Medication info
Birihepa Tablet (Tenofovir Disoproxil)

Birihepa Tablet (Tenofovir Disoproxil)

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

MFDS item code 201706562 · Approved 2017.08.11 · Insurance code 641606480

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. 2. Patients with renal impairment For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. In patients with mild renal impairment, no dose interval adjustment is necessary (creatinine clearance 50-80mL/min). Regularly monitor the estimated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dose interval adjustment based on creatinine clearance Creatinine clearance (mL/min)a Patients on hemodialysis ≥50 30-49 10-29 Recommended interval for taking 1 tablet Every 24 hours Every 48 hours Every 72-96 hours Every 7 days or approximately 12 hours after hemodialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance <10mL/min who are not receiving hemodialysis; therefore, no dosage 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. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to provide dosage recommendations for pediatric patients with renal impairment.

Ingredients

Manufacturer
Daewoong 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 medication is used in adults and children over 12 years of age to treat HIV-1 infection in combination with other antiretroviral agents. In particular, this medication should not be taken with other drugs that contain tenofovir. It is also used for the treatment of chronic hepatitis B, in which case the patient's condition must be monitored closely. In summary, this medication is 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. 2. Patients with renal impairment For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. In patients with mild renal impairment, no dose interval adjustment is necessary (creatinine clearance 50-80mL/min). Regularly monitor the estimated creatinine clearance and serum phosphate (see Warning 3). Table 1. Dose interval adjustment based on creatinine clearance Creatinine clearance (mL/min)a Patients on hemodialysis ≥50 30-49 10-29 Recommended interval for taking 1 tablet Every 24 hours Every 48 hours Every 72-96 hours Every 7 days or approximately 12 hours after hemodialysisb a. Calculated using ideal (lean) body weight. b. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with creatinine clearance <10mL/min who are not receiving hemodialysis; therefore, no dosage 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. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to provide dosage recommendations for pediatric patients with renal impairment.

Precautions

This medication can lead to a rapid worsening of hepatitis if treatment is suddenly stopped, so it should be continued according to the healthcare provider's instructions. Patients with allergies to any components of this medication or individuals with certain genetic disorders such as lactose intolerance should not take it. This medication is mainly excreted through the kidneys, so patients with impaired kidney function should undergo kidney function tests before taking it, and kidney status should be monitored regularly during treatment. Care must be taken when taking this medication with other drugs that affect the kidneys, and in particular, the combination with certain antiviral medications is prohibited. This medication can affect bone health, so patients at risk for osteoporosis or fractures should consider bone density testing, and if they experience pain in bones or muscles, they should consult their doctor immediately. As it contains sulfite, it may cause allergic reactions or asthma attacks in some patients, so asthmatic patients should take particular care. Mild side effects such as diarrhea, headache, and nausea may occur during treatment; if symptoms worsen, the healthcare provider should be informed. It can be used during pregnancy, but pregnant individuals should consult a doctor before taking it, and breastfeeding is not recommended while on this medication. The safety and efficacy of this medication in children and the elderly have limited data, so consultation with a specialist is necessary before taking it. In case of overdose, seek medical attention immediately for appropriate treatment, and some drugs may be removed through hemodialysis. This medication should be stored at room temperature and kept out of reach of children. Finally, during the course of taking this medication, weight, blood sugar, and blood lipid levels should be monitored regularly, and if any abnormalities occur, appropriate management should be conducted.

Side effects

  • worsening of hepatitis
  • hypersensitivity
  • acute kidney failure
  • Fanconi syndrome
  • hypophosphatemia
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular dysfunction
Show 103 more
  • sulfite anaphylaxis
  • asthma attack
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • abdominal pain
  • lumbago
  • gagging
  • vomiting
  • dyspepsia
  • lipid accumulation disorder
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • appetite loss
  • abdominal distension
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • weight loss
  • pneumonia
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute tubular necrosis
  • interstitial nephritis
  • renal failure
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • 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
  • convulsions
  • cholelithiasis
  • liver cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • liver fibrosis
  • hand fracture
  • fever-induced neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • nail ingrowth
  • urticaria
  • myofibrosis
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urinary stones
  • dysuria
  • renal cysts
  • ureteral calculi
  • anemia
  • splenomegaly
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper airway cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • oculomotor disorders
  • conjunctival congestion
  • benign prostatic hyperplasia

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, avoid storing it in excessively hot or cold places, and it is recommended to store it at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Light 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.