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INTRODUCTION
CALCISOME NASAL SPRAY contains Calcitonin which belongs to the group of medicines called Calcium Metabolism Modifiers. It is used to treat postmenopausal osteoporosis (weak or brittle bones caused during menopause) in women who crossed 5 years of menopause when other treatments are not appropriate.
Prior to the treatment, the doctor will perform a skin test to determine whether you are allergic to Calcitonin or not. During treatment with CALCISOME NASAL SPRAY, your doctor may take several bone-related tests to evaluate improvement in your condition. You may also be prescribed with vitamin D or calcium supplements, along with CALCISOME NASAL SPRAY to improve your disease condition.
Before using CALCISOME NASAL SPRAY inform your doctor if you have low blood calcium levels or any type of cancer as a precaution. Do not use CALCISOME NASAL SPRAY without consulting your doctor if you are pregnant or breastfeeding.
The most common side effects of using CALCISOME NASAL SPRAY are nasal irritation, headache, back pain and muscle pain. Consult your doctor if any of these side effect worsens.
USES OF CALCISOME NASAL SPRAY
It is used among women (greater than 5 years of menopause) to:
- Treat postmenopausal osteoporosis
HOW CALCISOME NASAL SPRAY WORKS
CALCISOME NASAL SPRAY stops the action of certain bone cells (such as osteoclasts) that destroys the bone mass. This action prevents bone loss and helps in building bone mass and density. As a result, it makes your bones stronger and reduces the risk of fracture.
DIRECTIONS FOR USE
Use CALCISOME NASAL SPRAY as advised by your physician. It is for intranasal use only. Prior to the use, prime the device by pressing 2-3 puffs in the air. Place the nozzle of the device inside your nostril and gently press the pump to release the spray.
As CALCISOME NASAL SPRAY must be stored in the refrigerator, allow it to come to room temperature before use.
Your doctor will decide the suitable dose, the number of sprays and duration of therapy for you depending on your age, body weight and health condition. Do not stop using CALCISOME NASAL SPRAY without consulting your doctor.
SIDE EFFECTS OF CALCISOME NASAL SPRAY
COMMON
- Back pain, muscle pain
- Headache
- Runny nose
- Nasal irritation or dryness
RARE
Stop using CALCISOME NASAL SPRAY and contact your doctor immediately if you experience any of the following side effects such as:
- severe allergic reactions (such as skin rash, itching, swelling of the face, lips, eyes, tongue or throat causing wheezing or difficulty in breathing, chest tightness, fall in blood pressure, increased heartbeat)
- signs of hypocalcemia (such as tingling or numbness of fingers, toes or around the mouth)
- severe nasal irritation with nasal bleeding, redness, swelling or soreness, crusting sensation and nasal dryness
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a pain-relieving balm on the head if necessary. Do not consume alcohol. Contact your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
There are no adequate studies to confirm the effects of CALCISOME NASAL SPRAY on pregnant women. Therefore, CALCISOME NASAL SPRAY should be used in pregnant women, only if considered necessary by the physician.
BREASTFEEDING
There are no adequate studies to confirm whether CALCISOME NASAL SPRAY can pass through breast milk or not. Therefore, CALCISOME NASAL SPRAY should be used in breastfeeding women, only if considered necessary by the physician.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if your ability is affected by CALCISOME NASAL SPRAY.
ALLERGY
Talk to your doctor before using CALCISOME NASAL SPRAY if you are allergic to Calcitonin.
OTHERS
Before using CALCISOME NASAL SPRAY, inform your doctor if you have:
- hypocalcaemia (low calcium levels in blood)
- any form of cancer
Use in pediatrics:
CALCISOME NASAL SPRAY is generally not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor before using it.
Use in geriatrics:
CALCISOME NASAL SPRAY should be used with caution in elderly patients (aged above 65 years). Therefore, consult your doctor before using it.
INTERACTIONS
A. Drug - Drug interactions:
Before using CALCISOME NASAL SPRAY, inform your doctor if you are taking any of the following medicines such as:
- medicines used to treat depression and mania (Ex. lithium)
- other medicines used to treat osteoporosis (Ex. alendronate, zoledronic acid)
Overdosage:
If you or anyone else accidentally took more CALCISOME NASAL SPRAY contact your doctor or go to the nearest hospital straight away.
SYNOPSIS
| Drug | : | Calcitonin |
| Pharmacological Category | : | Calcitonin Receptor Agonist |
| Therapeutic Indication | : | Postmenopausal Osteoporosis |
| Dosage Forms | : | Injection, Nasal Spray |
MORE INFORMATION
- Keep CALCISOME NASAL SPRAY out of the sight and reach of children
- Store CALCISOME NASAL SPRAY in a refrigerator between 2 to 8°C
FAQs ABOUT CALCISOME NASAL SPRAY
What is the use of CALCISOME NASAL SPRAY?
CALCISOME NASAL SPRAY is used to treat postmenopausal osteoporosis (weak or brittle bones caused during menopause) in women who crossed 5 years of menopause when other treatments are not appropriate.
How to use CALCISOME NASAL SPRAY?
CALCISOME NASAL SPRAY is for intranasal use only. Prior to the use, prime the device by pressing 2-3 puffs in the air. Place the nozzle of the device inside your nostril and gently press the pump to release the spray.
What are the side effects of CALCISOME NASAL SPRAY?
The most common side effects of using CALCISOME NASAL SPRAY are nasal irritation, headache, back pain and muscle pain. Consult your doctor if any of these side effect worsens.
Can elderly patients use CALCISOME NASAL SPRAY?
Yes, elderly patients can use CALCISOME NASAL SPRAY after consulting their doctor.
Can CALCISOME NASAL SPRAY cure osteoporosis?
Yes. CALCISOME NASAL SPRAY helps in preventing osteoporosis and helps in gaining back the lost bone mass in postmenopausal women.
How CALCISOME NASAL SPRAY works?
CALCISOME NASAL SPRAY stops the action of certain bone cells (such as osteoclasts) that destroys the bone mass. This action prevents bone loss and helps in building bone mass and density. As a result, it makes your bones stronger and reduces the risk of fracture.
Can I stop therapy with CALCISOME NASAL SPRAY once my symptoms subside?
No. Do not stop using CALCISOME NASAL SPRAY without consulting your doctor once your symptoms subside, as it may reverse the healed condition. Continue to use CALCISOME NASAL SPRAY as long as instructed by your doctor.
Can CALCISOME NASAL SPRAY cause cancer?
Yes. CALCISOME NASAL SPRAY might cause cancer when used in long-term. Therefore, contact your doctor for advice before using it.
REFERENCES
1. KD. Tripathi. Drugs affecting Calcium Balance. Essentials of Medical Pharmacology. 7th Edition. 2013. Page – 340.
2. C H Chesnut 3rd 1, S Silverman, K Andriano, H Genant, A Gimona, S Harris, D Kiel, M LeBoff, M Maricic, P Miller, C Moniz, M Peacock, P Richardson, N Watts, D Baylink. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. Pubmed.gov. September 2000. [Accessed on 29th November 2022] https://pubmed.ncbi.nlm.nih.gov/10996576/
3. Novartis Pharma Stein AG. U.S. Food & Drug Administration. [Revised in September 2017] [Accessed on 29th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020313s036lbl.pdf
4. Novartis Pharmaceutical Corporation. U.S. Food & Drug Administration. [Revised in July 2011] [Accessed on 29th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020313s033lbl.pdf
5. Par Pharmaceutical. Calcitonin. [Revised in June 2016] [Accessed on 29th November 2022] https://www.parsterileproducts.com/pdfs/catalog/generic/Calcitonin_PI_20200506.pdf
6. Calcitonin. Apotex Inc. [Revised in November 2017] [Accessed on 29th November 2022] https://www1.apotex.com/products/us/downloads/pil/calc_naso_pil.pdf
7. Apotex Corp. Dailymed. [Revised in January 2021] [Accessed on 29th November 2022]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c82eb602-12e1-692b-d660-f8d5b5736b54&audience=professional
USEFUL DIAGNOSTIC TESTS
- Blood Calcium Levels
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