Physicians Ez Use B-12 Compliance
FDA Drug Information • Also known as: Physicians Ez Use B-12 Compliance
- Brand Names
- Physicians Ez Use B-12 Compliance
- Route
- INTRAMUSCULAR, SUBCUTANEOUS, TOPICAL
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (4.5-7.0). Cyanocobalamin appears as dark, red crystals or as an amorphous or crystalline, red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The Vitamin B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below: image description
What Is Physicians Ez Use B-12 Compliance Used For?
Uses For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injection INDICATIONS AND USAGE Cyanocobalamin is indicated for Vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B 12 absorption test (Schilling test).
Dosage and Administration
Directions apply to skin as needed discard after single use DOSAGE AND ADMINISTRATION Avoid using the intravenous route. Use of this product intravenously will result in almost all of the vitamin being lost in the urine. Pernicious Anemia Parenteral Vitamin B 12 is the recommended treatment and will be required for the remainder of the patient’s life. The oral form is not dependable. A dose of 100 mcg daily for six or seven days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every three to four days for another two to three weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed. Patients With Normal Intestinal Absorption Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B 12 preparation. If other vitamin deficiencies are present, they should be treated. Schilling test The flushing dose is 1000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Pernicious Anemia Parenteral Vitamin B 12 is the recommended treatment and will be required for the remainder of the patient’s life. The oral form is not dependable. A dose of 100 mcg daily for six or seven days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every three to four days for another two to three weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed. Patients With Normal Intestinal Absorption Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B 12 preparation. If other vitamin deficiencies are present, they should be treated. Schilling test The flushing dose is 1000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ). Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological Polycythemia vera. Gastrointestinal Mild transient diarrhea. Dermatological Itching; transitory exanthema. Miscellaneous Feeling of swelling of entire body. Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ). Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological Polycythemia vera. Gastrointestinal Mild transient diarrhea. Dermatological Itching; transitory exanthema. Miscellaneous Feeling of swelling of entire body.
Warnings and Precautions
Warnings For external use only Flammable - keep away from fire or flame Do not use with electrocautery procedures When using this product do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor Stop use and ask a doctor if condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Patients with early Leber’s disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral Vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal ‘‘Gasping Syndrome’’ in premature infants.
Contraindications
CONTRAINDICATIONS Sensitivity to cobalt and/or Vitamin B 12 is a contraindication.
Overdosage
OVERDOSAGE No overdosage has been reported with this drug.
How Supplied
HOW SUPPLIED Cyanocobalamin Injection, USP is supplied as follows: Product Code Strength Each 4401 1,000 mcg per mL 1 mL fill in a 2 mL vial NDC 63323-044-00 1 mL Multiple Dose Vial Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.