Coveram medicine 5mg/10mg Servier treat hypertension (30 tablets)

amlodipine:

absorption: Perindopril absorbs quickly after drinking. Perindopril's peak concentration and Perindoprilat metabolites are achieved after 1 hour and 3-4 hours respectively.

Distribution: Perindoprilate bonding protein accounts for 20% of plasma proteins, mainly attached to ACE enzymes and dosage depends on dosage. The distribution volume (VD) is about 0.2 liters/kg with non -cohesive perindoprilat.

Metabolism: Foods that limit metabolism to Perindoprilat. Perindopril metabolizes into Perindoprilat activity and 5 other non -active substances.

Elimination: Perindopril's waste sale time in plasma is 1 hour. Perindoprilat is discharged through the urine and the semi -discharged time of the non -linked part is about 17 hours, reaching a stable state within 4 days.

amlodipine

Absorption: Amlodipine absorbs well after drinking, reaching the peak concentration in the blood after 6 - 12 hours. Absolute bioavailability is 64 - 80% and is not affected by food.

Distribution: The distribution volume (VD) is about 21 liters/kg. About 97.5% amlodipine bonding plasma protein.

Metabolism: Amlodipine metabolizes mostly in the liver to prevent the metabolic inactive.

Elimination: The last waste sale time is about 35 - 50 hours. About 60% of the dose will be discharged through the urine, of which 10% is non -metabolized amlodipine.

What to do when overdose?

Symptoms:

Treatment:

Clinical hypotension is clinically due to amlodipine overdose that need support for heart support including regular heart monitoring and respiratory function, edema of the limbs and pay attention to the volume of circulation and urine.

Using a vasoconstrictor may be useful in restoring blood vessels and blood pressure in the absence of contraindications. Venous calcium gluconate can be effective against the effect of calcium channel blockers.

Gastric lavage may be valid in some cases. Using activated carbon until 2 hours after using amlodipine 10 mg reduces the absorption rate of amlodipine. Dialysis is not effective because amlodipine is closely attached to plasma proteins.

For Perindopril, data overdose is limited. Symptoms related to the overdose of enzyme inhibitors may include hypotension, circulatory shock, electrolyte disorders, kidney failure, respiratory increase, tachycardia, chest drum, slow rhythm, dizziness, anxiety and cough.

Extremely recommended treatment is the isometric salt vein intravenous. If hypotension appears, patients should be in a shockproof position. If possible, consider Angiotensin II and/or intravenous catecholamin.

It is possible to remove Perindopril from the circulatory system through dialysis. The span is indicated in the case of a slow heart rate that does not respond to treatment. Should continue monitoring the signs of survival, concentration of electrolytes and creatinine in serum.

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.

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.

Coveram:

Be cautious when using

related to perindopril

Hypersensitivity/eagles:

Facility on the face, limb, lips, mucosa, tongue, subjects and/or larynx are rarely recorded in patients treated with enzyme inhibitors, including Perindopril. This phenomenon can appear at any time during treatment.

If this phenomenon occurs, stop immediately Coveram and take appropriate and continuous monitoring measures until these symptoms are completely over. In general, the phenomenon of local and lips swelling is usually cured without treatment, although antihistamine drugs may have the effect of reducing symptoms.

Evaluation related to laryngeal edema can be fatal. When tongue edema, subject or larynx can cause respiratory obstruction, immediately use emergency measures. This measure includes the use of Adrenalin with or not accompanied by ventilation measures. Patients should be closely monitored until the symptoms of complete retreat.

Patients with a history of angioedema are not related to the treatment of transferred enzyme inhibitors that can increase the risk of angioedema when using enzyme inhibitors.

Evaluation in the intestinal tract is rarely recorded in patients treated with transferred enzyme inhibitors.

These patients show signs of abdominal pain (with or without nausea or vomiting); In some cases, there is no previous edema and C-1 esterase level is normal.

Evaluation is diagnosed with abdominal CT scan, or ultrasound or during surgery and the regression of symptoms after stopping the use of enzyme inhibitors. The intestinal angioedema should be considered in distinguished diagnosis in patients using enzyme inhibitors with abdominal pain.

Combining Perindopril with Sacubitril/Valsartan is contraindicated by increasing the risk of angioed.

Sacubitril/ Valsartan is only started to use 36 hours after the end of Perindopril's final dose. If treated with Sacubitril/Valsartan, Perindopril therapy will only start 36 hours after the last dose of sacubitril/valsartan.

Simultaneously used with MTor inhibitors (such as syrolimus, Everolimus, Temsirolimus):

Patients with simultaneous use with MTor inhibitors (such as syrolimus, Everolimus, temsirolimus) may increase the risk of angioedema (such as respiratory or tongue, with or without respiratory decline).

Hypersensitivity reactions in the process of filtering low density lipoprotein (LDL):

Rarely experiencing life -threatening response in patients using enzyme inhibitors transferred during filtering low density lipoprotein type as dextran sulphat. Anaphylactic reactions can be avoided by temporarily stop taking enzyme inhibitors before each filter.

Anaphylactic reaction during sensitivity:

Patients taking enzyme inhibitors during the treatment of sensitivity (such as membrane insect venom) have encountered anaphylactic reactions. Anaphylactic reactions may be avoided in these patients when temporarily stopped the enzyme inhibitors, but these reactions may reappear if unintentionally exposed to allergens.

leukopenia/grain leukemia/thrombocytopenia/anemia:

leukopenia/ granulocytosis, thrombocytopenia and anemia have been recorded in patients using enzyme inhibitors. Rarely appear leukopenia in patients with normal renal function and no other complex factors.

Should be especially cautious when taking Perindopril for patients with glue vascular disease, patients who are treating immunosuppressive, treaturinol or processes, or combining these risk factors, especially if the patient has previously impaired renal function. Some patients in these patients have severe infections, sometimes not responding to positive antibiotic treatments.

If using Perindopril for these patients, periodic monitoring should be monitored by the number of white blood cells and patients should be instructed to notify any signs of infection (such as sore throat, fever).

Aortic hypertension:

There is the ability to increase the risk of hypotension and renal failure when the patient has narrowing of the kidney artery on both sides or the kidney artery stenosis leads to the kidney function on the one hand is treated with the inhibition of the enzyme. Treatment with diuretics may be a contributing factor. Kidney failure may even appear with slight changes in serum creatinine in patients with kidney stenosis on one side.

Double blockade of Renin - Angiotensin - Aldosteron (RAAS):

There is evidence that the simultaneous use of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors increases the risk of hypotension, hyperkalemia and impaired renal function (including acute renal failure). Dual blockade of RAAS systems using a combination of enzyme inhibitors, Angiotensin II receptor inhibitors or Aliskiren therefore is not recommended.

If the dual blockade therapy is certainly considered necessary, this use is only performed under the supervision of the expert and should be closely monitored regularly for kidney, electrolyte and blood pressure.

Enzyme inhibitors and Angiotensin II receptor inhibitors should not be used simultaneously in patients with diabetic kidney disease.

Increase Aldosterone Tien Phat:

Patients with hypertrophy of primary aldosterone are generally not responding to anti-hypertension drugs that operate through inhibition of the renin-angiotensin system. Therefore the use of this drug is not recommended.

Hypotension:

Enzyme inhibitors can cause hypotension. Symptoms of hypotension are recognized as rare in patients with unnamed hypertension and is likely to appear more in patients with reduced circulatory volume such as diuretics treatment, salt -limiting diet, hemolysis, diarrhea or vomiting or on serious hypertension patients dependent on renin.

In patients with high risk of hypotension, symptoms should be closely monitored, kidney function and serum potassium concentration during Coveram treatment.

Similar considerations are applied to patients with myocardial oral disease, excessive hypotension can lead to myocardial infarction or stroke.

If the blood pressure appears, the patient should be on the back and if necessary, the veins of the sodium chloride solution should be inferior to 9 mg/ml (0.9%). Hypoglycemia is not contraindicated for the next dose, the next dose can often be used without fear when blood pressure has increased after the collection of circulating mass.

Aortic stenosis and hypertrophic myocardial valve:

Be cautious when taking enzyme inhibitors transferred to patients with mitral stenosis and clogged output of the left ventricle such as aortic stenosis or hypertrophic cardiomyopathy.

kidney failure:

In the case of renal failure (Creatinine clearance

Potassium and creatinine control is regularly part of medical practice for patients with impaired renal function.

In some patients on both sides of the renal artery or one side of the kidney stenosis, which has been treated with transferred enzyme inhibitors, the phenomenon of increased blood urea and serum creatinine, often recovered after stopping treatment. This is especially likely to occur in patients with renal impairment. The risk of severe hypotension and renal failure increases if there is a manifestation of hypertension.

Some patients with hypertension without manifestation of the previous kidney disease have hyperurine and creatinine urea, usually mild and transient, especially when used simultaneously Perindopril and diuretics. This is more likely to occur in patients who have impaired renal function before.

Hepatic failure:

Enzyme inhibitors are rarely related to the syndrome that starts with cholestasis jaundice and progresses into serious liver necrosis and (sometimes) death. The mechanism of this syndrome is not well known. Patients using enzyme inhibitors with jaundice and significant liver enzymes should stop using inhibitors of enzymes and appropriate medical monitoring.

Race:

Enzyme inhibitors increases the rate of angioedema in black skin patients in other skin -colored patients.

The transferred enzyme inhibitors may be less effective in lowering blood pressure on black people than other skin -colored people, which may be due to the more commonly common plasma renin activity in the population of hypertension patients with hypertension.

ho:

cough has been recorded when using the transferred enzyme inhibitor. Cough is characterized by dry, persistent and out of treatment. Coughing caused by transferred enzyme inhibitors should be considered as part of cough diagnosis.

surgery/anesthesia:

In patients undergoing major surgery or during anesthesia, using drugs that can cause hypotension, coveram can inhibit the formation of secondary angiotensin II to compensate for released. Coveram should be stopped one day before surgery. If hypotension appears and hypotension is considered to be due to this mechanism, it is necessary to adjust by increasing the volume of circulation.

Hemorrhage:

Serum hyperpass has been recorded in some patients treated with enzyme inhibitors, including Perindopril. Factors that increase blood potassium include renal failure, worsening renal function, age (> 70 years old), diabetes, events that occur, especially dehydration, acute cardiomemia loss, metabolic acidosis and simultaneous use with potassium diuretics (such as Spironolacton, Eplerenon, Triamteren or Amilorid, Solo or combination), supplements of potassium or replacement salts; Or patients taking other drugs that increase serum potassium (such as heparin, co-trimoxazole known as trimethoprim/sulfamethoxazole).

Use potassium supplements, potassium diuretic or alternative salts containing special potassium in patients with impaired renal function can significantly increase serum potassium.

Hyperboly hyperkalemia can cause serious arrhythmia, sometimes death. If the simultaneous use of Perindopril with any of the above drugs is really necessary, should be used carefully and regularly monitor blood potassium concentration.

Patients with diabetes:

In patients with diabetes treated with oral diabetes or insulin drugs, it is advisable to strictly control blood glucose in the first month of treatment with enzyme inhibitors.

related to amlodipine

Safety and effectiveness of amlodipine in the hypertension has not been established.

heart failure:

Should be careful treatment for patients with heart failure.

In a long-term study, compared to the place of placebo, patients with severe heart failure (NYHA III-IV), pulmonary edema events have been reported higher in the treatment group with amlodipine compared to the placebo group. Calcium channel blockers, including amlodipine, should be used carefully in patients with congestive heart failure because they can increase the risk of cardiovascular events and mortality later.

Hepatic failure:

In patients with impaired liver function, the waste time of amlodipine is prolonged and the area under the curve (AUC) is higher; The dose recommendations have not been set. Therefore, it is recommended to start treating amlodipine with low doses and cautiousness when starting and increasing the dose. Requires a slow dosage increase and strict control in patients with severe liver failure.

Elderly:

Need to increase the dose with caution in elderly patients.

kidney failure:

Amlodipine may be used for patients with renal impairment at normal doses. Change plasma amlodipine concentration is not related to the level of renal failure. Amlodipine cannot be removed by dialysis.

involves coveram

All warnings related to each component, as listed above, are applied to Coveram fixed tablets.

excipients:

Due to the presence of lactose, patients with rare genetic diseases such as galactose tolerance, glucose-galactose malabsorption, or a shortage of lactase enamel should not use this drug.

The ability to drive and operate machinery

amlodipine can affect the ability to drive and operate machinery mild - medium level, because it has the potential to cause dizziness headache, fatigue, exhaustion, nausea or impaired reaction. Be cautious when starting treatment with coveram.

Pregnancy

related to Perindopril:

It is not recommended to use enzyme inhibitors in the first three months of pregnancy. Contraindicated use of enzyme inhibitors transferred in the middle and last three months of pregnancy.

Except for the need to continue treating with enzyme inhibitors, patients planning to get pregnant should turn to other antihypertensive drugs that are considered safe during pregnancy. When a patient is diagnosed with pregnancy, it is advisable to stop treating with enzyme inhibitors immediately and if possible, you should start an alternative treatment.

The use of enzyme inhibitors transferred in the three months and the last three months of pregnancy is known to be toxic to the fetus (reduced kidney function, amniotic fluid, skull slowly) and toxicity in infants (kidney failure, hypotension, hyperkalemia).

If the patient uses an enzyme inhibitor in three months between pregnancy, it is recommended that the ultrasound should be taken to check the kidney function and the fetal skull.

Infants whose mothers use enzyme inhibitors, they should be closely monitored by the risk of hypotension.

Related to amlodipine:

Amlodipine's safety on pregnant women has not been established.

Only recommend used in pregnant women when there is no safer alternative measure and when the risk is due to the disease is greater than the mother and the fetus.

Breastfeeding period

Related to Perindopril:

Due to the lack of information related to the use of Perindopril during breastfeeding, it is not recommended to use Perindopril and should be replaced by other treatments that have been better known for safety during breastfeeding, especially when raising infants or premature babies.

Related to amlodipine:

Amlodipine is excreted through breast milk. It is currently unknown the effect of amlodipine on breastfeeding. The decision to continue/ stop breastfeeding or continue/ stop treatment with amlodipine should be considered based on the benefits of breastfed babies and Amlodipine's treatment benefits on the mother.

Drug interaction

involving Perindopril

Renin-Anotensin-Aldosteron (RAAS) dual blockbounds by using a combination of enzyme inhibitors, Angiotensin II or Aliskiren receptor inhibitors are more frequency of adverse frequency such as hypotension, hyperkalemia and impaired renal function (including acute renal failure) when compared with the use of remedy for drug-impact drugs on the system.

Medications that cause hyperkalemia:

Một số thuốc hoặc liệu pháp có thể làm tăng khả năng bị tăng kali máu: aliskiren, các muối kali, các thuốc lợi tiểu giữ kali, các thuốc ức chế enzyme chuyển, các thuốc đối kháng thụ thể angiotensin-II, các thuốc NSAID, các thuốc heparin, các chất ức chế miễn dịch như ciclosporin hoặc tacrolimus, trimethoprim và dạng phối hợp liều với sulfamethoxazol (co-trimoxazole). The combination of these drugs increases the risk of hyperkalemia.

Combining coordination:

Aliskiren:

In patients with diabetes or renal failure, the risk of hyperkalemia, worsening the kidney function and the rate of disease and cardiovascular death increases.

Extra body treatment:

The body treatment leads to blood exposure to negative charged surfaces such as a juris or dialysis with certain high -speed filters (such as polyacrylonitril film) and removing low density lipoprotein with dextran sulphate due to increased risk of sensitivity. If this treatment is required, it is necessary to consider using another type of filter or another anti -hypertension drug.

sacubitril/valsartan:

Concomitance Perindopril's use with Sacubitril/ Valsartan is contraindicated due to the coordination of neprilysin inhibitors and enzyme inhibitors that can increase the risk of angioedema. Sacubitril/ Valsartan is only started to use 36 hours after Perindopril's last dose. Perindopril therapy only starts 36 hours after the last dose of Sacubitri/ Valsartan.

Uncountable coordination:

Aliskiren:

In patients without diabetes or renal failure, the risk of hyperkalemia, worsening kidney function and rate of disease and cardiovascular death increases.

Agent enzyme inhibitors and Angiotensin receptor blockers:

In patients with atherosclerosis, heart failure or diabetes with internal organs, a combination of transferred enzyme inhibitors and Angiotensin receptor blockers related to the frequency of blood pressure, fainting, hyperkalemia, and worsening the kidney function (including acute renal failure) higher than using only one drug that acts on the Renin-Andosterone system.

Dual inhibitor (for example, a combination of an enzyme inhibitor with an Angiotensin II receptor antagonistic drug) should be limited in specific cases accompanied by close monitoring of kidney function, potassium and blood pressure levels.

estramustine:

The risk of increasing unwanted effects such as nerveema (angioedema).

co-trimoxazole (trimethoprim/ ulfamethoxazole):

Patients with simultaneous use of co-trimoxazole ( trimethoprim /sulfamethoxazole) may increase the risk of hyperkalemia.

Potassium diuretics (such as triamterene, amiloride ...), potassium salts:

Hemorrhage hyperka (can cause death), especially in the case of kidney failure (the effect of hyperkalemia).

Perindopril combination with the above drugs is not recommended. If this combination is indicated, be careful and regularly check serum potassium. To use Spironolactone in case of heart failure, see below.

Lithi:

Increased lithe and toxic lithium recovery has been recorded when used simultaneously with lithiums with transferred enzyme inhibitors. It is not recommended to use Perindopril with Lithi. If necessary, it is necessary to coordinate, recommend should closely monitor serum lithium concentration.

Caution should be particularly cautious:

Anti -diabetic drugs (insulin, oral hypoglycemic drugs):

Concentrated use of enzyme inhibitors and anti -diabetic drugs (insulin, oral hypoglycemic drugs) may increase the effect of hypoglycemia of blood glucose. This phenomenon seems to occur more in the first weeks of combined treatment and in patients with renal failure.

Diuretics do not keep potassium:

Patients who use diuretics, and especially in patients with volume and/ or salt, may be excessively reduced blood pressure after starting treatment with enzyme inhibitors. The likelihood of hypotension can decrease by stopping diuretics, increasing volume or amount of salt put into the body before starting treatment in low amounts and increasing the dose of Perindopril slowly.

In arterial hypertension, when the previous diuretic use may cause a decrease in volume/ salt, or to stop diuretics before starting treatment with an enzyme inhibitor, in this case, a potassium -free diuretic can be used later or must start using the enzyme inhibitor in low doses and increase the dose of slowly.

In congestive heart failure treated with diuretics, the enzyme inhibitor should be started at a very low dose, maybe after reducing the diuretic dose does not hold potassium.

In all cases, renal function (creatinine concentration) needs to be monitored in the first few weeks using enzyme inhibitors.

Potassium diuretics (Eplerenon, Spironolactone):

With Epleron or Spironolactone dose from 12.5 mg to 50 mg daily and with low dose of the transferred enzyme inhibitors:

In the treatment of heart failure II-IV (NYHA) with blood emulsion rates

Before starting combining treatment, checking no hyperkalemia and kidney failure.

Advice to closely monitor blood potassium and blood creatinine at once a week in the first month of treatment and monthly treatment.

racecadotril:

Enzyme inhibitors (such as perindopril) have been known to cause angioedema. This risk may increase when used simultaneously with racecadotril (a drug used to prevent acute diarrhea).

Mtor inhibitors (such as syrolimus, everolimus, temsirolimus ):

Treated patients in combination with MTOR inhibitors may increase the risk of angioed.

Non -steroid anti -inflammatory drugs (NSAIDs) include the dose of aspirin ≥ 3 g/day:

When concurrent use of enzyme inhibitors and non-steroid anti-inflammatory drugs (such as acetylsalicylic acid at an anti-inflammatory dose, COX-2 inhibitors and non-selective steroid anti-inflammatory drugs), anti-hypertension effects may be impaired. Simultaneous use of transferred enzyme inhibitors and non -steroid anti -inflammatory drugs may increase the risk of worsening renal function, including the possibility of acute renal impairment and increased serum potassium concentration, especially in patients with poor kidney function before. Should be cautious when combined, especially in elderly patients. Patients should be fully rehydrated and consider monitoring of kidney function after starting treatment and periodic treatment.

Careful coordination:

Gliptine (linagliptine, saxagliptine, sitagliptine, vildagliptine): increased the risk of angioedema, due to dipeptidyl peptidase IV (DPP-IV) reduced activity by gliptine, in patients treated simultaneously with an enzyme inhibitor.

Sympathetic medications: Sympathetic medications can reduce the anti -hypertension effect of enzyme inhibitors.

Gold: Nitritoid reactions (symptoms including blushing, nausea, vomiting and hypotension) are rarely recorded in patients being treated with injected gold (sodium aurothiomalate) and simultaneous use with enzyme inhibitors including perindopril.

related to amlodipine

Uncountable coordination:

dantrolen (intravenous):

Due to the risk of hyperkalemia, it is recommended not to simultaneously use a calcium channel blocker such as amlodipine with dantrolen in patients with the ability to increase malignant body temperature and in the treatment of malignant body temperature.

Caution should be particularly cautious:

CYP3A4 induction drugs:

When combined with the known CYP3A4 induction drugs, the amlodipine concentration in plasma may change. Therefore, it is necessary to control blood pressure and consider adjusting the dose during and after the combination of drugs, especially with strong induction drugs CYP3A4 (for example, Rifampicin, Hypericum Perforatum).

CYP3A4 inhibitors:

Simultaneous use of amlodipine with strong and medium inhibitors CYP3A4 (Protease inhibitors, Azol derivatives, macrolids such as erythromycin and clarithromycin, verapamil or diltiazem) can significantly increase amlodipine levels. Clinical manifestations corresponding to this pharmacokinetic change of the drug can be more clear in elderly patients. Therefore, clinical monitoring and dose adjustment.

There is an increase in the risk of hypotension in patients using clarithromycin with amlodipine. It is recommended to closely monitor patients when using simultaneously amlodipine with clarithromycin.

Coordination needs to consider:

Amlodipine's hypotension effect plus the hypotension effect of other anti -hypertension drugs.

tacrolimus:

There is a risk of increased blood tacrolimus concentration when combined with amlodipine. To avoid the toxicity of Tacrolimus, blood concentration should be monitored and adjust the appropriate tacrolimus dose when taking amlodipine in patients treated with tacrolimus.

Mtor inhibitors:

MTor inhibitors such as syrolimus, temsirolimus and everolimus are substrates of CYP3A. Amlodipine is a weak CYP3A inhibitor. When combined with mtor inhibitors, Amlodipine can increase the concentration of MTor inhibitors.

ciclosporine:

There are no drug interactive studies between ciclosporine and amlodipine controlled in healthy volunteers or other populations except for kidney transplant patients, when they notice increases the bottom concentration (average of 0%-40%) of ciclosporine . Ciclosporine concentration should be considered in kidney transplant patients using amlodipine, and reducing ciclosporine dose if necessary.

simvastatin:

Amlodipin 10 mg multi -dose combination treatment with simvastatin 80 mg increases 77% of simvastatin concentration compared to simvastatin treatment. Limit the dose of simvastatin in patients using Amlodipin 20 mg daily.

Other coordinates:

Use amlodipine with grapefruit or grapefruit juice is not recommended due to amlodipine bioavailability may increase above some patients leading to increased hypotension effect of the drug.

involves coveram

Caution should be particularly cautious:

baclofen:

Increase anti -hypertension effect. Control blood pressure and adjust the dose of anti -hypertension drugs if necessary.

Coordination needs to consider:

Antihypertensive drugs (such as beta blockers) and vasodilators: simultaneous use of these drugs may increase the hypotension effect of Perindopril and Amlodipine. Using the drug simultaneously with nitroglycerin and other nitrates or other vasodilators may cause more severe hypotension, so it is advisable to be carefully considered.

Corticosteroids, tetracosactid: reduce anti -hypertension effect (due to the effect of holding water and salt of corticosteroids).

Alpha blockers (Prazosin, Alfuzosin, Doxazosin, Tamsulosin, Terazosin): Increased anti -hypertension and increased risk of antihypertension.

Amifostin: can increase the anti -hypertension effect of amlodipine.

Three -round antidepressants/psychotic/anesthetic drugs: Increasing anti -hypertension effects and increasing the risk of hypotension.