Ziscar tablets 5mg Each tablet contains:
Lisinopril Dihydrate equivalent to Lisinopril Ziscar tablets 10mg Each tablet contains:
Lisinopril Dihydrate equivalent to Lisinopril Ziscar tablets 20mg Each tablet contains:
Lisinopril Dihydrate equivalent to Lisinopril
20mg
5mg
10mg
DESCRIPTION
Lisinopril is an oral long-acting angiotensin converting enzyme inhibitor, Lisinopril, a synthetic peptide derivative, is chemically described as-(S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate.
PHARMACODYNAMICS AND CLINICAL EFFECTS:
Hypertension: Administration of Lisinopril to patients with hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is usually not observed although it can occur and should be anticipated in volume and/or salt-depteted patients.
(See WARNINGS.)
When given together with thiazide-type diuretics, the blood pressure lowering effects of the two drugs are approximately additive. In most patients studied, onset of antihypertensive activity was seen at one hour after oral administration of an individual dose of Lisinopril with peak reduction of blood pressure achieved by 6 hours. Although an antihypertensive effect was observed 24 hours after dosing with recommended single daily dose, the effect was more consistent and the mean effect was considerably larger in some studies with doses of 20 mg or more than with lower doses. However, at all doses studied, the mean antihypertensive effect was substantially smaller 24 hours after dbsing than it 'was 6 hours after dosing.
The antihypertensive effects of Lisinopril are maintained during longterm therapy. Abrupt withdrawal of Lisinopril has not been associated with a rapid increase in blood pressure, or a significant increase in blood pressure compared to pretreatment levels.
Dose of Lisinopril and/or diuretic is increased. Similar considerations may apply to patients with ischemic heart or cerebrovascular disease, or in patients with acute myocardial infarction, in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident.
Lisinopril has been shown to be well tolerated and effective in controlling blood pressure.
(See PRECAUTIONS.)
INDICATIONS AND USAGE:
Hypertension: ZISCAR is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
Heart Failure:
ZISCAR is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.
ACUTE MYOCARDIAL INFARCTION; Ziscar is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival, In using ZISCAR, 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 ZISCAR does not have a similar risk. (See WARNINGS.)
CONTRAINDICATIONS
ZISCAR is contra indicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin converting enzyme inhibitor.
WARNINGS
Anaphylactoid and Possibly Related Reactions: Presumably because angitensin-converting enzyme inhibitors affect the metabolism of elcosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors {including ZISCAR) may be subject to a variety of adverse reactions, some of them serious.
Angioedema:
Angioedema of the face, extremities, lips, tongue glottis and/or \arynx has been reported in patients treated with Angiotensin converting enzyme inhibitors, including Lisinopril. ZISCAR should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms have 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 i? 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 3 patent airway should be promptly provided.
(See ADVERSE REACTIONS.)
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving ari ACE inhibitor.
(See also INDICATIONS USAGE and CONTRAINDICATIONS).
Hypotension: Excessive hypotension is rare in patients with uncomplicated hypertension treated with ZISCAR alone. Evidence from the two-dose trial suggested that incidence of hypotension may increase with dose of lisinopril in heart failure patients. Discontinuation of therapy because of continuing symptomatic hypotension usualfy is not necessary when dosing instructions are followed; caution should be observed when initiating therapy.
(See DOSAGE AND ADMINISTRATION.)
Patients at risk of excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute.renal failure and/or death,
(See PRECAUTIONS, DRUG INTERACTIONS and ADVERSE REACTJONS.)
In patients at risk of excessive hypotension patients with ischemicjteart or cerebrovascular disease & myocardial infarction, therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of ZISCAR and/or diuretic is increased.
Hepatic Failure:
Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic, jaundice and progresses to fulminant hepatic necrosis and (sometimes) death.
Foetal/Neonatal Morbidity and Mortality:
ACE inhibitors can cause foetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the wodd literature. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. *
PRECAUTIONS General
Impaired Renal Function: As a consequence of inhibiting the reninangiotensin-aldosterone system, changes in renal function may.be anticipated in susceptible individuals, In patients with severe congestive heart failure whose renal function may depend on the activity of the fenin-angiotensin.-aldosterone system, treatment with angiotensin converting enzyme inhibitors, including Lisinopril may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. This is more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or ZISCAR may be required.
Evaluation of patients with hypertension, heart failure, or myocardial Infarction should always include assessment of renal function.
(See DOSAGE AND ADMINISTRATION.) Hyperkalemia:
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 ZISCAR.
(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," almost always resolving after discontinuation of therapy.
Surgery/Anesthesia:
In patients undergoing major surgery or during anesthesia with agents that produce hypotension.
DRUG INTERACTIONS •
Hypotension - Patients on Diuretic Therapy: Patients on diuretics and especially those, in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Lisinopril.
Indomethacin:
In a study in 36 patients with mild to moderate hypertension where the antihypertensive effects of Lisinopril alone were compared to Lisinopril given concomitantly with indomethacin, the use of indomethacin was associated with a reduced effect, although the difference between the two regimens was not significant.
Other Agents: Lisinopril has been used concomitantly with nitrates and/or digoxin Propranolol or hydrochlorolhiazide without evidence of clinically, significant adverse interactions. The presence of food in the stomach does not alter the bioavailability of Lisinopril.
Agents Increasing Serum Potassium:
Use of Lisinopril with potassium sparing diuretics (e.g., spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Lithium: Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors.
USE IN PREGNANCY:
The use of ZISCAR dunng pregnancy is not recommended. Nursing Mother:
It is not known whether lisinopril is secreted in human milk because many drugs are secreted in human milk, caution should be exercised if ZISCAR giving to woman who are at breast feeding. Paediatric Use: Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Body as a Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid Reactions during Membrane Exposure), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise.
Cardiovascular:
Cardiac arrest; .myocardial infarction or cerebrovascular accident possibly secondary to "excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia and premature ventricular contractions), palpitations, transient ischemic attacks, paroxysmal nocturnal dyspnea, orthostatic hypotension, decreased blood pressure, peripheral edema, vasculitis.
Digestive:
Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (see WARNINGS, Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth.
Hematologic:
Rare C3ses of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia. Endocrine: Diabetes mellitus.
Metabolic:
Weight loss, dehydration, fluid overload, gout, weight gain.
Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, lumbago.
Nervous System/Psychiatric:
Stroke, ataxia, memory impairment, tremor, peripheral neuropathy (e.g., dysesthesia), spasm, paresthesia, confusion, insomnia, somnolence, hypersomnia, irritability and nervousness;
Respiratory System:
Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, bronchitis, vyheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea. Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, flushing, diaphoresis. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson syndrome;, causal relationship has not been established.
Special Senses:
Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste alteration. Urogenital System: Acite renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction, (see PRECAUTIONS and - DOSAGE AND ADMINISTRATION)
, pyelonephritis, dysuria, urinary tract infection, breast pain.
Foetal/Neonatal Morbidity and Mortality:
See WARNINGS, Foetal/Neonatal Morbidity and Mortality.
Cough: See PRECAUTIONS - Cough
Clinical Laboratory Test Findings Serum Electrolytes: Hyperkalemia (See PRECAUTIONS), hyponatremia.
Creatinine, Blood Urea Nitrogen: Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy,
Hemoglobin and Hematocrit:
Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred.
Liver Function Tests: Rarely, elevations of liver enzymes and/or serum bilirubin have occurred. (See WARNINGS, Hepatic Failure.)
DRUG INTERACTIONS •
Hypotension - Patients on Diuretic Therapy: Patients on diuretics and especially those, in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with Lisinopril.
Indomethacin:
In a study in 36 patients with mild to moderate hypertension where the antihypertensive effects of Lisinopril alone were compared to Lisinopril given concomitantly with indomethacin, the use of indomethacin was associated with a reduced effect, although the difference between the two regimens was not significant.
Other Agents:
Lisinopril has been used concomitantly with nitrates and/or digoxin Propranolol or hydrochlorolhiazide without evidence of clinically, significant adverse interactions. The presence of food in the stomach does not alter the bioavailability of Lisinopril.
Agents Increasing Serum Potassium:
Use of Lisinopril with potassium sparing diuretics (e.g., spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Lithium: Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors.
USE IN PREGNANCY:
The use of ZISCAR dunng pregnancy is not recommended. Nursing Mother:
It is not known whether lisinopril is secreted in human milk because many drugs are secreted in human milk, caution should be exercised if ZISCAR giving to woman who are at breast feeding. Paediatric Use: Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS
Body as a Whole: Anaphylactoid reactions (see WARNINGS, Anaphylactoid Reactions during Membrane Exposure), syncope, orthostatic effects, chest discomfort, pain, pelvic pain, flank pain, edema, facial edema, virus infection, fever, chills, malaise.
Cardiovascular:
Cardiac arrest; .myocardial infarction or cerebrovascular accident possibly secondary to "excessive hypotension in high risk patients (see WARNINGS, Hypotension); pulmonary embolism and infarction, arrhythmias (including ventricular tachycardia, atrial tachycardia, atrial fibrillation, bradycardia and premature ventricular contractions), palpitations, transient ischemic attacks, paroxysmal nocturnal dyspnea, orthostatic hypotension, decreased blood pressure, peripheral edema, vasculitis.
Digestive:
Pancreatitis, hepatitis (hepatocellular or cholestatic jaundice) (see WARNINGS, Hepatic Failure), vomiting, gastritis, dyspepsia, heartburn, gastrointestinal cramps, constipation, flatulence, dry mouth.
Hematologic:
Rare C3ses of bone marrow depression, hemolytic anemia, leukopenia/neutropenia and thrombocytopenia. Endocrine: Diabetes mellitus.
Metabolic:
Weight loss, dehydration, fluid overload, gout, weight gain.
Musculoskeletal: Arthritis, arthralgia, neck pain, hip pain, low back pain, joint pain, leg pain, knee pain, shoulder pain, arm pain, lumbago.
Nervous System/Psychiatric:
Stroke, ataxia, memory impairment, tremor, peripheral neuropathy (e.g., dysesthesia), spasm, paresthesia, confusion, insomnia, somnolence, hypersomnia, irritability and nervousness;
Respiratory System:
Malignant lung neoplasms, hemoptysis, pulmonary infiltrates, bronchospasm, asthma, pleural effusion, pneumonia, eosinophilic pneumonitis, bronchitis, vyheezing, orthopnea, painful respiration, epistaxis, laryngitis, sinusitis, pharyngeal pain, pharyngitis, rhinitis, rhinorrhea. Skin: Urticaria, alopecia, herpes zoster, photosensitivity, skin lesions, skin infections, pemphigus, erythema, flushing, diaphoresis. Other severe skin reactions have been reported rarely, including toxic epidermal necrolysis and Stevens-Johnson syndrome;, causal relationship has not been established.
Special Senses:
Visual loss, diplopia, blurred vision, tinnitus, photophobia, taste alteration. Urogenital System: Acite renal failure, oliguria, anuria, uremia, progressive azotemia, renal dysfunction, (see PRECAUTIONS and - DOSAGE AND ADMINISTRATION)
, pyelonephritis, dysuria, urinary tract infection, breast pain.
Foetal/Neonatal Morbidity and Mortality: See WARNINGS, Foetal/Neonatal Morbidity and Mortality.
Cough: See PRECAUTIONS - Cough
Clinical Laboratory Test Findings Serum Electrolytes: Hyperkalemia (See PRECAUTIONS), hyponatremia.
Creatinine, Blood Urea Nitrogen:
Minor increases in blood urea nitrogen and serum creatinine, reversible upon discontinuation of therapy,
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.4 g% and 1.3 vol%, respectively) occurred.
Liver Function Tests:
Rarely, elevations of liver enzymes and/or serum bilirubin have occurred. (See WARNINGS, Hepatic Failure.)
OVERDOSAGE
The symptoms of over dosages may include hypotension, electrolyte disturbance and renal failure. Measures to prevent absorption and methods to speed elimination should be employed.
DOSAGE AND ADMINISTRATION Hypertension
Initial Therapy: In patients with uncomplicated essential hypertension not on diuretic therapy, the recommended initial dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response.
The usual dosage range is 20 to 40 mg per day administered in a- single daily dose. Diuretic Treated Patients: In hypertensive patients who are currently being treated with a diuretic, The diuretic should be discontinued, if possible, for two to three days before beginning therapy with ZISCAR to reduce the likelihood of hypotension.
(See WARNINGS.)
If the diuretic; cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for at least two hours and until blood oressure has stabilized for at least an additional hour. (See WARNINGS and PRECAUTIONS. DRUG INTERACTIONS.)
Dosage Adjustment in Renal Impairment: The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily.
Heart Failure
ZISCAR is indicated as adjunctive therapy with diuretics and (usually) digitalis. The recommended starting dose is 5 mg once a day. The initial dose should be administered under medical observation, especially in those patients with low blood pressure (systolic brood pressure below 100 mmHg). Observation should continue until blood pressure is stable. The concomitant diuretic dose should be reduced, if possible, to help minimize hypovolemia which may contribute to hypotension. (See WARNINGS, PRECAUTIONS and DRUG INSTERACTION)
The usual effective dosage range is 5 to 40 mg per day administered as a single daily dose. The dose of ZISCAR can be increased by increments of no greater than 10 mg, at intervals of no less than 2 weeks to the highest tolerated dose, up to a maximum of 40 mg daily.
Acute Myocardial Infarction: In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, the first dose of ZISCAR is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg of. ZISCAR once daily. Dosing should continue for six weeks. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers.
Patients with a low systolic blood pressure (= 120 mmHg) when treatment is started or during the first 3 days after the infarct should be given a lower 2.5 mg oral dose of ZISCAR (see WARNINGS). If hypotension occurs (systolic blood pressure = 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reductions to 2.5 mg if needed. If prolonged hypotension occurs (systolic blood pressure < 90 mmHg for more than 1 hour) ZISCAR should be withdrawn.
DOSAGE ADJUSTMENT IN PATIENTS WITH MYOCARDIAL INFARCTION WITH RENAL IMPAIRMENT;
In acute myocardial infarction, treatment with ZISCAR should be initiated with caution in patients with evidence of renal dysfunction.
Use in Elderly:
In general, biood pressure response and adverse experiences were similar in younger and older patients given similar doses of Lisinopril Pharmacokinetic studies, however-, indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients, so that dosage adjustments should be made with particular caution.
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