Calcitonin salmon

What is Calcitonin salmon?

• Calcitonin salmon (Calcimar Injection; Miacalcin Injection) is a calcitonin.
• 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.
• Calcitonin Salmon Injection, USP, Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin.

Calcitonin

Calcitoninpeptide

What are the uses of this medicine?

Calcitonin salmon (Calcimar Injection; Miacalcin Injection) is used for the following conditions:

• Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable.
• Treatment of hypercalcemia.
• Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated.

Limitations of use:

• Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis.

How does this medicine work?

• Calcitonin salmon is a calcitonin receptor agonist.
• Calcitonin salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized.
• Calcitonin salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action.
• The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to calcitonin salmon or any of the excipients.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• lithium

• Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium.
• The dose of lithium may require adjustment.

Is this medicine FDA approved?

• Initial U.S. Approval: 1975.

How should this medicine be used?

Recommended dosage: Paget’s Disease of Bone:

• The recommended dose of calcitonin salmon injection for treatment of symptomatic Paget’s disease of bone is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly.

Hypercalcemia:

• The recommended starting dose of calcitonin salmon injection for early treatment of hypercalcemia is 4 USP Units/kg body weight every 12 hours by subcutaneous or intramuscular injection.
• Increase to 8 USP Units/kg every 12 hours if no improvement in 1-2 days.
• Increase further to 8 USP Units/kg every 6 hours if no improvement after 2 more days.

Postmenopausal Osteoporosis:

• The recommended dose of calcitonin salmon injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 USP Units (0.5 mL) per day administered subcutaneously or intramuscularly.
• Ensure adequate calcium and vitamin D intake (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).

Administration:

• Calcitonin salmon comes as a solution to be injected under the skin (subcutaneously) or into the muscle (intramuscularly).
• It is usually used once a day or once every other day.
• Your doctor, nurse, or pharmacist will show you how to administer the medication.
• Follow all directions carefully.
• Dispose of all empty syringes and vials as directed by your healthcare provider.
• Visually inspect calcitonin salmon injection vials. Calcitonin salmon injection is a clear, colorless, solution.
• If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.
• If the volume of calcitonin salmon injection to be injected exceeds 2 mL, intramuscular injection is preferable and the total dose should be distributed across multiple sites of injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 200 USP Units per mL sterile solution in 2 mL multi-dose vials

This medicine is available in fallowing brand namesː

• Calcimar Injection
• Miacalcin Injection

What side effects can this medication cause?

The most common side effects of this medicine include:

• Nausea
• Local inflammatory reactions at the site of subcutaneous or intramuscular injection
• Skin rashes
• pruritus of the ear lobes
• Nocturia
• feverish sensation
• pain in the eyes
• poor appetite
• abdominal pain
• pedal edema
• salty taste

Calcitonin salmon can cause serious side effects which may include:

• Hypersensitivity Reactions, including anaphylaxis
• Hypocalcemia
• Malignancy

What special precautions should I follow?

• Serious hypersensitivity reactions have been reported in patients receiving calcitonin salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Consider skin testing prior to treatment in patients with suspected hypersensitivity to calcitonin salmon.
• Hypocalcemia has been reported. Ensure adequate intake of calcium and vitamin D.
• A meta-analysis of 21 clinical trials suggests an increased risk of overall malignancies in calcitonin salmon-treated patients. The benefits for the individual patient should be carefully considered against possible risks.
• Circulating antibodies to calcitonin salmon have been reported with calcitonin salmon injection. May cause loss of response to treatment.
• Instruct patients and other persons who may administer calcitonin salmon injection in sterile injection technique. Also instruct patients to dispose of needles properly.
• 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 with postmenopausal osteoporosis or Paget’s disease of bone to maintain an adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) intake.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea and vomiting

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• The pharmacologic actions of calcitonin salmon injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.

Can this medicine be used in pregnancy?

• There are no studies with calcitonin salmon injection in pregnant women to inform a drug associated risk for birth defects or miscarriage.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• CALCITONIN SALMON

Inactive ingredients:

• ACETIC ACID
• PHENOL
• SODIUM ACETATE
• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured for:

• Leucadia Pharmaceuticals
• Carlsbad, CA USA

Manufactured by:

• Grand River Aseptic Manufacturing
• Grand Rapids MI USA

What should I know about storage and disposal of this medication?

• Store in a refrigerator between 2° to 8°C (36° to 46°F).
• Protect from freezing.

• Dailymed label info on Calcitonin salmon
• FDA Calcitonin salmon

Calcitonin salmon Resources
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