EBITAC Forte 20mg/12.5mg Farmak treatment for hypertension (2 blisters x 10 tablets)
Dosage form Box of 2 blisters x 10 tablets
Specifications Enalapril, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Enalapril | 20mg |
| Hydrochlorothiazide | 12.5mg |
Uses
indications
EBITAC Forte is indicated for hypertension treatment.
Pharmacokology
enalapril
Enalapril is an angiotensin enzyme inhibitor, which works by enalaprilat as an enalapril metabolic substance after taken.
Enalapril lowers 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 I transform into angiotensin II (strong vascular contractions) thanks to the inhibition of angiotensin conversion 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 powerful vasodilator, these two effects of Enalapril can explain why there is no relevance proportional between the Renin concentration 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, steak 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 rising. 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 unchanged during Enalapril treatment. Blood urea nitrogen (bun) and serum creatinine sometimes increase when treated with enalapril for a long time, but more common in people with kidney damage 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 protein -urinary secretion. Enalapril has also proved to increase insulin sensitivity in people with hypertension or without diabetes. Enalapril does not reduce lipid metabolism at any level.
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.
hydrochlorothiazid also reduces the activity of the carbon dioxide, so it increases the secretion of bicarbonate but this effect is usually small compared to the effect of Cl- excretion 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.
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 drug absorption.
After absorption, Enalapril is hydrolyzed in the liver into Enalaprilate. 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 congestion 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 urine in the form of enalaprilate and non -metabolic form, the rest of the drug eliminated in feces.
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 should be adjusted.
hydrochlorothiazid passes through the placenta, distributed and reaches high concentrations in the fetus. The diuretic effect appears after drinking 2 hours, reaching a maximum after 4 hours and lasts 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, 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 Forte 20mg/12.5mg Farmak treatment for hypertension (2 blisters x 10 tablets)
How to use
oral medication.
Dosage
The dose of EBITAC Forte is determined mainly by the dosage and usage with enalapril Maleat 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
Symptomic hypotension may occur after the beginning of EBITAC Forte. Therefore, diuretic treatment should be stopped for 2-3 days before starting treatment with EBITAC Forte.
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
Within 4 weeks, if the treatment results are not achieved, the dose increases or the addition of other anti -hypertension drugs must be considered.
Elderly
In clinical studies, the efficiency and tolerance of Enalapril Maleat and Hydrochlorothiazid simultaneously similar to hypertension patients in both the elderly and young.
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. Hemorrhage can be eliminated enalapril from circulation.
Overdose of hydrochlorothiazid 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. Note that it should not be used double the prescribed dose.
Side Effects
When using EBITAC Forte, 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 was a sign that hypotension was severe after taking the first Enalapril dose, up to 2-3% of people in clinical trials to stop treatment, especially for people with heart failure, sodium lowering, 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 kidney function (ultra -temporary increase and increased serum creatinine levels) occurred in about 20% of people with hypertension due to kidney disease, especially in people with kidney artery narrowing on both sides or kidney artery stenosis in humans with only one kidney.
Common, ADR> 100
DA: rash.
Other: kidney failure.
Uncommon: 1/1000 urine: proteinuria. Rare, ADR Other: hypersensitivity, depression, fading, stuffy nose, muscle pain, bronchospasm and asthma. Instructions on how to handle ADR Please notify the doctor the unwanted effects encountered during the use of the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
EBITAC FORTE medicine is contraindicated in the following cases:
Severe renal failure (Creatinine clearance
History of veins related to ACE inhibitors. Pregnant women phase 2 and phase 3 (from the 4th month onwards). Renal artery stenosis. Be careful when taking the drug with people with severe renal 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. There is no information on the effects of enalapril and hydrochlorothiazide on the ability to drive and operate machinery. enalapril Like other ACE inhibitors, Enalapril can cause disease and death for the fetus and infants when the mother is pregnant. Using the medication in the middle 3 months and the last 3 months of pregnancy can cause disease leading to pregnancy and damage to babies, including: lowering blood pressure, reducing newborn skulls, recovery or non -recovery and death. Must stop using Enalapril as soon as possible after being pregnant. hychlorothiazid 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 in the last 3 months of pregnancy. enalapril excreted into breast milk. With the usual dose of treatment, the risk of harmful effects for breastfeeding is very low. hydrochlorothiazid: The drug enters breast milk with the amount of child which can be harmful to the baby and inhibit 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. enalapril Use enalapril simultaneously with a number of other vasodilators (eg nitrate) or anesthetic drugs that can cause severe hypotension. 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 salt use before starting treatment with enalapril. Use enalapril simultaneously with lenin release drugs: Enalapril's hypotension effect increases by drugs that release lenin with anti -hypertension effect (for example, diuretics). Use Enalapril simultaneously with drugs that increase serum potassium, for example, when using enalapril simultaneously with potassium -keeping pills, potassium or potassium supplements, which can cause serum hyperpoints, especially in kidney failure, so you 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 damage 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 significance. hydrochlorothiazide When used with the following drugs can interact with alcohol, barbiturate or addictive sleeping pills: increase the potential of vertical hypotension. Anti -diabetic drugs (oral and insulin drugs): need to be adjusted due to hyperlem of blood glucose. Other antihypertensive drugs: Calm effects or increased hypotension. corticosteroid, ACTH: increase power outages, especially hypokalemia. Amines hypertension (eg norepinephrin): may reduce response to hypertension but not enough to prevent use. muscle relaxants, which can increase response to muscle relaxants. Lithi: Do not use with diuretics, because of reducing lithium clearance and increased 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 also monitor 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. Be cautious when used
The ability to drive and operate machinery
pregnancy
breastfeeding period
drug interaction
Storage
Store less than 300C, avoid light.
Keep drugs out of reach of children.
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