Atenolol And Chlorthalidone (Atenolol And Chlorthalidone)

Trade Name : Atenolol and Chlorthalidone

Northstar Rx LLC.

TABLET

Strength 5025 mg/1mg/1

ATENOLOL; CHLORTHALIDONE Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atenolol And Chlorthalidone (Atenolol And Chlorthalidone) which is also known as Atenolol and Chlorthalidone and Manufactured by Northstar Rx LLC.. It is available in strength of 50; 25 mg/1; mg/1 per ml. Read more

Atenolol And Chlorthalidone (Atenolol And Chlorthalidone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Atenolol and chlorthalidone tablets are for the treatment of hypertension. It combines the antihypertensive activity of two agents: a beta-selective (cardioselective) hydrophilic blocking agent (atenolol) and a monosulfonamyl diuretic (chlorthalidone). Atenolol is Benzeneacetamide, 4-[2'-hydroxy-3'-[(1-methylethyl) amino] propoxy]-.
Atenolol, USP is a white or almost white powder and is sparingly soluble in water; soluble in absolute alcohol and practically insoluble in ether.
Chlorthalidone is 2-Chloro-5-(1-hydroxy-3-oxo-1-isoindolinyl) benzene sulfonamide:
Chlorthalidone, USP is white to yellowish crystalline powder.
Each atenolol and chlorthalidone tablet, USP intended for oral administration contains atenolol 50 mg or 100 mg and chlorthalidone 25 mg. In addition, each uncoated tablet contains the following inactive ingredients: citric acid, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, pregelatinized starch and silicified microcrystalline cellulose.

Atenolol and chlorthalidone have been used singly and concomitantly for the treatment of hypertension. The antihypertensive effects of these agents are additive, and studies have shown that there is no interference with bioavailability when these agents are given together in the single combination tablet. Therefore, this combination provides a convenient formulation for the concomitant administration of these two entities. In patients with more severe hypertension, atenolol and chlorthalidone tablets may be administered with other antihypertensives such as vasodilators.
Atenolol
Atenolol is a beta-selective (cardioselective) beta-adrenergic receptor blocking agent without membrane stabilizing or intrinsic sympathomimetic (partial agonist) activities. This preferential effect is not absolute, however, and at higher doses, atenolol inhibits beta-adrenoreceptors, chiefly located in the bronchial and vascular musculature.
Pharmacodynamics
In standard animal or human pharmacological tests, beta-adrenoreceptor blocking activity of atenolol has been demonstrated by: (1) reduction in resting and exercise heart rates and cardiac output, (2) reduction of systolic and diastolic blood pressure at rest and on exercise, (3) inhibition of isoproterenol induced tachycardia and (4) reduction in reflex orthostatic tachycardia.
A significant beta-blocking effect of atenolol, as measured by reduction of exercise tachycardia, is apparent within one hour following oral administration of a single dose. This effect is maximal at about 2 to 4 hours and persists for at least 24-hours. The effect at 24 hours is dose related and also bears a linear relationship to the logarithm of plasma atenolol concentration. However, as has been shown for all beta blocking agents, the antihypertensive effect does not appear to be related to plasma level.
In normal subjects, the beta-selectivity of atenolol has been shown by its reduced ability to reverse the beta-mediated vasodilating effect of isoproterenol as compared to equivalent beta-blocking doses of propranolol. In asthmatic patients, a dose of atenolol producing a greater effect on resting heart rate than propranolol resulted in much less increase in airway resistance. In a placebo controlled comparison of approximately equipotent oral doses of several beta blockers, atenolol produced a significantly smaller decrease of FEV1 than nonselective beta blockers, such as propranolol and unlike those agents did not inhibit bronchodilation in response to isoproterenol.
Consistent with its negative chronotropic effect due to beta blockade of the SA node, atenolol increases sinus cycle length and sinus node recovery time. Conduction in the AV node is also prolonged. Atenolol is devoid of membrane stabilizing activity, and increasing the dose well beyond that producing beta blockade does not further depress myocardial contractility. Several studies have demonstrated a moderate (approximately 10%) increase in stroke volume at rest and exercise.
In controlled clinical trials, atenolol given as a single daily dose, was an effective antihypertensive agent providing 24 hour reduction of blood pressure. Atenolol has been studied in combination with thiazide-type diuretics and the blood pressure effects of the combination are approximately additive. Atenolol is also compatible with methyldopa, hydralazine and prazosin, the combination resulting in a larger fall in blood pressure than with the single agents. The dose range of atenolol is narrow, and increasing the dose beyond 100 mg once daily is not associated with increased antihypertensive effect. The mechanisms of the antihypertensive effects of beta-blocking agents have not been established. Several mechanisms have been proposed and include: (1) competitive antagonism of catecholamines at peripheral (especially cardiac) adrenergic neuron sites, leading to decreased cardiac output, (2) a central effect leading to reduced sympathetic outflow to the periphery and (3) suppression of renin activity. The results from long-term studies have not shown any diminution of the antihypertensive efficacy of atenolol with prolonged use.
Pharmacokinetics and Metabolism
In man, absorption of an oral dose is rapid and consistent but incomplete. Approximately 50% of an oral dose is absorbed from the gastrointestinal tract, the remainder being excreted unchanged in the feces. Peak blood levels are reached between 2 and 4 hours after ingestion. Unlike propranolol or metoprolol, but like nadolol, hydrophilic atenolol undergoes little or no metabolism by the liver, and the absorbed portion is eliminated primarily by renal excretion. Atenolol also differs from propranolol in that only a small amount (6 to 16%) is bound to proteins in the plasma. This kinetic profile results in relatively consistent plasma drug levels with about a fourfold interpatient variation. There is no information as to the pharmacokinetic effect of atenolol on chlorthalidone.
The elimination half-life of atenolol is approximately 6 to 7 hours and there is no alteration of the kinetic profile of the drug by chronic administration. Following doses of 50 mg or 100 mg, both beta-blocking and antihypertensive effects persist for at least 24 hours. When renal function is impaired, elimination of atenolol is closely related to the glomerular filtration rate; but significant accumulation does not occur until the creatinine clearance falls below 35 mL/min/1.73m(see prescribing information for atenolol tablets).
Atenolol Geriatric Pharmacology
In general, elderly patients present higher atenolol plasma levels with total clearance values about 50% lower than younger subjects. The half-life is markedly longer in the elderly compared to younger subjects. The reduction of atenolol clearance follows the general trend that the elimination of renally excreted drugs is decreased with increasing age.
Chlorthalidone
Chlorthalidone is a monosulfonamyl diuretic which differs chemically from thiazide diuretics in that a double ring system is incorporated in its structure. It is an oral diuretic with prolonged action and low toxicity. The diuretic effect of the drug occurs within 2 hours of an oral dose. It produces diuresis with greatly increased excretion of sodium and chloride. At maximal therapeutic dosage, chlorthalidone is approximately equal in its diuretic effect to comparable maximal therapeutic doses of benzothiadiazine diuretics. The site of action appears to be the cortical diluting segment of the ascending limb of Henle's loop of the nephron.

Atenolol and chlorthalidone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 atenolol and chlorthalidone.
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 1 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 (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
This fixed dose combination drug is not indicated for initial therapy of hypertension. If the fixed dose combination represents the dose appropriate to the individual patient's needs, it may be more convenient than the separate components.

Atenolol and chlorthalidone tablets are contraindicated in patients with: sinus bradycardia; heart block greater than first degree; cardiogenic shock; overt cardiac failure (see ); anuria; hypersensitivity to this product or to sulfonamide-derived drugs.

No data

No data

Atenolol and chlorthalidone tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient. The adverse effects observed for atenolol and chlorthalidone tablets are essentially the same as those seen with the individual components.

In addition, a variety of adverse effects not observed in clinical trials with atenolol but reported with other beta-adrenergic blocking agents should be considered potential adverse effects of atenolol. Nervous System: Reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, decreased performance on neuropsychometrics; Cardiovascular: Intensification of AV block (see ); Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm and respiratory distress.

No specific information is available with regard to overdosage and atenolol and chlorthalidone tablets in humans. Treatment should be symptomatic and supportive and directed to the removal of any unabsorbed drug by induced emesis, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Further consideration should be given to dehydration, electrolyte imbalance and hypotension by established procedures.

DOSAGE MUST BE INDIVIDUALIZED (See ).
Chlorthalidone is usually given at a dose of 25 mg daily; the usual initial dose of atenolol is 50 mg daily. Therefore, the initial dose should be one atenolol and chlorthalidone 50mg/25mg tablet given once a day. If an optimal response is not achieved, the dosage should be increased to one atenolol and chlorthalidone 100mg/25mg tablet given once a day.
When necessary, another antihypertensive agent may be added gradually beginning with 50 percent of the usual recommended starting dose to avoid an excessive fall in blood pressure.
Since atenolol is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs until creatinine clearance falls below 35 mL/min/1.73m(normal range is 100 to 150 mL/min/1.73m); therefore, the following maximum dosages are recommended for patients with renal impairment.

Atenolol and Chlorthalidone Tablets, USP are uncoated tablets.
Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg are white to off white, round, biconvex, bevelled tablets, with debossing of '11' above breakline and '67' below breakline on one side and plain on the other side and are supplied as follows:
NDC 16714-936-01 in bottle of 100 tablets
Atenolol and Chlorthalidone Tablets USP, 100 mg/25 mg are white to off white, round, biconvex, beveled tablets, with debossing of '11' over '68' on one side and plain on the other side and are supplied as follows:
NDC 16714-937-01 in bottle of 100 tablets
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please address medical inquiries to, [email protected] Tel.: 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Manufactured by:
Cadila Healthcare Ltd.
Ahmedabad, India.
Rev.: 02/2019

NDC 16714-936-01
Atenolol and Chlorthalidone Tablets, USP 50 mg/25 mg
Rx only
100 Tablets
NDC 16714-937-01
Atenolol and Chlorthalidone Tablets, USP 100 mg/25 mg
Rx only
100 Tablets

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Atenolol And Chlorthalidone (Atenolol And Chlorthalidone)

Trade Name : Atenolol and Chlorthalidone

TABLET

Delivery Process

Product information is meant for

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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About GNH

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Atenolol And Chlorthalidone (Atenolol And Chlorthalidone)

Trade Name : Atenolol and Chlorthalidone

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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Losartan Potassium (Losartan Potassium)

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