Methenamine; Sodium Salicylate Tablets

What is this medication?

METHENAMINE; SODIUM SALICYLATE (meth EN a meen; SOE dee um sa LIS i late) relieves symptoms caused by irritation of the urinary tract, such as pain, burning, and passing frequent small amounts of urine. It will not treat a urinary tract infection (UTI). This product contains a salicylate.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): AZO Urinary Tract Defense, Cystex, CYSTEX PLUS, URO-PAIN

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Dehydration
• Diet low in salt
• Frequently drink alcohol
• Gout
• Heart disease
• High blood pressure
• Kidney disease
• Liver disease
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to methenamine, sodium salicylate, NSAIDs, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the label. You can take it with or without food. If it upsets your stomach, take it with food.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use. It should only be used as needed.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir
• Ketorolac
• Probenecid

This medication may also interact with the following:

• Alcohol
• Certain medications for diabetes
• Certain medications for gout
• Certain medications that prevent and treat blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Diuretics
• Other NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• Steroid medications, such as prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. If you need to use this medication for more than 3 days, talk to your care team.

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

Do not take other medications that contain aspirin, ibuprofen, or naproxen with this medication. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medications contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This medication can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Smoking, drinking alcohol, older age, and poor health can also increase risks. Call your care team right away if you have stomach pain or blood in your vomit or stool.

Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team if you are pregnant before taking this medication. Taking this medication between weeks 20 and 30 of pregnancy may harm your unborn baby. Your care team will monitor you closely if you need to take it. After 30 weeks of pregnancy, do not take this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Rash, fever, and swollen lymph nodes

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Headache
• Loss of appetite
• Nausea
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.