Polythiazide

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Polythiazide
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]; Adeel Jamil, M.D. [3]

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Overview

Polythiazide is a thiazide diuretic that is FDA approved for the treatment of edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy and various forms of renal dysfunction; and hypertension.. Common adverse reactions include cardiac dysrhythmia, hypotension, disorder of glucose regulation, hypercalcemia, hyperuricemia, hypokalemia, hypomagnesemia hyponatremia, immune hypersensitivity reaction, systemic lupus erythematosus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Edema=

  • Dosing Information
  • Usual dosage: 1-4 mg PO qd
Antihypertensive
  • Dosing Information
  • Usual dosage: 2-4 mg PO qd

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Polythiazide in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Polythiazide in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Polythiazide in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Polythiazide in pediatric patients.

Contraindications

Anuria. Hypersensitivity to this or other sulfonamide derived drugs.

Warnings

Thiazides should be used 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. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs. 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.

PRECAUTIONS

Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals. All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance; namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop with thiazides as with any other potent diuretic, especially with brisk diuresis, when severe cirrhosis is present, or during concomitant use of corticosteroids or ACTH. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Digitalis therapy may exaggerate metabolic effects of hypokalemia especially with reference to myocardial activity. Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt except in rare instances when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice. Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy. Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Latent diabetes mellitus may become manifest during thiazide administration. Thiazide drugs may increase the responsiveness to tubocurarine. The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient. Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. If progressive renal impairment becomes evident, as indicated by a rising nonprotein nitrogen or blood urea nitrogen, a careful reappraisal of therapy is necessary with consideration given to withholding or discontinuing diuretic therapy. Thiazides may decrease serum PBI levels without signs of thyroid disturbance.

Adverse Reactions

Clinical Trials Experience

  • Gastrointestinal System Reactions
  • Central Nervous System Reactions
  • Hematologic Reactions
  • Dermatologic—Hypersensitivity Reactions
  • Cardiovascular Reaction
  • F. Other

Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.

Postmarketing Experience

There is limited information about the post marketing experience.

Drug Interactions

There is no FDA guidance on the use of Polythiazide with respect to specific drug interactions.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Thiazides cross the placental barrier and appear in cord blood. The use of thiazides in pregnant women requires that the anticipated benefit be weighed against possible hazards to the fetus. These hazards include fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.
Pregnancy Category (AUS): Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop nursing.

Labor and Delivery

There is no FDA guidance on use of Polythiazide during labor and delivery.

Nursing Mothers

Thiazides appear in breast milk. If use of the drug is deemed essential, the patient should stop nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Polythiazide in geriatric settings.

Gender

There is no FDA guidance on the use of Polythiazide with respect to specific gender populations.

Race

There is no FDA guidance on the use of Polythiazide with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Polythiazide in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Polythiazide in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Polythiazide in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Polythiazide in patients who are immunocompromised.

Administration and Monitoring

Administration

Therapy should be individualized according to patient response. This therapy should be titrated to gain maximal therapeutic response as well as the minimal dose possible to maintain that therapeutic response. The usual dosage of Renese tablets for diuretic therapy is 1 to 4 mg daily, and for antihypertensive therapy is 2 to 4 mg daily.

Monitoring

There is limited information about the drug monitoring.

IV Compatibility

There is limited information about the IV Compatibility.

Overdosage

There is limited information regarding Polythiazide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Polythiazide drugbox 01.png
Polythiazide
Systematic (IUPAC) name
6-chloro-2-methyl-3-{[(2,2,2-trifluoroethyl)thio]methyl}-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide
Identifiers
CAS number 346-18-9
ATC code C03AA05
PubChem 4870
Chemical data
Formula C11H13ClF3N3O4S3 
Mol. mass 439.88 g/mol
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

The mechanism of action results in an interference with the renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic potency. The mechanism whereby thiazides function in the control of hypertension is unknown.

Structure

Polythiazide drugbox 01.png

Pharmacodynamics

There is no FDA information on the use of Polythiazide with respect to pharmacodynamics.

Pharmacokinetics

There is no FDA information on the use of Polythiazide with respect to pharmacokinetics.

Nonclinical Toxicology

There is no FDA information on the use of Polythiazide with respect to nonclinical toxicology.

Clinical Studies

There is limited information regarding Polythiazide Clinical Studies in the drug label.

How Supplied

RENESE (polythiazide) Tablets are available as: 1 mg white, scored tablets in bottles of 100 (NDC 0069-3750-66). 2 mg yellow, scored tablets in bottles of 100 (NDC 0069-3760-66). 4 mg white, scored tablets in bottles of 100 (NDC 0069-3770-66).

Storage

There is limited information regarding Polythiazide Storage in the drug label.

Images

Drug Images

No image.jpg

Drug Name: Polythiazide
Ingredient(s): dibasic calcium phosphate, lactose, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, starch, vanillin
Imprint: Pfizer;375
Dosage: 1 mg
Color(s): White
Shape: Round
Size (mm): 7
Score: 2
NDC:0069-3750-66

Drug Label Author: Pfizer Labs

This pill image is provided by the National Library of Medicine's PillBox.
No image.jpg

Drug Name: Polythiazide
Ingredient(s): dibasic calcium phosphate, lactose, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, starch, vanillin
Imprint: Pfizer;376
Dosage: 2 mg
Color(s): Yellow
Shape: Round
Size (mm): 9
Score: 2
NDC:0069-3760-66

Drug Label Author: Pfizer Labs

This pill image is provided by the National Library of Medicine's PillBox.
No image.jpg

Drug Name: Polythiazide
Ingredient(s): dibasic calcium phosphate, lactose, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, starch, vanillin
Imprint: Pfizer;377
Dosage: 4 mg
Color(s): White
Shape: Round
Size (mm): 9
Score: 2
NDC:0069-3770-66

Drug Label Author: Pfizer Labs

This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

Polythiazide label 01.png
This image of the FDA label is provided by the National Library of Medicine.
Polythiazide panel 01.png
This image of the FDA label is provided by the National Library of Medicine.
Polythiazide panel 02.jpg
This image of the FDA label is provided by the National Library of Medicine.
Polythiazide panel 03.jpg
This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is no FDA guidance on the use of Polythiazide with respect to FDA Provided Patient Information.

Precautions with Alcohol

Alcohol-Polythiazide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Polythiazide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information about the Look-Alike Drug Names.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


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