Medication info
Tenowon Tablet (Tenofovir Disoproxil)

Tenowon Tablet (Tenofovir Disoproxil)

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

MFDS item code 201706551 · Approved 2017.08.11 · Insurance code 641906690

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
Adult dose
2. Patients with Renal Impairment Drug exposure increased significantly when this drug was administered to patients with moderate to severe renal impairment. Therefore, in patients with a baseline creatinine clearance of <50mL/min, the dosing interval for this drug should be adjusted according to Table 1. These dosing interval adjustment recommendations are based on a model of single-dose pharmacokinetic data from patients with various degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. Since the safety and efficacy of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, renal function and clinical response to treatment should be closely monitored in these patients (see Warning 3). No dosing interval adjustment is necessary for patients with mild renal impairment (creatinine clearance 50-80mL/min), and calculated creatinine clearance and serum phosphorus should be monitored regularly (see Warning 3). Table 1 Dosing Interval Adjustment According to Creatinine Clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Hemodialysis patients: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. This drug should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with a creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.
Child dose
Adults and pediatric patients 12 years of age and older (35kg or more): Take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil) for the treatment of HIV-1 or chronic hepatitis B. 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 dosage recommendations.

Ingredients

Manufacturer
Boryung 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 agents for the treatment of HIV-1 infection in adults and children aged 12 years and older. It is also effective for the treatment of chronic hepatitis B and can be used in patients aged 12 and older. However, caution must be exercised regarding usage precautions when starting treatment for chronic hepatitis B. It is important not to take this medication with combination formulations that include tenofovir. Overall, this medication is used for the treatment of HIV-1 infection and chronic hepatitis B.

How to take

Adult dose

2. Patients with Renal Impairment Drug exposure increased significantly when this drug was administered to patients with moderate to severe renal impairment. Therefore, in patients with a baseline creatinine clearance of <50mL/min, the dosing interval for this drug should be adjusted according to Table 1. These dosing interval adjustment recommendations are based on a model of single-dose pharmacokinetic data from patients with various degrees of renal impairment, including patients with end-stage renal disease requiring hemodialysis, who were not infected with HIV or HBV. Since the safety and efficacy of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate or severe renal impairment, renal function and clinical response to treatment should be closely monitored in these patients (see Warning 3). No dosing interval adjustment is necessary for patients with mild renal impairment (creatinine clearance 50-80mL/min), and calculated creatinine clearance and serum phosphorus should be monitored regularly (see Warning 3). Table 1 Dosing Interval Adjustment According to Creatinine Clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Hemodialysis patients: every 7 days or approximately 12 hours after dialysisb a. Calculated using ideal (lean body) weight. b. Administer once weekly, generally assuming 3 hemodialysis sessions of approximately 4 hours each per week. This drug should be administered after dialysis is completed. The pharmacokinetics of tenofovir have not been evaluated in patients with a creatinine clearance below 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Child dose

Adults and pediatric patients 12 years of age and older (35kg or more): Take 1 tablet once daily (equivalent to 245mg of tenofovir disoproxil) for the treatment of HIV-1 or chronic hepatitis B. 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 dosage recommendations.

Precautions

This medication may cause sudden worsening of hepatitis if treatment is discontinued; therefore, regular check-ups at the hospital are necessary for several months after stopping treatment. This medication should not be taken by individuals allergic to this product or its ingredients. Patients with lactose intolerance or certain genetic disorders should not take this medication due to the lactose it contains. This medication should not be taken with other medications containing tenofovir, and the risk of side effects may increase when combined with certain drugs. Patients with impaired kidney function should undergo kidney function tests before taking this medication and should regularly check their kidney condition during treatment. Caution is needed when taking this medication with drugs that can strain the kidneys, and in some cases, the dosing interval of this medication may need to be adjusted. This medication may affect bone health, so patients with low bone density or a risk of fractures should consult their physician before taking it. If persistent or worsening pain occurs in bones or muscles, immediate medical attention should be sought. This product contains sulfites, so individuals allergic to sulfites should exercise caution. During treatment, side effects such as headache, diarrhea, nausea, rash, and fatigue may occur; if symptoms are severe, consult a physician. Women who are pregnant or planning to become pregnant should consult their doctor before taking this medication and should only take it during pregnancy when absolutely necessary. Nursing women are advised to avoid breastfeeding as this medication can be transmitted through breast milk. Children under 12 years of age or weighing less than 35 kg should not use this medication, as safety and efficacy have not been established for this population. Elderly patients over 65 years should be cautious due to the potential for decreased kidney and liver function. In case of overdose, seek immediate medical attention for appropriate treatment, and blood dialysis can remove this medication from the body. This medication should be stored at room temperature, and kept out of reach of children. When combined with other medications, there may be potential drug interactions, so it is essential to inform healthcare providers, especially regarding drugs that affect kidney function.

Side effects

  • Hepatitis aggravation
  • hypersensitivity
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular dysfunction
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  • sulfite anaphylaxis
  • asthma attack
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • fatigue
  • nausea
  • dizziness
  • abdominal pain
  • back pain
  • dyspepsia
  • vomiting
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • rash reaction
  • fatigue
  • sinusitis
  • upper respiratory infection
  • nasopharyngitis
  • dizziness
  • appetite loss
  • abdominal distension
  • chest pain
  • weight loss
  • pneumonia
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • fatigue
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • urinary tract infection
  • gastroenteritis
  • shingles
  • septic shock
  • deterioration of condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • flank pain
  • sensory decrease
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizure
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic insufficiency
  • hepatic fibrosis
  • hand fracture
  • febrile neutropenia
  • leukopenia
  • thrombocytopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • onychocryptosis
  • urticaria
  • myofascial pain
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureteral stone disease
  • anemia
  • splenomegaly
  • appetite decrease
  • eating disorder
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • oculomotor dysfunction
  • conjunctival injection
  • 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 prevent air and moisture from entering, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

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.