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Sodium fluoride/ potassium nitrate

Generic Name: sodium fluoride/potassium nitrate (SOE-dee-um FLUR-ide/po-TAS-ee-um NYE-trate)
Brand Name: PreviDent 5000 Sensitive

Sodium fluoride/ potassium nitrate is used for:

Preventing tooth decay. It is also used to help reduce painful sensitivity of the teeth to touch; sweets; or hot, cold, or acidic substances.

Sodium fluoride/potassium nitrate is a topical fluoride toothpaste. It works by strengthening the tooth enamel.

Do NOT use sodium fluoride/ potassium nitrate if:

  • you are allergic to any ingredient in sodium fluoride/potassium nitrate

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

Before using sodium fluoride/ potassium nitrate:

Some medical conditions may interact with sodium fluoride/potassium nitrate. 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 kidney problems

Some MEDICINES MAY INTERACT with sodium fluoride/potassium nitrate. However, no specific interactions with sodium fluoride/potassium nitrate are known at this time.

Ask your health care provider if sodium fluoride/potassium nitrate 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 sodium fluoride/ potassium nitrate:

Use sodium fluoride/potassium nitrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Use sodium fluoride/potassium nitrate in place of your regular toothpaste unless your doctor tells you otherwise.
  • Place at least a 1-inch strip of the paste onto a soft bristle toothbrush.
  • Brush the teeth thoroughly for at least 1 minute, then spit out the paste. Do NOT swallow. Rinse the mouth well. Spit out the rinse water.
  • Be sure to brush all sensitive areas of the teeth.
  • Use sodium fluoride/potassium nitrate on a regular schedule to get the most benefit from it.
  • Using sodium fluoride/potassium nitrate at the same time each day will help you remember to use it.
  • If you miss a dose of sodium fluoride/potassium nitrate, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use sodium fluoride/potassium nitrate.

Important safety information:

  • Do NOT use more than the recommended dose or use for longer than 4 weeks without checking with your doctor.
  • If your symptoms do not get better or if they get worse, check with your doctor.
  • Sodium fluoride/potassium nitrate may cause harm if a large amount is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Sodium fluoride/potassium nitrate should not be used in CHILDREN younger than 12 years old without checking with your doctor or dentist; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using sodium fluoride/potassium nitrate while you are pregnant. It is not known if this medicine is found in breast milk after topical use. If you are or will be breast-feeding while you use sodium fluoride/potassium nitrate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of sodium fluoride/ potassium nitrate:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody vomit; burning in the mouth; diarrhea; drooling; nausea; sore tongue; stomach pain or cramping; or vomiting.

Proper storage of sodium fluoride/potassium nitrate:

Store sodium fluoride/potassium nitrate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep sodium fluoride/potassium nitrate out of the reach of children and away from pets.

General information:

  • If you have any questions about sodium fluoride/potassium nitrate, please talk with your doctor, pharmacist, or other health care provider.
  • Sodium fluoride/potassium nitrate 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take sodium fluoride/potassium nitrate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. 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 sodium fluoride/potassium nitrate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to sodium fluoride/potassium nitrate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using sodium fluoride/potassium nitrate.

Issue Date: June 3, 2015