Brand Name(s): Pivya^®

WHY is this medicine prescribed?

Pivmecillinam is used for the treatment of certain types of urinary tract infections (UTIs; infection of the bladder or kidney) in adult female patients. Pivmecillinam is in a class of medications called penicillins. It works by killing bacteria.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Pivmecillinam comes as a tablet to take by mouth. It is usually taken with or without food three times a day for 3 to 7 days. Take pivmecillinam at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pivmecillinam exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with pivmecillinam. If your symptoms do not improve or get worse, call your doctor.

Take pivmecillinam until you finish the prescription, even if you feel better. If you stop taking pivmecillinam too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking pivmecillinam,

• tell your doctor and pharmacist if you are allergic to pivmecillinam, penicillins; cephalosporin antibiotics such as cefaclor, cefadroxil, cefazolin (Ancef, Kefzol), cefdinir, cefditoren, cefepime (Maxipime), cefixime (Suprax), cefotaxime (Claforan), cefotetan, cefoxitin (Mefoxin), cefpodoxime, cefprozil, ceftaroline (Teflaro), ceftazidime (Fortaz, Tazicef, in Avycaz), ceftibuten, ceftriaxone, cefuroxime (Ceftin, Zinacef), and cephalexin (Keflex); any other medications; or any of the ingredients in pivmecillinam tablets. Ask your pharmacist for a list of the ingredients

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking pivmecillinam. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have carnitine deficiency from an inherited disorder (something you were born with) such as methylmalonic aciduria or propionic acidemia or porphyria (disorder resulting from build up of certain chemicals related to red blood cell proteins). Your doctor will probably tell you not to take pivmecillinam.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pivmecillinam, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Pivmecillinam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• diarrhea
• itching
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
• vaginal itching or thick, white vaginal discharge
• rash, itching, hives; difficulty breathing or wheezing
• extreme redness or peeling or blistering of skin or insides of the mouth
• dizziness, confusion, tiredness, muscle pains
• worrying, confusion, pain in stomach or legs or arms, muscle weakness or confusion

Pivmecillinam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the blister pack container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 20, 2024.