Forti-D

Cholecalciferol (vitamin D3).

Soft gelatin cap: 1,000 IU: Each soft gelatin capsule contains: Cholecalciferol (Vitamin D3) 1,000 IU %RDA^*: 165%.
^*%RDA: Recommended Daily Allowances.
%RDA based on diet of 2150 kcal.
2,000 IU: Each soft gelatin capsule contains: Cholecalciferol (Vitamin D3) 2,000 IU %RDA^*: 335%.
^*%RDA: Recommended Daily Allowances.
%RDA based on diet of 2150 kcal.
5,000 IU: Each soft-capsule contains: Cholecalciferol 5,000 IU (equivalent to Vitamin D3 125 mcg).
Soft capsule, clear and glossy, purple colored, transparent, oblong, 8 minims.
Syr: 400 IU: Each 5 mL contains: Cholecalciferol (Vitamin D3) 400 IU %RDA^* 65%.
^*%RDA: Recommended Daily Allowances.
%RDA based on diet of 2150 kcal.
1,000 IU: Each 5 mL contains: Cholecalciferol (Vitamin D3) 1,000 IU %RDA^* 165%.
^*%RDA: Recommended Daily Allowances.
%RDA based on diet of 2150 kcal.
Excipients/Inactive Ingredients: Potassium Sorbate.
Soft gelatin cap: 1,000 IU: Gelatin (Bovine), Ethyl vanillin, FD&C Blue No. 1 CI 42090, D&C Yellow No. 10 CI 47005.
2,000 IU: Gelatin (Bovine), Ethyl Vanillin, Ponceau 4R CI 16255, Iron Oxide Black CI 77499.
5,000 IU: Medium-Chain Triglycerides, Gelatin, Sorbitol Sorbitan Solution, Citric Acid, Lecithin, Ethyl Vanillin, FD&C Red No. 40, Buthyl Hydroxy Anisole, Buthyl Hydroxy Toluene, FD&C Blue No. 1, Iron Oxide Black.
Syr: 400 IU: Strawberry flavor, Sucrose, Sorbitol, FD&C Red #40 CI No. 16035.
1,000 IU: Orange flavor, Sucrose, Sorbitol, FD&C Yellow #6 CI No. 15985.
Contains alcohol <1%.

Soft gelatin cap: 5,000 IU: Pharmacotherapy group: Vitamin D and analogues.
Pharmacology: Pharmacodynamics: Absorption: Cholecalciferol is easily absorbed in the small intestine.
In its biologically active form, Cholecalciferol stimulates calcium absorption through the intestines, assimilate calcium into the osteoid and release of calcium from bone tissue. In the small intestine, Cholecalciferol in its active form triggers rapid and delayed absorption of calcium. Cholecalciferol also stimulates passive and active transport of phosphate. In the kidney, Cholecalciferol in its active form inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroid is directly inhibited by the biologically active form of Cholecalciferol.
In addition, PTH secretion is also inhibited by increased calcium absorption in small intestine under the influence of the biologically active Cholecalciferol.
Elimination: Cholecalciferol and other forms of vitamin D are excreted in the feces and urine.
Pharmacokinetics: The pharmacokinetic of Cholecalciferol is well known. Cholecalciferol is almost completely absorbed from gastrointestinal tract with the presence of dietary fats and bile acids, Cholecalciferol is stored in fat cells and the half-life is about 50 days.
Cholecalciferol is metabolized by microsomal hydroxylase to be 25-hydrocholecalciferol (25(OH)D3, calcidiol) which is the main storage form of vitamin D3 which is further hydroxylated in the kidney to be the active metabolite 1,25 dihydroxycholecalciferol (calcitriol). These metabolites circulate in the blood and are bound to a specific α-globulin.
After a single oral dose of cholecalciferol, the maximum serum concentrations of the primary storage form are reached after approximately 7 days. 25-hydroxycholecalciferol (25(OH)D3) is then slowly eliminated with an apparent half-life in serum of about 50 days. Cholecalciferol and its metabolites are excreted mainly in the bile and feces. After high doses of Cholecalciferol, the serum concentration of 25(OH)D3 may increase for several months. Overdose-induced hypercalcemia may persist for several weeks (see "OVERDOSAGE").

Soft gelatin cap: 1,000 IU, 2,000 IU/Syr: 1,000 IU: To fulfill the needs of vitamin D immediately during certain conditions such as elderly, pregnant and nursing mothers, high risk/patient with infections or patient with autoimmune diseases.
Soft gelatin cap: 5,000 IU: Forti-D 5000 is indicated to increase serum 25-hydroxycholecalciferol (25(OH)D) level in patients with Vitamin D deficiency (serum levels of 25(OH)D <30 ng/mL).
Syr: 400 IU: Vitamin D3 supplementation.

Soft gelatin cap: 1,000 IU: Adult and children over 12 years: 1 soft gelatin capsule daily.
5,000 IU: Adult and adolescent over 12 years: 1 soft-capsule daily, taken after meals.
Doses should be adjusted based on the levels of 25-hydroxycholecalciferol (25(OH)D) serum and not exceeded 5000 IU/day or according to the doctor's instructions depending on the patient's needs and condition.
Direction of Use: Soft gelatin cap: 2,000 IU: Adult: Used with a maximum dosage of 4000 IU/day until it reaches the optimum serum 25-hydroxycholecalciferol (25(OH)D) level (40-60 ng/mL) for a maximum of 30 (thirty) days of use.
Syr: 400 IU: Children >6 years: Once daily, 1 measuring spoon (5 mL).
Adult: Once daily, 1 measuring spoon (5 mL).
Pregnant and nursing women: Once daily, 1 measuring spoon (5 mL).
1,000 IU: Adult and children >12 years: Once daily, 1 measuring spoon (5 mL).

Soft gelatin cap: 5,000 IU: The symptoms of hypercalcemia: Anorexia, thirst, nausea and vomiting, constipation, diarrhea, muscle weakness, fatigue, confusion, polydipsia, polyuria, muscle and joint pain, nephrocalinosis, renal stones, vertigo, and cardiac arrhythmias in severe cases. Hypercalcemia in severe cases could cause coma or death. High calcium levels for a long time can cause renal damage and soft tissue calcification. Overdose can cause hypervitaminosis, hypercalcemia, and hyperphosphatemia.
Treatment of hypercalcemia: A normalization of hypercalcemia due to vitamin D intoxication lasts several weeks. The recommendation for the treatment of hypercalcemia is to avoid any further administration of vitamin D, including supplements, dietary intakes, and sunlight exposure. A low calcium or calcium-free diet can also be considered. Rehydration and the treatment with diuretics (e.g.: furosemide) to ensure adequate diuresis should be considered. Additional treatment with calcitonin or corticosteroids can also be considered. Phosphate infusions should not be administered to lower hypercalcemia of hypervitaminosis D because of the dangers of metastatic calcification.

Soft gelatin cap: Cholecalciferol must not be used in patients with: Hypersensitivity to the vitamin D and its analogues or with other components in the formula.
1,000 IU, 5,000 IU: Hypercalcemia and/or hypercalciuria.
Calcium nephrolithiasis or nephrocalcinosis.
Hypervitaminosis D.
Severe renal impairment and renal failure.

Soft gelatin cap: 2,000 IU: Health supplements for special needs only obtained through pharmacy.
Consult with pharmacist/doctor.

Soft gelatin cap: 1,000 IU/Syr: 1,000 IU: Check the level of vitamin D in the blood after 6 (six) months of use or more.
Consult to the doctor for use in pregnant and nursing mothers.
Stop use if allergy symptoms occur.
Calcium consumption according to the Recommended Dietary Allowance (RDA) to avoid hypercalcemia.
Soft gelatin cap: 2,000 IU: Check level of vitamin D serum in the blood after 3 (three) months of use.
For patients with pregnancy, breastfeeding, kidney disease, kidney stones, liver disease, heart disease, lung disease, epilepsy and parathyroid hormone disorders consult to doctor before taking vitamin D.
Do not take vitamin D if allergic reaction occurs.
Calcium consumption should not exceed the Recommended Dietary Allowance (RDA).
5,000 IU: Cholecalciferol should be used with caution in patients with impairment of renal function and the calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D in the form of Cholecalciferol is not metabolized normally and other forms of vitamin D should be used.
Cholecalciferol cannot be used by patients with a tendency to renal calculi containing calcium.
Caution is required in patients receiving treatment for cardiovascular disease, such as cardiac glycosides (see "INTERACTIONS"). There is a risk of hypocalcemia in patients with digitalis toxicity.
High dose of Cholecalciferol should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regards to the calcium content in serum and urine.
The need of additional calcium supplementation should be considered for individual patients. Calcium supplements should only be given under medical supervision. Medical supervision is required whilst on treatment to prevent hypercalcemia.
The use of vitamin D in the treatment of hyperparathyroidism associated with cardiovascular disease is not recommended since it can cause renal failure.
Effects on ability to drive and operate machines: There have been no studies on the effect on driving or operating the machine. Cholecalciferol has no known side effects that might affect its ability to drive or operate the machine.

Soft gelatin cap: 5,000 IU: Pregnancy: Cholecalciferol 5000 IU should not be used during pregnancy unless the clinical condition of the woman requires treatment with Cholecalciferol, at a dose necessary to overcome the deficiency.
Women should follow instructions of medical practitioner during pregnancy since their needs may differ depending on the severity of their condition and respond to the treatment.
Based on human experience and animal research, vitamin D overdose causes physical and mental impairment, as well as congenital heart and eye abnormalities, when Cholecalciferol is administered during pregnancy.
Lactation: Cholecalciferol and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed. However, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.

Soft gelatin cap: 1,000 IU/Syr: 1,000 IU: Hypercalcemia, hypercalciuria, pruritus, rash, urticaria hypersensitivity reactions, nausea, vomiting.
Soft gelatin cap: 2,000 IU: Do not take vitamin D if allergic reaction occurs, including face/tongue/lips are swollen, difficult to swallow, itching, pruritus, rash, urticaria, and difficulty in breathing.

Soft gelatin cap: 5,000 IU: Stop use if severe allergic symptoms occur, including face, lips, tongue, and throat are swollen, difficult to swallow, itching and difficulty in breathing.
Uncommon side effects (less than 1/100): Hypercalciuria and hypercalcemia.
Rare side effects (less than 1/1000): Pruritus, rash, urticaria.

Soft gelatin cap: 1,000 IU/Syr: 1,000 IU: If the patient is taking the following drugs, consult the doctor: Phosphate infusion, cardiac glycoside, thiazide diuretic, metabolites of vitamin D3 or vitamin D analogues, phenytoin, phenobarbital, primidone, rifampicin, isoniazid, orlistat, liquid paraffin, cholestyramine, glucocorticoid, multivitamin and mineral, calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin, calcium salt, conivaptan, aripiprazole, axitinib, saxagliptin, bile acid sequestrant, CYP3A4 inducer, deferasirox, mineral oil, orlistat, sevelamer, tocilizumab.
Soft gelatin cap: 5,000 IU: Phosphate infusions should not be administered to lower hypercalcemia of hypervitaminosis D because of the risks of metastatic calcification.
Patients who treats with cardiac glycosides may be susceptible to high calcium levels and should monitor ECG parameters and calcium levels. If the calcium level in the urine reaches 7.5 mmol/24 hours (300 mg/24 hours), the dosage should be reduced or therapy should be discontinued.
Simultaneous administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcemia since it can decrease the calcium excretion in the urine. Patients who received long-term therapy should monitor their calcium levels in plasma and urine.
Concurrent used of Cholecalciferol with vitamin D metabolites or analogues, serum calcium levels should be closely monitored.
Anti-convulsant (e.g.: phenytoin, phenobarbital, primidone) may reduce the effect of Cholecalciferol due to hepatic enzyme induction.
Rifampicin may reduce the effectiveness of Cholecalciferol due to hepatic enzyme induction.
Isoniazid may reduce the effectiveness of Cholecalciferol since it can inhibit the metabolic activation of Cholecalciferol.
Drugs that cause fat malabsorption (e.g.: orlistat, liquid paraffin and cholestyramine) may interfere the absorption of Cholecalciferol.
The cytotoxic agent actinomycin and imidazole anti-fungal agents may interfere vitamin D activity by inhibiting the conversion of 25-hydroxycholecalciferol to 1,25-hydroxy-cholecalciferol by the renal enzyme, 25-hydroxycholecalciferol-1-hydroxylase.
Concurrent use of glucocorticoids can reduce the effectiveness of vitamin D.
Avoid taking multivitamins and minerals (Vitamin A, D, E, K, folic acid and iron), calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin at the same time.
Vitamin D can increase the levels/effects of aluminium hydroxide, cardiac glycosides, magnesium salts, sucralfate, vitamin D analogues.
Levels/effects of vitamin D can increase when administered with calcium salt and conivaptan.
Vitamin D can decrease levels/effects of aripiprazole, axitinib and saxagliptin.
Levels/effects of vitamin D can decrease when administered with bile acid sequestrant, corticosteroids (systemic), CYP3A4 inducers, deferasirox, mineral oil, orlistat, sevelamer, tocilizumab, anti-convulsant, hydantoin, barbiturates or primidone.

Syr: Shake well before use.

Store in dry place at temperature below 30°C.
Soft gelatin cap: 1,000 IU: Protect from light and moisture.
2,000 IU: Protect from light and humidity.
5,000 IU: Protect from light.
Syr: Keep the bottle tightly closed.
Protect from light.
FORTI-D 400/1000 Syrup may not be used more than 60 days after the bottle is opened.

Vitamins A, D & E

A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.

Soft gelatin cap, syr: B; Soft gelatin cap 5,000 IU: K