Medication info
Eshepa Tablet (Tenofovir Disoproxil Hemifumarate)

Eshepa Tablet (Tenofovir Disoproxil Hemifumarate)

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

MFDS item code 201707649 · Approved 2017.10.30 · Insurance code 651205050

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 (equivalent to 245 mg of tenofovir disoproxil) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. 2. 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. No adjustment to the dosing interval is needed in patients with mild renal impairment (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysisb 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. a. Calculated using ideal (lean) body weight. b. Generally, administer once weekly, assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours. This medicine should be administered after dialysis is completed.
Child dose
Pediatric patients aged 12 years and older (35 kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245 mg of tenofovir disoproxil) once daily. It may be taken with or without food. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35 kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

Ingredients

Manufacturer
Samchundang 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 12 years and older for the treatment of HIV-1 infection in combination with other antiretroviral agents. However, it should not be taken with tenofovir-containing combination therapies. It is also used for patients with chronic hepatitis B, which is intended for treatment in adults and children 12 years and older. The precautions for use should be verified when starting treatment for chronic hepatitis B. This medication is effective for both HIV-1 infection and chronic hepatitis B treatment.

How to take

Adult dose

Adults For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245 mg of tenofovir disoproxil) once daily. It may be taken with or without food. The optimal duration of treatment for chronic hepatitis B is unknown. 2. 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. No adjustment to the dosing interval is needed in patients with mild renal impairment (creatinine clearance 50-80mL/min); regularly monitor calculated creatinine clearance and serum phosphate (see Warning 3). Table 1. Adjustment of dosing interval according to creatinine clearance Creatinine clearance (mL/min)a ≥50: every 24 hours 30-49: every 48 hours 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or approximately 12 hours after dialysisb 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. a. Calculated using ideal (lean) body weight. b. Generally, administer once weekly, assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours. This medicine should be administered after dialysis is completed.

Child dose

Pediatric patients aged 12 years and older (35 kg or more) For the treatment of HIV-1 or chronic hepatitis B, take 1 tablet (equivalent to 245 mg of tenofovir disoproxil) once daily. It may be taken with or without food. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35 kg. There are no data to support dosage recommendations for pediatric patients with renal impairment.

Precautions

This medication may cause a sudden worsening of hepatitis if treatment is discontinued; therefore, it must be taken continuously according to the physician's instructions. Patients who have allergies to any components of this medication or have certain genetic metabolic disorders should not take it. Since this medication is primarily excreted by the kidneys, patients with reduced kidney function should undergo kidney function tests before taking it and should routinely monitor their kidney status during treatment. This medication should not be taken with certain other antiviral agents, particularly those that may cause renal toxicity. If symptoms such as bone pain, fractures, or muscle weakness occur during treatment, consult healthcare professionals immediately; a bone density test may be required. It can be used during pregnancy if necessary, but a discussion with a healthcare professional is essential before use. Nursing mothers are advised to avoid breastfeeding during treatment. For pediatric patients under 12 years of age or those weighing less than 35 kg, its safety and efficacy have not been sufficiently established, so caution is advised. Elderly patients are at increased risk of impaired liver and kidney function; therefore, monitoring should be more diligent during use. In case of overdose, seek medical attention immediately for appropriate treatment; some components of this medication may be removed by hemodialysis. This medication should be stored at room temperature away from moisture or air exposure, out of reach of children, and in its original container to prevent degradation.

Side effects

  • Worsening of hepatitis
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular syndrome
  • rash
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  • diarrhea
  • headache
  • pain
  • depression
  • weakness
  • nausea
  • dizziness
  • vomiting
  • dyspepsia
  • fatty liver disease
  • joint pain
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fever
  • abdominal pain
  • low back pain
  • loss of appetite
  • abdominal bloating
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • sweating
  • weight loss
  • increased serum amylase
  • hepatic steatosis
  • hepatitis
  • increased liver enzymes
  • rhabdomyolysis
  • muscle weakness
  • myopathy
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • weakness
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • abdominal discomfort
  • chronic gastritis
  • epigastric discomfort
  • melena
  • dry mouth
  • duodenal ulcer
  • hemorrhoids
  • intestinal metaplasia
  • portal hypertensive gastropathy
  • upper respiratory infection
  • urinary tract infection
  • gastroenteritis
  • Helicobacter infection
  • shingles
  • localized infection
  • periodontitis
  • pneumonia
  • dental pulpitis
  • septic shock
  • chest discomfort
  • worsening condition
  • feeling strange
  • feeling hot
  • granulomatous lesions
  • weight loss
  • increased alpha-1-fetoprotein
  • increased blood alkaline phosphatase
  • increased blood cholesterol
  • increased neutrophils
  • decreased urine output
  • metastatic brain tumor
  • hepatic neoplasm
  • skin papilloma
  • hair loss
  • erythema multiforme
  • sialadenitis
  • paronychia
  • urticaria
  • myofibrillar myopathy
  • herniated disc
  • osteoarthritis
  • limb pain
  • decreased sensation
  • cerebral infarction
  • dementia
  • diabetic neuropathy
  • metabolic encephalopathy
  • confusion
  • seizures
  • gallstones
  • gallbladder disease
  • cirrhosis
  • cholecystitis
  • alcoholic sclerosis
  • liver cyst
  • liver dysfunction
  • liver fibrosis
  • missed drug dosages
  • foreign material
  • hand fracture
  • humeral fracture
  • ligament sprain
  • sleep disorder
  • bladder dysfunction
  • urinary stones
  • dysuria
  • renal cysts
  • ureteral stone disease
  • anemia
  • febrile neutropenia
  • leukopenia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorders
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • deep vein thrombosis
  • conjunctival hemorrhage
  • corneal degeneration
  • ocular movement disorders
  • ocular congestion
  • graft-versus-host disease
  • 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 exposure to air or moisture. It's best to maintain the storage temperature between 1 to 30 degrees Celsius to prolong 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.

Questions about this medicine

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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.