Components:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 26.06.2023
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Top 20 medicines with the same components:
Telmisartan
Arterial hypertension.
essential hypertension,
reduction of mortality and incidence of cardiovascular diseases in adult patients:
- with cardiovascular diseases of atherothrombotic origin (ischemic heart disease, stroke or peripheral artery disease in the anamnesis),
- with type 2 diabetes mellitus with target organ damage.
arterial hypertension,
reduced cardiovascular morbidity and mortality in patients 55 years and older with a high risk of cardiovascular disease, including a history of atherothrombosis such as coronary heart disease, stroke or peripheral artery atherosclerosis, or a history of type 2 diabetes mellitus with documented target organ damage.
Inside, regardless of the meal. Adults — 40 mg once a day. In some patients, the therapeutic effect can be achieved by using a dose of 20 mg/day. If there is no reduction in blood pressure to the desired level, the dose can be increased to 80 mg once a day. The maximum effectiveness of the antihypertensive effect of the drug is usually noted 4-8 weeks after the start of treatment.
Patients with severe hypertension — up to 160 mg/day or in combination with hydrochlorothiazide 12.5–25 mg/day.
Inside, regardless of the meal. The recommended dose for adults is 40 mg once a day. In some patients, a hypotensive effect can be achieved by prescribing the drug at a dose of 20 mg/day. In the absence of a decrease in blood pressure to the desired level after 2 weeks, the dose can be increased to 80 mg once a day. The use of Pritor is possible in combination with thiazide diuretics, for example, with hydrochlorothiazide (such a combination provides an additional reduction in blood pressure). When considering the possibility of increasing the dose of telmisartan, it should be remembered that the maximum hypotensive effect is usually achieved 4-8 weeks after the start of treatment
In patients with mild renal insufficiency, no dosage changes are required. In patients with mild to moderate hepatic impairment, the daily dose of Pritor should not exceed 40 mg / day. In elderly patients, the drug is prescribed in the usual dose.
Currently, there is no data on the safety and effectiveness of the Pritor in children.
Inside, once a day, washed down with liquid, regardless of the meal.
Arterial hypertension. The initial recommended dose of Actelsar® it is 1 tab. (40 mg) 1 time per day. In some patients, 20 mg/day may be effective. A dose of 20 mg can be obtained by dividing the 40 mg tablet in half according to the risk. In cases where the therapeutic effect is not achieved, the recommended dose of Actelsar® it can be increased to a maximum of 80 mg once a day. As an alternative, the drug Actelsar® it can be taken in combination with thiazide diuretics, such as hydrochlorothiazide, which, when used together, had an additional antihypertensive effect.
When deciding whether to increase the dose, it should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after the start of treatment.
Reducing mortality and the incidence of cardiovascular diseases. Recommended dose of Actelsar® - 80 mg once a day. In the initial period of treatment, monitoring of blood pressure levels is recommended, and correction of antihypertensive therapy may be required.
Special patient populations
Impaired renal function. The experience of using telmisartan in patients with severe renal insufficiency or patients on hemodialysis is limited. These patients are recommended a lower initial dose-20 mg/day (see "Special services"). For patients with mild to moderate renal impairment, no dose adjustment is required. Concomitant use of Actelsar® aliskiren is contraindicated in patients with renal insufficiency (GFR less than 60 ml / min/1.73 m2) (see "Contraindications").
Concomitant use of Actelsar® with ACE inhibitors, it is contraindicated in patients with diabetic nephropathy (see "Contraindications").
Impaired liver function. Actelsar preparation® it is contraindicated in patients with severe hepatic insufficiency (class C according to the Child-Pugh classification) (see "Contraindications"). In patients with mild and moderate hepatic insufficiency (class A and B according to the Child-Pugh classification, respectively), the drug is prescribed with caution, the dose should not exceed 40 mg once a day (see "With caution»).
Old age. For elderly patients, no dose adjustment is required.
Children and adolescents. Use of Actelsar® in children and adolescents under 18 years of age, it is contraindicated due to the lack of safety and efficacy data (see "Contraindications").
Inside, regardless of the meal, with water.
Arterial hypertension. The initial recommended dose of Actelsar® — 40 mg/day (1 table). In some patients, a dose of 20 mg/day (1/2 table 40 mg) may be effective. In cases where the therapeutic effect is not achieved, the maximum recommended dose of Actelsar is® it can be increased to 80 mg/day (1 tab. 80 mg or 2 tab. 40 mg). When deciding whether to increase the dose, it should be taken into account that the maximum antihypertensive effect is usually achieved within 4-8 weeks after the start of treatment.
Reduction of cardiovascular morbidity and mortality. Recommended dose of Actelsar® - 80 mg/day (1 table). In the initial period of treatment, additional correction of blood pressure may be required.
Special patient groups
Impaired renal function. There is limited experience with the use of telmisartan in patients with severe renal impairment or who are on hemodialysis. Such patients require a low initial dose of 20 mg. Patients with mild to moderate renal impairment do not need to adjust the dose.
Liver function disorders. In patients with mild to moderate hepatic impairment, the daily dose of Actelsar® it should not exceed 40 mg. Use in severe liver function disorders is contraindicated (see "Contraindications").
Old age. The dosage regimen does not require any changes.
Hypersensitivity, impaired biliary tract patency, severe liver or kidney function disorders, hereditary fructose intolerance, pregnancy, breastfeeding, childhood and adolescence.
hypersensitivity to the active substance or any excipients of the drug,
pregnancy and breastfeeding,
obstructive diseases of the biliary tract,
severe hepatic impairment (Child-Pugh Class C)),
co-administration with aliskiren in patients with diabetes mellitus or severe renal impairment (GFR less than 60 ml / min/1.73 m2) (see "Interaction" and " Special instructions»),
hereditary fructose intolerance (due to the presence of sorbitol in the tablet),
concomitant use with ACE inhibitors in patients with diabetic nephropathy (see "Interaction" and " Special instructions»),
age under 18 (efficacy and safety not established).
With caution: bilateral stenosis of the renal arteries or stenosis of the artery of the only functioning kidney, impaired renal function, mild to moderate hepatic impairment, decreased BCC against the background of previous diuretic use, restricted salt intake, diarrhea or vomiting, hyponatremia, hyperkalemia, post-kidney transplant condition (no experience with the use), severe chronic heart failure, aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism (efficacy and safety have not been established), use in patients of the black race.
hypersensitivity to the active substance or auxiliary components of the drug,
obstructive diseases of the biliary tract,
severe hepatic impairment (Child-Pyo Class C)),
concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and / or moderate or severe renal impairment (GFR less than 60 ml / min/1.73 m2),
concomitant use with ACE inhibitors in patients with diabetic nephropathy,
pregnancy,
breastfeeding period,
age under 18 (efficacy and safety not established).
With caution: bilateral renal artery stenosis or single kidney artery stenosis (see "Special instructions"), mild to moderate hepatic and/or renal impairment (see "Special instructions"), decreased BCC due to previous diuretic therapy, salt restriction, diarrhea or vomiting, hyponatremia, hyperkalemia, post-kidney transplant conditions (no experience), chronic heart failure, aortic and mitral valve stenosis, idiopathic hypertrophic subaortic stenosis (hypertrophic obstructive cardiomyopathy), primary hyperaldosteronism.
Use Arbitel-40 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Arbitel-40. Talk to your pharmacist if you have questions about this information.
- Take Arbitel-40 by mouth with or without food.
- Do not remove the tablet from the blister seal until you are ready to take your dose.
- Take Arbitel-40 on a regular schedule to get the most benefit from it. Taking Arbitel-40 at the same time each day will help you remember to take it.
- Continue to take Arbitel-40 even if you feel well. Do not miss any doses.
- If you miss a dose of Arbitel-40, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Arbitel-40.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Arbitel-40 belongs to a class of medicines known as angiotensin II receptor blockers. It is used to treat high blood pressure, prevention and treatment of heart attack (myocardial Infarction) and heart failure; when heart is unable to pump sufficient blood. It is also used for kidney failure in patients with diabetes.
See also:
What other drugs will affect Arbitel-40?
Aliskiren: Do not co-administer aliskiren with Arbitel-40 in patients with diabetes. Avoid use of aliskiren with Arbitel-40 in patients with renal impairment (GFR < 60 mL/min).
Digoxin: When Arbitel-40 was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing Arbitel-40 for the purpose of keeping the digoxin level within the therapeutic range.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Arbitel-40. Therefore, monitor serum lithium levels during concomitant use.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Arbitel-40, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Arbitel-40 and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Arbitel-40 may be attenuated by NSAIDs including selective COX-2 inhibitors.
Ramipril and Ramiprilat: Co-administration of Arbitel-40 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3-and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4-and 1.5-fold, respectively. In contrast, Cmax and AUC of Arbitel-40 decrease by 31% and 16%, respectively. When co-administering Arbitel-40 and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of Arbitel-40. Concomitant use of Arbitel-40 and ramipril is not recommended.
Other Drugs: Co-administration of Arbitel-40 did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Arbitel-40 is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Arbitel-40 is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.
From the nervous system: headache, dizziness, fatigue, insomnia, anxiety, depression, convulsions.
From the respiratory system: upper respiratory tract infections (including pharyngitis, sinusitis, bronchitis), cough.
From the cardiovascular system: pronounced decrease in blood pressure, bradycardia, tachycardia, chest pain.
From the digestive system: nausea, dyspepsia, diarrhea, abdominal pain, increased activity of "hepatic" transaminases.
From the musculoskeletal system: myalgia, arthralgia, lower back pain, tendinitis-like symptoms.
From the urinary system: peripheral edema, urinary tract infections, hypercreatininemia.
Allergic reactions: skin rash, etc.
Laboratory parameters: rarely-hyperkalemia, anemia or hyperuricemia.
Other: flu-like syndrome, rarely-erythema, pruritus, syncope, dyspnea, eosinophilia, thrombocytopenia, angioedema, urticaria.
According to WHO, adverse effects are classified according to their frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency unknown — according to available data, it was not possible to determine the frequency of occurrence.
Within each group, according to the frequency of occurrence, adverse reactions are presented in descending order of severity.
Infectious and parasitic diseases: infrequently-urinary tract infections, including cystitis, upper respiratory tract infections, including pharyngitis and sinusitis, rarely-sepsis, including fatal.
From the blood and lymphatic system: infrequently-anemia, rarely-eosinophilia, thrombocytopenia.
On the part of the immune system: rarely — anaphylactic reaction, hypersensitivity.
From the side of metabolism and nutrition: infrequently-hyperkalemia, rarely-hypoglycemia (in patients with diabetes mellitus).
From the side of the psyche: infrequently-insomnia, depression, rarely-anxiety.
From the nervous system: infrequently-fainting, rarely-drowsiness.
On the part of the organ of vision rarely: visual disorders.
On the part of the organ of hearing and labyrinth disorders: rarely-vertigo.
From the heart: infrequently-bradycardia, rarely-tachycardia.
From the side of the vessels: infrequently-pronounced decrease in blood pressure, orthostatic hypotension.
From the respiratory system, chest and mediastinal organs: infrequently-shortness of breath, cough, very rarely-interstitial lung disease.
From the gastrointestinal tract: infrequently-abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, rarely-dry mouth, discomfort in the stomach, violation of taste sensations.
From the liver and biliary tract: rarely-impaired liver function/liver damage.
From the skin and subcutaneous tissues: infrequently-skin itching, hyperhidrosis, rash, rarely-angioedema (also fatal), eczema, erythema, urticaria, drug rash, toxic skin rash.
From the musculoskeletal system and connective tissue: infrequently-back pain (sciatica), muscle spasms, myalgia, rarely-arthralgia, pain in the extremities, pain in the tendons (tendinitis-like syndrome).
From the kidneys and urinary tract: infrequently-impaired renal function, including acute renal failure.
General disorders and disorders at the injection site: infrequently-chest pain, asthenia (weakness), rarely-flu-like syndrome.
Influence on the results of laboratory and instrumental studies: infrequently-an increase in the concentration of creatinine in the blood plasma, rarely-a decrease in the content of Hb, an increase in the content of uric acid in the blood plasma, an increase in the activity of liver enzymes and CK.
The overall incidence of telmisartan side effects in patients with hypertension in controlled trials is usually comparable to placebo (41.4 vs. 43.9%). The observed cases of side effects did not correlate with the gender, age, or race of the patients. The safety profile of the drug in patients treated with telmisartan for the prevention of cardiovascular morbidity and mortality corresponds to the data obtained in patients with arterial hypertension.
The frequency of adverse effects is presented as follows: very common (≥1/10 appointments), common (1/10–1/100 appointments), infrequent (1/100–1/1000 appointments), rare (1/1000–1/10000 appointments), very rare (<1/10000 appointments).
Infectious and parasitic diseases: infrequently-upper respiratory tract infections (including pharyngitis and sinusitis), urinary tract infections (including cystitis), rarely-sepsis, including fatal cases (the mechanism of occurrence is unknown).
From the blood and lymphatic system: infrequently-anemia, rarely-eosinophilia, thrombocytopenia.
On the part of the immune system: rarely — anaphylactic reactions, hypersensitivity.
From the side of metabolism and nutrition: infrequently-hyperkalemia, rarely-hypoglycemia (in patients with diabetes mellitus).
Mental disorders: infrequently-depression, insomnia, rarely-anxiety.
From the nervous system: infrequently-fainting, rarely-drowsiness.
On the part of the visual organ: rarely-visual disorders.
On the part of the organ of hearing and labyrinth disorders: rarely-vertigo.
From the heart: infrequently-bradycardia, rarely-tachycardia.
From the side of the vessels: infrequently-orthostatic hypotension, decreased blood pressure (the effect was noted in patients with controlled blood pressure who used telmisartan to reduce cardiovascular morbidity and mortality against the background of standard therapy).
From the respiratory system, chest and mediastinal organs: infrequently-shortness of breath, cough, very rarely-interstitial lung disease (post-marketing data, causal relationship is not established).
From the gastrointestinal tract: infrequently-abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, rarely - discomfort in the stomach, dry mouth, dysgeusia.
From the liver and biliary tract: rarely-impaired liver function/liver disease (most cases were detected in patients in Japan).
From the skin and subcutaneous tissues: infrequently-hyperhidrosis, itching, skin rash, rarely-angioedema (fatal), eczema, erythema, urticaria, drug and toxic rash.
From the musculoskeletal system and connective tissue: infrequently-myalgia, back pain, muscle spasms, rarely-arthralgia, pain in the extremities, pain in the tendons (symptoms similar to the manifestation of tendinitis).
From the kidneys and urinary tract: infrequently-impaired renal function, including acute renal failure.
Common disorders and disorders together.: infrequently-chest pain, general weakness, rarely-flu-like syndrome.
Laboratory and instrumental data: infrequently-an increase in the level of creatinine in the blood, rarely-an increase in the concentration of uric acid, an increase in the activity of liver enzymes, an increase in the activity of CK, a decrease in the level of Hb in the blood serum.
Symptoms: pronounced decrease in blood pressure.
Treatment: symptomatic therapy, hemodialysis is ineffective.
Symptoms: The most pronounced manifestations of overdose were a marked decrease in blood pressure and tachycardia, and bradycardia, dizziness, increased serum creatinine concentration, and acute renal failure were also reported.
Treatment: telmisartan is not eliminated by hemodialysis. Patients ' condition should be carefully monitored and symptomatic as well as supportive treatment should be provided. The approach to treatment depends on the time elapsed after taking the drug and the severity of the symptoms. Recommended measures include provoking vomiting and / or gastric lavage, it is advisable to take activated charcoal. You should regularly monitor the content of electrolytes and creatinine in the blood plasma. If there is a marked decrease in blood pressure, the patient should take a horizontal position with raised legs, while it is necessary to quickly replenish the BCC and electrolytes
No cases of overdose have been identified.
Symptoms: pronounced decrease in blood pressure, tachycardia, bradycardia.
Treatment: symptomatic therapy, hemodialysis is ineffective.