Medication info
Tenofovir Disoproxil Fumarate Tablet

Tenofovir Disoproxil Fumarate Tablet

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

MFDS item code 201706586 · Approved 2017.08.14 · Insurance code 653805260

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. For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval for this medicine with reference to Table 1. Creatinine clearance 50-80mL/min: No adjustment to the dosing interval for this medicine is necessary. Creatinine clearance (mL/min) ≥50: Recommended 300mg dosing interval: every 24 hours Creatinine clearance (mL/min) 30-49: Recommended 300mg dosing interval: every 48 hours Creatinine clearance (mL/min) 10-29: Recommended 300mg dosing interval: every 72-96 hours Patients on hemodialysis: Recommended 300mg dosing interval: every 7 days or approximately 12 hours after completion of dialysis In general, administer once weekly, 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 or 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 weighing less than 35kg with chronic hepatitis B: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support a dose recommendation.

Ingredients

Manufacturer
Shinil 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 for the treatment of HIV-1 infection in adults and children over 12 years of age, usually in combination with other antiretroviral drugs. However, it should not be taken together with other combination products containing tenofovir. It is also used for the treatment of chronic hepatitis B in adults and children over 12 years old. When treating chronic hepatitis B, standard precautions must be strictly adhered to. This medication helps effectively in 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. For patients with baseline creatinine clearance <50mL/min, adjust the dosing interval for this medicine with reference to Table 1. Creatinine clearance 50-80mL/min: No adjustment to the dosing interval for this medicine is necessary. Creatinine clearance (mL/min) ≥50: Recommended 300mg dosing interval: every 24 hours Creatinine clearance (mL/min) 30-49: Recommended 300mg dosing interval: every 48 hours Creatinine clearance (mL/min) 10-29: Recommended 300mg dosing interval: every 72-96 hours Patients on hemodialysis: Recommended 300mg dosing interval: every 7 days or approximately 12 hours after completion of dialysis In general, administer once weekly, 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 or 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 weighing less than 35kg with chronic hepatitis B: Safety and efficacy have not been established. Pediatric patients with renal impairment: There are no data to support a dose recommendation.

Precautions

This medication is an antiviral agent used for the treatment of chronic hepatitis B and HIV-1 infection. Abruptly stopping this medication can lead to a rapid deterioration of hepatitis, so continued monitoring is necessary for several months after therapy ceases. Patients with a history of allergy to this medication or specific genetic disorders such as lactose intolerance should not take it. Additionally, this medication should not be taken with other drugs containing tenofovir or adefovir. Patients with impaired or worsening kidney function should have their kidney function monitored regularly before and during the use of this medication, and dosing intervals should be adjusted based on kidney function. It is advisable to avoid taking it with nonsteroidal anti-inflammatory drugs (NSAIDs), which can place additional burden on the kidneys. This medication may have side effects associated with reduced bone density; thus, patients with a risk of fractures or osteoporosis should consider bone density testing. If pain in the bones or muscles persists during treatment, consult a doctor immediately. This medication can cause various side effects; common symptoms include headache, diarrhea, nausea, rash, and depression. It is relatively safe to use during pregnancy; however, it must be used under the direction of a physician during pregnancy. Breastfeeding mothers are advised to avoid breastfeeding while taking this medication. The safety and efficacy have not been established for children under 12 years or those weighing less than 35 kg. Caution is required for elderly patients over 65 years due to the potential for liver and kidney function decline. In the event of an overdose, seek immediate medical care for appropriate treatment and monitoring, as this medication can be removed by hemodialysis. Store this medication at room temperature away from direct sunlight and ensure it is kept out of reach of children.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • tubular myopathy
Show 128 more
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • weakness
  • nausea
  • dizziness
  • abdominal pain
  • low back pain
  • indigestion
  • vomiting
  • lipomatosis
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • sweating
  • anorexia
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • weight loss
  • pneumonia
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • weakness
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • abdominal pain
  • hepatitis
  • rash
  • osteomalacia
  • muscle weakness
  • acute renal failure
  • renal failure
  • elevated serum creatinine
  • progression of liver disease
  • hepatitis flare
  • indigestion
  • constipation
  • gastroesophageal reflux disease
  • vomiting
  • ascites
  • abdominal distension
  • urinary tract infection
  • gastroenteritis
  • shingles
  • pneumonia
  • septic shock
  • weakness
  • worsening condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • arthralgia
  • flank pain
  • sensory loss
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • liver fibrosis
  • hand fracture
  • fever-induced neutropenia
  • leukopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • ingrown toenails
  • urticaria
  • myofascial pain
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • dementia
  • confusion
  • cholecystitis
  • hepatic cyst
  • liver neoplasm
  • skin papilloma
  • sleep disorder
  • bladder dysfunction
  • urinary stones
  • dysuria
  • renal cyst
  • ureteral calculi
  • anemia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorder
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • 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 medication may be sensitive to air and moisture, thus should be stored in a tightly sealed container. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help retain the medication's efficacy for a longer period.

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.