Paser

Generic name: Aminosalicylic Acid
Drug class: Aminosalicylates

What is Paser used for?

Paser is a prescription medicine that is used to treat TB (tuberculosis).

Description

PASER granules are a delayed release granule preparation of aminosalicylic acid (p-aminosalicylic acid; 4-aminosalicylic acid) for use with other anti-tuberculosis drugs for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli. The granules are designed for gradual release to avoid high peak levels not useful (and perhaps toxic) with bacteriostatic drugs. Aminosalicylic acid is rapidly degraded in acid media; the protective acid-resistant outer coating is rapidly dissolved in neutral media so a mildly acidic food such as orange, apple or tomato juice, yogurt or apple sauce should be used.

Aminosalicylic acid (p-aminosalicylic acid) is 4-Amino-2-hydroxybenzoic acid. PASER granules are the free base of aminosalicylic acid and do NOT contain sodium or a sugar. The molecular formula is C7H7NO3 with a molecular weight of 153.14. With heat p-aminosalicylic acid is decarboxylated to produce CO2 and m-aminophenol. If the airtight packets are swollen, storage has been improper. DO NOT USE if packets are swollen or the granules have lost their tan color and are dark brown or purple.

The structural formula is:

Paser

PASER granules are supplied as off-white tan colored granules with an average diameter of 1.5 mm and an average content of 60% aminosalicylic acid by weight. The acid resistant outer coating will be completely removed by a few minutes at a neutral pH. The inert ingredients are:

  • colloidal silicon dioxide
  • dibutyl sebacate
  • hydroxypropyl methyl cellulose
  • methacrylic acid copolymer
  • microcrystalline cellulose
  • talc

The packets contain 4 grams of aminosalicylic acid for oral administration three times a day by sprinkling on apple sauce or yogurt to be eaten without chewing. Suspension in an acidic fruit drink such as orange juice or tomato juice will protect the coating for at least 2 hours. Swirling the juice in the glass will help resuspend the granules if they sink.

Mechanism of Action

Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis. It inhibits the onset of bacterial resistance to streptomycin and isoniazid. The mechanism of action has been postulated to be inhibition of folic acid synthesis (but without potentiation with antifolic compounds) and/or inhibition of synthesis of the cell wall component, mycobactin, thus reducing iron uptake by M. tuberculosis.

Before taking Paser, tell your doctor:

  • If you are allergic to Paser; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have kidney disease.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Paser with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Paser?

  • Tell all of your health care providers that you take Paser. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Paser.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Do not use longer than you have been told. A second infection may happen.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye’s syndrome. Reye’s syndrome causes very bad problems to the brain and liver.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Paser while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Paser best taken?

Use Paser as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Mix in fruit punch or apple, cranberry, grape, grapefruit, orange, or tomato juice and drink.
  • Granules may be sprinkled on applesauce or yogurt. Do not chew.
  • Do not use if packet is swollen or granules are dark brown or purple.
  • Keep taking Paser as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of Paser that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Any unexplained bruising or bleeding.
  • Feeling confused.
  • Fever or chills.
  • Skin irritation.
  • Not hungry.
  • Very upset stomach or throwing up.
  • Severe diarrhea.
  • Shortness of breath.
  • A big weight loss.
  • Night sweats.
  • Swollen gland.
  • Sore throat.
  • Feeling very tired or weak.
  • Change in eyesight.

What are some other side effects of Paser?

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.
  • Upset stomach or throwing up.
  • Diarrhea.
  • You may see parts of Paser in your stool. This is normal and not a cause for concern.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Paser?

  • Store in a refrigerator or freezer. This medicine may be stored at room temperature for short periods of time.
  • Protect from heat.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

Principal Display Panel – 4g Carton Label

NDC 49938-107-04
PASER® Aminosalicylic Acid
Delayed-release Granules
4 Grams
30 Unit Dose Packets
STORE BELOW 59°F (15°C)
ALTERNATIVELY STORE IN A
REFRIGERATOR OR FREEZER
AVOID EXCESSIVE HEAT
Caution: Federal law prohibits dispensing without prescription

Principal Display Panel – 4g Carton Label

SRC: NLM .

Leave a Reply