Gloritel CT Uses

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Consists of Chlorthalidone, Telmisartan

What is Chlorthalidone (Gloritel CT)?

Chlorthalidone (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) is available only with your doctor's prescription.

Chlorthalidone (Gloritel CT) 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 (Gloritel CT)?

Use Chlorthalidone (Gloritel CT) 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 Chlorthalidone (Gloritel CT).

Uses of Chlorthalidone (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT), usually in combination with a low-salt diet, may be considered in the management of chronic hypoparathyroidism to reduce urinary calcium losses.

Chlorthalidone (Gloritel CT) description

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A benzenesulfonamide-phthalimidine that tautomerizes to a benzophenones form. It is considered a thiazide-like diuretic. [PubChem]

Chlorthalidone (Gloritel CT) dosage

Chlorthalidone (Gloritel CT) 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:

Additional dosage information:

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 (Gloritel CT) 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 (Gloritel CT) is contraindicated in patients with anuria.

Chlorthalidone (Gloritel CT) therapy should be used with caution in severe renal disease. In patients with renal disease, Chlorthalidone (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT). However, systemic lupus erythematosus has not been observed following Chlorthalidone (Gloritel CT) administration.

Hypokalemia may develop with Chlorthalidone (Gloritel CT) 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 (Gloritel CT) therapy. Thiazide-like diuretics have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia.

The antihypertensive effects Chlorthalidone (Gloritel CT) 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 (Gloritel CT) 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.

More about Chlorthalidone (Gloritel CT)

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Chlorthalidone (Gloritel CT) interactions

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What other drugs will affect Chlorthalidone (Gloritel CT)?

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Allopurinol

Concurrent use may increase incidence of hypersensitivity reactions to allopurinol.

Amphotericin B, corticosteroids

May intensify potassium depletion.

Anticholinergics

May increase Chlorthalidone (Gloritel CT) absorption.

Anticoagulants

May diminish anticoagulant effects.

Bile acid sequestrants

May reduce Chlorthalidone (Gloritel CT) absorption. Give Chlorthalidone (Gloritel CT) at least 2 h before bile acid sequestrant.

Calcium salts

Hypercalcemia may develop.

Diazoxide

May cause hyperglycemia.

Digitalis glycosides

Diuretic-induced hypokalemia and hypomagnesemia may precipitate digitalis-induced arrhythmias.

Lithium

May decrease renal excretion of lithium.

Loop diuretics

Synergistic effects may result in profound diuresis and serious electrolyte abnormalities.

Methenamines, NSAIDs

May decrease effectiveness of Chlorthalidone (Gloritel CT).

Sulfonylureas, insulin

May decrease hypoglycemic effect of sulfonylureas.

Laboratory Test Interactions

Increased serum bilirubin levels. Serum magnesium levels in uremic patients may be increased.

Chlorthalidone (Gloritel CT) side effects

See also:
What are the possible side effects of Chlorthalidone (Gloritel CT)?

Applies to Chlorthalidone (Gloritel CT): oral tablet

In addition to its needed effects, some unwanted effects may be caused by Chlorthalidone (Gloritel CT) (the active ingredient contained in Chlorthalidone (Gloritel CT)). 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 (Gloritel CT):

Incidence not known:

Minor Side Effects

Some of the side effects that can occur with Chlorthalidone (Gloritel CT) 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:

Chlorthalidone (Gloritel CT) contraindications

See also:
What is the most important information I should know about Chlorthalidone (Gloritel CT)?

Hypersensitivity to Chlorthalidone (Gloritel CT), 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 (Gloritel CT)?

Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Telmisartan (Gloritel CT) is available only with your doctor's prescription.

Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).

Studies of Telmisartan (Gloritel CT) in this setting do not exclude the possibility that Telmisartan (Gloritel CT) 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 (Gloritel CT) with an ACE inhibitor is not recommended.

How should I use Telmisartan (Gloritel CT)?

Use Telmisartan (Gloritel CT) 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 (Gloritel CT).

Uses of Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) description

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

Telmisartan (Gloritel CT) dosage

Telmisartan (Gloritel CT) Dosage

Generic name: Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) tablets may be administered with other antihypertensive agents.

Telmisartan (Gloritel CT) tablets may be administered with or without food.

2.2  Cardiovascular Risk Reduction

The recommended dose of Telmisartan (Gloritel CT) 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 (Gloritel CT) are effective in reducing the risk of cardiovascular morbidity and mortality.

When initiating Telmisartan (Gloritel CT) 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 (Gloritel CT) (Telmisartan (Gloritel CT))

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Telmisartan (Gloritel CT) interactions

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What other drugs will affect Telmisartan (Gloritel CT)?

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

Digoxin: When Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT). 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 (Gloritel CT), 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 (Gloritel CT) and NSAID therapy.

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

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

Other Drugs: Co-administration of Telmisartan (Gloritel CT) did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) side effects

See also:
What are the possible side effects of Telmisartan (Gloritel CT)?

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 (Gloritel CT) 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 (Gloritel CT) (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 (Gloritel CT) 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 (Gloritel CT) and at a Greater Rate Than Patients Treated with Placebo

Telmisartan (Gloritel CT)

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 (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Telmisartan (Gloritel CT) 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 (Gloritel CT) tablets.

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

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of Telmisartan (Gloritel CT) in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Telmisartan (Gloritel CT) 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 (Gloritel CT) and 7.6% on placebo. The only serious adverse events at least 1% more common on Telmisartan (Gloritel CT) 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 (Gloritel CT). 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 (Gloritel CT).

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 (Gloritel CT).

Telmisartan (Gloritel CT) contraindications

See also:
What is the most important information I should know about Telmisartan (Gloritel CT)?

Hypersensitivity to Telmisartan (Gloritel CT) or to any of the excipients of Telmisartan (Gloritel CT).

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 (Gloritel CT), the use of Telmisartan (Gloritel CT) 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 (Gloritel CT) 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 (Gloritel CT) is contraindicated during lactation since it is not known whether it is excreted in human milk.

Animal studies have shown excretion of Telmisartan (Gloritel CT) in breast milk.



Active ingredient matches for Gloritel CT:

Chlorthalidone/Telmisartan


Unit description / dosage (Manufacturer)Price, USD
Gloritel CT 80mg/12.5mg Tablet (Oaknet Healthcare Pvt Ltd)$ 0.13

List of Gloritel CT substitutes (brand and generic names):

GLORITEL-CT 40 MG/12.5 MG TABLET 1 strip / 10 tablets each (Oaknet Life Sciences Private Limited)$ 1.17
Ibtel-CT 40mg Tablet (Indiabulls pharmaceutical ltd)$ 0.15
Ibtel-CT 6.25mg Tablet (Indiabulls pharmaceutical ltd)$ 0.11
INDITEL CH 40 MG/6.25 MG TABLET 1 strip / 10 tablets each (Zydus Cadila)$ 1.25
INDITEL CH -40 TABLET 1 strip / 10 tablets each (Zydus Cadila)$ 1.67
INDITEL CH -80 TABLET 1 strip / 10 tablets each (Zydus Cadila)$ 2.82
Inditel CH 40mg Tablet (Zydus Cadila)$ 0.18
Inditel CH 6.25mg Tablet (Zydus Cadila)$ 0.14
MACSART CH TABLET 1 strip / 10 tablets each (Macleods Pharmaceuticals Pvt Ltd)$ 1.34
MACSART-CH tab 10's (Macleods (Procare AHT))$ 1.17
MISART C TABLET 1 strip / 10 tablets each (Tas Med India Pvt Ltd)$ 1.15
NEWTEL CH 40MG TABLET 1 strip / 10 tablets each (Systopic Laboratories Pvt Ltd)$ 0.60
NEWTEL-CH tab 10's (Systopic)$ 0.60
Oritel-CH 20 Tablet (Orris Pharmaceuticals)$ 0.12
Oritel-CH 40 Tablet (Orris Pharmaceuticals)$ 0.14
SAFETELMI CT 40 MG/12.5 MG TABLET 1 strip / 10 tablets each (MSN Laboratories Ltd)$ 1.19
SAFETELMI CT 80 MG/12.5 MG TABLET 1 strip / 10 tablets each (MSN Laboratories Ltd)$ 2.14
Safetelmi CT 80 mg/12.5 mg Tablet (MSN Laboratories)$ 0.21
SARTEL C 40 MG/12.5 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd)$ 1.73
SARTEL C 80 MG/12.5 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd)$ 2.43
Sartel-C 40 Tablet (Intas Pharmaceuticals Ltd)$ 0.17
TAZLOC CT 40 MG/6.25 MG TABLET 1 strip / 10 tablets each (USV Ltd)$ 1.32
TAZLOC CT 40 MG TABLET 1 strip / 10 tablets each (USV Ltd)$ 1.59
TAZLOC CT 80 MG TABLET 1 strip / 10 tablets each (USV Ltd)$ 2.62
TAZLOC-CT bilayer coated tab 10's (USV)$ 2.38
Tazloc-CT 40 Tablet (USV)$ 0.17
Tazloc-CT 6.25 Tablet (USV)$ 0.14
Tazloc-CT 80 Tablet (USV)$ 0.26
Tazpure-CH 40mg/12.5mg Tablet (Arrient Healthcare Pvt Ltd)$ 0.15
Tazpure-CH 80mg/12.5mg Tablet (Arrient Healthcare Pvt Ltd)$ 0.22
TECHLOR 40 MG/12.5 MG TABLET 1 strip / 10 tablets each (Cipla)$ 1.56
TECHLOR 80MG/12.5MG TABLET 1 strip / 10 tablets each (Cipla)$ 2.75
TECHLOR tab 10's (Cipla)$ 2.38
Techlor 80mg/12.5mg Tablet (Cipla)$ 0.27
Tel Cad CD 80 mg Tablet (Aprica Pharmaceuticals Pvt Ltd)$ 0.28
TEL-CAD CD 40 MG TABLET 1 strip / 10 tablets each (Aprica Pharmaceuticals Pvt Ltd)$ 1.02
TEL-CAD CD 80 MG TABLET 1 strip / 10 tablets each (Aprica Pharmaceuticals Pvt Ltd)$ 2.76
TELDAY CH 40 MG TABLET 1 strip / 10 tablets each (Torrent Pharmaceuticals Ltd)$ 1.54
TELDAY CH 80 MG TABLET 1 strip / 10 tablets each (Torrent Pharmaceuticals Ltd)$ 2.57
Telday CH 40 Tablet (Torrent Pharmaceuticals Ltd)$ 0.15
TELEACT CT 40 MG TABLET 1 strip / 10 tablets each (Ranbaxy Laboratories Ltd)$ 1.63
TELEACT CT 80 MG TABLET 1 strip / 10 tablets each (Ranbaxy Laboratories Ltd)$ 2.60

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. 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).
  3. PubChem. "Telmisartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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