Carbamazepine — May lead to symptomatic hyponatremia. Staggering the dosage of hydrochlorothiazide and ion exchange resins e. Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension , renal failure, and death.
Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice , thrombocytopenia , and possibly other adverse reactions that have occurred in adults. This condition should be corrected prior to administration of Diovan HCT, or the treatment should start under close medical supervision. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system e. Monitor renal function periodically in these patients.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Systemic Lupus Erythematosus Hydrochlorothiazide: Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Lithium Interaction Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of valsartan or thiazide diuretics.
Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Monitor serum electrolytes periodically. If hypokalemia is accompanied by clinical signs e. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides.
Some patients with heart failure have developed increases in potassium with Diovan therapy. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Acute Myopia And Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Metabolic Disturbances Hydrochlorothiazide Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.
Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Diovan HCT. Female patients of childbearing age should be told about the consequences of exposure to Diovan HCT during pregnancy.
Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible. A patient receiving Diovan HCT should be cautioned that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician.
The patients should be told that if syncope occurs, Diovan HCT should be discontinued until the physician has been consulted. All patients should be cautioned that inadequate fluid intake, excessive perspiration , diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. A patient receiving Diovan HCT should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.
No carcinogenicity, mutagenicity, or fertility studies have been conducted with the combination of valsartan and hydrochlorothiazide. However, these studies have been conducted for valsartan as well as hydrochlorothiazide alone. Based on the preclinical safety and human pharmacokinetic studies, there is no indication of any adverse interaction between valsartan and hydrochlorothiazide. These doses in mice and rats are about 2. Mutagenicity assays did not reveal any valsartan-related effects at either the gene or chromosome level.
These assays included bacterial mutagenicity tests with Salmonella Ames and E. The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella Typhimurium strains TA 98, TA , TA , TA , and TA and in the Chinese Hamster Ovary CHO test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene.
These doses of hydrochlorothiazide in mice and rats represent 19 and 1. Use In Specific Populations Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Diovan HCT as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. 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.
Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Diovan HCT, unless it is considered lifesaving for the mother.
Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Diovan HCT for hypotension, oliguria , and hyperkalemia [see Use in Specific Populations]. Hydrochlorothiazide Thiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma.
Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It 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 the course of EPH Edema, Proteinuria , Hypertension gestosis pre-eclampsia , these drugs should not be used to treat hypertension in pregnant women. The use of hydrochlorothiazide for other indications e.
Nursing Mothers It is not known whether valsartan is excreted in human milk. Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels.
Hydrochlorothiazide is excreted in human breast milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Diovan HCT, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Neonates with a history of in utero exposure to Diovan HCT If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion.
No overall difference in the efficacy or safety of valsartan-hydrochlorothiazide was observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment Valsartan No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease. Hydrochlorothiazide Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
The most likely manifestations of overdosage would be hypotension and tachycardia ; bradycardia could occur from parasympathetic vagal stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension should occur, supportive treatment should be instituted.
Valsartan is not removed from the plasma by dialysis. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion hypokalemia , hypochloremia , hyponatremia and dehydration resulting from excessive diuresis.
If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. These no adverse effect doses in rats and marmosets, respectively, represent Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction , stimulation of synthesis and release of aldosterone , cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland.
Its action is therefore independent of the pathways for angiotensin II synthesis. There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity about fold for the AT1 receptor than for the AT2 receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT1 receptor about one th that of valsartan itself.
Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. Do not take valsartan and hydrochlorothiazide if you have low or no urine output anuria , or if you have allergic reactions to certain drugs known as sulfonamides.
Serious side effects may occur with valsartan and valsartan and hydrochlorothiazide, such as: Low blood pressure hypotension , especially if you take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea.
Lie down if you feel faint or dizzy and call your doctor right away. Call your doctor if you have swelling in your feet, ankles, or hands or have unexplained weight gain.
Serious side effects may occur with valsartan and hydrochlorothiazide, such as: Call your doctor right away if you get an unusual rash. Call your doctor right away if you have eye pain or decrease in vision. Tell your doctor about all your medical conditions, including if you are pregnant or plan to become pregnant, have any allergies, have a heart condition, have liver or kidney problems, have or have had gallstones, have lupus, or are breast-feeding.
Valsartan or valsartan and hydrochlorothiazide may pass into your breast milk and can harm your baby. You should not take valsartan or valsartan and hydrochlorothiazide and breast-feed. People with and without allergy problems or asthma who take valsartan and hydrochlorothiazide may get allergic reactions.
Tell your doctor about all the medicines you take. If you are taking valsartan or valsartan and hydrochlorothiazide, especially tell your doctor if you take other medicines for high blood pressure or a heart problem; water pills diuretics ; potassium supplements or a salt substitute containing potassium; or aspirin or other medicines called non-steroidal anti-inflammatory drugs NSAIDs, like ibuprofen or naproxen ; diabetes medicine including insulin; narcotic pain medicines; sleeping pills; or lithium, a medicine used to treat some types of depression.
If you are taking valsartan and hydrochlorothiazide, tell your doctor if you develop any of the following signs of fluid and electrolyte problems: The most common side effects seen with valsartan in people with high blood pressure are headache, dizziness, flu symptoms, tiredness, and stomach abdominal pain. The most common side effects of valsartan seen in people with heart failure are dizziness, low blood pressure, diarrhea, joint and back pain, tiredness, and high blood potassium.
Common side effects of valsartan used to treat people after a heart attack that caused them to stop taking the drug are low blood pressure, cough, high blood creatinine decreased kidney function , and rash.
Acute renal failurerenal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, generic replacement diovan hct, bone marrow failure, generic replacement diovan hct, worsening of diabetes control, generic replacement diovan hct, hypokalemiablood lipids increased, hyponatremiahypomagnesemiahypercalcemiahypochloremic alkalosis, impotenceand visual impairment. Since they do not prevent or alter the course of EPH Edema, ProteinuriaHypertension gestosis pre-eclampsiathese replacements should not be generic to treat hypertension in pregnant women. Call your doctor right away if you get an unusual rash. Valsartan has diovan greater affinity diovan fold for the AT1 receptor than for the AT2 receptor. The most likely replacements of overdosage would be hypotension and tachycardia ; bradycardia could occur from parasympathetic vagal stimulation. In controlled hct trials including over patients, patients were exposed to valsartan 80, hct, and mg and concomitant hydrochlorothiazide Gender Pharmacokinetics of valsartan do not differ generic between males and females. Monitor serum electrolytes periodically. Neonates with a history of in utero exposure to Diovan HCT If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion, generic replacement diovan hct. Systemic Lupus Erythematosus Hydrochlorothiazide: Hydrochlorothiazide, generic replacement diovan hct, like other diuretics, can cause placental hypoperfusion. Potentiation of orthostatic hypotension may occur. Tell your doctor about all your hct conditions, including if you are pregnant or plan to become pregnant, have any allergies, have a heart condition, have liver diovan kidney problems, have or have had gallstones, have replacement, or are breast-feeding.
Acute renal failuregeneric replacement diovan hct, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, asthenia, acute angle-closure glaucoma, bone marrow hct, worsening of replacement control, generic replacement diovan hct, hypokalemiadiovan lipids increased, hyponatremiahypomagnesemiageneric replacement diovan hct, hypercalcemiahypochloremic alkalosis, impotenceand visual impairment. You should not take valsartan or valsartan and hydrochlorothiazide and breast-feed. These no adverse effect doses in rats and marmosets, respectively, represent The latter finding regarding race is based on pooled data and should be viewed with caution, because antihypertensive drugs that affect the renin-angiotensin system that is, ACE inhibitors and angiotensin II blockers have generally been found hct be less effective in low-renin hypertensives frequently blacks than in high-renin hypertensives frequently whites. Hydrochlorothiazide was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella Typhimurium strains Hct 98, TAgeneric replacement diovan hct, TATAand TA and in the Chinese Hamster Diovan CHO test for hct aberrations, or in generic in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Hydrochlorothiazide The following additional adverse reactions have been reported in postmarketing experience with hydrochlorothiazide: Abrupt withdrawal of valsartan has not been generic replacement a rapid diovan in blood pressure. Correction of hypokalemia and any coexisting hypomagnesemia is recommended prior to the initiation of thiazides. Metabolic Disturbances Hydrochlorothiazide Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. If hypokalemia is accompanied by clinical signs e. Since they do not prevent or alter the course of EPH Edema, ProteinuriaHypertension gestosis pre-eclampsiathese drugs diovan not be generic to treat hypertension in pregnant women. Closely hct infants with histories of in utero exposure to Diovan HCT for hypotension, oliguriaand hyperkalemia [see Use in Specific Populations]. The results from an in vitro study with generic liver tissue indicate that valsartan is a replacement of the replacement uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. Valsartan replacements not inhibit CYP isozymes at clinically relevant concentrations. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. In diovan trials, the antihypertensive effect of once daily valsartan 80 mg was similar to that of once daily enalapril 20 mg or once generic lisinopril 10 mg.
Call your doctor hct away if you get an unusual rash. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. In generic trials, the antihypertensive effect of once daily valsartan 80 mg was diovan to that of once daily enalapril 20 mg or once daily lisinopril 10 mg. Sandoz develops, produces, generic replacement diovan hct, and markets these medicines, generic replacement diovan hct, as well as active pharmaceutical and biotechnological replacements. Novartis is providing the information in this press release as of this date and replacements not undertake any obligation to update any forward-looking statements hct in this press release as a result of new information, future events or otherwise. If replacement occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. Concomitant use of valsartan with other agents that block diovan renin-angiotensin system, potassium-sparing diuretics e. Acute Myopia Diovan Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an generic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Use of thiazides hct pregnancy is generic with a risk of fetal or neonatal jaundice or thrombocytopenia. Discuss treatment options with women planning to become pregnant.
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