Erastapex Plus 20/12.5 mg and 40/12.5 mg Film Coated Tablets

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COMPOSITION

  • Each tablet 20/12.5 mg contains 20 mg olmesartan medoxomil + 12.5 mg hydrochlorothiazide.
  • Each tablet 40/12.5 mg contains 40 mg olmesartan medoxomil + 12.5 mg hydrochlorothiazide.
  • Inactive: Lactose, colloidal silicon dioxide, maize starch, magnesium stearate, red iron oxide, yellow iron oxide, methocel, talc, titanium dioxide.

PHARMACOLOGICAL ACTION

Angiotensin II is the principal pressor agent of the renin-angiotensin system with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal re-absorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis.

Hydrochlorothiazide acts by removing the excess water from the body by increasing the production of urine consequently reducing the volume of fluids circulating in the body and decreasing the blood pressure.

PHARMACOKINETICS

Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. Olmesartan appears to be eliminated with a terminal elimination half-life of approximately 13 hours.

The peak plasma concentration of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan. Following the oral administration of Erastapex Plus, median time to peak concentrations is 1 to 2 hours and protein binding of hydrochlorothiazide is 68%.

Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, approximately 35% to 50% of the absorbed dose is recovered in urine while the remainder is eliminated in feces via the bile.

Olmesartan is highly bound to plasma proteins (99%).

Hydrochlorothiazide is excreted as unchanged active substance in urine and 60% of oral dose is eliminated as unchanged within 48 hours. The terminal elimination half life 10-15 hours.

INDICATIONS AND USAGE

Erastapex Plus is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil alone.

DOSAGE AND ADMINISTRATION

The recommended dose is one tablet/day.

CONTRAINDICATIONS

  • Hypersensitivity to any component of this product. 
  • Severe renal impairment, severe hepatic impairment, cholestasis and biliary obstructive disorders.
  • Hypokalemia, hypercalcemia, hypernatremia and hyperuricemia.
  • Severe congestive heart failure, renal artery stenosis. Aortic and mitral valve stenosis.
  • The concomitant use of Erastapex Plus with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR< 60 ml/min/1.732).

SIDE EFFECTS

Dizziness, syncope, hyperuricemia, hypertriglyceridemia, palpitation, orthostatic hypotension, rash, eczema, fatigue, weakness.

DRUG INTERACTIONS

  • Other products used to treat high blood pressure.
  • Other diuretics.
  • Non-steroidal anti-inflammatory.
  • Potassium supplements.
  • Lithium or anti-depressant medicines.
  • Insulin and diabetes medicine.
  • Antacid, corticosteroid, muscle relaxant.

WARNINGS & PRECAUTIONS

  • When pregnancy is detected, Erastapex Plus should be discontinued as soon as possible. 
  • Not used in patients using high doses of diuretics.
  • Like all groups of angiotensin converting enzymes, not to be used in patients with congestive heart failure. 

Dual blockade of the renin-angiotensin-aldosterone system (RAAS):

There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.

If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Do not take Erastapex Plus:

If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

PREGNANCY AND LACTATION

Not used during pregnancy and lactation as it can cause fetal and neonatal morbidity and death.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

INSTRUCTIONS FOR PATIENTS

To be used under medical supervision.

PACKAGE AND STORAGE

  • Erastapex Plus 20 mg/12.5 mg: Carton box contains 3 Alu/Alu blisters each of 10 F.C. tablets.
  • Erastapex Plus 40 mg/12.5 mg: Carton box contains 3 Alu/Alu blisters each of 10 F.C. tablets. 
  • Store in a dry place at temperature below 30 °C.
  • Manufactured by: Apex Pharma - S.A.E - Badr City- Egypt.
  • Keep All Medicines Out of Reach of Children

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