OCTAHEAL B12
Introduction
Cyanocobalamin is a man-made form of vitamin B12 used to prevent and treat low blood levels of this vitamin. Vitamin B12 is important to maintain the health of your metabolism, blood cells, and nerves. Serious vitamin B12 deficiency may result in a low number of red blood cells (anemia), stomach/intestine problems, and permanent nerve damage.Octaheal B12_manufactured by Faran Shimi pharmaceutical company_ is available in 1000µg capsules. 15 capsules are packed in a blister and 4 blisters are packaged in one box with a leaflet.
Important Information
Indications
• Vitamin B12 deficiency
• Aphthous stomatitis, simple, recurrent (off-label use)
Dosing and Administration:
One capsule, once a day with main meal and full glass of water.
Interactions
Food interactions: Heavy ethanol consumption >2 weeks may impair vitamin B12 absorption.
Drug interactions: Chloramphenicol (Systemic): May diminish the therapeutic effect of Vitamin B12.
Risk C: Monitor therapy
Contraindications & Cautions
Contraindications
Hypersensitivity to cyanocobalamin (vitamin B12), cobalt, or any component of the formulationWarnings/Precautions
Concerns related to adverse effects:• CNS effects: Vitamin B12 deficiency for >3 months results in irreversible degenerative CNS lesions; neurologic manifestations will not be prevented with folic acid unless vitamin B12 is also given. Spinal cord degeneration might also occur when folic acid used as a substitute for vitamin B12 in anemia prevention.
• Hypokalemia: treatment of severe vitamin B12 megaloblastic anemia may result in severe hypokalemia, sometimes fatal, due to intracellular potassium shift upon anemia resolution; however, in more recent experience, while some patients may experience hypokalemia with initial treatment, this is unlikely to be clinically significant.
• Thrombocytosis: Treatment of severe vitamin B12 megaloblastic anemia may result in thrombocytosis.
Disease-related concerns: • Leber disease: Patients with Leber disease who received vitamin B12 treatment have suffered from severe rapid optic atrophy. Use of cyanocobalamin in these patients is not recommended.
• Megaloblastic anemia: Vitamin B12 doses >10 mcg daily may produce a hematologic response in patients with folate deficient megaloblastic anemia and mask previously unrecognized folate deficiency; vitamin B12 is not a substitute for folic acid.
• Polycythemia vera: Vitamin B12 deficiency masks signs of polycythemia vera; vitamin B12 administration may unmask this condition.
Side Effects
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. >10%:Infection: Infection (12% to 13%)
1% to 10%: Central nervous system: Paresthesia (4%)
Gastrointestinal: nausea (4%)
Respiratory: Rhinitis (4% to 8%)
Frequency not defined:
Cardiovascular: Cardiac failure, thrombosis (peripheral)
Dermatologic: Pruritus, skin rash (transient)
Endocrine & metabolic: Hypokalemia
Gastrointestinal: Diarrhea
Hematologic & oncologic: Polycythemia vera, thrombocythemia
Respiratory: Pulmonary edema
Miscellaneous: Swelling
Storage:
Store below 25◦C and protect from light and moisture. Keep out of the reach and sight of children.
