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Logo OSSIPLEX RETARD® tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

OSSIPLEX RETARD® tablets

COMPOSITION:
Each sugar-coated, enteric coated, sustained release tablet contains:
Sodium Fluoride 25 mg
Ascorbic Acid 200 mg

PHARMACOLOGICAL CLASSIFICATION:
A. 24 Mineral substitutes

PHARMACOLOGICAL ACTION:
Sodium fluoride has been shown to increase the radiographic density of trabecular bone and to decrease the vertebral fracture rate through new bone formation by increased numbers of osteoblasts.

INDICATIONS:
OSSIPLEX RETARD is indicated in the management of patients with ESTABLISHED VERTEBRAL OSTEOPOROSIS, diagnosed either by the presence of a traumatic vertebral fracture and/or a markedly decreased spinal bone mineral density.

CONTRA-INDICATIONS:
Allergy to any of the ingredients of this preparation.
Osteomalacia and hyperparathyroid osteopathy.
Pregnancy and women of child-bearing age (unless safe contraceptive measures are used)
Impaired renal function.
Impaired liver function and blood dyscrasias.
Children and youths.

WARNINGS:
Patients on fluoride therapy MUST TAKE A CALCIUM SUPPLEMENT OF 1 g OF ELEMENTAL CALCIUM A DAY IN ORDER TO ENSURE ADEQUATE MINERALISATION OF THE NEWLY FORMED BONE. It isessential that the calcium compound and OSSIPLEX RETARD are given at different times, at least two hours apart. (See also interactions).
OSSIPLEX RETARD is not recommended as a prophylactic agent in patients with mild early bone loss and is also not the therapy of choice if osteoporosis affects predominantly the hip.
It is recommended that the decision to initiate therapy with OSSIPLEX RETARD be made on the advice of an expert in osteoporosis.

DOSAGE AND DIRECTIONS FOR USE:
Treatment with OSSIPLEX RETARD should only be initiated following bone mineral densitometry of the spine and hip, detailed radiological investigation, limited serum biochemistries (calcium, phosphate and alkaline phosphatase) and assessment by a Medical Practitioner acquainted with the management of osteoporosis.
It is essential to confirm the diagnosis of genuine osteoporosis (e.g. excluding hyperparathyroidism and osteomalacia) and to exclude secondary causes of osteoporosis (which may require therapy in its own right). OSSIPLEX RETARD should not be given merely on the basis of reduced bone density on an X-ray.
Sodium flouride has been shown to be effective and safe at a dose of 50 mg per day. The dose may be adjusted to the individual patient's weight, aiming at giving the dose nearest to 1 mg/kg/day of sodium fluoride. IN PRACTICE, THIS USUALLY AMOUNTS TO ONE OSSIPLEX RETARD TABLET IN THE MORNING AND ONE IN THE EVENING. Tablets should be swallowed whole (i.e. not chewed) with a little liquid after meals.
THE RECOMMENDED DOSAGE REGIMEN CONSISTS OF ALTERNATING CYCLES OF 3 MONTHS ON OSSIPLEX RETARD THERAPY FOLLOWED BY 3 MONTHS OFF OSSIPLEX THERAPY. THE TOTAL TREATMENT PERIOD IS USUALLY BETWEEN 3 AND 5 YEARS.
Should bone density decline again following cessation of treatment, another course of OSSIPLEX RETARD may be given, but not sooner than 2 years after the first. In addition to the calcium supplement, patients not regularly exposed to sunlight should also be given a vitamin D supplement to ensure intestinal absorption of calcium. There is a latent period of about one year before densitometric improvement is demonstrable. Therefore densitometry needs to be performed only once a year. A reduction in the vertebral fracture rate may be expected only from the second year onwards.
It is important to note that not all patients respond to sodium fluoride and that 15-25% may show no increase in bone density. Bone density (spine, hip) should therefore be measured annually and if bone density of the spine has not improved after 2 years, continuation of therapy should be reconsidered. Radiographs of the spine should also be taken periodically (e.g. every 2 years) to assess fracture rate.
OSSIPLEX RETARD has no pain-relieving activity and is not indicated in the management of acute vertebral fracture.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS
Gastro-intestinal symptoms (e.g. nausea or epigastric discomfort) may occasionally occur at the beginning of treatment. These may subside spontaneously in the course of time. After several months treatment, osteoarticular pain and swelling may occur in the ankle and knee region. These complaints may be due to stress fractures and should be treated as such. OSSIPLEX RETARD should be discontinued until symptoms resolve.

PRECAUTIONS:
Caution is advised when OSSIPLEX RETARD is used by patients with a history of peptic ulcer or hiatus hernia.

MEDICINE INTERACTIONS:
Calcium, aluminium and magnesium containing medicines (e.g. antacids) should not be ingested with OSSIPLEX RETARD. At least two hours must elapse between ingestion of these substances and OSSIPLEX RETARD.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sodium fluoride is corrosive; when taken by mouth in quantities in excess of about 250 mg it causes salivation, nausea and vomiting, epigastric pain and diarrhoea. Large doses cause thirst, perspiration, paralysis, muscular weakness and clonic convulsions, followed by respiratory and cardiac failure; there may be renal failure; death may occur within 2-4 hours.
Empty the stomach by aspiration and lavage with lime water of a 1% solution of calcium chloride or other calcium salt. Calcium gluconate injection, 10 mL of a 10% solution may be given intravenously to control convulsions and repeated every 4 to 6 hours if needed. The circulation should be maintained by infusion of suitable electrolyte solution. Respiration may require assistance. Haemodialysis has been used.

IDENTIFICATION:
White sugar-coated tablets.

PRESENTATION:
Packs of 60 tablets. (6 aluminium/aluminium blisterpack strips of 10 tablets each).

STORAGE INSTRUCTIONS:
Store in a cool, dark place, preferably, in the unit carton (below 25°C). KEEP OUT OF REACH OF CHILDREN AND MOISTURE

REGISTRATION NUMBER:
W/3.2/0223

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
Co. Reg. No.: 04/00252/06
7 Fairclough Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
FEBRUARY, 1997

PRODUCT UNDER LICENCE FROM GEBRO-FIEBERBRUNN, AUSTRIA

                30007 AO/132/1-99 H

Updated on this site: November 2000

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