Phil Inter Pharma


Full Prescribing Info
Each capsule contains: Active ingredient: Calcitriol (Vitamin D) 0.25 mcg.
Inactive ingredients: Soy bean oil, gelatin, glycerin, methyl-p-hydroxybenzoate, propyl p-hydroxybenzoate, 70% D-Sorbitol, yellow ferric oxide, titanium dioxide.
Pharmacology: Pharmacokinetics: Vitamin D substances are well absorbed from the gastrointestinal tract. The presence of bile is essential for adequate intestinal absorption; absorption may be decreased in patients with decreased fat absorption.
Vitamin D and its metabolites circulate in the blood bound to a specific α-globulin. Vitamin D can be stored in adipose and muscle tissue for long periods of time. It is slowly released from storage sites and from the skin where it is formed in the presence of sunlight or ultraviolet light, Ergocalciferol and colecalciferol have a slow onset and a long duration of action; calcitriol and its analogue alfacalcidol however, have a more rapid action and shorter half-lives.
Colecalciferol and ergocalciferol are hydroxylated in the liver by the enzyme vitamin D 25-hydroxylase to form 25-hydroxycalciferol (calcifediol) and 25-hydroxyergocalciferol respectively. These compounds undergo further hydroxylation in the kidneys by the enzyme vitamin D 1-hydroxylase to form the active metabolites 1,25-dihydroxycholecalciferol (calcitriol) and 1,25-dihydroxyergocalciferol respectively. Further metabolism also occurs in the kidneys, including the formation of 1,24,25-trihydroxy derivatives. Of the synthetic analogues, alfacalcidol, dihydrotachysterol, and doxecalciferol are converted directly in the liver to their active metabolites (calcitriol, 25-hydroxydihydrotachysterol, and 1,25-dihydroxyergocalciferol respectively).
Vitamin D compounds and their metabolites are excreted mainly in the bile and faeces with only small amounts appearing in urine; there is some enterohepatic recycling but it is considered to have a negligible contribution to vitamin D status. Certain vitamin D substances may be distributed into breast milk.
Treatment and prevention of Vitamin D deficiency states and hypocalcemia in disorders such as hypoparathyroidism and secondary hyperparathyroidism associated with chronic renal failure.
Treatment of established post-menopausal osteoporosis.
Dosage/Direction for Use
The usual initial adult oral dose is 0.25 mcg (1 capsule) daily or on alternate days are given, increased if necessary, in steps of 0.25 mcg (1 capsule) at intervals of 2 to 4 weeks, to a usual dose of 0.5 mcg (2 capsules) to 1 mcg (4 capsules) daily.
For moderate to severe secondary hyperparathyroidism in dialysis patients, initial doses of 0.5 mcg (2 capsules) to 4 mcg (8 capsules) have been given three times a week, increased if necessary in steps of 0.25 mcg (1 capsule) to 1 mcg (4 capsules) at intervals of 2 to 4 weeks to maximum of 8 mcg (16 capsules) given three times a week.
In established postmenopausal osteoporosis, a dose of 0.25 mcg (1 capsule) twice daily is recommended.
When vitamin D substances are given in pharmacological doses, dosage must be individualized for each patient, and should be based on regular monitoring of plasma-concentrations (initially once or twice weekly), to optimized clinical response and avoid hypercalcaemia.
All kinds of diseases related to hypercalcemia.
Patients with history of hypersensitivity to this drug or any components of this drug.
Patient with evidence of vitamin D toxicity.
Pregnant women: since it had not yet been established that this drug is safe in pregnant women or women suspected of being pregnant, administration to these kind of people should be carried out after comparing possible risks which can occur in a mother and fetus with therapeutic benefits following medication.
Infants below 3 years and being taken hemodialysis: it should be administered to these patients after comparing risks which can be able to occur individually with therapeutic benefits because of lack of experience about using this drug in such cases.
Special Precautions
Vitamin D should not be given to patients with hypercalcaemia. It should be used with caution in infants, who may have increased sensitivity to its effects, and patients with renal impairment or calculi, or heart disease, who might be at increased risk of organ damage if hypercalcaemia occurred. Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification.
It is advised that patients receiving pharmacological doses of vitamin D should have their plasma-calcium concentration monitored at regular intervals, especially initially or if symptoms suggest toxicity. Similar monitoring is recommended in infants if they are breast fed by mothers receiving pharmacological doses of vitamin D.
Use In Pregnancy & Lactation
Pregnant women: since it had not yet been established that this drug is safe in pregnant women or women suspected of being pregnant, administration to these kind of people should be carried out after comparing possible risks which can occur in a mother and fetus with therapeutic benefits following medication.
Adverse Reactions
Excessive intake of vitamin D leads to the development of hyperphosphataemia or hypercalcaemia. Associated effects of hypercalcaemia include hypercalciuria, ectopic calcification, and renal and cardiovascular damage.
Symptoms of overdosage include anorexia, lassitude, nausea and vomiting, constipation or diarrhea, nocturia, sweating, headache, thirst, somnolence, and vertigo. Interindividual tolerance to vitamin D varies considerably; infants and children are generally more susceptible to its toxic effects. The vitamin should be withdrawn if toxicity occurs. It has been stated that vitamin D dietary supplementation may be detrimental in persons already receiving an adequate intake through diet and exposure to sunlight, since the difference between therapeutic and toxic concentrations is relatively small.
Hypersensitivity reactions have occurred.
*Inform the doctor in case of any adverse reactions related to drug use.
Drug Interactions
There is an increased risk of hypercalcaemia if vitamin D is given with thiazide diuretics, calcium, or phosphate. Plasma-calcium concentrations should be monitored in such situations. Some antiepileptics may increase vitamin D requirements (e.g. Carbamazepine, Phenobarbital, Phenytoin, and Primidone). Rifampicin and Isoniazid may reduce the effectiveness of vitamin D. Corticosteroids may counteract the effect of vitamin D. Ketoconazole may inhibit the metabolism of Paricalcitol and these drugs should be used with caution together; care should be taken when using Paricalcitol with other potent inhibitors of the cytochrome P450 isoenzyme CYP3A4.
Store at temperatures not exceeding 30°C.
Shelf Life: 36 months from the manufacturing date.
ATC Classification
A11CC04 - calcitriol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Softgel cap 0.25 mcg x 30's, 100's.
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