Introduction About LARETOL INJECTION

LARETOL INJECTION contains Calcitriol, which belongs to the class of medications called vitamin D analogs. Calcitriol is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It significantly reduces elevated parathyroid hormone levels and shows improvement in renal osteodystrophy.

LARETOL INJECTION is not recommended for use if you have hypercalcemia (increased levels of calcium levels in the blood) or vitamin D toxicity (high vitamin D levels). Consult your doctor before taking it.

LARETOL INJECTION should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. Consult your doctor for advice. Before using LARETOL INJECTION, inform your doctor if you are breastfeeding, as it is known whether it may pass through the breast milk.

The safety and efficacy of LARETOL INJECTION are not established in children and adolescents under 18 years of age. LARETOL INJECTION should be used with caution with elderly patients. Consult your doctor before taking it.

The most common side effects of receiving LARETOL INJECTION are hypercalcemia (high calcium levels in the blood). Consult your doctor if you experience any side effects after receiving LARETOL INJECTION.

Uses Of LARETOL INJECTION

• To manage hypocalcemia in patients undergoing chronic renal dialysis
• Reduces elevated parathyroid hormone levels

How LARETOL INJECTION Works

LARETOL INJECTION elevates the plasma levels of calcium by stimulating intestinal calcium uptake, increasing reabsorption of calcium by the kidneys, and possibly increasing the release of calcium from skeletal stores. It works by helping the body use more of the calcium found in foods or supplements and regulating the body's production of parathyroid hormone.

How to use LARETOL INJECTION

LARETOL INJECTION will be given to you only by a doctor or a nurse into a vein (intravenously). Your doctor will decide the correct dose and duration of LARETOL INJECTION for you depending upon your age, body weight, and disease condition.

Side Effects Of LARETOL INJECTION

How To Manage Side Effects

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines while you are feeling dizzy. Do not drink alcohol, as it can aggravate your dizziness. Contact your doctor if your dizziness does not improve.

Warning & Precautions

Pregnancy

Monitoring required

LARETOL INJECTION should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. Consult your doctor for advice.

Breastfeeding

Consult your doctor

Before using LARETOL INJECTION, inform your doctor if you are breastfeeding, as it is known whether it may pass through the breast milk.

Allergy

Contraindicated

Do not receive LARETOL INJECTION if you are allergic to calcitriol or any of the other ingredients in this medicine.

Use In Pediatrics

Consult your doctor

The safety and efficacy of LARETOL INJECTION are not established in children and adolescents under 18 years of age. Consult your doctor before taking it.

Use In Geriatrics

Use with Caution

LARETOL INJECTION should be used with caution with elderly patients. Consult your doctor before taking it.

Interactions

A. Drug-Drug Interactions:

Before receiving LARETOL INJECTION, inform your doctor if you are taking any of the following medicines:

• medicines used to manage heartburn and indigestion (magnesium-containing antacids)
• medicines containing vitamin D or vitamin D analogues (Ex. ergocalciferol, cholecalciferol)
• medicines used to manage heart conditions (Ex. digitalis)
• anticonvulsants (medicines used to manage epilepsy) Ex. barbiturates, diphenylhydantoin
• corticosteroids (medicines used to manage pain and inflammation) Ex. prednisone and cortisone
• medicines used to manage high blood pressure or kidney problems Ex. hydrochlorothiazide

Overdosage:

LARETOL INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so you are unlikely to receive an overdose. Overdosage may cause hypercalcemia, hypercalciuria, and hyperphosphatemia. Consult your doctor if you experience any unusual symptoms after receiving LARETOL INJECTION.

Synopsis

More Information

• Keep LARETOL INJECTION out of reach of children.
• Store LARETOL INJECTION below 25°C

FAQs About LARETOL INJECTION

Q: How does LARETOL INJECTION work?

A: LARETOL INJECTION increases the amount of calcium in the blood by increasing absorption of calcium from the intestines, reducing any loss of calcium from the kidneys, and reducing levels of serum parathyroid hormone.

Q: Is LARETOL INJECTION safe during pregnancy?

A: LARETOL INJECTION should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus. Consult your doctor for advice.

Q: Who should not receive LARETOL INJECTION?

A: LARETOL INJECTION is not recommended for use if you are allergic to calcitriol or have hypercalcemia (increased levels of calcium levels in the blood) or vitamin D toxicity (high vitamin D levels). Consult your doctor before using it.

Q: What precautions must be taken while using LARETOL INJECTION?

A: Before receiving LARETOL INJECTION, inform your doctor if you have high levels of serum phosphorus, hypercalcemia (a high level of calcium in the blood) or hypercalciuria (an increase in the amount of calcium excreted in the urine), are dehydrated, or have had surgical operations.

References

1. Peter A. Friedman. Agents affecting mineral ion Homeostatsis and Bone Turnover. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 12th ed. New York, McGraw-Hill Medical 2011. Page -1291.

2. KD Tripathi MD. Hormones and Related drugs: Thyroid Hormones and Thyroid Inhibitors. Essentials of Medical Pharmacology 7th Edition. New Delhi, May 2013. Page –338.

3. M. Kitaoka, N. Onoda, H. Kitamura, F. Koiwa, M. Tanaka & M. Fukagawa. Percutaneous Calcitriol injection therapy (PCIT) for secondary hyperparathyroidism: multicentre trial. Nephrology Dialysis Transplantation, 2003; [Accessed on 10th February 2024] https://pubmed.ncbi.nlm.nih.gov/12771298/

4. AbbVie Pty Ltd; 2012 [Accessed on 10th February 2024] https://gp2u.com.au/static/pdf/C/CALCIJEX-CMI.pdf

5. Abbott Laboratories, 2012; Inc. Hospira; U.S. Food & Drug Administration; [Accessed on 10th February 2024] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf

6. SteriMax Inc. Calcitriol. [Revised in February 2016] [Accessed on 10th February 2024] https://sterimaxinc.com/wp-content/uploads/2016/03/Calcitriol-Injection-USP-PM-Clean-March-10-2016.pdf

Useful Diagnostic Tests

• CalciumPth-Intact Molecule Parathyroid Hormone
• Magnesium, Serum
• Alkaline Phosphatase, Serum
• Phosphorous- Urine
• Vitamin D 1,25 Dihydroxy
• Basic Bone Care
• Advance Bone Care
• Comprehensive Bone Care
• Esr Automated
• Phosphorus-Inorganic, Serum
• Basic Arthritis Care Plan
• Bone Strength Package
• Arthritis Profile-Basic
• Arthritis Profile-Advanced
• Pth-Intact Molecule Parathyroid Hormone