Captopril and hydrochlorothiazide

What is Captopril and Hydrochlorothiazide?

• Captopril and hydrochlorothiazide (Capozide) is combination of captopril and hydrochlorothiazide is used to treat high blood pressure.
• Captopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors.
• Hydrochlorothiazide is in a class of medications called diuretics ('water pills').

Captopril structure

Captopril ball-and-stick model

Hydrochlorothiazide

What are the uses of this medicine?

• Captopril and hydrochlorothiazide (Capozide) is indicated for the treatment of hypertension.
• This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.

How does this medicine work?

Captopril:

• Captopril (kap' toe pril) was the first ACE inhibitor to be approved for use in the United States and is still widely used for therapy of hypertension and heart failure.
• Like other ACE inhibitors, captopril inhibits the conversion of angiotensin I, a relatively inactive molecule, to angiotensin II which is the major mediator of vasoconstriction and volume expansion induced by the renin-angiotensin system.
• Other enzymes besides that which converts angiotensin I to II may also be inhibited, which may account for some of the side effects of the ACE inhibitors.

Hydrochlorothiazide:

• Thiazides affect the renal tubular mechanism of electrolyte reabsorption.
• At maximal therapeutic dosage all thiazides are approximately equal in their diuretic potency.
• Thiazides increase excretion of sodium and chloride in approximately equivalent amounts.
• Natriuresis causes a secondary loss of potassium and bicarbonate.
• The mechanism of the antihypertensive effect of thiazides is unknown.
• Thiazides do not affect normal blood pressure.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitive to captopril or any other angiotensin-converting enzyme inhibitor.
• anuria
• hypersensitivity to hydrochlorothiazide or other sulfonamide-derived drugs.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• valsartan and sacubitril (Entresto) or if you have stopped taking it within the last 36 hours.
• amphotericin B (Ambisome, Amphotec, others)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as indomethacin (Indocin, Tivorbex)
• calcium supplements
• cancer chemotherapy medications
• cholestyramine (Prevalite)
• colestipol (Colestid)
• digoxin (Lanoxin)
• insulin or oral medications for diabetes
• lithium (Lithobid)
• medications for gout such as probenecid (Probalan)
• medications that suppress the immune system such as methenamine (Hiprex, Urex)
• monoamine oxidase (MAO) inhibitors such as phenelzine (Nardil) and tranylcypromine (Parnate)
• nitrates such as isosorbide dinitrate (Isordil, in Bidil), isosorbide mononitrate (Monoket), and nitroglycerin (Nitro-Dur, Nitrostat, others)
• oral steroids such as dexamethasone , methylprednisolone (Medrol), and prednisone (Rayos)
• other diuretics
• other medications for high blood pressure
• pain medications
• phenobarbital (Luminal)
• potassium supplements

Is this medicine FDA approved?

• Captopril was approved for use in the United States in 1981 and current indications are for hypertension, congestive heart failure, left ventricular dysfunction after myocardial infarction, and treatment and prevention of diabetic nephropathy.

How should this medicine be used?

Recommended dosage:

• This fixed combination drug may be used as initial therapy or substituted for previously titrated doses of the individual components.
• When captopril and hydrochlorothiazide are given together it may not be necessary to administer captopril in divided doses to attain blood pressure control at trough (before the next dose).
• Also, with such a combination, a daily dose of 15 mg of hydrochlorothiazide may be adequate.
• Treatment may, therefore, be initiated with Captopril and Hydrochlorothiazide tablets 25 mg/15 mg once daily.
• For patients insufficiently responsive to the initial dose, additional captopril or hydrochlorothiazide may be added as individual components or by using Captopril and Hydrochlorothiazide tablets 50 mg/15 mg, 25 mg/25 mg or 50 mg/25 mg, or divided doses may be used.
• Because the full effect of a given dose may not be attained for 6 to 8 weeks, dosage adjustments should generally be made at 6 week intervals, unless the clinical situation demands more rapid adjustment.
• In general, daily doses of captopril should not exceed 150 mg and of hydrochlorothiazide should not exceed 50 mg.

Administration:

• The combination of captopril and hydrochlorothiazide comes as a tablet to take by mouth.
• It is usually taken once or twice a day on an empty stomach, 1 hour before meals.
• To help you remember to take captopril and hydrochlorothiazide, take it around the same time(s) every day.
• Your doctor may start you on a low dose of captopril and hydrochlorothiazide and gradually increase your dose, not more than once every 6 to 8 weeks.
• Captopril and hydrochlorothiazide controls high blood pressure but does not cure it.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Captopril and Hydrochlorothiazide Tablets, USP 25 mg/25 mg

This medicine is available in fallowing brand namesː

• Capozide

What side effects can this medication cause?

The most common side effects of this medicine include:

• proteinuria
• renal insufficiency
• renal failure
• nephrotic syndrome
• polyuria
• oliguria
• urinary frequency
• Neutropenia/agranulocytosis
• anemia
• thrombocytopenia
• pancytopenia
• Rash
• pruritus, and sometimes with fever
• arthralgia
• eosinophilia
• Hypotension
• Tachycardia
• chest pain
• palpitations
• Angina pectoris
• myocardial infarction
• Raynaud's syndrome
• congestive heart failure
• Dysgeusia
• Angioedema
• Cough

What special precautions should I follow?

• Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy.
• Patients should be told to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of neutropenia, or of progressive edema which might be related to proteinuria and nephrotic syndrome.
• All patients should be cautioned that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume.
• Patients should be advised not to use potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes without consulting their physician.
• Patients should be warned against interruption or discontinuation of medication unless instructed by the physician.
• Heart failure patients on captopril therapy should be cautioned against rapid increases in physical activity.
• Patients should be informed that Captopril and Hydrochlorothiazide tablets should be taken one hour before meals
• Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril. Swelling confined to the face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuation of treatment; some cases required medical therapy.
• Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor.
• Neutropenia (< 1000/mm3) with myeloid hypoplasia has resulted from use of captopril. In general, neutrophils returned to normal in about two weeks after captopril was discontinued, and serious infections were limited to clinically complex patients.
• In general, neutrophils returned to normal in about two weeks after captopril was discontinued, and serious infections were limited to clinically complex patients.
• Total urinary proteins greater than 1 g per day were seen in about 0.7 percent of patients receiving captopril. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria.
• ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women.
• Thiazides should be used with caution in severe renal disease. 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Captopril overdose:

• hypotension

Hydrochlorothiazide overdose:

• lethargy
• coma
• dehydration
• Gastrointestinal irritation
• hypermotility
• increase in BUN

Management of overdosage: In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Captopril:

• Correction of hypotension would be of primary concern.
• Volume expansion with an intravenous infusion of normal saline is the treatment of choice for restoration of blood pressure.
• While captopril may be removed from the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the circulation of neonates or children.
• Peritoneal dialysis is not effective for removing captopril; there is no information concerning exchange transfusion for removing captopril from the general circulation.

Hydrochlorothiazide:

• In addition to gastric lavage and supportive therapy for stupor or coma, symptomatic treatment of gastrointestinal effects may be needed.
• The degree to which hydrochlorothiazide is removed by hemodialysis has not been clearly established.
• Measures as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function should be instituted.

Can this medicine be used in pregnancy?

• ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women.
• The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CAPTOPRIL
• HYDROCHLOROTHIAZIDE

Inactive ingredients:

• ANHYDROUS LACTOSE
• COLLOIDAL SILICON DIOXIDE
• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• CELLULOSE, MICROCRYSTALLINE
• STARCH, CORN
• SODIUM LAURYL SULFATE
• FD&C YELLOW NO. 6

Who manufactures and distributes this medicine?

• Mylan Pharmaceuticals Inc.
• Morgantown, WV

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from moisture.

• Dailymed label info on Captopril and hydrochlorothiazide
• FDA Captopril and hydrochlorothiazide

Captopril and hydrochlorothiazide Resources
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Common ACE inhibitors include the following:

• Benazepril
• Captopril
• Enalapril
• Fosinopril
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Trandolapril