Luride – Fluoride Tablets

by | Nov 22, 2011 | FDA | 1 comment

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From www.Drugs.com

What is Luride?

Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.

Luride  is used as a medication to prevent tooth decay in people that have a low level of fluoride in their drinking water. Luride is also used to prevent tooth decay in people who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.

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

What is the most important information I should know about Luride?

You should not use Luride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using Luride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use Luride, or you may need special tests while you are using it.

Do not take Luride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

What should I discuss with my healthcare provider before taking Luride?

You should not use Luride if the level of fluoride in your drinking water is greater than 0.7 parts per million (ppm).

Before using Luride, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use Luride, or you may need special tests while you are using it.

Talk to your doctor and dentist before taking Luride  if you are pregnant or could become pregnant during treatment. Talk to your doctor and dentist before taking Luride if you are breast-feeding. The American Dental Association’s Council on Dental Therapeutics recommends the use of Luride by children up to 13 years of age; the American Academy of Pediatrics recommends fluoride supplementation by children until the age of 16 years of age. Do not give a 1-mg tablet to a child younger than 3 years old, or when your drinking water fluoride content is equal to or greater than 0.3 ppm.

How should I take Luride?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medicine with a full glass of water. Do not take Luride with milk or other dairy products. Calcium can make it harder for your body to absorb fluoride.

Suck on the Luride lozenge until it dissolves completely in your mouth. Do not chew the lozenge or swallow it whole.

The chewable forms of Luride  can be chewed, swallowed, dissolved in the mouth, added to drinking water or fruit juice, or added to water for use in infant formula or other food.

The Luride drops can be taken by mouth undiluted, or mixed with fluid or food.

If you mix Luride with food or water, drink or eat this mixture right away. Do not save it for later use.

It is important to take Luride regularly to get the most benefit.

Store Luride at room temperature away from moistureand heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).

What should I avoid while taking Luride?

Do not take fluoride with milk, other dairy products, or calcium supplements. Calcium can make it harder for your body to absorb fluoride.

Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Many antacids contain calcium, which can interfere with fluoride absorption.

Luride (fluoride) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of the following side effects:

  • discolored teeth;
  • weakened tooth enamel; or
  • any changes in the appearance of your teeth.

Less serious side effects may include:

  • stomach upset;
  • headache; or
  • weakness.

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.

Side Effects of Luride – for the Consumer

Luride Chewable Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Luride Chewable Tablets. Seek medical attention right away if any of these SEVERE side effects occur when using Luride Chewable Tablets:

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.

Luride Drops

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Luride Drops. Seek medical attention right away if any of these SEVERE side effects occur when using Luride Drops:

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.

This is from the St. John’s Providence Health System website:

What side effects may I notice from receiving this medicine? (sodium fluoride = Luride)

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • black, tarry stools
  • burning mouth, sore tongue
  • discolored teeth
  • pain in the bones or joints

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • nausea, vomiting
  • stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do NOT use Luride Chewable Tablets if:

  • you are allergic to any ingredient in Luride Chewable Tablets
  • your drinking water has a fluoride content greater than 0.6 parts per million (ppm)

Contact your doctor or health care provider right away if any of these apply to you.
Except under special circumstances, this medication should not be used when the following medical conditions exist:
Arthralgia or{27}{39}
Gastrointestinal ulceration{08}{27}{40}    (conditions may be exacerbated, especially with high doses)

Renal insufficiency, severe{05}{08}    (condition may be exacerbated; may lead to higher blood levels of fluoride due to a decrease in excretion of fluoride; dosage reduction may be necessary {36})

  1. Spencer H, Kramer L, Gatza C, Norris C, Wiatrowski E, Gandhi V. Fluoride metabolism in patients with chronic renal failure. Arch Int Med 1980; 140: 1331-5.

***

Richard Sauerheber says:

Note that Luride pills apparently contain 1 mg of sodium fluoride (NaF), approximately the same amount of fluoride in 1.4 liters of water, the low amount of water that some people drink.

For a person to take a Luride pill each day, he or she will have to visit a doctor and get a prescription, which will instruct him not to take the pill if he or she reside in a water district where the fluoride level is .7 ppm or greater.

On the other hand a person may drink any amount of fluoridated water with no prescription and with no instruction as to who should not consume the water nor how much water one may consume nor for how long one may drink such fluoridated water.

These guidelines come from www.Drugs.com, which in turn come from the Physicians Desk Reference, which is a compendium of FDA opinions.

For some reason – probably political pressure – the FDA has not placed the same limits on consumption of fluoridated drinking water as it has on Luride.

The FDA should issue a statement: If you want to consume fluoride, go to your physician, get checked out, get a prescription for Luride, and consume it until the prescription runs out. We have approved the cautious consumption of pharmaceutical grade sodium fluoride under a doctor’s supervision. We have not approved drinking water fluoridation.

 ***

Professof Sauerheber also says:

The FDA allows Luride to be given by prescription. Luride is not banned, and that is synonymous with being approved. But according to letters FDA sent to New Jersey Assemblyman John V. Kelly in 1995, Luride was never actually officially approved by FDA through proper application/approval procedures. It was complicated by the fact that the drug had been in use prior to 1962 without FDA approval, which was not legally required then. Unfortunately FDA allows the material to remain on the market because FDA devotes its efforts primarily to evaluate new products. Kelly wrote, “It should boggle one’s mind that the inability to demonstrate safety and effectivenes of fluorides to the FDA has gone unnoticed by those proposing fluoridating water, but after many years in the legislature nothing surprises me anymore.”

The Goodman and Gilman’s Pharmacologic Basis of Therapeutics listing for Luride is in agreement with those who feel the FDA approves the use of Luride by prescription limited by required dosage instructions. For those who feel Luride has never been formally approved and is not FDA approved, then the evidence for that is found in the fact that sodium fluoride is not listed as an approved drug in the U.S. Pharmacopia. One can argue either position. I would assume there are some at the FDA who think it was once approved, and many who think it was never approved, and some who think it was once approved but is not now, and so on.

It’s a mess, but of course all agree that Luride is not approved by anyone for over the counter use. Currently, pharmacies sell Luride only by prescription.We are all hoping the FDA will finally definitely take a stand make up their mind officially, and settle all this.

1 Comment

  1. Daron Gramolini

    Most people will have some problem with allergies or allergic reactions at some point in their lives. Allergic reactions can range from mild and annoying to sudden and life-threatening. Most allergic reactions are mild, and home treatment can relieve many of the symptoms. An allergic reaction is more serious when severe allergic reaction (anaphylaxis) occurs, when allergies cause other problems (such as nosebleeds, ear problems, wheezing, or coughing), or when home treatment doesn’t help.

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