Medication info
Tenorid Tablets (Tenofovir Disoproxil)

Tenorid Tablets (Tenofovir Disoproxil)

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

MFDS item code 201706559 · Approved 2017.08.11 · Insurance code 647804560

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. 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 ≥50: 1 tablet every 24 hours 30-49: 1 tablet every 48 hours 10-29: 1 tablet every 72-96 hours Patients on hemodialysis: 1 tablet every 7 days or approximately 12 hours after hemodialysisb 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. Pediatric patients with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established.

Ingredients

Manufacturer
Samjin 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 combination with other antiretroviral drugs to treat HIV-1 infection in adults and children aged 12 years or older. It is also effective in the treatment of chronic hepatitis B in adults and children aged 12 years or older. However, when starting treatment for chronic hepatitis B, careful consideration of precautions is necessary. Furthermore, this medication should not be taken with tenofovir-containing combination products, and it must be used only after consulting with a healthcare professional. This efficacy effectively treats 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. 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 ≥50: 1 tablet every 24 hours 30-49: 1 tablet every 48 hours 10-29: 1 tablet every 72-96 hours Patients on hemodialysis: 1 tablet every 7 days or approximately 12 hours after hemodialysisb 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. Pediatric patients with chronic hepatitis B who weigh less than 35kg: Safety and efficacy have not been established.

Precautions

This medication can severely worsen hepatitis upon discontinuation, so it is essential to monitor liver function closely for an extended period after stopping treatment. Patients with allergies to any of the ingredients in this medication or those with specific hereditary lactose intolerance should not use it. It should not be taken with other drugs that have similar components or certain specific drugs, especially for patients with compromised kidney function who should use it with caution. Patients with kidney impairment should adjust the dosing intervals and frequently monitor their kidney condition. Special caution is necessary when taking this medication with other drugs that may affect kidney function. Given that this drug may affect bone health, patients with bone pain or a risk of fractures should regularly check their bone condition. Because it contains sodium bisulfite, some patients may experience allergic reactions or asthma symptoms, so those with hypersensitivity should exercise caution. It can be relatively safely used during pregnancy, but it should be used only when necessary, and breastfeeding should be avoided. The safety and efficacy in children under 12 years old or weighing less than 35 kg have not been established. Elderly patients should take care when using this medication, considering the possibility of liver and kidney function decline. In case of overdose, immediately inform a healthcare professional, and if necessary, the drug can be removed through hemodialysis. This medication should be stored at room temperature and kept in a secure place out of reach of children. During treatment, regularly check weight, blood sugar, and lipid levels, and if any unusual symptoms appear, consult a doctor immediately. There may be drug interactions with this medication, so if other medications are being taken, please inform a healthcare professional.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • tubular injury
  • bone pain
  • limb pain
  • fractures
  • muscle pain
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  • muscle weakness
  • sulfite anaphylaxis
  • asthma attack
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • abdominal pain
  • low back pain
  • dyspepsia
  • vomiting
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety disorder
  • pneumonia
  • rash reaction
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • dizziness
  • nausea
  • vomiting
  • loss of appetite
  • abdominal distension
  • sweating
  • weight loss
  • chest pain
  • pneumonia
  • urticaria
  • rhabdomyolysis
  • osteomalacia
  • muscular disorders
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • allergic reactions
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • hepatic steatosis
  • hepatitis
  • elevated liver enzymes
  • 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 deficit
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic failure
  • hepatic fibrosis
  • hand fractures
  • febrile neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • alopecia
  • erythema multiforme
  • sialadenitis
  • onychocryptosis
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cysts
  • ureterolithiasis
  • anemia
  • splenomegaly
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular motility disorders
  • 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 or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps to keep the drug’s efficacy and safety intact for a long time.

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.