Ramipril Comp ls 2.5/12.5 mg - 7 Tablet

Angiotensin-Converting Enzyme (ACE) Inhibitor and thiazide diuretic combination therapy used in the treatment of hypertension.

-Administer in the morning with water and without regard to meals. -Safety Advice (continue): -Gout can be precipitated by hydrochlorothiazide, especially in patients with a history of gout, a familial predisposition to gout, or chronic renal failure. -Hypersensitivity reactions may occur with hydrochlorothiazide. -Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma, typically occurring within hours to weeks following initiation. -Photosensitization may occur. -Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus. -Thiazide diuretics may decrease renal calcium excretion; consider avoiding use in patients with hypercalcemia. -Hydrochlorothiazide can cause SLE exacerbation or activation. -Hydrochlorothiazide is not effective in patients with a creatinine clearance <30 mL/minute; therefore, it may not be a useful agent in many elderly patients. -In case of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.

-Side effects due to Ramipril: -Increased blood urea nitrogen and increased serum creatinine, angioedema, a dry hacking-nonproductive cough that is typically associated with tickling or scratching in the throat and hyperkalemia. -Hypotension, cough, angina pectoris, orthostatic hypotension, syncope, hyperkalemia, diarrhea, nausea, vomiting, dizziness, fatigue, headache, vertigo, increased serum creatinine, renal insufficiency, edema, palpitations, symptomatic hypotension, diaphoresis, erythema multiforme, onycholysis, pemphigoid, pemphigus, skin photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, weight gain, abdominal pain, anorexia, constipation, dysgeusia, dyspepsia, dysphagia, gastroenteritis, pancreatitis, sialorrhea, xerostomia, impotence, decreased hematocrit, decreased hemoglobin, hemolytic anemia, pancytopenia, purpuric disease, thrombocytopenia, hepatic failure, hepatitis, jaundice, amnesia, anxiety, depression, drowsiness, insomnia, malaise, nervousness, neuralgia, neuropathy, paresthesia, seizure, arthralgia, arthritis, myalgia, tremor, visual disturbance, hearing loss, tinnitus, acute kidney injury, increased blood urea nitrogen, dyspnea and epistaxis. -Side effects due to Hydrochlorothiazide: Skin photosensitivity, hypokalemia, hypomagnesemia, hypercalcemia, and hyponatremia, hyperuricemia, myopia and acute angle-closure glaucoma, hypersensitivity angiitis, hypotension (including orthostatic), alopecia, skin rash, toxic epidermal necrolysis, urticaria, glycosuria, hypomagnesemia, abdominal cramps, anorexia, constipation, diarrhea, gastric irritation, nausea, vomiting, aplastic anemia, thrombocytopenia, anaphylaxis, dizziness, headache, paresthesia, restlessness, vertigo, asthenia, muscle spasm, blurred vision, xanthopsia, acute kidney injury and fever.

-Should not be given to patients suffering from hypersensitivity to Ramipril and hydrochlorothiazide. -Should not be given to patients suffering from patients with a history of hereditary/idiopathic angioedema. -Should not be given to patients suffering from bilateral or unilateral (in patients with a single kidney) renal artery stenosis. -May cause anemia because, ACE inhibitors can suppress the production of erythropoietin. This is more likely to occur in the presence of chronic kidney disease. -Anaphylactic reaction/nonimmune anaphylaxis can occur with ACE inhibitors. -Symptomatic hypotension with or without syncope can occur (usually with the first several doses); effects are most often observed in volume-depleted patients. -Use with caution in patients with severe aortic stenosis. -Avoid use in patients with ascites due to cirrhosis. -Use with caution in patients with collagen vascular disease. -Use with caution in patients with hepatic impairment. -Use with caution in patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction. -Use with caution in patients with renal impairment. -ACE inhibitor may cause dry, hacking, nonproductive cough that usually occurs within the first few months of treatment and should generally resolve within 1 to 4 weeks after discontinuation of the ACE inhibitor. -ACE inhibitors may cause hyperkalemia. -For the rest of safety advice refer to Dosage and Administration.

-Store at room temperature. -Drug interactions (continue): -Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of blood pressure lowering agents. -Potassium salts: May enhance the hyperkalemic effect of angiotensin-converting enzyme inhibitors. -Potassium-sparing diuretics: May enhance the hyperkalemic effect of angiotensin-converting enzyme inhibitors. -Pregabalin: Angiotensin-converting enzyme inhibitors may enhance the adverse/toxic effect of Pregabalin. -Sacubitril: Angiotensin-Converting Enzyme Inhibitors may enhance the adverse/toxic effect of Sacubitril. -Salicylates: May enhance the nephrotoxic effect of ACE inhibitors. -Tizanidine: May enhance the hypotensive effect of ACE inhibitors. -Trimethoprim: May enhance the hyperkalemic effect of ACE inhibitors. Interactions due to Hydrochlorothiazide: -Alcohol (Ethyl): May enhance the orthostatic hypotensive effect of thiazide diuretics. -Allopurinol: Thiazide diuretics may enhance the potential for allergic or hypersensitivity reactions to allopurinol. -Angiotensin-converting enzyme inhibitors: Thiazide diuretics may enhance the hypotensive effect of angiotensin-converting enzyme inhibitors. -Antidiabetic Agents: Thiazide diuretics may diminish the therapeutic effect of Antidiabetic Agents. -Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): Thiazide diuretics may enhance the hypercalcemic effect of Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron). -Nonsteroidal Anti-Inflammatory Agents: Thiazide diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. -Vitamin D Analogs: Thiazide diuretics may enhance the hypercalcemic effect of Vitamin D Analogs. -Lithium: Thiazide diuretics may decrease the excretion of lithium. -Licorice: May enhance the hypokalemic effect of thiazide diuretics. -Calcium Salts: Thiazide diuretics may decrease the excretion of calcium salts. -Beta2-Agonists: May enhance the hypokalemic effect of thiazide diuretics.

Interactions due to Ramipril: -Alfuzosin: May enhance the hypotensive effect of blood pressure lowering agents. -Allopurinol: Angiotensin-converting enzyme inhibitors may enhance the potential for allergic or hypersensitivity reactions to allopurinol. -Angiotensin II receptor blockers: May enhance the adverse/toxic effect of angiotensin-converting enzyme inhibitors. -Antipsychotic agents: blood pressure lowering agents may enhance the hypotensive effect of antipsychotic agents. -Azathioprine: Angiotensin-converting enzyme inhibitors may enhance the myelosuppressive effect of Azathioprine. -Dapoxetine: May enhance the orthostatic hypotensive effect of angiotensin-converting enzyme inhibitors. -Duloxetine: blood pressure lowering agents may enhance the hypotensive effect of Duloxetine. -Ferric Gluconate: Angiotensin-converting enzyme inhibitor may enhance the adverse/toxic effect of Ferric Gluconate. -Ferric Hydroxide Polymaltose Complex: Angiotensin-converting enzyme inhibitors may enhance the adverse/toxic effect of Ferric Hydroxide Polymaltose Complex. -Heparin: May enhance the hyperkalemic effect of angiotensin-converting enzyme inhibitors. -Iron Dextran Complex: Angiotensin-converting enzyme inhibitors may enhance the adverse/toxic effect of Iron Dextran Complex. -Levodopa-containing products: blood pressure lowering agents may enhance the hypotensive effect of Levodopa-containing products. -Lithium: Angiotensin-converting enzyme inhibitors may increase the serum concentration of Lithium. -Loop diuretics: May enhance the hypotensive effect of Angiotensin-converting enzyme inhibitors. -Nicorandil: May enhance the hyperkalemic effect of angiotensin-converting enzyme inhibitors. -Nonsteroidal Anti-Inflammatory Agents: Angiotensin-converting enzyme inhibitors may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. -For the rest of interactions see Storage.

-Drugs that act on the renin-angiotensin system can cause injury to the developing fetus. Ramipril crosses the placenta. Exposure to an angiotensin-converting enzyme (ACE) inhibitor during the first trimester of pregnancy may be associated with an increased risk of fetal malformations. Drugs that act on the renin-angiotensin system are associated with oligohydramnios, when treatment of hypertension in pregnancy is indicated, ACE inhibitors should generally be avoided due to their adverse fetal events. -Ramipril and thiazide diuretics are found in breast milk. Use in breastfeeding women is contraindicated. -Ask your physician before taking any medication during pregnancy and lactation.

PHAROPHARMA