Fortical

DRUG DESCRIPTION

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:

FORTICAL® (calcitonin-salmon) Amino acid sequence - Illustration

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 are more likely to occur, such as:

  • bleeding from your nose;
  • runny or stuffy nose;
  • dryness, itching, tenderness, or...

Read All Potential Side Effects and See Pictures of Fortical »

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...

Read All Potential Precautions of Fortical »


Fortical Consumer (continued)

SIDE EFFECTS: Runny nose, nose bleeds, nasal irritation, dry nose with crusting, headache, dizziness, nausea, flushing of the face, or back pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: nasal sores.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 product.


Fortical Patient Information Including Side Effects

Brand Names: Fortical, Miacalcin Nasal

Generic Name: calcitonin nasal (Pronunciation: kal si TOE nin)

  • What is calcitonin nasal (Fortical)?
  • What are the possible side effects of calcitonin nasal (Fortical)?
  • What is the most important information I should know about calcitonin nasal (Fortical)?
  • What should I discuss with my healthcare provider before using calcitonin nasal (Fortical)?
  • How should I use calcitonin nasal (Fortical)?
  • What happens if I miss a dose (Fortical)?
  • What happens if I overdose (Fortical)?
  • What should I avoid while using calcitonin nasal (Fortical)?
  • What other drugs will affect calcitonin nasal (Fortical)?
  • Where can I get more information?

What is calcitonin nasal (Fortical)?

Calcitonin is a man-made form of a hormone that occurs naturally in the thyroid gland.

Calcitonin nasal is used to treat osteoporosis in women who have been in menopause for at least 5 years.

Calcitonin nasal may also be used for purposes not listed in this medication guide.

What are the possible side effects of calcitonin nasal (Fortical)?

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 are more likely to occur, such as:

  • bleeding from your nose;
  • runny or stuffy nose;
  • dryness, itching, tenderness, or general discomfort of your nose;
  • crusting, scabs, or sores inside your nose;
  • redness in or around your nose;
  • warmth, redness, or tingly feeling under your skin;
  • headache;
  • back pain; or
  • nausea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about calcitonin nasal (Fortical)?

To make sure you are not allergic to this medication, your doctor may perform an allergy skin test before your first dose of calcitonin nasal.

Before using calcitonin nasal, tell your doctor if you have any nasal or sinus problems such as nasal deformities, a chronic infection, or nasal pain.

Avoid using any other nasal sprays or medicines at the same time you use calcitonin nasal unless your doctor has told you to.

Call your doctor at once if you have any type of severe irritation of your nose, or if you feel light-headed or faint.

Less serious nasal irritation is more likely to occur, such as minor bleeding, redness, itching, tenderness, dryness, crusting, scabs, or nasal congestion.

To be sure this medication is not causing harmful side effects to the inside of your nose, your doctor may want to check your nasal passages on a regular basis. Do not miss any scheduled visits to your doctor.

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