such as osteoporosis in people taking certain medication such as systemic
corticosteroids (e.g. prednisone), phenytoin, phenobarbitone etc.
DOSAGE AND ADMINISTRATION
Take 1 tablet daily after meals or as directed by the physician
Nutraceutical Product Daily recommendation of Vitamin D and Calcium *
SUPPLEMENT FACTS Adult Women & Men Calcium (Daily) Vitamin D (Daily)
19 through 49 years 1,000 mg 400-800 IU
Each film coated tablet contains: 50 years and over 1,200 mg 800-1000 IU
Elemental Calcium....................................................500 mg Children & Adolescents Calcium (Daily) Vitamin D (Daily)
Vitamin D3 (Cholecalciferol) Food Grade...............800 I.U. 1 through 3 years 500 mg 400 IU
Vitamin K2 (MK-7) Food grade................................90 mcg 4 through 8 years 800 mg 400 IU
(PharmEvo Specs.) 9 through 18 years 1,300 mg 400 IU
Pregnant & Breast feeding Women Calcium (Daily) Vitamin D (Daily)
DESCRIPTION 18 years and under 1,300 mg 400-800 IU
19 years and over 1,000 mg 400-800 IU
KALSOB is a combination product containing calcium, Vitamin D3
(Cholecalciferol) and Vitamin K2 (menaquinone-7) that helps strengthen *National Osteoporosis foundation recommendations.
bones and aids the in treatment/prevention of osteoporosis, osteomalacia,
hypo-parathyroidism and other bone disorders or to overcome deficiencies of Recommended Daily Allowances of Vitamin K*
calcium and vitamin D in certain populations and disease states. It is also used Age Male Female Pregnancy Lactation
to improve and maintain bone mineral density (BMD), bone health and
strength. Birth to 6 months 2.0 mcg 2.0 mcg
7–12 months 2.5 mcg 2.5 mcg
PHARMACOLOGICAL PROPERTIES
1–3 years 30 mcg 30 mcg
Physiological and Therapeutic Properties 4–8 years 55 mcg 55 mcg
Calcium 9–13 years 60 mcg 60 mcg
Calcium is essential for the functional integrity of the nervous, muscular, and 14–18 years 75 mcg 75 mcg 75 mcg 75 mcg
skeletal systems. The major fraction (99%) of calcium is in the skeletal
structure primarily as hydroxyapatite, Ca10(PO4)6(OH)2; small amounts of 19+ years 120 mcg 90 mcg 90 mcg 90 mcg
calcium carbonate and amorphous calcium phosphates are also present. The
calcium of bone is in a constant exchange with the calcium of plasma. Since *NIH (National institute of health)
the metabolic functions of calcium are essential for life, when there is a
disturbance in the calcium balance because of dietary deficiency or other CONTRAINDICATIONS
causes, the stores of calcium in bone may be depleted to fill the body's more
acute needs. This may lead to bone disorders including osteoporosis. Calcium KALSOB must not be used in patients with:
supplementation along with Vitamin D has been shown to reduce the risk of • Hypersensitivity to any of the active substances (Vitamin D or its analogues,
osteoporosis and osteomalacia. calcium or Vitamin K or its analogues)
Vitamin D3 (Cholecalciferol) Due to calcium / cholecalciferol components, KALSOB tablets must not be
Cholecalciferol is produced within the skin under the influence of UV used in:
radiation including sunlight. In its biologically active form, cholecalciferol
stimulates intestinal calcium absorption, incorporation of calcium into the • Hypercalcaemia and/or hypercalciuria
osteoid, and release of calcium from bone tissue. In the small intestine it • Nephrolithiasis (Renal calculi)
promotes rapid and delayed calcium uptake. The passive and active transport • Hypervitaminosis D
of phosphate is also stimulated. In the kidney, it inhibits the excretion of • Severe renal impairment
calcium and phosphate by promoting tubular resorption. The production of • Metastatic calcification
parathyroid hormone (PTH) in the parathyroids is inhibited directly by the
biologically active form of cholecalciferol. PTH secretion is inhibited WARNINGS AND PRECAUTIONS
additionally by the increased calcium uptake in the small intestine under the
influence of biologically active cholecalciferol. This product should not be used in certain medical conditions, including:
Along with calcium supplementation, Vitamin D reduces the risk of osteopo- • High calcium/vitamin D levels (hypercalcemia/hypervitaminosis D)
rosis and osteomalacia. • Fat mal-absorption syndromes as the absorption of Vitamin K is fat-depen-
dent
Vitamin K2 • Known allergy to calcium, Vitamin D or Vitamin K containing products
Vitamin K2 is required to activate osteocalcin, an important protein secreted by
osteoblasts, the body’s bone-building cells. When vitamin K2 is activated, • Cardiovascular disease (Heart/blood vessel disease). There is a risk of
osteocalcin can draw calcium into the bones where osteoblasts then incorpo- potential exacerbation of cardiac disorders and arteriosclerosis related to
rate it into the bone matrix. In addition, vitamin K2, when combined with persistent hypercalcemic effects during therapeutic use of calcium/Vitamin D
vitamin D3, helps inhibit osteoclasts, the cells responsible for bone resorption. products.
Vitamin K2 helps increase the amount of calcium deposited in bones and helps
build bone density. • Renal calculi (Kidney stones)
THERAPEUTIC USES • Renal diseases (Kidney disease). Cholecalciferol should be used with
caution in patients with impairment of renal function due to the potential
KALSOB tablets are used to prevent and treat conditions related to calcium exacerbation of hypercalcemic effects during therapeutic use. The effect on
and vitamin D deficiency such as: calcium and phosphate levels should also be monitored. The risk of soft tissue
• a) Osteoporosis calcification should be taken into account. In patients with severe renal
• b) OsteomalaciaHypoparathyroidism insufficiency, vitamin D in the form of cholecalciferol is not metabolized
• c) Musculoskeletal pain normally and other forms of vitamin D should be used.
KALSOB tablets are also used to overcome calcium and vitamin D deficien-
cies in certain populations and disease states such as: • Certain immune system disorder (Sarcoidosis). Cholecalciferol should be
• a) Postmenopausal women prescribed with caution to patients suffering from sarcoidosis because of the
• b) Bone recovery after fractures risk of increased metabolism of vitamin D to its active form. These patients
should be monitored with regard to the calcium content in serum and urine
KALSOB tablets may also be used to prevent or treat bone-related disorders
• Liver disease. In patients with liver impairment, Vitamin D absorption may
be markedly impaired; conversion to active metabolite calcifediol may be
reduced significantly, with the requirement of high doses of cholecalciferol.
Agents not requiring hepatic hydroxylation are preferred in this condition. It is Lactation
not reasonable to use cholecalciferol in severe liver impairment. Based on the information below, KALSOB in therapeutic doses of 1 tablet
daily is considered safe during breast feeding
• Certain bowel diseases (Crohn's disease, whipple's disease) that may cause
fat mal-absorption and impair the absorption of Vitamin K Cholecalciferol and its metabolites are excreted in breast milk. Caution is
required with high doses to prevent the potential risk of hypercalcemia in
• Hyperlipidemia: Cholecalciferol may cause a potential exacerbation of LDL infants. Serum calcium monitoring is advised. Potential benefits of treatment
elevation with cholecalciferol should be weighed against potential risks before prescrib-
ing it to breast feeding mothers.
• Low levels of bile/biliary obstruction that may lead to fat mal-absorption and
impair the absorption of Vitamin K Calcium is secreted in breast milk in significant amounts. However, infant
harm is not expected if the maternal calcium levels are maintained within the
• Untreated phosphate imbalance. There is a risk of metastatic calcification; normal range. Adverse effects in nursing infants have not been reported.
normalization of phosphate levels is indicated prior to therapy with
cholecaciferol. Maternal medication with Vitamin K and its analogues is compatible with
breast feeding. No risk is expected with 90 mcg of menaquinone.
ADVERSE REACTIONS
OVERDOSAGE
Common: Constipation or stomach upset may occur.
Uncommon: Hypercalcemia/hypercalciuria, Nausea/vomiting, loss of Calcium and Vitamin D3
appetite, unusual weight loss, mental/mood changes, change in the amount of Acute or chronic overdose of Cholecalciferol or calcium can cause hypercal-
urine, bone/muscle pain, headache, increased thirst, increased urination, caemia, an increase in the serum and urinary concentrations of calcium. The
weakness, tiredness, fast/pounding heartbeat. symptoms of hypercalcaemia are not very specific and consist of nausea,
Rare: Serious allergic reaction, including: rash, itching/swelling (especially of vomiting, diarrhoea often in the early stages and later constipation, anorexia,
the face/tongue/throat), severe dizziness, trouble breathing. fatigue, headache, muscle and joint pain, muscle weakness, polydipsia,
polyuria, formation of renal calculi, nephrocalcinosis, kidney failure, and
DRUG INTERACTIONS calcification of soft tissues, changes in ECG measurements, arrhythmias and
pancreatitis may develop. In rare and isolated cases there are reports that
• Calcium can decrease the absorption of other drugs such as tetracycline hypercalcaemia is fatal.
antibiotics (e.g., doxycycline, minocycline), bisphosphonates (e.g., alendro-
nate), estramustine, levothyroxine, and quinolone antibiotics (e.g., ciprofloxa- The treatment with calcium and Vitamin D must be discontinued. A low
cin, levofloxacin). There should be a gap of at least 4 hours when taking these calcium or calcium-free diet can also be considered.Treatment with thiazide
drugs with KALSOB. diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be
• Certain medications can decrease the absorption of vitamin D (bile acid discontinued. Treatment: rehydration, and, according to severity of hypercal-
sequestrants such as cholestyramine/colestipol, mineral oil, orlistat). There caemia, isolated or combined treatment with loop diuretics, bisphosphonates,
should be a gap of at least 4 hours when taking these drugs with KALSOB. calcitonin and corticosteroids should be considered. Serum electrolytes, renal
• Patients co-treated with cardiac glycosides along with cholecalciferol may be function and diuresis must be monitored. In severe cases, ECG and CVP
susceptible to high calcium levels and should have ECG parameters and should be followed.
calcium levels monitored. It is recommended to reduce the dose or interrupt
treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 A normalization of hypercalcaemia due to vitamin D intoxication lasts several
mg/24 hours). weeks. Phosphate infusions should not be administered to lower hypercalcae-
• Simultaneous administration of benzothiadiazine derivatives (thiazide mia of hypervitaminosis D because of the dangers of metastatic calcification
diuretics increases the risk of hypercalcaemia because they decrease the
calcium excretion in the urine. The calcium levels in plasma and urine should Vitamin K2 (Menaquinone)
therefore be monitored for patients undergoing long-term treatment with
calcium/Vitamin D supplementation. There are no reports of Vitamin K overdose available in literature. Toxicity is
• Anti-convulsants e.g. phenytoin, phenobarbital, primidone, carbamazapine unlikely following oral exposure. Patient should be monitored in case of
may diminish the effect of cholecalciferol due to hepatic enzyme induction. overdose and treated for any symptoms that may develop as a result of
Rifampicin may reduce the effectiveness of cholecalciferol due to hepatic overdose.
enzyme induction.
• Isoniazid may reduce the effectiveness of cholecalciferol due to inhibition of PRESENTATION
the metabolic activation of cholecalciferol. Pack of 10 & 30 film coated tablets.
• The cytotoxic agent actinomycin and imidazole antifungal agents interfere
with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D INSTRUCTIONS
to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin Use as advised by the physician.
D-1-hydroxylase. Keep out of the reach of children.
• Concomitant use of glucocorticoids can decrease the effect of vitamin D Store at room temperature below 30 °C.
• Vitamin K supplementation may decrease the effectiveness of anticoagulant Protect from light, heat & moisture.
drugs such as warfarin. INR should be monitored closely and warfarin dose
adjustment may be needed to optimize the effectiveness of warfarin, in
patients taking concomitant Vitamin K supplements
USE IN SPECIAL POPULATIONS
Pregnancy
Use of a supplement containing calcium, cholecalciferol and Vitamin K2
(menaquinone) is considered safe for pregnant mothers.
DI:KALB 01 12/2017
Manufactured by:
No data is available regarding pregnancy outcomes after exposure to cholecal-
ciferol (Vitamin D3). Cholecalciferol should be used during pregnancy
preferably only if the clinical condition of the woman requires treatment with
cholecalciferol, at a dose necessary to overcome the deficiency.
There are no adequate or well-controlled studies for the use of calcium in
pregnant women. Fetal harm is not expected if the maternal calcium levels are PharmEvo (Pvt). Ltd.
maintained within the normal range. However, hypercalcemia during pregnan- (Nutraceutical Division)
cy may increase the risk for maternal and neonatal complications, such as Plot No. A-29, North Western
stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroid- Industrial Zone. Port Qasim,
ism. Karachi-75020, Pakistan.
www.pharmevo.biz
There are no adequate or well-controlled studies for the use of Vitamin K Company E. No.: 00712
analogues in pregnant women. Fetal harm is not expected with 90 mcg of Product E. No.: 00712.0005
Vitamin K2. Nevertheless, Vitamin K supplements should be given to pregnant ®
women only if the potential benefit outweighs the potential risk to the fetus.
