant. There is insufficient safety data for neonates, particularly those under 1 month old, thus caution is advised for their use. The elderly may exhibit unusual reactions more easily due to weakened body functions; therefore, dosage and administration intervals should be adjusted accordingly, and their condition closely monitored. This medication may cause false-positive results in some urine tests, requiring careful interpretation of test results.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling
  • difficulty breathing
  • shock
  • symptoms of anaphylaxis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • hepatitis
  • jaundice
  • acute renal failure
Show 8 more
  • severe colitis
  • asthma
  • respiratory distress
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory problems
  • liver abnormalities
  • severe swelling or urination issues

Mild side effects

  • Generalized flushing
  • angioedema
  • sensory disturbances
  • syncope
  • hypertension
  • vasodilation
  • rash
  • erythema
  • itching
  • fever
Show 19 more
  • lymphadenopathy
  • arthralgia
  • serum sickness-like reaction
  • agranulocytosis
  • granulocytopenia
  • pancytopenia
  • anemia
  • thrombocytopenia
  • eosinophilia
  • lymphocytosis
  • leukopenia
  • aplastic anemia
  • hemolytic anemia
  • reversible neutropenia
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated BUN
  • elevated serum creatinine

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

Storage

This medication is sensitive to light, so it should be stored in a container that does not allow light to enter. Additionally, it is important to maintain room temperature between 1°C and 30°C when storing the medication. This helps to safely preserve the drug's effectiveness.

Appearance and packaging

Appearance

A hard capsule with a blue opaque upper part and a white opaque lower part filled with a light 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.