One-Alpha 2mcg/ml Oral Drops

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Dr. Mohd Izzat Amir Bin Awang
Reviewed byDr. Mohd Izzat Amir Bin AwangDoctor of Medicine (MD), University of Mansoura - Manchester
Dr. Adeline Carol Peters
Written byDr. Adeline Carol PetersBachelor of Medicine and Bachelor of Surgery (MBBS) — Manipal Academy of Higher Education (MAHE)

Last updated:

Overview

One-Alpha 2mcg/ml Oral Drops is an oral liquid containing alfacalcidol 2 micrograms per ml. In the manufacturer’s information for One-Alpha drops, each drop delivers about 0.1 microgram of alfacalcidol, which allows very small, precise doses to be measured with the integral dropper. Alfacalcidol (1α-hydroxyvitamin D3) is a synthetic vitamin D analogue that the liver converts into calcitriol, the active hormonal form of vitamin D, without needing the kidney activation step that ordinary vitamin D3 requires.

Alfacalcidol is used under medical supervision in conditions involving disturbed calcium and vitamin D metabolism, such as low calcium in newborns, certain types of rickets and bone softening, and bone and calcium disorders linked to reduced kidney function or parathyroid problems. Because calcitriol strongly increases calcium and phosphate absorption, the dose is calculated individually by a doctor, often according to body weight in babies and children, and is adjusted using regular blood tests. The drop form is mainly intended for infants, children and others who need small or finely adjusted doses or who cannot swallow capsules.

One-Alpha drops are not an everyday vitamin D drop for babies and must not be used as a substitute for, or together with, a routine infant vitamin D supplement unless a doctor specifically advises it. In the manufacturer’s information, the drops also contain ethanol, sorbitol and methyl parahydroxybenzoate, which may matter for some patients. Please refer to the product label and packaging for the exact ingredients and bottle size of the pack supplied.

Directions for Use

Use One-Alpha Oral Drops only as instructed by your doctor. Count the exact number of drops prescribed using the dropper built into the bottle and give them by mouth; the manufacturer’s information advises rounding any half-drop dose up to the next whole drop. Give the dose at about the same time each day.

For babies and children, a parent or carer should give each dose and keep a record of it to avoid accidental double dosing. Do not change the number of drops or stop treatment without speaking to the doctor, and keep all appointments for blood tests, as the dose is adjusted according to calcium and phosphate results. Close the bottle properly after each use.

Dosage

The dose of alfacalcidol is individual and must always follow the doctor’s instructions. In babies and children it is usually calculated according to body weight, while adults and older adults are given doses based on their condition; in every age group the doctor typically starts with a cautious dose and adjusts it in small steps according to blood test results.

There is no standard self-selected dose for this product, and the drop count should never be guessed from the strength on the label. If a dose is missed, ask your doctor or pharmacist for advice rather than giving a double dose. If too much has been taken, especially by a child, contact a doctor or go to the nearest emergency department promptly, because excess alfacalcidol can cause high blood calcium.

Shelf Life

Refer to the expiry date printed on the product packaging. In the manufacturer’s information for One-Alpha drops, an opened bottle should be used within 4 months when kept refrigerated; please follow the in-use period stated on the label of the pack you receive and note the date you first open the bottle.

Storage Instructions

  • In the manufacturer’s information, One-Alpha Oral Drops are stored in a refrigerator at 2–8°C, in the outer carton to protect from light. Please follow the storage instructions on the label of the pack supplied.
  • Keep the bottle tightly closed and out of the sight and reach of children, as accidental swallowing can cause high calcium levels.

Side Effects

  • Common: High blood calcium (hypercalcaemia) or high blood phosphate, which may cause nausea, vomiting, thirst, passing more urine, tiredness, weakness, poor feeding or irritability in babies, muscle or bone pain, or confusion.
  • Common: Abdominal pain or discomfort, skin rash and itching.
  • Uncommon: Headache, nausea, vomiting, diarrhoea, constipation, muscle pain and general tiredness or weakness.
  • Uncommon: Increased calcium in the urine, kidney stones or calcium deposits in the kidneys or other tissues.
  • Uncommon: Stomach upset and diarrhoea related to the macrogol-based ingredient in the drops; delayed allergic reactions to methyl parahydroxybenzoate are possible.
  • Serious: Worsening kidney function, confusion, hives or other allergic reactions. Seek medical attention promptly if these occur.

Contraindications

  • Known allergy to alfacalcidol or to any of the other ingredients in the drops, including methyl parahydroxybenzoate.
  • High blood calcium levels (hypercalcaemia).
  • Metastatic calcification (abnormal calcium deposits in body tissues).
  • Hereditary fructose intolerance, because the drops contain sorbitol, unless a doctor has assessed the risk.
  • Use in pregnancy is generally not recommended unless a doctor decides it is clearly needed.

Drug / Food Interactions

  • Other vitamin D products, including routine infant vitamin D drops and multivitamins: increase the risk of high calcium and should not be combined without the doctor’s advice.
  • Calcium supplements and thiazide diuretics: may increase the risk of high blood calcium; calcium levels should be monitored.
  • Digoxin and other digitalis medicines: high calcium levels increase the risk of irregular heartbeat.
  • Magnesium-containing antacids or laxatives: may lead to high magnesium levels, especially in kidney disease.
  • Aluminium-containing products (e.g. aluminium hydroxide, sucralfate): may raise aluminium levels in the blood.
  • Bile acid sequestrants (e.g. cholestyramine): may reduce absorption; give alfacalcidol at least 1 hour before or 4–6 hours after them.
  • Certain anticonvulsants (e.g. phenytoin, carbamazepine, phenobarbital, primidone): may speed up vitamin D breakdown so dose adjustment may be needed.
  • Food and formula: calcium-fortified formula or foods add to total calcium intake; tell the doctor what milk or formula the child takes.

Quick Tips

  • Count the drops carefully every time and give exactly the number prescribed.
  • Keep a simple daily chart when giving the drops to a baby or child so that no dose is given twice.
  • Do not give other vitamin D drops or multivitamins alongside One-Alpha unless the doctor approves.
  • Keep all blood test appointments, as they guide safe dose changes.
  • Write the opening date on the bottle and store it as stated on the label.
  • Watch for signs of high calcium, such as vomiting, poor feeding, unusual sleepiness, excessive thirst or constipation, and contact the doctor early.

Ingredients / Active Ingredients

  • Active ingredient: Alfacalcidol (1α-hydroxyvitamin D3) 2mcg per ml
  • Other ingredients: Ethanol, sorbitol, methyl parahydroxybenzoate, macrogolglycerol hydroxystearate, sodium citrate, citric acid, all-rac-alpha-tocopherol, purified water (refer to the product label of the pack supplied)
  • Active ingredient: Alfacalcidol (1α-hydroxyvitamin D3) 2 micrograms per ml (about 0.1 microgram per drop according to the manufacturer’s information).
  • Dosage form: Oral drops with an integral dropper.
  • Ingredients of note in the manufacturer’s information: Ethanol, sorbitol, methyl parahydroxybenzoate (E218), macrogolglycerol hydroxystearate and sodium citrate; refer to the product label for the full list.

Relevant Information

Precautions: Alfacalcidol strongly affects blood calcium and phosphate, so it should only be used under medical supervision with regular blood tests, particularly in babies and children, people with kidney disease and anyone on higher doses. Use in infants and children should only be under a doctor’s supervision with a carefully calculated dose. Extra care is needed in people with kidney stones, sarcoidosis or other granulomatous diseases, or heart conditions treated with digoxin. The drops contain a small amount of ethanol and sorbitol, which should be considered in babies and in people with hereditary fructose intolerance. Pregnancy is generally a reason to avoid this product unless a doctor decides otherwise, and during breastfeeding the baby may need to be monitored for high calcium.

When to See a Doctor or Pharmacist: Contact the doctor promptly if the person taking the drops develops persistent vomiting, poor feeding, constipation, excessive thirst, passing large amounts of urine, unusual sleepiness or irritability, muscle weakness, confusion, irregular heartbeat or a skin rash. Speak to a doctor or pharmacist before starting any other vitamin, calcium product, antacid or new medicine during treatment.

Frequently Asked Questions

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