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FLURA-DROPS
Overview
What is FLURA-DROPS?
Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are dye free. Each 4 drop dose of 2.21 mg (full strength) contains 1.0 mg of the fluoride ion (F-) from 2.21 mg sodium fluoride (NaF).
Each 4 drops for oral administration contains sodium fluoride equivalent to 1.0 mg of the fluoride ion and the following inactive ingredients: Purified Water USP, methylparaben and propylparaben.
What does FLURA-DROPS look like?
What are the available doses of FLURA-DROPS?
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What should I talk to my health care provider before I take FLURA-DROPS?
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How should I use FLURA-DROPS?
For once daily, self-administered, systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries. Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to 3 years of age and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.
Follow the directions for using this medication provided by your doctor. This medicine may be given undiluted or mixed with a non-dairy liquid.
What interacts with FLURA-DROPS?
Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under the age of 6 months.
Do not administer Fluoride Liquid (any strength) to pediatric patients under age 6 months.
What are the warnings of FLURA-DROPS?
Psychosis has been reported in sensitive individuals given anticholinergic drugs including hyoscyamine sulfate. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, anxiety, decreased anxiety, fatigue, insomnia, agitation and mannerisms and inappropriate affect. These CNS signs and symptoms usually resolve within 12 to 48 hours after discontinuation of the drug.
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
Keep out of the reach of children.
What are the precautions of FLURA-DROPS?
General:
Please refer to CONTRAINDICATIONS, WARNINGS,
and OVERDOSAGE
Drug Interactions:
Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.
Nursing Mothers:
It is not known if fluoride ion is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are administered to nursing women.
Pediatric Use:
The use of Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well-controlled studies on fluoride supplementation from birth through adolescence.
Geriatric Use:
Not indicated for use in geriatric patients.
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What are the side effects of FLURA-DROPS?
Allergic rash and other idiosyncrasies have rarely been reported.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What should I look out for while using FLURA-DROPS?
Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under the age of 6 months.
Do not administer Fluoride Liquid (any strength) to pediatric patients under age 6 months.
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
Keep out of the reach of children.
What might happen if I take too much FLURA-DROPS?
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 up to 24 hours. If less than 5 mg sodium fluoride/kg body weight (i.e. less than 2.3 mg sodium fluoride/lb body weight) has 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 sodium fluoride/kg of body weight (i.e. more than 6.9 mg sodium fluoride/lb of body weight), induce vomiting and seek emergency medical help.
How should I store and handle FLURA-DROPS?
Sorry No Records found
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sodium fluoride acts systemically (before tooth eruption) and topically (post eruption) by increasing tooth resistance to acid dissolution, by promoting remineralization, and by inhibiting the carcinogenic microbial process.
Non-Clinical Toxicology
Kirkman 2.21 mg Sodium Fluoride Liquid, Flura-Drops are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to pediatric patients under the age of 6 months.Do not administer Fluoride Liquid (any strength) to pediatric patients under age 6 months.
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using.
Keep out of the reach of children.
Life-Threatening Respiratory Depression
Discuss the risk of respiratory depression with patients, explaining that the risk is greatest when starting methadone hydrochloride oral concentrate or when the dose is increased . Advise patients how to recognize respiratory depression and to seek medical attention if they are experiencing breathing difficulties.
Symptoms of Arrhythmia
Instruct patients to seek medical attention immediately if they experience symptoms suggestive of an arrhythmia (such as palpitations, near syncope, or syncope) when taking methadone hydrochloride oral concentrate.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death . Instruct patients to take steps to store methadone hydrochloride oral concentrate securely. Advise patients to dispose of unused methadone hydrochloride oral concentrate by flushing down the toilet.
Abuse Potential
Inform patients that methadone hydrochloride oral concentrate contains methadone, a Schedule II controlled substance that is subject to abuse . Instruct patients not to share methadone hydrochloride oral concentrate with others and to take steps to protect methadone hydrochloride oral concentrate from theft or misuse.
Risks from Concomitant Use of Alcohol and other CNS Depressants
Inform patients that the concomitant use of alcohol with methadone can increase the risk of life-threatening respiratory depression. Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter drug products that contain alcohol, during treatment with methadone hydrochloride oral concentrate .
Inform patients that potentially serious additive effects may occur if methadone is used with other CNS depressants, and not to use such drugs unless supervised by a health care provider.
Instruct patients how to properly take methadone hydrochloride oral concentrate, including the following:
Serotonin Syndrome:
Inform patients that methadone hydrochloride oral concentrate could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications (see and ).
MAOI Interaction
Inform patients to avoid taking methadone hydrochloride oral concentrate while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking methadone hydrochloride oral concentrate .
Adrenal Insufficiency:
Inform patients that methadone hydrochloride oral concentrate could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms.
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in methadone hydrochloride oral concentrate. Advise patients how to recognize such a reaction and when to seek medical attention .
Neonatal Opioid Withdrawal
Advise women that if they are pregnant while being treated with methadone hydrochloride oral concentrate, the baby may have signs of withdrawal at birth and that withdrawal is treatable.
Lactation
Instruct nursing mothers using methadone hydrochloride oral concentrate to watch for signs of methadone toxicity in their infants, which include increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to their baby’s healthcare provider immediately if they notice these signs. If they cannot reach the healthcare provider right away, instruct them to take the baby to the emergency room or call 911 (or local emergency services) .
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
Please refer to CONTRAINDICATIONS, WARNINGS,
and OVERDOSAGE
Allergic rash and other idiosyncrasies have rarely been reported.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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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