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Sodium Fluoride
Overview
What is FLUORIDEX?
Fluoridex toothpaste is a self-applied topical fluoride dentifrice containing 1.1% (w/w) sodium fluoride for the prevention and control of dental caries, and 5% (w/w) Potassium Nitrate for relief of tooth sensitivity.
Sensitivity Relief:
Sensitivity Relief SLS Free
What does FLUORIDEX look like?
What are the available doses of FLUORIDEX?
• Sensitivity Relief: Green toothpaste containing 1.1% Sodium Fluoride, 5% Potassium Nitrate (Mint). (3)
• Sensitivity Relief SLS Free: Green toothpaste containing 1.1% Sodium Fluoride, 5% Potassium Nitrate (Mint). (3)
What should I talk to my health care provider before I take FLUORIDEX?
8.1 Pregnancy
Pregnancy Category B It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissues. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Maternal exposure to 12.2 mg fluoride/kg of body weight (rats) or 13.1 mg/kg of body weight (rabbits) did not affect the litter size or fetal weight and did not increase the frequency of skeletal or visceral malformations. There are no adequate or well controlled clinical studies in pregnant women. However, epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Heavy exposure to fluoride during in utero development may result in skeletal fluorosis which becomes evident in childhood.
8.3 Nursing Mothers
It is not known if fluoride is excreted in human milk. However, many drugs are excreted in milk, and caution should be exercised when products containing fluoride are administered to a nursing woman. Reduced milk production was reported in farm-raised fox when the animals were fed a diet containing a high concentration of fluoride (98-137 mg/kg of body weight). No adverse effects on parturition, lactation, or offspring were seen in rats administered fluoride up to 5 mg/kg of body weight.
8.4 Pediatric Use
The use of Fluoridex toothpaste in children age 6-16 as a caries preventive is supported by pioneering clinical studies with 1.1% sodium fluoride gels in mouth trays in students age 11-14 years conducted by Englander, et al.2-4 Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Prescribing physicians and dentists should consider total fluoride exposure (dental care plus food, water, and other sources) when prescribing the product for use in children. Please refer to the CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS sections.
8.5 Geriatric Use
Subjects referenced in clinical studies of 1.1% (w/v) sodium fluoride, included 15 percent age 65 and over, with 1 percent age 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger clients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in clients with impaired renal function. Because elderly clients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
How should I use FLUORIDEX?
Fluoridex toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries.
• Follow these instructions or use as instructed by a dental professional.• Adults and children age 6 or older, apply a thin ribbon or pea-sized amount of Fluoridex toothpaste to a toothbrush and brush thoroughly on all tooth surfaces for at least one minute.
After use:
• Adults should expectorate. For best results, do not eat, drink, or rinse for 30 minutes.
• Children, age 6 to 16, should expectorate after use and rinse mouth thoroughly.
• Use twice daily as your normal dentifrice or as directed by your dental professional.
What interacts with FLUORIDEX?
Sorry No Records found
What are the warnings of FLUORIDEX?
Sorry No Records found
What are the precautions of FLUORIDEX?
Sorry No Records found
What are the side effects of FLUORIDEX?
Sorry No records found
What should I look out for while using FLUORIDEX?
Do not use in children under 12 years of age unless recommended by a dentist or physician.
What might happen if I take too much FLUORIDEX?
Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5 mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5 mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg of body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.
How should I store and handle FLUORIDEX?
Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). 4 oz. (112 g) net wt. tube• Sensitivity Relief NDC 59883-031-04• Sensitivity Relief SLS Free NDC 59883-030-04Store at controlled room temperature 15°-30° C (59°-86° F)4 oz. (112 g) net wt. tube• Sensitivity Relief NDC 59883-031-04• Sensitivity Relief SLS Free NDC 59883-030-04Store at controlled room temperature 15°-30° C (59°-86° F)4 oz. (112 g) net wt. tube• Sensitivity Relief NDC 59883-031-04• Sensitivity Relief SLS Free NDC 59883-030-04Store at controlled room temperature 15°-30° C (59°-86° F)4 oz. (112 g) net wt. tube• Sensitivity Relief NDC 59883-031-04• Sensitivity Relief SLS Free NDC 59883-030-04Store at controlled room temperature 15°-30° C (59°-86° F)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
A treatment dose (a thin ribbon) of Fluoridex 5000 ppm sodium fluoride toothpaste contains 2.5 mg fluoride. A 4 oz. tube contains 566 mg fluoride.
Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.
Non-Clinical Toxicology
Do not use in children under 12 years of age unless recommended by a dentist or physician.Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents.
Antagonism has been demonstrated between clindamycin and erythromycin . Because of possible clinical significance, these two drugs should not be administered concurrently.
DO NOT SWALLOW.
• Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
• Prolonged daily ingestion may result in various degrees of dental fluorosis in children with developing dentition, especially if the water fluoridation exceeds 0.6 ppm, since younger children frequently cannot perform the brushing process without significant swallowing.
• Use in children under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis.
• Read directions carefully before using.
• Keep out of reach of infants and children.
• Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
• See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician.
Allergic reactions and other idiosyncrasies have rarely been reported.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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