Diovan HCT Tablets and Night Sweats

Diovan side effects can include night sweats, nocturnal hydrosis, and hot flash like symptoms. This page helps to understand the morphine side effects, HCT side effects that cause increased sweating and flushing. This drug has many warnings associated with it  regardless of purchasing discount online or generic. This information is always subject to change please consult you doctor before taking this medicine. 

Prescribing Information

The following prescribing information is based on official labeling in effect July 2004.

 USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Diovan HCT should be discontinued as soon as possible. See WARNINGS: Fetal/Neonatal Morbidity and Mortality.

PRECAUTIONS

Serum Electrolytes

Valsartan--Hydrochlorothiazide

In the controlled trials of various doses of the combination of valsartan and hydrochlorothiazide the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 4.5%; the incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.3%. Two patients (0.3%) discontinued from a trial for decreases in serum potassium.

In controlled clinical trials of Diovan HCT® (valsartan and hydrochlorothiazide, USP), the average change in serum potassium was near zero in subjects who received Diovan HCT 160/12.5 mg, but the average subject who received Diovan HCT 80/12.5 mg, 80/25 mg or 160/25 mg experienced a mild reduction in serum potassium.

In clinical trials, the opposite effects of valsartan (80 or 160 mg) and hydrochlorothiazide (12.5 mg) on serum potassium approximately balanced each other in many patients. In other patients, one or the other effect may be dominant. Periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Hydrochlorothiazide

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.

Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmia and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability).

Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.

Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy 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.g., patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. 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 second- and third-trimester exposure to drugs that act on the renin-angiotensin system, and they should also be told that these consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

Symptomatic Hypotension:   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.

Potassium Supplements:   A patient receiving Diovan HCT should be told not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.

ADVERSE REACTIONS

Diovan HCT® (valsartan and hydrochlorothiazide, USP) has been evaluated for safety in more than 1,300 patients, including over 360 treated for over 6 months, and 170 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse experiences with Diovan HCT was comparable to placebo.

The overall frequency of adverse experiences was neither dose-related nor related to gender, age or race. In controlled clinical trials, discontinuation of therapy due to side effects was required in 3.6% of valsartan-hydrochlorothiazide patients and 4.3% of placebo patients. The most common reasons for discontinuation of therapy with Diovan HCT were headache, fatigue and dizziness.

The adverse experiences that occurred in controlled clinical trials in at least 2% of patients treated with Diovan HCT and at a higher incidence in valsartan-hydrochlorothiazide (n=730) than placebo (n=93) patients included dizziness (9% vs 7%), viral infection (3% vs 1%), fatigue (5% vs 1%), pharyngitis (3% vs 1%), coughing (3% vs 0%) and diarrhea (3% vs 0%).

Headache, upper respiratory infection, sinusitis, back pain and chest pain occurred at a more than 2% rate but at about the same incidence in placebo and valsartan-hydrochlorothiazide patients.

Dose-related orthostatic effects were seen in less than 1% of patients. A dose-related increase in the incidence of dizziness was observed in patients treated with Diovan HCT from 80/12.5 mg (6%) to 160/25 mg (16%).

Other adverse experiences that have been reported with valsartan-hydrochlorothiazide (>0.2% of valsartan-hydrochlorothiazide patients in controlled clinical trials) without regard to causality, are listed below:

Body as a Whole:   Allergic reaction, anaphylaxis, asthenia, and dependent edema.

Cardiovascular:   Palpitations, syncope, and tachycardia.

Dermatologic:   Flushing, rash, sunburn, and increased sweating.

Digestive:   Increased appetite, constipation, dyspepsia, flatulence, dry mouth, nausea, abdominal pain, and vomiting.

Metabolic:   Dehydration and gout.

Musculoskeletal:   Arthralgia, muscle cramps, muscle weakness, arm pain, and leg pain.

Neurologic and Psychiatric:   Anxiety, depression, insomnia, decreased libido, paresthesia, and somnolence.

Respiratory:   Bronchospasm, dyspnea, and epistaxis.

Special Senses:   Tinnitus, vertigo, and abnormal vision.

Urogenital:   Dysuria, impotence, micturition frequency, and urinary tract infection.

Valsartan

In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, hydrochlorothiazide, or lisinopril were 20%, 19%, 69% respectively (p <0.001).

Other reported events seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Post-Marketing Experience

The following additional adverse reactions have been reported in post-marketing experience:

Hypersensitivity:   There are rare reports of angioedema;

Digestive:   Elevated liver enzymes and very rare reports of hepatitis;

Renal:   Impaired Renal Function;

Clinical Laboratory Tests:   Hyperkalemia;

Dermatologic:   Alopecia.

Hydrochlorothiazide

Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body as a Whole:   weakness;

Digestive:    pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation;

Hematologic:    aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia;

Hypersensitivity:   purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions;

Metabolic:    hyperglycemia, glycosuria, hyperuricemia;

Musculoskeletal:   muscle spasm;

Nervous System/Psychiatric:   restlessness;

Renal:   renal failure, renal dysfunction, interstitial nephritis;

Skin:    erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis;

Special Senses:   transient blurred vision, xanthopsia.

Clinical Laboratory Test Findings

In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Diovan HCT.

Creatinine:   Minor elevations in creatinine occurred in 1.4% of patients taking Diovan HCT and 1.1% given placebo in controlled clinical trials.

Hemoglobin and Hematocrit:   Greater than 20% decreases in hemoglobin and hematocrit were observed in 0.1% and 1.0%, respectively, of Diovan HCT patients, compared with 0.0% in placebo-treated patients.

Liver Function Tests:   Occasional elevations (greater than 150%) of liver chemistries occurred in Diovan HCT-treated patients.

Neutropenia:   Neutropenia was observed in 0.6% of patients treated with Diovan HCT and 0.0% of patients treated with placebo.

Serum Electrolytes:    See PRECAUTIONS