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Cardiovascular Agents

Sezstad 10

Packaging:                            

Blister of 10 tablets. Box of 1 blisters

Blister of 10 tablets. Box of 3 blisters

Blister of 10 tablets. Box of 6 blisters

Composition:

Each tablet contains:

Ezetimibe                 10 mg

Excipients q.s         1 tablet

Shelf – Life:  

24 months from the date of manufacturing 

  • Indications
  • Contraindications
  • Adverse reactions
  • Dosage and administration

  • 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.

  • Hypersensitivity to the active substance or to any of the excipients.
  • 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.

Pregnancy and Lactation:

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 the use 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.

  • Common: Headache, abdominal pain, diarrhea, rash, angioedema, fatigue, chest pain, and arthralgia.
  • Rare: Raised liver ezymes or hepatitis, pancreatitis, thrombocytopenia, cholelithiasis, and cholescystitis.

Administration

  • 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.
  • The daily dose of ezetimibe may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.

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.

Dosage

  • 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.

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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