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DIURIL CHLOROTHIAZIDE 250 mg/5mL Suspension — NDC 65649-0311-12 package photo

DIURIL CHLOROTHIAZIDE 250 mg/5mL Suspension

by Salix Pharmaceuticals, Inc · 1 BOTTLE in 1 CARTON (65649-311-12) / 237 mL in 1 BOTTLE
NDC 65649-0311-12
🏷️ FDA NDC (as labeled) 65649-311-12 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⚠ On shortage
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Chlorothiazide Oral Suspension is currently reported in shortage by the FDA. Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 65649-311-12
Product NDC 65649-311
11-digit billing NDC 65649031112
NCPDP billing unit ML — per mL (volume)
RxCUI 213439, 309198
UNII 77W477J15H
Application # NDA011870
SPL Set ID bd936e35-1af8-42da-bcc0-f22489d68574
Established class (EPC) Thiazide Diuretic
Physiologic effect Increased Diuresis
Chemical class Thiazides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1962-02-15
Marketing end 2028-01-31
Route ORAL
Dosage form SUSPENSION
Substance CHLOROTHIAZIDE
GPI-14 37600020001805
GPI class Diuril
GCN Seq No 008172
GCN 34790
HICL code 003646
Ingredient (HICL) Chlorothiazide
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1F
Therapeutic class — specific (HIC3) Thiazide And Related Diuretics
AHFS code 24:36.20.00
AHFS class Thiazide Diuretics (24:36)
FDB label name DIURIL 250 MG/5 ML ORAL SUSP
FDB brand name Diuril
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 65649-311-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65649-0311-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Thiazide Diuretic class.

Pharmacologic class Thiazide Diuretic
Drug family (ATC) Thiazides, plain
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSalix Pharmaceuticals, Inc
Application holderSALIX PHARMACEUTICALS INC
FDA applicationNDA011870 (NDA)
Labeler code65649
First marketedFeb 1962
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DIURIL 250 MG/5 ML ORAL SUSP Ingredient Chlorothiazide
📖 What it is MedlinePlus · NLM

Chlorothiazide is used alone or in combination with other medications to treat high blood pressure. Chlorothiazide is used to treat edema (fluid retention; excess fluid held in body tissues) caused by various medical problems, including heart, kidney, and liver disease and to treat edema caused by using certain medications including estrogen and corticosteroids. Chlorothiazide is in a class of medications called diuretics ('water pills'). It works by causing the kidneys to get rid of unneeded water and salt from the body into the urine. High blood pressure is a common condition, and when not t...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a water pill — it helps your kidneys flush out extra salt and fluid that's building up in your body. Depending on the form you're taking, it treats fluid retention (edema) fro...
  • What exactly is chlorothiazide supposed to do for me?
  • You'll take it by mouth, usually once or twice a day. Your doctor might also put you on an every-other-day or a few-days-per-week schedule — that actually helps prevent your electr...
  • How and when should I take the oral suspension (liquid)?
📖 Read our full Chlorothiazide guide →
8
Nutrient depletion considerations

Chlorothiazide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 2944357O2O
    A natural gum derived from the tragacanth shrub, used as a thickener, stabilizer, and binder in medicines. It helps create the right consistency and keeps ingredients evenly mixed throughout the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.277 $65.55 / 237 ml
Medicaid paysCMS SDUD · 12 mo $0.3303 $78.28 / 237 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Feb 2024 $0.280 $0.277
▼ Down 1% over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Diuril 250 mg/5mLthis 65649-0311-12 Salix 1 bottle $0.277 FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1962
On the market since
Feb 1962
📍
2026
Currently FDA-listed
64 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 65649-0311-12, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
11.3K
Units reimbursed last 4 qtrs
1.3M
Gross reimbursed last 4 qtrs
$413.2K
Avg / prescription
$36.71
Avg / unit
$0.3303
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$0.3303
gross reimbursed
vs
NADAC / mL
$0.2766
acquisition cost
=
Spread
+$0.0537
+19% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
37% FFS 63% MCO
Fee-for-service · 4,142 Rx Managed care · 7,112 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 8,730 units · 112 per 100k residents WA Idaho: 4,724 units · 241 per 100k residents ID Montana: no data reported MT North Dakota: 3,985 units · 509 per 100k residents ND Minnesota: 29,498 units · 514 per 100k residents MN Wisconsin: 12,824 units · 217 per 100k residents WI Michigan: 40,857 units · 407 per 100k residents MI New York: 53,305 units · 272 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 1,117 units · 26.4 per 100k residents OR Nevada: 24,268 units · 760 per 100k residents NV Wyoming: no data reported WY South Dakota: 4,312 units · 469 per 100k residents SD Iowa: 1,852 units · 57.7 per 100k residents IA Illinois: 84,538 units · 674 per 100k residents IL Indiana: 5,473 units · 79.8 per 100k residents IN Ohio: 52,539 units · 446 per 100k residents OH Pennsylvania: 109,726 units · 847 per 100k residents PA New Jersey: 39,247 units · 422 per 100k residents NJ Massachusetts: 17,213 units · 246 per 100k residents MA California: 113,509 units · 291 per 100k residents CA Utah: 5,940 units · 174 per 100k residents UT Colorado: 19,330 units · 329 per 100k residents CO Nebraska: 6,550 units · 331 per 100k residents NE Missouri: 13,620 units · 220 per 100k residents MO Kentucky: 19,644 units · 434 per 100k residents KY West Virginia: 9,689 units · 547 per 100k residents WV Virginia: 7,564 units · 86.8 per 100k residents VA Maryland: 37,253 units · 603 per 100k residents MD Connecticut: 28,084 units · 776 per 100k residents CT Rhode Island: no data reported RI Arizona: 29,153 units · 392 per 100k residents AZ New Mexico: 3,008 units · 142 per 100k residents NM Kansas: 6,628 units · 225 per 100k residents KS Arkansas: 10,930 units · 356 per 100k residents AR Tennessee: 6,335 units · 88.9 per 100k residents TN North Carolina: 29,584 units · 273 per 100k residents NC South Carolina: 8,678 units · 162 per 100k residents SC Delaware: 12,366 units · 1,199 per 100k residents DE Oklahoma: 12,453 units · 307 per 100k residents OK Louisiana: 32,830 units · 718 per 100k residents LA Mississippi: 23,224 units · 790 per 100k residents MS Alabama: 18,201 units · 356 per 100k residents AL Georgia: 34,951 units · 317 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 134,537 units · 441 per 100k residents TX Florida: 121,936 units · 539 per 100k residents FL
Units reimbursed · per 100k residents
26.41,199
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Delaware 1,199 /100k
2 Pennsylvania 847 /100k
3 Mississippi 790 /100k
4 Connecticut 776 /100k
5 Nevada 760 /100k
6 Louisiana 718 /100k
7 Illinois 674 /100k
8 Maryland 603 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diuril — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diuril. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$498.55
Claims incl. refills
12
Beneficiaries
Spend / beneficiary
Spend / claim
$41.55
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65649-0311-12 You're viewing this 1 BOTTLE in 1 CARTON (65649-311-12) / 237 mL in 1 BOTTLE 1962-02-15 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

INDICATIONS AND USAGE DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. DIURIL is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Use in Pregnancy - Routine use of diuretics during normal pregnancy 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 toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy ). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary.

During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief.

Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.

⏱️ Dosage and Administration ~1 min read

DOSAGE AND ADMINISTRATION Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response. Adults For Edema The usual adult dosage is 500 mg to 1,000 mg (10 mL to 20 mL) once or twice a day.

Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. For Control of Hypertension The usual adult starting dosage is 500 mg or 1,000 mg (10 mL to 20 mL) a day as a single or divided dose.

Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2,000 mg (40 mL) a day in divided doses. Infants and Children For Diuresis and For Control of Hypertension The usual pediatric dosage is 5 mg to 10 mg per pound (10 mg/kg to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day (2.5 mL to 7.5 mL or ½ to 1½ teaspoonfuls of the oral suspension daily) in infants up to 2 years of age or 1,000 mg per day in children 2 to 12 years of age.

In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required (see PRECAUTIONS , Pediatric Use ).

Contraindications 11 words

CONTRAINDICATIONS Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

⚠️ Warnings 113 words

WARNINGS Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides 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. Thiazides may add to or potentiate the action of other antihypertensive drugs. Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported. Lithium generally should not be given with diuretics (see PRECAUTIONS , Drug Interactions ).

🤒 Adverse Reactions 165 words

ADVERSE REACTIONS The following adverse reactions have been reported and, within each category, are listed in 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 pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance (see PRECAUTIONS ), hyperglycemia, glycosuria, hyperuricemia.

Musculoskeletal: Muscle spasm. Nervous System/Psychiatric: Vertigo, paresthesias, 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. To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~1 min read

Drug Interactions When given concurrently the following drugs may interact with thiazide diuretics. Alcohol, Barbiturates, or Narcotics - potentiation of orthostatic hypotension may occur. Antidiabetic Drugs (Oral Agents and Insulin) - dosage adjustment of the antidiabetic drug may be required.

Other Antihypertensive Drugs - additive effect or potentiation. Cholestyramine and Colestipol Resins - Both cholestyramine and colestipol resins have the potential of binding thiazide diuretics and reducing diuretic absorption from the gastrointestinal tract. Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia.

Pressor Amines (e.g., Norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use. Skeletal Muscle Relaxants, Nondepolarizing (e.g., Tubocurarine) - possible increased responsiveness to the muscle relaxant. Lithium - generally should not be given with diuretics.

Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with DIURIL. Non-steroidal Anti-inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 (COX-2) Inhibitors - In some patients, the administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.

Therefore, when DIURIL and non-steroidal anti-inflammatory agents or selective COX-2 inhibitors are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. In some patients with compromised renal function (e.g., elderly patients or patients who are volume-depleted, including those on diuretic therapy) who are being treated with NSAIDs, including selective COX-2 inhibitors, the co-administration of angiotensin II receptor antagonists or ACE inhibitors may result in a further deterioration of renal function, including possible acute renal failure.

These effects are usually reversible. These interactions should be considered in patients taking NSAIDs including selective COX-2 inhibitors concomitantly with diuretics and angiotensin II antagonists or ACE inhibitors. Therefore, the combination should be administered with caution, especially in the elderly.

🔄 Drug / Laboratory Test Interactions 19 words

Drug/Laboratory Test Interactions Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS , General ).

🤰 Pregnancy 120 words

Pregnancy Teratogenic Effects - Although reproduction studies performed with chlorothiazide doses of 50 mg/kg/day in rabbits, 60 mg/kg/day in rats and 500 mg/kg/day in mice revealed no external abnormalities of the fetus or impairment of growth and survival of the fetus due to chlorothiazide, such studies did not include complete examinations for visceral and skeletal abnormalities. It is not known whether chlorothiazide can cause fetal harm when administered to a pregnant woman; however, thiazides cross the placental barrier and appear in cord blood.

DIURIL should be used during pregnancy only if clearly needed (see INDICATIONS AND USAGE ). Nonteratogenic Effects - Chlorothiazide may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.

🧒 Pediatric Use 58 words

Pediatric Use There are no well-controlled clinical trials in pediatric patients. Information on dosing in this age group is supported by evidence from empiric use in pediatric patients and published literature regarding the treatment of hypertension in such patients (see DOSAGE AND ADMINISTRATION, Infants and Children ). _____________ **Calculations based on a human body weight of 50 kg

🧓 Geriatric Use 141 words

Geriatric Use Clinical studies of DIURIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see WARNINGS ).

🆘 Overdosage 114 words

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 chlorothiazide sodium is removed by hemodialysis has not been established. The oral LD 50 of chlorothiazide is 8.5 g/kg, greater than 10 g/kg, and greater than 1 g/kg, in the mouse, rat and dog, respectively.

🧬 Clinical Pharmacology 135 words

CLINICAL PHARMACOLOGY The mechanism of the antihypertensive effect of thiazides is unknown. DIURIL does not usually affect normal blood pressure. DIURIL affects the distal renal tubular mechanism of electrolyte reabsorption.

At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. DIURIL increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.

After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Pharmacokinetics and Metabolism DIURIL is not metabolized but is eliminated rapidly by the kidney. The plasma half-life of chlorothiazide is 45-120 minutes.

After oral doses, 10-15% of the dose is excreted unchanged in the urine. Chlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

📦 How Supplied / Storage and Handling 98 words

HOW SUPPLIED DIURIL ® (chlorothiazide) Oral Suspension, 250 mg of chlorothiazide per 5 mL, is a yellow, syrupy liquid, and is supplied as follows: NDC 65649-311-12 250 mg per 5 mL 237 mL Storage DIURIL (chlorothiazide) Oral Suspension: Keep container tightly closed. Protect from freezing, –20°C (–4°F) and store at room temperature, 15° to 30°C (59° to 86°F). Distributed by: Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA DIURIL is a registered trademark of Merck Sharp & Dohme Corp. used under license. © 2021 Salix Pharmaceuticals, Inc. or its affiliates Rev.

11/2021 9768400

📋 Description 125 words

DESCRIPTION DIURIL ® (chlorothiazide) is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 6 CIN 3 O 4 S 2 and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide.

It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. DIURIL Oral Suspension contains 250 mg of chlorothiazide per 5 mL, alcohol 0.4%, with methylparaben 0.1%, propylparaben 0.02%, and benzoic acid 0.1% added as preservatives. The inactive ingredients are D&C Yellow 10, flavors, glycerin, purified water, sodium saccharin, sucrose and tragacanth.

Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.