EBITAC 12.5 Farkmak treatment for heart failure, hypertension (2 blisters x 10 tablets)

Dosage form Box of 2 blisters x 10 tablets
Specifications Enalapril, hydrochlorothiazide

Ingredient

Composition informationContent
Enalapril10mg
Hydrochlorothiazide12.5mg

Uses

Indications

EBITAC 12.5 drugs are indicated in the following cases:

  • Treatment of hypertension.

    Enalapril is an angiotensin transferring enzyme inhibitor, which works by enalaprilat as an enalapril metabolism after taken. Enalapril reduces blood pressure in normal blood pressure, hypertension and has a good effect on hemodynamics in people with congestion heart failure, mainly due to inhibition of the Renin - Angiotensin - Aldosteron system. Enalapril prevents angiotensin transforming into angiotensin II (strong vascular contractions) thanks to the inhibition of angiotensin transferring enzymes (ACE). Enalapril also reduces serum aldosteron, leading to a decrease in sodium retention, increasing the Kallikrein - Kinin vasodilation system and can change Prostanoid metabolism and inhibit sympathetic nervous system.

    Because the enzyme converts angiotensin plays an important role of decomposition, enalapril also inhibits Bradykinin decomposition. Because Bradykinin is also a strong vasodilator, these two effects are enalapril that can explain why there is no relevance proportional between the level of renin and clinical response to Enalapril treatment.

    In humans of hypertension, Enalapril reduces blood pressure by reducing the entire peripheral resistance, accompanied by a slight increase or no increase in the heart frequency, systolic flow or heart flow. The drug causes artery dilatation and maybe even veins. Enalapril often reduces systolic and diastolic blood pressure by about 10-15% in both lying and sitting positions. Hypoglycemia and tachycardia rarely occur, but more often more common in blood sodiums or hypoglycemia.

    In people with congestion, enalapril, often combined with cardiac glycosides and diuretics, reducing the entire peripheral resistance, pulmonary artery pressure, heart size and average artery pressure and right atrial pressure. Heart index, cardiac amount, systolic volume and tolerance of exertion increases. Enalapril decreased after the burden. Left ventricular hypertrophy decreases after 2-3 months of using angiotensin transferring enzyme inhibitors, because angiotensin II is a strong heart muscle growth. Renal blood flow may increase, but glomerular filtration is usually constant during Enalapril treatment.

    Blood urea nitrogen (bun) and serum creatinine sometimes increases when treated with enalapril for a long time, but is more common in people with a total kidney injury from before or in people with hypertension due to kidney. In addition, the kidney function can deteriorate while treating with ACE inhibitors in people with poor perfusion kidneys.

    In people with diabetes, Enalapril reduces proteinuria secretion. Enalapril has also proved to increase insulin sensitivity in people with hypertension or without diabetes. Enalapril does not reduce lipid metabolism at any extent.

    hydrochlorothiazide

    hydrochlorothiazid and thiazid diuretics increase the secretion of sodium chloride and water attached to the mechanism of inhibiting the reabsorption of sodium and chlorine ions in the distance. The excretion of other electrolytes also increases, especially potassium and magnesi, and calcium decreases. Hydroclorothiazid also reduces the activity of the carbon dioxide should increase bicarbonate secretion but this effect is usually small compared to the clicking effect and does not significantly change the urine pH. Thiazids have a moderate diuretic effect, because about 90% of sodium ions have been reabsorbed before arriving in the distance is the main position of the drug.

    hydrochlorothiazid has the effect of lowering blood pressure, firstly due to a decrease in plasma volume and extracellular fluids related to sodium urine. Then, during the use of the drug, the effect of lowering blood pressure depends on the decrease in peripheral resistance, through the gradual adaptation of blood vessels from the reduction of Na+concentration. Therefore, the hypotension effect of hydrochlorothiazid is shown slowly after 1-2 weeks, while the diuretic effect occurs quickly and can be seen right after a few hours. Hydrochlorothiazid increases the effects of other antihypertensive drugs.

    pharmacokinetic pharmacokinetics

    enalapril

    After drinking, about 60% of Enalapril dose is absorbed from the gastrointestinal tract. The peak concentration of the serum is reached within 0.5 - 1.5 hours. Half life elimination of the drug is about 11 hours. Hemorrhagic effect lasts about 24 hours. Food does not affect the absorption of drugs. After absorption, Enalapril is hydrolyzed in the liver into Enalaprilat. The peak concentration of the serum enalaprilate appears within 3 to 4 hours. Take an Enalapril dose of hypotension usually about 1 hour after drinking, lowering up to 4-6 hours and usually lasts for 12 - 24 hours. Blood pressure can be reduced slowly and must be treated for a number of weeks to achieve adequate effects.

    Enalapril's hemodynamic effects begins to be slower and lasts longer than Captopril. In people with congestive heart failure, Enalapril's hemodynamic effect is clearly within 2-4 hours and may last 24 hours after taking a dose. About 50 - 60% Enalapril binds to plasma proteins. About 60% of oral dose excreted into pepper water in the form of enalaprilat and are not transferring, the child of the pipe tobacco is waste.

    hydrochlorothiazide

    After taken, hydrochlorothiazid is relatively fast, about 65 - 75% of the dose of use, but this ratio may decrease in heart failure people. Hydrochlorothiazid accumulated in red blood cells. The drug excreted mainly through the kidneys, mostly in the form of non -metabolic. Half of the lifetime of hydrochlorothiazid is about 9.5 - 13 hours, but may last in the case of renal failure so the dose adjustment should be adjusted. Hydrochlorothiazid passes through the placenta, distributed and reached high concentrations in the fetus.

    diuretic effects appear after drinking 2 hours, reaching maximum after 4 hours and lasting about 12 hours. Anti -hypertension effect is much slower than diuretic effects and can only achieve adequate effect after 2 weeks, even with the optimal dose between 12.5 - 25 mg/day. It is important to know that the anti -hypertension effect of hydrochlorothiazid is usually optimal at 12.5 mg. Modern clinical treatment and clinical trial guidelines emphasize the lowest and optimal use of doses, which reduces the risk of harmful effects. The important issue is to wait enough time to assess the body's response to the hypotension effect of hydrochlorothiazid, because the effect on the peripheral resistance takes time to be clear.

  • Before taking EBITAC 12.5 Farkmak treatment for heart failure, hypertension (2 blisters x 10 tablets)

    How to use

    EBITAC 12.5 drugs are taken orally.

    Dosage

    The dose of EBITAC 12.5 is determined mainly by the dose and usage with enalapril maleate components. The dosage of the drug must be adjusted depending on the individual.

    Adults

    Hypertension:

    The usual dose is a tablet, once a day. If necessary, the dosage can be increased to two tablets, once a day.

    Simultaneous treatment with diuretics:

    Hypotension can occur after the beginning of EBITAC 12.5, so diuretic treatment should be stopped for 2-3 days before starting treatment with EBITAC 12.5.

    Dosage for patients with renal failure:

    Thiazide is not suitable for patients with renal impairment and ineffective at the values ​​of creatinine 30 ml/ min or lower (i.e. average or severe renal failure). In patients with creatinine clearance> 30 and

    heart failure:

    should use EBITAC under the monitoring of a doctor. If the patient has severe heart failure (degree 4), impaired renal function and/or an abnormal trend of electrolytes, it must be carefully monitored at the hospital right from the beginning of treatment. This principle is also applied when combined with enalapril with vasodilators. The appropriate dose in the first week is 2.5 mg of enalapril daily used daily for the first 3 days, using 2.5 mg of Enalapril twice daily for the next 4 days.

    Note: Patients should use Enalapril 5 mg tablets to get a sufficient dose for the first time of treatment, or consult the treating doctor. The dose may then be gradually increased to the normal maintenance dose of 20 mg (2 tablets of EBITAC 12.5) daily, disposable or divided into 2 times in the morning and evening. In rare cases, there may be a dose of up to 4 EBITAC tablets 12.5/day. Adjust the dose for 2 - 4 weeks.

    Askoned left ventricular failure function:

    The initial dose is 2.5 mg of Enalapril used 2 times/ day in the morning and evening; Adjust the continuous dose until the appropriate dose as described above to 2 tablets EBITAC 12.5/day, divided into 2 times, used in the morning and evening.

    Note: Patients should use 2 enalapril 5 mg tablets to get a sufficient dose for the first time of treatment, or consult the treating doctor. Hypertension and kidney function must be monitored before and after starting treatment to avoid severe hypotension and renal failure. If possible, diuretics should be reduced before starting with enalapril. Should monitor serum potassium concentration and adjust to normal levels.

    Elderly

    In effective clinical studies and enalapril Maleate and Hydrochlorothiazide use, similar to patients with hypertension in both elderly and young people.

    Children

    has not been determined effectively and safety when using drugs in children. Ask your doctor before using.

    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? The outstanding feature of Enalapril overdose is severe hypotension. When an overdose occurs, Enalapril should be stopped and monitor patients closely, apply symptomatic and supportive treatments such as vomiting, gastric lavage, plasma intravenous and sodium chloride to maintain blood pressure and treat electrolyte imbalance. Hemodiac can eliminate enalapril from circulation.

    Overdose of hydrochlorothiazide is mainly water and electrolyte disorders due to a lot of urinary tract. If using digitalis, hypoglycemia increases arrhythmia.

    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. Do not use double the prescribed dose.

    Side Effects

    When using EBITAC 12.5, you may experience unwanted effects (ADR).

    ADR is usually mild and transient, but about 3% to 6% of drug users have to stop treatment. There has been a symptoms of hypotension quite severe symptoms after the first enalapril dose; Up to 2-3% of people in clinical trials have to stop treatment, especially for people with heart failure, sodium hypoglycemia, and for the elderly treated simultaneously with diuretics.

    In people with congestion often appears symptomatic blood pressure, bad kidney function and increases the concentration of serum potassium, especially during the first time using Enalapril in the person treated simultaneously with diuretics.

    The worsening of the kidneys (the temporary monk and the increased serum creatinine level) occurred in about 20% of people with kidney hypertension, especially in narrowed kidney stenosis on both sides or kidney artery stenosis in humans with only one kidney.

    Common, ADR> 1/100

  • Nervous system: headache, dizziness, fatigue, insomnia, abnormalities, sympathy.
  • Digestive: Disorders of taste, diarrhea, nausea, vomiting and abdominal pain.
  • Cardiovascular: Evana, severe hypotension, hypotension posture, fainting, brushing chest, and chest pain.
  • skin: rash.
  • respiratory: dry cough, possibly due to increased kinin in tissue or prostaglandin in the lungs.
  • Other: renal failure.
  • Uncommon, 1/1000

  • Hematology: Hemoglobin and hematocrit, granulocytes, neutropenia.
  • urine: proteinuria.
  • Central nervous system: panic, agitation, severe depression.
  • Rare, ADR

  • Digestive: intestinal obstruction, pancreatitis, hepatitis is poisoned by bile, increases oral litrees.
  • Other: hypersensitivity, depression, blurred vision, stuffy nose, muscle pain, bronchospasm and asthma.
  • Instructions on how to handle ADR

    When experiencing 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

    EBITAC 12.5 contraindications in the following cases:

  • allergies or hypersensitivity to Enalapril Maleatate, hydrochlorothiazide or any excipients of the drug.
  • eagown at the beginning of treatment as ACE inhibitors in general.
  • kidney narrowing on both sides of the kidneys or kidney artery narrowing only one kidney.
  • Aortic valve stenosis and severe congestion cardiac disease.
  • Hypotension previously.
  • gout.
  • Addision (adrenal impairment).
  • Blood calcium hyperemia.
  • sensitive to drugs derived from sulfonamide.
  • Hepatic impairment and severe renal failure (Creatinine clearance
  • Pregnant women phase 2 and phase 3 (from the 4th month onwards).
  • Precautions when used

    Be careful when taking the drug with people with severe kidney failure, liver failure, gout. For suspected kidney stenosis, blood creatinine requires before starting treatment.

    Be cautious when taking medicine with the elderly because it is easy to imbalance electrolytes.

    For people with diabetes: Pay attention to adjust the drug (insulin, hypoglycemic drugs).

    The ability to drive and operate machinery

    There is no information on the effects of Enalapril and Hydrochlorothiazide on the ability to drive and operate machinery.

    Pregnancy

    enalapril

    Like other ACE inhibitors, Enalapril can cause disease and death for the fetus and infants when the pregnant mother uses the drug. Using drugs in the middle 3 months and the last 3 months of pregnancy can cause disease leading to pregnancy and damage to newborns, including: lowering blood pressure, reducing newborn skulls, recovery or non -recovery and death. Enalapril must be stopped as soon as possible after detecting pregnancy.

    hydrochlorothiazide

    There are many notifications proving, thiazid diuretics are through the placenta into the fetus, causing electrolytes, platelets and jaundice in newborns. So do not use this group of drugs for the last 3 months of pregnancy.

    breastfeeding period

    enalapril

    Enalapril excreted in breast milk. With the usual dose of treatment, the risk of harmful effects for breastfeeding is very low.

    hydrochlorothiazide

    The drug enters breast milk with the amount of child harmful and inhibits milk secretion. Therefore, it is necessary to consider not using medication or stop breastfeeding depending on the degree of need for the drug for the mother.

    Drug interaction

    enalapril

    Use enalapril simultaneously with some other vasodilators (eg nitrate) or anesthetic drugs that can cause severe blood pressure. In this case, the patient should be closely monitored and adjusted by increasing the volume of circulatory (infusion).

    Using enalapril simultaneously with diuretics can occasionally cause excessive hypotension after starting treatment with enalapril. In that case, diuretics should be stopped or increased before using salt before starting treatment with enalapril.

    Use enalapril simultaneously with lenin release drugs: Enalapril's hypotension effects increased by drugs that release lenin with anti -hypertension effect (for example, diuretics).

    Use enalapril simultaneously with drugs that increase serum potassium, for example, when used simultaneously enalapril with potassium -keeping pills, potassium supplements or potassium -containing salt, which can cause hyperkalus, especially in people with renal failure, so they should monitor patients closely and regularly monitor potassium concentration.

    Using enalapril simultaneously with lithium may increase blood lithium levels leading to lithium poisoning.

    Use Enalapril simultaneously with sympathetic bronchodilators, nonsteroidal anti -inflammatory drugs (NSAID) can reduce the hypotension effect of Enalapril.

    Use enalapril simultaneously with oral contraceptives that increase the risk of vascular lesions and difficult to control blood pressure.

    Use enalapril simultaneously with beta - adrenergic blockers, methyldopa, nitrates, calcium blockers, hydralazin, prazosin, and digoxin does not show clinical side effects.

    hydrochlorothiazide

    When used with the following drugs can interact with thiazid, alcohol, barbiturate or addictive sleeping pills: increase the potential of lowering blood pressure.

    anti -diabetic drugs (oral and insulin drugs): need to be adjusted due to hyperglycemia.

    Other antihypertensive drugs: the effect of synergies or increased hypotension potential.

    corticosteroid, ACTH: increase power outages, especially hypokalemia.

    Amines of hypertension (eg norepinephrin): may reduce response to hypertension but not enough to prevent use.

    Muscle relaxants: may increase in response to muscle relaxants.

    lithium: should not be used with diuretics, because reducing lithium excretion in the kidneys and increasing the toxicity of this substance.

    Non -steroid anti -inflammatory drugs: may reduce diuretic, sodium urinary effects and lower blood pressure effects in some patients. So if used, must be monitored to see if the desired effect of diuretic.

    quinidine: easily causing torsion, vibration causes death. Thiazid reduces the effects of anticoagulants, gout drugs. Thiazid increases the effects of anesthesia, glycoside, vitamin D.

    cholestyramin or colestipol: The potential to attach thiazid diuretics, reducing the absorption of these drugs through the gastrointestinal tract.

    Storage

    Store at less than 30 ° C, avoid light.

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