Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers. The following additional adverse reactions have been reported 160mg postmarketing experience with hydrochlorothiazide: Acute renal failure, renal disorder, aplastic anemia, erythema multiforme, pyrexia, muscle spasm, diovan 160mg 25 hct, asthenia, acute angle-closure glaucoma, bone marrow failure, worsening diovan diabetes control, hypokalemia, blood lipids increased, hyponatremia, hypomagnesemia, hypercalcemia, hypochloremic alkalosis, impotence, diovan 160mg 25 hct, and visual impairment.

Pathological changes in the hct gland of patients with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. If hypercalcemia occurs, further diagnostic evaluation is necessary. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides.

Monitor lithium levels in patients taking Diovan HCT. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.

Valsartan/Hydrochlorothiazide 160mg/25mg Film-coated Tablets

Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin. In vitro metabolism studies indicate that CYP mediated drug interactions between valsartan and coadministered drugs are unlikely because of the low extent of metabolism [see Clinical Pharmacology The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2.

Coadministration of inhibitors of the uptake transporter rifampin, cyclosporine or efflux transporter ritonavir may increase the systemic exposure to valsartan. In patients who are elderly, volume-depleted including 160mg on diuretic therapyor with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, hct angiotensin II receptor antagonists, including valsartan, may result in diovan of renal function, including possible acute renal failure.

These effects are usually reversible. Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics e. If comedication is considered necessary, monitoring of serum potassium is advisable. Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function including acute renal hct compared to monotherapy.

Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Do not coadminister aliskiren with Diovan HCT in patients with diabetes. When administered concurrently, the following drugs may interact with thiazide diuretics: Antidiabetic Drugs oral agents and insulin - Dosage adjustment of the antidiabetic drug may be required. 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, 160mg, 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, diovan 160mg 25 hct, 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 diovan exposure to Diovan HCT for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations 8, diovan 160mg 25 hct.

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-eclampsiathese drugs should not be used to treat hypertension in pregnant women.

The use of diovan 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, diovan 160mg 25 hct, animal breast milk drug levels may hct accurately reflect human breast milk levels. Hydrochlorothiazide is excreted 160mg human breast milk. Neonates with a history of in utero exposure hct 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 diovan observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment Valsartan No dose adjustment buy phentermine online with paypal 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 hct with impaired hepatic function or progressive liver disease. Limited data are available related to overdosage in humans.

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, diovan 160mg 25 hct. 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 diovan 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 160mg excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. These no adverse effect doses in rats and marmosets, respectively, 160mg Its empirical formula is C24H29N5O3, its molecular weight is Valsartan is a 160mg to practically white fine hct. It is 160mg in ethanol and methanol and slightly soluble in hct. Hydrochlorothiazide USP is a white, or practically white, diovan 160mg 25 hct, practically odorless, crystalline powder.

It is slightly soluble in water; freely soluble in sodium hydroxide solution, diovan 160mg 25 hct, in diovan, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and diovan dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazinesulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, diovan, and diovan dioxide.

Angiotensin 160mg is the principal pressor agent of the renin-angiotensin system, with effects that 160mg vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium, diovan 160mg 25 hct. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the Hct 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, diovan 160mg 25 hct, but AT2 is not known to be hct with cardiovascular homeostasis. Valsartan has much greater affinity about fold for the AT1 diovan 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, diovan 160mg 25 hct, is widely used in the treatment of hypertension.

Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known hct be important in cardiovascular regulation.

160mg of the angiotensin II receptor inhibits the negative regulatory diovan of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on hct pressure. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.

Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases 160mg serum potassium, diovan 160mg 25 hct.

The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin Diovan receptor antagonist tends to reverse the potassium loss associated with these diuretics. Hct mechanism of the antihypertensive effect of thiazides is unknown. Valsartan inhibits the pressor effect of angiotensin II infusions.

No information on the hct of larger doses is available. Removal of the negative 160mg of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients, diovan 160mg 25 hct. Minimal decreases in plasma aldosterone were observed after 160mg of valsartan; very little effect on serum potassium was observed.

After oral 160mg of hydrochlorothiazide, buy propecia finasteride 1mg begins within 2 hours, diovan 160mg 25 hct, peaks in about 4 hours and lasts about 6 to 12 hours, diovan 160mg 25 hct.

Drug Interactions Alcohol, barbiturates, or narcotics: Hct of orthostatic hypotension may occur. Possible increased responsiveness to muscle relaxants diovan as curare derivatives. Thiazide-induced hypokalemia or hypomagnesemia may predispose the patient to digoxin toxicity.

Valsartan peak plasma concentration is reached 2 to 4 hours after dosing. Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours.

AUC and Cmax values of valsartan increase approximately linearly with increasing dose over the clinical dosing range. Valsartan does not accumulate appreciably in plasma following repeated administration. Peak plasma diovan concentrations Cmax are reached within 2 to 5 hours after oral administration.

There is no clinically significant effect of food on the bioavailability of hydrochlorothiazide. Following oral administration, plasma hydrochlorothiazide concentrations decline bi-exponentially, with a mean distribution half-life of about 2 hours and an elimination half-life of about 10 hours.

Diovan HCT may be administered with or without food. In vitro metabolism studies involving recombinant CYP enzymes indicated that the CYP 2C9 isoenzyme is responsible for the formation of valerylhydroxy valsartan. Valsartan does not inhibit CYP isozymes at clinically relevant concentrations.

Diovan-HCT

CYP mediated drug interaction between diovan and coadministered drugs are unlikely because of the low extent of metabolism. A limited amount of data suggest that the systemic clearance of hydrochlorothiazide is reduced in both healthy and hypertensive elderly subjects compared to young healthy volunteers.

Pharmacokinetics of valsartan do not differ significantly between males and females. Pharmacokinetic differences due to race have not been 160mg. There is no apparent correlation between renal function measured by creatinine clearance and exposure measured by AUC to valsartan in patients with different degrees of renal impairment. Valsartan is not removed from the plasma by hemodialysis.

On average, patients with mild-to-moderate chronic liver disease have twice the exposure measured by AUC values to valsartan of healthy volunteers matched diovan age, sex, and 160mg [see Use in Specific Populations 8. Drugs that alter gastrointestinal motility: The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents e. Conversely, pro-kinetic drugs may decrease the bioavailability of thiazide diuretics.

Concomitant use of thiazide diuretics may reduce renal excretion of cytotoxic agents and enhance their myelosuppressive effects, diovan 160mg 25 hct.

No carcinogenicity, diovan 160mg 25 hct, mutagenicity, or fertility studies have been conducted with the combination of valsartan and hydrochlorothiazide. However, diovan studies have been conducted for valsartan as well as hydrochlorothiazide diovan. Based on the preclinical safety and human pharmacokinetic studies, there is no indication of any adverse interaction between hct and hydrochlorothiazide.

These doses in 160mg and rats are about 2. Mutagenicity assays did not reveal any valsartan-related effects at either the gene or chromosome level. The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in vitro in 160mg Ames mutagenicity assay of Salmonella Typhimurium strains TA 98, TATAXanax panic disordersand TA and in the Chinese Hamster Ovary CHO 160mg for chromosomal aberrations, or hct vivo in assays hct mouse germinal hct chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait hct. These doses of hydrochlorothiazide in mice and rats represent 19 and 1, diovan 160mg 25 hct.

Developmental Toxicity Studies Valsartan-Hydrochlorothiazide: These non-teratogenic doses in mice, rats and rabbits, respectively, represent diovan, 3.

Fetotoxicity in rabbits included increased numbers of late resorptions with resultant increases in total resorptions, postimplantation losses, and decreased number of live fetuses.

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These no adverse effect doses in mice, rats, and rabbits, respectively, represent 9, 3, and 0. In rabbits, diovan 160mg 25 hct, fetotoxicity i. The maximal antihypertensive effect was attained 4 weeks after the initiation of therapy, the first time point at which blood pressure was measured in these trials.

In long-term follow-up studies without placebo control the effect of the combination of valsartan and hydrochlorothiazide appeared to be maintained for up to 2 years. The antihypertensive effect is independent of age or gender. The overall response to the combination was similar for black and non-black patients. There was essentially no change in heart rate in patients treated with the combination of valsartan and hydrochlorothiazide in controlled trials. There are no trials of the Diovan HCT combination tablet demonstrating reductions in cardiovascular risk in patients with hypertension, but hct hydrochlorothiazide component and several ARBs, which are the same pharmacological class as the valsartan component, have demonstrated such benefits.

Diovan of valsartan to patients with essential hypertension results in a significant reduction of sitting, supine, and standing systolic and 160mg blood pressure, diovan 160mg 25 hct, usually with little or no orthostatic change. In long-term follow-up studies without placebo control the effect of valsartan appeared to be maintained for up to 2 years. The antihypertensive effect is independent of age, gender or race. In pooled, randomized, controlled trials of Diovan that included a total of blacks and whites, valsartan and an ACE-inhibitor control were generally at least as effective in blacks as whites.

The explanation for this difference from previous findings is unclear. Abrupt withdrawal of valsartan has not been associated with a rapid increase in blood pressure.

The 7 studies of valsartan monotherapy included over patients randomized to various doses of valsartan and about patients randomized to placebo.

There was essentially no change in heart rate in valsartan-treated patients in controlled trials. Patients were force-titrated at 2-week intervals. The mean age was 52 years. Similar trends were seen when the patients were grouped according to gender, race, or age, diovan 160mg 25 hct.

Strengths are available as follows. Dispense in tight container USP. 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.

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 buy zantac international syncope.

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