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Phos-Flur
Overview
What is Phos-Flur?
Phos-Flur® Gel contains 0.5% fluoride ion (F-) from 1.1% sodium fluoride in an aqueous gel containing 0.1 molar phosphate, pH 5.1. For daily self-topical use as a dental caries preventative in adults and pediatric patients age 6 years and over. This prescription product is not a dentifrice.
What does Phos-Flur look like?
What are the available doses of Phos-Flur?
Sorry No records found.
What should I talk to my health care provider before I take Phos-Flur?
Sorry No records found
How should I use Phos-Flur?
A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride in an acidulated gel is safe and extraordinarily effective as a caries preventive in orthodontic patients when applied frequently with mouthpiece applicators. Phos-Flur® Gel in a squeeze tube is a particularly convenient dosage form which permits the application of a thin ribbon of gel onto a toothbrush as well as a mouthpiece tray.
Follow these instructions unless otherwise instructed by your dental professional:
What interacts with Phos-Flur?
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
What are the warnings of Phos-Flur?
There are no adequate and well-controlled studies of fluconazole in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed to high dose maternal fluconazole (400 to 800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus (see ).
What are the precautions of Phos-Flur?
General
Laboratory tests indicate that repeated use of acidulated phosphate fluoride topical gel may cause dulling of porcelain and ceramic restorations unless protected from contact. Do not place in porcelain or glass containers. Not for systemic treatment. DO NOT SWALLOW.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a study conducted in rodents, no carcinogenesis was found in male and female mice and female rats treated with fluoride at dose levels ranging from 4.1 to 9.1 mg/kg of body weight. Equivocal evidence of carcinogenesis was reported in male rats treated with 2.5 and 4.1 mg/kg of body weight. In a second study, no carcinogenesis was observed in rats, males or females, treated with fluoride up to 11.3 mg/kg of body weight. Epidemiological data provide no credible evidence for an association between fluoride, either naturally occurring or added to drinking water, and risk of human cancer.
Fluoride ion is not mutagenic in standard bacterial systems. It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and rodent cells at doses much higher than those to which humans are exposed. data are conflicting. Some studies report chromosome damage in rodents, while other studies using similar protocols report negative results.
Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated. Adverse effects on reproduction were reported for rats, mice, fox, and cattle exposed to 100 ppm or greater concentrations of fluoride in their diet or drinking water. Other studies conducted in rats demonstrated that lower concentrations of fluoride (5 mg/kg of body weight) did not result in impaired fertility and reproductive capabilities.
Pregnancy
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.
Pediatric Use
The use of Phos-Flur® Gel in pediatric age groups 6 to 16 years 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. Safety and effectiveness in pediatric patients below the age of 6 years have not been established. Please refer to the and sections.
Geriatric Use
Of the total number of subjects in clinical studies of 1.1% (w/v) sodium fluoride, 15 percent were 65 and over, while 1 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, 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 patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What are the side effects of Phos-Flur?
Contact with abraded or sensitive gingival tissue may produce discomfort. Allergic reactions and other idiosyncrasies have been rarely reported.
What should I look out for while using Phos-Flur?
Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.
Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.
What might happen if I take too much Phos-Flur?
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.
A treatment dose (a thin ribbon) of Phos-Flur® Gel contains approximately 1.31 mg fluoride. One 1.8 oz. net wt. tube contains approximately 247 mg fluoride.
How should I store and handle Phos-Flur?
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.ArrayStore at 20-25°C (68-77°F) [see USP Controlled Room Temperature].ArrayManufactured by:Hi-Tech Pharmacal Co., Inc.Amityville, NY 11701Made in U.S.A.Array1.8 oz. (56 g) net wt. plastic tubes.Mint: NDC 0126-0131-66
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 pediatric patients under age 6 years unless recommended by a dentist or physician.Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.
Specific drug interaction studies have not been conducted with Levofloxacin Ophthalmic Solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
Laboratory tests indicate that repeated use of acidulated phosphate fluoride topical gel may cause dulling of porcelain and ceramic restorations unless protected from contact. Do not place in porcelain or glass containers. Not for systemic treatment. DO NOT SWALLOW.
Contact with abraded or sensitive gingival tissue may produce discomfort. Allergic reactions and other idiosyncrasies have been rarely 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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