Based on in vitro data, no interaction would be expected with drugs whose metabolism is dependent upon cytochrome P isoenzymes 1A1, 1A2, 2A6, 2B6, 2D6, 2E1, or 3A4. In separate studies of patients receiving maintenance doses of warfarin, hydrochlorothiazide, or digoxin, irbesartan administration for 7 days has no effect on the pharmacodynamics of warfarin prothrombin time or pharmacokinetics of digoxin.
The pharmacokinetics of irbesartan are not affected by coadministration of nifedipine or hydrochlorothiazide. Surviving females receiving this dose about 1. Irbesartan was found to cross the placental barrier in rats and rabbits.
Clinical Studies Hypertension The antihypertensive effects of AVAPRO were examined in 7 placebo-controlled 8- to week trials in patients with baseline diastolic blood pressures of 95 to mmHg.
Doses of 1 to mg were included in these trials in order to fully explore the dose-range of irbesartan. Two of the seven placebo-controlled trials identified above examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination. The 7 studies of irbesartan monotherapy included a total of patients randomized to irbesartan 1- mg and patients randomized to placebo. No further increase in effect was seen at dosages greater than mg. The dose-response relationships for effects on systolic and diastolic pressure are shown in Figures 1 and 2.
Figures 1 and 2 Once-daily administration of therapeutic doses of irbesartan gave peak effects at around 3 to 6 hours and, in one ambulatory blood pressure monitoring study, again around 14 hours. This was seen with both once-daily and twice-daily dosing.
In a continuous ambulatory blood pressure monitoring study, oncedaily dosing with mg gave trough and mean hour responses similar to those observed in patients receiving twice-daily dosing at the same total daily dose.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first see section 4. Aliskiren-containing products or ACE-inhibitors: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function including acute renal failure compared to the use of a single RAAS-acting agent see sections 4.
Similar effects have been very rarely reported with irbesartan so far. Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with CoAprovel. Therefore, the combination of lithium and CoAprovel is not recommended see section 4. If the combination proves necessary, careful monitoring of serum lithium levels is recommended. Medicinal products affecting potassium: However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia e.
Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels e.
Adequate monitoring of serum potassium in patients at risk is recommended see section 4. Medicinal products affected by serum potassium disturbances: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter. Additional information on irbesartan interactions: Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated. The pharmacokinetic of digoxin was not altered by co-administration of irbesartan. Additional information on hydrochlorothiazide interactions: Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol; Calcium salts: If calcium supplements or calcium sparing medicinal products e.
Electrolytes should be monitored during concomitant use. If possible, another class of diuretics should be used; Other interactions: Thiazides may increase the risk of adverse effects caused by amantadine. Thiazides may reduce the renal excretion of cytotoxic medicinal products e.
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy see sections 4. 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.
When pregnancy is detected, discontinue Diovan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters 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, 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 for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations 8. Diovan was excreted in the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels.
The pharmacokinetics of Diovan have been evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology Diovan was generally well tolerated in children 6 to 16 years and the adverse experience profile was similar to that described for adults. In children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.
There is limited clinical experience with Diovan in pediatric patients with mild to moderate hepatic impairment [see Warnings and Precautions 5. These kidney effects in neonatal rats represent expected exaggerated pharmacological effects that are observed if rats are treated during the first 13 days of life.
Thus latent diabetes mellitus may become manifest during thiazide therapy. The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient. If progressive renal impairment becomes evident, consider withholding or discontinuing diuretic therapy. Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy. Impaired Hepatic Function Valsartan As the majority of valsartan is eliminated in the bile, patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, showed lower valsartan clearance higher AUCs.
Care should be exercised in administering valsartan to these patients. Impaired Renal Function Valsartan As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system e.
Similar outcomes have been reported with Diovan. In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. In a 4-day trial of valsartan in 12 patients with unilateral renal artery stenosis, no significant increases in serum creatinine or blood urea nitrogen were observed.
There has been no long-term use of valsartan in patients with unilateral or bilateral renal artery stenosis, but an effect similar to that seen with ACE inhibitors should be anticipated.
Hydrochlorothiazide Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function. Information for Patients Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to drugs that act on the renin- angiotensin system. Discuss other treatment options with female patients 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.
Drug Interactions Valsartan No clinically significant pharmacokinetic interactions were observed when valsartan was coadministered with amlodipine, atenolol, cimetidine, digoxin, furosemide, glyburide, hydrochlorothiazide, or indomethacin. The valsartan-atenolol combination was more antihypertensive than either component, but it did not lower the heart rate more than atenolol alone.
Coadministration of valsartan and warfarin did not change the pharmacokinetics of valsartan or the time-course of the anticoagulant properties of warfarin. The inhibitory or induction potential of valsartan on CYP is also unknown. Hydrochlorothiazide When administered concurrently the following drugs may interact with thiazide diuretics: Alcohol, barbiturates, or narcotics - Potentiation of orthostatic hypotension may occur. Antidiabetic drugs oral agents and insulin - Dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs - Additive effect or potentiation. Cholestyramine and colestipol resins - Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Skeletal muscle relaxants, nondepolarizing e. Lithium - Should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.
Refer to the package insert for lithium preparations before use of such preparations with Diovan HCT. Non-steroidal anti-inflammatory Drugs - In some patients, the administration of a non-steroidal anti inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.
Therefore, when Diovan HCT and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Medicinal products affected by serum potassium disturbances: Impotence Other reported events seen less frequently in clinical trials included chest pain, syncope, diovan 150mg, anorexia, vomiting, and angioedema. Thiazides should be discontinued before carrying out tests for parathyroid function. Pediatric Use Safety and effectiveness in pediatric patients have not been established. The antihypertensive effect persists over 24 hours after dosing. Each film-coated tablet contains mg valsartan and 25mg hydrochlorothiazide. Increase of dosage of probenecid or sulfinpyrazone may be necessary. Given their similar pharmacodynamic properties, these results are also relevant for other ACE inhibitors and angiotensin II receptor blockers. Co-Diovan should not be used in these diovan. If you also take certain drugs to lower your cholesterol bile acid-binding resins such as cholestyramine or colestipoltake this product at least 4 hours before or at least 4 to 6 hours after these medications. There are rare reports of 150mg.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. No data are available. Addition of diovan diuretic has a greater effect than dose increases beyond 80 mg, diovan 150mg. Notes Do not share this medication with others. Hepatic Insufficiency The pharmacokinetics of irbesartan following repeated oral administration are not significantly affected in patients with mild to moderate cirrhosis of the liver. Zachte contactlens die u vertellen. Valsartan does price amitriptyline walmart accumulate appreciably in plasma following repeated administration. Rarely probably less often than once in every thousand pregnanciesno alternative to a drug acting on the 150mg system will be found. Hydrochlorothiazide is contraindicated in patients with severe renal impairment see section 4. Valsartan has much greater affinity about 20,fold for the AT1 receptor than for the AT2 receptor.
Diovan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation. Pharmacodynamics In healthy subjects, single oral irbesartan doses of up to mg produced dose-dependent inhibition of the pressor effect of angiotensin II infusions. Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting. There was no difference between valsartan and 150mg in all-cause mortality based on age, gender, race, baseline therapies or underlying disease. Adverse Drug Reactions Adverse drug diovan are ranked by frequency, diovan 150mg, the most frequent first, using the following convention: The diovan relationships for effects on systolic and diastolic pressure are shown in Figures 1 and 2. If symptomatic hypotension should occur, supportive treatment should be instituted. Elevated liver enzymes and very rare reports of hepatitis. Cholestyramine and colestipol resins 150mg Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins, diovan 150mg. Dr Sease discloses that she has served on the speakers' bureau for Novartis. Caution is advised in long-term administration of these drugs. No association between race and Diovan levels was noted, diovan 150mg. Results appearing to favour placebo composite mortality and morbidity was Patients with severe chronic heart failure or 150mg conditions with stimulation of the renin-angiotensin-aldosterone-system In patients whose renal function may depend 150mg the activity of the renin-angiotensin-aldosterone system e.
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