Probenecid

Name: Probenecid

Uses of Probenecid

Probenecid is a prescription medication used to lower uric acid levels associated with gout and gouty arthritis and prevent attacks. Gout is a form of arthritis that causes attacks of sudden burning pain, stiffness, and swelling in a joint (usually a toe). It is also used to increase the effectiveness of some antibiotics.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What is probenecid?

Probenecid helps your body pass uric acid out through the urine, which lowers the levels of uric acid in the body.

Probenecid is used to treat gout and gouty arthritis. Probenecid is also sometimes given together with penicillin antibiotics to make them more effective.

Probenecid may also be used for other purposes not listed in this medication guide.

Advice to Patients

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a

  • Potential for drug to increase incidence of gouty arthritis attacks during therapy initiation.a b Continue probenecid during acute attacks, without changing dose, and add therapeutic dosages of colchicine or other anti-inflammatory agents.b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • Importance of informing patients of other important precautionary information.a (See Cautions.)

probenecid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Fast or irregular breathing
  • puffiness or swellings of the eyelids or around the eyes
  • shortness of breath, troubled breathing, tightness in chest, or wheezing
  • changes in the skin color of the face occurring together with any of the other side effects listed here
  • or skin rash, hives, or itching occurring together with any of the other side effects listed here

Check with your doctor as soon as possible if any of the following side effects occur:

Less common
  • Bloody urine
  • difficult or painful urination
  • lower back or side pain (especially if severe or sharp)
  • skin rash, hives, or itching (occurring without other signs of an allergic reaction)
Rare
  • Cloudy urine
  • cough or hoarseness
  • fast or irregular breathing
  • fever
  • pain in back and/or ribs
  • sores, ulcers, or white spots on lips or in mouth
  • sore throat and fever with or without chills
  • sudden decrease in the amount of urine
  • swelling of face, fingers, feet, and/or lower legs
  • swollen and/or painful glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow eyes or skin
  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
  • joint pain, redness, or swelling
  • loss of appetite
  • nausea or vomiting (mild)
Less common
  • Dizziness
  • flushing or redness of face (occurring without any signs of an allergic reaction)
  • frequent urge to urinate
  • sore gums

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

How is this medicine (Probenecid) best taken?

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

  • Take with or without food.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

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.

How do I store and/or throw out Probenecid?

  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take probenecid or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to probenecid. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Probenecid Tablets, USP

Probenecid Tablets, USP

500 mg

Rx only

Probenecid - Clinical Pharmacology

Probenecid is a uricosuric and renal tubular blocking agent. It inhibits the tubular reabsorption of urate, thus increasing the urinary excretion of uric acid and decreasing serum urate levels. Effective uricosuria reduces the miscible urate pool, retards urate deposition, and promotes resorption of urate deposits.

Probenecid inhibits the tubular secretion of penicillin and usually increases penicillin plasma levels by any route the antibiotic is given. A 2-fold to 4-fold elevation has been demonstrated for various penicillins.

Probenecid also has been reported to inhibit the renal transport of many other compounds including aminohippuric acid (PAH), aminosalicylic acid (PAS), indomethacin, sodium iodomethamate and related iodinated organic acids, 17 –ketosteroids, pantothenic acid, phenolsulfonphthalein (PSP), sulfonamides, and sulfonylureas. See also Drug Interactions.

Probenecid decreases both hepatic and renal excretion of sulfobromophtalein (BSP). The tubular reabsorption of phosphorus is inhibited in hypoparathyroid but not in euparathyroid individuals.

Probenecid does not influence plasma concentrations of salicylates, nor the excretion of streptomycin, chloramphenicol, chlortetracycline, oxytetracycline, or neomycin.

How is Probenecid Supplied

Probenecid Tablets, USP are available containing 500 mg of Probenecid, USP.

The tablets are capsule shaped, film-coated yellow, debossed LCI on one side and 1367 on the other side. They are available as follows:

NDC 10135-541-10 bottles of 1000 tablets

STORE AT 20˚ to 25˚C (68˚-77˚F) [See USP Controlled Room Temperature]

PROTECT FROM LIGHT.

Dispense in a well closed, light-resistant container using a child-resistant closure as defined in the USP.

MANUFACTURED BY
LANNETT COMPANY, INC.
PHILADELPHIA, PA 19136

DISTRIBUTED BY
MARLEX PHARMACEUTICALS, INC.
NEW CASTLE, DE 19720
Made in the USA

Revised 07/12, Revision 1 10-243

Pharmacology

Competitively inhibits the reabsorption of uric acid at the proximal convoluted tubule, thereby promoting its excretion and reducing serum uric acid levels; increases plasma levels of weak organic acids (penicillins, cephalosporins, or other beta-lactam antibiotics) by competitively inhibiting their renal tubular secretion

Absorption

Rapid and complete

Metabolism

Hepatic

Excretion

Urine

Onset of Action

Effect on penicillin levels: 2 hours; Uric acid renal clearance: 30 minutes

Time to Peak

Serum: 2 to 4 hours

Half-Life Elimination

Dose dependent: Normal renal function: 6 to 12 hours

Protein Binding

85% to 95%

Dosing Renal Impairment

GFR <30 mL/minute: Avoid use (reduced efficacy with renal impairment)

Note: Probenecid is not recommended as first-line urate-lowering therapy (ULT) monotherapy in patients with renal impairment (CrCl <50 mL/minute) (Khanna 2012).

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

(web3)