facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

FORTICAL- calcitonin salmon spray, metered


  1. What Is Fortical Nasal Spray?
  2. Do Not Use Fortical Nasal Spray If You:
  3. Before You Use Fortical Nasal Spray, Tell Your Healthcare Provider If You:
  4. Especially Tell Your Healthcare Provider If You Take:
  5. How Should I Use Fortical Nasal Spray?
  6. Fortical Nasal Spray May Cause Serious Side Effects, Including:
  7. Irritation Of Your Nose Can Happen While You Are Using Fortical Nasal Spray, Especially If You Are Over 65 Years Of Age. Call Your Healthcare Provider Right Away If You Have Any Of These Symptoms Of Nose Irritation:
  8. What Are The Ingredients In Fortical Nasal Spray?
  9. Important Information About Your Fortical Nasal Spray:
  10. Patient Information

What Is Fortical Nasal Spray? 

Fortical Nasal Spray is a prescription medicine used to treat osteoporosis in women more than 5 years after menopause. Fortical Nasal Spray should be used for women who cannot use other treatments or who choose not to use other treatments for osteoporosis.

It is not known if Fortical Nasal Spray lowers the chance of having bone fractures.

Calcitonin-salmon the active ingredient in Fortical Nasal Spray has not been shown to be effective in women less than 5 years after menopause.

It is not known if Fortical Nasal Spray is safe and effective in children under 18 years of age.

Do Not Use Fortical Nasal Spray If You: 

  • are allergic to calcitonin-salmon or any of the ingredients in Fortical Nasal Spray.

Before You Use Fortical Nasal Spray, Tell Your Healthcare Provider If You: 

  • have any other medical conditions
  • have low calcium levels in your blood
  • are pregnant or plan to become pregnant. It is not known if Fortical Nasal Spray can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Fortical Nasal Spray passes into your breast milk. You and your healthcare provider should decide if you will use Fortical Nasal Spray or breastfeed.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially Tell Your Healthcare Provider If You Take: 

  • lithium. Your healthcare provider may need to change your dose of lithium while you use Fortical Nasal Spray.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How Should I Use Fortical Nasal Spray? 

  • For detailed instructions,

Fortical Nasal Spray May Cause Serious Side Effects, Including: 

  • allergic reactions.Some people have had an allergic reaction when using Fortical Nasal Spray. Some reactions may be serious and can be life threatening. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of these symptoms of an allergic reaction.
    • trouble breathing
    • swelling of your face, throat or tongue
    • fast heartbeat
    • chest pain
    • feel dizzy or faint

If you might be allergic to calcitonin-salmon, your healthcare provider should do a skin test before you use Fortical Nasal Spray.

  • low calcium levels in your blood (hypocalcemia).Fortical Nasal Spray may lower the calcium in your blood. If you have low blood calcium before you start using Fortical Nasal Spray, it may get worse during treatment. Your low blood calcium must be treated before you use Fortical Nasal Spray. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your healthcare provider right away if you have any of these symptoms of low blood calcium:
    • numbness or tingling in your fingers, toes, or around your mouth
    Your healthcare provider should:
    • do blood tests while you use Fortical Nasal Spray
    • prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you use Fortical Nasal Spray.

Take your calcium and vitamin D as your healthcare provider tells you to.

  • nose irritation

Irritation Of Your Nose Can Happen While You Are Using Fortical Nasal Spray, Especially If You Are Over 65 Years Of Age. Call Your Healthcare Provider Right Away If You Have Any Of These Symptoms Of Nose Irritation: 

  • crusting
  • dryness
  • redness or swelling
  • nose sores (ulcers)
  • nose bleeds

Your healthcare provider may stop your treatment with Fortical Nasal Spray until your nose irritation symptoms go away.

  • risk of cancer

People who use calcitonin-salmon, the medicine in Fortical Nasal Spray, may have an increased risk of cancer. Your healthcare provider should check while you are using Fortical to

  • Store open bottles of Fortical Nasal Spray at room temperature , 68 F to 77 F (20 C to 25 C).
  • Store unopened bottles of Fortical Nasal Spray in the refrigerator between 36 F to 46 F (2 C to 8 C). Do not freeze.
  • Store Fortical Nasal Spray bottles in an upright position.
  • Safely throw away Fortical Nasal Spray in the trash after you have used 30 doses (sprays).

Keep Fortical Nasal Spray and all other medicines out of the reach of children.

General Information about the safe and effective use of Fortical Nasal Spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Fortical Nasal Spray for a condition for which it was not prescribed. Do not give Fortical Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about Fortical Nasal Spray. If you would like more information about Fortical Nasal Spray talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Fortical Nasal Spray that is written for health professionals.

For more information, go to www.upsher-smith.com or call 1-888-650-3789.

What Are The Ingredients In Fortical Nasal Spray? 

Active Ingredient: calcitonin-salmon

Inactive Ingredients: sodium chloride, citric acid, phenylethyl alcohol, benzyl alcohol, polysorbate 80, hydrochloric acid or sodium hydroxide and purified water.

Instructions for Use
Fortical
[f r-t -k l]
(calcitonin-salmon[rDNA origin])
Nasal Spray

For Nasal Use Only

Important Information About Your Fortical Nasal Spray: 

  • A single spray of Fortical Nasal Spray contains 1 daily dose of medicine.
  • Each Fortical Nasal Spray bottle contains the right amount of medicine. The bottle may not be completely filled to the top. This is normal.
  • This package contains 1 bottle of Fortical Nasal Spray and 1 screw-on pump.

Figure

  • Store unopened bottles of Fortical Nasal Spray in the refrigerator between 36 F to 46 F (2 C to 8 C). Do not freeze.
  • After you open your bottle of Fortical Nasal Spray, store it at room temperature between 68 F to 77 F (20 C to 25 C) in an upright position. Do not shake the bottle.

Preparing your Fortical Nasal Spray

Remove the bottle from your refrigerator and let it reach room temperature.

Step 1Step 1.Opening the Bottle.Set bottle on a flat surface like a table or counter top. Hold the bottle firmly while unscrewing the cap to avoid spilling any Fortical Nasal Spray.
Important: If your pharmacist attached the pump for you, skip to Step 4.
Step 2Step 2.Unwrapping the Pump.Carefully cut the wrapper with scissors or knife, and tear away from the pump. Be careful not to cut, bend, or touch the feed tube at the bottom.
Step 3Step 3. Attaching the Pump.Hold the bottle on a flat surface (like a table), and screw the pump onto bottle by gripping the grooves of the pump and twisting clockwise until the pump is tightly sealed to the bottle.
Step 4Step 4. Removing Cap.To remove the cap from the pump, twist slightly while pulling up. Save the cap to replace after each use.
Step 5Save the lock tab, and push it back onto the pump after each use to avoid accidentally wasting any Fortical Nasal SprayStep 5. Removing the Lock Tab.Grasp the lock tab between the thumb and forefinger, while holding the bottle on a flat surface. Pull sideways to remove the tab and unlock the pump.
Step 6Step 6. Prime New Pump Before First Use.
Before you use a new bottle of Fortical Nasal Spray for the first time, you will need to prime it. This will make sure you get the right dose of medicine each time you use it. After you attach the pump to the bottle, and the pump and bottle have reached room temperature, you should:
  • Hold the bottle upright.
  • With your index and middle fingers on each side of the top of the pump, and with your thumb under the bottle, push the pump down.
  • Push the pump down at least 5 times, until you

    • Unopened, refrigerated bottles can be used until the expiration date stamped on the bottle and box.
    • Throw away Fortical Nasal Spray after you use 30 doses (sprays).

    This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

    Distributed by
    UPSHER-SMITH LABORATORIES, INC.
    Maple Grove, MN USA 55369
    www.upsher-smith.com

    Revised 0714

Patient Information 

See FDA-approved patient labeling (Patient InformationandInstructions for Use).

  • Instruct patients on pump assembly, priming of the pump, and nasal introduction of Fortical nasal spray. Although instructions for patients are supplied with the individual bottle, procedures for use should be demonstrated to each patient [seeDosage and Administration (2.2)]. Patients should notify their healthcare provider if they develop significant nasal irritation [seeWarnings and Precautions (5.3)].
  • Inform patients of the potential increase in risk of malignancy [seeWarnings and Precautions (5.4)].
  • Advise patients to maintain an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) intake [seeDosage and Administration (2.3)].
  • Instruct patients to seek emergency medical help or go to the nearest hospital emergency room right away if they develop any signs or symptoms of a serious allergic reaction.
  • Advise patients how to correctly store unopened and opened product [seeHow Supplied/Storage and Handling (16)]. Advise patients that the bottle should be discarded after 30 doses, because after 30 doses, each spray may not deliver the correct amount of medication even if the bottle is not completely empty.

Distributed by
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN USA 55369

US Patent RE 40,182
US Patent RE 43,580
US Patent 6,440,392

Revised 0714



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com