Product Monograph - Fluotic
INDICATIONS
Non-surgical cases
In patients with diagnosed neurosensorial hearing loss or tinnitus due to otospongiosis, especially if accompanied by a positive Schwartze sign indicating a vascular active focus.
In patients with postural imbalance and/or vertigo caused by a lesion of the posterior labyrinth consecutive to otospongiosis and in patients with radiologically demonstrated demineralization of the cochlear capsule.
Post-surgical cases
In patients where, following surgery, a soft vascular focus is encountered at the oval window or when the patients begins to experience progressive neurosensorial deterioration after successful stapedectomy.
CONTRAINDICATIONS
Since the safety of FLUOTIC® (sodium fluoride) has not been established in pregnant women, in children and adolescents up to 18 years old, FLUOTIC® should not be used in these patients.
FLUOTIC® is also contraindicated in severe renal insufficiency and in patients with an active peptic ulcer.
WARNINGS
FLUOTIC® (sodium fluoride) is not intended for dental use. FLUOTIC® should preferably be prescribed with a daily supplement of calcium and vitamin D.
Control of patients
It is important to make periodic examinations of patients as follows:
S Clinical examination of patients should be made every 6 to 12 months along with a renal function test and a serum fluoride determination;
S Radiological examination to exclude the possibility of fluorosis should be made every two years;
S Clinical experience has shown that the optimum sodium fluoride serum level should be between 8 to 12 :mol/L.
ADVERSE EFFECTS
FLUOTIC® (sodium fluoride), at the recommended dosage, is usually well tolerated. Mild reactions consisting of gastro-intestinal complaints, musculoskeletal pain and skin rash may occur.
OVERDOSE: SYMPTOMS & TREATMENT
Symptoms of acute fluoride poisoning are as follows: initial symptoms are secondary to the local action of fluoride on the mucosa of the gastro-intestinal tract. Salivation, nausea, abdominal pain, vomiting and diarrhea are frequent. Systemic symptoms are varied and severe. The patient shows signs of increasing irritability of the nervous system, including paresthesias, a positive Chvostek sign, hyperactive reflexes, and tonic and clonic convulsions.
These signs are related to the calcium-binding effect of fluoride. Hypocalcemia and hypoglycemia are frequent laboratory findings. The signs may be delayed for several hours. Pain in various muscle groups may occur. The blood pressure falls, presumably due to central vasomotor depression as well as a direct toxic action on cardiac muscle. The respiratory center is first stimulated and later depressed. Death usually results from either respiratory paralysis or cardiac failure. It is stated that the lethal dose of sodium fluoride for man is about 5 g; however, recovery has been reported in patients ingesting much larger doses, whereas a dose as low as 2 g has been fatal. In children, as little as 0.5 g of sodium fluoride may be fatal.
Treatment
The principles of the treatment of fluoride poisoning are as follows:
- 1. Act quickly.
- 2. Start intravenous therapy with glucose in isotonic saline solution to maintain blood sugar and to have a venous channel available for transfusion in the event of shock. 3. Wash the stomach with limewater (0.15% calcium hydroxide solution) and then give limewater at frequent intervals.
- 4. Have calcium gluconate available for intravenous administration and watch closely for signs of tetany.
- 5. Maintain high urine volumes with parenteral fluid.
DOSAGE AND ADMINISTRATION
The average dose of FLUOTIC® (sodium fluoride) is one tablet of 20 mg three times a day with meals.
Clinical experience with sodium fluoride in osteoporosis, multiple myeloma and ostopongiosis has shown that best results can be achieved by the addition of a calcium salt and of vitamin D.
The addition of calcium, preferably calcium carbonate, 2 to 3 grams a day, is of prime importance since the use of sodium fluoride alone has been associated with a fall of serum calcium and hyperparathyroidism. The net result is osteomalacia and increased bone resorption which may negate any beneficial effect that fluoride may have on bone formation. The effect of fluoride alone on bone is well known. Stimulation of osteoblastic bone formation occurs but in the absence of additional calcium, the bone is incompletely mineralized.
Recalcification of the focus is the indication to reduce the dosage to a maintenance level, while continued or increased activity as shown by polytomography, positive Schwartze sign and neurosensorial loss progression are the indications to continue treatment or to increase the dosage.
AVAILABILITY
Each red, enteric film-coated tablet, imprinted with the Nordic logo, contains 20 mg of sodium fluoride.
Non-medicinal ingredients: colloidal silicon dioxide, diethyl phthalate, lactose monohydrate, microcrystalline cellulose, Opadry orange YS-1-6215 and stearic acid. Gluten-free. Bottles of 100 tablets.
CHEMISTRY
Cubic or tetragonal crystals soluble in water and insoluble in alcohol.
PHARMACOLOGY
Sodium fluoride is rapidly and almost completely absorbed from the gastro-intestinal tract.
Certain cations such as calcium, magnesium, aluminium and iron retard the absorption of fluoride ion by forming low-solubility complexes in the gastro-intestinal tract.
Fluoride can be detected in all organs and tissues and especially in bones, thyroid, aorta and kidney. Fluoride is predominantly deposited in the skeleton and teeth and the degree of skeletal storage is related to age and intake. 50% of a given dose is excreted in the urine while the rest forms a chemical bond with bone.