Nhà máy Stada
Stada
stada
stada
Cardiovascular Agents

Fenostad 200

 

Pack size:

Box of 3 blisters x 10 capsules.

 

Composition:

Each capsule contains fenofibrate (micronized) 200.0 mg

 

Shelf-life:  

24 months from the date of manufacturing. 

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Fenostad 200 is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

  • Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol.
  • Mixed hyperlipidaemia when a statin is contraindicated or not tolerated.
  • Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled.
     
  • Fenostad 200 should be taken with food.
    Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months) complementary or different therapeutic measures should be considered.
     
  • Adults:
    The recommended initial dose is one capsule taken daily during a main meal.
  • Geriatric populations:
    In elderly patients, without renal impairment, the usual adult dose is recommended.
  • Renal impairment:
    Dosage reduction is required in patients with renal impairment. In patients with severe chronic kidney disease, fenofibrate is not recommended.
  • Hepatic impairment:
    Fenofibrate is not recommended for use in patients with hepatic impairment due to the lack of data.
  • Paediatric population:
    The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. Therefore the use of fenofibrate is not recommended in paediatric subjects under 18 years.


Or as prescribed by physicians.

 

  • Hypersensitivity to fenofibrate or to any ingredient of the drug.
  • Severe renal dysfunction.
  • Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).
  • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
  • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.
  • Known gallbladder disease.

     

Common

  • Gastrointestinal disorders, epigastric fullness, nausea, meteorism, mild diarrhea.
  • Hives, urticaria, cutaneous non-specific rash.
  • Rise in serum transaminases.
  • Muscular pain.

Rare

  • Cholelithiasis.
  • Loss of libido and impotence, hypospermia.
  • Leucopenia.

     

  • Documentation of good renal function and liver function is mandatory before beginning treatment with fibrates.
  • In patients taking anticoagulants, the dose of anticoagulant should be reduced by about one third and adjusted if necessary when treatment with fenofibrate is started. Check the prothrombin level more frequently and adapt the dosage of oral anticoagulant during treatment by fenofibrate and 8 days after its interruption.
  • Hypothyroidism may be a factor predisposing to the muscle syndrome.
  • Systematic measurement of transaminases every 3 months, during the first 12 months of treatment.
  • Temporary interruption of treatment in case of an increase in SGPT (ALT) to > 100 IU.
  • Do not combine hepatotoxic substances with fenofibrate.
  • Biliary complications are more prone to occur in patients with biliary cirrhosis or gallstones.
  • If after a few months of administration (3 - 6 months) a satisfactory reduction of serum concentration of lipids is not obtained, other therapy (complementary or different) should be envisaged.
  • Pregnancy: This drug should not be used during pregnancy.
  • Lactation: No data are available. However, because of safety, this drug should not be used in nursing women.
  • Effects on ability to drive and use machines: No effect noted.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



Visitors Counter

Online
27
Total