Medication info
Hepalod Tablet (Tenofovir Disoproxil)

Hepalod Tablet (Tenofovir Disoproxil)

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

MFDS item code 201805211 · Approved 2018.12.21 · Insurance code 650205010

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
Adult dose
Adults Take 1 tablet (equivalent to 245mg of tenofovir disoproxil) once daily for the treatment of HIV-1 or chronic hepatitis B. 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 according to Table 1. Creatinine clearance 50-80mL/min: No adjustment of the dosing interval is necessary; regularly monitor calculated creatinine clearance and serum phosphorus. Creatinine clearance ≥50mL/min: 1 tablet every 24 hours Creatinine clearance 30-49mL/min: 1 tablet every 48 hours Creatinine clearance 10-29mL/min: 1 tablet every 72-96 hours Patients on hemodialysis: 1 tablet every 7 days or approximately 12 hours after dialysis. Assuming hemodialysis is performed 3 times weekly for approximately 4 hours per session, administer once weekly. 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
Children 12 years of age and older (35kg or more) Take 1 tablet (equivalent to 245mg of tenofovir disoproxil) once daily for the treatment of HIV-1 or chronic hepatitis B. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. 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 support dosage recommendations.

Ingredients

Manufacturer
AhnGuk Pharmaceuticals 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 the age of 12 in combination with other antiretroviral agents for the treatment of HIV-1 infection. However, it should not be taken with other combination products that contain tenofovir. It is also effective for the treatment of chronic hepatitis B, which applies to patients aged 12 and older. Common precautions should be carefully considered prior to starting treatment. This medication is used for the treatment of HIV-1 infection and chronic hepatitis B.

How to take

Adult dose

Adults Take 1 tablet (equivalent to 245mg of tenofovir disoproxil) once daily for the treatment of HIV-1 or chronic hepatitis B. 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 according to Table 1. Creatinine clearance 50-80mL/min: No adjustment of the dosing interval is necessary; regularly monitor calculated creatinine clearance and serum phosphorus. Creatinine clearance ≥50mL/min: 1 tablet every 24 hours Creatinine clearance 30-49mL/min: 1 tablet every 48 hours Creatinine clearance 10-29mL/min: 1 tablet every 72-96 hours Patients on hemodialysis: 1 tablet every 7 days or approximately 12 hours after dialysis. Assuming hemodialysis is performed 3 times weekly for approximately 4 hours per session, administer once weekly. 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

Children 12 years of age and older (35kg or more) Take 1 tablet (equivalent to 245mg of tenofovir disoproxil) once daily for the treatment of HIV-1 or chronic hepatitis B. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. 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 support dosage recommendations.

Precautions

This medication is an antiviral drug used for the treatment of hepatitis B. Sudden discontinuation of treatment may worsen hepatitis, so regular liver monitoring must continue for several months after stopping. Patients allergic to this medication or with specific genetic issues such as lactose intolerance should not take it. Also, this medication should not be taken with certain other antiviral agents, as serious side effects may occur with co-administration. Patients with poor kidney function must frequently monitor renal function before and during usage, and if renal function declines significantly, the dosing interval should be adjusted. Caution is needed when taken with other drugs that may burden the kidneys, and alternative treatments should be considered if necessary. It can also affect bone health, so bone density monitoring may be necessary, and immediate consultation with a physician is advised if there is pain in bones or muscles. This medication contains sodium bisulfite, which may cause allergic reactions or asthma symptoms in some patients. During treatment, side effects such as headache, diarrhea, nausea, fatigue, and depression may occur, and severe abnormal symptoms should be reported to healthcare providers immediately. It can generally be used safely during pregnancy, but medical consultation is necessary when administered during pregnancy. Nursing mothers are advised to avoid breastfeeding while taking this medication. Use in children under the age of 12 or weighing less than 35 kg is not recommended due to the lack of established safety and effectiveness. Elderly patients or those with reduced kidney function should exercise particular caution when taking this medication, and dose adjustment may be necessary. In case of overdose, seek medical attention immediately as appropriate treatment should be administered, and blood dialysis may remove the drug. This medication should be stored away from direct sunlight and kept at room temperature, out of reach of children.

Side effects

  • Worsening of hepatitis
  • hypersensitivity
  • acute kidney failure
  • Fanconi syndrome
  • renal impairment
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular syndrome
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  • sulfite anaphylaxis
  • asthma attack
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • myasthenia
  • nausea
  • dizziness
  • abdominal pain
  • back pain
  • dyspepsia
  • vomiting
  • fatty liver
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • loss of appetite
  • abdominal distension
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • weight loss
  • pneumonia
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute kidney failure
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • proteinuria
  • polyuria
  • myasthenia
  • allergic reaction
  • angioedema
  • lactic acidosis
  • hypokalemia
  • hypophosphatemia
  • dyspnea
  • pancreatitis
  • increased amylase
  • abdominal pain
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • osteomalacia
  • fractures
  • muscle weakness
  • myopathy
  • acute kidney failure
  • kidney failure
  • acute tubular necrosis
  • Fanconi syndrome
  • proximal tubular syndrome
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • kidney failure
  • increased creatinine
  • proteinuria
  • polyuria
  • myasthenia
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • vomiting
  • ascites
  • abdominal distension
  • urinary tract infection
  • gastroenteritis
  • shingles
  • pneumonia
  • septic shock
  • deterioration of condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • arthralgia
  • flank pain
  • sensory loss
  • cerebral infarction
  • diabetic neuropathy
  • metabolic brain disease
  • seizures
  • cholelithiasis
  • cirrhosis
  • alcoholic sclerosis
  • hepatic insufficiency
  • liver fibrosis
  • hand fractures
  • febrile neutropenia
  • leukopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sialadenitis
  • nail ingrowth
  • urticaria
  • myofibrosis
  • herniated disc
  • osteoarthritis
  • limb pain
  • dementia
  • confusion
  • sleep disorders
  • bladder dysfunction
  • nephrolithiasis
  • dysuria
  • renal cyst
  • ureteral calculi
  • anemia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper airway cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • oculomotor dysfunction
  • 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 must be kept at room temperature between 1 and 30 degrees Celsius. Proper storage ensures the medication's effectiveness.

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.