Alendronate Sodium + Vitamin D3 Pharmacology

Alendronate Sodium + Vitamin D3

About Alendronate Sodium + Vitamin D3
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Mechanism of Action of Alendronate Sodium + Vitamin D3
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Pharmacokinets of Alendronate Sodium + Vitamin D3
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Onset of Action for Alendronate Sodium + Vitamin D3
N/A
Duration of Action for Alendronate Sodium + Vitamin D3
N/A
Half Life of Alendronate Sodium + Vitamin D3
N/A
Side Effects of Alendronate Sodium + Vitamin D3
N/A
Contra-indications of Alendronate Sodium + Vitamin D3
N/A
Special Precautions while taking Alendronate Sodium + Vitamin D3
N/A
Pregnancy Related Information
Use with caution
Old Age Related Information
N/A
Breast Feeding Related Information
Contraindicated
Children Related Information
N/A
Indications for Alendronate Sodium + Vitamin D3
1.Osteoporosis
2.Paget?s disease
Interactions for Alendronate Sodium + Vitamin D3
N/A
Typical Dosage for Alendronate Sodium + Vitamin D3
1 tab once weekly
Schedule of Alendronate Sodium + Vitamin D3
N/A
Storage Requirements for Alendronate Sodium + Vitamin D3
N/A
Effects of Missed Dosage of Alendronate Sodium + Vitamin D3
N/A
Effects of Overdose of Alendronate Sodium + Vitamin D3
N/A

Alendronate Sodium

About Alendronate Sodium
Bisphosphonate Derivative, Bone resorption inhibitor.

Mechanism of Action of Alendronate Sodium
It preferentially localized to the sites of action and inhibits prenylation of GTP-binding proteins involved in cytoskeletal organization, membrane ruffling and vesicle movement. This results by osteoclasts inactivation, impaired vesicle fusion and enhanced apoptosis (bone resorption inhibition).
Pharmacokinets of Alendronate Sodium
Absorption- Poorly absorbed after oral administration
Distribution- Widely distributed into soft tissues and then redistributed into bone.78% bound to the plasma proteins
Metabolism- Doesn`t metabolized
Excretion- Excreted through urine as unchanged form
Onset of Action for Alendronate Sodium
N/A
Duration of Action for Alendronate Sodium
N/A
Half Life of Alendronate Sodium
N/A
Side Effects of Alendronate Sodium
1. Nausea.
2. Dyspepsia.
3. Abdominal cramps.
4. Flatulence.
5. Diarrhea.
6. Gastric and Duodenal ulceration.
7. Osteonecrosis
8. Skin rash.
9. Stevens-Johnson syndrome.
10. Epidermal necrolysis.
11. Uveitis.
12. Scleritis.


Contra-indications of Alendronate Sodium
1. Hypersensitivity to the drug.
2. Dysphasia.
3. Symptomatic esophageal diseases.
4. Frequent heartburn.
5. Gastritis.
6. Gastro esophageal reflux disease
7. Hiatal hernia.
8. Ulcers.
9. Renal function.
10. Duodenitis.
Special Precautions while taking Alendronate Sodium
1. Digestion problems.
2. Esophagus problems.
3. Intestine problems.
4. Stomach problems.
5. Kidney problems

Pregnancy Related Information
Use with caution
Old Age Related Information
Use with caution
Breast Feeding Related Information
Contraindicated.
Children Related Information
Use with caution
Indications for Alendronate Sodium
1. Osteoporosis
2. Paget`s disease

Interactions for Alendronate Sodium
Asprin: Risks of upper GI adverse effects increased.
Calcium supplements antacids: Interfere with absorption of alendronate.
Typical Dosage for Alendronate Sodium
Adult
Oral-
For osteoporosis:10-30mg daily
For corticosteroid-induced osteoporosis: 5 - 10 mg daily
Paget`s disease of bone: 40mg daily for 6 months
All doses are taken with water at least 30 minutes before first food, beverage, or medication of the day

Schedule of Alendronate Sodium
H
Storage Requirements for Alendronate Sodium
Store at controlled room temperature. Keep away from light and moisture.
Effects of Missed Dosage of Alendronate Sodium
Take the missed dose as soon as noticed and if it is the time for next dose then skip the missed dose. Continue the regular schedule. Do not double the dose.
Effects of Overdose of Alendronate Sodium
Give symptomatic and supportive treatment. Administer antacids or milk to prevent the adverse effects

Vitamin D3

About Vitamin D3
N/A
Mechanism of Action of Vitamin D3
Vitamin D3 is a form of vitamin D. It is also called as Cholecalciferol.7-Dehydrocholesterol is the precursor of vitamin D3 and only forms the vitamin after being exposed to UV radiation.After exposure to the sun, cholecalciferol is sent to the liver to be hydroxylated where it becomes 25-Hydroxyvitamin D3.Next, it is sent to the kidney and once again hydroxylated becoming 1,25-Hydroxyvitamin D3. 1,25-Hydroxyvitmain D3 is the active form of vitamin D3, for this reason vitamin D is often referred to as a prohormone.Vitamin D exerts it`s action by influencing calcium homoeostasis. It increases the intestinal absorption of calcium and phosphate. It binds to the cytoplasmic Vitamin D receptor and translocates to the nucleus and thus increases the synthesis of specific m RNA and regulates protein synthesis. It increases the synthesis of a carrier protein for calcium called "calbindin" or calcium binding protein. Activation of Vitamin D receptor enhances endocytotic capture of calcium and it`s transport across duodenal mucosal cells in a vesicular form. Vitamin D promotes resorption of calcium and phosphate from bone by enhancing recruitment and differentiation of osteoclast precursors in the bone remodeling units. It helps in bone mineralization.
Pharmacokinets of Vitamin D3
Absorption: Well absorbed orally in the presence of bile salts, Malabsorption and steatorrhoea interfere with it`s absorption.
Distribution: Widely distributed in a protein bound form. It is stored in adipose tissue and liver.
Metabolism: It is hydroxylated in to both active and inactive metabolites and also metabolized in kidney.
Excretion: Metabolites are excreted mainly through bile.
Onset of Action for Vitamin D3
N/A
Duration of Action for Vitamin D3
N/A
Half Life of Vitamin D3
N/A
Side Effects of Vitamin D3
1. Hypercalcaemia
2. Fatigue
3. Weakness
4. Diarrhoea
5. Vomiting
6. Sluggishness
7. Albuminuria
8. Polyuria
9. Calcification of soft tissues (blood vessels, parenchymal organs including heart)
10. Arrhythmias
11. Renal stones
12. Growh retardation in children
13. Hypertension
14. Anorexia
15. Nausea
16. Constipation
17. Elevated liver enzymes
Contra-indications of Vitamin D3
1. Hypercalcaemia
2. Hypervitaminosis D
3. Renal osteodystrophy with hyperphosphatemia
4. Renal impairment
Special Precautions while taking Vitamin D3
1. Renal diseases
2. Renal stones
3. Cardiac diseases
4. Arteriosclerosis
5. Coronary diseases
Pregnancy Related Information
Use with caution
Old Age Related Information
Use with caution
Breast Feeding Related Information
Use with caution
Children Related Information
Use with caution
Indications for Vitamin D3
1. Rickets and Osteomalacia
2. Hypoparathyroidism
3. Fanconi`s syndrome
4. Osteoporosis
Interactions for Vitamin D3
Antacids: Hypermagnesemia may develop in patients on renal dialysis who take magnesium containing antacids.
Digitalis glycosides: May precipitate cardiac arrhythmias due to hypercalcemia.
Verapamil: Atrial fibrillation may occur.
Cholestyramine: Intestinal absorption of Vitamin D may be reduced.
Mineral Oil: Prolonged use of mineral oil may result in reduced absoprtion of Vitamin D.
Phenytoin, Barbiturates: Half life of vitamin D may be reduced.
Thaizide diuretics: Hypoparathyroid patients on Vitamin D may develop hypercalcemia due to thiazide diuretics.
Typical Dosage for Vitamin D3
Oral:
Adults:
Nutritional Rickets and Osteomalacia: 25 to 125mcg daily in normal gastrointestinal absorption. In severe malabsorption; 250mcg to 7.5mg orally or 250mcg I.M.
Vitamin dependent Rickets: 250mcg to 1.5mg daily
Hypoparathyroidism: 625mcg to 5mg daily with calcium supplements
Fanconi`s syndrome: 1.25 to 5mg daily
Osteoporosis: 25 to 250mcg daily or 1.25mg once weekly with calcium and fluoride supplements.
Hypophosphatemia: 250mcg to 1.5mg along with phosphate supplements
Children:
Nutritional Rickets and Osteomalacia: 25 to 125mcg daily in normal gastrointestinal absorption. In severe malabsorption; 250mcg to 625mcg orally
Vitamin dependent Rickets: 75 to 125mcg daily.
Fanconi`s syndrome: 625mcg to 1.25mg daily
Hypophosphatemia: 1 to 2mg daily with phosphate supplements. Increase the dose in increments of 250 to 500mcg at intervals of 3 to 4months until desired therapeutic response is obtained.

Schedule of Vitamin D3
N/A
Storage Requirements for Vitamin D3
Store in a well closed container in a cool place. Protect from light and excess heat. Keep out of reach of children.
Effects of Missed Dosage of Vitamin D3
Take the missed dose as soon as noticed and if it is the time for next dose then skip the missed dose. Continue the regular schedule. Do not double the dose.
Effects of Overdose of Vitamin D3
Provide supportive and symptomatic treatment. Stops the treatment and starting a low calcium diet. Increases the fluid intake and administer Loop diuretics like furosemide may be given with saline I.V. infusion to increase calcium excretion. Calcitonin may decrease hypercalcaemia.

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