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CoAprovel

CoAprovel

irbesartan + hydrochlorothiazide

Manufacturer:

sanofi-aventis

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Per 150/12.5 mg tab Irbesartan 150 mg, hydrochlorothiazide 12.5 mg. Per 300/12.5 mg tab Irbesartan 300 mg, hydrochlorothiazide 12.5 mg. Per 300/25 mg tab Irbesartan 300 mg, hydrochlorothiazide 25 mg
Indications/Uses
HTN. Alone or in combination w/ other antihypertensive agents eg, β-adrenergic blocking agent, long-acting Ca-channel blocking agent. As initial therapy in patients who are likely to need multiple drugs to achieve their BP goals.
Dosage/Direction for Use
Initially 150 mg/12.5 mg once daily. May be increased after 1-2 wk to max of 300 mg/25 mg once daily. Patient whose BP is not adequately controlled w/ irbesartan 300 mg monotherapy 300 mg/12.5 mg once daily. Patient whose BP is not adequately controlled w/ hydrochlorothiazide or irbesartan 150 mg alone 150 mg/12.5 mg daily. May be increased to 300 mg/12.5 mg. Max: 300 mg/25 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to irbesartan or other sulfonamide-derived drugs eg, thiazides. History of allergy or bronchial asthma. Anuria. Co-administration w/ aliskiren-containing medicines in patients w/ diabetes or w/ moderate to severe renal impairment (GFR <60 mL/min/1.73 m2); ACE inhibitors in patients w/ diabetic nephropathy.
Special Precautions
Risk of symptomatic hypotension in Na- or vol-depleted patients. Correct vol- &/or Na-depletion prior to initiating therapy. May induce hypoglycemia in diabetic patients; dose adjustment of insulin or antidiabetics may be required. Exacerbation or activation of SLE. Dual blockade of renin-angiotensin-aldosterone system (RAAS) is not recommended. Electrolyte & metabolic imbalances. Risks of hypotension, hyperkalemia & changes in renal function w/ ACE inhibitor or w/ aliskiren. Patients w/ psoriasis or history of psoriasis; whose renal function depends on activity of the RAAS (eg, hypertensive patients w/ renal artery stenosis in 1 or both kidneys, or patients w/ severe CHF). Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive motor vehicles or operate machinery. Severe hepatic impairment or progressive liver disease. Not recommended in severe renal impairment (CrCl ≤30 mL/min). Not to be used during pregnancy. Lactation. Ped patients. Hydrochlorothiazide: Choroidal effusion, secondary acute angle closure glaucoma &/or acute myopia. Increased risk of non-melanoma skin cancer (eg, basal & squamous cell carcinoma). Not to be taken by patients who previously experienced acute resp distress syndrome following intake. Post-sympathectomy patient.
Adverse Reactions
Increased BUN, creatinine & creatine kinase; dizziness; nausea/vomiting; abnormal urination; fatigue.
Drug Interactions
Irbesartan: Combination w/ aliskiren-containing medicinal products is contraindicated in patients w/ DM or moderate to severe renal impairment. Combination w/ ACE inhibitors is contraindicated in patients w/ diabetic nephropathy. May increase serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase kalemia. May deteriorate renal function including possible acute renal failure & may attenuate antihypertensive effect w/ NSAIDs including COX-2 inhibitors. Adjust dose of concomitant antidiabetic treatment eg, repaglinide. Increase serum lithium conc & toxicity. Hydrochlorothiazide: Thiazide diuretic-induced orthostatic hypotension may be potentiated w/ alcohol, barbiturates or narcotics. May elevate blood glucose levels w/ antidiabetic drugs (eg, oral agents & insulin). May raise blood level of uric acid w/ antigout medication. Diuretic-induced hypokalemia may accentuate cardiac arrhythmias w/ cardiac glycosides (eg, digoxin) & other antiarrhythmic drugs (eg, sotalol). May increase serum Ca levels. May delay or decrease absorption w/ cholestyramine resin & colestipol HCl. Increased serum lithium conc & lithium toxicity. Reduced effects w/ endogenous prostaglandin synthesis inhibitors (eg, NSAIDs). May potentiate actions of other antihypertensives especially ganglionic or peripheral adrenergic-blocking drugs. May potentiate effects of nondepolarizing muscle relaxants, pre-anesth & anesth used in surgery eg, tubocurarine. Risk of symptomatic hyponatremia w/ carbamazepine.
MIMS Class
Angiotensin II Antagonists / Diuretics
ATC Classification
C09DA04 - irbesartan and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
CoAprovel tab 150/12.5 mg
Packing/Price
28's (P833.93/pack)
Form
CoAprovel tab 300/12.5 mg
Packing/Price
28's (P1,373.22/pack)
Form
CoAprovel tab 300/25 mg
Packing/Price
28's (P1,373.22/pack)
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