B-12 Compliance Injection

Name: B-12 Compliance Injection

Warnings

For External Use Only.

Flammable, keep away from fire or flame.

Do not use

  • with electrocautery procedures
  • in the eyes

Stop use and ask a doctor if

  • Irritation or redness develops
  • condition persists for more than 72 hours, consult a physician
  • Cleansing of an injection site

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Wipe injection site vigorously and discard

Inactive Ingredient

  • Water

Principal Display Panel - Cyanocobalamin 1 mL Multiple Dose Vial Label

NDC 0517-0031-25

CYANOCOBALAMIN
INJECTION, USP

1000 mcg/mL

FOR IM OR SC USE ONLY

1 mL VIAL

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Cyanocobalamin Injection, USP

Side Effects

Pain/redness at the injection site, mild diarrhea, itching, or a feeling of swelling all over the body may occur. If any of these effects persist or worsen, tell 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.

This medication may cause low potassium levels in the blood (hypokalemia). Tell your doctor right away if any of these unlikely but serious side effects occur: muscle cramps, weakness, irregular heartbeat.

People who have a rare blood disorder (polycythemia vera) may rarely have symptoms related to this disorder while taking cyanocobalamin. Seek immediate medical attention if any of these rare but very serious symptoms occur: chest pain (especially with shortness of breath), weakness on one side of the body, sudden vision changes, slurred speech.

Get medical help right away if you have any very serious side effects, including: swelling ankles/feet, trouble breathing, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List B-12 Compliance Kit side effects by likelihood and severity.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs that may affect blood cell production (e.g., chloramphenicol, anti-cancer drugs, HIV drugs), other vitamins/nutritional supplements (especially folic acid).

Certain other drugs may interfere with laboratory tests for vitamin B12 levels, possibly causing false test results. Tell laboratory personnel and all your doctors if you take any of the following: anti-infective drugs (e.g., amoxicillin, erythromycin), methotrexate, pyrimethamine.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

Overdose with this medication is very unlikely. However, if someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., serum potassium levels, complete blood count, hematocrit, vitamin B12 levels) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

This product is not a substitute for a proper diet. Remember that it is best to get your vitamins from healthy foods. Vitamin B12 is commonly found in many foods from animals, especially liver, kidney, fish and shellfish, meat, and dairy foods.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

For Healthcare Professionals

Applies to cyanocobalamin: compounding powder, injectable solution, intramuscular solution, nasal gel, nasal spray, oral tablet, oral tablet extended release, sublingual lozenge, sublingual tablet

Cardiovascular

Frequency not reported: Congestive heart failure, peripheral vascular thrombosis, cardiac arrest, low blood pressure[Ref]

Hypersensitivity

Patients sensitized to the injectable product are often able to tolerate the oral route without problems.[Ref]

Frequency not reported: Anaphylactic shock and death, allergic hypersensitivity reactions[Ref]

Gastrointestinal

Frequency not reported: Mild transient diarrhea, prolonged abdominal pain, prolonged nausea or vomiting[Ref]

Nervous system

Frequency not reported: Severe dizziness, drowsiness, muscular paralysis, loss of consciousness[Ref]

Dermatologic

Frequency not reported: Itching, transitory exanthema, acneiform eruptions, bullous eruptions[Ref]

Respiratory

Frequency not reported: Pulmonary edema[Ref]

Metabolic

Frequency not reported: Hypokalemia[Ref]

Oncologic

Frequency not reported: Polycythemia vera[Ref]

Ocular

Frequency not reported: Vision problems[Ref]

Other

Frequency not reported: Feeling of swelling of entire body[Ref]

Some side effects of cyanocobalamin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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