Consumer Health
CDR Fortos
Product Name
CDR Fortos®.
Name and strength of active ingredients
Each effervescent tablet contains:
Calcium (in form of calcium carbonate 1,500 mg) 600 mg (75% Thai RDI)
Vitamin D3 400 I.U. (200% Thai RDI
Product description
Orange white to reddish white, speckled, cylindrical biplane tablets with an odour of orange.
Pharmacodynamics/Pharmacokinetics
Pharmacodynamics
Calcium is the most abundant mineral found in our body. It is indispensable for the growth and development of bones. The skeleton contains 99% of the body’s calcium stores. Long term calcium deficiency can cause osteoporosis, a disease of low bone mass, weaker bone and many symptoms
i.e. back pain, kyphosis, loss of height and fractures. An adequate supply of calcium is therefore very important during growth, pregnancy and lactation, in old age and especially in menopausal period.
Vitamin D3 increases calcium absorption from small intestine. It regulates the calcium and
phosphate content of body uids. It is important for maintaining normal blood calcium levels, contributes to the growth of the bone matrix and ensures normal calcification. Requirements of Vitamin D3 are increased during growth, pregnancy and lactation, in old age and menopausal. CDR Fortos helps to strengthen the bones through ages, prevent osteoporosis which may happen in later of life and promotes healing of fractures.
CDR Fortos in effervescent form is easily solubilized. Vitamin D3 in CDR Fortos helps increase calcium absorption.
Pharmacokinetics
Human health and well-being is naturally dependent on the continuous uptake and management of vitamins and trace elements and their absorption, distribution,metabolism and elimination are maintained by specific physiological mechanisms. As the effervescent tablet, it is completely or already dissolved in the gastro-intestinal tract, a good availability of these compounds is assured. The pharmacokinetic properties of the individual components of this product have been extensively documented.
Calcium In the stomach, calcium ions are released as a function of pH. Calcium administered as
calcium carbonate is absorbed to 20 - 30% and the absorption takes place mainly in the duodenum through vitamin D-dependent, saturable, active transport. Calcium is eliminated in urine, feces and sweat. The urinary calcium excretion is a function of glomerular filtration and tubular reabsorption of calcium.
Vitamin D Vitamin D is absorbed in the small intestine and bound to specific alpha globulins and
transported to the liver where it is metabolized to 25-hydroxy-cholecalciferol. A second hydroxylation to 1, 25-dehydroxy-cholecalciferol occurs in the kidney. This metabolite is responsible for the vitamin’s ability to increase the absorption of calcium. Not metabolized vitamin D is stored in tissues such as fat and muscle. Vitamin D is eliminated via feces and urine.
Indications
• To prevent osteoporosis in various causes, i.e. postmenopausal period, aging, corticosteroid
induced osteoporosis.
• For the treatment of osteoporosis caused by calcium deficiency.
• To prevent osteomalacia (softening of the bones).
• As a supplement to meet increased calcium and vitamin D needs, particularly during growth periods (childhood, adolescence), during pregnancy and breast-feeding, during fractures, in old age and menopausal period.
Recommended dose
Take one effervescent tablet daily, or as recommended by the doctor.
Mode of administration
Dissolved in a glass of water (at least 200 mL), the tablet provides a pleasant orange- avored drink. Recommend to drink immediately after dissolution is completed. Since the level of CO2 will decrease during the period of time, and will cause the calcium precipitation.
The effervescent tablets contain aspartame, sorbitol and sucrose esters of fatty acids. It is suitable for diabetics.
Contraindications
• Known hypersensitivity to any ingredient in the drug product
• Hypercalcaemia and/or conditions resulting in hypercalcaemia such as sarcoidosis, malignancy,
and primary hyperthyroidism
• Severe hypercalciuria
• Impaired renal function
• Existing Hypervitaminosis D
• Nephrolithiasis
Warnings and Precautions
• The recommended dosage must not be exceeded. Overdose of calcium and vitamin D is associated with increased adverse effects including hypercalcaemia and/or hypercalciuria. Care should be taken not to exceed a total intake of 2,500 mg of calcium and 4,000 IU of vitamin D from all sources including dietary.
• Patients receiving other single vitamins or multivitamin preparations, containing vitamin D and/or calcium, any other medication or those under medical care must consult a health care professional before taking this medicinal product.
• This product must not be taken by patients with phenylketonuria since the product contains a
source of phenylalanine (aspartame).
• During long-term treatment with calcium + vitamin D combination product, the serum and urinary calcium levels, and kidney function must be monitored through measurements of serum creatinine, especially in elderly patients and concomitant treatment with cardiac glycosides, calcium channel blockers, and/or thiazide diuretics.
• The combination product must be used with caution in immobilized patients, owing to an
increased risk of hypercalcaemia.
• Must not be taken by patients suffering from hereditary fructose intolerance, glucose-galactose
malabsorption or sucrase isomaltase insu ciency.
• This product contains sodium. To be taken into consideration by patients on a controlled
sodium diet.
Interactions with other medicaments
Manifold potential interactions are reported in the literature for the single ingredients. Thus patients receiving any other medication or those under medical care should consult a physician or health care professional before taking this medicinal product.
Drug-interactions
Calcium:
Divalent cations such as calcium form complexes with certain substances resulting in decreased absorption of both substances. Because these interactions occur in the GI tract, taking calcium separately from other drugs should minimize the potential for interaction. It is usually su cient to separate intake of these drugs by at least 2 hours before or 4 - 6 hours after calcium supplementation, unless otherwise specified.
Substances that form complexes include:
• Antibiotics and antivirals (e.g. Tetracyclines, Quinolones, Protease Inhibitors).
• Levothyroxine; Patients should take levothyroxine at least 4 hours before or 4 hours after
calcium supplementation.
• Phosphates, biphosphonates and fluorides; Patients should take bisphosphonates at least 30
minutes before calcium, but preferably at a different time of day.
• Eltrombopag.
Calcium and/or Vitamin D:
• Thiazide diuretics: Thiazide diuretics reduce the urinary excretion of calcium. Due to an increased risk of hypercalcemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
• Cardiac glycosides and Calcium Channel Blockers: Hypercalcemia increases the risk of fatal cardiac arrhythmias with cardiac glycosides such as digoxin and reduces effectiveness of calcium channel blockers such as verapamil in atrial fibrillation. It is recommended to monitor serum calcium levels, in people taking calcium and/or vitamin D and these medications, concurrently.
Vitamin D:
Some medication may decrease the gastro-intestinal absorption of vitamin D. Separation of intake between these medications and vitamin D by at least 2 hours before or 4-6 hours after vitamin D should minimize this interaction.
Such medications include:
• Ion exchange resins e.g. cholestyramine.
• Laxatives e.g. mineral oil, stimulant laxative such as senna.
• Orlistat.
• Carbamazepine, phenytoin or barbiturates: Carbamazepine, phenytoin, or barbiturates increase
metabolism of vitamin D to its inactive metabolite reducing the effect of vitamin D3.
Food/ Supplement interactions Calcium:
• Oxalic acid, phytic acid: Oxalic acid, found in spinach and rhubarb, and phytic acid, found in whole cereals may inhibit calcium absorption. It is not recommended to take calcium products within 2 hours of eating foods containing high oxalic acid and phytic acid concentrations.
• Iron, Zinc, Magnesium: Calcium supplements may decrease the absorption of dietary iron, zinc, and magnesium. This might be a factor in people at high risk for deficiency of these minerals. Patient at risk for deficiency should take calcium supplements at bedtime, instead of with meals, to avoid inhibiting dietary mineral absorption.
Pregnancy and lactation
This Calcium + vitamin D combination product is generally considered safe during pregnancy and lactation when the recommended doses are taken. However, the product should only be administered in pregnancy and lactation when clinically indicated and recommended by the physician. The recommended dose should not be exceeded since chronic overdose might be harmful to the fetus and neonates.
During pregnancy and lactation, total daily intake from food and supplements should not exceed 2,500 mg calcium and 4,000 IU vitamin D.
In animals, overdoses of vitamin D during pregnancy have been shown to have teratogenic effects. There is no evidence that vitamin D at the recommended doses is teratogenic in humans.
Maternal hypercalcaemia, possibly caused by excessive vitamin D intake during pregnancy, has been associated with hypercalcaemia in neonates, which may lead to several adverse effects in the fetus, including suppression of parathyroid hormone, hypocalcaemia, tetany, seizures and aortic valve stenosis syndrome, the features of which may include retinopathy, mental or growth.
Vitamin D and calcium are excreted into breast milk. This must be taken into consideration if the infant is receiving any respective supplements.
Fertility
To date, there is no evidence to suggest that vitamin D and/or calcium cause adverse reproductive
effects in humans.
Undesirable e ects
The following adverse reactions have been identified during post-approval use of calcium + vitamin D combination product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders
Gastrointestinal and abdominal pain, constipation, diarrhea, atulence, nausea and vomiting may occur.
Immune System Disorders
Allergic reaction, anaphylactic reaction, anaphylactic shock.
Rare hypersensitivity reactions with respective laboratory and clinical manifestations include asthma syndrome, mild to moderate reactions affecting either skin, and/or respiratory tract, gastrointestinal tract, and/or cardiovascular system. Symptoms may include as rash, urticaria, oedema, pruritus, cardio-respiratory distress, and very rarely, severe reactions, including anaphylactic shock have been reported.
Overdose and treatment
There is no evidence that this product can lead to an overdose when used as recommended. Most, if not all reports concerning overdoses are associated with concomitant intake of high dosed single and/or multivitamin preparations.
Total ingestion of calcium and vitamin D in excess of 2,500 mg of Calcium and 4,000 IU/day of
vitamin D may cause toxicity.
Patients with hypercalcaemia or conditions associated with hypercalcaemia, renal insu ciency, and/or propensity for nephrolithiasis, are susceptible to calcium and vitamin D toxicity at lower doses. Use of the product in these patient populations should be avoided.
Acute or long-term overdose of calcium and vitamin D, especially in susceptible patients, can cause hypervitaminosis D, hypercalcaemia, hypercalciuria, and hyperphosphatemia. Consequences include renal insufficiency, “Milk-alkali syndrome”, vascular and soft tissue calcification including calcinosis leading to nephrolithiasis.
Uncharacteristic initial symptoms, such as abrupt onset of headache, confusion, and gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting might be indicative of an acute overdose.
If such symptoms occur, treatment must be stopped and a health care professional consulted. Laboratory and clinical manifestations of toxicity and hypercalcaemia are highly diverse and dependent on the patient’s susceptibility and surrounding circumstances. Symptoms may include anorexia, weight loss, thirst, polyuria, and interference with the absorption of other minerals. Changes in lab values may include increase in aspartate aminotransferase and alanine aminotransferase blood concentrations. Chronic overdose can lead to calcification of vessels and organs secondary to hypercalcaemia. Extreme hypercalcaemia can result in coma and death.
Storage condition
Store CDR Fortos® in their original package and keep the tube tightly closed. Store below 25°C, protect from moisture.
This product containing desiccant, do not allow children to play with the empty packaging as they could swallow the desiccant.
Dosage forms and packaging available
10 Effervescent tablets containing aluminium tube. Name and address of Marketing Authorization Holder Bayer Thai Co., Ltd.
130/1 North Sathon Road, Silom, Bangrak, Bangkok 10500, Thailand. Manufactured by: PT Bayer Indonesia, Depok, Indonesia.
Date of revision of package insert
December 2016.
References
1. Company Core Data Sheet; Calcium + Vitamin D Combination Product (Version 3.0, 3rd Feb 2012).
2. Justification document for Calcium + Vitamin D Combination Product (1st Nov 2011).
3. Justification document for Calcium + Vitamin D Combination Product – Safety sections
(19th Dec 2011).