Description and Composition of Bexatan Plus
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Bexatan Plus is a combination of Olmesartan Medoxomil, an angiotensin II receptor blocker (AT1 subtype) and Hydrochlorothiazide (HCTZ), a thiazide diuretic. Olmesartan Medoxomil, a prodrug, is hydrolyzed to Olmesartan during absorption from the gastrointestinal tract.
Indications and Uses of Bexatan Plus
Bexatan Plus (Olmesartan Medoxomil and Hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. This drug may be used alone or in combination with other antihypertensive drugs. It is not indicated for the initial therapy of hypertension.
Dosage and Administration of Bexatan Plus
The recommended starting dose of Bexatan Plus is one tablet (20/12.5 mg) once daily in patients whose blood pressure is not adequately with controlled Hydrochlorothiazide monotherapy or who experience dose limiting adverse reactions with Hydrochlorothiazide. Dose can be titrated up to two tablets (40/25 mg) after 2 to 4 weeks, if necessary. Patients titrated to the individual components (Olmesartan and Hydrochlorothiazide) may instead receive the corresponding dose of Bexatan Plus.
Patients with Renal Impairment: The usual regimens of therapy with Bexatan Plus may be followed provided the patient’s creatinine clearance is >30 ml/min, In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Bexatan Plus is not recommended.
Patients with Hepatic Impairment: No dosage adjustment is necessary with hepatic impairment
Contraindications of Bexatan Plus
Patients who are hypersensitive to any component of this product.
Patients with anuria or hypersensitivity to other sulfonamide derived drugs; as this product contains Hydrochlorothiazide.
Adverse Reactions
The following adverse events were also reported at a rate of > 2%, but were as, or more, common in the placebo group:
headache and urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhea, SGOT increased, GGT increased, SGPT increased, hyperlipemia, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash.
Warning & Precautions
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia. Serum and urine electrolyte determinations are important when the patient is vomiting excessively or receiving parenteral fluids.
Warning signs or symptoms of fluid and electrolyte imbalance, respective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop, especially with brisk diuresis is present, or after prolonged therapy.
High Risk Group
Pregnant women
Pregnancy Categories C (first trimester) and D (second and third trimesters).
Nursing Mothers
Olmesartan and Thiazides is secreted at low concentration in the milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.
Impaired Renal Function In patients whose renal function may depend upon the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure), treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death.
Drug Interaction with Bexatan Plus
- Olmesartan medoxomil: No significant drug interactions were reported in studies in which Olmesartan medoxomil was co administered with Hydrochlorothiazide, digoxin or warfarin in healthy volunteers.
- Hydrochlorothiazide: Alcohol, Barbiturates, or Narcotics causes potentiation of orthostatic hypotension.
- Dosage adjustment of the antidiabetic drug may be required if one is on Bexatan Plus.
- Other Antihypertensive Drugs: additive effect or potentiation
- Absorption of Hydrochlorothiazide is impaired in the presence of Cholestyramine and Colestipol.
- Resins: Single doses of either cholestyramine or colestipol resins bind the Hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent.
- Corticosteroids: ACTH intensified electrolyte depletion, particularly hypokalemia.
- Skeletal Muscle Relaxants, Non depolarizing (e.g. Tubocurarine possible increased responsiveness to the muscle relaxant.
- Lithium: should not generally be given with diuretics.
- Administration of a NSAID can reduce the diuretic, natriuretic and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.
Pharmaceutical Precautions
Keep out of the reach of children. Keep in a dry place, below 30°C. Protect from light.
Commercial Pack of Bexatan Plus
Bexatan Plus Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Olmesartan Medoxomil BP 20 mg and Hydrochlorothiazide BP 12.5 mg.
Manufactured by
BEXIMCO PHARMACEUTICALS LTD.
126, Kathaldia, Auchpara, Tongi, Gazipur Bangladesh 3020006576.
Bexatan is registered trademark of Beximco Pharmaceuticals Ltd.
Distributed in Nigeria by Standard Generics Limited
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