Defrol 200000IU/ml (Oral & IM) Injectable Solution

✔️ Mode of Action

Vitamin D3 is a fat-soluble sterol. It is necessary for the regulation of calcium and phosphate homoeostasis and bone mineralisation. Vitamin D is also essential for healthy bones as it aids in Calcium absorption from the GI tract. In addition to this, it stimulates bone formation.

✔️ Defrol Injection (Vitamin D3/Cholecalciferol)

Treatment

• Rickets: 1 ampoule every 2 weeks for 1 month, followed by 1 ampoule every 4 months.
• Osteoporosis: 1 ampoule every 2 weeks for 3 months.
• Osteomalacia: 1 ampoule every 2 weeks for 3 months.
• Hypocalcaemic tetany: 1 ampoule every 4 months; dose may be increased to 2 ampoules if required.
• Menopause: 1 ampoule every 6 months.
• Vitamin D deficiency: 1 ampoule; repeat after 1–6 months if necessary.

Prevention

• Pregnancy: Half ampoule during the 6th or 7th month.
• Breastfeeding: Half ampoule every 6 months.
• Children up to 5 years: 1 ampoule every 6 months.
• Adolescents: 1 ampoule every 6 months.
• Elderly: Half ampoule every 3 months.

Use only as directed by a registered physician.

✔️ Administration Instructions | Defrol (Vitamin D3/Cholecalciferol)

Oral use of injection

1. Snap open the ampoule.
2. Pour the contents into a spoon.
3. Mix with water or milk before administration.

Intramuscular (IM) use

1. Open the ampoule.
2. Administer by intramuscular injection following standard medical procedures.

✔️ Vitamin D3 may interact with several medications:

• Phenytoin and barbiturates may reduce Vitamin D activity by increasing its metabolism.
• Glucocorticoids can decrease the effectiveness of Vitamin D.
• Combined use with digitalis or other cardiac glycosides alongside calcium may increase the risk of cardiac toxicity; ECG and calcium monitoring are recommended.
• Cholestyramine, ion-exchange resins, and paraffin oil may decrease gastrointestinal absorption of Vitamin D.
• Actinomycin and imidazole antifungals may inhibit the activation of Vitamin D in the kidneys, reducing its therapeutic effect.

✔️ Side Effects | Defrol (Vitamin D3/Cholecalciferol)

Possible adverse effects include:

• Loss of appetite
• Headache
• Nausea
• Vomiting
• Abdominal discomfort
• Constipation
• Hypercalcaemia or symptoms related to elevated calcium levels, especially with excessive dosing

✔️ Overdose of Defrol (Vitamin D3/Cholecalciferol)

Excessive Vitamin D intake may lead to hypercalcaemia.

Symptoms include:

• Nausea and vomiting
• Excessive thirst
• Frequent urination
• Constipation
• Weakness
• Loss of appetite
• Fatigue

Long-term overdose may result in calcium deposition in blood vessels and soft tissues. Management involves discontinuation of Vitamin D supplementation, correction of dehydration, and appropriate supportive treatment.

✔️ Defrol should not be used in patients with:

• Hypercalcaemia
• Vitamin D toxicity
• Hypersensitivity to Vitamin D3 or any formulation ingredient

✔️ Pregnancy & Lactation

Vitamin D3 is safe during pregnancy at doses up to 4,000 IU daily.

• Routine supplementation is generally 400 IU/day, although higher doses may be prescribed in women with confirmed deficiency.
• Vitamin D passes into breast milk, but toxicity in nursing infants has not been reported. When supplementing breastfed infants, total Vitamin D intake from both mother and child should be considered.

✔️ Use Vitamin D3 cautiously in patients with:

• Renal impairment
• Liver disease
• Primary hyperparathyroidism
• Lymphoma
• Tuberculosis
• Granulomatous disorders

Regular monitoring of serum calcium is recommended in patients receiving high-dose therapy, those with kidney disease, and during pregnancy or lactation.

Patients taking Digoxin or thiazide diuretics should consult their healthcare provider before using Vitamin D supplements.

✔️ Storage:

• Store below 25°C in a cool, dry place.
• Protect from light and moisture.
• Keep out of the reach of children.