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CaloMist Nasal Spray

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CaloMist Nasal Spray

CaloMist Nasal Spray

INDICATIONS

Vitamin B12 Deficiency

CaloMist Nasal Spray is indicated for maintenance of vitamin B12 concentrations after normalization with intramuscular vitamin B12 therapy in patients with vitamin B12 deficiency who have no nervous system involvement.

Important Limitations of Use

CaloMist Nasal Spray has not been evaluated for the treatment of newly diagnosed vitamin B12 deficiency.

CaloMist Nasal Spray is not suitable for use in the vitamin B12 absorption test (Schilling Test).

The effectiveness of CaloMist Nasal Spray in patients with nasal pathology (e.g., nasal congestion, allergic rhinitis, upper respiratory infections) has not been determined. Treatment with CaloMist Nasal Spray should be deferred until nasal symptoms have subsided [see WARNINGS and PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended initial dose of CaloMist Nasal Spray is one spray in each nostril once daily (25 mcg per nostril, total daily dose 50 mcg). The dose should be increased to one spray in each nostril twice daily (total daily dose 100 mcg) for patients with an inadequate response to once daily dosing.

The dosing of CaloMist Nasal Spray and other intranasal medications should be separated by several hours, and these patients should have more frequent monitoring of vitamin B12 concentrations because of the potential for erratic absorption.

Priming (Activation) of Pump

The pump must be primed before the bottle is used for the first time. To prime the pump, place the nozzle between the first and second finger with the thumb on the bottom of the bottle. Pump the unit firmly and quickly then repeat this priming an additional 6 times for a total of 7 priming sprays. Now the nasal spray is ready for first-time use. If 5 or more days elapse since last use, the pump must be re-primed with two re-priming sprays.

Additional instructions are provided in the patient instruction sheet [see Patient Counseling Information].

Dosage Forms and Strengths

CaloMist Nasal Spray (cyanocobalamin, USP) is a solution of cyanocobalamin, USP, for administration as a metered spray to the nasal mucosa. Each bottle of CaloMist Nasal Spray contains 18 mL of a 25 mcg/0.1 mL solution of cyanocobalamin. The spray solution has a pH between 6.5 and 7.5. After initial priming, each spray delivers 25 mcg of cyanocobalamin. Each bottle will deliver 60 sprays for a total of thirty 50 mcg doses of CaloMist Nasal Spray.

HOW SUPPLIED

AND STORAGE AND HANDLING

CaloMist Nasal Spray is available as a metered dose spray in 30 mL plastic bottles containing 18 mL of solution. CaloMist Nasal Spray is available in a dosage strength of 25 mcg cyanocobalamin, USP, per actuation (0.1 mL/actuation). CaloMist Nasal Spray is provided in a carton containing one bottle of nasal spray solution affixed with a nasal spray pump, a package insert, and a patient instruction sheet. One bottle delivers thirty 50 mcg doses (60 sprays) (NDC 0256-0203-01).

Storage

Protect from light. Store upright at a controlled temperature of 15 to 30° C (59 to 86° F).

Protect from freezing.

Manufactured by: Fleming Pharmaceuticals., Fenton, MO 63026 USA
calomist@flemingcompany.com., 1-800-343-0164. FDA rev date: 7/27/2007

Last reviewed on RxList: 8/16/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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