"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
(calcitonin-salmon rDNA origin) Nasal Spray
For Intranasal Use Only
- Patient Information:
Details with Side Effects
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
The active ingredient in FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin-salmon produced by chemical synthesis.
This is shown by the following graphic formula:
It is provided in a 3.7 mL fill glass bottle as a solution for intranasal administration with sufficient medication for at least 30 doses. Each spray delivers 200 International Units calcitonin-salmon in a volume of 0.09 mL.
Active Ingredient: Calcitonin-salmon 2200 International Units/mL, corresponding to 200 International Units per actuation (0.09 mL).
Inactive Ingredients: Sodium Chloride USP, Citric Acid USP, Phenylethyl Alcohol USP, Benzyl Alcohol NF, Polysorbate 80 NF, Hydrochloric Acid NF or Sodium Hydroxide NF (added as necessary to adjust pH) and Purified Water USP.
What are the possible side effects of calcitonin nasal (Fortical, Miacalcin Nasal)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- feeling light-headed, fainting; or
- severe nasal irritation.
Less serious side effects may include:
- bleeding from your nose;
- runny or stuffy nose;
- dryness, itching, tenderness, or general discomfort of your nose;
- crusting, scabs, or sores inside your...
What are the precautions when taking calcitonin-salmon (rdna origin) (Fortical)?
Before taking calcitonin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication is used mainly in women after menopause. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this...
Last reviewed on RxList: 8/26/2011
This monograph has been modified to include the generic and brand name in many instances.
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