Diovan hct 320mg 25mg

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

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback 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 blood pressure. Hydrochlorothiazide is a thiazide diuretic. 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 in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown. Valsartan inhibits the pressor effect of angiotensin II infusions. No information on the effect of larger doses is available. Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients.

Minimal decreases in plasma aldosterone were observed after administration of valsartan; very little effect on serum potassium was observed. After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Drug Interactions Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Possible increased responsiveness to muscle relaxants such 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 hydrochlorothiazide 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.

The steady state volume of distribution of valsartan after intravenous administration is small 17 L , indicating that valsartan does not distribute into tissues extensively. 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. CYP mediated drug interaction between valsartan 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.

Gender Pharmacokinetics of valsartan do not differ significantly between males and females. Race Pharmacokinetic differences due to race have not been studied. Renal Insufficiency 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. Use in Specific Populations ]. Hepatic Insufficiency On average, patients with mild-to-moderate chronic liver disease have twice the exposure measured by AUC values to valsartan of healthy volunteers matched by age, sex, and weight [see Use in Specific Populations ]. Drug Interactions Hydrochlorothiazide Drugs that alter gastrointestinal motility: Precautions Precautions Before taking this medication , tell your doctor or pharmacist if you are allergic to valsartan or hydrochlorothiazide ; or if you have any other allergies.

This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy.

Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. Severe sweating , diarrhea , or vomiting can increase the risk for lightheadedness or a serious loss of body water dehydration.

Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program , or diet. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

This product may affect your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products.

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