Novapress

Hypertension:Novapress (Novapress tablets, USP) is indicated for the treatment of hypertension.

In using Novapress, consideration should be given to the risk of neutropenia/agranulocytosis.

Novapress may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, Novapress should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations.

Novapress is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Novapress and thiazides are approximately additive.

Heart Failure: Novapress is indicated in the treatment of congestive heart failure usually in combination with diuretics and digitalis. The beneficial effect of Novapress in heart failure does not require the presence of digitalis, however, most controlled clinical trial experience with Novapress has been in patients receiving digitalis, as well as diuretic treatment.

Left Ventricular Dysfunction After Myocardial Infarction:Novapress is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction ≤40% and to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients.

Diabetic Nephropathy:Novapress is indicated for the treatment of diabetic nephropathy (proteinuria >500 mg/day) in patients with type I insulin-dependent diabetes mellitus and retinopathy. Novapress decreases the rate of progression of renal insufficiency and development of serious adverse clinical outcomes (death or need for renal transplantation or dialysis).

In considering use of Novapress, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients.

Novapress is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Novapress works by blocking a substance in the body that causes blood vessels to tighten. As a result, the blood vessels relax. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Novapress is also used to help treat heart failure. It is also used in some patients after a heart attack. After a heart attack, some of the heart muscle is damaged and weakened. The heart muscle may continue to weaken as time goes by. This makes it more difficult for the heart to pump blood. Novapress may be started within the first few days after a heart attack to increase survival rate.

Novapress is also used to treat kidney problems caused by diabetes (diabetic nephropathy).

Novapress is available only with your doctor's prescription.

Novapress should be taken one hour before meals. Dosage must be individualized.

Hypertension:Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting Novapress.

The initial dose of Novapress (Novapress tablets, USP) is 25 mg b.i.d. or t.i.d. If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d. Concomitant sodium restriction may be beneficial when Novapress is used alone.

The dose of Novapress in hypertension usually does not exceed 50 mg t.i.d. Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added. The diuretic dose may be increased at one- to two-week intervals until its highest usual antihypertensive dose is reached.

If Novapress is being started in a patient already receiving a diuretic, Novapress therapy should be initiated under close medical supervision, with dosage and titration of Novapress as noted above.

If further blood pressure reduction is required, the dose of Novapress may be increased to 100 mg b.i.d. or t.i.d. and then, if necessary, to 150 mg b.i.d. or t.i.d. (while continuing the diuretic). The usual dose range is 25 to 150 mg b.i.d. or t.i.d. A maximum daily dose of 450 mg Novapress should not be exceeded.

For patients with severe hypertension (e.g., accelerated or malignant hypertension), when temporary discontinuation of current antihypertensive therapy is not practical or desirable, or when prompt titration to more normotensive blood pressure levels is indicated, diuretic should be continued but other current antihypertensive medication stopped and Novapress dosage promptly initiated at 25 mg b.i.d. or t.i.d., under close medical supervision.

When necessitated by the patient’s clinical condition, the daily dose of Novapress may be increased every 24 hours or less under continuous medical supervision until a satisfactory blood pressure response is obtained or the maximum dose of Novapress is reached. In this regimen, addition of a more potent diuretic, e.g., furosemide, may also be indicated.

Beta-blockers may also be used in conjunction with Novapress therapy, but the effects of the two drugs are less than additive.

Heart Failure:Initiation of therapy requires consideration of recent diuretic therapy and the possibility of severe salt/volume depletion. In patients with either normal or low blood pressure, who have been vigorously treated with diuretics and who may be hyponatremic and/or hypovolemic, a starting dose of 6.25 or 12.5 mg t.i.d. may minimize the magnitude or duration of the hypotensive effect; for these patients, titration to the usual daily dosage can then occur within the next several days.

For most patients the usual initial daily dosage is 25 mg t.i.d. After a dose of 50 mg t.i.d. is reached, further increases in dosage should be delayed, where possible, for at least two weeks to determine if a satisfactory response occurs. Most patients studied have had a satisfactory clinical improvement at 50 or 100 mg t.i.d. A maximum daily dose of 450 mg of Novapress should not be exceeded.

Novapress should generally be used in conjunction with a diuretic and digitalis.

Novapress therapy must be initiated under very close medical supervision.

Left Ventricular Dysfunction After Myocardial Infarction:The recommended dose for long-term use in patients following a myocardial infarction is a target maintenance dose of 50 mg t.i.d.

Therapy may be initiated as early as three days following a myocardial infarction. After a single dose of 6.25 mg, Novapress therapy should be initiated at 12.5 mg t.i.d. Novapress should then be increased to 25 mg t.i.d. during the next several days and to a target dose of 50 mg t.i.d. over the next several weeks as tolerated.

Novapress may be used in patients treated with other post-myocardial infarction therapies, e.g., thrombolytics, aspirin, beta blockers.

Diabetic Nephropathy:The recommended dose of Novapress for long term use to treat diabetic nephropathy is 25 mg t.i.d.

Other antihypertensives such as diuretics, beta blockers, centrally acting agents or vasodilators may be used in conjunction with Novapress if additional therapy is required to further lower blood pressure.

Dosage Adjustment in Renal Impairment:Because Novapress is excreted primarily by the kidneys, excretion rates are reduced in patients with impaired renal function. These patients will take longer to reach steady-state Novapress levels and will reach higher steady-state levels for a given daily dose than patients with normal renal function. Therefore, these patients may respond to smaller or less frequent doses.

Accordingly, for patients with significant renal impairment, initial daily dosage of Novapress should be reduced, and smaller increments utilized for titration, which should be quite slow (one- to two-week intervals). After the desired therapeutic effect has been achieved, the dose should be slowly back-titrated to determine the minimal effective dose. When concomitant diuretic therapy is required, a loop diuretic (e.g., furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment.

See also:
What is the most important information I should know about Novapress?

Do not use Novapress if you are pregnant. Novapress can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not use this medication if you are allergic to Novapress or to any other ACE inhibitor, such as benazepril (Lotensin), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

If you have kidney disease or diabetes, you should not take Novapress if you are also taking aliskiren (Tekturna, Tekamlo, Valturna, Amturnide).

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Novapress.

Do not use salt substitutes or potassium supplements while taking Novapress, unless your doctor has told you to.

Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking Novapress. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Use Novapress as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Novapress by mouth on an empty stomach 1 hour before meals.
• Novapress works best if it is taken at the same time each day.
• Drink plenty of fluids while taking Novapress. Not drinking enough fluids or excessive sweating, diarrhea, or vomiting can lead to light-headedness or fainting.
• Continue to take Novapress even if you feel well. Do not miss any doses.
• If you miss a dose of Novapress, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Novapress.

Novapress is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat heart failure, protect the kidneys from harm due to diabetes, and to improve survival after a heart attack.

Novapress is an ACE inhibitor and works by relaxing blood vessels so that blood can flow more easily.

How to use Novapress

Take this medication by mouth on an empty stomach (at least 1 hour before meals) as directed by your doctor, usually two to three times a day.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

For the treatment of high blood pressure, it may take up to 2 weeks before you get the full benefit of this medication. For the treatment of heart failure, it may take weeks to months before you get the full benefit of this medication. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).

See also:
What other drugs will affect Novapress?

Dual Blockade Of The Renin-Angiotensin System (RAS)

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 failure) 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. Closely monitor blood pressure, renal function and electrolytes in patients on Novapress and other agents that block the RAS.

Do not coadminister aliskiren with Novapress in patients with diabetes. Avoid use of aliskiren with Novapress in patients with renal impairment (GFR < 60 ml/min).

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase – 2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including Novapress, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Novapress and NSAID therapy. The antihypertensive effect of ACE inhibitors, including Novapress, may be attenuated by NSAIDs.

Hypotension - Patients on Diuretic Therapy: Patients on diuretics and especially those in whom diuretic therapy was recently instituted, as well as those on severe dietary salt restriction or dialysis, may occasionally experience a precipitous reduction of blood pressure usually within the first hour after receiving the initial dose of Novapress.

The possibility of hypotensive effects with Novapress can be minimized by either discontinuing the diuretic or increasing the salt intake approximately one week prior to initiation of treatment with Novapress (Novapress tablets, USP) or initiating therapy with small doses (6.25 or 12.5 mg). Alternatively, provide medical supervision for at least one hour after the initial dose. If hypotension occurs, the patient should be placed in a supine position and, if necessary, receive an intravenous infusion of normal saline. This transient hypotensive response is not a contraindication to further doses which can be given without difficulty once the blood pressure has increased after volume expansion.

Agents Having Vasodilator Activity: Data on the effect of concomitant use of other vasodilators in patients receiving Novapress for heart failure are not available; therefore, nitroglycerin or other nitrates (as used for management of angina) or other drugs having vasodilator activity should, if possible, be discontinued before starting Novapress. If resumed during Novapress therapy, such agents should be administered cautiously, and perhaps at lower dosage.

Agents Causing Renin Release: Novapress's effect will be augmented by antihypertensive agents that cause renin release. For example, diuretics (e.g., thiazides) may activate the renin-angiotensinaldosterone system.

Agents Affecting Sympathetic Activity: The sympathetic nervous system may be especially important in supporting blood pressure in patients receiving Novapress alone or with diuretics. Therefore, agents affecting sympathetic activity (e.g., ganglionic blocking agents or adrenergic neuron blocking agents) should be used with caution. Beta-adrenergic blocking drugs add some further antihypertensive effect to Novapress, but the overall response is less than additive.

Agents Increasing Serum Potassium: Since Novapress decreases aldosterone production, elevation of serum potassium may occur. Potassium-sparing diuretics such as spironolactone, triamterene, or amiloride, or potassium supplements should be given only for documented hypokalemia, and then with caution, since they may lead to a significant increase of serum potassium. Salt substitutes containing potassium should also be used with caution.

Lithium: Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. These drugs should be coadministered with caution and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, it may increase the risk of lithium toxicity.

Cardiac Glycosides: In a study of young healthy male subjects no evidence of a direct pharmacokinetic Novapress-digoxin interaction could be found.

Loop Diuretics: Furosemide administered concurrently with Novapress does not alter the pharmacokinetics of Novapress in renally impaired hypertensive patients.

Allopurinol: In a study of healthy male volunteers no significant pharmacokinetic interaction occurred when Novapress and allopurinol were administered concomitantly for 6 days.

Gold

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE inhibitor therapy including Novapress.

Drug/Laboratory Test Interaction

Novapress may cause a false-positive urine test for acetone.

See also:
What are the possible side effects of Novapress?

Applies to Novapress: oral liquid, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Novapress (the active ingredient contained in Novapress). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Novapress:

Less common:

• Chest pain
• cloudy urine
• fast, pounding, or irregular heartbeat or pulse

• Arm, back, or jaw pain
• bloody urine
• chest discomfort
• chest tightness or heaviness
• decreased blood pressure
• decreased or increased frequency or amount of urine
• dilated neck veins
• increased thirst
• irregular breathing
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• low blood pressure
• lower back or side pain
• nausea
• paleness or cold feeling in fingertips and toes
• sweating
• swelling of face, fingers, feet, or lower legs
• tingling or pain in fingers or toes when exposed to cold
• troubled breathing or wheezing
• unusual tiredness or weakness
• vomiting
• weight gain

• Bleeding gums
• bloody, black, or tarry stools
• blurred vision
• chills
• confusion
• cough
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• high fever
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• swollen glands
• unusual bleeding or bruising

Minor Side Effects

Some of the side effects that can occur with Novapress may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Change in taste
• feeling of warmth
• itching skin
• loss of taste
• rash
• redness of the face, neck, arms, and occasionally, upper chest

Novapress is a potent, competitive inhibitor of angiotensin-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Novapress may be used in the treatment of hypertension.