Medication info
Bailif Tablets (Tenofovir Disoproxil)

Bailif Tablets (Tenofovir Disoproxil)

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Disoproxil›245mg / 1 tablet
Manufacturer / importer
Hanwha Pharmaceutical Co., Ltd.
Appearance
Light blue almond-shaped film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201706565 · Approved 2017.08.11 · Insurance code 651602270

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 once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment In patients with baseline creatinine clearance <50mL/min, adjust the dosing interval according to Table 1. No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); routinely monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. This medicine 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 recommendations 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 once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Safety and efficacy have not been established in pediatric patients with chronic hepatitis B weighing less than 35kg. No data are available to support dose recommendations for pediatric patients with renal impairment.

Ingredients

Manufacturer
Hanwha Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of chronic hepatitis B and HIV-1 infection

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

This drug is used for the treatment of HIV-1 infection in adults and children over 12 years old, and is administered in combination with other antiretroviral agents. It is also used for the treatment of chronic hepatitis B in adults and children over 12 years old. However, it is important not to take this drug with other combination products containing tenofovir, and to follow general precautions when treating chronic hepatitis B. This drug is safely and effectively used 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 once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. Patients with renal impairment In patients with baseline creatinine clearance <50mL/min, adjust the dosing interval according to Table 1. No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min); routinely monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dosing interval adjustment according to creatinine clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. This medicine 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 recommendations 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 once daily (equivalent to 245mg of tenofovir disoproxil). It may be taken with or without food. Safety and efficacy have not been established in pediatric patients with chronic hepatitis B weighing less than 35kg. No data are available to support dose recommendations for pediatric patients with renal impairment.

Precautions

This drug may cause a sudden exacerbation of hepatitis if treatment is stopped, therefore regular examinations must be conducted for several months after discontinuation. Do not take this drug if you are allergic to its components or have certain hereditary lactose metabolism disorders. It is prohibited to use this drug in conjunction with other medications containing the same ingredient or specific drugs, so consultation with a physician is mandatory. Patients with impaired kidney function should undergo a kidney function test before taking this drug and regularly check their kidney function during treatment. Caution is necessary when used with other medications that can burden the kidneys, particularly non-steroidal anti-inflammatory drugs (NSAIDs) should not be used in combination. Bone health may be affected, so patients with low bone density or at risk for osteoporosis should consider bone density testing according to their doctor's instructions. This drug contains sulfite components and may cause allergic reactions or asthma symptoms, so those with a history of sulfite allergy should use caution. It can be used during pregnancy, but should be taken under medical supervision when necessary, and breastfeeding is not recommended as the medication can be passed through breast milk. The safety and efficacy of this drug have not been sufficiently established in children under 12 years of age or those weighing less than 35 kg. Elderly patients may have decreased liver or kidney function, so caution is needed during use. In case of overdose, contact a medical institution immediately for appropriate treatment, and some components of this drug can be removed through dialysis. This drug should be stored at room temperature, and kept safely out of reach of children.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • renal impairment
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • muscle weakness
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  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • abdominal pain
  • low back pain
  • dyspepsia
  • vomiting
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • loss of appetite
  • abdominal distension
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • sweating
  • weight loss
  • pneumonia
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • hypophosphatemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • elevated liver enzymes
  • rhabdomyolysis
  • osteomalacia
  • acute tubular necrosis
  • proximal tubular dysfunction
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • vomiting
  • ascites
  • abdominal distension
  • urinary tract infection
  • gastroenteritis
  • shingles
  • septic shock
  • worsening condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • flank pain
  • sensory loss
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • liver failure
  • liver fibrosis
  • hand fracture
  • fever-induced neutropenia
  • leukopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • ingrowing toenails
  • urticaria
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureteral calculi
  • anemia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular motility disorders
  • conjunctival injection
  • benign prostatic hyperplasia

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

Storage

This drug may be sensitive to air and moisture, so it must be stored in a closed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's efficacy and safety for a long time.

Appearance and packaging

Appearance

Light blue almond-shaped film-coated tablets

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.