Teli 40/Teli 80 Uses

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What is Teli 40/Teli 80?

Teli 40/Teli 80 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.

Teli 40/Teli 80 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.

Teli 40/Teli 80 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, Teli 40/Teli 80 relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Teli 40/Teli 80 is available only with your doctor's prescription.

Teli 40/Teli 80 indications

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Hypertension: Treatment of essential hypertension.

Cardiovascular Risk Reduction: Teli 40/Teli 80 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 of cardiovascular events can be evidenced by 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. Teli 40/Teli 80 can be used in additional to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).

Studies of Teli 40/Teli 80 in this setting do not exclude that it 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 Teli 40/Teli 80 with an ACE inhibitor is not recommended.

How should I use Teli 40/Teli 80?

Use Teli 40/Teli 80 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 Teli 40/Teli 80.

Uses of Teli 40/Teli 80 in details

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Teli 40/Teli 80 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.

Teli 40/Teli 80 description

Teli 40/Teli 80 is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as Teli 40/Teli 80 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 Teli 40/Teli 80 may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.

Teli 40/Teli 80 dosage

Teli 40/Teli 80 Dosage

Generic name: Teli 40/Teli 80 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 Teli 40/Teli 80 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 Teli 40/Teli 80 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.

Teli 40/Teli 80 tablets may be administered with other antihypertensive agents.

Teli 40/Teli 80 tablets may be administered with or without food.

2.2  Cardiovascular Risk Reduction

The recommended dose of Teli 40/Teli 80 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 Teli 40/Teli 80 are effective in reducing the risk of cardiovascular morbidity and mortality.

When initiating Teli 40/Teli 80 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 Teli 40/Teli 80 (Teli 40/Teli 80)

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Teli 40/Teli 80 interactions

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What other drugs will affect Teli 40/Teli 80?

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Aliskiren: Do not co-administer aliskiren with Teli 40/Teli 80 in patients with diabetes. Avoid use of aliskiren with Teli 40/Teli 80 in patients with renal impairment (GFR < 60 mL/min).

Digoxin: When Teli 40/Teli 80 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 Teli 40/Teli 80 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 Teli 40/Teli 80. 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 Teli 40/Teli 80, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Teli 40/Teli 80 and NSAID therapy.

The antihypertensive effect of angiotensin II receptor antagonists, including Teli 40/Teli 80 may be attenuated by NSAIDs including selective COX-2 inhibitors.

Ramipril and Ramiprilat: Co-administration of Teli 40/Teli 80 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 Teli 40/Teli 80 decrease by 31% and 16%, respectively. When co-administering Teli 40/Teli 80 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 Teli 40/Teli 80. Concomitant use of Teli 40/Teli 80 and ramipril is not recommended.

Other Drugs: Co-administration of Teli 40/Teli 80 did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Teli 40/Teli 80 is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Teli 40/Teli 80 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.

Teli 40/Teli 80 side effects

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What are the possible side effects of Teli 40/Teli 80?

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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

Teli 40/Teli 80 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 Teli 40/Teli 80 (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 Teli 40/Teli 80 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 Teli 40/Teli 80 and at a Greater Rate Than Patients Treated with Placebo

Teli 40/Teli 80

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 Teli 40/Teli 80 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 Teli 40/Teli 80 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 Teli 40/Teli 80 monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Teli 40/Teli 80 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 Teli 40/Teli 80 tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Teli 40/Teli 80 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% Teli 40/Teli 80 patients compared with 0.3% placebo patients. One Teli 40/Teli 80-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 Teli 40/Teli 80; all marked elevations occurred at a higher frequency with placebo. No Teli 40/Teli 80-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of Teli 40/Teli 80 in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Teli 40/Teli 80 for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on Teli 40/Teli 80 and 7.6% on placebo. The only serious adverse events at least 1% more common on Teli 40/Teli 80 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 Teli 40/Teli 80. 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 Teli 40/Teli 80.

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 Teli 40/Teli 80.

Teli 40/Teli 80 contraindications

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What is the most important information I should know about Teli 40/Teli 80?

Hypersensitivity to Teli 40/Teli 80 or to any of the excipients of Teli 40/Teli 80.

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 Teli 40/Teli 80, the use of Teli 40/Teli 80 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 Teli 40/Teli 80 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: Teli 40/Teli 80 is contraindicated during lactation since it is not known whether it is excreted in human milk.

Animal studies have shown excretion of Teli 40/Teli 80 in breast milk.



Active ingredient matches for Teli 40/Teli 80:

Telmisartan in Philippines.


Unit description / dosage (Manufacturer)Price, USD
Teli 40 tab 40 mg 30's (Cadila Pharma)
Teli 80 tab 80 mg 30's (Cadila Pharma)

List of Teli 40/Teli 80 substitutes (brand and generic names):

Teli 80mg Tablet (Cadila Pharmaceuticals Ltd.)$ 0.17
TELIBEST tab 40 mg x 10's (Walton)$ 0.70
Telicad 20mg TAB / 10 (Cadomed)$ 0.36
Telicad 40mg TAB / 10 (Cadomed)$ 0.70
TELICAD tab 20 mg x 10's (Cadomed)$ 0.36
TELICAD tab 40 mg x 10's (Cadomed)$ 0.70
Telicad H 40mg/12.5mg Tablet (Cadomed)$ 0.09
Telicus 40mg Tablet (Pficus De Med Pvt Ltd)$ 0.08
TELIDIN tab 40 mg x 10's (Divine Savior)$ 0.70
TELIMED 40MG TABLET 1 strip / 10 tablets each (M D C Pharmaceuticals P Ltd)$ 0.78
Telimed H Tablet (M D C Pharmaceuticals P Ltd)$ 0.10
Telista 20mg TAB / 100 (Lupin Laboratories Ltd.)$ 3.61
Telista 40mg TAB / 10 (Lupin Laboratories Ltd.)$ 0.86
20 mg x 100's (Lupin Laboratories Ltd.)$ 3.61
40 mg x 10's (Lupin Laboratories Ltd.)$ 0.86
Telista 80 mg Tablet (Lupin Laboratories Ltd.)$ 0.13
Telista 40 mg Tablet (Lupin Laboratories Ltd.)$ 0.10
Telista 20 mg Tablet (Lupin Laboratories Ltd.)$ 0.05
TELISTA 20 MG TABLET 1 strip / 15 tablets each (Lupin Laboratories Ltd.)$ 0.64
TELISTA 40 MG TABLET 1 strip / 15 tablets each (Lupin Laboratories Ltd.)$ 1.16
TELISTA 80 MG TABLET 1 strip / 15 tablets each (Lupin Laboratories Ltd.)$ 1.77
TELISTA tab 20 mg x 10's (Lupin Laboratories Ltd.)$ 0.36
TELISTA tab 40 mg x 15's (Lupin Laboratories Ltd.)$ 1.63
TELISTA tab 80 mg x 10's (Lupin Laboratories Ltd.)$ 0.99
Telista 20mg Tablet (Lupin Laboratories Ltd.)$ 0.04
Telista 40mg Tablet (Lupin Laboratories Ltd.)$ 0.08
Telista 80mg Tablet (Lupin Laboratories Ltd.)$ 0.12
Telista- H Telmisartan 40mg, Hydrochlorothiazide 12.5mg TAB / 100$ 7.89
Telista- RM Ramipril 2.5mg, Telmisartan40mg TAB / 10$ 0.86
Telista- RM Ramipril 5mg, Telmisartan 40mg TAB / 10$ 0.95
Telitoss 40mg Tablet (Novalab Healthcare Pvt Ltd)$ 0.07
20 mg x 10X10 (Troikaa Parenterals Pvt. Ltd.)$ 3.61
40 mg x 10X10 (Troikaa Parenterals Pvt. Ltd.)$ 6.99
Telkaa 20 mg Tablet (Troikaa Parenterals Pvt. Ltd.)$ 0.04
Telkaa 40 mg Tablet (Troikaa Parenterals Pvt. Ltd.)$ 0.07
Telkaa 20mg TAB / 10x10 (Troikaa Parenterals Pvt. Ltd.)$ 3.61
Telkaa 40mg TAB / 10x10 (Troikaa Parenterals Pvt. Ltd.)$ 6.99
TELKAA tab 20 mg x 10's (Troikaa Parenterals Pvt. Ltd.)$ 0.36
TELKAA tab 40 mg x 10's (Troikaa Parenterals Pvt. Ltd.)$ 0.70
Telkaa 20mg TAB / 10x10 (Troikaa Parenterals Pvt. Ltd.)$ 3.61
Telkaa 40mg TAB / 10x10 (Troikaa Parenterals Pvt. Ltd.)$ 6.99
TELKOM 20MG TABLET 1 strip / 10 tablets each (Knoll)$ 0.55

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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