One Alpha 1mcg Caps 10×10 Blister

DIN

00474525

Size

100 Capsules

SKU

6230410154602

Directions

An initial dose of 0.25 mcg/day is recommended for the first 2 months.

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INFORMATION FOR THE PATIENT

What the medication is used for:

One Alpha® is a vitamin D analog used for the management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in patients with chronic renal failure.

Pediatric use: The safety and efficacy of One Alpha® in children has not been established

What it does:

One Alpha® contains the active ingredient alfacalcidol, which is a form of vitamin D. Alfacalcidol is transformed to calcitriol to stimulate intestinal calcium and phosphorus absorption.

When it should not be used:

One Alpha® should not be used

  • Simultaneously with other vitamin D products or derivatives.
  • While breastfeeding as One Alpha® may be excreted in human milk

What the medicinal ingredient is:

Alfacalcidol

What the nonmedicinal ingredients are:

Sesame oil and all-rac-αtocopherol; shell composition: gelatin, glycerol, potassium sorbate, red iron oxide E172 and black iron oxide E172

What dosage forms it comes in:

Capsule, drops, and liquid injection

ABOUT THE DISEASE

Chronic Renal Failure:

Individuals with renal failure cannot transform enough vitamin D into calcitriol naturally, causing low levels of calcium in the blood and bone disorders. This medication helps to increase the amount of vitamin D in the body by overpassing the conversion step in the kidneys. Common disorders associated with chronic renal failure are:

  • Hypocalcemia: when the body does not absorb enough calcium
  • Secondary hyperparathyroidism: excess parathyroid hormone production as a result of renal failure
  • Osteodystrophy: alterations in bones due to renal failure

PATIENT RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

PRESCRIBING INFORMATION

Click here to download the Prescribing Information

FREQUENTLY ASKED QUESTIONS

How does this medication work? What will it do for me?

One Alpha® (alfacalcidol) is a vitamin D analog used for the management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adult patients with chronic renal failure

What are the possible side effects of this medication?

Common side effects include: pruritus, weakness, headache, red eyes, somnolence, nausea and vomiting, cardiac arrhythmia, dry mouth, and excessive thirst, constipation, muscle pain, metallic taste, polyuria, anorexia, weight loss, nocturia, conjunctivitis, corneal calcification, photophobia, rhinorrhea, pancreatitis, hyperthermia, decreased libido, albuminuria, and hypertension.

Each person may react differently to a treatment. If you think this medication may be causing side effects, talk to your doctor or pharmacist

How should this medication be taken?

Typically, this medication is taken once daily, though doctors’ orders should be followed if otherwise expressed.

What should I do if I miss a dose?

If you forget to take a dose, take it as soon as you can. But, if it is almost time for your next dose, do not double the dose

How should this medication be stored?
  • 25 mcg and 1 mcg capsule: below 25°C
  • Drops: 2-8°C
  • Injection liquid: 2-8°C
What other drugs could interact with this medication?

One Alpha® interacts with:

  • Digitalis glycosides
  • Mineral oil used as a laxative
  • Thiazide diuretics or calcium containing preparations
  • Vitamin D
  • Anticonvulsants
  • Antacids containing magnesium
  • Aluminum containing preparations
  • Bile acid sequestrants

If you are taking any of these medications, speak to your doctor or pharmacist before taking One Alpha products.

What forms does this medication come in?
One Alpha® products are available in capsule, tablet, and an injectable liquid
Are there any precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health. These factors may affect how you should use this medication.

The therapeutic margin with One Alpha® is narrow, therefore, the optimal daily dose must be carefully titrated for each individual patient.

One Alpha® should not be used in the following cases:

  • Pregnancy, unless clearly necessary
  • Concomitantly with other vitamin D products or derivates

One Alpha® should be used with caution in the following cases:

  • Patients with calcification of pulmonary tissue as this may result in cardiac disease.
  • While breastfeeding.

Patients with granulomatous diseases. 


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