Telmisartan Combix Uses

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What is Telmisartan Combix?

Telmisartan Combix is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Telmisartan Combix is also used to lower the risk of heart attacks or stroke in patients 55 years of age and older who have diabetes or heart problems.

Telmisartan Combix is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, Telmisartan Combix relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Telmisartan Combix is available only with your doctor's prescription.

Telmisartan Combix indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Hypertension

Telmisartan Combix is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

It may be used alone or in combination with other antihypertensive agents.

Cardiovascular Risk Reduction

Telmisartan Combix is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.

High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage. Telmisartan Combix can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).

Studies of Telmisartan Combix in this setting do not exclude the possibility that Telmisartan Combix may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.

Use of Telmisartan Combix with an ACE inhibitor is not recommended.

How should I use Telmisartan Combix?

Use Telmisartan Combix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Telmisartan Combix.

Uses of Telmisartan Combix in details

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.
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Telmisartan Combix 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.

Telmisartan Combix description

Telmisartan Combix is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as Telmisartan Combix bind to the angiotensin II type 1 (AT1) receptors with high affinity, causing inhibition of the action of angiotensin II on vascular smooth muscle, ultimately leading to a reduction in arterial blood pressure. Recent studies suggest that Telmisartan Combix may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.

Telmisartan Combix dosage

Telmisartan Combix Dosage

Generic name: Telmisartan Combix 20mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

2.1  Hypertension

Dosage must be individualized. The usual starting dose of Telmisartan Combix tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg.

Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan Combix is required, a diuretic may be added.

No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.

Telmisartan Combix tablets may be administered with other antihypertensive agents.

Telmisartan Combix tablets may be administered with or without food.

2.2  Cardiovascular Risk Reduction

The recommended dose of Telmisartan Combix tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of Telmisartan Combix are effective in reducing the risk of cardiovascular morbidity and mortality.

When initiating Telmisartan Combix therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.

More about Telmisartan Combix (Telmisartan Combix)

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Telmisartan Combix interactions

See also:
What other drugs will affect Telmisartan Combix?

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Aliskiren: Do not co-administer aliskiren with Telmisartan Combix in patients with diabetes. Avoid use of aliskiren with Telmisartan Combix in patients with renal impairment (GFR < 60 mL/min).

Digoxin: When Telmisartan Combix 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 Telmisartan Combix 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 Telmisartan Combix. 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 Telmisartan Combix, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Telmisartan Combix and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Telmisartan Combix may be attenuated by NSAIDs including selective COX-2 inhibitors.

Ramipril and Ramiprilat: Co-administration of Telmisartan Combix 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 Telmisartan Combix decrease by 31% and 16%, respectively. When co-administering Telmisartan Combix 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 Telmisartan Combix. Concomitant use of Telmisartan Combix and ramipril is not recommended.

Other Drugs: Co-administration of Telmisartan Combix did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan Combix is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan Combix 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.

Telmisartan Combix side effects

See also:
What are the possible side effects of Telmisartan Combix?

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The following adverse reaction is described elsewhere in labeling:

Renal dysfunction upon use with ramipril

  Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

Telmisartan Combix has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of Telmisartan Combix (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with Telmisartan Combix and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with Telmisartan Combix and at a Greater Rate Than Patients Treated with Placebo

Telmisartan Combix

n=1455

%

Placebo

n=380

%

Upper respiratory tract infection 7 6
Back pain 3 1
Sinusitis 3 2
Diarrhea 3 2
Pharyngitis 1 0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with Telmisartan Combix tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with Telmisartan Combix in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with Telmisartan Combix monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Telmisartan Combix tablets:

Autonomic Nervous System: impotence, increased sweating, flushing; Body as a Whole: allergy, fever, leg pain, malaise; Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia; Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic: gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal: arthritis, arthralgia, leg cramps; Psychiatric: anxiety, depression, nervousness; Resistance Mechanism: infection, fungal infection, abscess, otitis media; Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis; Vascular: cerebrovascular disorder; and Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Telmisartan Combix tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Telmisartan Combix patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Telmisartan Combix patients compared with 0.3% placebo patients. One Telmisartan Combix-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with Telmisartan Combix; all marked elevations occurred at a higher frequency with placebo. No Telmisartan Combix-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of Telmisartan Combix in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Telmisartan Combix for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on Telmisartan Combix and 7.6% on placebo. The only serious adverse events at least 1% more common on Telmisartan Combix than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

  Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Telmisartan Combix. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Telmisartan Combix.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including Telmisartan Combix.

Telmisartan Combix contraindications

See also:
What is the most important information I should know about Telmisartan Combix?

Hypersensitivity to Telmisartan Combix or to any of the excipients of Telmisartan Combix.

Biliary obstructive disorders and severe hepatic impairment.

The concomitant use with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).

In case of rare hereditary conditions that may be incompatible with an excipient of Telmisartan Combix, the use of Telmisartan Combix is contraindicated.

Use in pregnancy: The use of angiotensin II receptor antagonists is not recommended during the 1st trimester of pregnancy and should not be initiated during pregnancy.

Nonclinical studies with Telmisartan Combix do not indicate teratogenic effect, but have shown fetotoxicity.

Angiotensin II receptor antagonist exposure during the 2nd and 3rd trimester is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia).

Unless continued and angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonist should be stopped immediately and if appropriate, alternative therapy should be started.

Should exposure to angiotensin II receptor antagonists have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken angiotensin II receptor antagonist should be closely observed for hypotension.

Use in lactation: Telmisartan Combix is contraindicated during lactation since it is not known whether it is excreted in human milk.

Animal studies have shown excretion of Telmisartan Combix in breast milk.



Active ingredient matches for Telmisartan Combix:

Telmisartan in Spain.


List of Telmisartan Combix substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Telmisat 20mg TAB / 10 (Biocon Limited)$ 0.62
Telmisat 40mg TAB / 10 (Biocon Limited)$ 1.11
Telmisat 80mg TAB / 10 (Biocon Limited)$ 2.08
20 mg x 10's (Biocon Limited)$ 0.56
40 mg x 10's (Biocon Limited)$ 1.02
80 mg x 10's (Biocon Limited)$ 1.89
Telmisat 80 mg Tablet (Biocon Limited)$ 0.19
Telmisat 40 mg Tablet (Biocon Limited)$ 0.11
Telmisat 20 mg Tablet (Biocon Limited)$ 0.06
TELMISAT - 20 TABLET 1 strip / 10 tablets each (Biocon Limited)$ 0.56
TELMISAT - 40 TABLET 1 strip / 10 tablets each (Biocon Limited)$ 1.02
TELMISAT - 80 TABLET 1 strip / 10 tablets each (Biocon Limited)$ 1.56
TELMISAT tab 20 mg x 10's (Biocon Limited)$ 0.62
TELMISAT tab 40 mg x 10's (Biocon Limited)$ 1.11
TELMISAT tab 80 mg x 10's (Biocon Limited)$ 2.08
Telmisat 20mg Tablet (Biocon Limited)$ 0.06
Telmisat 40mg Tablet (Biocon Limited)$ 0.10
Telmisat 80mg Tablet (Biocon Limited)$ 0.16
Telmisat- H Telmisartan 40mg, Hydrochlorothiazide 12.5mg TAB / 10$ 1.25
Telmisat- R Telmisartan 40mg, Ramipril2.5mg TAB / 10$ 1.06
Telmisat- R Telmisartan 40mg, Ramipril 5mg TAB / 10$ 1.51
Telmisoft 40mg Tablet (Innovexia Life Sciences Pvt Ltd)$ 0.01
Telmistal 40mg Tablet (Stallion Laboratories Pvt Ltd)$ 0.09
Telmistar 40mg TAB / 10x10 (Avyukt)$ 10.86
TELMISTAR tab 40 mg x 10's (Avyukt)$ 1.09
Telmistar-H Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. TAB / 10x10 (Avyukt)$ 12.14
Telmistar-H Telmisartan 40 mg, hydrochlorothiazide 12.5 mg. TAB / 10 (Avyukt)$ 1.21
TELMISTAR-H tab 10's (Avyukt)$ 1.21
TELMISURE tab 40 mg x 10's (Medicron)
TELMISURGE 40 MG TABLET 1 strip / 10 tablets each (Obsurge Biotech Ltd)$ 0.74
TELMISURGE 80 MG TABLET 1 strip / 10 tablets each (Obsurge Biotech Ltd)$ 1.04
Telmisurge 40mg Tablet (Obsurge Biotech Ltd)$ 0.07
Telmisurge 80mg Tablet (Obsurge Biotech Ltd)$ 0.10
Telmitac 40mg TAB / 10 (Polard)$ 1.10
TELMITAC tab 40 mg x 10's (Polard)$ 1.10
Telmital 80mg Tablet (Talent India )$ 0.16
TELMITAN tab 40 mg x 15's (Accilex)$ 1.30
TELMITAN tab 80 mg x 10's (Accilex)$ 1.67

References

  1. DailyMed. "AMLODIPINE BESYLATE; TELMISARTAN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Telmisartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Telmisartan". http://www.drugbank.ca/drugs/DB00966 (accessed September 17, 2018).

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