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Cardiovascular Agents

Sezstad 10

 

Pack size:                            

Box of 3 blisters x 10 tablets.


Composition:

Each tablet contains ezetimibe 10 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

  • Primary hypercholesterolaemia.
  • Monotherapy: is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated.
  • Co-administered with an HMG – CoA reductase inhibitor (statin): is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone.
  • Homozygous familial hypercholesterolaemia (HoFH).
  • Co-administered with a statin: is indicated as adjunctive therapy to diet for use in patients with HoFH.
  • Homozygous sitosterolaemia (phytosterolaemia).
  • Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia.
     
  • Sezstad 10 is administered orally at any time of the day, with or without food.
    The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment.
  • Concomitant lipid-lowering therapy
    Ezetimibe may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect.
  • Co-administration with bile acid sequestrants
    Dosing of ezetimibe should occur either at least 2 hours before or 4 hours after administration of a bile acid sequestrant.
  • The recommended dose is one tablet daily.
  • Children and adolescents ≥ 10 years: No dosage adjustment is required.
  • Children < 10 years: ezetimibe is not recommended for use in children below age 10 due to insufficient data on safety and efficacy.
  • Patients with hepatic impairment or renal impairment: No dosage adjustment is necessary in patients with mild hepatic impairment or renal impairment.
  • Use in the elderly: No dosage adjustment is required for elderly patients.


Or as prescribed by physicians.

 

  • Hypersensitivity to the active substance or to any ingredient of the drug.
  • Therapy with ezetimibe co-administered with a statin is contraindicated during pregnancy and lactation.
  • Ezetimibe co-administered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.

     

Common

  • Headache, abdominal pain, diarrhea, rash, angioedema, fatigue, chest pain, and arthralgia.

Rare

  • Raised liver ezymes or hepatitis, pancreatitis, thrombocytopenia, cholelithiasis, and cholescystitis.

     

  • Liverenzymes
    In controlled co-administration trials in patients receiving ezetimibe with a statin, consecutive transaminase elevations (≥ 3 the upper limit of normal (ULN)) have been observed. When ezetimibe is co-administered with a statin, liver function test should be performed at initiation of therapy and according to the recommendation ofthe statin.
  • Skeletalmuscle
    In post-marketing experience with ezetimibe, cases ofmyopathy and rhabdomyolysis have been reported. If myopathy is suspected based on muscle symptoms or is confirmed by a creatine phosphokinase level > 1 0 times the ULN, ezetimibe, any statin, and any of these other agents that patient is taking concomitantly should be immediately discontinued.
  • Excipient
    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
  • Pregnancy
    Ezetimibe should be given to pregnant women only if clearly necessary. No clinical data are available on the use of ezetimibe during pregnancy. Animal studies on theuse of ezetimibe in monotherapy have shown no evidence of direct or indirect harmful effects on pregnancy, embryofetal development, birth or postnatal development.
  • Lactation
    Ezetimibe should not be used during lactation. Studies on rats have shown that ezetimibe is secreted into breast milk. It is not known if ezetimibe is secreted into human breast milk.
  • Effects on ability to drive and use machines
    No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported.

     

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



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