Sodium fluoride; potassium nitrate is a prescription topical toothpaste containing fluoride and a sensitivity agent, potassium nitrate. It is approved for use in adults and children 12 years and older. Sodium fluoride; potassium nitrate should not be used in children younger than 12 years of age unless recommended by a health care provider.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Sodium fluoride; potassium nitrate is applied to the teeth in the form of toothpaste, gel, or cream.
-Advise patients to rinse their mouth after each use.
-Advise patients to not swallow or ingest sodium flouride; potassium nitrate.
Monograph content under development
There are little data regarding the effects of fluoride on human pregnancy; however, studies conducted in areas with high levels of fluoridated water showed no increase in birth defects. Additionally, animal studies have not shown fluoride to be teratogenic or otherwise cause an increase in birth defects. Heavy exposure during in utero development may lead to skeletal fluorosis, which becomes apparent in childhood.
It is not known whether sodium fluoride; potassium nitrate is excreted in breast milk. When used as directed, significant absorption of sodium fluoride or potassium nitrate is not expected by the mother or the breast-feeding infant. Reduced milk production was reported in foxes when the animals were fed a diet containing a high concentration of fluoride. No adverse effects on parturition, lactation, or offspring were seen in rats that were given fluoride.
Fluoride is primarily eliminated by the kidney, and the risk of fluoride toxicity may be greater in patients with renal impairment. Use caution when selecting a dose, and consider monitoring renal function.
For the treatment of dentin desensitization and dental caries prophylaxis:
Topical dosage (1.1% sodium fluoride and 5% potassium nitrate dental paste):
Adults, Adolescents, and Children 12 years or older: Use twice daily. Apply at least 1 inch to a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, expectorate and rinse mouth thoroughly.
Maximum Dosage Limits:
-Adults
2 topical oral applications/day. Do not swallow. -Geriatric
2 topical oral applications/day. Do not swallow. -Adolescents
2 topical oral applications/day. Do not swallow. -Children
12 years of age: 2 topical oral applications/day. Do not swallow.
Less than 12 years of age: Safe and effective use has not been established.
-Infants
Safe and effective use has not been established.
-Neonates
Safe and effective use has not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Sodium Fluoride; Potassium Nitrate products.
Mechanism of Action:-Sodium Fluoride: Fluoride available in the oral cavity plays a part in the prevention of tooth decay. Fluoride in saliva has a small bactericidal action. Saliva provides a buffering action that neutralizes plaque acids. If plaque acids are not neutralized, demineralization of the tooth occurs. Once the buffering action restores plaque pH, remineralization can take place. This is the critical point at which fluoride is essential. Minerals deposited as fluoroapatite in surface tooth enamel are more resistant to erosion than hydroxyapatite. These new surfaces contain few pits and fissures, further reducing likely spots for decay. When dentin is exposed, possibly as a result of receding gums, it is sensitive to external stimuli. Application of topical sodium fluoride allows for insoluble material to be deposited in the dental tubules, blocking the transmission of unpleasant stimuli.
-Potassium Nitrate: Potassium nitrate inhibits nerve impulse transmission to prevent discomfort caused by exposed dentin.
Sodium fluoride; potassium nitrate is applied topically to the teeth. Absorption of improperly swallowed toothpaste containing fluoride can be significant. Fluoride can be detected in all tissues and organs throughout the body but does not accumulate in non-calcified tissue. Teeth represent a small repository of fluoride because of their relatively small mass. Most of the fluoride in teeth is concentrated in dental enamel, and secondly at the dentinoenamel junction. Fluoride in teeth is not readily released. Excretion of fluoride is mainly renal with small amounts excreted in the feces. About 90% is filtered by the glomerulus, with reabsorption by the renal tubules.