Pivmecillinam

Pivmecillinam is used to treat certain types of urinary tract infections in adult females.

Pivmecillinam may also be used for reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Pivmecillinam is usually taken 3 times per day for 3 to 7 days.

You may take pivmecillinam with or without food, but take it at the same time each day.

Your doctor will perform tests to make sure pivmecillinam is the right treatment for you.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Pivmecillinam will not treat a viral infection (flu or a common cold).

Call your doctor if your symptoms do not improve, or if they get worse.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Store this medicine in the original container at cool room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have any allergies.

You should not use pivmecillinam if you are allergic to pivmecillinam or similar medicines such as:

• carbapenem;
• penicillin; or
• a cephalosporin antibiotic (Keflex, Omnicef, and others).

You should not take pivmecillinam if you have:

• carnitine deficiency; or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Tell your doctor if you have or have ever had:

• low blood sodium;
• hypoglycemia;
• anxiety, confusion;
• stomach pain;
• seizures;
• tiredness;
• decreased muscle mass, muscle weakness or aches;
• if you take valproic acid, valproate, or use other drugs that cause carnitine deficiency; or
• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant.

This medicine may cause false results for isovaleric acidemia in the newborn if the mother takes this medicine during pregnancy. Tell the laboratory staff that you use pivmecillinam.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Pivmecillinam may cause serious side effects. Call your doctor right away if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it happens months after your last dose).

Common side effects of pivmecillinam may include:

• nausea; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Urinary Tract Infection:

Females aged 18 years and older: 185 mg (1 tablet) orally 3 times a day for 3 to 7 days, as clinically indicatedComments:-This drug should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.-When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. -In the absence of culture and susceptibility data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Use: For the treatment of uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus

Take the medicine as soon as you can, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, drinks, or activities.

Other drugs may affect pivmecillinam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.