Cyanocobalamin (CaloMist Nasal Spray)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Cyanocobalamin (CaloMist Nasal Spray)

CaloMist Nasal Spray
(cyanocobalamin, USP)

DRUG DESCRIPTION

Cyanocobalamin is a synthetic form of vitamin B12 with activity equivalent to the endogenous form of vitamin B12. The chemical name is α-(5,6-dimethylbenzimidazolyl) cyanocobamide. The cobalt content is 4.35%. The molecular formula is C63H88CoN14O14P, which corresponds to a molecular weight of 1355.4 and the following structural formula:

CaloMist Nasal Spray (cyanocobalamin, USP) Structural Formula Illustration

Cyanocobalamin occurs as dark red crystals, orthorhombic needles, or crystalline red powder and is very hygroscopic in the anhydrous form, and sparingly to moderately soluble in water (1:80). The pharmacologic activity of cyanocobalamin is destroyed by heavy metals (iron) and strong oxidizing or reducing agents (Vitamin C), but not by autoclaving for short periods of time (15-20 minutes) at 121° C. The vitamin B12 coenzymes are very unstable in light.

Each bottle of CaloMist Nasal Spray contains cyanocobalamin, sodium chloride, sodium phosphate monobasic, benzyl alcohol, sodium hydroxide, and benzalkonium chloride in purified water with an attached spray pump unit.

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

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.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below and in Table 1 reflect exposure in 25 subjects (age range 27-82 years; 17 women; 21 Caucasians) with vitamin B12 deficiency (12 with pernicious anemia, 4 secondary to gastrointestinal surgery, 9 with unknown cause) who received CaloMist Nasal Spray 50 mcg daily for 8 weeks in an uncontrolled clinical trial. Prior to enrollment, all subjects were required to have normal vitamin B12 levels with intramuscular vitamin BI2 injections. One patient who completed the study developed epistaxis on Day 12 of dosing and was noted to have irritation of the right nasal septum at study end. This patient had pre-existing allergic rhinitis and required a doubling of the CaloMist Nasal Spray dose during the last week of the study because of declining vitamin B12 concentrations.

Table 1. Potentially related adverse reactions reported during 8 weeks of treatment with CaloMist Nasal Spray in an uncontrolled clinical trial.

Preferred Term CaloMist Nasal Spray (cyanocobalamin)
(N=25)
n (%)
Arthralgia 3 (12%)
Dizziness 3 (12%)
Headache 3 (12%)
Nasopharyngitis 3 (12%)
Rhinorrhea 3 (12%)
Bronchitis 2 (8%)
Nasal Discomfort 2 (8%)
Pain 2 (8%)
Rash 2 (8%)
Asthma 1 (4%)
Back Pain 1 (4%)
Cough 1 (4%)
Epistaxis 1 (4%)
Hypersomnia 1 (4%)
Influenza Like Illness 1 (4%)
Malaise 1 (4%)
Pharyngolaryngeal Pain 1 (4%)
Postnasal Drip 1 (4%)
Procedural Pain 1 (4%)
Pyrexia 1 (4%)
Scab 1 (4%)
Sinus Headache 1 (4%)
Sinusitis 1 (4%)
Tooth Abscess 1 (4%)

Experience with Parenteral Vitamin B12

The following adverse reactions have been reported with parenteral vitamin B12:

Generalized: Anaphylactic shock and death

Cardiovascular: Pulmonary edema and congestive heart failure early in treatment Peripheral vascular thrombosis

Hematological : Polycythemia vera

Gastrointestinal: Mild transient diarrhea Dermatological: Itching; transitory exanthema

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of cyanocobalamin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Angioedema and angioedema-like reactions [See WARNINGS and PRECAUTIONS]

Read the CaloMist Nasal Spray (cyanocobalamin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Most antibiotics, methotrexate, and pyrimethamine invalidate the vitamin B12 diagnostic blood assays.

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

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Laboratory Monitoring

Hematocrit, reticulocyte count, vitamin B12, folate, and iron levels should be obtained prior to treatment. All hematologic parameters, including vitamin B12 concentrations, should be normal before initiating treatment with CaloMist Nasal Spray. Periodic monitoring of serum vitamin B12 concentrations must be obtained to confirm adequacy of therapy. Vitamin B12 concentrations and complete blood counts should be monitored one month after starting CaloMist Nasal Spray and then at 3 to 6 month intervals thereafter. Patients with borderline-low vitamin B12 concentrations (<300 ng/L) should also undergo measurement of methylmalonic acid and homocysteine concentrations, which are more sensitive measures of vitamin B12 deficiency in this setting.

Patients with declining or abnormally low vitamin B12 concentrations despite maximal doses of CaloMist Nasal Spray should be switched back to intramuscular vitamin B12 injections. Vitamin B12 deficiency that is inadequately treated for longer than three months may produce irreversible neurological damage.

Use in Patients With Nasal Pathology

CaloMist Nasal Spray has not been evaluated in patients with nasal pathology. Treatment with CaloMist Nasal Spray should be deferred until nasal symptoms have subsided. Patients with chronic nasal symptoms or significant nasal pathology are not ideal candidates for intranasal vitamin B12 therapy. If CaloMist Nasal Spray therapy is attempted in these patients, vitamin B12 concentrations should be monitored more frequently than in patients without nasal pathology because of the potential for erratic or blunted absorption.

Use in Patients with Leber's Disease

Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Cyanocobalamin should not be used in these patients.

Anaphylaxis and Angioedema

Anaphylactic shock, death, and angioedema were not reported in the CaloMist Nasal Spray clinical trial but have been reported with parenteral vitamin B12 administration.

Megaloblastic Anemia

Megaloblastic anemia has many causes, including vitamin B12 deficiency and folate deficiency. Folic acid may result in a hematological response in patients with vitamin B12 deficiency, but will not prevent irreversible neurological manifestations. Vitamin B12 is not an appropriate treatment for folate deficiency.

Hypokalemia, thrombocytosis, and sudden death may occur when severe megaloblastic anemia is treated intensely with vitamin B12. Serum potassium and the platelet count should be carefully monitored in this setting.

Blunted Response to Vitamin B12 Therapy

Infections, uremia, concurrent iron or folic acid deficiency, and drugs with bone marrow suppressant properties (e.g., chloramphenicol) may blunt the therapeutic response to vitamin B12 products, including CaloMist Nasal Spray.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no long-term studies in animals that have evaluated the carcinogenic potential of any of the vitamin B12 products, including CaloMist Nasal Spray. There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this malignancy has been attributed to the underlying pathology of pernicious anemia and not to treatment with vitamin B12.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with CaloMist Nasal Spray. Although vitamin B12 is an essential vitamin and requirements are increased during pregnancy, it is not known whether CaloMist Nasal Spray can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CaloMist Nasal Spray should be given to a pregnant woman only if clearly needed. Adequate and well-controlled studies have not been conducted in pregnant women.

Nursing Mothers

Although vitamin B12 is an essential vitamin and requirements are increased during lactation, it is not known whether CaloMist Nasal Spray can cause harm to an infant when administered to a nursing woman. Vitamin B12 appears in the milk of nursing mothers in concentrations that approximate the mother's vitamin B12 blood level. Caution should be exercised when CaloMist Nasal Spray is administered to a nursing woman.

Pediatric Use

Because CaloMist Nasal Spray has not been studied in children, safety and effectiveness have not been established in pediatric patients.

Geriatric Use

Clinical studies of CaloMist 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Renal/Hepatic Impairment

Patients with vitamin B12 deficiency and concurrent renal or hepatic disease may require increased doses or more frequent administration of vitamin B12 therapy.

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

OVERDOSE

No information provided.

CONTRAINDICATIONS

Sensitivity to cobalt, vitamin B12, or any component of this product [see WARNINGS and PRECAUTIONS].

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

CLINICAL PHARMACOLOGY

Mechanism of Action

Vitamin B12 is essential for growth, cell reproduction, hematopoiesis, and nucleoprotein and myelin synthesis. Rapidly dividing cells (e.g., epithelial cells, bone marrow, myeloid cells) have the greatest requirement for vitamin B12. In tissues, vitamin B12 is essential for the conversion of methylmalonate to succinate and for the synthesis of methionine from homocysteine. In the absence of vitamin B12, tetrahydrofolate cannot be regenerated from 5-methyl tetrahydrofolate, and functional folate deficiency occurs. Vitamin B12 also may be involved in sulfhydryl-activated enzyme systems associated with fat and carbohydrate metabolism and protein synthesis.

Pharmacodynamics

In 24 vitamin B12 deficient patients who were stabilized on intramuscular (IM) vitamin B12 therapy, once daily intranasal dosing with CaloMist Nasal Spray for 8 weeks resulted in serum vitamin B12 concentrations that were within the target range (>200 ng/L) and slightly higher than those seen 2 to 4 weeks after administration of IM vitamin B12 (see Figure 1 - average mean increase from Visit 1 to Visits 3-6 = 45 ng/L). Twenty-three of these 24 patients received 50 mcg of CaloMist Nasal Spray daily for the duration of the trial; the remaining patient required doubling of the CaloMist Nasal Spray dose from 50 mcg to 100 mcg daily during the last week of the study because of declining vitamin B12 concentrations. One of the 25 patients dosed with CaloMist Nasal Spray was excluded from the efficacy analyses because a diagnosis of vitamin B12 deficiency could not be confirmed.

Figure 1 : Mean Vitamin B12 Serum Levels Over 8 Weeks of Intranasal (IN) Vitamin B12 Dosing in 24 Subjects Stabilized on Intramuscular (IM) Vitamin B12

Mean Vitamin B12 Serum Levels Over 8 Weeks of Intranasal (IN) Vitamin B12 Dosing in 24 Subjects Stabilized on Intramuscular (IM) Vitamin B12  - illustration

Notes:

- Weeks -2 to -4 correspond to 2 to 4 weeks post last IM injection
- CaloMist Nasal Spray was initiated at Week 0.
- Figure shows mean vitamin B12 serum levels with 95% confidence intervals.

Pharmacokinetics Distribution

In the blood, vitamin BI2 is bound to transcobalamin II (a specific B-globulin carrier protein) and is distributed to tissues and stored primarily in the liver and bone marrow.

Elimination

About 3-8 mcg of vitamin B12 is secreted into the gastrointestinal tract daily via the bile. In subjects with sufficient intrinsic factor, all but about 1 mcg is reabsorbed. When vitamin B12 is administered in doses that saturate the binding capacity of plasma proteins and the liver, the unbound vitamin B12 is rapidly eliminated in the urine. Retention of vitamin B12 in the body is dose-dependent.

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

PATIENT INFORMATION

PATIENT COUNSELING INFORMATION

[See FDA-approved Patient Labeling]

Important Information for Patients

Patients with a chronic underlying cause of vitamin B12 deficiency will require indefinite administration of a vitamin B12 product, such as CaloMist Nasal Spray. Noncompliance or inadequate treatment with vitamin B12 therapy may result in recurrence of anemia and the development or worsening of irreversible neurological damage.

The dosing of CaloMist Nasal Spray and other intranasal medications should be separated by several hours.

Vitamin B12 concentrations should be monitored one month after CaloMist Nasal Spray initiation or dose change and every 3-6 months thereafter.

Careful instructions on the priming of the actuator and nasal administration of CaloMist Nasal Spray should be given to the patient, and the procedures for use should be demonstrated.

Patient Instruction Sheet

Instructions for Using CaloMist Nasal Spray. Read the following instructions carefully before using CaloMist Nasal Spray.

  • Use CaloMist Nasal Spray as directed by your doctor.

NOTE: CaloMist Nasal Spray is prefilled to give 30 doses (60 sprays of medicine). One dose is one spray in each nostril once a day.

CaloMist Nasal Spray Pump Priming: Before you use the medicine for the first time the nasal spray pump unit must be readied (primed).

CaloMist Nasal Spray Pump Priming - Illustration 1

1. Hold the nasal spray bottle upright with your index finger on top of one of the two arms of the pump. Remove the clear protective cap from the top of the nozzle. (See Diagram 1)

2. Remove the safety clip from the nasal spray pump. (See Diagram 1)

CaloMist Nasal Spray Pump Priming - Illustration 2

3. While holding the nasal spray bottle upright with your index and middle fingers on the two side arms of the pump, and your thumb on the bottom of the bottle, press the arms down firmly and quickly. (See Diagram 2)

4. Repeat Step 3, 6 more times for a total of 7 priming sprays. You should see a full spray of medicine with the 7th priming spray. (See Diagram 2)

NOTE: You must prime CaloMist Nasal Spray with two re-priming sprays if you do not use for five days or more.

Your CaloMist Nasal Spray is now ready to use.

Blow your nose gently to clear both nostrils - Illustration 3

1. Blow your nose gently to clear both nostrils. (See Diagram 3)

2. Hold the nasal spray bottle upright with your first and second fingers on the two side arms of the pump, and your thumb on the bottom of the bottle. (See Diagram 4)

3. Gently insert the nasal spray pump to one nostril (about ½ inch), pointing the tip towards the back of the nose. (See Diagram 4)

Gently insert the nasal spray pump to one nostril - illustration 4

4. With your other hand (the one not holding the bottle) use a finger to gently push close your other nostril (the one without a spray pump inserted). (See Diagram 4)

5. Tilt your head forward and press the arms of the nasal spray bottle down firmly and quickly.

6. Sniff in gently during and right after a spray and return your head to an upright position. Repeat these steps for the other nostril.

7. Wipe the nozzle of the nasal spray pump with a clean tissue after use. Replace the safety clip and clear cover on the nasal spray pump.

8. Store CaloMist Nasal Spray upright at room temperature, 59 to 86° F (15 to 30° C). Do not freeze.

Discard CaloMist Nasal Spray after 30 doses (60 sprays).

  1. Unscrew the cap, rinse the bottle and pump assembly under a water faucet.
  2. Dispose of all parts in a trashcan.

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

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

>

PATIENT INFORMATION

PATIENT COUNSELING INFORMATION

[See FDA-approved Patient Labeling]

Important Information for Patients

Patients with a chronic underlying cause of vitamin B12 deficiency will require indefinite administration of a vitamin B12 product, such as CaloMist Nasal Spray. Noncompliance or inadequate treatment with vitamin B12 therapy may result in recurrence of anemia and the development or worsening of irreversible neurological damage.

The dosing of CaloMist Nasal Spray and other intranasal medications should be separated by several hours.

Vitamin B12 concentrations should be monitored one month after CaloMist Nasal Spray initiation or dose change and every 3-6 months thereafter.

Careful instructions on the priming of the actuator and nasal administration of CaloMist Nasal Spray should be given to the patient, and the procedures for use should be demonstrated.

Patient Instruction Sheet

Instructions for Using CaloMist Nasal Spray. Read the following instructions carefully before using CaloMist Nasal Spray.

  • Use CaloMist Nasal Spray as directed by your doctor.

NOTE: CaloMist Nasal Spray is prefilled to give 30 doses (60 sprays of medicine). One dose is one spray in each nostril once a day.

CaloMist Nasal Spray Pump Priming: Before you use the medicine for the first time the nasal spray pump unit must be readied (primed).

CaloMist Nasal Spray Pump Priming - Illustration 1

1. Hold the nasal spray bottle upright with your index finger on top of one of the two arms of the pump. Remove the clear protective cap from the top of the nozzle. (See Diagram 1)

2. Remove the safety clip from the nasal spray pump. (See Diagram 1)

CaloMist Nasal Spray Pump Priming - Illustration 2

3. While holding the nasal spray bottle upright with your index and middle fingers on the two side arms of the pump, and your thumb on the bottom of the bottle, press the arms down firmly and quickly. (See Diagram 2)

4. Repeat Step 3, 6 more times for a total of 7 priming sprays. You should see a full spray of medicine with the 7th priming spray. (See Diagram 2)

NOTE: You must prime CaloMist Nasal Spray with two re-priming sprays if you do not use for five days or more.

Your CaloMist Nasal Spray is now ready to use.

Blow your nose gently to clear both nostrils - Illustration 3

1. Blow your nose gently to clear both nostrils. (See Diagram 3)

2. Hold the nasal spray bottle upright with your first and second fingers on the two side arms of the pump, and your thumb on the bottom of the bottle. (See Diagram 4)

3. Gently insert the nasal spray pump to one nostril (about ½ inch), pointing the tip towards the back of the nose. (See Diagram 4)

Gently insert the nasal spray pump to one nostril - illustration 4

4. With your other hand (the one not holding the bottle) use a finger to gently push close your other nostril (the one without a spray pump inserted). (See Diagram 4)

5. Tilt your head forward and press the arms of the nasal spray bottle down firmly and quickly.

6. Sniff in gently during and right after a spray and return your head to an upright position. Repeat these steps for the other nostril.

7. Wipe the nozzle of the nasal spray pump with a clean tissue after use. Replace the safety clip and clear cover on the nasal spray pump.

8. Store CaloMist Nasal Spray upright at room temperature, 59 to 86° F (15 to 30° C). Do not freeze.

Discard CaloMist Nasal Spray after 30 doses (60 sprays).

  1. Unscrew the cap, rinse the bottle and pump assembly under a water faucet.
  2. Dispose of all parts in a trashcan.

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

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

CaloMist Nasal Spray Patient Information Including Side Effects

Brand Names: CaloMist, Nascobal

Generic Name: cyanocobalamin (nasal) (Pronunciation: sye AN oh koe BAL a min)

What is nasal cyanocobalamin (CaloMist Nasal Spray)?

Cyanocobalamin is a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.

Cyanocobalamin is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.

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

What are the possible side effects of nasal cyanocobalamin (CaloMist Nasal Spray)?

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 a serious side effect such as:

  • chest pain;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • unusual warmth, redness, or pain in an arm or leg.

Less serious side effects may include:

  • headache, dizziness, weakness;
  • nausea, upset stomach, diarrhea;
  • numbness or tingling;
  • runny nose, sneezing, sore throat, swollen tongue;
  • fever;
  • joint pain; or
  • itching or rash.

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.

Read the CaloMist Nasal Spray (cyanocobalamin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about nasal cyanocobalamin (CaloMist Nasal Spray)?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Avoid eating or drinking hot foods or liquids within 1 hour before or after using the nasal form of this medication.

Tell your doctor if you develop nasal congestion, a cold, or allergies. The nasal spray may not work as well if you are congested.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

Side Effects Centers

CaloMist Nasal Spray Patient Information including How Should I Take

What should I discuss with my healthcare provider before using nasal cyanocobalamin (CaloMist Nasal Spray)?

You should not use this medication if you are allergic to cobalt, or if you have Leber's disease. Cyanocobalamin can lead to optic nerve damage (and possibly blindness) in people with Leber's disease.

Before using cyanocobalamin, tell your doctor if you have:

  • any type of infection;
  • iron or folic acid deficiency;
  • kidney or liver disease; or
  • if you are receiving any medication or treatment that affects bone marrow.

Tell your doctor if you develop nasal congestion, a cold, or allergies. Nasal cyanocobalamin may not work as well if your nose is congested.

FDA pregnancy category C. It is not known whether this medication can harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cyanocobalamin passes into breast milk, but it is not known whether cyanocobalamin could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use nasal cyanocobalamin (CaloMist Nasal Spray)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose needs may change if you become pregnant, if you breast-feed, or if you eat a vegetarian diet. Tell your doctor about any changes in your diet or medical condition.

To use nasal cyanocobalamin.

  • Gently blow your nose to clear any mucus.
  • Prime the nasal gel pump before your first use and whenever it has been longer than 2 days between uses. Pump the gel unit several times until a gel droplet appears at the tip, then pump 2 more times.
  • Prime the nasal spray before your first use by pumping the spray a few times until a fine mist appears. Prime the pump 1 time before each use thereafter.
  • Insert the tip of the nasal pump about half an inch into your nostril, pointing it toward the back of the nose.
  • Gently press your other nostril closed with your finger, and tilt your head forward. Pump and sniff gently at the same time. Return your head to an upright position.
  • Remove the pump from your nose. Rub your nostril gently for a few seconds.
  • Clean the tip of the spray or gel pump with a clean tissue and recap.

To be sure this medication is helping your condition, your blood will need to be tested every 3 to 6 months. This will help your doctor determine the correct dose and how long to treat you with cyanocobalamin. Do not miss any scheduled appointments.

To treat pernicious anemia, you will have to use this medication on a regular basis for the rest of your life. Not using the medication can lead to irreversible nerve damage in your spinal cord.

Pernicious anemia is also treated with folic acid to help maintain red blood cells. However, folic acid will not treat Vitamin B12 deficiency and will not prevent possible damage to the spinal cord. Use all of your medications as directed.

Store this medication at room temperature away from moisture, heat, and light. Keep the nasal gel in the prescription vial when not in use. Store the nasal spray upright.

Side Effects Centers

CaloMist Nasal Spray Patient Information including If I Miss a Dose

What happens if I miss a dose (CaloMist Nasal Spray)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (CaloMist Nasal Spray)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cyanocobalamin is not likely to cause life-threatening symptoms.

What should I avoid while using nasal cyanocobalamin (CaloMist Nasal Spray)?

Do not drink hot liquid or eat hot food within 1 hour before or after you use nasal cyanocobalamin.

Avoid drinking large amounts of alcohol while you are being treated with cyanocobalamin.

Avoid using any other nasal medications that your doctor has not recommended or prescribed.

What other drugs will affect nasal cyanocobalamin (CaloMist Nasal Spray)?

Before using cyanocobalamin, tell your doctor if you are taking any of the following medications:

  • antibiotics;
  • methotrexate (Rheumatrex);
  • pyrimethamine (Daraprim);
  • colchicine; or
  • if you drank a lot of alcohol within the past 2 weeks.

This list is not complete and there may be other drugs that can interact with cyanocobalamin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about nasal cyanocobalamin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.04. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com