Stamlo-T 40mg/5mg Dr. R.Deddy treats hypertension (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Telmisartan, amlodipine

Ingredient

Composition information	Content
Telmisartan	40mg
Amlodipine	5mg

Uses

indications

Stamlo-T drugs are indicated in the following cases:

Treatment of idiopathic hypertension in adults:

Additional treatment: Tablets combined with Telmisartan + Amlodipine doses (abbreviated as "Telmisartan + Amlodipine FDC") is indicated in adults with uncontrolled blood pressure completely with amlodipine. Telmisartan + Amlodipine FDC contains the same content and ingredients.

ATC code: C09DB04.

Mechanism of action

Telmisartan Amlodipine contains a combination of two anti -hypertension active ingredients with additional mechanisms to control blood pressure in patients with idiopathic hypertension: an Angiotensin II receptor antagonist, Telmisartan, and a Calci dihydropyridinic channel, amlodipine.

The combination of these active ingredients is effective against hypertension, reducing blood pressure at a stronger level than the active ingredients.

Telmisartan/amlodipine used once a day to reduce blood pressure effectively and appropriately for 24 hours when used at treatment dose.

telmisartan

Telmisartan is an oral and antagonistic drug that is effective Angiotensin II (ATL). Telmisartan occupies Angiotensin II position with a very high affinity at the position associated with the AT1 receptor is the position responsible for the known effects of Angiotensin II. Telmisartan does not manifest any copper activity at the AT1 receptor.

Telmisartan is selected with AT1 receptor. This cohesion is extended. Telmisartan does not show affinity for other receptors, including AT2 and other AT receptors are less known. The function of these receptors is unknown, as well as the effect when they are excessive stimulation due to angiotensin II, which is a substance with increased concentration due to telmisartan. Plasma aldosterone concentration is reduced by Telmisartan. Telmisartan does not inhibit plasma renin in humans or ionic channel blockers. Telmisartan does not inhibit the enzyme Angiotensin (Kinase II), which is the enzyme that has the effect of teaching Bradykinin. Therefore, the drug is less likely to cause adverse effects through Bradykinin intermediaries.

In humans, a dose of 80 mg Telmisartan has almost completely inhibited hypertension due to Angiotensin II. This inhibitory effect is maintained for 24 hours and up to 48 hours is still recorded.

After the first Telmisartan dose, anti -hypertension effects gradually within 3 hours. The maximum reduction of blood pressure is usually achieved after 4 to 8 weeks after the beginning of treatment and maintenance in long -term treatment.

Anti -hypertension effect continuously lasts for 24 hours after taking the drug and 4 hours before the next dose is recorded by a blood pressure monitor when traveling. This is confirmed by the consistent peak rate of over 80% after taking the dose of 40 and 80 mg Telmisartan in clinical studies with a placeborned control. There is a clear trend for the willow relationship and time to recover the centrifugal blood pressure to the basic level. In this regard, the data is concerned about the inconsistent diastolic blood pressure.

In patients with hypertension, Telmisartan reduces both systolic and diastolic blood pressure without affecting the heart rate. The contribution to diuretic effects and stimulating sodium secretion in the urine of the drug to its hypotension effect has not been determined. Telmisartan's low voltage effect can be compared to other substances representing other hypotension drugs (proven in clinical trials comparing Telmisartan with amlodipine, Atenolol, Enalapril, Hydrochlorothiazide and Lisinopril).

After stopping the sudden Telmisartan treatment, the blood pressure gradually returns to the values as before treatment for a few days without evidence of hypertension again.

The rate of dry cough is significantly reduced in patients with Telmisartan treatment compared to angiotensin transferring enzyme inhibitors in clinical trials when directly comparing two anti -hypertension treatments.

amlodipine

Amlodipine is a calcium ionic inhibitor entering the cell, belonging to the dihydropyridine group (slow channel blockers or calcium ions) and inhibiting the membrane calcium that penetrates the membrane into the heart muscle and blood vessel smooth muscles. The mechanism of amlodipine's anti -hypertension effect is due to the effect of direct relaxation on blood vessel smooth muscles, resulting in reducing peripheral resistance and reducing blood pressure. Test data shows that amlodipine is linked to both locations to connect dihydropyridine and not dihydropyridine. Amlodipine is relatively selective on the vessel, with a stronger effect on blood vessel muscle cells compared to myocardial cells.

In patients with hypertension, the one -time daily dose significantly reduces clinical blood pressure in both lying on their backs and stands for 24 hours. Due to the slow onset, acute low blood pressure is not the problem when using amlodipine.

In patients with normal kidney -functional hypertension, amlodipine's treatment dose levels reduce anti -blood vascular resistance and glomerular filtration and increase renal perfusion flow effectively without changing glomerular filter or proteinuria.

Amlodipine is not related to any adverse effects on metabolism or changes in plasma lipids and is suitable for use in asthma patients, diabetes and gout.

pharmacokinetic pharmacokinetics

Telmisartan/amlodipine ratio and absorption level is equivalent to the bioavailability of telmisartan and amlodipine when used in the form of separate tablets.

absorption

Telmisartan is quickly absorbed, although the number of absorption changes. Absolute average bioavailability of Telmisartan is about 50%. When Telmisartan is used with food, the reduction of the area under the plasma concentration curve over time (AUC0 -∞) of Telmisartan varies about 6% (40 mg dose) to approximately 19% (160 mg dose). 3 hours after taking the drug, plasma concentrations are similar when Telmisartan is hungry or with food.

After taking single-doses of amlodipine, amlodipine's peak plasma concentration is achieved within 6-12 hours. Absolute bioavailability is determined in about 64% and 80%. Amlodipine's bioavailability is not affected by food.

distribution

Telmisartan is mostly linked to plasma proteins (> 99.5%), mainly with albumin and alpha-1 acid Glycoprotein. The average distribution volume in a stable state (VDSS) is approximately 500 l.

Amlodipine's distribution volume is about 21 l/kg. In vitro studies with amlodipine show that about 97.5% of the drug in circulation is linked to plasma proteins in hypertension patients.

Biological metabolism

Telmisartan is transformed in a path associated with glucuronid with mother molecules. These links do not show pharmacological effects.

amlodipine is metabolized (about 90%) through the liver into non -active metabolites.

Elimination

Telmisartan has a dynamic pharmacokinetic properties according to the dual exponation function with a selling time of more than 20 hours. The maximum concentration in plasma (cmax) and at a narrower range, the area under the cigarette concentration curve in plasma - time (AUC) increases not commensurate with the dose. There is no evidence of Telmisartan's accumulation phenomenon of clinical significance. The concentration of plasma drugs in women is higher than that of men, with no effects on effectiveness.

After oral (and intravenous), Telmisartan is almost excreted through feces, mainly in a constant form. The excretion accumulated through the urine is

Amlodipine is eliminated from plasma in two phases, with the end of the sale period from 30 hours to 50 hours in accordance with the daily dose once. Plasma concentrations in a stable state are achieved after the drug continues for 7-8 days. 10% amlodipine initially and 60% amlodipine in the form of metabolism is excreted through urine.

linear/non -linear

Telmisartan's AUC mitigation does not reduce the effectiveness of treatment. There is no linear relationship between dose and plasma concentration. CMAX and lower AUC range increase in an unbalanced way with a dose of over 40 mg.

Amlodipine shows linear pharmacokinetics.

pharmacokinetics in special subjects

Children (under 18 years old)

There are no pharmacokinetic data in this patient group.

Gender influence

Observed the gender difference in the plasma concentration of Telmisartan, with CMAX and AUC higher than 3 and 2 times corresponding to women compared to men without effects related to efficiency.

Elderly patients

Telmisartan pharmacokinetics are not different in young and elderly patients.

Time to achieve the peak concentration of amlodipine plasma is similar in the elderly and young people. In elderly patients, Amlodipine clearance tends to decrease with AUC increase and the sale time.

Patients with renal failure

In patients with mild and severe mild renal impairment, observing Telmisartan concentration in plasma doubled. However, lower plasma concentrations are observed in patients with renal impairment. Telmisartan is highly linked to plasma proteins in patients with renal impairment and cannot be removed by dialysis.

Semi -selling time does not change in patients with renal failure. Amlodipine's pharmacokinetics is not significantly affected in patients with physical failure.

Patients with liver failure

Dynamic studies in patients with hepatic impairment show that Telmisartan's absolute bioavailability increased by nearly 100%. Telmisartan's waste sale time does not change in patients with liver failure. The clearance of amlodipine in patients with hepatic failure leads to an increase in AUC by 40 - 60%.

Before taking Stamlo-T 40mg/5mg Dr. R.Deddy treats hypertension (4 blisters x 7 tablets)

How to use

Telmisartan + Amlodipine FDC can be used with food or not with food. Telmisartan+Amlodipine FDC should be used with some liquids.

Dosage

Telmisartan + Amlodipine FDC dose is recommended to be one tablet per day.

The maximum dose is recommended as Telmisartan +Amlodipine FDC 80 mg/10 mg, one tablet daily. Telmisartan+Amlodipine FDC is designated for long -term treatment.

Do not use amlodipine with grapefruit or grapefruit juice because bioavailability can increase in some patients leading to increased hypotension effect.

additional treatment

Telmisartan + Amlodipine FDC 80 mg/10 mg can be used in patients with non -control blood pressure completely with telmisartan + amlodipine FDC 40 mg/10 mg or telmisartan + amlodipine FDC80mg/5mg.

Telmisartan + Amlodipine FDC 80 mg/5 mg can be used in patients with non -control blood pressure completely with telmisartan + amlodipine FDC 40 mg/5 mg.

Telmisartan + Amlodipine FDC 40mg/10 mg can be used in patients with non -controlled blood pressure entirely with amlodipine 10 mg.

Telmisartan + Amlodipine FDC 40 mg/5 mg can be used in patients with non -controlled blood pressure completely with amlodipine 5 mg of monomers.

Needs for separate doses for each ingredient (ie amlodipine and telmisartan) before changing the dose combined with a fixed combination. When clinically appropriate, it is possible to consider changing directly from single treatment to fixed combination therapy.

Patients who have used 10 mg amlodipine but have many side effects such as edema, can switch to Telmisartan + Amlodipine FDC 40 mg/5 mg once a day, while reducing the dose of amlodipine without reducing the antihypertensive effect as expected.

alternative treatment

Patients who are using Telmisartan and Amlodipine individual tablets can be used instead of Telmisartan + Amlodipine FDC containing combined with the content and ingredients in a tablet once a day, for example to increase convenience or compliance.

Special target groups

Elderly patients

No need to adjust the dose for elderly patients. Very little information available in elderly patients.

Patients with renal failure

No need to adjust the dosage for patients with mild to medium renal failure. Experienced in patients with severe kidney failure or hemorrhage. Be careful when using Telmisartan +Amlodipine FDC in those patients because Amlodipine and Telmisartan cannot be separated.

Patients with liver failure

Should be carefully used Telmisartan + Amlodipine FDC in patients with mild to moderate liver failure. Telmisartan's dosage should not exceed 40 mg once a day. Telmisartan+Amlodipine FDC is contraindicated in patients with severe liver failure.

Pediatric patients

Safety and effectiveness of Telmisartan +Amlodipine FDC in children under 18 years old has not been determined. No 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?

symptoms

Signs and symptoms of overdose may be related to increased pharmacological effects. The most typical manifestations of Telmisartan overdose are low blood pressure and tachycardia; Slow heart rate, dizziness, increased serum creatinine and acute renal failure have also been reported.

Amlodipine overdose can lead to excessive peripheral dilatation and have the ability to reflect tachycardia. The body low blood pressure is noticeably and may last to the point of shock accompanied by death.

How to handle

Patients should be closely monitored, symptomatic treatment and supportive treatment. The processing depends on the time after taking the drug and the severity of the symptoms.

Proposal measures include vomiting and/or gastric wash. Activated carbon can be helpful in treating overdose for both telmisartan and amlodipine.

Should regularly monitor electrolytes in serum and creatinine. If hypotension occurs, the patient should be placed in the position of lying on his back, lifting his legs, and the salt water quickly.

Please see more information about drugs in the instructions for the use of drugs attached.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

When using Stamlo-T medicine, you may experience unwanted effects (ADR).

Safety records

The most common adverse reaction includes dizziness and peripheral edema. Heavy fainting rarely occur (less than 1 case over 1,000 patients).

Safety and tolerance of Telmisartan/Amlodipine have been assessed in 5 controlled clinical studies with more than 3500 patients, over 2500 people used Telmisartan in combination with Amlodipine.

List of unwanted effects

The adverse reaction has been grouped according to the frequency according to the following convention: Very common (≥ 1/10); Common (≥ 1/100 to

In each frequency group, the adverse reaction is presented in the order of severity.

System Telmisartan + Amlodipine FDC amlodipine Meet upper respiratory infections including sore throat and sinusitis, urinary tract infections including cystitis Blood

less common

leukopenia, thrombocytopenia

Hypersensitivity Blood (in patients with diabetes) Change mood rarely depression, anxiety, insomnia

Tower bundle

> Disorders of ears and internal ears Vascular disorders The chest and mediastinum rarely ho Difficulty breathing difficulty breathing, rhinitis Chemistry

less common abdominal pain, diarrhea, nausea flatulence changes the habits of the intestine

is very rare Foul hair loss, bleeding, skin discoloration, increased sweating

rarely

eczema, Hong Ban, rash

Evaluation (can death), rash, skin poisoning, urticaria.

Mechanical Meet renal failure, including acute renal failure urination disorders, burning Breasts

rarely

erectile dysfunction

less common weakness, chest pain, fatigue, edema Experiment

less common liver enzyme increased serum creatinine weight gain, weight loss Hemoglobin

2: Most cases of abnormal liver/liver disorders after using Telmisartan occurs in Japanese patients. Japanese patients are more likely to experience these adverse reactions.

3: Cases of interstitial lung disease (mainly interstitial pneumonia and Eosin pneumonia) have been reported from experience after circulation with Telmisartan.

Instructions on how to handle ADR:

Notify the physician with unwanted effects when using the drug.

Warnings

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

contraindicated

Stamlo-T anti-contraindications in the following cases:

Hypersensitivity to active ingredients, with dihydropyridine derivatives or any ingredients in the excipient. high).

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

pregnancy

Do not start treatment with Angiotensin II receptor antagonists during pregnancy. Unless the continued use of Angiotensin II receptor antagonists are considered to be essential, patients who are intended to be pregnant should switch to alternative anti -hypertension therapies that have safe data proven to use during pregnancy. When diagnosed with pregnancy, immediately treated with angiotensin II receptor antagonists, and if appropriate, should start with an alternative therapy.

liver failure

Telmisartan is excreted mainly through bile. It may be expected to decrease in patients with bile congestion or liver failure. Moreover, like calcium antagonists, Amlodipine's exhaust time is prolonged in patients with liver failure and the recommendations for this patient has not been set. Therefore, Telmisartan/Amlodipine should be used carefully in these patients.

Hypertension due to renal artery

Ability to increase the risk of severe hypotension and renal function when the patient has narrowed kidney narrowing on both sides or the nephrotic stenosis to the only kidney is still the function treated with drugs that affect the renin-anidensin-aldosterone system (RAAS).

kidney failure and kidney transplant

Recommend should monitor the concentration of potassium and serum creatinine when using telmisartan/ amlodipine in patients with renal failure. There is no experience in using telmisartan/amlodipine in new kidney transplant patients. Telmisartan and Amlodipine are not separated.

Reducing internal volume

Symptomic low blood pressure, especially after the first dose, can occur in patients with decreased volume and/or sodium reduction, for example, due to excessive diuretic treatment, too strict salt, diarrhea or vomiting. Such conditions should be treated before using telmisartan/amlodipine. If hypotension occurs with Telmisartan/Amlodipine, the patient should be placed in the back and, if needed, intravenously the normal physiological saline solution. Can continue treatment when blood pressure has been stable.

Dual-Renin-Anotensin-Aldosterone (RAAS)

There is evidence that the simultaneous use of ACE inhibitors, Angiotensin II or Aliskiren receptor blockers increases the risk of hypotension, hyperkalemia and reducing kidney function (including acute renal failure). It is not recommended to use the RAAS dual closing wind style through a combination of ACE inhibitors, Angiotensin II or Aliskiren receptor blockers.

If dual tank maple therapy is considered absolutely necessary, this should only be applied under the supervision of experts and must closely monitor kidney function, electrolyte and blood pressure.

Do not simultaneously use ACE inhibitors and Angiotensin II receptor blockers in patients with diabetic kidney disease.

Other diseases stimulate the renin-ankiotensin-aldosterone system

In patients with vascular tone and renal function depends mainly on the activity of the renin-angiotensin-aldosterone system (for example, patients with severe congestive heart failure or attached kidney disease, including kidney artery stenosis), drug treatments affect this system related to acute hypotension, tongeline increase, small or less acute nephrotic failure.

Increasing aldosterone increases

Patients with raw primary aldosterone increased in general will not respond to antihypertensive drugs that work by inhibition of the renin-angiotensin system. Therefore, Telmisartan should not be used.

Aortic stenosis and heart valve, myocardial hypertrophy

Like other vasodilators, special attention should be paid to patients with aortic stenosis or mitral stenosis, or hypertrophic congestion.

unstable angina, acute myocardial infarction

There is no data that supports the use of telmisartan/amlodipine in unstable angina and transparent or within a month after myocardial infarction.

heart failure

In a long-term place of fatal control (praise-2) of amlodipine in patients with NYHA III heart failure and IV ischemic, Amlodipine is related to increased reports on pulmonary edema although there is no significant difference in the frequency of heart attack becomes a placebo.

Patients with diabetes are treated with insulin or antihypertensive drugs

In these patients, hypoglycemia may occur when treated with Telmisartan. Therefore, in these patients should consider the appropriate monitoring of blood glucose; Insulin or anti -diabetic dosage should be adjusted when specified.

Hyarass hyperka

The use of drugs that affect the renin-anidensin-aldosterone system can cause hyperkalemia. Hyperbysical hyperpasses can be fatal in the elderly, in patients with renal impairment, in patients with diabetes, in patients treated simultaneously with other drugs that may increase potassium levels, and/or in patients with Gia Phat events.

Before considering the use of drugs that affect the renin-ankiotensin-aldosterone system, it is advisable to evaluate the ratio between risks and benefits.

The main risk factors leading to hyperkalemia are considered:

Diabetes, renal failure, age (70 years old). The medicinal products or the therapeutic layers of drug products that can cause hyperkalemia are salt-containing substances containing potassium, potassium diuretics, ACE inhibitors, Angiotensin II receptor inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs, including selective COX-2 inhibitors), Heparin, immunosuppressive drugs (cyclosporin or tacrolimus), and and and Tacrolimus) Trimethoprim.

Should closely monitor blood potassium in these patients.

Other

Like any anti -hypertension drug, excessive hypoglycemia in patients with myocardial ischemia or cardiovascular disease due to anemia can cause myocardial infarction or stroke.

The effect of the drug on the ability to drive and operate machinery

This drug has an average effect on the ability to drive and operate machinery. It should be recommended that patients may have adverse reactions such as fainting, sleeping, dizziness or dizziness during treatment. Therefore, it is necessary to be cautious when driving or using machines. If patients experience these side effects, avoid dangerous effects such as driving or using machines.

Use drugs for women during pregnancy and lactation

Pregnancy

There is little data on the use of telmisartan/amlodipine in pregnant women. Researching reproductive toxicity in animals with Telmisartan/Amlodipine has not been done.

telmisartan

Do not recommend the use of angiotensin II receptor receptor drugs in the first three months of pregnancy. The use of Angiotensin II receptor is contraindicated in the three months and the last three months of pregnancy.

Studies with Telmisartan on animals have shown toxicity on fertility.

Epidemiological evidence about the risk of teratogenicity after exposure to ACE inhibitors in the first three months of pregnancy has not been concluded; However, it is not possible to rule out a small increase in risk. Although there is no epidemiological data controlled at risk for Angiotensin II receptor antagonists, there may be similar risks to this drug. Unless the continued use of Angiotensin II receptor antagonists are considered to be essential, patients who are intended to be pregnant should switch to alternative anti -hypertension therapies that have safe data established for use during pregnancy. When diagnosed with pregnancy, immediately stop treatment with Angiotensin II receptor antagonists and if appropriate, should start with replacement therapy.

Angiotensin II receptor antagonistic drugs for the second and third three months of pregnancy causing fetal toxicity in humans (impaired renal function, low amniotic fluid, retardation of skull growth) and infant toxicity (kidney failure, hypotension, hyperkalemia).

If an angiotensin II receptor antagonistic medication is used from three months of pregnancy, it is recommended that the ultrasound will check the kidney function and the skull.

Babies whose mothers treated Angiotensin II receptor countervailers should be closely monitored to detect low blood pressure.

amlodipine

Data from a small number of pregnant women who use drugs does not show Amlodipine or other calcium receptor anti -receptors that affect the health of the fetus. However, there may be prolonged labor risk.

Breastfeeding period

Because there is no information on the use of telmisartan and/or amlodipine during breastfeeding, it is not recommended to use Telmisartan/Amlodipine and replacement therapies with safe data that have been better established when breastfeeding will be more suitable, especially when breastfeeding or premature babies.

fertility

There is no data available from clinical studies with controls with a fixed form of dosage or each component.

There has been no research on toxicity on fertility with a combination of telmisartan and amlodipine.

In preclinical studies, there is no observation of Telmisartan's effects on fertility in both male and female. Similarly, there is no effect on fertility in both male and female is reported to amlodipine.

Sperm recovery changes at the tip of sperm can reduce the fertilization that has been observed for calcium channel inhibitors in preclinical and in vitro studies. There is no clinical involvement.

Drug interaction

does not observe the interaction between the two components of the form of a fixed dose combination in clinical trials.

The common interactions of the combination form

No studies on this drug interaction.

Note when using simultaneously

Other anti -hypertension drugs

The effect of reducing blood pressure of telmisartan/amlodipine may be increased due to simultaneous use with other anti -hypertension drugs.

The drugs are capable of lowering blood pressure

Based on the pharmacological properties, it is thought that some of the following drugs are likely to increase the lowering effectiveness of all anti -hypertension drugs including this drug, for example, Baclofen, amifostine, neurological or antidepressants. In addition, vertical low blood pressure may be worse due to alcohol use.

corticosteroids.

Reduce anti -hypertension effect.

interactions related to telmisartan

Do not use simultaneously

Potassium -saving diuretic or potassium supplements: Angiotensin II receptor antagonists such as Telmisartan, diuretics that cause potassium -reducing diuretics. Potassium -saving diuretic such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements, or salt containing potassium can increase serum potassium. If indicated to use simultaneously because of hypokalemia, caution and regular monitoring of serum potassium.

Lithium: There has been a report on the inverse of serum and toxic lithium concentration while simultaneous use of lithium with angiotensin transfer inhibitors and angiotensin II receptor antagonists, including telmisartan. If the combination is necessary, should carefully monitor serum lithium concentration.

Other anti-voltage drugs that work on the Renin-Anotensin-Aldosterone (RAAS): Clinical test data shows that the double closing of the Renin-Anotensin-Aldosterone (RAAS) through the use of ACE inhibitors, Angiotensin II receptor blockers or Aliskiren is related to the frequency of side reactions as higher than blood pressure, increased blood and hypertension, bloodstyopia (including acute renal failure) compared to the use of a factor.

Be cautious when using simultaneously

Non-steroid anti-inflammatory drugs: NSAIDs (Acetylsalicylic acid in anti-inflammatory doses, COX-2 inhibitors and non-selective NSAIDs) can reduce anti-blood pressure effects of Angiotensin II receptor antihypertension.

In some patients with impaired renal function (for example, patients with dehydration or elderly patients with impaired renal function), simultaneous use of Angiotensin II receptor antagonists and cyclo-oxygenase inhibitors can impair kidney function, may include acute renal failure that can be recovered. Therefore, be careful when using combination, especially in the elderly. Patients need to drink enough water and need to consider monitoring kidney function after starting combined and periodic treatment.

Ramipril: In a simultaneous study of Telmisartan and Ramipril, it leads to an increase of 2.5 times AUC0-24 and CMAX of Ramipril and Ramiprilat. The clinical significance of this finding is not known.

Note when using simultaneously

Digoxin: Observed the phenomenon of increasing the average concentration in plasma (49%) and the median bottom concentration (20%) of digoxin when used simultaneously with digoxin.

When starting, adjusting and stopping using Telmisartan, monitoring digoxin levels to maintain digoxin levels within treatment.

Interactions related to amlodipine

Be cautious when using simultaneously

CYP3A4 inhibitors: With simultaneous use with CYP3A4 erythromycin inhibitors in young patients and diltiazem in elderly patients, the concentration of amlodipine in plasma increases by 22% and 50% respectively. However, the clinical involvement of this finding is uncertain. CYP3A4 (Ketoconazole, Itraconazole, Ritonavir) cannot Use amlodipine carefully with CYP3A4 inhibitors. However, there is no disadvantage because this interaction is reported.

CYP3A4 induction drugs: There is no data on the effects of CYP3A4 induction drugs on amlodipine. The simultaneous use of CYP3A4 induction drugs (e.g. Rifampicin, Hypericum Perforatum) can lead to lower amlodipine concentration in plasma.

Grapefruit and grapefruit juice: Simultaneously use 240 ml of grapefruit juice with a single dose of 10 mg of amlodipine in 20 healthy volunteers without significantly the pharmacokinetic properties of Amlodipine. It is not recommended to simultaneously use amlodipine with grapefruit or grapefruit juice in patients because of the bioavailability of amlodipine may increase and can lead to hypertension.

Note when using simultaneously

tacrolimus: There is a risk of increasing the level of tacrolimus in the blood when used simultaneously with amlodipine but the pharmacokinetic mechanism of this interaction is not fully understood. To avoid the toxicity of Tacrolimus, use Amlodipine in patients using Tacrolimus to monitor the concentration of Tacrolimus in the blood and adjust the dosage of Tacrolimus when suitable.

Cyclosporine: There is no medical interactive research that has been conducted with cyclosporine and amlodipine in healthy volunteers or other groups of objects except for patients with kidney implants, there there is an increase in the base concentration of cyclosporine variable (average 0% - 40%). Consider to monitor cyclosporine levels in kidney implant patients when taking amlodipine, and should reduce the dosage of cyclosporine as needed.

Combining combination of amlodipine doses with simvastatin 80 mg increases the level of exposure to Simvastatin by 77% compared to the single simvastatin. Therefore, simvastatin dose in patients using amlodipine should be limited to 20 mg per day.

Other drugs: Amlodipine has been used safely with digoxin, warfarin, Atorvastatin, Sildenafil, antacids (Aluminum Hydroxide, Magnesium hydroxide, simeticone), cimetidine, antibiotics and oral hypoglycemic drugs. When using Amlodipine and Sildenafil, each independent agent has its own reduction effect.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

Other drugs

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