Citric acid and potassium citrate

You should not use this medication if you are allergic to it, or if you have certain conditions. Be sure your doctor knows if you have:

• high levels of potassium in your blood (hyperkalemia);

• a serious heart rhythm disorder called ventricular fibrillation;

• kidney failure with sodium loss;

• Addison's disease (an adrenal gland disorder);

• a large tissue injury such as a severe burn; or

• if you are severely dehydrated.

You should not take citric acid and potassium citrate tablets if you have problems with your esophagus, stomach, or intestines that make it difficult for you to swallow or digest pills.

Before using citric acid and potassium citrate, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;

• if you are taking a "potassium-sparing" diuretic (water pill) such as amiloride (Midamor, Moduretic), spironolactone (Aldactone, Aldactazide), triamterene (Dyrenium, Dyazide, Maxzide).

• a urinary tract infection;

• untreated or uncontrolled diabetes;

• a peptic ulcer in your stomach;

• congestive heart failure, enlarged heart, or history of heart attack;

• other heart disease or high blood pressure;

• diabetes;

• a blockage in your stomach or intestines; or

• chronic diarrhea (such as ulcerative colitis, Crohn's disease).

If you have any of these conditions, you may need a dose adjustment or special tests to safely take citric acid and potassium citrate.

It is not known whether this medication is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether potassium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include numbness and tingling, confusion, heavy feeling in your arms or legs, muscle weakness, limp feeling, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• severe stomach pain, ongoing diarrhea or vomiting;

• black, bloody, or tarry stools;

• coughing up blood;

• fast, slow, or uneven heart rate;

• muscle weakness, pain, or twitching;

• numbness or tingly feeling in your hands or feet, or around your mouth;

• confusion, anxiety, weakness, mood changes, or feeling irritable;

• swelling in your ankles or feet; or

• seizure (convulsions).

Less serious side effects may include:

• mild nausea, vomiting, or upset stomach;

• mild or occasional diarrhea; or

• appearance of a citric acid and potassium citrate tablet in your stool.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

The following drugs can interact with citric acid and potassium citrate. Tell your doctor if you are using any of these:

• eplerenone (Inspra);

• candesartan (Atacand), losartan (Cozaar, Hyzaar), valsartan (Diovan), or telmisartan (Micardis);

• quinidine (Quinaglute, Quinidex, Quin-Release);

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

• any type of diuretic (water pill) such as bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), indapamide (Lozol), metolazone (Mykrox, Zarxolyn), or torsemide (Demadex).

This list is not complete and there may be other drugs that can interact with citric acid and potassium citrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Swelling of belly.
• Very upset stomach or throwing up.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain.
• Loose stools (diarrhea).
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of citric acid / potassium citrate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.