Presentation
Ramoril 2.5 Plus: Each tablet contains Ramipril BP 2.5 mg and Hydrochlorothiazide BP 12.5 mg
Ramoril 5 Plus: Each tablet contains Ramipril BP 5 mg and Hydrochlorothiazide BP 25 mg
Descriptions
Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which after hydrolysis to ramiprilat, blocks the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. So, inhibition of ACE by ramipril results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and decreased aldosterone secretion. Thus ramipril exerts its antihypertensive activity. It is also effective in the management of heart failure and reduction of the risk of stroke, myocardial infarction and death from cardiovascular events. It is long acting and well tolerated; so, can be used in long term therapy.
Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of Hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so co-administration of anangiotensin converting enzyme (ACE) inhibitor tends to reverse the potassium loss associated with these diuretics.
Indications
Ramoril 2.5 Plus & Ramoril 5 Plus is indicated for the treatment of hypertension.
Dosage & Administration
A patient whose blood pressure is not adequately controlled with Ramipril (or another ACE inhibitor) alone or with Hydrochlorothiazide (or another thiazide diuretic) alone may be switched to combination therapy with Ramoril 2.5 Plus or Ramoril 5 Plus. The usual starting dose of Ramoril 2.5 Plus or Ramoril 5 Plus is one tablet once daily. If necessary, the dose may be increased to two tablets of Ramoril 2.5 Plus or Ramoril 5 Plus once daily.
Dosage in renal impairment: In patients with a creatinine clearance between 60 and 30 ml/min, treatment should be initiated with Ramipril 1.25 mg monotherapy. If blood pressure is not adequately controlled, the dose of Ramipril may be increased to 2.5 mg. If blood pressure is still not controlled, patient may be switched to one tablet of Ramoril 2.5 Plus once daily. Dosage may be titrated upward to Ramoril 5 Plus until blood pressure is controlled.
Side Effects
This drug is generally well tolerated. dizziness, headache, fatigue and asthenia are commonly reported side-effects. Other side-effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhea, rash, urticaria, oliguria, anxiety, amnesia etc. Angioneurotic edema, anaphylactic reactions and hyperkalemia have also been reported rarely.
Precautions
Ramoril 2.5 Plus or Ramoril 5 Plus should be used with caution in patients with impaired renal function, hyperkalemia, hypotension, surgery/anesthesia and impaired hepatic function.
Contraindications
Ramoril 2.5 Plus or Ramoril 5 Plus is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Because of the Hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Use in Pregnancy & Lactation
Pregnancy: Not recommended
Nursing mother: Not recommended
Overdose
Ramipril: Limited data on human overdosage are available. The most likely clinical manifestations would be symptoms attributable to hypotension. Because the hypotensive effect of Ramipril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat Ramipril overdosage by infusion of normal saline solution.
Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia, may accentuate cardiac arrhythmias. The degree to which Hydrochlorothiazide is removed by hemodialysis has not been established.
Commercial Packaging
Ramoril 2.5 Plus: Each box contains 3 blister strips of 10 tablets.
Ramoril 5 Plus: Each box contains 3 blister strips of 10 tablets.
P- 14 images link
http://www.inceptapharma.com/products/Ramorl-2plus.jpg
http://www.inceptapharma.com/products/Ramoril-5-Plus.jpg
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