Medication info
Rinofed Tablet (Tenofovir Disoproxil)

Rinofed Tablet (Tenofovir Disoproxil)

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

MFDS item code 201706560 · Approved 2017.08.11 · Insurance code 643903580

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
Adult dose
Adults and 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. 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 with reference to Table 1. Creatinine clearance 50-80mL/min: No dose interval adjustment is necessary. Creatinine clearance ≥50: Take 1 tablet every 24 hours Creatinine clearance 30-49: Take 1 tablet every 48 hours Creatinine clearance 10-29: Take 1 tablet every 72-96 hours Patients on hemodialysis: Take 1 tablet every 7 days or approximately 12 hours after hemodialysis. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. No dosage recommendations are available for patients with creatinine clearance <10mL/min who are not receiving hemodialysis.
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. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to provide dosage recommendations for pediatric patients with renal impairment.

Ingredients

Manufacturer
Samil 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 over 12 years of age for the treatment of HIV-1 infection in combination with other antiretroviral drugs. It is particularly important not to take it in conjunction with other fixed-dose combinations that contain tenofovir. Additionally, it is used for the treatment of chronic hepatitis B, applicable to adults and children over 12 years of age. In the case of chronic hepatitis B treatment, it is essential to be aware of the general precautions for use. Thus, this medication is effectively used for the treatment of both HIV-1 infection and chronic hepatitis B.

How to take

Adult dose

Adults and 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. 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 with reference to Table 1. Creatinine clearance 50-80mL/min: No dose interval adjustment is necessary. Creatinine clearance ≥50: Take 1 tablet every 24 hours Creatinine clearance 30-49: Take 1 tablet every 48 hours Creatinine clearance 10-29: Take 1 tablet every 72-96 hours Patients on hemodialysis: Take 1 tablet every 7 days or approximately 12 hours after hemodialysis. Assuming 3 hemodialysis sessions per week, each lasting approximately 4 hours, administer once weekly. This medicine should be administered after hemodialysis is completed. No dosage recommendations are available for patients with creatinine clearance <10mL/min who are not receiving hemodialysis.

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. The safety and efficacy of this medicine have not been established in pediatric patients with chronic hepatitis B who weigh less than 35kg. There are no data to provide dosage recommendations for pediatric patients with renal impairment.

Precautions

This medication may cause a sudden worsening of hepatitis if treatment is stopped, so close monitoring of liver condition for an extended period after discontinuation is necessary. Those allergic to this medication or its components should not use it, and individuals with genetic issues such as lactose intolerance should also avoid taking it. This medication is primarily excreted by the kidneys; therefore, those with impaired kidney function must have kidney function tests prior to taking it and should regularly monitor kidney status during treatment. Taking it with other specific medications may increase the risk of side effects, thus it is essential to consult with a doctor or pharmacist to avoid concurrent use. This medication may impact bone health; if there is a risk of osteoporosis or fractures, bone density screening should be considered, and calcium and vitamin D supplementation may be beneficial if needed. It contains sulfite components, so individuals with asthma or allergies may experience severe allergic reactions; caution is advised. While you may experience symptoms such as diarrhea, headache, and nausea during treatment, consult a healthcare professional if symptoms are severe. It may be used during pregnancy if necessary, but if you are pregnant or planning to become pregnant, you must consult a doctor, and it is recommended to avoid breastfeeding during this time. This medication is not used in children under 12 years of age or those weighing less than 35 kg, as safety and efficacy have not been adequately established. In case of overdose, immediately notify healthcare professionals and seek appropriate treatment; some components can be removed through hemodialysis. Store in a cool place out of reach of children and keep in the original container for safety.

Side effects

  • Worsening of hepatitis
  • acute renal failure
  • Fanconi syndrome
  • kidney disorder
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • proximal tubular dysfunction
  • sulfite anaphylaxis
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  • asthma attack
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • asthenia
  • nausea
  • dizziness
  • abdominal pain
  • back pain
  • dyspepsia
  • vomiting
  • lipodystrophy
  • arthralgia
  • myalgia
  • insomnia
  • peripheral neuropathy
  • anxiety disorder
  • pneumonia
  • fever
  • loss of appetite
  • abdominal distension
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • nasopharyngitis
  • lightheadedness
  • nausea
  • vomiting
  • fatigue
  • asthenia
  • chest pain
  • sweating
  • weight loss
  • pneumonia
  • increased serum amylase
  • fatty liver
  • hepatitis
  • elevated liver enzymes
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute tubular necrosis
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • hypophosphatemia
  • dyspnea
  • pancreatitis
  • fatty liver
  • hepatitis
  • elevated liver enzymes
  • rash
  • rhabdomyolysis
  • osteomalacia
  • muscle weakness
  • myopathy
  • acute renal failure
  • renal failure
  • acute tubular necrosis
  • Fanconi syndrome
  • proximal tubular dysfunction
  • interstitial nephritis
  • nephrogenic diabetes insipidus
  • renal failure
  • increased creatinine
  • proteinuria
  • polyuria
  • asthenia
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • vomiting
  • ascites
  • abdominal distension
  • urinary tract infection
  • gastroenteritis
  • shingles
  • pneumonia
  • septic shock
  • pneumonia
  • asthenia
  • worsening condition
  • increased ALT
  • increased AST
  • hepatocellular carcinoma
  • metastatic brain tumor
  • osteoporosis
  • arthralgia
  • flank pain
  • spinal pain
  • sensory impairment
  • cerebral infarction
  • diabetic neuropathy
  • metabolic encephalopathy
  • seizures
  • gallstones
  • cirrhosis
  • alcoholic sclerosis
  • liver failure
  • liver fibrosis
  • hand fracture
  • febrile neutropenia
  • leukopenia
  • deep vein thrombosis
  • corneal degeneration
  • graft-versus-host disease
  • hair loss
  • erythema multiforme
  • sweat gland inflammation
  • ingrown toenails
  • hives
  • fibromyalgia
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • dementia
  • confusion
  • sleep disturbances
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureterolithiasis
  • anemia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorder
  • cough
  • rhinitis
  • upper respiratory cough syndrome
  • hypertension
  • conjunctival hemorrhage
  • ocular movement 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 or moisture; therefore, it must be stored in a tightly sealed container. It is recommended to maintain room temperature between 1 degree and 30 degrees Celsius. Storing it this way 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.