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Fosamax Plus D

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What Is FOSAMAX PLUS D?

FOSAMAX PLUS D (alendronate sodium and cholecalciferol) is a combination of a bisphosphonate(alendronate sodium) and vitamin D (cholecalciferol).

Alendronic acid.svg
Colecalciferoldos.jpg

What are the uses of this medicine?

FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for:

  • Treatment of osteoporosis in postmenopausal women
  • Treatment to increase bone mass in men with osteoporosis

How does this medicine work?

Alendronate Sodium At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts.

Cholecalciferol

  • Vitamin D3 in skin and dietary vitamin D3 (absorbed into chylomicrons) is converted to 25-hydroxyvitamin D3 in the liver.
  • Conversion to the active calcium-mobilizing hormone 1,25-dihydroxyvitamin D3 (calcitriol) in the kidney is stimulated by both parathyroid hormone and hypophosphatemia.
  • The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.

Who Should Not Use this medicine?

This medicine cannot be used in:

  • FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency
  • Patients with abnormalities of the esophagus which delay emptying such as stricture or achalasia
  • Patients who are not able to stand /sit upright for at least 30 minutes
  • Patients with hypocalcemia
  • Patients with hypersensitivity to any component of this product


Is this medicine FDA approved?

  • It was approved for use in the United States in 2005.

How should this medicine be used?

Treatment of Osteoporosis in Postmenopausal Women

  • The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly.

Treatment to Increase Bone Mass in Men with Osteoporosis

  • The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly.
  • Swallow tablets whole with 6-8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day.
  • Not lie down for at least 30 minutes after taking FOSAMAX PLUS D and until after food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage forms:

  • 70 mg/2800 international units tablets
  • 70 mg/5600 international units tablets

What side effects can this medication cause?

Common possible side effects of this medicine include:

  • abdominal pain
  • acid regurgitation
  • constipation
  • diarrhea
  • dyspepsia
  • musculoskeletal pain
  • nausea

Some serious side effects including:

  • Esophagus problems
  • Low calcium levels in your blood (hypocalcemia)
  • Bone, joint, or muscle pain
  • Severe jaw bone problems (osteonecrosis)
  • Unusual thigh bone fractures

What special precautions should I follow?

  • Instruct patients to follow dosing instructions.
  • Discontinue if new or worsening symptoms occur.
  • Discontinue use if Severe Bone, Joint, Muscle Pain develop.
  • Patients with new thigh or groin pain should be evaluated to rule out an incomplete femoral fracture.

What to do in case of emergency/overdose?

Alendronate

  • No specific information is available on the treatment of overdosage with alendronate.
  • Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage.
  • Milk or antacids should be given to bind alendronate.
  • Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.
  • Dialysis would not be beneficial.

Cholecalciferol


Can this medicine be used in pregnancy?

  • Discontinue when pregnancy is recognized

Can this medicine be used in children?

  • FOSAMAX PLUS D is not for use in children.

What should I know about storage and disposal of this medication?

  • Store FOSAMAX PLUS D at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep FOSAMAX PLUS D away from light.
  • Keep FOSAMAX PLUS D package and tablets dry.
  • Store FOSAMAX PLUS D in the original package.

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