Hydroxocobalam 1000mcg/ml Inj, 30ml
It is used to help with some kinds of anemia.It is used to treat or prevent low vitamin B12.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Vitamin B12 analog, Hematopoietic agent
Pharmacologic Class
Cobalamin
Pregnancy Category
Category C (for therapeutic doses, though essential vitamin)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxocobalamin is a form of vitamin B12. It's used to treat and prevent vitamin B12 deficiency, which can cause anemia (low red blood cells) and nerve problems. It's given as an injection, usually into a muscle or under the skin.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color. Dispose of used needles in a designated needle/sharp disposal box, and do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storing and Disposing of Your Medication
In most cases, this medication will be administered in a hospital or doctor's office. If you need to store it at home, follow the storage instructions provided by your doctor. Protect the medication from light and keep it in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into a muscle. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles, or if the solution has changed color. Dispose of used needles in a designated needle/sharp disposal box, and do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storing and Disposing of Your Medication
In most cases, this medication will be administered in a hospital or doctor's office. If you need to store it at home, follow the storage instructions provided by your doctor. Protect the medication from light and keep it in a safe location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Maintain a balanced diet, but understand that dietary intake alone may not be sufficient if the deficiency is due to malabsorption (e.g., pernicious anemia).
- Regular follow-up appointments and blood tests are crucial to monitor treatment effectiveness and adjust dosing if needed.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For pernicious anemia/B12 deficiency: 1000 mcg (1 mg) intramuscularly (IM) or subcutaneously (SC) daily for 7 days, then weekly for 4 weeks, followed by monthly maintenance.
Dose Range:
1000 - 1000 mg
Condition-Specific Dosing:
Severe neurological involvement:
1000 mcg IM/SC every other day until no further improvement, then monthly.
Maintenance therapy:
1000 mcg IM/SC monthly.
Pediatric Dosing
Neonatal:
Not established (specific dosing for deficiency varies, often lower doses)
Infant:
Not established (specific dosing for deficiency varies, often lower doses)
Child:
For B12 deficiency: 100 mcg IM/SC daily for 10-15 days, then 100 mcg monthly for maintenance. Doses vary based on specific deficiency and age.
Adolescent:
Similar to adult dosing for B12 deficiency: 1000 mcg IM/SC daily for 7 days, then weekly for 4 weeks, followed by monthly maintenance.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but monitor B12 levels and clinical response.
Dialysis:
No specific adjustment needed; hydroxocobalamin is water-soluble and excess is excreted. Dialysis may remove some, but supplementation is typically continued as needed.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but monitor B12 levels and clinical response.
Pharmacology
Mechanism of Action
Hydroxocobalamin is a naturally occurring form of vitamin B12. It is converted in the body to the active coenzymes, methylcobalamin and 5-deoxyadenosylcobalamin. These coenzymes are essential for cell replication, hematopoiesis, and myelin synthesis. Specifically, methylcobalamin is required for the activity of methionine synthase, which converts homocysteine to methionine, and 5-deoxyadenosylcobalamin is required for the activity of methylmalonyl-CoA mutase, which converts methylmalonyl-CoA to succinyl-CoA.
Pharmacokinetics
Absorption:
Bioavailability:
Nearly 100% via IM/SC injection.
Tmax:
Approximately 1 hour after IM injection.
FoodEffect:
Not applicable for parenteral administration.
Distribution:
Vd:
Not readily quantifiable, widely distributed to body tissues, with significant storage in the liver (50-90% of total body stores).
ProteinBinding:
Highly bound to specific plasma proteins (transcobalamins).
CnssPenetration:
Limited, but essential for neurological function; crosses blood-brain barrier to some extent.
Elimination:
HalfLife:
Approximately 6 days (for total body stores, but plasma half-life is shorter, around 2-5 days).
Clearance:
Primarily renal, with some enterohepatic recirculation.
ExcretionRoute:
Renal (unchanged and metabolites), some via bile.
Unchanged:
A significant portion of administered dose is excreted unchanged in urine, especially with higher doses.
Pharmacodynamics
OnsetOfAction:
Hematologic response (reticulocytosis) typically seen within 3-5 days; neurological improvement is slower, over weeks to months.
PeakEffect:
Hematologic peak effect within 5-10 days; neurological improvement continues over time.
DurationOfAction:
Monthly injections are sufficient for maintenance due to significant body stores, particularly in the liver.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Swelling
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Diarrhea
* Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Swelling
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Diarrhea
* Irritation at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Persistent fatigue or weakness
- Numbness or tingling in hands or feet
- Difficulty walking or balance problems
- Memory issues or confusion
- Sore, red tongue
- Unexplained weight loss
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. As directed by your doctor, regular blood tests will be necessary to monitor your condition, and you should discuss any concerns or questions with your doctor. Additionally, this medication may interfere with certain laboratory tests, so it is crucial to notify all healthcare providers and laboratory personnel that you are taking this drug. If you are pregnant, planning to become pregnant, or breastfeeding, you must consult your doctor to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Generally considered to have very low toxicity, even at high doses.
- Possible mild, transient side effects like headache, nausea, diarrhea, or rash.
- Very rare: allergic reactions.
What to Do:
Discontinue drug if severe allergic reaction occurs. Otherwise, supportive care. Call 1-800-222-1222 (Poison Control) for advice if concerns arise.
Drug Interactions
Moderate Interactions
- Chloramphenicol (may antagonize hematologic response to B12 in anemic patients)
- Folic acid (large doses may mask B12 deficiency symptoms)
Minor Interactions
- Metformin (can decrease B12 absorption)
- Proton pump inhibitors (PPIs) (can decrease B12 absorption with long-term use)
- H2-receptor antagonists (can decrease B12 absorption with long-term use)
- Colchicine (can decrease B12 absorption)
- Neomycin (can decrease B12 absorption)
- Aminosalicylic acid (can decrease B12 absorption)
Monitoring
Baseline Monitoring
Serum Vitamin B12 levels
Rationale: To confirm diagnosis of deficiency.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential and reticulocyte count
Rationale: To assess severity of anemia (macrocytic, megaloblastic) and monitor hematologic response.
Timing: Prior to initiation of therapy.
Serum potassium
Rationale: To monitor for hypokalemia, which can occur during initial treatment of severe megaloblastic anemia due to increased cellular uptake of potassium.
Timing: Prior to initiation of therapy and during the first few days of treatment for severe cases.
Methylmalonic acid (MMA) and Homocysteine levels
Rationale: To confirm B12 deficiency (elevated levels) and monitor biochemical response.
Timing: Prior to initiation of therapy.
Routine Monitoring
Complete Blood Count (CBC) with differential and reticulocyte count
Frequency: Weekly for the first month, then monthly until stable, then as clinically indicated.
Target: Normalization of red blood cell indices (MCV), hemoglobin, and reticulocyte count.
Action Threshold: Lack of hematologic response or worsening anemia.
Serum Vitamin B12 levels
Frequency: 3-6 months after initiation of maintenance therapy, then annually or as clinically indicated.
Target: Within normal range (e.g., >200 pg/mL or higher depending on lab and clinical context).
Action Threshold: Persistently low levels despite therapy, indicating malabsorption or inadequate dosing.
Neurological assessment
Frequency: Regularly during initial treatment and maintenance.
Target: Improvement or stabilization of neurological symptoms (e.g., paresthesias, gait disturbance).
Action Threshold: Worsening or new neurological symptoms.
Symptom Monitoring
- Fatigue
- Weakness
- Pale skin
- Sore tongue (glossitis)
- Paresthesias (tingling, numbness in hands/feet)
- Difficulty walking or balance issues
- Memory problems or cognitive changes
- Mood changes (irritability, depression)
Special Patient Groups
Pregnancy
Vitamin B12 is essential during pregnancy. While hydroxocobalamin is generally considered safe and necessary for treating deficiency, it is classified as Category C for therapeutic doses due to limited controlled studies. However, the benefits of treating B12 deficiency in pregnancy generally outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Essential for neural tube development; deficiency is a greater risk than supplementation.
Second Trimester:
Continued need for fetal development.
Third Trimester:
Continued need for fetal development and maternal health.
Lactation
Vitamin B12 is excreted into breast milk and is essential for infant development. Hydroxocobalamin is considered compatible with breastfeeding (L1 - Safest) as it is a natural form of the vitamin and necessary for both mother and infant.
Infant Risk:
Low risk; beneficial for infant.
Pediatric Use
Dosing must be carefully adjusted based on age, weight, and severity of deficiency. Essential for normal growth and neurological development. Long-term treatment may be required for congenital deficiencies.
Geriatric Use
Elderly patients are at higher risk for B12 deficiency due to age-related malabsorption (e.g., atrophic gastritis, decreased intrinsic factor). Dosing is generally similar to adults, but careful monitoring of neurological status and B12 levels is important.
Clinical Information
Clinical Pearls
- Hydroxocobalamin is often preferred over cyanocobalamin for B12 deficiency due to its longer retention in the body and absence of cyanide moiety.
- Parenteral administration (IM or SC) is crucial for patients with malabsorption syndromes (e.g., pernicious anemia, gastrectomy, Crohn's disease) where oral absorption is impaired.
- Initial treatment of severe megaloblastic anemia with B12 can cause hypokalemia due to rapid cellular uptake of potassium; monitor serum potassium levels.
- Neurological symptoms of B12 deficiency may be irreversible if treatment is delayed.
- Folic acid supplementation can mask the hematological signs of B12 deficiency while allowing neurological damage to progress; always rule out B12 deficiency before treating megaloblastic anemia with folic acid alone.
Alternative Therapies
- Cyanocobalamin (another synthetic form of Vitamin B12, available orally, IM, SC, intranasally)
- Methylcobalamin (active form of Vitamin B12, available orally, sublingually)
- Adenosylcobalamin (active form of Vitamin B12, less commonly used as a supplement)
Cost & Coverage
Average Cost:
Varies widely (e.g., $10-$50+) per 30ml vial (1000mcg/ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide crucial information, including the name of the medication taken, the amount, and the time it was taken, to facilitate prompt and appropriate care.