Hydrochlorothiazide

Direct_rx
Human Prescription Drug
NDC 61919-580

Hydrochlorothiazide is a human prescription drug labeled by 'Direct_rx'. National Drug Code (NDC) number for Hydrochlorothiazide is 61919-580. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Hydrochlorothiazide drug includes Hydrochlorothiazide - 12.5 mg/1 . The currest status of Hydrochlorothiazide drug is Active.

Drug Information:

Drug NDC:	61919-580
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:	Hydrochlorothiazide
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:	Hydrochlorothiazide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Direct_rx
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
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:	HYDROCHLOROTHIAZIDE - 12.5 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:	21 Aug, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 Jun, 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:	ANDA090510
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, 2024
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:	Direct_Rx
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	199903
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.
NUI:	N0000175359 N0000175419 M0471776
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	0J48LPH2TH
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 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 CS:	Thiazides [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Increased Diuresis [PE] Thiazide Diuretic [EPC] Thiazides [CS]
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
61919-580-90	90 CAPSULE in 1 BOTTLE (61919-580-90)	21 Aug, 2019	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.

Other medicines with the same generic name

Product Elements:

Hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide cellulose, microcrystalline magnesium stearate silicon dioxide gelatin sodium lauryl sulfate titanium dioxide ferrosoferric oxide starch, corn u;130

Indications and Usage:

Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ace inhibitors. 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 pregnancy. diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. dependent edema in pregnancy resulting from restriction of venous r Read more...

eturn 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 which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which 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 which is not relieved by rest. in these cases a short course of diuretics may provide relief and may be appropriate.

Warnings:

Acute myopia and secondary angle-closure glaucoma: hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. untreated acute angle-closure glaucoma can lead to permanent vision loss. the primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. diabetes and hypoglycemia: latent diabetes mellitus may become manifest and diabetic patients given thiazides may require adjustment of their insulin dose. renal disease: cumulative effects of the thiazides may develop in patients with impaired renal function. in such patients, thiaz Read more...

ides may precipitate azotemia.

Dosage and Administration:

For control of hypertension: the adult initial dose of hydrochlorothiazide capsules is one capsule given once daily whether given alone or in combination with other antihypertensives. total daily doses greater than 50 mg are not recommended.

Contraindications:

Hydrochlorothiazide capsules are contraindicated in patients with anuria. hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.

Adverse Reactions:

The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. in controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. the following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the order of decreasing severity. body as a whole: weakness. cardiovascular: hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmon Read more...

ary edema, photosensitivity, fever, urticaria, rash, purpura. metabolic: electrolyte imbalance (see precautions), hyperglycemia, glycosuria, hyperuricemia. musculoskeletal: muscle spasm. nervous system/psychiatric: vertigo, paresthesia, dizziness, headache, restlessness. renal: renal failure, renal dysfunction, interstitial nephritis (see warnings). skin: erythema multiforme including stevens-johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. special senses: transient blurred vision, xanthopsia. urogenital: impotence. whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Overdosage:

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. if digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. in the event of overdosage, symptomatic and supportive measures should be employed. emesis should be induced or gastric lavage performed. correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. if required, give oxygen or artificial respiration for respiratory impairment. the degree to which hydrochlorothiazide is removed by hemodialysis has not been established. the oral ld50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

Description:

Hydrochlorothiazide, usp is the 3,4-dihydro derivative of chlorothiazide. its chemical name is 6-chloro-3,4-dihydro-2h-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. its molecular formula is c7h8cln3o4s2; its molecular weight is 297.74; and its structural formula is: [structure of hydrochlorothiazide] it is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. inactive ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate and black iron oxide.

Clinical Pharmacology:

Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. a portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. with continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions. hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide and may reduce glomerular filtration rate. metabolic toxicities associated with excessive electrolyte changes caused by hydrochlorothiazide have been shown to be dose-related. pharmacokinetics and metabolism hydrochlorothiazide is well absorbed (65% to 75%) following oral administration. absorption of hydrochlorothiazide is reduced in patients with congestive heart failure. peak plasma co Read more...

ncentrations are observed within 1 to 5 hours of dosing, and range from 70 to 490 ng/ml following oral doses of 12.5 to 100 mg. plasma concentrations are linearly related to the administered dose. concentrations of hydrochlorothiazide are 1.6 to 1.8 times higher in whole blood than in plasma. binding to serum proteins has been reported to be approximately 40% to 68%. the plasma elimination half-life has been reported to be 6 to 15 hours. hydrochlorothiazide is eliminated primarily by renal pathways. following oral doses of 12.5 to 100 mg, 55% to 77% of the administered dose appears in urine and greater than 95% of the absorbed dose is excreted in urine as unchanged drug. in patients with renal disease, plasma concentrations of hydrochlorothiazide are increased and the elimination half-life is prolonged. when hydrochlorothiazide is administered with food, its bioavailability is reduced by 10%, the maximum plasma concentration is reduced by 20%, and the time to maximum concentration increases from 1.6 to 2.9 hours. pharmacodynamics acute antihypertensive effects of thiazides are thought to result from a reduction in blood volume and cardiac output, secondary to a natriuretic effect, although a direct vasodilatory mechanism has also been proposed. with chronic administration, plasma volume returns toward normal, but peripheral vascular resistance is decreased. the exact mechanism of the antihypertensive effect of hydrochlorothiazide is not known. thiazides do not affect normal blood pressure. onset of action occurs within 2 hours of dosing, peak effect is observed at about 4 hours, and activity persists for up to 24 hours. clinical studies in an 87 patient 4-week double-blind, placebo controlled, parallel group trial, patients who received hydrochlorothiazide had reductions in seated systolic and diastolic blood pressure that were significantly greater than those seen in patients who received placebo. in published placebo-controlled trials comparing 12.5 mg of hydrochlorothiazide to 25 mg, the 12.5 mg dose preserved most of the placebo-corrected blood pressure reduction seen with 25 mg.

How Supplied:

Hydrochlorothiazide capsules usp, 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "u" on cap and "130" on the body in grey ink along the horizontal axis bottle of 100: bottle of 500: bottle of 1000: store at 200 to 250c (680 to 770f) [see usp controlled room temperature]. protect from light, moisture, freezing, -200c (-40f). keep container tightly closed. rx only please address medical inquiries to unichem's toll free # 1-866-562-4616.

Package Label Principal Display Panel:

580-90

Comments/ Reviews:

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