Medication info
Povierd Tablet (Tenofovir Disoproxil Fumarate)

Povierd Tablet (Tenofovir Disoproxil Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Tenofovir Disoproxil Fumarate›300mg / 1 tablet
Manufacturer / importer
Korea United Pharmaceutical Co., Ltd.
Appearance
Pale blue almond-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201708476 · Approved 2017.12.21 · Insurance code 644309260

Summary

Main use
Treatment of chronic hepatitis B and HIV-1 infection
Who takes it
Adults · Children
Adult dose
For the treatment of adult HIV-1 infection or chronic hepatitis B, take 1 tablet (300mg) once daily. 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 according to Table 1. No adjustment to the dosing interval is necessary for patients with mild renal impairment (creatinine clearance 50-80mL/min) Creatinine clearance (mL/min)a ≥50: every 24 hours Creatinine clearance (mL/min)a 30-49: every 48 hours Creatinine clearance (mL/min)a 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or after a total of approximately 12 hours of dialysisb The pharmacokinetics of tenofovir have not been evaluated in patients with a creatinine clearance of less than 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.
Child dose
For pediatric patients aged 12 years and older (weighing at least 35kg) with HIV-1 or chronic hepatitis B, take 1 tablet (300mg) 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 35kg.

Ingredients

Manufacturer
Korea United 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 pediatric patients aged 12 years and older for the treatment of HIV-1 infection in combination with other antiretroviral agents. However, caution should be taken not to take this medication with other tenofovir-containing combination products. It is also used in the treatment of chronic hepatitis B in adults and pediatric patients aged 12 years and older, and general precautions must be followed at the start of treatment. This medication helps to effectively treat HIV-1 infection and chronic hepatitis B.

How to take

Adult dose

For the treatment of adult HIV-1 infection or chronic hepatitis B, take 1 tablet (300mg) once daily. 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 according to Table 1. No adjustment to the dosing interval is necessary for patients with mild renal impairment (creatinine clearance 50-80mL/min) Creatinine clearance (mL/min)a ≥50: every 24 hours Creatinine clearance (mL/min)a 30-49: every 48 hours Creatinine clearance (mL/min)a 10-29: every 72-96 hours Patients on hemodialysis: every 7 days or after a total of approximately 12 hours of dialysisb The pharmacokinetics of tenofovir have not been evaluated in patients with a creatinine clearance of less than 10mL/min who are not receiving hemodialysis; therefore, no dosing recommendations are available for these patients.

Child dose

For pediatric patients aged 12 years and older (weighing at least 35kg) with HIV-1 or chronic hepatitis B, take 1 tablet (300mg) 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 35kg.

Precautions

This medication is an antiviral agent used for the treatment of hepatitis B virus (HBV) infection. Discontinuing treatment may lead to a sudden worsening of hepatitis, so regular monitoring should occur for several months after stopping the medication. Individuals allergic to this medication or its components should not take it. Patients with lactose intolerance or certain genetic metabolic disorders should also avoid this medication. This medication should not be taken in combination with other tenofovir products or adefovir dipivoxil. Patients with impaired kidney function should undergo regular monitoring of renal function, as this medication is excreted through the kidneys, and dosage intervals should be adjusted if necessary. Particularly, patients taking high doses of non-steroidal anti-inflammatory drugs (NSAIDs) should be cautious due to the risk of renal damage. It may affect bone health, and patients at risk for osteoporosis or fractures should consider bone density testing, and calcium and vitamin D supplements may be beneficial. This medication contains Yellow No. 5 colorant, so patients allergic to this component should exercise caution. Common side effects may include headache, diarrhea, nausea, fatigue, and rash; if severe adverse reactions occur, medical personnel should be consulted immediately. Insufficient safety data is available during pregnancy, so it should only be used when absolutely necessary, and breastfeeding mothers are advised to avoid breastfeeding. Safety and efficacy have not been established for children under 12 years of age or who weigh less than 35 kg. Caution is needed when administering to elderly patients aged 65 years and older, considering renal and liver function. In case of overdose, seek immediate medical attention, and some drugs may be removed by dialysis. Store this medication at room temperature away from children, ensuring it is kept in its original container to maintain quality.

Side effects

  • Worsening of hepatitis
  • acute renal failure
  • Fanconi syndrome
  • hypophosphatemia
  • renal impairment
  • bone pain
  • limb pain
  • fractures
  • muscle pain
  • muscle weakness
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  • decreased bone density
  • osteomalacia
  • arthralgia
  • rash
  • diarrhea
  • headache
  • pain
  • depression
  • generalized weakness
  • nausea
  • dizziness
  • vomiting
  • dyspepsia
  • fever
  • abdominal pain
  • low back pain
  • insomnia
  • peripheral neuropathy
  • anxiety
  • pneumonia
  • fatigue
  • sinusitis
  • upper respiratory tract infection
  • rhinitis
  • weight loss
  • loss of appetite
  • sweating
  • rhabdomyolysis
  • hepatic steatosis
  • hepatitis
  • elevated liver enzymes
  • acute tubular necrosis
  • proximal tubular dysfunction
  • interstitial nephritis
  • renal failure
  • proteinuria
  • polyuria
  • generalized weakness
  • allergic reaction
  • lactic acidosis
  • hypokalemia
  • dyspnea
  • pancreatitis
  • elevated amylase
  • hepatitis erythema
  • dyspepsia
  • constipation
  • gastroesophageal reflux disease
  • ascites
  • gastric ulcer
  • gastritis
  • abdominal discomfort
  • chronic gastritis
  • epigastric discomfort
  • dry mouth
  • duodenal ulcer
  • hemorrhoids
  • intestinal metaplasia
  • portal hypertension gastropathy
  • upper respiratory tract infection
  • urinary tract infection
  • gastroenteritis
  • Helicobacter infection
  • shingles
  • localized infection
  • periodontitis
  • pulpitis
  • septic shock
  • chest discomfort
  • worsening condition
  • feeling strange
  • feeling hot
  • granulomatous lesions
  • increased alpha-1-fetoprotein
  • increased serum alkaline phosphatase
  • increased serum cholesterol
  • increased neutrophil count
  • decreased urine output
  • benign neoplasm
  • malignant and unspecified
  • skin papilloma
  • hair loss
  • erythema multiforme
  • sialadenitis
  • nail ingrowth
  • urticaria
  • muscle fiber disease
  • flank pain
  • herniated disc
  • osteoarthritis
  • limb pain
  • trigger finger
  • sensory decrease
  • cerebral infarction
  • dementia
  • confusion
  • convulsions
  • cholelithiasis
  • gallbladder disease
  • cirrhosis
  • cholecystitis
  • alcoholic sclerosis
  • liver cyst
  • liver dysfunction
  • liver fibrosis
  • missed medication doses
  • foreign substance
  • hand fracture
  • humeral fracture
  • ligament sprain
  • sleep disorder
  • bladder dysfunction
  • urolithiasis
  • dysuria
  • renal cyst
  • ureteral calculosis
  • anemia
  • fever-induced neutropenia
  • leukopenia
  • splenomegaly
  • thrombocytopenia
  • decreased appetite
  • eating disorder
  • cough
  • rhinitis
  • upper airway cough syndrome
  • hypertension
  • deep venous thrombosis
  • conjunctival hemorrhage
  • corneal degeneration
  • oculomotor dysfunction
  • 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 closed container to protect it from exposure to air or moisture, and it is safe to store at room temperatures between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pale 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.