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INTRODUCTION
ALPHADOL 0.25MCG CAPSULE contains Alfacalcidol which belongs to the group of medicines called Vitamin D analogues. It is used to treat osteodystrophy (changes in bone caused by kidney failure) and changes in parathyroid glands (responsible for producing parathyroid hormone which controls the amount of calcium in the body).
ALPHADOL 0.25MCG CAPSULE is also used to treat hypocalcaemia (decreased calcium levels) in newborn babies and osteomalacia or rickets (softening and deformity of the bones due to lack of calcium).
During the treatment with ALPHADOL 0.25MCG CAPSULE, your doctor may conduct blood tests to determine the amount of calcium and phosphorus in the blood, an enzyme called alkaline phosphatase or the parathyroid hormone. You may also have other tests such as X-rays to determine the dose that fits you.
ALPHADOL 0.25MCG CAPSULE is not recommended for use in patients with hypercalcaemia (high levels of calcium in the blood), calcification (high levels of calcium in your body tissues). Contact your doctor before taking.
ALPHADOL 0.25MCG CAPSULE should be used with caution in patients with kidney disease or kidney stones and granulomas or sarcoidosis (collection of inflammatory cells). Contact your doctor before taking.
ALPHADOL 0.25MCG CAPSULE should be used with caution in pregnant and breastfeeding women. Consult with your doctor before taking. ALPHADOL 0.25MCG CAPSULE can be used in children and elderly patients. Your doctor will decide the correct dose and duration depending on your age, body weight and disease condition. Consult with your doctor before taking.
The most common side effects of taking ALPHADOL 0.25MCG CAPSULE are abdominal pain, rash, itching. Contact your physician if the symptoms worsen or doesn’t improve.
USES OF ALPHADOL 0.25MCG CAPSULE
Treats:
- osteodystrophy
- hyperparathyroidism
- hypoparathyroidism
- hypocalcaemia (decreased calcium levels) in newborn babies
- osteomalacia or rickets
HOW ALPHADOL 0.25MCG CAPSULE WORKS
ALPHADOL 0.25MCG CAPSULE works by increasing the amount of vitamin D (controls the levels of calcium and phosphorus required for healthy bones and teeth) in the body. ALPHADOL 0.25MCG CAPSULE stimulates calcium absorption in the intestines, increases urinary calcium excretion and serum calcium levels, and suppresses parathyroid hormone (PTH) secretion. Thus, increasing the levels of calcium and phosphate in the body and restoring the essential functions and activities of vitamin D.
DIRECTIONS FOR USE
Take ALPHADOL 0.25MCG CAPSULE as advised by your physician. Swallow the medicine with water and do not crush or chew the medicine. Dose and duration will be decided by your physician depending on your age, body weight and disease condition.
SIDE EFFECTS OF ALPHADOL 0.25MCG CAPSULE
COMMON
- abdominal pain
- rash, itching
UNCOMMON
- headache
- nausea, vomiting, diarrhoea, constipation,
- muscle pain
- fatigue
- calcinosis (deposition of calcium in the body)
- feeling weak or unwell.
RARE
- dizziness.
Stop taking ALPHADOL 0.25MCG CAPSULE and contact your physician immediately if you experience any of the following side effects:
- signs of allergic reaction such as severe rashes, swelling of face or throat causing difficulty breathing
- signs of too much calcium or phosphate in your body such as muscle pain or bone pain and weakness, need to pass urine more often, feeling thirsty, fatigue, nausea, vomiting, constipation, loss of appetite, sweating a lot, headache, confusion, drowsiness
- signs of kidney problems such as decreased frequency of urination, swelling of feet or ankles, fever, pain in one side (kidney stones)
HOW TO MANAGE SIDE EFFECTS
Stomach pain:
Try to rest and relax. Eat small and frequent meals. Keep a heating pad on your stomach. Contact your doctor if the stomach pain worsens.
Itchy skin:
Avoid hot showers because hot water can irritate the skin. Do not scratch the affected area. Use sunscreen and protective clothing when outdoors. Regularly use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if the itching worsens.
Headache:
Take rest and relax. Drink plenty of water and electrolytes. Apply a pain-relieving balm on the head if needed. Do not consume alcohol. Contact your doctor if your headache does not improve.
Nausea or vomiting:
Take ALPHADOL 0.25MCG CAPSULE, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if nausea and vomiting worsen.
Diarrhoea:
Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not take any medicine on your own to treat diarrhoea. Contact your doctor if diarrhoea worsens.
Constipation:
Eat fibre-rich foods such as fresh fruits, vegetables, and cereals. Drink more water and exercise regularly. Contact your doctor if constipation does not improve
Dizziness:
Try to rest and relax. Get enough sleep. Do not drive or operate any machinery if you feel dizzy. Avoid alcohol consumption as it aggravates dizziness. Contact your doctor if the dizziness worsens.
WARNING & PRECAUTIONS
PREGNANCY
ALPHADOL 0.25MCG CAPSULE should be used with caution in pregnant women. Contact your doctor before taking ALPHADOL 0.25MCG CAPSULE
BREASTFEEDING
ALPHADOL 0.25MCG CAPSULE should be used with caution in breastfeeding women. Contact your doctor before taking ALPHADOL 0.25MCG CAPSULE
DRIVING AND USING MACHINES
Do not drive or operate machines if you feel dizzy after taking [GBNKEYWORD
KIDNEY
ALPHADOL 0.25MCG CAPSULE should be used with caution in patients with kidney disease or kidney stones. Contact your doctor before taking ALPHADOL 0.25MCG CAPSULE
ALLERGY
Do not take ALPHADOL 0.25MCG CAPSULE if you are allergic to Alfacalcidol, Sesame oil, or to other ingredients of this medicine.
OTHERS
ALPHADOL 0.25MCG CAPSULE is not recommended for use if you have:
- hypercalcaemia (high levels of calcium in the blood)
- calcification (elevated calcium levels in body tissues).
Before taking ALPHADOL 0.25MCG CAPSULE, inform your doctor if you have:
- granulomas or sarcoidosis
Use in paediatrics:
ALPHADOL 0.25MCG CAPSULE can be used in newborn babies, premature babies, and children. Your doctor will decide the correct dose and duration for your child depending on your child’s age, body weight and disease condition. Consult with your child’s doctor before giving ALPHADOL 0.25MCG CAPSULE to your child.
Use in geriatrics:
ALPHADOL 0.25MCG CAPSULE can be used in elderly patients. Your doctor will decide the correct dose and duration for depending on your age, body weight and disease condition. Consult with your doctor before giving taking.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ALPHADOL 0.25MCG CAPSULE, inform your doctor if you are taking any of the following medicine:
- barbiturates, phenytoin, carbamazepine or primidone (medicines used for treating fits)
- digoxin (medicine used for heart failure)
- thiazide diuretics such as chlorthiazide (medicines used for high blood pressure)
- other medicines that contain vitamin D or calcium (Ex. calcipotriol, doxercalciferol, calcitrol)
- antacids containing magnesium or aluminium (medicines used for heartburn or indigestion)
- bile acid sequestrants such as cholestyramine (medicines used for lowering cholesterol levels)
Overdosage:
If you or anyone else accidentally take too much of ALPHADOL 0.25MCG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage include too much calcium or phosphate in your blood causing weakness or pain in muscles or bones, need to pass urine more often, feeling thirsty, fatigue, nausea, vomiting, constipation, loss of appetite, sweating a lot, headache, confusion, drowsiness.
SYNOPSIS
| Drug | : | Alfacalcidol |
| Pharmacological Category | : | Vitamin D analogues |
| Therapeutic Indication | : | Osteodystrophy, Hyperparathyroidism, Hypoparathyroidism, Hypocalcaemia in new born babies, Osteomalacia or rickets |
| Dosage Forms | : | Tablet, Capsule, Soft gel capsule |
MORE INFORMATION
- Keep ALPHADOL 0.25MCG CAPSULE out of the sight and reach of children
- Store ALPHADOL 0.25MCG CAPSULE below 30°C
FAQs ABOUT ALPHADOL 0.25MCG CAPSULE
What is ALPHADOL 0.25MCG CAPSULE used for?
It is used to treat osteodystrophy (changes in bone caused by kidney failure), changes in parathyroid glands (responsible for producing the parathyroid hormone which controls the amount of calcium in the body) including hyperparathyroidism (glands may make the amount of calcium in your blood too high) and hypoparathyroidism (glands may make the amount of calcium in your blood too low), Low levels of calcium in the blood of newborn babies (hypocalcaemia) and osteomalacia or rickets (softening and deformity of the bones due to lack of calcium). Contact your doctor before taking ALPHADOL 0.25MCG CAPSULE.
What are the side effects of ALPHADOL 0.25MCG CAPSULE?
The most common side effects of taking ALPHADOL 0.25MCG CAPSULE are abdominal pain, rash, itching. Contact your physician if the symptoms worsen.
Is it safe to take ALPHADOL 0.25MCG CAPSULE?
Yes. ALPHADOL 0.25MCG CAPSULE is safe when it is taken in the dose prescribed your physician and it is not recommended for use in patients with allergic history to alfacalcidol, hypercalcaemia (high levels of calcium in the blood), calcification (high levels of calcium in your body tissues). Contact your doctor before taking.
Do I need to undergo any tests while being treated with ALPHADOL 0.25MCG CAPSULE?
During the treatment with ALPHADOL 0.25MCG CAPSULE, your doctor may conduct blood tests to determine the amount of calcium and phosphorus in the blood, an enzyme called alkaline phosphatase or the parathyroid hormone. You may also have other tests such as X-rays to determine the dose that fits you.
Do I need to take any other medicines along with ALPHADOL 0.25MCG CAPSULE to maintain calcium and phosphate levels?
Your doctor may prescribe another medicine called a phosphate binding agent or a calcium supplement to take as well as ALPHADOL 0.25MCG CAPSULE. This will help to keep the right amount of calcium and phosphate in your blood. Consult with your doctor.
REFERENCES
1. K.D. Tripathi. Hormones and drugs affecting calcium balance. Essentials of medical pharmacology. Eighth edition. 2019. Page – 368.
2. Mahidol University. A Randomised Trial Comparing Pulse Calcitriol and Alfacalcidol for the Treatment of Secondary Hyperparathyroidism in Haemodialysis Patients. NIH U.S. National Library of Medicine. ClinicalTrials.gov. May 2010. [Accessed on 29th July 2022] https://clinicaltrials.gov/ct2/show/NCT01115543
3. A Shiraishi, S Higashi, H Ohkawa, N Kubodera, T Hirasawa, I Ezawa, K Ikeda, E Ogata. The advantage of alfacalcidol over vitamin D in the treatment of osteoporosis. NIH National Library of Medicine, National Centre for Biotechnology Information. Pubmed.gov. October 1999. [Accessed on 29th July 2022] https://pubmed.ncbi.nlm.nih.gov/10485984/
4. LEO Pharma A/S. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 29th July 2022] https://www.medicines.org.uk/emc/files/pil.5516.pdf
USEFUL DIAGNOSTIC TESTS
- 1,25- Dihydroxy Vitamin D3
- Serum calcium
- Serum Phosphorus
PRODUCT DETAILS
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