Drug Reference

Cobamamide

Vitamin B12 (cyanocobalamin and analogues)

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Therapeutic class
Vitamin B12 (cyanocobalamin and analogues)
Habit forming
No
Availability
Prescription (Rx)

Available as

0.1 MG

FDA label sections are from openFDA and may not reflect the most recent labeling — confirm against the current DailyMed label.

Uses
INDICATION PaxLyte is indicated in the TREATMENT of vitamin deficiency – specifically vitamin B 12 deficiency, and the PREVENTION of vitamin B 12 -cofactor deficiency, l-methylfolate.
How it works
MECHANISM OF ACTION VITAMIN B 12 [TREATMENT]; FOLATE [PREVENTION]; OTHER [SUPPLEMENTATION]; Vitamin B 12 is essential for the synthesis of methionine from homocysteine - a reaction which also requires l-methylfolate as a necessary cofactor.
How to use / dosing
DOSAGE AND ADMINISTRATION The normal dose, is one capsule daily OR as directed by a licensed healthcare practioner; preferably on an empty stomach.
Side effects
ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of vitamin B 9 .

Safety advice

Conservative summary derived from FDA labeling — defaults to “consult your doctor” unless the label is explicit. Not a substitute for your clinician’s advice.

PregnancyNo information
No specific information in the FDA label.
BreastfeedingNo information
No specific information in the FDA label. Check LactMed →
AlcoholNo information
No specific information in the FDA label.
DrivingNo information
No specific information in the FDA label.
KidneyNo information
No specific information in the FDA label.
LiverNo information
No specific information in the FDA label.
Warnings & precautions
PRECAUTIONS Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Daily doses of 0.1 mg or more of folic acid (vitamin B 9 ) may obscure pernicious anemia. Hematologic improvement can occur while neurological damage progresses. Exclusive use of folic acid to treat vitamin B 12 -deficient macrocytic anemia can lead to progressive and irreversible neurological damage. Vitamin B 12 deficiency allowed to progress for over 3 months may cause permanent spinal cord lesions. Doses of vitamin B 12 exceeding 10 mcg daily may produce hematologic response in patients with vitamin B 9 deficiency. Indiscriminate administration may mask the true diagnosis.
Current FDA labels (DailyMed)

2 marketed products on record (RxNorm)

Authoritative sources

Reference only — not clinical advice. Verify against current FDA labeling and consult a licensed provider. About half of pediatric drug use is off-label and is not reflected in FDA labels; absence of pediatric information does not mean a medicine is unused or unsafe in children.