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DRUGS & SUPPLEMENTS
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Riva-Enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of Riva-Enalapril maleate and thiazides are approximately additive.
In using Riva-Enalapril maleate, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that Riva-Enalapril maleate does not have a similar risk.
In considering use of Riva-Enalapril maleate, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS, Head and Neck Angioedema.)
Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including Riva-Enalapril maleate. This may occur at any time during treatment. In such cases Riva-Enalapril maleate should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., Subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided.
Intestinal Angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved
after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor.
Anaphylactoid reactions during desensitization: Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.
Anaphylactoid reactions during membrane exposure: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
If excessive hypotension occurs, the patient should be placed in the supine position and, if necessary, receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses of Riva-Enalapril maleate, which usually can be given without difficulty once the blood pressure has stabilized. If symptomatic hypotension develops, a dose reduction or discontinuation of Riva-Enalapril maleate or concomitant diuretic may be necessary.
In a published retrospective epidemiological study, infants whose mothers had taken an ACE inhibitor during their first trimester of pregnancy appeared to have an increased risk of major congenital malformations compared with infants whose mothers had not undergone first timester exposure to ACE inhibitor drugs. The number of cases of birth defects is small and the findings of this study are not yet been repeated.
The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to the ACE-inhibitor exposure.
These adverse effects do not appear to have resulted from intrauterine ACE-inhibitor exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to ACE inhibitors only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should make every effort to discontinue the use of Riva-Enalapril maleate as soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no alternative to ACE inhibitors will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.
If oligohydramnios is observed, Riva-Enalapril maleate should be discontinued unless it is considered lifesaving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed towards support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function. Riva-Enalapril, which crosses the placenta, has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure.
No teratogenic effects of Riva-Enalapril were seen in studies of pregnant rats, and rabbits. On a body surface area basis, the doses used were 57 times and 12 times, respectively, the maximum recommended human daily dose (MRHDD).
Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin converting enzyme inhibitors, including Riva-Enalapril maleate, may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death.
In clinical studies in hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine were observed in 20 percent of patients. These increases were almost always reversible upon discontinuation of Riva-Enalapril and/or diuretic therapy. In such patients renal function should be monitored during the first few weeks of therapy.
Some patients with hypertension or heart failure with no apparent pre-existing renal vascular disease have developed increases in blood urea and serum creatinine, usually minor and transient, especially when Riva-Enalapril maleate has been given concomitantly with a diuretic. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or Riva-Enalapril maleate
may be required.
Evaluation of patients with hypertension or heart failure should always include assessment of renal function.
Hyperkalemia: Elevated serum potassium (greater than 5.7 mEq/L) was observed in approximately one percent of hypertensive patients in clinical trials. In most cases these were isolated values which resolved despite continued therapy. Hyperkalemia was a cause of discontinuation of therapy in 0.28 percent of hypertensive patients. In clinical trials in heart failure, hyperkalemia was observed in 3.8 percent of patients but was not a cause for discontinuation.
Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes, which should be used cautiously, if at all, with Riva-Enalapril maleate. (See Drug Interactions.)
Cough: Presumably due to the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, always resolving after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough.
Surgery/Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension, Riva-Enalapril may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hypotension: Patients should be cautioned to report light-headedness, especially during the first few days of therapy. If actual syncope occurs, the patients should be told to discontinue the drug until they have consulted with the prescribing physician.
All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; patients should be advised to consult with the physician.
Hyperkalemia: Patients should be told not to use salt substitutes containing potassium without consulting their physician.
Neutropenia: Patients should be told to report promptly any indication of infection (e.g., sore throat, fever) which may be a sign of neutropenia.
Pregnancy: Female patients of childbearing age should be told about the consequences of exposure to ACE inhibitors. These patients should be asked to report pregnancies to their physicians as soon as possible.
NOTE: As with many other drugs, certain advice to patients being treated with Riva-Enalapril is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
Agents Causing Renin Release: The antihypertensive effect of Riva-Enalapril maleate is augmented by antihypertensive agents that cause renin release (e.g., diuretics).
Non-steroidal Anti-inflammatory Agents: In some patients with compromised renal function who are being treated with nonsteroidal anti-inflammatory drugs, the co-administration of Riva-Enalapril may result in a further deterioration of renal function. These effects are usually reversible.
In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving Riva-Enalapril maleate. In this study there was no evidence of a blunting of the antihypertensive action of Riva-Enalapril maleate. However, reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.
Other Cardiovascular Agents: Riva-Enalapril maleate has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions.
Agents Increasing Serum Potassium: Riva-Enalapril maleate attenuates potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. Potassium sparing agents should generally not be used in patients with heart failure receiving enalapril maleate.
Lithium: Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. A few cases of lithium toxicity have been reported in patients receiving concomitant Riva-Enalapril maleate and lithium and were reversible upon discontinuation of both drugs. It is recommended that serum lithium levels be monitored frequently if Riva-Enalapril is administered concomitantly with lithium.
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 Riva-Enalapril.
Neither Riva-Enalapril maleate nor the active diacid was mutagenic in the Ames microbial mutagen test with or without metabolic activation. Riva-Enalapril was also negative in the following genotoxicity studies: rec-assay, reverse mutation assay with E.coli, sister chromatid exchange with cultured mammalian cells and the micronucleus test with mice, as well as in an in vivo cytogenic study using mouse bone marrow.
There were no adverse effects on reproductive performance of male and female rats treated with up to 90 mg/kg/day of Riva-Enalapril (26 times the MRHDD when compared on a body surface area basis).
Riva-Enalapril maleate is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.
For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with Riva-Enalapril maleate reporting adverse experiences was comparable to placebo.
| Enalapril Maleate Incidence (discontinuation) | Placebo (n=230) Incidence |
Body As A Whole | | |
Fatigue | 3.0 (<0.1) | 2.6 |
Orthostatic Effets | 1.2 (<0.1) | 0.0 |
Asthenia | 1.1 (0.1) | 0.9 |
Digestive | | |
Diarrhea | 1.4 (<0.1) | 1.7 |
Nausea | 1.4 (0.2) | 1.7 |
Nervous/Psychiatric | | |
Headache | 5.2 (0.3) | 9.1 |
Dizziness | 4.3 (0.4) | 4.3 |
Respiratory | | |
Cough | 1.3 (0.1) | 0.9 |
Skin | | |
Rash | 1.4 (0.4) | 0.4 |
| Enalapril Maleate (n=673) Incidence (discontinuation) | Placebo (n=339) Incidence |
Body As A Whole | | |
Orthostatic Effects | 2.2 (0.1) | 0.3 |
Syncope | 2.2 (0.1) | 0.9 |
Chest Pain | 2.1 (0.0) | 2.1 |
Fatigue | 1.8 (0.0) | 1.8 |
Abdominal Pain | 1.6 (0.4) | 2.1 |
Asthenia | 1.6 (0.1) | 0.3 |
Cardiovascular | | |
Hypotension | 6.7 (1.9) | 0.6 |
Orthostatic Hypotension | 1.6 (0.1) | 0.3 |
Angina Pectoris | 1.5 (0.1) | 1.8 |
Myocardial Infarction | 1.2 (0.3) | 1.8 |
Digestive | | |
Diarrhea | 2.1 (0.1) | 1.2 |
Nausea | 1.3 (0.1) | 0.6 |
Vomiting | 1.3 (0.0) | 0.9 |
Nervous/Psychiatric | | |
Dizziness | 7.9(0.6) | 0.6 |
Headache | 1.8 (0.1) | 0.9 |
Vertigo | 1.6 (0.1) | 1.2 |
Respiratory | | |
Cough | 2.2 (0.0) | 0.6 |
Bronchitis | 1.3 (0.0) | 0.9 |
Dyspnea | 1.3 (0.1) | 0.4 |
Pneumonia | 1.0 (0.0) | 2.4 |
Skin | | |
Rash | 1.3 (0.0) | 2.4 |
Urogenital | | |
Urinary Tract Infection | 1.3 (0.0) | 2.4 |
Body As A Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid and Possibly Related Reactions).
Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction; pulmonary edema; rhythm disturbances including atrial tachycardia and bradycardia; atrial fibrillation; palpitation, Raynaud’s phenomenon.
Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see WARNINGS, Hepatic Failure), melena, anorexia, dyspepsia, constipation, glossitis, stomatitis, dry mouth.
Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression.
Musculoskeletal: Muscle cramps.
Nervous/Psychiatric: Depression, confusion, ataxia, somnolence, insomnia, nervousness, peripheral neuropathy (e.g., paresthesia, dysesthesia), dream abnormality.
Respiratory: Bronchospasm, rhinorrhea, sore throat and hoarseness, asthma, upper respiratory infection, pulmonary infiltrates, eosinophilic pneumonitis.
Skin: Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pemphigus, herpes zoster, erythema multiforme, urticaria, pruritus, alopecia, flushing, diaphoresis, photosensitivity.
Special Senses: Blurred vision, taste alteration, anosmia, tinnitus, conjunctivitis, dry eyes, tearing.
Urogenital: Renal failure, oliguria, renal dysfunction, flank pain, gynecomastia, impotence.
Miscellaneous: A symptom complex has been reported which may include some or all of the following: a positive ANA, an elevated erythrocyte sedimentation rate, arthralgia/arthritis, myalgia/ myositis, fever, serositis, vasculitis, leukocytosis, eosinophilia, photosensitivity, rash and other dermatologic manifestations.
Angioedema: Angioedema has been reported in patients receiving Riva-Enalapril maleate with an incidence higher in black than in non-black patients. Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis and/or larynx occurs, treatment with Riva-Enalapril maleate should be discontinued and appropriate therapy instituted immediately.
Hypotension: In the hypertensive patients, hypotension occurred in 0.9 percent and syncope occurred in 0.5 percent of patients following the initial dose or during extended therapy. Hypotension or syncope was a cause for discontinuation of Therapy in 0.1 percent of hypertensive patients. In heart failure patients, hypotension occurred in 6.7 percent and syncope occured in 2.2 percent of patients. Hypotension or syncope was a cause for discontinuation of therapy in 1.9 percent of patients with heart failure.
Fetal/Neonatal Morbidity and Mortality: See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Cough: See PRECAUTIONS, Cough.
Pediatric Patients
The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.
Creatinine, Blood Urea Nitrogen: In controlled clinical trials minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy, were observed in about 0.2 percent of patients with essential hypertension treated with Riva-Enalapril maleate alone. Increases are more likely to occur in patients receiving concomitant diuretics or in patients with renal artery stenosis. In patients with heart failure who were also receiving diuretics with or without digitalis, increases in blood urea nitrogen or serum creatinine, usually reversible upon discontinuation of Riva-Enalapril maleate and/or other concomitant diuretic therapy, were observed in about 11 percent of patients. Increases in blood urea nitrogen or creatinine were a cause for discontinuation in 1.2 percent of patients.
Hematology: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g percent and 1.0 vol percent, respectively) occur frequently in either hypertension or congestive heart failure patients treated with Riva-Enalapril maleate but are rarely of clinical importance unless another cause of anemia coexists. In clinical trials, less than 0.1 percent of patients discontinued therapy due to anemia. Hemolytic anemia, including cases of hemolysis in patients with G-6-PD deficiency, has been reported; a causal relationship to Riva-Enalapril cannot be excluded.
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin have occurred (see WARNINGS, Hepatic Failure).
The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution.
Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis. (See WARNINGS, Anaphylactoid reactions during membrane exposure.)
If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.)
The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with Riva-Enalapril Maleate Tablets alone, a diuretic may be added.
Concomitant administration of Riva-Enalapril Maleate Tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium.
Dosage Adjustment in Hypertensive Patients with Renal Impairment
The usual dose of Riva-Enalapril is recommended for patients with a creatinine clearance >30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance ≤30 mL/min (serum creatinine ≥3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
Renal Status | Creatinine- Clearance ml/min | Initial Dose mg/day |
Normal Renal Function | >80 mL/min | 5 mg |
Mild Impairment | ≤80> 30 mL/min | 5 mg |
Moderate to Severe Impairment | ≤30 mL/min | 2.5 mg |
Dialysis Patients*** | - - | 2.5 mg on dialysis days† |
†Dosage on nondialysis days should be adjusted depending on the blood pressure response.
Heart Failure
Riva-Enalapril Maleate Tablets are indicated for the treatment of symptomatic
heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses.
The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses.
After the initial dose of Riva-Enalapril Maleate Tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of Riva-Enalapril Maleate Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Asymptomatic Left Ventricular Dysfunction
In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses).
After the initial dose of Riva-Enalapril Maleate Tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS, Drug Interactions.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of Riva-Enalapril Maleate Tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.
Dosage Adjustment in Patients with Heart Failure and Renal Impairment or Hyponatremia
In patients with heart failure who have hyponatremia (serum sodium less than 130 mEq/L) or with serum creatinine greater than 1.6 mg/dL, therapy should be initiated at 2.5 mg daily under close medical supervision. (See DOSAGE AND ADMINISTRATION, Heart Failure, WARNINGS and PRECAUTIONS, Drug Interactions.) The dose may be increased to 2.5 mg b.i.d., then 5 mg b.i.d. and higher as needed, usually at intervals of four days or more if at the time of dosage adjustment there is not excessive hypotension or significant deterioration of renal function. The maximum daily dose is 40 mg.
Pediatric Hypertensive Patients
The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients.
(See CLINICAL PHARMACOLOGY, Clinical Pharmacology in Pediatric Patients.)
Riva-Enalapril maleate is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/ min/1.73 m2, as no data are available.
Preparation of Suspension (for 200 mL of a 1.0 mg/mL suspension)
Add 50 mL of Bicitra®** to a polyethylene terephthalate (PET) bottle containing ten 20 mg tablets of Riva-Enalapril maleate and shake for at least 2 minutes. Let concentrate stand for 60 minutes. Following the 60-minute hold time, shake the concentrate for an additional minute. Add 150 mL of Ora-Sweet SFTM*** to the concentrate in the PET bottle and shake the suspension to disperse the ingredients.
The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 30 days. Shake the suspension before each use.
Riva-Enalapril Maleate Tablets, USP | |||
---|---|---|---|
NDC number | Strength | Description | Quantity |
NDC 0615-4589-39 | 2.5 mg | White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side. 923 | Blisterpacks of 30's. |
NDC 0615-4590-39 NDC 0615-4590-31 | 5 mg | White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side. 924 | Blisterpacks of 30's and 31's. |
NDC 0615-4591-39 NDC 0615-4591-31 | 10 mg | Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side. 925 | Blisterpacks of 30's and 31's. |
NDC 0615-4593-39 | 20 mg | Light Beige, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side. 926 | Blisterpacks of 30's. |
Store below 30°C (86°F) and avoid transient temperatures above 50°C (122°F). Keep container tightly closed. Protect from moisture.
Dispense in a tight container as per USP, if product package is subdivided.
___________________________________________________________________________________________________________________________________
** Registered trademark of Alza Corporation.
*** Trademark of Paddock Laboratories, Inc.
Manufactured by:
Wockhardt Limited,
Mumbai, India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Rev. 080610
Riva-Enalapril Maleate Tablets,
USP 2.5mg
Principal Display Panel-Enalapril 2.5mg
Riva-Enalapril Maleate Tablets,
USP 5mg
Principal Display Panel-Enalapril 5mg
Riva-Enalapril Maleate Tablets,
USP 10mg
Principal Display Panel-Enalapril 10mg
Riva-Enalapril Maleate Tablets,
USP 20mg
Principal Display Panel-Enalapril 20mg
Depending on the reaction of the Riva-Enalapril after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Riva-Enalapril not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Riva-Enalapril addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology