Medication info
BIRIBA Tablets (Tenofovir Disoproxil Fumarate)

BIRIBA Tablets (Tenofovir Disoproxil Fumarate)

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

MFDS item code 201802720 · Approved 2018.06.29 · Insurance code 641606640

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 a baseline creatinine clearance of <50mL/min: For a creatinine clearance of 30-49mL/min, take 300mg every 48 hours; for 10-29mL/min, take 300mg every 72-96 hours; for patients receiving hemodialysis, take 300mg every 7 days or approximately 12 hours after completion of a total dialysis session. Assuming 3 hemodialysis sessions of approximately 4 hours each per week, administer once weekly. This medicine should be administered after dialysis is completed. Patients with mild renal impairment: No adjustment to the dosing interval of this medicine is necessary for a creatinine clearance of 50-80mL/min. Regularly monitor the estimated creatinine clearance, serum phosphate, urine glucose, and urine protein. There are no dosing guidelines for patients with a creatinine clearance below 10mL/min who are not receiving hemodialysis.
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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dose recommendations.

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 for the treatment of HIV-1 infection in combination with other antiretroviral agents, and it should not be taken with combination products containing tenofovir. It is also used for the treatment of chronic hepatitis B and is intended for children over 12 years of age and adults. General precautions must be strictly followed when treating chronic hepatitis B. This medication is used for the treatment of both 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 a baseline creatinine clearance of <50mL/min: For a creatinine clearance of 30-49mL/min, take 300mg every 48 hours; for 10-29mL/min, take 300mg every 72-96 hours; for patients receiving hemodialysis, take 300mg every 7 days or approximately 12 hours after completion of a total dialysis session. Assuming 3 hemodialysis sessions of approximately 4 hours each per week, administer once weekly. This medicine should be administered after dialysis is completed. Patients with mild renal impairment: No adjustment to the dosing interval of this medicine is necessary for a creatinine clearance of 50-80mL/min. Regularly monitor the estimated creatinine clearance, serum phosphate, urine glucose, and urine protein. There are no dosing guidelines for patients with a creatinine clearance below 10mL/min who are not receiving hemodialysis.

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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support dose recommendations.

Precautions

Discontinuing this medication may lead to a rapid deterioration of hepatitis, so regular liver condition tests should be performed for several months after stopping treatment. Patients with allergies to any ingredient contained in this medication or those with a genetic lactose intolerance should not take it. This medication should not be taken with certain other drugs, so it is essential to consult a physician if other medications are being taken. Patients with reduced kidney function should undergo kidney function tests before taking this medication, and kidney status should be monitored regularly during treatment. This medication may affect bone health, so patients with osteoporosis or a risk of fractures should consider bone density testing and take calcium and vitamin D supplements if necessary. If unusual pain or muscle weakness occurs during treatment, medical professionals should be notified immediately. During pregnancy, this medication should only be used when absolutely necessary, and it is advisable for breastfeeding mothers to avoid breastfeeding while taking this medication. Use is recommended only for patients over 12 years of age or weighing more than 35kg; safety and efficacy have not been established for younger patients or those weighing less than this. Elderly patients should be cautious about taking this medication due to the potential for reduced kidney and liver function. In case of overdose, immediate medical assistance should be sought, and if necessary, blood dialysis can be performed to remove this medication. This medication should be stored at room temperature and kept safe from children's access.

Side effects

  • Worsening hepatitis
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • kidney impairment
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal renal tubular disease
Show 117 more
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • vomiting
  • indigestion
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety disorder
  • pneumonia
  • fever
  • abdominal pain
  • low back pain
  • loss of appetite
  • abdominal distention
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • weight loss
  • pneumonia
  • pancreatitis
  • increased amylase
  • fatty liver
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • muscle diseases
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • rash reaction
  • lipomatosis
  • insomnia
  • sleep disorders
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • urinary tract infection
  • gastroenteritis
  • herpes zoster
  • septic shock
  • worsening condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • flank pain
  • sensory impairment
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • convulsions
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • hepatic fibrosis
  • hand fracture
  • fever-induced neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • onychocryptosis
  • urticaria
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • dementia
  • confusion
  • gallbladder disease
  • cholecystitis
  • missed drug dosage
  • foreign body
  • humeral fracture
  • ligament sprain
  • sleep disorders
  • bladder dysfunction
  • urinary stones
  • dysuria
  • renal cyst
  • ureteral calculosis
  • anemia
  • splenomegaly
  • decreased appetite
  • eating disorder
  • cough
  • rhinitis
  • upper respiratory 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 medication should be stored in a tightly sealed container to protect it from air and moisture, and it is recommended to keep it at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pale blue almond-shaped film-coated tablets

Package unit

30 tablets per 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.