Tanatril Tablets 5mg tanabe treatment of hypertension (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Imidapril

Ingredient

Composition information	Content
Imidapril	5mg

Uses

Indications

tanatril 5mg drug is indicated for use in cases of hypertension in adults.

Pharmacokic

Imidapril hydrochlorid is precursor; After drinking, hydrolyzed to form the metabolism of dicarboxylic acid (imidaprilat) with the activity of inhibiting the enzyme transferring angiotensin. Imidaprilate inhibits the activity of the enzyme inhibitors (ACE), enzymes are widely distributed in the blood and endothelial cells of many types of tissue. The hypotension effect of imidapril hydrochlorid is due to ACE inhibition, thereby curbing the formation of angiotensin II, resulting in direct or indirectly dilated the peripheral vessel and reducing the barrier of the vascular wall.

Imidapril's hypotension effect in treating hypertension is the main result of inhibiting the Renin-Anotensin-Aldosteron system. Renin is an endogenous enzyme synthesized by the kidneys and releases into the circulatory system, which is converted Angiotensinogen to angiotensin I, a decapeptide quite passive. Angiotensin I is converted into angiotensin Il by the enzyme that converts angiotensin, peptidylpeptidase. Angiotensin II is a substance that has artery and hypertension, as well as stimulating the adrenal glands to release aldosteron. The effect of inhibiting enzyme transferring angiotensin reduces angiotensin II led to a decrease in vascular activity and reducing aldosteron secretion.

Although the later decrease is small, slightly increasing the concentration of serum potassium can occur, along with sodium and fluid loss. The effect of angiotensin II on the excretion is terminated, resulting in increased plasma renin activity.

One of the other effects of the enzyme that converts the degeneration of the vasodilation of Kinin Peptid Bradykinin into an inactive metabolic substance. Therefore, ACE inhibitors lead to increased activity of the Kalikreinkinin system during blood circulation and on the spot, which can contribute to peripheral vasodilation by stimulating the prostaglandin system. It is possible that this mechanism is related to the hypotension effect of ACE inhibitors and causes some side effects of the drug.

Imidapril lower blood pressure in the sitting position, lying on your back and standing at the same level that does not affect the heart rate. The strongest hypotension effect after 6 - 8 hours of taking medicine.

Some patients need a few weeks of treatment to achieve optimal control effect. Hypotension effects are maintained when prolonged treatment. Sudden use of drugs does not increase blood pressure rapidly.

blood flow through the kidneys increases and the rate of glomerular filtration does not change.

pharmacokinetics

Imidapril hydrochlorid metabolized for 4 metabolites and mother imidapril hydrochlorid. Of the 4 metabolites, only the form of di-carboxylic acid (imidaprilat) is pharmacological activity.

absorption:

Healthy people take the single dose of 10mg Imidapril hydrochlorid, the drug reaches the peak concentration in plasma after drinking 2 hours and excreted from plasma with the sale time of about 2 hours. Imidaprilate is an active metabolitus of Imidapril, reaching the peak concentration (about 15 ng/ml), after taking Imidapril 6 - 8 hours, gradually excreted from plasma with the selling time of about 8 hours.

Metabolism and elimination:

Healthy people who take the initial dose of 10mg Imidapril hydrochlorid, 25.5% of the dose will be eliminated through urine for 24 hours.

accumulation:

Healthy people who take the initial dose of 10 mg Imidapril hydrochlorid once a day, use for 1 week, the imidaprilate concentration in plasma has stable state after 3-5 days of taking the drug. There are no signs of accumulation of drugs. In patients with renal function, the imidaprilate peak content in plasma increases and will slowly eliminate from plasma.

Before taking Tanatril Tablets 5mg tanabe treatment of hypertension (10 blisters x 10 tablets)

How to use

Should take medicine at the same time of the day at about 15 minutes before meals, this is the condition that the drug effect has been proven.

Dosage

Adults

Starting dose 5mg x 1 time/ day.

If the optimal blood pressure is not achieved after 3 weeks of treatment, daily dose should increase 10mg, this is the most effective daily dosage. However, a small number of patients may need to increase daily dose to 20mg (maximum recommended dose), or must be coordinated with diuretics.

There is no adequate assessment of the benefits of Imidapril combination with other hypertension treatments when used for patients.

Older patients (older or 65 years old)

The starting dose is 2.5mg x 1 time/ day. Dosage should be determined according to the response of blood pressure.

The maximum dose is 10mg x 1 time/day.

Patients with renal failure

Imidapril and metabolites with imidaprilate pharmacological activity are excreted mainly through the kidneys. Kidney function should be assessed before starting with Imidapril in patients suspected of impaired renal function. Creatinine clearance should be determined before treatment with Cockcroft & Gault formula (Nephron 1976, 16: 31 - 41)

Patients with liver failure

The starting dose recommends 2.5mg x 1 time/day. Be cautious when indicating the drug for this group of patients.

Patients with increased risk of hypotension when taking the first dose

Lagging blood pressure when taking the first dose may occur in high -risk patients. Requirements at the beginning of treatment, if possible, adjust the shortage of salt and/ or body fluid, stop using diuretics for 2-3 days before the treatment of the enzyme inhibitors. If this adjustment is impossible, it is recommended to take the starting dose of 2.5mg. In patients with increased and heart failure, hypotension is a symptom that has been reported after treatment with enzyme inhibitors.

In these patients, the recommended dose is 2.5mg x 1 time/ day under tight medical supervision. Patients are at high risk of acute, severe blood pressure after taking the first dose, should be monitored medical, encourage monitoring in the hospital, within 68 hours after taking the first dose and whenever Imidapril or a diuretics are simultaneously increased. The starting dose should be 2.5mg. This also applies to patients with angina and cerebrovascular pain. These patients increased the risk of myocardial infarction or stroke due to excessive hypotension.

Children

The safety and effectiveness of tanatril has not been determined because there is no enough research data.

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?

After overdose, the patient should be closely monitored and best in a special care unit. Electrolytes in serum and creatinine should be monitored regularly, treatment measures depend on the properties and levels of symptoms. Prevent absorption and accelerate removal of smoking such as gastric lavage, adsorbent and sodium sulfate within 30 minutes after drinking.

If hypotension occurs, it is necessary to quickly add salt and fluid. Angiotensin II treatment should be considered. Bradycardia or vagal reaction should be treated using atropine. The use of a pacemaker may be considered. Imidapril and Imidaprilate can be removed from the circulatory system by hemorrhage. Avoid using polyacrylonitrile-flux.

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

Common, ADR> 1/100

Kidney: increased bun and serum creatinine;

Neurological - Mental: headache , delirium, dizziness; Cardiovascular: Hypotension;

Respiratory: cough, discomfort;

liver: Increase SGOT and SGPT;

Hypersensitivity: rash, itching;

Other: hyperkalemia;

Uncommon, 1/1000

Blood: decreased: red blood cells, hemoglobine, hematocrit, platelets. Increase: Eosin leukemia.

kidney: proteinuria.

Mental - Mental: Stunned when standing up, insomnia.

Cardiovascular: Brushing the chest. Digestive: Nausea, vomiting, discomfort in the stomach, abdominal pain, anorexia, diarrhea . liver: increased alkaline phosphatase and ldh, jaundice.

Other: Tinnitus, abnormal taste, thirst, increase creatinine phosphokinase (CPK), chest tightness, tired, edema, red face, change taste, weakness.

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

Contraindicated

People with a history of hypersensitivity to any component of the drug.

People with a history of mucosal edema (medication edema such as Angiotensin (ACE) ..., genetic edema, stacked mucosal edema, spontaneous mucosa ... may encounter mucosal edema with shortness of breath).

People who are in the process of adsorbent separation use Dextran sulfate fixed with cellulose, tryptophan fixed with polyvinyl alcohol or polyethylene terephthalate (shocking).

The person who is dialysis with acrylonitril methallyl sulfonate sodium (AN69) is due to anaphylactic symptoms.

Pregnant or pregnant women.

Diabetics are being treated with Aliskiren Fumarat (except for patients who cannot control blood pressure even when treated with other anti -hypertension drugs). The increased risk of non -fatal stroke, hyperkalemia, and or has been reported.

Renal failure with or without hemolysis (serum creatinine clearance

Precautions when using

Use cautiously (need to use tanatril carefully in the following patients)

Renal failure: Changing renal function can be predicted in sensitive people in inhibition of the Renin Angiotensin Aldosteron system. Therefore, Imidapril is like other ACE inhibitors, so it is used to be used for patients with renal impairment. Dosage must be reduced for patients with creatinine clearance in about 30 - 80 ml/min.

Do not use imidapril for patients with creatinine clearance below 30 ml/min due to limited use experience.

Strictly monitor the function of caution during treatment. Kidney failure is reported related to ACE inhibitors. Mainly in patients with severe heart failure or kidney disease, including renal artery stenosis. Some patients, before, did not suffer from kidney disease, may increase blood urea level because of creatinine when used simultaneously with diuretics. Requirement of dosage of ACE inhibitors and/or diuretics, should monitor kidney function during the first week of treatment.

PEOPLE PEOPLE ARCHITECTURE BLOOD or both sides of the kidney.

People with cerebrovascular disorders (strong hypotension can cause blood flow to the brain, worse than the patient state).

Elderly.

People with hyperkalemia.

Important cautions

The group of patients includes: People with serious hypertension, who are in dialysis, who are taking diuretics (especially for beginners to use diuretic drugs), who are following strict salt diets may experience excessive blood pressure after starting tanatril, so start with lower dose, then increase the dose, and tightly monitor the patient.

Do not take 24 hours before surgery.

Aortic stenosis on one side or both sides of the kidney, the renal function may be impaired rapidly due to reducing blood flow to the kidneys and reducing glomerular filtration pressure. Tanatril should not be used in these patients unless treatment with this drug is really necessary.

People with hyperkalemia, symptoms may be worse. Tanatril should not be used in these patients unless treated with this drug is really necessary. Because in patients with hyperkalemia is usually caused by renal failure and/or diabetes that have not been controlled, so carefully monitor the concentration of blood potassium.

Patients may have kidney failure, hyperkalemia and hypotension when combined with Aliskiren Fumarate. Do not simultaneously use tanatril and Aliskiren Fumarate in patients with glomerular filtration, estimated

In patients with diabetes in diabetes related to type 1 diabetes, there may be severe impaired renal function or hyperkalemia during the beginning of treatment (about 1 month). Creatinine and potassium concentrations should be monitored during the beginning of treatment. If the renal function is decreased rapidly or the concentration of blood potassium increases, the dose should be reduced or stopped using the drug.

Aortic valve stenosis or mitral valve stenosis/ myocardial hypertrophy: Like other ACE inhibitors, need to be cautious when indicating imidapril for patients with the output of the left ventricle.

Neutral leukemia/ grain leukemia, thrombocytopenia and rare anemia in patients using ACE inhibitors, including Imidapril. In patients with normal kidney function, no risk factors, neutropenia is very rare. Very cautious when using Imidapril in patients with blood vessel collagen, immunosuppressive treatment, Allopurinol or Procainamid or combined with risk factors, especially kidney failure, some patients with severe infections in some special cases do not respond to strong antibiotics.

If using Imidapril for these patients, before treatment should check the number of white blood cells and also check the difference of the number every 2 weeks in the first 3 months of Imidapril treatment, and periodically. During the treatment process, patients should be instructed to report any signs of infection (eg sore throat, fever) when discovering the difference in number of white blood cells.

Use Imidapril and medications simultaneously if detected or suspected neutropenia (neutrophils below 1000 mm3). Most patients, neutrophils will return to normal when using Imidapril.

Patients with hypertension due to renal artery disease: increased the risk of hypotension and renal failure in patients with narrowed kidney stenosis on both sides or one side when combined with ACE inhibitors. Loss of renal function may occur with only slight changes of serum creatinine. In these patients, began to be placed under strict medical supervision and with low doses, and closely monitor kidney function.

Kidney transplantation: No experience in Imidapril treatment for new kidney transplant patients.

Anaphylactic reactions during sensitivity: Anaphylactic reactions that threaten life rarely in patients who are treating sensitivity due to insect toxins when receiving another ACE inhibitor. In these patients, anaphylactic reactions can be avoided by temporarily stop using ACE inhibitors. Be cautious when using ACE inhibitors in patients in the process of anesthesia.

Patients with liver failure: Rare, ACE inhibitors are related to cholest or hepatitis or liver necrosis and sometimes death. The mechanism of this syndrome has not been cleared. Patients with ACE inhibitors with symptoms of jaundice or liver enzyme increases significantly, so they stop using ACE inhibitors and use a suitable treatment.

Diabetes patients: Hemorrhagic levels should be closely monitored in patients who have had diabetes before being treated with oral or insulin injection in the first month of ACE inhibitors.

lactose: tanatril contains lactose. Patients with rare genetic problems are galactose intolerance, lactase deficiency or glucose-galactose abutments should not be taken.

Dual-Renin-Anotensin-Aldosteron (RAAS) Renin-Aldosteron (RAAS): There is evidence that the use of ACE inhibitors, Angiotensin II receptor blocks or Aliskiren increases are at risk of hypotension, hyperkalemia and reducing kidney function (including renal failure). It is not recommended that the double-analiotensin-aldosteron rendosteron system through a combination of enzyme inhibitors, angiotensin II or Aliskirin receptor blockers. If double blocked therapy is absolutely necessary, regular monitoring of kidney, electrolyte and blood pressure must be regularly monitored. Inhibition of enzyme and angiotensin II transferred and tumbling is not used simultaneously in diabetics of kidney disease.

Elderly: Must be careful when taking the drug for this object, starting with lower dose (for example: 2.5 mg) and careful monitoring of patients. Tanatril excreted mainly through the kidneys, the elderly often impaired the kidney function, leading to high levels of drug levels and easily encounter unwanted effects. In addition, excessive hypotension causes danger to the elderly (cerebral infarction ...)

Children: Not yet determined the safety of the drug for children.

Precautions: Tanatril tablets are packed in pressed shells (PTP), need to tell patients to remove the drug from the packet of the packet before drinking (have encountered the case of patients swallowing the ptp shell, the sharp corners of the shell can be cut into the esophagus mucosa, causing serious complications such as medium inflammatory inflammation).

The ability to drive and operate machinery

Due to the effect of lowering the blood pressure of the drug can cause dizziness or dizziness, patients need to be cautious when participating in activities that require alertness such as driving, working on high or operating machinery ...

Pregnancy

Contraindicated tanatril in pregnant women or suspected pregnancy due to the risk of amniotic fluid, fetal, hypotension, kidney failure, hyperkalemia, reducing brain production in newborns in the three months between or at the end of pregnancy. Folding limbs and fear of facial fear may be due to amniotic fluid.

Breastfeeding period

Do not use tanatril during breastfeeding. If necessary to use the drug, to stop breastfeeding.

Drug interaction

Contraindications:

Use Dextran Cellulose Sulfate to adsorb LDL-CHOLesterol (LDL: Liposorber): Dextran Cellulose Sulfate Electrical charges that promote kinine production in blood and Imidapril HCl interacts with Bradykinin's metabolism mechanism. The coordination increases the accumulation of Bradykinin leading to anaphylaxis.

Patients with competent fertilizer with acrylonitrile methallyl sulfonate sodium: Polyelectrolyte an69 promotes the production of kinin in the blood, so Imidapril HCl interacts with the metabolic substance of Bradykinin and accumulates Bradykinin leading to anaphylaxis.

Precautions when coordinating:

Potassium diuretics (spironolactone, triamterene ...), Potassium supplements: increased serum potassium content.

Aliskiren Fumarate: may experience kidney failure, hyperkalemia and hypotension.

Trichlormethiazide, hydrochlorothiazide ...): strong hypotension after the beginning of using imidapril.

Lithium (Lithi carbonate) preparations: may have lithium poisoning (drowsiness, tremor, disorder ...).

Indomethacin anti -inflammatory drugs (Indomethacin): Reducing the hypotension effect of imidapril.

Preparation contains kallidinogenase: excessive hypotension.

Hematoplasty (nitrate ...): Increased hypotension.

Diuretics do not keep potassium: The risk of sudden hypotension and/ or acute renal failure when starting with ACE inhibitors.

Gold: Nitritoid reaction (blush, nausea, vomiting, hypotension).

Diabetes treatment (insulin, sulphonamid): increases hypoglycemic effects.

Triple -round antidepressants, sedative drugs: Increases the effect of lowering blood pressure and has the risk of posture hypotension.

Rifampicin: Reducing the serum concentration of imidapril and active metabolites, which can reduce the lowering effect.

Sympathetic nerve stimulants: reducing the effect of lowering blood pressure.

Storage

Store in closed boxes, below 30 ° C. Avoid sunlight. Avoid moist after opening.

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