DEVIT-3 I.M AMPOULE Solution/Oil

What is DEVIT-3 I.M AMPOULE

DEVIT-3 I.M. Ampoule is a high-dose injectable form of Vitamin D3 (Cholecalciferol), containing 300,000 IU per 1 mL ampoule. It is formulated in an oil-based solution, typically sunflower oil, to facilitate intramuscular (IM) or oral administration. This preparation is used to correct or prevent vitamin D deficiencies, particularly in cases where oral supplementation is inadequate or impractical.

Indications include:

• Vitamin D deficiency and insufficiency
• Osteomalacia and rickets
• Hypoparathyroidism and pseudohypoparathyroidism
• Osteoporosis (as adjunctive therapy with calcium)
• Familial hypophosphatemia
• Malabsorption syndromes affecting vitamin D uptake

DEVIT-3 is especially beneficial for patients with conditions that impair vitamin D absorption, such as gastrointestinal disorders, or for those requiring rapid replenishment of vitamin D stores.

How to use DEVIT-3 I.M AMPOULE

Administration:

• Intramuscular (IM) Injection: Administered into the gluteal or deltoid muscle by a healthcare professional.
• Oral Intake: The contents of the ampoule can be ingested directly or mixed with a small amount of food or drink, as advised by a physician.

General Guidelines:

• Use only under medical supervision.
• Do not exceed the prescribed dose.
• Ensure proper storage of the ampoule before use.

Special Considerations:

• In cases of malabsorption, IM administration is preferred.
• Monitor serum calcium and phosphate levels during treatment.

Always follow your healthcare provider's instructions regarding dosage and administration frequency.

Mode of Action DEVIT-3 I.M AMPOULE

Cholecalciferol (Vitamin D3) is a fat-soluble vitamin that plays a crucial role in calcium and phosphate homeostasis, essential for healthy bone formation and maintenance.

Mechanism:

• After administration, cholecalciferol is converted in the liver to 25-hydroxyvitamin D, then in the kidneys to its active form, 1,25-dihydroxyvitamin D (calcitriol).
• Calcitriol enhances intestinal absorption of calcium and phosphate.
• It facilitates normal bone mineralization and prevents hypocalcemic tetany.
• Regulates parathyroid hormone (PTH) levels, maintaining calcium balance.

This mechanism supports the treatment and prevention of bone disorders associated with vitamin D deficiency.

DEVIT-3 I.M AMPOULE Interactions DEVIT-3 I.M AMPOULE

Potential Drug Interactions:

• Thiazide diuretics: May increase the risk of hypercalcemia when used with vitamin D.
• Anticonvulsants (e.g., phenytoin, phenobarbital): Can accelerate vitamin D metabolism, reducing its efficacy.
• Glucocorticoids: May impair vitamin D activity, necessitating dosage adjustments.
• Cholestyramine and colestipol: Can decrease vitamin D absorption.
• Digitalis glycosides: Vitamin D-induced hypercalcemia may enhance the risk of digitalis toxicity.

Inform your healthcare provider about all medications and supplements you are taking to avoid potential interactions.

Dosage of DEVIT-3 I.M AMPOULE

Dosage varies based on age, condition, and severity of deficiency:

Adults:

• Vitamin D deficiency: 300,000 IU IM or orally every 6 weeks, as prescribed.
• Osteoporosis prevention: 800–1000 IU daily, often in combination with calcium supplements.

Children:

• 6 months to 1 year: Half an ampoule every 6 months for prevention.
• 1 to 18 years: One ampoule every 6 months for prevention.

Pregnancy:

• Half an ampoule administered intramuscularly during the 6th and 7th months, if indicated.

Dosage should be tailored to individual needs and monitored by a healthcare professional.

Possible side effects of DEVIT-3 I.M AMPOULE

Common side effects:

• Nausea
• Vomiting
• Constipation
• Dry mouth
• Headache

Serious side effects (indicative of hypercalcemia):

• Weakness
• Fatigue
• Loss of appetite
• Increased thirst and urination
• Confusion

Allergic reactions:

• Skin rash
• Swelling of the face, lips, or tongue
• Difficulty breathing

Seek immediate medical attention if you experience signs of an allergic reaction or symptoms of hypercalcemia.

DEVIT-3 I.M AMPOULE Contraindications DEVIT-3 I.M AMPOULE

Do not use DEVIT-3 I.M. Ampoule if you have:

• Hypercalcemia (elevated calcium levels)
• Hypervitaminosis D
• Hypersensitivity to cholecalciferol or any component of the formulation
• Severe renal impairment

Use with caution in patients with cardiovascular disease or those prone to kidney stones. Always consult a healthcare provider before initiating therapy.

Storage of DEVIT-3 I.M AMPOULE

Storage instructions:

• Store at temperatures below 25°C (77°F).
• Protect from light and moisture.
• Keep out of reach of children.
• Do not use after the expiration date indicated on the packaging.

Proper storage ensures the medication's efficacy and safety.