ZESTRIL Tablet

គុណភាពព្យាបាល

- ឱសថនេះប្រើសំរាប់ព្យាបាលជម្ងឺសម្ពាធឈាមឡើង ជំម្ងឺខ្សោយបេះដូង(Heart Failure) ជម្ងឺរលួយសាច់ដុំបេះដូង

- ឱសថនេះអាចបន្ថយការបញ្ចេញAlbuminតាមទឹកនោម រួមចំណែកក្នុងការជួយព្យាបាលជម្ងឺទឹកនោមផ្អែម(Renal complications of diabetes mellitus)។

កំរិតនិងរបៀបប្រើ

- ឱសថនេះ ត្រូវលេប1ថ្ងៃ1ដង ក្នុងពេលតែមួយជារៀងរាល់ថ្ងៃ ការជ្រាបចូលនៃឱសថមិនពាក់ព័ន្ធនឹងចំណីអាហារទេ (អាចលេបបាននៅពេលបាយ)។

- កំរិតប្រើអាចប្រែប្រួលទៅតាមលទ្ធផលព្យាបាល និងសភាពជម្ងឺរបស់បុគ្គល។

ក-ជម្ងឺសម្ពាធឈាមឡើង:

ឱសថនេះអាចប្រើតែឯង ឬចំរុះជាមួយឱសថប្រឆាំងសម្ពាធឈាមឡើងផ្សេងទៀត

- ជាទូទៅគឺលេប1ថ្ងៃ 1គ្រាប់ (កំរិត10ម.ក្រ) នៅពេលចាប់ផ្ដើមដំបូង។

- ចំពោះអ្នកជម្ងឺខ្សោយតម្រងនោមខ្លាំង ឬមានជម្ងឺបេះដូងធ្ងន់ធ្ងរត្រូវចាប់ផ្ដើមប្រើកំរិតខ្សោយ (2.5ម.ក្រ - 5ម.ក្រ) ជាការប្រសើរ។

- កំរិតប្រើទ្រទ្រង់សំរាប់ការលេបយូរអង្វែងគឺ 20ម.ក្រក្នុង1ថ្ងៃ តែបើសម្ពាធឈាមនៅតែមិនធ្លាក់ទេក្នុងរយៈពេល2-4សប្ដាហ៍ អាចបង្កើនកំរិតប្រើ តែមិនត្រូវប្រើលើសពី80ម.ក្រក្នុង1ថ្ងៃទេ។

ខ-ជម្ងឺខ្សោយបេះដូង (Heart Failure):

កំរិតប្រើចាប់ផ្ដើមពី 2.5ម.ក្រ ក្នុង1ថ្ងៃ ហើយអាចបង្កើនកំរិតប្រើបន្តិចម្ដងៗ តែមិនត្រូវប្រើលើសពី10ម.ក្រ ក្នុង1ថ្ងៃទេ (ការព្យាបាលនិងការប្រើប្រាស់ឱសថត្រូវស្ថិតនៅក្រោមការតាមដានរបស់គ្រូពេទ្យ)។

គ. រួមផ្សំក្នុងការទប់ស្កាត់ផលវិបាកបណ្ដាលមកពីជម្ងឺទឹកនោមផ្អែម កំរិតប្រើគឺ 10ម.ក្រក្នុង1ថ្ងៃ ហើយអាចកើនឡើងដល់20ម.ក្រ ក្នុង1ថ្ងៃ

- គួរជៀសវាងប្រើចំពោះកុមារនិងស្ត្រីបំបៅកូន។

- Treatment of hypertension

- Treatment of symptomatic heart failure

- Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction

- Renal complications of diabetes mellitus: In normotensive insulin-dependent and hypertensive non-insulin-dependent diabetes mellitus patients who have incipient nephropathy characterized by micro albuminuria, Zestril reduces urinary albumin excretion rate.

Posology and method of administration

Zestril should be administered orally in a single daily dose.

Zestril should be taken at approximately the same time each day. The absorption of Zestril tablets is not affected by food.

The dose should be individualised according to patient profile and blood pressure response.

- Hypertension

Zestril may be used as monotherapy or in combination with other classes of antihypertensive therapy.

Starting dose

10mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose.

A starting dose of 2.5-5mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment.

Maintenance dose

20mg administered in a single daily dose. In general if the desired therapeutic effect cannot be achieved in a period of 2-4 weeks on a certain dose level, the dose can be further increased. The maximum dose used in long-term, controlled clinical trials was 80mg/day.

See the package insert about the details below:

- Diuretic-treated patients

- Hypertensive Paediatric Patients aged 6-16 years

Heart Failure

In patients with symptomatic heart failure, Zestril should be used as adjunctive therapy to diuretics and, where appropriate, digitalis or beta-blockers. Zestril may be initiated at a starting dose of 25mg once a day, which should be administered under medical supervision to determine the initial effect on the blood pressure. The dose of Zestril should be increased:

- By increments of no greater than 10mg

- At intervals of no loss than 2 weeks

- To the highest dose tolerated by the patient up to a maximum of 35mg once daily.

Dose adjustment should be based on the clinical response of individual patients. Patients at high risk of symptomatic hypotension e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy should have these conditions corrected, if possible, prior to therapy with Zestril. Renal function and serum potassium should be monitored.

Acute myocardial infarction

Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin, and beta-blockers. Intravenous or transdermal glyceryl trinitrate may be used together with Zestril.

Starting dose (first 3 days after infarction)

Treatment with Zestril may be started within 24 hours of the onset of symptoms. Treatment should not be started if systolic blood pressure is lower than 100mmHg. The first dose of Zestril is 5mg given orally, followed by 5mg after 24 hours, 10mg after 48 hours and then 10mg once daily. Patients with a low systolic blood pressure (120mmHg or less) when treatment is started or during the first 3 days after the infarction should be given a lower dose 2.5mg orally.

In cases of renal impairment (creatinine clearance <80ml/min), the initial Zestril dosage should be adjusted according to the patient’s creatinine clearance.

Maintenance dose

10mg once daily. If hypotension occurs (systolic blood pressure less than or equal to 100mmHg) a daily maintenance dose of 5mg may be given with temporary reductions to 2.5mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90mmHg for more than 1 hour) Zestril should be withdrawn.

Treatment should continue for 6 weeks and then the patient should be re-evaluated. Patients who develop symptoms of heart failure should continue with Zestril.

Renal complications of diabetes mellitus

In normotensive insulin-dependent diabetes mellitus patients, the daily dose is 10mg Zestril once daily which can be increased to 20mg once daily, if necessary, to achieve a sitting diastolic blood pressure below 75mmHg. In hypertensive non-insulin-dependent diabetes mellitus patients, the dose schedule is as above to achieve a sitting diastolic blood pressure below 90mmHg.

In cases of renal impairment (creatinine clearance <80mL/min), the initial Zestril dosage should be adjusted according to the patient’s creatinine clearance.

Other people

In clinical studies, there was no age-related change in the efficacy or safety profile of the drug. When advanced age is associated with decrease in renal function, however, the guidelines set out in Table 1 (see the package insert) should be used to determine the starting dose of Zestril. Thereafter, the dosage should be adjusted according to the blood pressure response.

Use in kidney transplant patients: See the package insert.

ហាមប្រើចំពោះ៖

- អ្នកធ្លាប់មានប្រតិកម្មជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ

- អ្នកមានប្រវត្តិជម្ងឺហើមសរសៃ (Angioedema)

- ស្ត្រីមានផ្ទៃពោះក្នុងត្រីមាសទី2 ឬ ទី3។

- Hypersensitivity to Zestril, to any of the excipients or any other angiotensin-converting enzyme (ACE) inhibitor.

- History of angioedema associated with previous ACE inhibitor therapy.

- Hereditary or idiopathic angioedema

- Second or third trimesters of pregnancy

- In combination with aliskiren-containing medicines in patients with diabetes mellitus (typeⅠorⅡ) or with moderate to severe renal impairment (GFR <60mL/min/1.73m2).

ផលវិបាក៖

- ផលវិបាកសាមញ្ញ: វិលមុខ ឈឺក្បាល វិលមុខនៅពេលក្រោកឈរ ក្អក រាក ក្អួត ឈឺពោះ នោមតិច។

- ផលវិបាកវិសាមញ្ញ ឬកម្រនឹងកើតមាន: អត្រាជាតិស្ករចុះ ដេកមិនស្រួល ហូបមិនឆ្ងាញ់ ខួរក្បាលមិនល្អ បេះដូងលោតញាប់ លោតខ្លាំង រលាកច្រមុះ ស្ងួតមាត់ ជាំស្បែក រមាស់ ហើមមុខ ហើមម្រាមដៃម្រាមជើង កម្លាំងផ្លូវភេទចុះខ្សោយ អស់កម្លាំង។

Blood and the lymphatic system disorders

rare: decreases in haemoglobin, decrease in haematocrit

very rare: bone marrow depression, anaemia, thrombocytopenia, leucopenia, neutropenia, agranulocytosis, haemolytic anaemia, lymphadenopathy, autoimmune disease.

Metabolism and nutrition disorders

very rare: hypoglycaemia

Nervous system and psychiatric disorders

common: dizziness, headache

uncommon: mood alterations, paraesthesia, vertigo, taste disturbance, sleep disturbances, hallucinations.

rare: mental confusion, olfactory disturbance

not known: depressive symptoms, syncope

Cardiac and vascular disorders

common: orthostatic effects (including hypotension)

uncommon: myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients, palpitations, tachycardia, Raynaud’s phenomenon.

Respiratory, thoracic and mediastinal disorders:

common: cough

uncommon: rhinitis

very rare: bronchospasm, sinusitis, allergic alveolitis/eosinophilic pneumonia

Gastrointestinal disorders:

common: diarrhoea, vomiting

uncommon: nausea, abdominal pain and indigestion dry mouth

very rare: pancreatitis, intestinal angioedema, hepatitis - either hepatocellular or cholestatic, jaundice and hepatic failure.

Skin and subcutaneous tissue disorders

uncommon: rash, pruritus, hypersensitivity/angioneurotic oedema, angioneurotic oedema of the face, extremities, lips, tongue, glottis, and/or larynx.

rare: urticaria, alopecia, psoriasis

very rare: diaphoresis, pemphigus, toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, cutaneous pseudo lymphoma.

A symptom complex has been reported which may include one or more of the following:

fever, vasculitis, myalgia, arthralgia/arthritis, a positive antinuclear antibodies (ANA), elevated red blood cell sedimentation rate (ESR), eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations may occur.

Renal and urinary disorders

common: renal dysfunction

rare: uraemia, acute renal failure

very rare: oliguria/anuria

Endocrine disorders

Not known: inappropriate antidiuretic hormone secretion

Reproductive system and breast disorders

uncommon: impotence

rare: gynaecomastia

General disorders and administration site conditions

uncommon: fatigue, asthenia

Investigations

uncommon: increases in blood urea, increases in serum creatinine, increases in liver enzymes, hyperkalaemia

rare: increases in serum bilirubin, hyponatraemia.

Safety data from clinical studies suggest that lisinopril is generally well tolerated in hypertensive paediatric patients, and that the safety profile in this age group in comparable to that seen in adults.

See the package insert about the details below:

- Antihypertensive agents

- Diuretics

- Potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes

- Lithium

- NSAIDs including acetylsalicylic acid ≥3g/day

- Gold

- Tricyclic antidepressants/Antipsychotics/Anaesthetics

- Sympathomimetics

- Antidiabetics

- Tissue Plasminogen Activators

- Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates

・ហាមប្រើចំពោះស្ត្រីមានផ្ទៃពោះក្នុងត្រីមាសទី2 ឬ ទី3។

・គួរជៀសវាងប្រើចំពោះស្ត្រីបំបៅកូន។

See the package insert about the details below:

Pregnancy

Lisinopril should not be used during the first trimester of pregnancy. Zestril is contraindicated in the second and third trimesters of pregnancy. When pregnancy is detected, lisinopril treatment should discontinue as soon as possible.

Breast feeding

Use of lisinopril is not recommended during breast-feeding.

ការប្រុងប្រយ័ត្ន៖

- ការប្រើឱសថនេះងាយនឹងធ្វើអោយមានសម្ពាធឈាមចុះ ពិសេសអ្នកប្រើឱសថបញ្ចុះទឹកនោម អ្នកតមប្រៃ(អំបិល) រាក ក្អួត អ្នកមានជម្ងឺបេះដូងខ្សោយ និងតម្រងនោមខ្សោយ ហេតុនេះកំរិតប្រើចាំបាច់ត្រូវត្រួតពិនិត្យអោយបានដិតដល់ជៀសវាងគ្រោះថ្នាក់។

- ចំពោះអ្នកជម្ងឺខ្លះ សម្ពាធឈាមចុះគ្រាន់តែជាផលវិបាកបណ្ដោះអាសន្នមិនចាំបាច់បន្ថយកំរិតប្រើទេ តែចំពោះអ្នកជម្ងឺខ្លះត្រូវបន្ថយកំរិតប្រើ ឬឈប់ប្រើតែម្ដង (ចូរពិគ្រោះជាមួយគ្រូពេទ្យ)។

See the package insert about the details below:

- Symptomatic hypotension

- Hypotension in acute myocardial infarction

- Aortic and mitral value stenosis/hypertrophic cardiomyopathy

- Renal function impairment

bilateral renal artery stenosis or stenosis of the artery to a solitary kidney

hypertensive patients

acute myocardial infarction

- Hypersensitivity/Angioedema

- Anaphylactoid reactions in haemodialysis patients

- Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis

- Desensitisation

- Hepatic failure

- Neutropenia/Agranulocytosis

- Dual blockade of the renin-angiotensin-aldosterone system (RAAS) with aliskiren-containing medicines

- Race

- Cough

- Surgery/Anaesthesia

- Hyperkalaemia

- Lithium

Zestril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin converting enzyme (ACE) that catalyses the conversion of angiotensinⅠto the vasoconstrictor peptide, angiotensinⅡ. AngiotensinⅡalso stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased vasopressor activity and reduces aldosterone secretion. The latter decrease may result in an increase in serum potassium concentration.