Chlorthalidone (Tellzy CH) 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Chlorthalidone (Tellzy CH) is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a hormone or steroid medicine.
Chlorthalidone (Tellzy CH) is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure.
Chlorthalidone (Tellzy CH) is available only with your doctor's prescription.
Chlorthalidone (Tellzy CH) 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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Treatment of arterial hypertension, essential or nephrogenic or isolated systolic. Treatment of stable, chronic heart failure of mild to moderate degree (New York Heart Association, NYHA: functional class II or III).
Oedema of specific origin
• Ascites due to cirrhosis of the liver in stable patients under close control.
• Oedema due to nephrotic syndrome.
Diabetes Insipidus.
How should I use Chlorthalidone (Tellzy CH)?
Use Chlorthalidone (Tellzy CH) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Chlorthalidone (Tellzy CH) by mouth with food, preferably in the morning.
Chlorthalidone (Tellzy CH) will increase urination. If you are taking 1 dose of Chlorthalidone (Tellzy CH) daily, take it in the morning to prevent this from affecting your sleep.
If you miss a dose of Chlorthalidone (Tellzy CH), 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 Chlorthalidone (Tellzy CH).
Uses of Chlorthalidone (Tellzy CH) 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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Use: Labeled Indications
Edema: Adjunctive treatment of edema associated with heart failure, renal impairment, hepatic cirrhosis, or corticosteroid and estrogen therapy.
Hypertension: Management of hypertension.
Guideline recommendations: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recommends if monotherapy is warranted, in the absence of comorbidities (eg, cerebrovascular disease, chronic kidney disease, diabetes, heart failure, ischemic heart disease, etc), that thiazide-like diuretics or dihydropyridine calcium channel blockers may be preferred options due to improved cardiovascular endpoints (eg, prevention of heart failure and stroke). ACE inhibitors and ARBs are also acceptable for monotherapy. Combination therapy may be required to achieve blood pressure goals and is initially preferred in patients at high risk (stage 2 hypertension or atherosclerotic cardiovascular disease [ASCVD] risk ≥10%) (ACC/AHA [Whelton 2017]).
Off Label Uses
Calcium nephrolithiasis
Data from a prospective, double-blind, randomized, placebo-controlled study support the use of Chlorthalidone (Tellzy CH) for the prevention of recurrent calcium nephrolithiasis.
Based on the European Society of Endocrinology consensus statement on the standards of care for hypoparathyroidism in adults, the Endocrine Society guidelines on the management of hypoparathyroidism, and the European Society of Endocrinology guidelines on the treatment of chronic hypoparathyroidism, Chlorthalidone (Tellzy CH), usually in combination with a low-salt diet, may be considered in the management of chronic hypoparathyroidism to reduce urinary calcium losses.
Chlorthalidone (Tellzy CH) description
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A benzenesulfonamide-phthalimidine that tautomerizes to a benzophenones form. It is considered a thiazide-like diuretic. [PubChem]
Chlorthalidone (Tellzy CH) dosage
Chlorthalidone (Tellzy CH) Dosage
Applies to the following strength(s): 50 mg; 25 mg; 100 mg; 15 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Edema
Hypertension
Additional dosage information:
Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis
Other Comments
Usual Adult Dose for Edema
Initial dose: 50-100 mg orally once a day.
Maintenance dose: 25-100 mg once a day or
50-200 mg every other day.
Usual Adult Dose for Hypertension
Initial dose: 25 mg orally once a day (15 mg for Thalitone).
Maintenance dose: 25-100 mg once a day (15-50 mg for Thalitone).
Renal Dose Adjustments
Chlorthalidone (Tellzy CH) is not expected to be filtered into the renal tubule (its site of action) when the glomerular filtration rate is less than 10 mL/min.
Liver Dose Adjustments
Data not available
Dose Adjustments
Dosage adjustments are recommended to be made no more frequently than weekly. Patients with liver disease or renal dysfunction should have dosage adjustments made cautiously.
Precautions
Chlorthalidone (Tellzy CH) is contraindicated in patients with anuria.
Chlorthalidone (Tellzy CH) therapy should be used with caution in severe renal disease. In patients with renal disease, Chlorthalidone (Tellzy CH) or related drugs may precipitate azotemia. Cumulative effects may develop in patients with impaired renal function. If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of the treatment is necessary with consideration given to withholding or discontinuing diuretic therapy.
Chlorthalidone (Tellzy CH) therapy should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Sensitivity reactions may be observed in patients with a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been observed with thiazide diuretics, which are structurally related to Chlorthalidone (Tellzy CH). However, systemic lupus erythematosus has not been observed following Chlorthalidone (Tellzy CH) administration.
Hypokalemia may develop with Chlorthalidone (Tellzy CH) as with any other diuretic, especially with brisk diuresis when severe cirrhosis is present. Interference with adequate oral electrolyte intake will also contribute to hypokalemia.
Any chloride deficit is generally mild and usually does not require specific therapy except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may be observed in edematous patients in hot weather, appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the treatment of choice.
Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving Chlorthalidone (Tellzy CH) therapy. Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia.
The antihypertensive effects Chlorthalidone (Tellzy CH) may be enhanced in the post-sympathectomy patient.
Calcium excretion is decreased by thiazide-like agents. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been reported in few patients on thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption and peptic ulceration have not been observed.
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be conducted at appropriate intervals.
Electrolyte abnormalities (i.e., hypokalemia, hyponatremia) and glucose intolerance may occur during Chlorthalidone (Tellzy CH) therapy.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
Data not available
Other Comments
The maximum daily dose for hypertension is 100 mg (50 mg for Thalitone).
The maximum daily dose for edema is 200 mg (120 mg for Thalitone).
Periodic monitoring of electrolytes is recommended, particularly in elderly patients and in patients receiving a high dose.
Applies to Chlorthalidone (Tellzy CH): oral tablet
In addition to its needed effects, some unwanted effects may be caused by Chlorthalidone (Tellzy CH) (the active ingredient contained in Chlorthalidone (Tellzy CH)). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Chlorthalidone (Tellzy CH):
Incidence not known:
Abdominal or stomach pain
black, tarry stools
bleeding gums
blistering, peeling, or loosening of skin
bloating
blood in urine or stools
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain
chills
clay-colored stools
cold sweats
confusion
constipation
cough or hoarseness
coughing up blood
darkened urine
diarrhea
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
dry mouth
fast heartbeat
fatigue
fever
flushed, dry skin
fruit-like breath odor
general feeling of tiredness or weakness
headache
increased hunger
increased thirst
increased urination
indigestion
itching
joint pain, stiffness, or swelling
loss of appetite
lower back or side pain
nausea
pain in joints or muscles
painful or difficult urination
pains in stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on skin
red irritated eyes
red skin lesions, often with a purple center
redness, soreness or itching skin
shortness of breath
skin rash
sore throat
sores, ulcers, or white spots on lips or in mouth
sores, welting, or blisters
sugar in the urine
sweating
swelling of feet or lower legs
swollen glands
tightness in chest
troubled breathing
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight loss
vomiting
vomiting of blood
weight loss
wheezing
yellow eyes or skin
Minor Side Effects
Some of the side effects that can occur with Chlorthalidone (Tellzy CH) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Incidence not known:
Cramping
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
feeling of constant movement of self or surroundings
hives
inability to have or keep an erection
increased sensitivity of skin to sunlight
loss in sexual ability, desire, drive, or performance
Hypersensitivity to Chlorthalidone (Tellzy CH), other sulfonamide-derived drugs, or any component of the formulation; anuria
Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See "Warnings/Precautions" for more detail.
Documentation of allergenic cross-reactivity for drugs thiazide-type diuretics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
What is Telmisartan (Tellzy CH)?
Telmisartan (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Telmisartan (Tellzy CH) is available only with your doctor's prescription.
Telmisartan (Tellzy CH) 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.
Hypertension
Telmisartan (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).
Studies of Telmisartan (Tellzy CH) in this setting do not exclude the possibility that Telmisartan (Tellzy CH) 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 (Tellzy CH) with an ACE inhibitor is not recommended.
How should I use Telmisartan (Tellzy CH)?
Use Telmisartan (Tellzy CH) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Telmisartan (Tellzy CH). Talk to your pharmacist if you have questions about this information.
Take Telmisartan (Tellzy CH) by mouth with or without food.
Do not remove the tablet from the blister seal until you are ready to take your dose.
Take Telmisartan (Tellzy CH) on a regular schedule to get the most benefit from it. Taking Telmisartan (Tellzy CH) at the same time each day will help you remember to take it.
Continue to take Telmisartan (Tellzy CH) even if you feel well. Do not miss any doses.
If you miss a dose of Telmisartan (Tellzy CH), 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 Telmisartan (Tellzy CH).
Uses of Telmisartan (Tellzy CH) 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.
Telmisartan (Tellzy CH) 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 (Tellzy CH) description
Telmisartan (Tellzy CH) is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as Telmisartan (Tellzy CH) 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 (Tellzy CH) may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.
Telmisartan (Tellzy CH) dosage
Telmisartan (Tellzy CH) Dosage
Generic name: Telmisartan (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) tablets may be administered with other antihypertensive agents.
Telmisartan (Tellzy CH) tablets may be administered with or without food.
2.2 Cardiovascular Risk Reduction
The recommended dose of Telmisartan (Tellzy CH) 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 (Tellzy CH) are effective in reducing the risk of cardiovascular morbidity and mortality.
When initiating Telmisartan (Tellzy CH) 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 (Tellzy CH) (Telmisartan (Tellzy CH))
Aliskiren: Do not co-administer aliskiren with Telmisartan (Tellzy CH) in patients with diabetes. Avoid use of aliskiren with Telmisartan (Tellzy CH) in patients with renal impairment (GFR < 60 mL/min).
Digoxin: When Telmisartan (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH). 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 (Tellzy CH), 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 (Tellzy CH) and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Telmisartan (Tellzy CH) may be attenuated by NSAIDs including selective COX-2 inhibitors.
Ramipril and Ramiprilat: Co-administration of Telmisartan (Tellzy CH) 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 (Tellzy CH) decrease by 31% and 16%, respectively. When co-administering Telmisartan (Tellzy CH) 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 (Tellzy CH). Concomitant use of Telmisartan (Tellzy CH) and ramipril is not recommended.
Other Drugs: Co-administration of Telmisartan (Tellzy CH) did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan (Tellzy CH) 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 (Tellzy CH) 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.
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 (Tellzy CH) 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 (Tellzy CH) (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 (Tellzy CH) 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 (Tellzy CH) and at a Greater Rate Than Patients Treated with Placebo
Telmisartan (Tellzy CH)
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 (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Telmisartan (Tellzy CH) tablets:
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 (Tellzy CH) tablets.
Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Telmisartan (Tellzy CH) 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 (Tellzy CH) patients compared with 0.3% placebo patients. One Telmisartan (Tellzy CH)-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 (Tellzy CH); all marked elevations occurred at a higher frequency with placebo. No Telmisartan (Tellzy CH)-treated patients discontinued therapy because of abnormal hepatic function.
Cardiovascular Risk Reduction
Because common adverse reactions were well characterized in studies of Telmisartan (Tellzy CH) in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Telmisartan (Tellzy CH) 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 (Tellzy CH) and 7.6% on placebo. The only serious adverse events at least 1% more common on Telmisartan (Tellzy CH) 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 (Tellzy CH). 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 (Tellzy CH).
Hypersensitivity to Telmisartan (Tellzy CH) or to any of the excipients of Telmisartan (Tellzy CH).
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 (Tellzy CH), the use of Telmisartan (Tellzy CH) 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 (Tellzy CH) 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 (Tellzy CH) is contraindicated during lactation since it is not known whether it is excreted in human milk.
Animal studies have shown excretion of Telmisartan (Tellzy CH) in breast milk.
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).
DailyMed. "ATENOLOL; CHLORTHALIDONE: 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).
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