Olmesan Plus® Tablet: Each tablet contains Olmesartan Medoxomil INN 20 mg and Hydrochlorothiazide BP 12.5 mg.
It is a combination of an angiotensin II receptor antagonist (ATâ‚ subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.
Dosing should be individualized. The usual recommended starting dose is one tablet of Olmesan Plus® (20/12.5) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets of Olmesan Plus® (40/25) once daily.
Replacement Therapy: Olmesartan medoxomil-Hydrochlorothiazide combination may be substituted for its titrated components.
A patient whose blood pressure is inadequately controlled by Olmesartan or Hydrochlorothiazide alone may be switched to once daily Olmesan Plus®. Dosing should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
If blood pressure is not controlled by Olmesartan alone, Hydrochlorothiazide may be added starting with a dose of 12.5 mg and later titrated to 25 mg once daily.
If a patient is taking hydrochlorothiazide, Olmesartan may be added starting with a dose of 20 mg once daily and titrated to 40 mg, for inadequate blood pressure control. If large doses of Hydrochlorothiazide have been used as monotherapy and volume depletion or hyponatremia is present, caution should be used when adding Olmesartan or switching to Olmesan Plus® as marked decreases in blood pressure may occur. Consideration should be given to reducing the dose of Hydrochlorothiazide to 12.5 mg before adding Olmesartan. The antihypertensive effect of Olmesan Plus® is related to the dose of both components over the range of 10 mg/12.5 mg to 40 mg/25 mg. The dose of Olmesan Plus® is one tablet once daily. More than one tablet daily is not recommended.
Olmesan Plus® may be administered with other antihypertensive agents.
Patients with Renal Impairment: The usual regimens of therapy with Olmesan 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 Olmesan Plus® is not recommended.
Patients with Hepatic Impairment: No dosage adjustment is necessary with hepatic impairment.
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 may occur.
Dosage adjustment of the antidiabetic drug may be required.
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.
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.
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, irrespective 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, when severe cirrhosis 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.
Store in cool & dry place. Keep away from children.