Miacalcin

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.

Miacalcin® (calcitonin-salmon) Nasal Spray is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:

 Miacalcin® (calcitonin-salmon) Structural Formula Illustration

It is provided in a 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 30 doses.

Active Ingredient: calcitonin-salmon 2200 I.U. per mL (corresponding to 200 I.U. per 0.09 mL actuation).

Inactive Ingredients: sodium chloride, benzalkonium chloride, hydrochloric acid (added as necessary to adjust pH) and purified water.

The activity of Miacalcin (calcitonin-salmon) Nasal Spray is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute of Biologic Standards and Control, Holly Hill, London.

What are the possible side effects of calcitonin injection (Miacalcin)?

You may have increased bone pain during the first few months of treatment with calcitonin injection. This is not a sign that the medication isn't working properly.

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
  • muscle stiffness.

Less serious side effects...

Read All Potential Side Effects and See Pictures of Miacalcin »

What are the precautions when taking calcitonin-salmon (Miacalcin)?

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 Miacalcin »


Miacalcin 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.


Miacalcin Patient Information Including Side Effects

Brand Names: Miacalcin

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

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

What is calcitonin injection (Miacalcin)?

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

Calcitonin injection is used to treat Paget's disease of bone, postmenopausal osteoporosis, or high levels of calcium in the blood (hypercalcemia).

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

What are the possible side effects of calcitonin injection (Miacalcin)?

You may have increased bone pain during the first few months of treatment with calcitonin injection. This is not a sign that the medication isn't working properly.

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
  • muscle stiffness.

Less serious side effects may include:

  • warmth, redness, itching, or tingly feeling under your skin;
  • nausea, loss of appetite, stomach pain;
  • vomiting;
  • skin rash or itching;
  • increased urination, especially at night;
  • eye pain;
  • swelling in your feet; or
  • swelling or irritation of the skin where an injection was given.

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 injection (Miacalcin)?

Do not use this medication if you are allergic to salmon calcitonin.

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

Calcitonin injection is not a cure for Paget's disease and you may have a relapse, especially if your body forms antibodies and you become immune to calcitonin. Talk with your doctor at any time if you think the medication is not working as well as it did before.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled appointments.

Calcitonin injection can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

It is important to use calcitonin injection regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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