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Drug overview for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
Generic name: CYANOCOBALAMIN/PYRIDOXINE HCL/THIAMINE
Drug class: Vitamin B-1
Therapeutic class: Electrolyte Balance-Nutritional Products
Thiamine is a water-soluble, B complex vitamin. Vitamin B12, a cobalt-containing B complex vitamin, is commercially available as cyanocobalamin and hydroxocobalamin, which are synthetic forms of vitamin B12. Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.
No enhanced Uses information available for this drug.
Generic name: CYANOCOBALAMIN/PYRIDOXINE HCL/THIAMINE
Drug class: Vitamin B-1
Therapeutic class: Electrolyte Balance-Nutritional Products
Thiamine is a water-soluble, B complex vitamin. Vitamin B12, a cobalt-containing B complex vitamin, is commercially available as cyanocobalamin and hydroxocobalamin, which are synthetic forms of vitamin B12. Hydroxocobalamin (Cyanokit(R)) is an antidote for cyanide poisoning.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for APATATE (cyanocobalamin/pyridoxine hcl/thiamine) have been approved by the FDA:
Indications:
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
Indications:
Vitamin deficiency prevention
Vitamin deficiency
Professional Synonyms:
Vitamin deficiency prophylaxis
The following dosing information is available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
For the treatment of pernicious anemia, the usual initial IM or subcutaneous dosage of cyanocobalamin is 100 mcg daily for 6-7 days. If clinical manifestations have improved and a reticulocyte response is observed, cyanocobalamin can then be administered in a dosage of 100 mcg every other day for 7 doses and then 100 mcg every 3-4 days for 2-3 weeks. Once hematologic values have returned to normal, cyanocobalamin can be administered IM or subcutaneously in a dosage of 100 mcg once monthly for life.
Folic acid should be used concomitantly if necessary.
For the treatment of vitamin B12 deficiency in adults, the usual IM dosage of hydroxocobalamin is 30 mcg daily for 5-10 days. Once clinical symptoms have subsided and the blood components have returned to normal, monthly IM maintenance doses of 100-200 mcg appear to be sufficient to maintain a normoblastic bone marrow. For the treatment of vitamin B12 deficiency in children, the usual total IM dose of hydroxocobalamin is 1-5 mcg over 2 or more weeks, given in single doses of 100 mcg.
For maintenance, the IM or subcutaneous pediatric dosage is at least 60 mcg per month; however, smaller doses may often suffice for deficiency states not caused by pernicious anemia.
The commercially available cyanocobalamin metered-dose pump delivers 0.1 mL of solution containing 500 mcg of the drug per actuation. The recommended initial dosage of cyanocobalamin nasal spray is 500 mcg (one actuation) administered intranasally once weekly.
The dosage may need to be increased in patients who experience a decline in serum vitamin B12 concentrations after 1 month of therapy with this preparation. Therapy with a parenteral vitamin B12 preparation may be necessary in patients who do not achieve a satisfactory response to intranasal cyanocobalamin.
Folic acid should be used concomitantly if necessary.
For the treatment of vitamin B12 deficiency in adults, the usual IM dosage of hydroxocobalamin is 30 mcg daily for 5-10 days. Once clinical symptoms have subsided and the blood components have returned to normal, monthly IM maintenance doses of 100-200 mcg appear to be sufficient to maintain a normoblastic bone marrow. For the treatment of vitamin B12 deficiency in children, the usual total IM dose of hydroxocobalamin is 1-5 mcg over 2 or more weeks, given in single doses of 100 mcg.
For maintenance, the IM or subcutaneous pediatric dosage is at least 60 mcg per month; however, smaller doses may often suffice for deficiency states not caused by pernicious anemia.
The commercially available cyanocobalamin metered-dose pump delivers 0.1 mL of solution containing 500 mcg of the drug per actuation. The recommended initial dosage of cyanocobalamin nasal spray is 500 mcg (one actuation) administered intranasally once weekly.
The dosage may need to be increased in patients who experience a decline in serum vitamin B12 concentrations after 1 month of therapy with this preparation. Therapy with a parenteral vitamin B12 preparation may be necessary in patients who do not achieve a satisfactory response to intranasal cyanocobalamin.
Thiamine hydrochloride is usually administered orally. When oral administration is not feasible, when malabsorption is suspected, or in patients with Wernicke's encephalopathy syndrome or high-output heart failure secondary to beriberi, the drug may be administered IM or IV; most clinicians prefer IV administration of thiamine hydrochloride for the treatment of high-output heart failure. Cyanocobalamin is administered by IM or deep subcutaneous injection.
Cyanocobalamin also is administered orally and intranasally. Hydroxocobalamin is administered by IM injection or IV infusion. Oral therapy with vitamin B12 preparations is markedly inferior to parenteral therapy and should be used only for the treatment of dietary vitamin B12 deficiency in patients with normal GI absorption.
Cyanocobalamin also is administered orally and intranasally. Hydroxocobalamin is administered by IM injection or IV infusion. Oral therapy with vitamin B12 preparations is markedly inferior to parenteral therapy and should be used only for the treatment of dietary vitamin B12 deficiency in patients with normal GI absorption.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
There are 0 contraindications.
There are 0 severe interactions.
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Levodopa/Pyridoxine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Pyridoxine increases levodopa metabolism, decreasing the amount of levodopa available to the central nervous system. CLINICAL EFFECTS: The pharmacologic effects of levodopa may be decreased. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid pyridoxine in patients receiving levodopa alone; however, the interaction can be minimized by giving levodopa with a peripheral decarboxylase inhibitor (e.g. carbidopa, benserazide). DISCUSSION: In patients with Parkinson's disease, as little as 10 mg of pyridoxine may reverse the clinical benefits as well as the adverse effects of levodopa. Coadministration of levodopa with either carbidopa or benserazide has minimized the effects of this interaction. |
INBRIJA, LEVODOPA |
| Patiromer/Thiamine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Patiromer may bind to thiamine.(1) CLINICAL EFFECTS: Concurrent use may result in decreased gastrointestinal absorption and loss of efficacy of thiamine.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of patiromer recommends administering patiromer at least 3 hours before or 3 hours after thiamine.(1) DISCUSSION: An in vitro binding study found potentially clinically significant binding of thiamine by patiromer. It is recommended to take these drugs 3 hours apart.(1) |
VELTASSA |
The following contraindication information is available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Leber's hereditary optic atrophy |
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atrophic gastritis |
| Hypokalemia |
The following adverse reaction information is available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 0 severe adverse reactions.
There are 2 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Diarrhea Pruritus of skin |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Adequate and well-controlled studies have not been conducted in pregnant women. However, vitamin B12 requirements are increased in pregnant women. Parenteral preparations should be used during pregnancy only when the potential benefits justify the potential risks to the fetus.
Vitamin B12 is distributed into human milk. Vitamin B12 requirements are increased in lactating women. Hydroxocobalamin may be administered to lactating women with suspected or known cyanocobalamin poisoning. There is no data available to determine when breastfeeding may be restarted following administration of IV hydroxocobalamin.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for APATATE (cyanocobalamin/pyridoxine hcl/thiamine)'s list of indications:
| Vitamin deficiency | |
| E56.9 | Vitamin deficiency, unspecified |
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