Medication info

Azidomine Capsule (Zidovudine)

Prescription medicationExpired
Ingredient · strength
Zidovudine›Strength being verified
Manufacturer / importer
Aprogen Biologics Co., Ltd.
Appearance
This is a hard capsule containing a fine white powder, both upper and lower parts being white.
Packaging
30 capsules/bottle, 60 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle, 500 capsules/bottle
Approval status
Expired

MFDS item code 198800284 · Notified 1988.09.30

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of HIV infection (AIDS, related syndromes, and early-stage and asymptomatic infection)
Who uses it
Adults
Adult dosage
Adults: Administer 500~600 mg daily in 2~6 divided doses in combination with other antiretroviral agents. Patients with hematologic toxicity: If hemoglobin decreases to less than 7.5 g/dL or by more than 25% from baseline, indicating severe anemia, or if the granulocyte count is less than 750/㎣ or decreases by more than 50% from baseline, indicating severe neutropenia, discontinue the dose until bone marrow recovery is confirmed. Once bone marrow recovery occurs, the dose may need to be adjusted according to the patient's tolerability and hematologic parameters, such as erythropoietin levels. Patients with renal impairment: Limited data indicate that plasma concentrations of this medicine do not increase significantly in patients with impaired renal function; therefore, adjustment of the initial dose is not specifically necessary. However, glucuronide metabolites may accumulate in patients with impaired renal function, and the effects of this accumulation are unknown. Monitor plasma concentrations of zidovudine (and its glucuronide metabolites) together with hematologic parameters to determine the need for ongoing dose adjustment. A dose of 100 mg every 6~8 hours is recommended for patients receiving hemodialysis or peritoneal dialysis. Patients with hepatic impairment: Limited data in patients with cirrhosis indicate that this medicine may accumulate in patients with impaired hepatic function because glucuronide conjugation is reduced. Dose adjustment may be necessary, but precise guidelines have not been established. If monitoring of plasma zidovudine concentrations is not possible, the attending physician should pay particular attention to signs of intolerance and may need to appropriately extend the dosing interval.

Ingredients

Manufacturer
Aprogen Biologics Co., Ltd.

Efficacy & effects

Treatment of HIV infection (AIDS, related syndromes, and early-stage and asymptomatic infection)

  • Acquired Immunodeficiency Syndrome
  • AIDS-related syndrome
  • HIV infection
  • decreased CD4 lymphocyte count
  • asymptomatic HIV infection
View approved original text

This medication is used for the treatment of HIV-infected individuals with Acquired Immunodeficiency Syndrome (AIDS) and AIDS-related syndromes. It is also effectively applied to early symptom patients with CD4 lymphocyte counts below 500 cells/mm² and asymptomatic HIV-infected adult patients with CD4 counts of 200 or lower or rapidly decreasing from 500 to 200. In other words, this drug helps improve immunodeficiency caused by HIV and prevent the progression of symptoms, enhancing the patient's quality of life through safe and effective treatment.

Dosage and Administration

Adult dosage

Adults: Administer 500~600 mg daily in 2~6 divided doses in combination with other antiretroviral agents. Patients with hematologic toxicity: If hemoglobin decreases to less than 7.5 g/dL or by more than 25% from baseline, indicating severe anemia, or if the granulocyte count is less than 750/㎣ or decreases by more than 50% from baseline, indicating severe neutropenia, discontinue the dose until bone marrow recovery is confirmed. Once bone marrow recovery occurs, the dose may need to be adjusted according to the patient's tolerability and hematologic parameters, such as erythropoietin levels. Patients with renal impairment: Limited data indicate that plasma concentrations of this medicine do not increase significantly in patients with impaired renal function; therefore, adjustment of the initial dose is not specifically necessary. However, glucuronide metabolites may accumulate in patients with impaired renal function, and the effects of this accumulation are unknown. Monitor plasma concentrations of zidovudine (and its glucuronide metabolites) together with hematologic parameters to determine the need for ongoing dose adjustment. A dose of 100 mg every 6~8 hours is recommended for patients receiving hemodialysis or peritoneal dialysis. Patients with hepatic impairment: Limited data in patients with cirrhosis indicate that this medicine may accumulate in patients with impaired hepatic function because glucuronide conjugation is reduced. Dose adjustment may be necessary, but precise guidelines have not been established. If monitoring of plasma zidovudine concentrations is not possible, the attending physician should pay particular attention to signs of intolerance and may need to appropriately extend the dosing interval.

Precautions

This drug may cause hematological toxicity, such as bone marrow suppression leading to decreased white blood cell count and severe anemia, so the patient's condition should be carefully monitored, and regular blood tests should be conducted. Caution is required as symptomatic myopathy, which can cause abnormalities in the muscles, may occur with long-term use. If used in conjunction with other antiretroviral agents, severe side effects such as lactic acidosis and significant hepatomegaly may occur, so it must be used according to the physician's instructions. This drug should not be used in patients with very low neutrophil counts or low hemoglobin levels, patients allergic to this drug or its components, and in severely impaired liver function in newborns. Patients taking ibuprofen should also avoid co-administration as it may increase bleeding risk. Caution should be exercised when using this drug in patients with slightly low neutrophil or hemoglobin counts, impaired kidney or liver function, patients with vitamin B12 deficiency, and in elderly patients due to the heightened drug concentration resulting from decreased kidney function. Various hematological adverse reactions such as anemia, leukopenia, and thrombocytopenia may occur with this drug, so regular blood tests and appropriate measures are needed if abnormal signs are detected. Multiple general and local side effects such as headaches, fatigue, myalgia, indigestion, rashes, insomnia, and dyspnea may occur; healthcare providers should be consulted if symptoms arise. In case of suspected severe lactic acidosis or liver toxicity, immediate discontinuation of this medication is required, and professional treatment is necessary. When purchasing medication from other hospitals or pharmacies during treatment with this drug, the healthcare provider must be informed, and potential interactions should be confirmed. Women who are pregnant or breastfeeding should use this drug with caution, especially as breastfeeding can seriously affect the baby and should be avoided. The safety in pediatric patients has not been sufficiently established, so it should only be used when absolutely necessary, and elderly patients need to be cautious due to the potential for increased drug concentration from impaired kidney function. In cases of overdose, even without special symptoms, a medical evaluation is necessary, and this drug cannot be effectively removed by hemodialysis or peritoneal dialysis. Some studies have reported potential genotoxicity, so it must be used with caution, particularly in patients at risk for liver disease.

Side effects

  • Aplastic anemia
  • erythrocyte aplasia
  • pancytopenia
  • anemia
  • leukopenia
  • neutropenia
  • thrombocytopenia
  • red cell aplastic anemia
  • lymphadenopathy
  • headache
Show 85 more
  • weakness
  • cold
  • cold symptoms
  • back pain
  • chest pain
  • fatigue
  • redistribution of body fat
  • increased serum lipids
  • increased blood glucose
  • malaise
  • fever
  • loss of appetite
  • abdominal pain
  • nausea
  • dyspepsia
  • dysphagia
  • lip swelling
  • tongue swelling
  • belching
  • gum bleeding
  • rectal bleeding
  • oral ulcers
  • gastritis
  • diarrhea
  • vomiting
  • constipation
  • abdominal bloating
  • acne
  • rash
  • itching
  • urticaria
  • anaphylactic reaction
  • myalgia
  • arthralgia
  • insomnia
  • numbness of hands and feet
  • anxiety
  • sensory disturbances
  • confusion
  • muscle cramping
  • tremor
  • twitching
  • hyperalgesia
  • depressed mood
  • emotional instability
  • neuroexcitation
  • syncope
  • forgetfulness
  • visual impairment
  • hoarseness
  • stress reaction
  • feeling of spaciousness
  • dizziness
  • drowsiness
  • difficulty breathing
  • cough
  • nosebleed
  • pharyngitis
  • rhinitis
  • sinusitis
  • anuria
  • polyuria
  • frequency
  • urination disorders
  • renal failure
  • hepatomegaly
  • cirrhosis
  • abnormal liver function tests
  • hemolytic anemia
  • severe hepatomegaly with steatosis
  • vasodilation
  • cardiomyopathy
  • congestive heart failure
  • vasculitis
  • sweating
  • change in body odor
  • pigmentation of nails
  • skin
  • and oral mucosa
  • taste disturbances
  • amblyopia
  • hearing loss
  • photophobia
  • seeing blurred as if through fog
  • gynecomastia

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

Storage

This medication should be stored in a container protected from light and kept at room temperature between 15 to 25 degrees Celsius to maintain its effectiveness over time.

Appearance and packaging

Appearance

This is a hard capsule containing a fine white powder, both upper and lower parts being white.

Package unit

30 capsules/bottle, 60 capsules/bottle, 100 capsules/bottle, 300 capsules/bottle, 500 capsules/bottle

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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.