Cholecalciferol
is the naturally occurring form of vitamin D. It is produced from
7-dehydrocholesterol, a sterol present in mammalian skin, by ultraviolet
radiation.
CLINICAL
PHARMACOLOGY
Pharmacodynamics:
Pharmacotherapeutic
group: Vitamin D3 (Fat soluble vitamin).
Vitamin D may
have anti-osteoporotic, immunomodulatory, anticarcinogenic, antipsoriatic,
antioxidant & mood-modulatory activities. Along with parathyroid hormone
& calcitonin, regulate serum calcium Concentration.

PHARMACOKINETICS:
Absorption:
Well absorbed from the GI tract. Presence of bile is essential for adequate
intestinal absorption. Hence absorption may be decreased in patients with
decreased fat absorption.

Distribution:
Bound to a specific a-globulin. Can be stored in adipose & muscle tissue
for long periods of time. Slowly released from storage sites & skin where
it is formed in the presence of sunlight or UV light. May distribute into
breast milk.

Metabolism:
Hydroxylated in the liver by the enzyme vitamin D 25-hydroxylase to form 25 -
hydroxycholecalciferol (calcifediol). Further hydroxylated in the kidneys by
the enzyme vitamin D1 - hydroxylase to form the active metabolites
1,25-dihydroxycholecalciferol (calcitriol). Further metabolism also occurs in
the kidneys, including the formation of the 1,24,25-trihydroxy derivatives.

Excretion:
Mainly in the bile & faeces with only small amounts appearing in urine.

Da-Da contains
cholecalciferol (vitamin D3). It is used in the following conditions:

· Prophylaxis of rickets and
osteomalacia (softening or weakening of bones due to a lack of vitamin D) in
children and adults.

· Prophylaxis of rickets in
preterm newborns.

· Treatment of vitamin D
deficiency (including rickets and osteomalacia) in children and adults;

· Prevention of vitamin D
deficiency in high-risk patients (including obese patients, patients with
difficulties to absorb vitamin D and patients on medications affecting vitamin
D metabolism).

· As an adjunct to specific
therapy for osteoporosis (disease which causes bones to become less dense,
gradually making them weaker, more brittle and likely to break) in patients
with vitamin D deficiency or at risk of vitamin D insufficiency.

DOSAGE:

Dosage as
advised by the Healthcare Professional

CONTRAINDICATIONS:

· Hypersensitivity to vitamin
D or any of the excipients in the product.

· Hypervitaminosi D
· Nephrolithiasis.
· Diseases or conditions
resulting in hypercalcaemia and/or hypercalciuria.
· Severe renal impairment.

PRECAUTIONS

Excessive
intake may lead to development of hyperphosphataemia or hypercalcaemia. It
should be used with caution in infants with renal impairment or calculi or
heart disease.

WARNINGS

The drug must
not be used in the following cases

Hypersensitivity
to any of the ingredients, mainly to vitamin D.

· 
Hypercalcemia (abnormally
high blood calcium levels).

· 
Hypercalciuria (excessive
urinary elimination of calcium).

· 
Calcium lithiasis (kidney
stones).

DRUG
INTERACTIONS

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION:

Concomitant
treatment with phenytoin or barbiturates can decrease the effect of vitamin D
because of metabolic activation. Concomitant use of glucocorticoids can
decrease the effect of vitamin D.

The effects of
digitalis and other cardiac glycosides may be accentuated with the oral
administration of calcium combined with Vitamin D. Strict medical supervision
is needed and, if necessary monitoring of ECG and calcium.

Simultaneous
treatment with ion exchange resins such as cholestyramine or laxatives such as
paraffin oil may reduce the gastrointestinal absorption of vitamin D.

The cytotoxic
agent actinomycin and imidazole antifungal agents interfere with vitamin D
activity by inhibiting the conversion of 25-hydroxyvitamin D to
1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin
D-1-hydroxylase.

FERTILITY,
PREGNANCY AND LACTATION:

There are no or
limited amount of data from the use of cholecalciferol in pregnant women.
Studies in animals have shown reproductive toxicity. The recommended daily
intake for pregnant women is 500 IU, however, in women who are considered to be
vitamin D deficient a higher dose may be required. During pregnancy women should
follow the advice of their medical practitioner as their requirements may vary
depending on the severity of their disease and their response to treatment.
Vitamin D 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.

SIDE
EFFECTS

Like all
medicines, this medicine can cause side effects, although not everybody gets
them.

Vitamin D can
cause the following undesirable effects, especially in overdose:

Metabolism and
nutrition disorders: Too high calcium levels in blood and urine
(hypercalcaemia, hypercalciuria).

Gastrointestinal
disorders: Constipation, bloating, feeling sick, stomach-ache, diarrhoea.

Frequency of
the occurrence of the above mentioned side effects is not known (cannot be
estimated from the available data).

STABILITY

See expiry on
the pack

AVAILABILITY

Da-Da drops in
a pack of 10ml

Da-Da drinkable
solution 200000IU unit dose, a pack of 20ml

INSTRUCTIONS

Dosage as
advised by the Healthcare Professional

Keep out of
reach of children

Avoid exposure
to heat, light and freezing.

Store below
25°C.

Dietary
Supplement: According to DRAP Act, 2012, this product is not an allopathic
drug.

Manufactured
for:

Don Valley

(Health Division)

31 km, Main
Ferozepur Road,

Lahore - 54400
Pakistan

www.donvalleypharma.com

Nutraceutical: This product is not for
treatment of any disease.

نیوٹراسیوٹیکل: یہ پراڈکٹ کسی بیماری کے علاج کیلئے نہیں ہے۔

DOSAGE:

Dosage as
advised by the Healthcare Professional

All our products are proudly made in Pakistan and are readily available in our facilities. Orders are processed and shipped out within 1-2 business days.