Co-Cinfaval 80/12.5 Tablets / Film-coated

Co-Cinfaval 80/12.5 Tablets / Film-coated is used for: Hypertension, Diabetic nephropathy

Hypertension 1 tablet/day PO (80-160 mg valsartan/12.5-25 mg hydrochlorothiazide); may be titrated after 1-2 weeks of therapy; not to exceed 320 mg valsartan/25 mg hydrochlorothiazide daily

Renal impairment: CrCl (ml/min) Dosage Recommendation <30 Not recommended.

Hypersensitivity to valsartan, hydrochlorothiazide or sulphonamides. Severe hepatic impairment, creatinine clearance <30ml/min, anuria, cirrhosis, biliary obstruction, conditions where there is increased potassium loss (e.g. salt losing nephropathies and pre-renal impairment of kidney function), refractory hypokalaemia, hyponatraemia, hypercalcaemia, hyperuricaemia, history of gout and uric acid stones, untreated Addison's disease. Pregnancy and lactation.

DM, postsympathectomy patients. May exacerbate SLE. Monitor serum potassium regularly. Observe for signs of fluid or electrolyte imbalance. Discontinue before testing for parathyroid function. May affect ability to drive or operate machinery. Elderly. Lactation: Discontinue drug, or do not nurse

Pregnancy Angiotensin system during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death; most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents; published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan; when pregnancy is detected discontinue therapy as soon as possible Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, and post-partum hemorrhage); hypertension increases fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with hypertension should be carefully monitored and managed accordingly Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death Valsartan Perform serial ultrasound examinations to assess intra-amniotic environment; fetal testing may be appropriate, based on week of gestation; however, oligohydramnios may not appear until after fetus has sustained irreversible injury; if oligohydramnios is observed, consider alternative drug treatment Closely observe neonates with histories of in utero exposure to drug for hypotension, oliguria, and hyperkalemia; in neonates with a history of in utero exposure to Diovan HCT, if oliguria or hypotension occurs, support blood pressure and renal perfusion; exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma; hydrochlorothiazidecan cause placental hypoperfusion; accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma; use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia; since they do not prevent or alter course of EPH (edema, proteinuria, hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women; use of hydrochlorothiazide for other indications (eg, heart disease) in pregnancy should be avoided Lactation There is limited information regarding presence of drug in human milk, effects on breastfed infant, or on milk production; valsartan is present in rat milk; hydrochlorothiazide is present in human breast milk Valsartan is present in rat milk. Hydrochlorothiazide is present in human breast milk Because of potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with this drug combination

Increased antihypertensive effect with other antihypertensive drugs. Monitor potassium frequently if used with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or drugs that may affect potassium levels (e.g. heparin, ciclosporin, drospirenone, amphotericin, corticosteroids, carbenoxolone). Reduced antihypertensive effect of valsartan and increased risk of renal impairment with NSAIDs. May reduce renal clearance of cytotoxic drugs (e.g. cyclophosphamide, methotrexate). Increased serum calcium with vitamin D or calcium salts. Potentially Fatal: Increased lithium levels with valsartan, monitor lithium levels. Increased risk of cardiac arrhythmia with dofetilide, avoid use.

Side effects of Hydrochlorothiazide + Valsartan : 1-10% Valsartan Hyperkalemia (4-10%), Dizziness (2-8%), Hypotension (1-7%), Fatigue (3%) Frequency Not Defined Hydrochlorothiazide Anorexia, Epigastric distress, Hypotension, Orthostatic hypotension, Photosensitivity, Anaphylaxis, Anemia, Confusion, Erythema multiforme, Stevens-Johnson syndrome, Exfoliative dermatitis including toxic epidermal necrolysis, Dizziness, Hypokalemia and/or hypomagnesemia, Hyperuricemia

Valsartan is an angiotensin II receptor antagonist and reduces blood pressure by blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II. Hydrochlorothiazide is a thiazide diuretic.

Co-Cinfaval 80/12.5 "80mg, 12.5mg" Tablets / Film-coated manufactured by Laboratorios Cinfa S.A. Its generic name is Hydrochlorothiazide + Valsartan. Co-Cinfaval 80/12.5 is availble in United Arab Emirates. Farmaco UAE drug index information on Co-Cinfaval 80/12.5 Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.