LISONORM Gedeon tablet treats idiopathic hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Lisinopril, amlodipine

Ingredient

Composition informationContent
Lisinopril10mg
Amlodipine5mg

Uses

indications

LISONORM drugs are indicated in the following cases:

  • Treatment of idiopathic hypertension. ATC code: C09BB03.

    lisinopril

    Lisinopril is an angiotensin conversion enzyme inhibitor, which reduces the plasma and plasma angiotensin II and aldosterone levels, but increases plasma bradykinin levels - a vascular dilatation agent. The drug reduces peripheral resistance and system blood pressure. These changes may be accompanied by an increase in cardiac amount while the heart frequency is constant and increases blood flow through the kidneys. In patients with high blood glucose, Lisinopril contributes to the restoration of the endothelial function.

    amlodipine

    Amlodipine is a calcium channel inhibitor of the dihydropyridine group. Amlodipine inhibits calcium flow into the heart muscle and smooth muscle cells by preventing calcium ion channels in the cell membrane. Amlodipine reduces the plain muscle tension of the artery, thereby reducing peripheral resistance, which reduces systemic blood pressure.

    Amlodipine relieves angina due to peripheral artery dilatation and cardiac levers. These effects are not accompanied by a reflex tachycardia, thus reducing the needs of the heart muscle in oxygen and energy. Amlodipine can relax the coronary artery (artery and artery), this effect improves the source of oxygen for the heart muscle, both in the healthy area as well as the anemia area.

    pharmacokinetics

    lisinopril

    lisinopril reaches a peak concentration in plasma about 6 hours after drinking; Birth is about 29%. Different from the angiotensin conversion enzyme inhibitors, Lisinopril is not associated with plasma proteins. Lisinopril is not metabolized in the body and is excreted into the urine in a constant form. The sale time is about 12.6 hours.

    amlodipine

    After drinking, Amlodipine is absorbed slowly and after the gastrointestinal tract completely. The absorption is not affected by food. The peak concentration in plasma (CMAX) is achieved after 6 hours to 10 hours. The bioavailability of Amlodipine is from 64% to 80%, the distribution is about 20 l/kg. During the system circulation, about 95% to 98% amlodipine connects to plasma proteins. Amlodipine is strongly metabolized through the liver into non -active substance. About 10% of the parent and 60% of metabolites are excreted into the urine.

    Amlodipine is eliminated in 2 phases, of which, the last phase selling time is about 30-50 hours. The drug reaches a stable plasma concentration after 7 days to 8 days of continuous treatment. In the liver, Amlodipine is converted into no longer active. This inactive substance and 10% of the mother is excreted through the urine. Amlodipine is not eliminated from the plasma.

  • Before taking LISONORM Gedeon tablet treats idiopathic hypertension (3 blisters x 10 tablets)

    How to use

    oral medication. Food does not affect the absorption of the drug, so it can be used before, during or after meals.

    Dosage

    recommended dose is 1 tablet of Lisonorm every day. The maximum dose is 1 tablet per day.

    For patients with renal failure

    To find the maximum starting dose and maintenance dose for patients with renal impairment, patients need to be titrated with the dose with lisinopril and amlodipine used individually. Amlodipine cannot be appraised.

    Lisinopril is only used for patients with optimal maintenance dose of 10 mg of lisinopril and 5 mg of Amlodipine after titration.

    Use drugs for children and adolescents

    It is not recommended to use Letero for people under 18 years of age because there is not enough data on the safety and effectiveness of the drug for this object.

    For people with liver failure

    Amlodipine elimination process may last in patients with liver failure, so it is not possible to determine the exact dosage for these subjects. Caution should be used when using Lisonorm for patients with liver failure.

    People over 65 years old

    Be careful when treating elderly patients.

    Optimal maintenance dose for the elderly should be titrated for each patient by combining freely Lisinopril and Amlodipine.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose?

    Need to treat symptoms (put the patient on the back, monitor the heart function and support the heart if needed, monitor blood pressure, balance fluid/electrolyte). If the hypotension occurs seriously, the foot must be high. If the infusion does not bring appropriate effect, can be supported by using more peripheral vasoconstrictions, unless there is contraindications. Angiotensin II can be considered. Calcium gluconate intravenous infusion may be useful to reverse the inhibition effect of calcium channels.

    It is possible to remove lisinopril from the system circulation by dialysis. However, because amlodipine is strongly connected to plasma proteins, the separation is not necessarily effective to eliminate this substance.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Lisonorm, you may experience unwanted effects (ADR).

    Common, 1/100 ≤ ADR

  • Nervous system disorders: dizziness, headache, sleep.
  • heart: Brush the chest drum.
  • circuit: Reducing posture blood pressure, flushing.

  • Respiratory, chest and mediastinum: cough.
  • Digestive system: diarrhea, vomiting, nausea, abdominal pain. kidney and urinary: renal function.

  • Common and local disorders: edema, fatigue.
  • Uncommon, 1/1000 ≤ ADR

  • Psychological disorders: mood change, sleep disorders, insomnia.
  • Nervous system disorders: dizziness, abnormalities, taste disorders, decreased sensations, fainting, tremor.
  • Eye: visual disorders.
  • ears and mesmerizing: tinnitus.
  • Heart: myocardial infarction, brushing chest drum, fast heartbeat. vessel: stroke, raynaud’s phenomenon, lower blood pressure.
  • Respiratory, chest and mediastitis: rhinitis, shortness of breath.
  • Digestive system: abdominal pain, nausea, vomiting, indigestion, dry mouth, changing habits of defecation.

    Skin and subcutaneous tissue: Hypersensitivity/Evaluation on the face, limbs, tongue, lips, bars and/or larynx, rash, bleeding, skin color change, sweating, itching, hair loss.

  • Systemic and connective tissue system: joint pain, muscle pain, cramps, back pain.
  • kidney and urinary: urinary disorders, night urine, increase the number of urination.
  • Reproductive and breast disorders: helpless, big breasts in men.
  • Common and local disorders: fatigue, weakness, chest pain.
  • Parameters in testing: hyperuremia, serum hypertreatinine, hyperkalemia, liver enzyme increased, increased or weight loss.
  • Rare, 1/10,000 ≤ ADR

  • Psychological disorders: Mental disorders.
  • Skin and subcutaneous tissue: Psoriasis, urticaria, hair loss. kidney and urinary: acute renal failure, hyperuremia.

  • Parameters in the test: Hemoglobin reduction, reduction of red blood cell volume, increased serum bilirubin, blood sodium lower.
  • Very rare, ADR

  • Blood and hematopoietic system: thrombocytopenia, bone marrow failure, leukopenia, neutropenia, plateletic decline, hemolytic anemia, anemia, lymphatic disease.
  • The immune system: Hypersensitivity, autoimmune diseases.

  • Metabolism and nutrition: increase/decrease blood glucose.
  • Nervous system disorders: peripheral neuropathy.
  • heart: myocardial infarction, ventricular tachycardia, atrial fibrillation, arrhythmia. vascular: Vascular inflammation.
  • Respiratory, chest and mediastinum: bronchospasm, allergic alveoli/lung disease hyperlemen likes eosin, sinusitis.
  • Digestive system: pancreatitis, gastritis, intestinal angio. liver: Hepatitis, hepatitis, jaundice. Skin and subcutaneous tissue: Poisoned epidermal necrosis, Stevens-Johnson syndrome, diverse roses. Pemphigut skin disease, sweating. One or more symptoms here can be notified: fever, vasculitis, muscle pain, joint pain/arthritis, positive ana, ESR increases, eosinophilic hyperthemis and eosinophilia, rash, light sensitivity or other skin diseases.

  • Kidney and urinary tract: little/little urinary.
  • When encountering side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    LISONORM 5 contraindications in the following cases:

  • Hypersensitivity to Lisinopril or with any enzyme inhibitors Angiotensin (ACE). Angiotensin conversion enzyme inhibitors. Prinzmetal).
  • pregnancy and lactation period.

    Caution when using

    Symptomatic hypotension

    If there is hypotension, the patient should be placed in the back position and if necessary, the fluid is compensated (intravenous infusion of physiological saline). Usually rehydration and/or sodium before starting treatment with Lisonorm, must monitor the degree of reducing the blood pressure of the drug after the starting dose.

    Like every medication when vasodilation must be cautious when using Letero for patients with aortic stenosis and mitral valve, congestion heart muscle disease.

    When renal function

    Only use Letero for patients who have been the optimal maintenance dose titration is 10 mg of lisinopril and 5 mg of Amlodipine.

    If the kidney function is damaged, it is necessary to stop using Lisonorm and replace it with therapy with each separate ingredient that is full titration. Sometimes it is also necessary to reduce data and/or stop taking diuretics.

    Tharma

    Need to stop Lisonorm immediately and continue to monitor the sick until the angioedema symptoms have completely overcome.

    If only edema on the face, lips and limbs can be stopped by themselves. However, antihistamine can be used to reduce symptoms.

    Appropriate measures include subcutaneous injection of 0.3 - 0.5 mg adrenaline (epinephrine) or slow intravenous injection of 0.1 mg of adrenaline, then use more glucocorticoid and antihistamine, and monitor living functions.

    Anaphylactic reactions in patients being dialysis

    may cause anaphylaxis in these patients. Therefore, it is necessary to avoid this combination of therapy and can be selected, or use another type of autopsy, or using another anti -hypertension drug.

    Anaphylactic reaction during decanting low density lipoprotein (LDL)

    Rarely experiencing anaphylactic reactions, which can avoid these reactions by temporarily stop taking the angiotensin conversion enzyme inhibitors before each decant.

    Sensitive bee/winged insects

    It is possible to avoid life -threatening anaphylactic reactions by suspending the an angiotensin conversion enzyme inhibitor.

    Poison with liver

    Patients who use leteral but have symptoms of jaundice or significantly increased liver enzymes that need to stop using Lisonorm and medical monitoring.

    Hepatic failure

    Amlodipine's exhaust half -life is prolonged in patients with liver failure. Because there is no appropriate dosage recommendation, be careful to consider the benefits and risks that may be available before using LISONORM for patients with liver failure.

    Poison with blood

    Need to use Letero is very careful for patients with collagen vascular disease, people who are treated inhibitors, use Allopurinol or Procainamide or combine these complication factors, especially when renal failure is available. Some of the above -mentioned patients will have severe infections and at some point does not respond to antibiotics.

    If Lisonorm is used for these objects, periodic examination of leukocytes and patients must notify the doctor any signs of infection.

    ho

    Cough due to angiotensin conversion enzyme inhibitors should be considered as part of cough diagnosis.

    surgery/anesthesia

    Using Lisinopril may inhibit the formation of secondary angiotensin II due to release of Renin release to compensate for hypotension. If suspected of lowering pressure occurs under this mechanism, it can be overcome by compensation.

    Elderly patients

    If the old age is accompanied by a reduction in kidney function, the dose should be adjusted as for patients with kidney failure.

    Hyperbonia

    Subjects at risk of developing hyperkalemia include kidney failure, diabetes, acute loss of heart failure, dehydration, metabolic acid infection or simultaneous use with potassium -keeping pills, potassium supplements or salt -treating substitutes or any drugs that dragged the increased serum potassium level (such as heparin). If needed simultaneously with the above substances, it is necessary to regularly monitor serum levels.

    The ability to drive and operate machinery

    Lisonorm can affect the ability to drive and operate machinery (especially at the beginning of using the drug).

    Pregnancy

    Contraindicated Lisonorm in pregnant women.

    breastfeeding period

    Contraindicated Lisonorm in nursing women.

    Drug interaction

    Medicines affect potassium content: Potassium -keeping drugs (e.g. Spironolacton, Amiloride and Triamterene), potassium supplements, or salt -containing salt substitutes can increase potassium content (for example Heparin) that can cause hyper -blood hyperkemia when combined with ACE, especially in ACE inhibitors People with other diseases.

    The diuretic drugs: This combination has an uniteing effect and may cause excessive hypotension. Lisinopril increases the excretion effect of potassium ureter.

    Other anti -hypertension drugs: When coordinating with Lisonorm, it may cause excessive hypotension. Using the drug simultaneously with glyceryl trinitrate and other nitrate or other vasodilators will reduce blood pressure.

    Triple -round antidepressants, anti -psychotic/anesthetic/addictive drugs in combination with ACE inhibitors can lower blood pressure.

    Alcohol increases the effect of hypotension.

    Allopurinol, processaamide, immunosuppressive drugs or cell pliers (systemic corticosteroids) may increase the risk of leukopenia when used with ACE inhibitors.

    Antacuki drugs that reduce the bioavailability of the Angiotensin conversion enzyme inhibitors.

    Parolic drugs can reduce the anti -hypertension effect of ACE inhibitors. Need to monitor patients carefully to make sure the desired effect has been achieved.

    Diabetes treatments when used with ACE inhibitors can increase the effect of hypoglycemia with the risk of hypotension.

    Non -steroid anti -inflammatory (NSAID): NSAID long -term use, including acetylsalicylic acid, is higher than 3 g/day that can reduce anti -hypertension effects of angiotensin conversion enzyme inhibitors.

    NSAIDs and ACE inhibitors have the effect of plus community to increase serum potassium and damage kidney function. These effects often recover. Rarely encounter acute renal failure, especially in patients with impaired renal function such as the elderly and people who are dehydrated.

    Lithium: Lithium excretion can be reduced when combined with ACE inhibitors, so it is necessary to monitor serum lithium level.

    Interactions related to amlodipine

    CYP3A4 inhibitors: may increase serum amlodipine levels than the inhibitory effect of diltiazem and need to be cautious when used in combination.

    CYP3A4 induction substances: may reduce serum amlodipine concentration. Amlodipine dose should be adjusted during treatment with CYP3A4 induction substances and after stopping the drug. Need to be careful when coordinating.

  • Storage

    Store at temperatures below 30 ° C in the drug box to avoid light.

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