pharmacopeia
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/api/v1/drug/chlorothiazide

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.

Sodium Chloride Symporter

Indications

Sourced from openFDA
  • Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.ICD-10: I50.9, R60.9

Contraindications

Sourced from openFDA
  • Anuria. Hypersensitivity to any component of this product or to other sulfonamide-derived drugs.contraindicated

Dosage & administration

Sourced from openFDA

Chlorothiazide sodium for injection should be reserved for patients unable to take oral medication or for emergency situations. Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response. Intravenous use in infants and children has been limited and is not generally recommended. When medication can be taken orally, therapy with chlorothiazide tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route. Chlorothiazide sodium for injection may be given slowly by direct intravenous injection or by intravenous infusion. Extravasation must be rigidly avoided. Do not give subcutaneously or intramuscularly. The usual adult dosage is 500 mg to 1 g 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. Directions for Reconstitution Use aseptic technique. Because chlorothiazide sodium for injection contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded. Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection. Never add less than 18 mL. When reconstituted with 18 mL of Sterile Water, the final concentration of intravenous chlorothiazide sodium is 28 mg/mL.

Warnings & precautions

Sourced from openFDA

Intravenous use in infants and children has been limited and is not generally recommended. 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

Sourced from openFDA

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. Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia. Renal: Renal failure, renal dysfunction, interstitial nephritis, (see WARNINGS ); hematuria (following intravenous use). Urogenital: Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Pregnancy Category C: 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. Chlorothiazide 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.

Overdosage

Sourced from openFDA

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. 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 intravenous LD 50 of chlorothiazide in the mouse is 1.1 g/kg.

Approval history

Sourced from openFDA
  • Oct 6, 1961NDANDA011870Salix Pharms
  • Oct 16, 2009ANDAANDA090896Fresenius Kabi Usa
  • Jul 26, 2011ANDAANDA091546Sun Pharm
  • Apr 22, 2013ANDAANDA202561Am Regent
  • May 29, 2015ANDAANDA202462Sagent Pharms Inc
  • Oct 3, 2024ANDAANDA218630Gland

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Diuril, Oral Suspension, 250 mg/5mL (NDC 65649-311-12)To be discontinued
    Sponsor: Salix Pharmaceuticals, a division of Bausch Health US, LLC
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,268 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use836.5%
  2. 2Dyspnoea816.4%
  3. 3Pyrexia776.1%
  4. 4Diarrhoea725.7%
  5. 5Hypotension715.6%
  6. 6Drug Ineffective655.1%
  7. 7Pneumonia645.0%
  8. 8Respiratory Failure635.0%
  9. 9Pain594.7%
  10. 10Vomiting564.4%
  11. 11Death514.0%
  12. 12Cough473.7%
  13. 13Headache473.7%
  14. 14Renal Failure453.5%
  15. 15Condition Aggravated423.3%

Literature

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Recent PubMed references pinned to Chlorothiazide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 355 ClinicalTrials.gov registrations naming Chlorothiazide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Chlorothiazide work?
Mechanism-of-action class: Sodium Chloride Symporter Inhibitors.
What is Chlorothiazide used for?
According to FDA labeling, Chlorothiazide carries indications including: Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Chlorothiazide?
Chlorothiazide is classified as Thiazides, plain, Thiazide Diuretic, Sodium Chloride Symporter Inhibitors, Decreased Blood Pressure, Decreased Intravascular Volume, Increased Distal Tubule Cl- Excretion, Increased Distal Tubule H+ Excretion, Increased Distal Tubule HCO3- Excretion, Increased Distal Tubule K+ Excretion, Increased Distal Tubule Na+ Excretion, Increased Diuresis.
What are the brand names for Chlorothiazide?
Chlorothiazide is marketed under brand names including Diuril.
What are the contraindications for Chlorothiazide?
Chlorothiazide labeling lists contraindications including: Anuria. Hypersensitivity to any component of this product or to other sulfonamide-derived drugs.. Always consult the full prescribing information and a clinician.
Note. Data for chlorothiazide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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