Ramoril 2.5 PlusTablet

Generic

Ramipril + Hydrochlorothiazide

Indications

Indicated for the treatment of mild to moderate hypertension in patients who have been stabilized on the individual components given in the same proportion (and for whom combination therapy is suitable).

Pharmacology

Ramipril is an angiotensin converting enzyme (ACE) inhibitor, which inhibits the conversion of angiotensin I to the vasoconstrictor chemical angiotensin II following hydrolysis to ramiprilat. As a result, ramipril inhibits ACE, resulting in lower plasma angiotensin II levels, lower vasopressor activity, and lower aldosterone production. Ramipril's antihypertensive effect is thus achieved. It can also help with heart failure treatment and lowering the risk of stroke, myocardial infarction, and mortality from cardiovascular events. It has a lengthy half-life and is well tolerated, thus it can be used for long-term treatment.

A thiazide diuretic is hydrochlorothiazide. Thiazides alter the electrolyte reabsorption processes in the kidney tubules, increasing sodium and chloride excretion in about equal quantities. Hydrochlorothiazide's diuretic effect reduces plasma volume, resulting in increased plasma renin activity, increased aldosterone secretion, increased urinary potassium loss, and decreased serum potassium. Because angiotensin II mediates the renin-aldosterone connection, co-administration of an ACE inhibitor tends to counteract the potassium loss associated with these diuretics.

Dosage & Administration

Dose Titration Guided by Clinical Effect. 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 Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg tablet.

Replacement Therapy: For convenience, patients receiving ramipril and hydrochlorothiazide from separate tablets may instead wish to receive tablets of combination of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg. If necessary, the dose may be increased to two tablets of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or Ramipril 5 mg + Hydrochlorothiazide 25 mg once daily.

Maximum daily dose: 10 mg ramipril and 50 mg hydrochlorothiazide (four tablets of Ramipril 2.5 mg + Hydrochlorothiazide 12.5 mg or two tablets of Ramipril 5 mg + Hydrochlorothiazide 25 mg).

Interaction

Combining Ramipril and Hydrochlorothiazide with diuretics or other antihypertensive medicines, or nitrates and tricyclic antidepressants, may enhance the antihypertensive effect. Patients who have previously been treated with diuretics may see a significant reduction in blood pressure. Blood sugar-lowering medicines may be less effective if you use ramipril or hydrochlorothiazide (antidiabetic agents, e.g. insulin and sulphonylurea derivatives). When Ramipril/Hydrochlorothiazide is used with acetyl salicylic acid or indomethacin, the antihypertensive efficacy is reduced, and acute renal failure might ensue. Alcohol may be amplified by ramipril / hydrochlorothiazide.

Contraindications

Patients who are hypersensitive to ramipril, hydrochlorothiazide, or other thiazide diuretics should not use this medication. Angioneurotic oedema is an inherited condition. Renal function is severely impaired. Patients with low blood pressure (hypotensive patients) or patients with an unstable circulatory condition (haemodynamically unstable patients) who are at danger of a life-threatening drop in blood pressure and renal failure. Electrolyte abnormalities that are clinically important, such as hypokalemia, hyponatremia, or hypercalcemia, that may worsen after therapy.

Side Effect

Ramipril and Hydrochlorothiazide are typically well tolerated together. Headache, dizziness, asthenia, nausea, vomiting, hypotension, cough, weakness, diarrhoea, fever, gastric irritation, pulmonary oedema, photosensitivity, electrolyte imbalance, hyperglycemia, hyperuricaemia, and vertigo are some of the most frequent side effects.

Pregnancy & Lactation

When given to pregnant women, ACE inhibitors can cause foetal and neonatal morbidity and mortality. Thiazides also pass through the placental barrier and are found in cord blood. Jaundice in the fetus or neonate, thrombocytopenia, and perhaps additional adverse responses have been reported in adults. When a pregnancy is found, the combination of Ramipril and Hydrochlorothiazide should be stopped as soon as feasible. Breast milk excretes this substance. Women using the combination of Ramipril and Hydrochlorothiazide should not breastfeed their babies because of the risk of significant side effects.

Precautions & Warnings

• Patients allergic to ramipril, to any other ACE inhibitor or to any of the excipients of ramipril should not use ramipril.
• Patients with a history of angioedema.
• is used at the same time as sacubitril / valsartan treatment. Do not start using ramipril until sacubatril / valsartan is excreted from the body. In the case of switching from ramipril to sacubitril / valsartan, do not start sacubitril / valsartan until the ramipril has been cleared from the body.
• Hemodynamically related renal artery stenosis, bilateral or unilateral single kidney.
• In patients with hypotension or hemodynamic instability.
• Aliskiren-containing drugs are used in patients with diabetes or moderate to severe renal impairment (creatinine clearance <60 ml / min).
• and angiotensin II receptor antagonist (AIIRA) in patients with diabetic nephropathy.
• During pregnancy.

The simultaneous use of ACE inhibitors and extracorporeal treatments that cause blood to come into contact with negatively charged surfaces should be avoided, as such use can cause severe allergic reactions. Such extracorporeal treatments include the use of certain high-performance membranes (eg, polyacrylonitrile) for dialysis or hemofiltration, and the use of dextran sulfate for the removal of low-density lipoproteins.

Therapeutic Class

Combined antihypertensive preparations

Storage Conditions

Store in a cool and dry place, protected from light.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.