CYANOCOBALAMIN spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Padagis Israel Pharmaceuticals Ltd

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyanocobalamin Nasal Spray is indicated for: Limitations of Use Cyanocobalamin Nasal Spray is contraindicated in patients with hypersensitivity to cobalt and/or vitamin B12 or any of its excipients [see Warnings and Precautions (5.2)] . Anaphylactic shock and death have been reported after parenteral vitamin B12 administration in sensitive patients. Risk Summary The limited available data on Cyanocobalamin Nasal Spray in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Animal reproduction studies have not been conducted with vitamin B12 . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary Vitamin B12 is present in the milk of lactating women in concentrations which approximate the mother’s vitamin B12 blood level. Vitamin B12 does not appear to pose more than a minimal risk to breastfeeding children. Safety and effectiveness have not been established in pediatric patients. Clinical studies of cyanocobalamin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Cyanocobalamin (sye-an-oh-Koe-BAL-a-min) Nasal Spray Cyanocobalamin Nasal Spray is for use in your nose only. Read this Instructions for Use before you start using Cyanocobalamin Nasal Spray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Your healthcare provider should teach you how to use Cyanocobalamin Nasal Spray before you use it for the first time. If you have any questions or do not understand the instructions, talk with your healthcare provider or pharmacist. Cyanocobalamin Nasal Spray contains only 1 spray. You do not need to prime Cyanocobalamin Nasal Spray before you use it. If you are eating hot foods or liquids, use Cyanocobalamin Nasal Spray at least one hour before or one hour afterwards because eating hot food or drinking hot liquids too soon before or after taking Cyanocobalamin Nasal Spray can cause you to have a runny nose and can affect the amount of Cyanocobalamin Nasal Spray you receive. How to use Cyanocobalamin Nasal Spray? Step 1. Blow your nose gently to clear both nostrils. Step 2. Hold Cyanocobalamin Nasal Spray with your thumb on the bottom and your index (pointer) finger and middle finger on either side of the nozzle (see Figure A). (Figure A) Step 3. Gently close 1 side of your nose (nostril) with your other index finger. Insert the nozzle into the open nostril about half an inch or as far as it feels comfortable and tilt your head slightly forward (see Figure B). Do not press the plunger yet. (Figure B) Step 4. Breathe in gently through your nose, close your mouth, and at the same time press the plunger firmly upwards with your thumb. Step 5. Remove the nozzle from your nostril. At the same time, keep your head straight for 10 to 20 seconds while gently breathing in through your nose and breathing out through your mouth. How to dispose of (throw away) Cyanocobalamin Nasal Spray? Cyanocobalamin Nasal Spray can be disposed of in your household trash. Place the Cyanocobalamin Nasal Spray in a container such as a zip-top or sealable plastic bag, and throw the container away in your household trash. Manufactured by Padagis® Yeruham, Israel www.padagis.com Rev 02-23 0H800 RC PH1 This Instructions for Use has been approved by the U.S. Food and Drug Administration                          Revised: 02/2023

Product summary:

Cyanocobalamin Nasal Spray is a nasal spray available in a dosage strength of 500 mcg cyanocobalamin/0.1 mL (per actuation). It is supplied in boxes of 4 single-use nasal spray devices and a package insert (NDC 45802-491-84). Protect from light. Keep covered in carton until ready to use. Store upright at controlled room temperature 15°C to 30°C (59°F to 86°F). Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN SPRAY
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYANOCOBALAMIN
NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CYANOCOBALAMIN
NASAL SPRAY.
CYANOCOBALAMIN NASAL SPRAY
INITIAL U.S. APPROVAL: 1942
INDICATIONS AND USAGE
Cyanocobalamin Nasal Spray is a vitamin B
indicated for:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 500 mcg cyanocobalamin/0.1 mL (per actuation) (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Vitamin B
maintenance therapy in adult patients with pernicious anemia who are
in remission
following intramuscular vitamin B
therapy and who have no nervous system involvement (1)
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Treatment of adult patients with dietary, drug-induced, or
malabsorption-related vitamin B
deficiency not due to pernicious anemia (1)
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Prevention of vitamin B
deficiency in adult patients with vitamin B
requirements in excess of
normal (1)
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Should not be used for the vitamin B
absorption test (Schilling test). (1)
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In patients with correctible or temporary causes of vitamin B
deficiency the benefit of continued
long-term use following correction of vitamin B
deficiency and underlying disease has not been
established. (1)
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In patients with active symptoms of nasal congestion, allergic
rhinitis or upper respiratory infection
effectiveness has not been established. (1)
Prior to treatment, obtain hematocrit, reticulocyte count, vitamin B
, folate, and iron levels. (2.1)
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The recommended initial dose is one spray (500 mcg) in one nostril
once weekly. (2.2)
Administer at least one hour before or one hour after ingestion of hot
foods or liquids. (2.2)
Monitor serum B
levels periodically. Obtain a serum B
level and peripheral blood count one month
after treatment initiation, then subsequently at intervals of 3 to 6
months. (2.3)
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If serum levels