Medication info
Tenofovir Disoproxil Fumarate Tablet

Tenofovir Disoproxil Fumarate Tablet

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Disoproxil Hemiedisylate›289.86mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Pale blue almond-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201707356 · Approved 2017.09.29 · Insurance code 657806110

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 For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. Creatinine clearance (mL/min)a ≥50: Every 24 hours Creatinine clearance (mL/min)a 30-49: Every 48 hours Creatinine clearance (mL/min)a 10-29: Every 72-96 hours Patients on hemodialysis: Every 7 days or approximately 12 hours after dialysisb No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min). a. Calculated using ideal (lean body) weight. b. Administer once weekly, assuming hemodialysis sessions of approximately 4 hours each, 3 times 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 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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to recommend a dose.

Ingredients

Manufacturer
Hana 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 drugs. However, it is important not to take it in combination with other fixed-dose combinations containing tenofovir. It is also used for patients with chronic hepatitis B, in which case general precautions must be adhered to at the start of treatment. This drug is effectively used for the treatment of two major infectious diseases.

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 For patients with a baseline creatinine clearance of <50mL/min, adjust the dosing interval of this medicine with reference to Table 1. Creatinine clearance (mL/min)a ≥50: Every 24 hours Creatinine clearance (mL/min)a 30-49: Every 48 hours Creatinine clearance (mL/min)a 10-29: Every 72-96 hours Patients on hemodialysis: Every 7 days or approximately 12 hours after dialysisb No adjustment of the dosing interval is necessary in patients with mild renal impairment (creatinine clearance 50-80mL/min). a. Calculated using ideal (lean body) weight. b. Administer once weekly, assuming hemodialysis sessions of approximately 4 hours each, 3 times 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 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. Pediatric patients with chronic hepatitis B weighing less than 35kg: Safety and efficacy have not been established. Pediatric patients with renal impairment: No data are available to recommend a dose.

Precautions

This medication can severely worsen hepatitis if treatment is stopped, so the liver condition must be monitored closely under medical supervision even after discontinuing treatment. Patients who are allergic to any of the ingredients in this drug or have certain genetic lactose-related disorders should not use it. This drug can affect kidney function, so patients with kidney disease or impaired kidney function must consult their physician before taking it and should have regular kidney function tests during treatment. Interactions may occur when taken with certain other medications, so if you are taking other medications, be sure to inform and consult your doctor or pharmacist. This drug can impact bone health, so patients at risk of osteoporosis or fractures should regularly undergo bone density tests and may need to take calcium and vitamin D supplements. Women who are pregnant or planning to become pregnant must consult their physician about the use of this drug, and breastfeeding should be avoided while on this medication. Pediatric patients under 12 years of age or weighing less than 35 kg have restricted use as safety and efficacy have not been sufficiently established. Elderly patients should use caution as there may be decreased liver, kidney, and heart function, and dosage adjustments or further testing may be necessary. In case of overdose, medical attention should be sought immediately, and this drug can be partially removed through hemodialysis. This medication should be stored in a tightly closed container away from air and moisture, at room temperature between 1 to 30 degrees Celsius, to maintain its efficacy.

Side effects

  • worsening of hepatitis
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular dysfunction
  • rash
Show 106 more
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • vomiting
  • dyspepsia
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • abdominal pain
  • back pain
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • anorexia
  • abdominal distension
  • sweating
  • weight loss
  • pneumonia
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • muscle disease
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • dyspepsia
  • 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
  • spinal pain
  • sensory loss
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic dysfunction
  • hepatic fibrosis
  • hand fracture
  • febrile neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • alopecia
  • erythema multiforme
  • sialadenitis
  • onychocryptosis
  • urticaria
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urinary stones
  • dysuria
  • kidney cyst
  • ureteral calculi
  • anemia
  • splenomegaly
  • hypertension
  • conjunctival hemorrhage
  • ocular motility disorder
  • 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 tightly closed container to protect from air or moisture, preferably at room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the drug can be maintained for a long time.

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.