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Hydrochlorothiazide
Overview
What is Microzide?
MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is CHClNOS; its molecular weight is 297.74; and its structural formula is:
It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
MICROZIDE is supplied as 12.5 mg capsules for oral use.
Inactive ingredients:
What does Microzide look like?
What are the available doses of Microzide?
Sorry No records found.
What should I talk to my health care provider before I take Microzide?
Sorry No records found
How should I use Microzide?
MICROZIDE is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, MICROZIDE may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy:
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 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 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.
For Control of Hypertension:
What interacts with Microzide?
Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
What are the warnings of Microzide?
Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, aof the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is thein the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population (adapted from refs. 2 and 3 with the author's permission). For further information, the reader is referred to a text on epidemiological methods.
Acute Myopia and Secondary Angle-Closure Glaucoma:
Diabetes and Hypoglycemia:
Renal Disease:
What are the precautions of Microzide?
Electrolyte and Fluid Balance Status:
Warning signs or symptoms of fluid and electrolyte imbalance include 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, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroid or adrenocorticotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis. Hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium rich foods.
Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricemia:
Impaired Hepatic Function:
Parathyroid Disease:
Drug Interactions
Alcohol, barbiturates, or narcotics -
Antidiabetic drugs -
Other antihypertensive drugs -
Cholestyramine and colestipol resins -
Corticosteroid, ACTH –
Pressor amines (e.g., norepinephrine) -
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) -
Lithium -
Non-steroidal anti-inflammatory drugs -
Drug/Laboratory Test Interactions -
Carcinogenesis, Mutagenesis, Impairment of Fertility
in vitro
Salmonella typhimurium
in vivo
Drosophila
in vitro
Aspergillus nidulans
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.
Pregnancy:
Array
Pregnancy Category B:
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Array
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Array
Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue hydrochlorothiazide, taking into account the importance of the drug to the mother.
Array
Pediatric Use:
Safety and effectiveness in pediatric patients have not been established.
Elderly Use:
A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e., > 65 years) with hydrochlorothiazide. Starting treatment with the lowest available dose of hydrochlorothiazide (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.
What are the side effects of Microzide?
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:
Cardiovascular:
Digestive:
Hematologic:
Hypersensitivity:
Metabolic:
Musculoskeletal:
Nervous System/Psychiatric:
Renal:
Skin:
Special Senses:
Urogenital:
Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
What should I look out for while using Microzide?
Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.
Acute Myopia and Secondary Angle-Closure Glaucoma:
Diabetes and Hypoglycemia:
Renal Disease:
What might happen if I take too much Microzide?
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 LD of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.
How should I store and handle Microzide?
Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3MICROZIDE (hydrochlorothiazide, USP) Capsules 12.5 mg are #4 Teal Opaque/Teal Opaque two piece hard gelatin capsules imprinted with MICROZIDE and 12.5 mg in black ink. They are supplied in bottles of 100 with child resistant closures (NDC 52544-622-01).Dispense in a tight, light-resistant container as defined in the USP.Keep out of reach of children.Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.Rx onlyFor all medical inquiries contact:WATSONMedical Communications Parsippany, NJ 07054 USA800-272-5525Manufactured By:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIADistributed By:Watson Pharma, Inc.Parsippany, NJ 07054 USARevised: October 2011174783-3
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrochlorothiazide is well absorbed (65% to 75%) following oral administration. Absorption of hydrochlorothiazide is reduced in patients with congestive heart failure.
Peak plasma concentrations 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 MICROZIDE 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.
Non-Clinical Toxicology
Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.Acute Myopia and Secondary Angle-Closure Glaucoma:
Diabetes and Hypoglycemia:
Renal Disease:
Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol sulfate.
Albuterol sulfate should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic anti-depressants or within 2 weeks of discontinuation of such agents, since the action of albuterol on the vascular system may be potentiated.
Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.
The ECG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics.
Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
Electrolyte and Fluid Balance Status:
Warning signs or symptoms of fluid and electrolyte imbalance include 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, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroid or adrenocorticotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis. Hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium rich foods.
Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricemia:
Impaired Hepatic Function:
Parathyroid Disease:
Drug Interactions
Alcohol, barbiturates, or narcotics -
Antidiabetic drugs -
Other antihypertensive drugs -
Cholestyramine and colestipol resins -
Corticosteroid, ACTH –
Pressor amines (e.g., norepinephrine) -
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) -
Lithium -
Non-steroidal anti-inflammatory drugs -
Drug/Laboratory Test Interactions -
Carcinogenesis, Mutagenesis, Impairment of Fertility
in vitro
Salmonella typhimurium
in vivo
Drosophila
in vitro
Aspergillus nidulans
Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.
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:
Cardiovascular:
Digestive:
Hematologic:
Hypersensitivity:
Metabolic:
Musculoskeletal:
Nervous System/Psychiatric:
Renal:
Skin:
Special Senses:
Urogenital:
Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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