Twynsta 40/5mg Boehringerer treatment of idiopathic hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Telmisartan, amlodipine
Ingredient
| Composition information | Content |
| Telmisartan | 40mg |
| Amlodipine | 5mg |
Uses
indications
Twynsta 40/5 mg drugs are indicated in the following cases:
Pharmacology
Telmisartan
Telmisartan is an Angiotensin II receptor antagonistic drug (type AT1). Telmisartan occupies Angiotensin II place with a very high affinity at the position associated with the AT1 receptor (location responsible for the effects of Angiotensin II). Telmisartan is not homogeneous at the AT1 receptor. Telmisartan is selected and prolonged with AT1 receptor.
Telmisartan has no affinity with AT2 receptors and other AT receptors. 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 aldosteron 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 breaking 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 inhibitor is maintained for 24 - 48 hours.
After the first dose of Telmisartan, anti -hypertension effects gradually within 3 hours. The maximum reduction of blood pressure is usually reached 4 weeks after the beginning of treatment and maintenance throughout the treatment period.
Anti -hypertension effect is maintained continuously for 24 hours after taking the drug, including 4 hours before the next dose. Peak - peak ratio always reaches over 80% after the dose of 40 and 80 mg Telmisartan in clinical studies are controlled to placebo.
Telmisartan reduces both systolic and diastolic blood pressure without affecting the pulse.
Telmisartan's anti -hypertension effect is equivalent to other drugs representing other anti -hypertension drugs.
When suddenly stop Telmisartan, the blood pressure will gradually return to the value as before treatment within a few days without the phenomenon of hypertension.
Treatment with Telmisartan will come with a significant reduction in left ventricular mass and left Ventricular mass index in patients with hypertension and left ventricular hypertrophy.
Treatment with Telmisartan reduces proteinuria (microscopic and general albumin) in hypertension patients with diabetes kidney disease.
Significantly less dry cough complications in patients treated with Telmisartan compared to patients using ACE inhibitors.
amlodipine
Amlodipine is an inhibitor of calcium ion into the cell, the dihydropyridine group (slow channel blockage or calcium ion antagonistic) and inhibit the membrane ionized ionized ionic ion into the heart muscle and blood vessel muscles.
Amlodipine's anti -hypertension mechanism is due to the effect of direct relaxation on blood vessels, reducing peripheral resistance and reducing blood pressure. Amlodipine is linked to both locations to connect dihydropyridine and not dihydropyridine.
Amlodipine is relatively selective on the vessel, acting on smooth muscle cells stronger than myocardial cell.
Dosage 1 time/day significantly reduces clinical blood pressure in both lying on the back 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 hypertension with normal renal function, amlodipine treatment dose levels reduce resistance to kidney blood vessels 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 patients with asthma, diabetes, gout.
Twynsta
Anti -hypertension effect is mainly achieved within 2 weeks after the beginning of treatment.
In patients with unprovered blood pressure with amlodipine 5 mg, Twynsta may give the effect of controlling blood pressure equivalent to Amlodipine 10 mg, which significantly reduces edema side effects.
In patients with good blood pressure controlled with Amlodipine 10 mg but edema, Twynsta 40/5 mg or 80/5 mg can control the same blood pressure that is less edema.
The effect of anti -hypertension of Twynsta is the same regardless of age, gender and in patients with or without diabetes.
Pharmacokinetics
absorption
Telmisartan is quickly absorbed, although the number of absorption changes. Telmisartan's absolute bioavailability is about 50%.
When used with food, Telmisartan's AUC changes about 6 - 19% (dose 40 - 160 mg). 3 hours after taking the medication, the same plasma concentration when Telmisartan is hungry or with food. AUC reduced less difficult to reduce the effectiveness of treatment.
After taking single doses of amlodipine, amlodipine plasma peak concentration is achieved within 6 - 12 hours. Absolute bioavailability is about 64 - 80%. Amlodipine's bioavailability is not affected by food.
Distribution
Over 99.5% Telmisartan is linked to plasma proteins, mainly with albumin and α1 glycoprotein. The average distribution volume in a stable state (VSS) is approximately 500L.
Amlodipine's distribution volume is about 21 l/kg. In vitro, about 97.5% amlodipine during circulation associated with plasma proteins.
Metabolism
Telmisartan is metabolized in the path of glucuronide links with mother molecules. These links have no pharmacological effects.
90% amlodipine metabolizes 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. CMAX and AUC increases not commensurate with the dose. There is no evidence to accumulate Telmisartan with clinical significance.
Telmisartan is mostly excreted in feces, mainly in a constant form, less than 2% of the excretion through the urine.
Amlodipine is excreted two phases, the sale time is 30-50 hours. Plasma concentrations in a stable state are achieved after continuing for 7-8 days. 10% amlodipine initially and 60% amlodipine in the form of metabolism is excreted through urine.
Before taking Twynsta 40/5mg Boehringerer treatment of idiopathic hypertension (3 blisters x 10 tablets)
How to use
can use Twynsta along with other anti -hypertension drugs. Twynsta can drink with or without food.
Dosage
Adults:
Should use Twynsta 1 time/day.
Alternative treatment in patients who are taking Telmisartan and Amlodipine individual tablets 1 tablet/time/day, to increase convenience or compliance.
Additional treatment in non -control patients are entirely with Telmisartan or Amlodipine.
Patients treated with amlodipine 10 mg experience unwanted reactions (edema ...) that can not increase the dose further, can switch to Twynsta 40/5 mg 1 time/day, reduce the content of amlodipine but generally do not reduce the response to the expected hypotension.
Starting treatment in patients is difficult to control blood pressure with 1 drug. The usual starting dose of Twynsta is 40/5 mg x 1 time/day. Patients who need stronger hypotension may start with Twynsta 80/5 mg 1 time/day.
Can increase to a maximum dose of 80/10 mg x 1 time/day if it is necessary to lower blood pressure after at least 2 weeks of treatment.
Patients with renal failure:
No dose adjustment in this object, including patients with dialysis. Amlodipine and telmisartan cannot be filtered by the filter.
Patients with liver failure:
Be cautious in patients with mild to moderate liver failure. Telmisartan dose should not exceed 40 mg x 1 time/day.
Elderly:
No dose adjustment.
Children, teenagers:
Not recommended for patients under 18 years of age due to lack of data on safety and efficiency.
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:
There is no experience in the overdose of Twynsta. Overdose signs and symptoms may be related to pharmacological effects.
The most typical manifestation of Telmisartan overdose is low blood pressure, tachycardia, which may appear slow heart rate.
Amlodipine overdose can lead to excessive peripheral vessels, reflected tachycardia. Low blood pressure is noticeably and perhaps lasting to the point of shock and death.
Treatment:
Support treatment. Calcium gluconate can be used to overcome the effects of calcium channel blockers. Telmisartan and Amlodipine are not removed by artificial kidney membranes.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Twynsta 40/5 mg, you may experience unwanted effects (ADR).
Skin: eczema, Hong ban, rash, itching.
Urinary: Night. When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Twynsta drug 40/5 mg contraindicated in the following cases:
Be cautious when using
Telmisartan is excreted mainly through bile. The clearance may be reduced in patients with biliary congestion or liver failure. Like calcium blockers, Amlodipine's exhaust time is prolonged in patients with liver failure and the recommended dose for this object has not been established, so cautious.
may increase the risk of severe hypotension and renal failure when the patient has narrowed kidney stenosis on both sides or the kidney stenosis to the only renal artery is still the function treated with drugs that affect the Renin - Angiotensin - Aldosterone (RAA) system.
Periodically monitor the concentration of potassium and serum creatinine when using Twynsta in patients with renal impairment. There is no experience in using Twynsta in new kidney transplant patients. Telmisartan and amlodipine cannot be filtered by the filter.
Symptomic low blood pressure, especially after the first dose, may occur in patients with a decrease in volume or reduced sodium (due to excessive diuretic treatment, too strict salt, diarrhea or vomiting). Should treat these conditions before using Twynsta.
There have been reports on renal function changes (including acute renal failure) due to the inhibition of RAA systems in sensitive patients, especially if used in combination with drugs that affect this system. Twynsta can be used with other anti -hypertension drugs, but it is not recommended that the RAA dual closing system (combining an ACE inhibitor or direct renin inhibitor Aliskiren with an Angiotensin II receptor antagonistic drug), so the specific identified cases need to be closely monitored by kidney function.
In patients with vascular tone and renal function depends largely on the activity of the RAA system (patients with severe congestive heart failure or kidney disease, renal artery stenosis), the treatment of drugs that affects the RAA system is associated with acute hypotension, increased blood nitrogen, urinary disorders or rarely causing acute renal insufficiency.
It is not recommended to use Telmisartan in patients with raw aldosterone hyperplasia due to not responding to anti -hypertension drugs through inhibiting the Renin - Angiotensin inhibiting effect.
Like other vasodilators, special attention should be paid to patients with aortic valve stenosis or mitral valve, congested myocardial disease.
There is no data on using Twynsta in patients with unstable angina and during or within 1 month of myocardial infarction.
In a long -term study, with a placebo (praise - 2) in patients with heart failure III - IV Nyha without the cause of ischemic, amlodipine related to increased number of cases of pulmonary edema, although there is no significant difference in the rate of patients with severe heart failure compared to placebo.
During the treatment process with drugs that affect the RAA system can cause hyperkalemia, especially when the patient has kidney failure, heart failure. Potassium monitoring in patients at risk. Concentrated with potassium diuretics, potassium supplements, salt -containing salt or other drugs that may cause an increase in potassium (heparin ...) can increase serum potassium, so be careful when combining Telmisartan.
Sorbitol -containing drugs, should not be used for patients with rare genetic diseases with fructose intolerance. In patients with diabetes, there is an additional cardiovascular risk (patients with diabetes with coronary artery disease - CAD), the risk of myocardial infarction leading to death and death from non -cardiovascular disease is expected to increase when treated with medications that reduce blood pressure (ARB, ACE inhibitors). In these patients, coronary artery disease (CAD) may have no manifestations and are not diagnosed. Patients with diabetes should be evaluated and diagnosed appropriately to detect and treat coronary artery disease before treatment with Twynsta.
Twynsta is effective when used in black skin patients (a group of patients with low renin content).
Like other anti -hypertension drugs, excessive reducing blood pressure in patients with ischemic heart disease can lead to myocardial infarction or stroke.
The ability to drive and operate machinery
There has been no research on the effects of drugs on driving and operating machinery. Should be cautious when driving and operating machinery, avoiding jobs that are likely to cause risks if there are side effects fainting, sleeping, dizziness, dizziness during treatment.
pregnancy
do not recommend using ARB during the first 3 months of pregnancy and should not start treatment during pregnancy. When diagnosing pregnancy, immediately stop treatment with these drugs, and if appropriate, should start using replacement therapy.
contraindicated use of ARB during the 3 months between and the last 3 months of pregnancy. Precaessing studies do not show that Telmisartan causes teratogenicity, but has a toxicity on the fetus (impaired renal function, amniotic fluid, skull slowly) and toxic to babies (kidney failure, low blood pressure, hyperkalemia).
Patients planning to get pregnant should switch to anti -hypertension therapy instead of being safer unless the continued use of ARB is essential.
If using ARB for 3 months between pregnancy, the ultrasound checks the kidney function and the skull.
Restricted data shows that amlodipine or other calcium receptor antagonists do not harm the health of the fetus. However, there may be prolonged labor risk.
The period of breastfeeding
unknown Telmisartan, Amlodipine whether or not to excrete in human milk or not. In Vivo, Telmisartan is excreted in milk. Due to the possibility of adultery effects in breastfeeding, deciding to stop breastfeeding or stopping treatment, depending on the importance of the drug for the mother.
infants whose mothers treated ARB should be closely monitored to detect low blood pressure.
Medicinal interaction
The effect of reducing blood pressure may increase when used simultaneously with other anti -hypertension drugs.
Based on pharmacological pharmacological, some drugs may increase the lowering effectiveness of all anti -hypertension drugs including Twynsta (Baclofen, Amifostine). In addition, vertical low blood pressure may be worse due to alcohol, barbiturates, addictive drugs, antidepressants.
corticosteroid (systemic line) reduces the effectiveness of anti -hypertension.
telmisartan
Telmisartan may increase the lower pressure of other anti -hypertension drugs. Uncultivated other significant interactions are clinically.
There has been a 20% increase in the median concentration of digoxin in plasma when combined with Telmisartan, so plasma digoxin concentration should be monitored.
In a simultaneous study of Telmisartan and Ramipril, it led to an increase of 2.5 times AUC and CMAX of 2 drugs. The clinical significance of this finding is not known.
There has been a report on the inverse of serum and toxic lithium concentration while using simultaneously lithium with ACE inhibitors. Some cases have been reported to the ARB group, including Telmisartan. Should monitor serum lithium concentration when used simultaneously.
Treatment with NSAID is likely to cause acute renal failure in patients with dehydration. The active ingredients acting on the Renin - Angiotensin system like Telmisartan may be effective in union. Patients using NSAID and Telmisartan should be fully rehydrated and should be monitored with kidney function when starting with combined treatment.
There has been a report on the effectiveness of anti -hypertension drugs such as Telmisartan due to inhibition of prostaglandin causing vasodilation during the combination of nsaid.
amlodipine
Do not use twynsta along with grapefruit, grapefruit juice can increase, causing excessive hypotension.
In a study in elderly patients showed that the amlodipine metabolism inhibits amlodipine, can be through CYP3A4 (plasma concentrations increased by about 50% and the efficiency of amlodipine is increased). Strong CYP3A4 inhibitors (Ketoconazole, Itraconazole, Ritonavir) can cause more plasma amlodipine levels than diltiazem.
Concomitance of CYP3A4 induction drugs (Carbamazepine, Phenobarbital, Phenytoin, Fosphenytoin, Primidone, Rifampicin, Hypericum Perforatum) can reduce plasma amlodipine concentration. Amlodipine dose should be monitored and adjusted during treatment with induction substances and after stopping use.
Simultaneous use of amlodipine and simvastatin 80 mg leads to an increase in simvastatin levels up to 77% compared to single simvastatin. Should limit the dose of simvastatin at 20 mg/day in patients using amlodipine.
Amlodipin can cause an increase in body absorption of immunosuppressants (cyclosporin, tacrolimus) when used simultaneously. Regularly monitor the bottom concentration of these drugs and adjust the dose as needed.
In the single treatment, Amlodipine is used safely with thiazide diuretic, β blockers, enzyme inhibitors, long -lasting nitrate, nitroglycerin -formed nitroglycerin under the tongue, NSAIDs, antibiotics and oral hypoglycemic drugs. When using a combination of Amlodipine and Sildenafil, the hypotension effect of each drug is independent.
Storage
Store in the packaging to avoid light and avoid moisture, no more than 30 ° C.
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