Medication info

Famgenciclovir Disoproxil Fumarate Tablet

Prescription medicationTabletOralExpired
Ingredient · strength
Tenofovir Disoproxil Fumarate›300mg / 1 tablet
Manufacturer / importer
Pangenscience Co., Ltd.
Appearance
Pale blue almond-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201907755 · Approved 2019.11.05

This product's status changed to Expired on 2024.11.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
Adult dose
Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300mg) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this drug according to Table 1. No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a ≥50: Recommended 300mg dosing interval: every 24 hours Creatinine clearance (mL/min)a 30-49: Recommended 300mg dosing interval: every 48 hours Creatinine clearance (mL/min)a 10-29: Recommended 300mg dosing interval: every 72-96 hours Patients on hemodialysis: Recommended 300mg dosing interval: every 7 days or after a total of approximately 12 hours of dialysisb b. Assuming hemodialysis for approximately 4 hours 3 times weekly, administer once weekly. This drug should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing guidelines are available for these patients.
Child dose
Pediatric patients aged 12 years and older (35kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300mg) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. The safety and efficacy of this drug have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

Ingredients

Manufacturer
Pangenscience Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B and HIV-1 infection

  • HIV-1 infection
  • chronic Hepatitis B
View approved original text

This medication is used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 and older. However, it should not be taken with combination products containing tenofovir. Additionally, it is used for treatment purposes in adults and children aged 12 and older with chronic Hepatitis B. General precautions regarding usage must be considered when treating chronic Hepatitis B. This drug is effective for the treatment of HIV-1 infection and chronic Hepatitis B.

How to take

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300mg) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval of this drug according to Table 1. No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a ≥50: Recommended 300mg dosing interval: every 24 hours Creatinine clearance (mL/min)a 30-49: Recommended 300mg dosing interval: every 48 hours Creatinine clearance (mL/min)a 10-29: Recommended 300mg dosing interval: every 72-96 hours Patients on hemodialysis: Recommended 300mg dosing interval: every 7 days or after a total of approximately 12 hours of dialysisb b. Assuming hemodialysis for approximately 4 hours 3 times weekly, administer once weekly. This drug should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing guidelines are available for these patients.

Child dose

Pediatric patients aged 12 years and older (35kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (300mg) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. The safety and efficacy of this drug have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

Precautions

This drug is an antiviral medication used to treat Hepatitis B virus infection. Sudden discontinuation of this medication may lead to severe exacerbation of hepatitis, so regular liver function tests should be conducted for several months after treatment cessation. Patients with allergies to this drug or its components, those with certain genetic disorders, and those taking other medications containing similar components should not use it. Patients with reduced kidney function or a history of kidney problems should regularly test kidney function before and during the use of this drug and may need to adjust the dosing interval as necessary. This drug should not be used in combination with other specific antiviral agents, and patients who are co-infected with HIV and Hepatitis B should use appropriate combination therapies as directed by a specialist. Long-term use may decrease bone density, so patients at risk of osteoporosis or fractures should consider bone density testing, and calcium and vitamin D supplementation may be beneficial. Side effects such as nausea, diarrhea, headache, rash, and fatigue may occur while taking this drug, and if severe symptoms arise, immediate consultation with a doctor is advised. Pregnant women may use this drug if necessary, but should consult with a doctor before use, and breastfeeding mothers are advised to avoid breastfeeding while taking this medication. This medication may interact with other drugs that can affect kidney function, so if other medications are being taken, it is essential to inform healthcare providers. In case of overdose, immediate medical attention should be sought, and some components may be removed through blood dialysis. This drug has not been established for safety and efficacy in children, particularly those under 12 years of age or weighing less than 35 kg, thus caution is advised. Elderly patients over 65 years old should be careful when taking this drug, considering the potential decline of liver and kidney function.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • renal impairment
  • bone pain
  • limb pain
  • fractures
  • muscle pain
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  • muscle weakness
  • dizziness
  • diarrhea
  • nausea
  • headache
  • pain
  • depression
  • asthenia
  • vomiting
  • dyspepsia
  • rash
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • abdominal pain
  • low back pain
  • lipomatosis
  • arthralgia
  • myalgia
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • fatigue
  • nausea
  • abdominal distension
  • appetite loss
  • chest pain
  • sweating
  • weight loss
  • elevated serum creatinine
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • proximal tubular acidosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • proteinuria
  • polyuria
  • allergic reaction
  • osteomalacia
  • osteoporosis
  • sensory disturbance
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • liver fibrosis
  • hand fracture
  • fever with neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • onychocryptosis
  • urticaria
  • myofascial pain
  • disc herniation
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureterolithiasis
  • anemia
  • splenomegaly
  • appetite decrease
  • eating disorders
  • cough
  • rhinitis
  • upper airway cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular movement disorders
  • ocular congestion
  • benign prostatic hyperplasia

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

Storage

This drug should be stored in a sealed container protected from air or moisture. Additionally, it is safest to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale blue almond-shaped film-coated tablet

Package unit

30 tablets/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.