Adwivalsar-CO 160/12.5 mg - 10 Scored F.C. Tablet

Angiotensin II receptor blocker and thiazide diuretic combination therapy used in the treatment of hypertension.

-Administer with or without food. -Avoid salt substitutes which contain potassium.

-Side effects due to hydrochlorothiazide: Skin photosensitivity, hypokalemia, hypomagnesemia, hypercalcemia, and hyponatremia may occur with hydrochlorothiazide, 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. -Side effects due to valsartan: Dizziness, increased blood urea nitrogen, hypotension, orthostatic hypotension, syncope, hyperkalemia, abdominal pain, diarrhea, nausea, upper abdominal pain, neutropenia, viral infection, fatigue, headache, orthostatic dizziness, vertigo, arthralgia, back pain, blurred vision, increased serum creatinine, renal insufficiency and dry cough.

-Should not be given to patients suffering from hypersensitivity to valsartan, hydrochlorothiazide. -Hyperkalemia may occur with ARBs; risk factors include renal dysfunction, diabetes mellitus, and concomitant use of potassium-sparing diuretics, potassium supplements. -Gout can be precipitated by hydrochlorothiazide. This risk may be increased with doses ≥25 mg. -During initiation of therapy, hypotension may occur, particularly in patients with heart failure or who are post-MI. -Hydrochlorothiazide may cause acute transient myopia and acute angle-closure glaucoma. -Photosensitization may occur. -May be associated with deterioration of renal function and/or increases in serum creatinine. -Use with caution in patients with significant aortic/mitral stenosis. -Use hydrochlorothiazide with caution in patients with prediabetes or diabetes mellitus. -Use caution in patients with biliary obstructive disorders or severe hepatic impairment. -Avoid use in patients with hypercalcemia. -Use valsartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. -Hydrochlorothiazide can cause SLE exacerbation or activation. -Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. -Hydrochlorothiazide is not effective in patients with a CrCl <30mL/minute; therefore, it may not be a useful agent in many elderly patients. -Do not double a dose to make up for a missed dose. -Incase 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.

Store at room temperature.

Interactions due to hydrochlorothiazide: -Alcohol (Ethyl): May enhance the orthostatic hypotensive effect of Thiazide and Thiazide-Like Diuretics. -Allopurinol: Thiazide and Thiazide-Like Diuretics may enhance the potential for allergic or hypersensitivity reactions to Allopurinol. -Angiotensin-Converting Enzyme Inhibitors: Thiazide and Thiazide-Like Diuretics may enhance the hypotensive effect of Angiotensin-Converting Enzyme Inhibitors. -Antidiabetic Agents: Thiazide and Thiazide-Like Diuretics may diminish the therapeutic effect of Antidiabetic Agents. -Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron): Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Multivitamins/Minerals (containing vitamins ADEK, Folate, Iron). -Nonsteroidal Anti-Inflammatory Agents: Thiazide and Thiazide-Like Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. -Vitamin D Analogs: Thiazide and Thiazide-Like Diuretics may enhance the hypercalcemic effect of Vitamin D Analogs. Interactions due to valsartan: -Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents. -Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. -Duloxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Duloxetine. -Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. -Levodopa-containing products: Blood Pressure Lowering Agents may enhance the hypotensive effect of levodopa-containing products. -Nonsteroidal anti-inflammatory agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of nonsteroidal anti-inflammatory agents. -Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of blood pressure lowering agents. -Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers.

-Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. -Hydrochlorothiazide is present in breast milk. Excretion of valsartan in breast milk is not known. Due to the potential for serious adverse reactions in the breastfeeding infant, breastfeeding is not recommended by during treatment. -Ask your physician before taking any medication during pregnancy or lactation.

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