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Indications
Ransys Plus® is indicated for the treatment of hypertension. This combination preparation is indicated in patients whose blood pressure is not adequately controlled on Olmesartan alone. It is not indicated for initial therapy. Ransys Plus may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Pharmacology
It is a powerful vascular consumption in Angiotensini, a powerful vascular consumer formed in Angiotensini in Angiotensini, primary vascular activity hormone and hypertension of the reninangiotensin system, and is an important element of the physiopathology of hypertension. . It also stimulates the secretion of aldosteron by the adrenal cortex. OlmeSartan blocks vasoconstrictor and aldosterones resets angiotensinisi by selectively blocking angiotensinisi combination of angiotensinii in a receptor (for example, vascular smooth muscle, adrenal gland) found in many organizations. Invitrobin search indicates that OlmeSartan is a reversible and competitive inhibitor of a receiver. OlmeSartan does not inhibit the enzyme that Ace (Kinasei, Angiotensini converts converted enzymes into angiotensinisi to annigiotensinii and reduce bradykinin.
The hydrochlorothiazide is a Diuretic Tia Jed. Thiazides influence the elongation mechanism of the re-absorption of electrolytes and increases the excretion of sodium and chloride in a substantially equivalent quantity. Indirectly, the diuretic activity of hydrochlorotiosides is increased as a result of the activity of plasma renin, increases the secretion of aldostileone and the loss of potassium and reduces serum potassium. The links of the reninalization of conformity are mediated by Ensinii with relief. In addition, the coordination of the angiotensini receptor antagonist tends to reverse the loss of potassium associated with these diuretics.
Dosage & Administration
Dosage must be individualized. Ransys Plus can be taken with or without food.
Adults: The usual recommended starting dose is one tablet of Ransys 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 Ransys Plus (40/25) once daily.
Elderly and renal impairment: In elderly patients the same dosage of the combination is recommended as for adults. No dosage adjustment is necessary in patients with mild to moderate renal impairment (Creatinine clearance is ≥ 30 ml/min, < 60 ml/min). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Ransys Plus is not recommended. Children and adolescents Ransys Plus is not recommended for use i n children below 18 years due to a lack of data on safety and efficacy.
Patients with Hepatic Impairment: No dosage adjustment is necessary with hepatic impairment.
Interaction
Olmesartan Medoxomil: No significant drug interactions were reported in studies in which Olmesartan Medoxomil was coadministered with Hydrochlorothiazide, Digoxin or warfarin in healthy volunteers.
Hydrochlorothiazide: When administered concurrently the following drugs may interact with thiazide diuretics: alcohol, barbiturates or narcotics, antidiabetic drugs, other antihypertensive drugs, cholestyramine and colestipol resins, corticosteroids, pressor amines (e.g. Norepinephrine), skeletal muscle relaxants (e.g. Tubocurarine), Lithium, NSAIDs etc.
Contraindications
This combination preparation is contraindicated in patients who are hypersensitive to the active substances, to any of the excipients or to other sulfonamide-derived substances (since Hydrochlorothiazide is a sulfonamide-derived medicinal product).
Side Effects
This combination tablet has been evaluated for safety in 1,243 hypertensive patients. It was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of this combination tablet. Some common side effects include: headache, urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhoea, SGOT (Serum Glutamic-Oxaloacetic Transaminase) increased, GGT (Gamma-Glutamyl Transferase) increased, SGPT (Serum Glutamic-Pyruvic Transaminase) increased, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash etc. Long term use of Olmesartan Medoxomil can cause sprue-like-enteropathy.
Pregnancy & Lactation
Pregnancy: Pregnancy Categories C (first trimester) and D (second and third trimesters). This combination drug should not be used during pregnancy.
Nursing Mothers: It is not known whether Olmesartan is excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Precautions & Warnings
All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia. Hypokalemia may develop, especially with rapid diuresis, when severe cirrhosis is present, or after prolonged therapy. As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Olmesartan.
Storage Conditions
Store at a temperature not exceeding 30 ºC in a dry place. Protect from light and moisture.
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