DrugindexOnline^{2nd edition}

Generic Name: Aminosalicylic Acid Controlled-Release Granules Packet (ah-MEE-no-SAL-ih-sill-ik)
Brand Name: Paser

Paser Controlled-Release Granules Packet is used for:

Treating tuberculosis (TB) in combination with other medicines. It is most commonly used in patients with Multi-drug-resistant TB (MDR-TB) or in situations in which therapy with isoniazid and rifampin is not possible due to a combination of resistance and/or intolerance.

Paser Controlled-Release Granules Packet is an anti-TB agent. It works by blocking the growth and reproduction of the TB bacteria.

Do NOT use Paser Controlled-Release Granules Packet if:

• you are allergic to any ingredient in Paser Controlled-Release Granules Packet
• you are a child with a viral infection (such as the flu or chickenpox)
• you have severe kidney disease

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paser Controlled-Release Granules Packet:

Some medical conditions may interact with Paser Controlled-Release Granules Packet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a viral infection (eg, the flu, chickenpox), liver problems, kidney problems, or certain nutritional problems
• if you are a child with a brain aneurysm or stroke, Kawasaki syndrome, or rheumatic disease

Some MEDICINES MAY INTERACT with Paser Controlled-Release Granules Packet. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Vitamin B₁₂ because effectiveness may be decreased by Paser Controlled-Release Granules Packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paser Controlled-Release Granules Packet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paser Controlled-Release Granules Packet:

Use Paser Controlled-Release Granules Packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Sprinkle granules on acidic food (eg, applesauce, yogurt) or mix with tomato, orange, grapefruit, grape, cranberry, or apple juice or fruit punch. Ask your doctor if you are unsure whether you can take Paser Controlled-Release Granules Packet with a certain food or drink.
• If you mix Paser Controlled-Release Granules Packet in juice and the granules sink to the bottom, swirl the juice to mix the granules before taking it. Take Paser Controlled-Release Granules Packet within 2 hours of mixing.
• Do not chew the granules.
• Do not use Paser Controlled-Release Granules Packet if the packet is swollen or if the granules have lost their tan color and have turned dark brown or purple. Inform your doctor or pharmacist immediately and return the medication.
• Take Paser Controlled-Release Granules Packet regularly to receive the most benefit from it. Taking Paser Controlled-Release Granules Packet at the same time each day will help you remember to take it.
• If you miss a dose of Paser Controlled-Release Granules Packet, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Paser Controlled-Release Granules Packet.

Important safety information:

• It may take several weeks for Paser Controlled-Release Granules Packet to work. Do not stop using Paser Controlled-Release Granules Packet without checking with your doctor.
• Paser Controlled-Release Granules Packet is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).
• It is important to use Paser Controlled-Release Granules Packet for the full course of treatment. Failure to do so may decrease the effectiveness of Paser Controlled-Release Granules Packet and increase the risk that the bacteria will no longer be sensitive to Paser Controlled-Release Granules Packet and will not be able to be treated by this or certain other antibiotics in the future.
• Long-term or repeated use of Paser Controlled-Release Granules Packet may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
• If you take Paser Controlled-Release Granules Packet for longer than one month you may need to take a vitamin B₁₂ supplement. Talk with your doctor for more information.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Paser Controlled-Release Granules Packet.
• Paser Controlled-Release Granules Packet may affect certain lab test results. Make sure lab personnel and your doctors know you use Paser Controlled-Release Granules Packet.
• The shells of the granules may be seen in the stool. This is normal and not a cause for concern.
• Diabetes patients - Paser Controlled-Release Granules Packet may cause incorrect test results with some urine ketone tests. Check with your doctor before you adjust the dose of your diabetes medicine or change your diet.
• LAB TESTS, including liver function and blood counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Paser Controlled-Release Granules Packet, discuss with your doctor the benefits and risks of using Paser Controlled-Release Granules Packet during pregnancy. Paser Controlled-Release Granules Packet is excreted in breast milk. If you are or will be breast-feeding while you are using Paser Controlled-Release Granules Packet, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Paser Controlled-Release Granules Packet:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dark urine; fainting; fast or irregular heartbeat; fever; loss of appetite; lower back pain; mental or mood changes; severe or persistent nausea or diarrhea; severe right-sided stomach pain; sluggish movement or speech; sore throat or chills; sweating; tremors; unusual bruising or bleeding; unusual or severe drowsiness; unusual tiredness or weakness; vision changes; yellowing of the eyes and skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Paser Controlled-Release Granules Packet:

Store Paser Controlled-Release Granules Packet in a refrigerator or freezer below 59 degrees F (15 degrees C). Packets may also be stored at room temperature for short periods of time. Avoid excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Paser Controlled-Release Granules Packet out of the reach of children and away from pets.

General information:

• If you have any questions about Paser Controlled-Release Granules Packet, please talk with your doctor, pharmacist, or other health care provider.
• Paser Controlled-Release Granules Packet is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paser Controlled-Release Granules Packet. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.