Chlorthalidone
Jubilant Cadista Pharmaceuticals,inc.
Human Prescription Drug
NDC 59746-760Chlorthalidone is a human prescription drug labeled by 'Jubilant Cadista Pharmaceuticals,inc.'. National Drug Code (NDC) number for Chlorthalidone is 59746-760. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Chlorthalidone drug includes Chlorthalidone - 25 mg/1 . The currest status of Chlorthalidone drug is Active.
Drug Information:
| Drug NDC: | 59746-760 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Chlorthalidone |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Chlorthalidone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Jubilant Cadista Pharmaceuticals,inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CHLORTHALIDONE - 25 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 31 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 01 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA211320 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | JUBILANT CADISTA PHARMACEUTICALS,INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197499
197500
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0359746761011
0359746760014
|
| UPC stands for Universal Product Code. |
| NUI: | N0000175359
N0000175420
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | Q0MQD1073Q
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Thiazide-like Diuretic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Increased Diuresis [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Increased Diuresis [PE]
Thiazide-like Diuretic [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59746-760-01 | 100 TABLET in 1 BOTTLE (59746-760-01) | 31 Mar, 2021 | N/A | No |
| 59746-760-36 | 1000 TABLET in 1 BOTTLE (59746-760-36) | 31 Mar, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Chlorthalidone chlorthalidone chlorthalidone chlorthalidone cellulose, microcrystalline crospovidone ferric oxide yellow magnesium stearate silicon dioxide starch, corn light yellow round shaped 103 chlorthalidone chlorthalidone chlorthalidone chlorthalidone cellulose, microcrystalline crospovidone fd&c blue no. 1 ferric oxide yellow magnesium stearate silicon dioxide starch, corn light green round shaped 1;3
Indications and Usage:
Indications and usage diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. usage in pregnancy: the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of preg
Read more...nancy. chlorthalidone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (however, see precautions , below). dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. there is hypervolemia during normal pregnancy that is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but that is associated with edema, including generalized edema, in the majority of pregnant women. if this edema produces discomfort, increased recumbency will often provide relief. in rare instances, this edema may cause extreme discomfort that is not relieved by rest. in these cases, a short course of diuretics may provide relief and be appropriate.
Warnings:
Warnings chlorthalidone should be used with caution in severe renal disease. in patients with renal disease, chlorthalidone or related drugs may precipitate azotemia. cumulative effects of the drug may develop in patients with impaired renal function. chlorthalidone 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 occur in patients with a history of allergy or bronchial asthma. the possibility of exacerbation or activation of systemic lupus erythematosus has been reported with thiazide diuretics, which are structurally related to chlorthalidone. however, systemic lupus erythematosus has not been reported following chlorthalidone administration.
Dosage and Administration:
Dosage and administration therapy should be initiated with the lowest possible dose. this dose should be titrated according to individual patient response to gain maximal therapeutic benefit while maintaining lowest dosage possible. a single dose given in the morning with food is recommended; divided daily doses are unnecessary. hypertension: initiation : therapy, in most patients, should be initiated with a single daily dose of 25 mg. if the response is insufficient after a suitable trial, the dosage may be increased to a single daily dose of 50 mg. if additional control is required, the dosage of chlorthalidone may be increased to 100 mg once daily or a second antihypertensive drug (step 2 therapy) may be added. dosage above 100 mg daily usually does not increase effectiveness. increases in serum uric acid and decreases in serum potassium are dose-related over the 25 to 100 mg/day range. maintenance : maintenance doses may be lower than initial doses and should be adjusted according
Read more...to individual patient response. effectiveness is well sustained during continued use. edema: initiation : adults, initially 50 to 100 mg daily, or 100 mg on alternate days. some patients may require 150 to 200 mg at these intervals or up to 200 mg daily. dosages above this level, however, do not usually produce a greater response. maintenance : maintenance doses may often be lower than initial doses and should be adjusted according to individual patient response. effectiveness is well sustained during continued use.
Contraindications:
Contraindications anuria. known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs.
Adverse Reactions:
Adverse reactions the following adverse reactions have been observed, but there is not enough systematic collection of data to support an estimate of their frequency. gastrointestinal system reactions : anorexia, gastric irritation nausea, vomiting cramping diarrhea constipation jaundice (intrahepatic cholestatic jaundice) pancreatitis central nervous system reactions : dizziness vertigo paresthesias headache xanthopsia hematologic reactions : leukopenia agranulocytosis thrombocytopenia aplastic anemia dermatologic-hypersensitivity reactions : purpura photosensitivity rash urticaria necrotizing angiitis (vasculitis) (cutaneous vasculitis) lyell's syndrome (toxic epidermal necrolysis) cardiovascular reactions : orthostatic hypotension may occur and may be aggravated by alcohol, barbiturates, or narcotics. other adverse reactions : hyperglycemia glycosuria hyperuricemia muscle spasm weakness restlessness impotence whenever adverse reactions are moderate or severe, chlorthalidone dosage s
Read more...hould be reduced or therapy withdrawn.
Overdosage:
Overdosage symptoms of acute overdosage include nausea, weakness, dizziness, and disturbances of electrolyte balance. the oral ld of the drug in the mouse and the rat is more than 25,000 mg/kg body weight. the minimum lethal dose (mld) in humans has not been established. there is no specific antidote, but gastric lavage is recommended, followed by supportive treatment. where necessary, this may include intravenous dextrose-saline with potassium, administered with caution.
Description:
Description chlorthalidone usp is an oral antihypertensive/diuretic. it is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. it is 2-chloro-5(1-hydroxy-3-oxo-1-isoindolinyl) benzenesulfonamide, with the following structural formula: chlorthalidone, usp is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in alcohol. chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone usp and the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, ferric oxide yellow, magnesium stearate, microcrystalline cellulose. the 50 mg tablet also contains fd&c blue #1. 879a89d8-9799-49d8-8033-77c4090cf1ed-01
Clinical Pharmacology:
Clinical pharmacology chlorthalidone is an oral diuretic with prolonged action (48â72 hours) and low toxicity. the major portion of the drug is excreted unchanged by the kidneys. the diuretic effect of the drug occurs in approximately 2.6 hours and continues for up to 72 hours. the mean half-life following a 50 to 200 mg dose is 40 hours. in the first order of absorption, the elimination half-life is 53 hours following a 50 mg dose, and 60 hours following a 100 mg dose. approximately 75 percent of the drug is bound to plasma proteins, 58 percent of the drug being bound to albumin. this is caused by an increased affinity of the drug to erythrocyte carbonic anhydrase. nonrenal routes of elimination have yet to be clarified. data are not available regarding percentage of dose as unchanged drug and metabolites, concentration of the drug in body fluids, degree of uptake by a particular organ or in the fetus, or passage across the blood-brain barrier. the drug produces copious diuresis
Read more...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.
How Supplied:
How supplied chlorthalidone tablets, usp are available containing 25 mg or 50 mg of chlorthalidone, usp. the 25 mg tablets are light-yellow colored, round shaped, uncoated, flat, bevelled edge tablets, debossed with '103'on one side of the tablet and blank on the other side. they are available as follows: ndc 59746-760-01 bottles of 100 with child-resistant closure ndc 59746-760-36 bottles of 1000 with child-resistant closure the 50 mg tablets are light-green colored, round shaped, uncoated, flat, bevelled edge scored tablets, debossed with 'i' to the left and '3'to the right of the score on one side of the tablet and blank on the other side. they are available as follows: ndc 59746-761-01 bottles of 100 with child-resistant closure store at 20 to 25° c (68 to 77° f). [see usp controlled room temperature]. protect from light. keep container tightly closed. avoid excessive heat. dispense in a tight container as defined in the usp. keep out of the reach of children. this product sh
Read more...ould be dispensed in a container with a child-resistant cap. manufactured by: inventia healthcare limited, f1-f1/1-f75/1, additional ambernath m.i.d.c., ambernath (east)-421506, dist. thane, maharashtra, india distributed by: jubilant cadista pharmaceuticals inc. salisbury, md 21801, usa. ate0614l/02 revised: february 2022
Package Label Principal Display Panel:
Package label.principal display panel 879a89d8-9799-49d8-8033-77c4090cf1ed-02 879a89d8-9799-49d8-8033-77c4090cf1ed-03