Medication info

Omacef Capsule 100 mg (Cefdinir Hydrate)

Prescription medicationHard capsuleOralApproval withdrawn
Ingredient · strength
Cefdinir Monohydrate›100mg / 1 capsule
Manufacturer / importer
JW Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a pink upper part and pink lower part containing white to light yellow granules.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 200711286 · Notified 2007.10.11

This product's status changed to Approval withdrawn on 2023.12.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory and ear, nose, and throat, skin and soft tissue, eye, dental, and genitourinary infections
Who takes it
Adults
Adult dose
Adults: Administer cefdinir 100 mg (potency) per dose orally 3 times daily. For patients on hemodialysis, administration of 100 mg (potency) once daily is preferred. Adjust the dose appropriately according to symptoms.

Ingredients

Manufacturer
JW Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory and ear, nose, and throat, skin and soft tissue, eye, dental, and genitourinary infections

  • Lymphangitis
  • abscess
  • chronic suppurative dermatitis
  • mastitis
  • perianal abscess
  • superficial secondary infections of trauma and surgical wounds
  • pharyngitis
  • acute bronchitis
  • tonsillitis
  • pneumonia
  • pyelonephritis
  • cystitis
View approved original text

This medication is effective against various bacterial strains causing diverse bacterial infections. It is used for skin and soft tissue infections such as lymphangitis and chronic suppurative dermatitis, and is also beneficial for treating superficial secondary infections of mastitis and wound sites. Additionally, it is effective against respiratory infections such as pharyngitis, acute bronchitis, tonsillitis, and pneumonia, as well as urinary tract infections like pyelonephritis and cystitis. It can also be utilized for female reproductive infections such as adnexitis and intrauterine infections, as well as the treatment of otitis media, sinusitis, periodontal disease, and cellulitis. Thus, it acts effectively for various infections, aiding in infection treatment.

How to take

Adult dose

Adults: Administer cefdinir 100 mg (potency) per dose orally 3 times daily. For patients on hemodialysis, administration of 100 mg (potency) once daily is preferred. Adjust the dose appropriately according to symptoms.

Precautions

This medication should not be used by patients who have previously experienced shock due to this medication or who have shown allergic reactions to this medication or its components, as well as to cefem antibiotics. Patients with a history of allergy to penicillin antibiotics should use this medication with caution due to the possibility of cross-allergic reactions between this medication and penicillin antibiotics. Additionally, patients with a history of asthma, rash, hives, or other allergic symptoms, severely impaired kidney function, patients who have difficulty in oral intake, patients in poor condition, elderly patients, and those with a previous history of colitis should exercise caution when using this medication. This medication can rarely cause severe side effects such as shock, anaphylaxis, serious skin diseases, blood abnormalities, pseudomembranous colitis, pneumonia, renal failure, and hepatitis, so any abnormal symptoms that occur during use should be immediately reported to a physician. Relatively common side effects such as diarrhea, vomiting, abdominal pain, skin rash, and itching may occur, so close monitoring is essential. When using this medication, it is important to check the susceptibility of the causative bacteria to prevent the emergence of resistant strains and to use it only for the necessary duration. To reduce the possibility of hypersensitivity reactions, it is recommended to conduct a thorough medical history and skin reaction tests beforehand. If an allergic reaction occurs, administration should be stopped immediately, and appropriate treatment should be received. This medication can alter the normal balance of gut flora, potentially leading to colitis, so if abdominal pain or diarrhea worsens, it should be discussed with healthcare personnel immediately. There may be interactions with other drugs such as iron supplements, antacids, and warfarin, necessitating adjustments to dosing time or careful administration. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this medication. In the case of children or infants, the safety of this medication has not been fully established, and caution in use is required. Elderly patients may experience side effects more easily due to decreased bodily function, so dosage and administration intervals should be adjusted, and they should be closely monitored. In cases of overdose, symptoms such as vomiting, diarrhea, and seizures may occur, and in patients with impaired kidney function, this medication can be removed via hemodialysis. This medication may affect the results of certain clinical tests, so this should be communicated to healthcare personnel during testing. When storing, keep out of the reach of children, avoiding humidity and direct sunlight. Lastly, during the use of this medication, urine may turn red, so please take note of this as well.

Side effects

  • Shock
  • oral dysesthesia
  • wheezing
  • dizziness
  • changes in stool
  • tinnitus
  • sweating
  • dyspnea
  • generalized flushing
  • angioedema
Show 63 more
  • urticaria
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • fever
  • headache
  • arthralgia
  • erythema on skin or mucous membranes
  • blisters
  • skin tension
  • burning sensation
  • pain
  • pancytopenia
  • agranulocytosis
  • pharyngodynia
  • malaise
  • thrombocytopenia
  • petechiae
  • purpura
  • hemolytic anemia
  • hemoglobinuria
  • symptoms of anemia
  • membranous colitis
  • bloody stool
  • abdominal pain
  • frequent diarrhea
  • cough
  • chest X-ray abnormalities
  • eosinophilia
  • interstitial pneumonia
  • PIE syndrome
  • acute renal failure
  • acute hepatitis
  • liver dysfunction
  • jaundice
  • erythema
  • rash
  • itching
  • edema
  • eosinophilia
  • granulocytopenia
  • elevated BUN
  • diarrhea
  • discomfort in the upper abdomen
  • nausea
  • vomiting
  • heartburn
  • loss of appetite
  • constipation
  • candidiasis
  • oral thrush
  • black hairy tongue
  • stomatitis
  • symptoms of vitamin K deficiency
  • hypoprothrombinemia
  • bleeding tendency
  • symptoms of vitamin B complex deficiency
  • glossitis
  • neuritis
  • paralysis
  • headache
  • dizziness
  • chest tightness

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The appropriate storage temperature is room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

A hard capsule with a pink upper part and pink lower part containing white to light yellow granules.

Package unit

30 capsules/bottle, 100 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.

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.