Ransys Plus 20 mg + 12.5 mg Tablet: Each tablet contains Olmesartan Medoxomil + Hydrochlorothiazide 20 mg + 12.5 mg.
Ransys Plus® is a combination preparation of Olmesartan Medoxomil & Hydrochlorothiazide. 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 is a Thiazide Diuretic that affects 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. Co-administration of an Angiotensin II receptor antagonist (like Olmesartan Medoxomil) tends to reverse the potassium loss associated with these diuretics (like Hydrochlorothiazide).
Ransys Plus® is indicated for the treatment of hypertension. This combination preparation is intended for 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 require multiple antihypertensive agents to achieve their blood pressure goals.
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 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 is recommended as for adults. No dosage adjustment is necessary in patients with mild to moderate renal impairment (Creatinine clearance ≥30 ml/min, <60 ml/min). In patients with severe renal impairment, loop diuretics are preferred over thiazides, so Ransys Plus® is not recommended.
Use in Pregnancy and Lactation
Pregnancy: Ransys Plus® falls under Pregnancy Category 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 it is secreted at low concentrations in lactating rats. Thiazides do appear in human milk. Due to the potential risk of adverse effects on the nursing infant, a decision should be made to either discontinue nursing or stop the drug, considering the importance of the medication for the mother.
Use in Children: The safety and effectiveness of Ransys Plus® in pediatric patients have not been established.
Children and Adolescents: Ransys Plus® is not recommended for use in children below 18 years, as there is no safety or efficacy data available.
Patients with Hepatic Impairment: No dosage adjustment is necessary in patients with hepatic impairment.
Olmesartan Medoxomil: No significant drug interactions were reported when Olmesartan Medoxomil was co-administered with Hydrochlorothiazide, Digoxin, or Warfarin in healthy volunteers.
Hydrochlorothiazide: When taken concurrently, thiazide diuretics may interact with alcohol, barbiturates, narcotics, antidiabetic drugs, other antihypertensive agents, cholestyramine, corticosteroids, norepinephrine, skeletal muscle relaxants (e.g., Tubocurarine), lithium, NSAIDs, etc.
Ransys Plus® is contraindicated in patients who are hypersensitive to any active substances, excipients, or other sulfonamide-derived substances (since Hydrochlorothiazide is a sulfonamide-derived drug).
This combination tablet has been evaluated for safety in 1,243 hypertensive patients and was well tolerated, with an incidence of adverse events similar to placebo. Most side effects were mild, transient, and not dose-dependent. Common side effects include headache, urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhea, elevated liver enzymes (SGOT, SGPT, GGT), increased creatine phosphokinase, hyperglycemia, arthritis, arthralgia, myalgia, coughing, rash, etc. Long-term use of Olmesartan Medoxomil can cause sprue-like enteropathy, which presents as severe chronic diarrhea and weight loss.
Overdose:
Olmesartan Medoxomil: Limited data exist regarding overdose in humans. The most likely effects of overdose include hypotension and tachycardia, while bradycardia could occur if parasympathetic (vagal) stimulation is present.
Hydrochlorothiazide: The most common signs of overdose include electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration, resulting from excessive diuresis.
All patients receiving thiazide therapy should be monitored for signs of electrolyte imbalance, including hyponatremia, hypochloremic alkalosis, and hypokalemia. Hypokalemia may occur, particularly with rapid diuresis, in cases of severe cirrhosis, or after prolonged therapy. Because Olmesartan inhibits the renin-angiotensin-aldosterone system, changes in renal function may occur in susceptible individuals.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.