Apresazide

(Generic versions may still be available.)

DRUG DESCRIPTION

WARNING

This fixed-combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static but must be reevaluated as conditions in each patient warrant.


Hydralazine HCI and hydrochlorothiazide is an antihypertensive-diuretic combination available as capsules for oral administration. Hydralazine HCI and hydrochlorothiazide capsules of 25 mg /25 mg contain 25 mg of hydralazine hydrochloride USP and 25 mg of hydrochlorothiazide USP; capsules of 50 mg /50 mg contain 50 mg of hydralazine hydrochloride USP and 50 mg of hydrochlorothiazide USP; and capsules of 100 mg /50 mg contain 100 mg of hydralazine hydrochloride USP and 50 mg of hydrochlorothiazide USP.

Each tablet also contains the following inactive ingredients: Corn starch, crospovidone, gelatin, lactose monohydrate, pharmaceutical glaze, sodium starch glycolate, stearic acid, talc, and titanium dioxide. In addition, the 25 mg/25 mg capsule contains ammonium hydroxide, ethylene glycol monoethyl ether, propylene glycol and synthetic black iron oxide; the 50 mg/50 mg capsule contains FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, synthetic red iron oxide and pharmaceutical shellac; and the 100 mg/50 mg capsule contains D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol and synthetic black iron oxide. Hydralazine hydrochloride is 1 hydrazinophthalazine monohydrochloride.

Hydralazine hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275 C with decomposition, and has a molecular weight of 196.64. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2.4-benzothiadiazine-7-sulfonamide 1 ,1 -dioxide. Chemical structure is as follows:

Hydrochlorothiazide USP is a white, or practically white, practically odorless crystalline powder. It is freely soluble in sodium hydroxide solution, in butylamine, and in dimethylformamide; sparingly soluble in methanol: slightly soluble in water: and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.75. Chemical structure is as follows:

What are the precautions when taking hydralazine and hydrochlorothiazide (Apresazide)?

Before taking this product, tell your doctor or pharmacist if you are allergic to it; or to similar diuretics (such as chlorthalidone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: inability to make urine (anuria), a certain heart condition (coronary heart disease), a certain heart valve problem (rheumatic heart disease of the mitral valve).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems, kidney problems, liver problems,...

Read All Potential Precautions of Apresazide


Apresazide Consumer (continued)

SIDE EFFECTS: Headache, pounding/fast heartbeat, dizziness, loss of appetite, nausea, vomiting, diarrhea, or abdominal pain may occur as your body adjusts to the medication. You may also experience decreased sexual ability or increased sensitivity to the sun. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may infrequently cause nerve problems. Tell your doctor promptly if you experience numbness or tingling. Your doctor may recommend a vitamin B6 supplement (pyridoxine).

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe tiredness, aching/swollen joints, rash on nose and cheeks, swollen glands, change in the amount of urine, bloody/pink urine, dark urine, yellowing eyes/skin, signs of infection (such as fever, chills, persistent sore throat), decrease in vision, eye pain, easy bruising/bleeding.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) or salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or salt/mineral loss: very dry mouth, thirst, muscle cramps/weakness, irregular heartbeat, unusual drowsiness, unusual decrease in the amount of urine, fainting, confusion, seizures.

Seek immediate medical attention if this rare but serious side effect occurs: chest/jaw/left arm pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to it; or to similar diuretics (such as chlorthalidone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: inability to make urine (anuria), a certain heart condition (coronary heart disease), a certain heart valve problem (rheumatic heart disease of the mitral valve).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel problems, kidney problems, liver problems, asthma, diabetes, lupus, gout, previous stroke, salt/mineral imbalance (such as imbalance of sodium/potassium/calcium/magnesium levels in the body), loss of too much body water (dehydration).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may reduce the potassium levels in your blood. Ask your doctor about increasing the amount of potassium in your diet or about using a salt substitute that contains potassium. Your doctor may prescribe a potassium supplement.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Older adults may be more sensitive to the side effects of this medication, especially dizziness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.



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