Westab One Tablets

Manufacturer WESTMINSTER PHARMACEUTICALS Active Ingredient Folic Acid, Cyanocobalamin, and Pyridoxine(FOE lik AS id, sye an oh koe BAL a min, & peer i DOKS een) Pronunciation FOE-lik AS-id, SYE-an-oh-KOE-bal-a-min, PEER-i-DOKS-een
It is used to help growth and good health.It is used to treat or prevent low vitamin B6.It is used to treat or prevent low vitamin B12.
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Drug Class
Vitamin Supplement; Nutritional Supplement
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Pharmacologic Class
Water-soluble Vitamins (B-complex vitamins)
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Pregnancy Category
Category A
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Westab One Tablets contain three important B vitamins: Folic Acid (B9), Cyanocobalamin (B12), and Pyridoxine (B6). These vitamins are essential for many body functions, including making healthy red blood cells, supporting nerve health, and helping your body use energy from food. They are often used to prevent or treat vitamin deficiencies, especially in people with certain medical conditions or dietary restrictions.
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How to Use This Medicine

Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Some medications may need to be taken on an empty stomach, so be sure to check with your pharmacist for specific guidance on how to take your medication.

Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush medications down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about the best way to dispose of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

What to Do If You Miss a Dose
If you miss a dose of your medication, 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.
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Lifestyle & Tips

  • Take the tablet with food if stomach upset occurs, although it can usually be taken with or without food.
  • Maintain a balanced diet rich in fruits, vegetables, whole grains, and lean proteins to ensure overall nutritional intake.
  • Inform your doctor about all medications and supplements you are taking, especially if you are on chemotherapy, anticonvulsants, or medications for Parkinson's disease.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Typically one tablet daily, or as directed by a healthcare professional. Common formulations contain Folic Acid 800 mcg - 1 mg, Cyanocobalamin 1000 mcg - 2500 mcg, Pyridoxine 25 mg - 50 mg.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

Nutritional Deficiency: One tablet daily for maintenance or correction of mild deficiencies.
Neuropathic Support: Higher doses may be used under medical supervision for specific conditions like diabetic neuropathy or other nerve-related issues.
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Pediatric Dosing

Neonatal: Not established for this combination product. Individual vitamin supplementation should be guided by a pediatrician.
Infant: Not established for this combination product. Individual vitamin supplementation should be guided by a pediatrician.
Child: Not established for this combination product. Individual vitamin supplementation should be guided by a pediatrician.
Adolescent: Dosing may be similar to adult doses for specific deficiencies, but should be guided by a healthcare professional.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required. Monitor for potential accumulation of pyridoxine in very high doses.
Severe: No specific adjustment typically required. Monitor for potential accumulation of pyridoxine in very high doses.
Dialysis: Water-soluble vitamins are dialyzable. Supplementation may be necessary, but specific dosing should be guided by a nephrologist.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required.
Severe: No specific adjustment typically required. Liver is involved in metabolism and storage of B12, but supplementation is generally safe.

Pharmacology

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Mechanism of Action

Folic Acid (Vitamin B9) is essential for DNA synthesis, cell growth, and red blood cell formation. It acts as a coenzyme in various metabolic processes, including the synthesis of purines and pyrimidines, and the metabolism of amino acids. Cyanocobalamin (Vitamin B12) is a coenzyme required for DNA synthesis, fatty acid metabolism, and myelin synthesis. It is crucial for the proper functioning of the nervous system and red blood cell maturation. Pyridoxine (Vitamin B6) is a coenzyme involved in over 100 enzyme reactions, primarily in amino acid metabolism, neurotransmitter synthesis (e.g., serotonin, norepinephrine, dopamine), and glycogenolysis. Together, these vitamins play critical roles in homocysteine metabolism, helping to convert homocysteine to methionine, which may support cardiovascular and neurological health.
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Pharmacokinetics

Absorption:

Bioavailability: Folic Acid: High (nearly 100% for synthetic form). Cyanocobalamin: Dose-dependent (approx. 1-5% for oral doses > 1 mcg, requires intrinsic factor). Pyridoxine: High (approx. 75%).
Tmax: Folic Acid: 1 hour. Cyanocobalamin: 8-12 hours (oral). Pyridoxine: 2-4 hours.
FoodEffect: Generally minimal impact on absorption for these vitamins. Folic acid absorption may be slightly reduced by food. B12 absorption requires intrinsic factor, which is not affected by food directly but by gastric pH.

Distribution:

Vd: Folic Acid: Widely distributed, concentrated in CSF. Cyanocobalamin: Stored primarily in the liver (90%). Pyridoxine: Widely distributed, highest concentrations in liver, muscle, and brain.
ProteinBinding: Folic Acid: Highly protein bound. Cyanocobalamin: Bound to transcobalamins. Pyridoxine: Bound to plasma proteins.
CnssPenetration: Yes (all three cross the blood-brain barrier to varying degrees).

Elimination:

HalfLife: Folic Acid: Approximately 3-4 hours (for unmetabolized folic acid). Cyanocobalamin: Approximately 6 days (for total body stores, but plasma half-life is shorter). Pyridoxine: Approximately 15-20 days (for PLP).
Clearance: Primarily renal for all three.
ExcretionRoute: Renal (urine) for all three. B12 also undergoes enterohepatic recirculation.
Unchanged: Folic Acid: Small amounts excreted unchanged. Cyanocobalamin: Small amounts excreted unchanged in urine, larger amounts in bile (reabsorbed). Pyridoxine: Metabolites excreted in urine.
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Pharmacodynamics

OnsetOfAction: Correction of deficiency symptoms may take weeks to months, depending on severity and specific vitamin. Biochemical effects (e.g., homocysteine reduction) may be seen sooner.
PeakEffect: Not applicable in the same way as acute drugs; refers to the time to achieve optimal body stores and clinical improvement.
DurationOfAction: Dependent on body stores and continued intake. Effects persist as long as adequate levels are maintained.

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek medical attention right away if you notice any of the following symptoms, which could indicate a serious reaction:

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
A burning, numbness, or tingling sensation that is not normal
Swelling

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Diarrhea
Itching
Feeling sleepy
Upset stomach
Headache

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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Seek Immediate Medical Attention If You Experience:

  • Unusual tingling or numbness in hands or feet (paresthesia)
  • Severe fatigue or weakness that does not improve
  • Persistent nausea, vomiting, or diarrhea
  • Skin rash or itching (rare, but possible allergic reaction)
  • Any new or worsening neurological symptoms
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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 allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with Leber's optic atrophy, a specific eye condition.
* If you are currently taking levodopa, as this may interact with the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you or someone else accidentally takes this drug, seek immediate medical attention. Additionally, if you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Folic Acid: Generally considered non-toxic, but very high doses may mask B12 deficiency symptoms.
  • Cyanocobalamin: Very low toxicity, no known adverse effects from excessive intake.
  • Pyridoxine: High doses (typically >200 mg/day long-term) can cause peripheral neuropathy (numbness, tingling, loss of sensation), ataxia (loss of coordination), and skin lesions.

What to Do:

If you suspect an overdose, especially with high doses of pyridoxine, contact your doctor or a poison control center immediately (1-800-222-1222). Discontinue the supplement. Treatment is generally supportive.

Drug Interactions

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Major Interactions

  • Folic Acid + Methotrexate: Folic acid can reduce the efficacy of methotrexate (a folate antagonist). Co-administration requires careful monitoring and dose adjustment of methotrexate.
  • Pyridoxine + Levodopa (without carbidopa): Pyridoxine can rapidly decarboxylate levodopa in the periphery, reducing its efficacy in Parkinson's disease. This interaction is largely mitigated when levodopa is co-administered with carbidopa.
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Moderate Interactions

  • Folic Acid + Anticonvulsants (e.g., Phenytoin, Phenobarbital, Primidone): Folic acid supplementation may decrease anticonvulsant levels, potentially increasing seizure risk. Conversely, anticonvulsants can lower folate levels.
  • Folic Acid + Sulfasalazine: Sulfasalazine can inhibit folic acid absorption.
  • Cyanocobalamin + Metformin: Metformin can decrease vitamin B12 absorption.
  • Cyanocobalamin + Proton Pump Inhibitors (PPIs) / H2 Blockers: These medications can reduce gastric acid, impairing B12 absorption from food (less impact on supplemental B12).
  • Pyridoxine + Isoniazid: Isoniazid can interfere with pyridoxine metabolism, leading to deficiency and peripheral neuropathy. Pyridoxine supplementation is often given with isoniazid.
  • Pyridoxine + Amiodarone: High doses of pyridoxine may reduce amiodarone levels.
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Minor Interactions

  • Folic Acid + Oral Contraceptives: May slightly increase folate requirements.
  • Pyridoxine + Hydralazine, Penicillamine: These drugs can increase pyridoxine excretion.

Monitoring

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Baseline Monitoring

Clinical symptoms of deficiency (e.g., fatigue, neurological symptoms, macrocytic anemia)

Rationale: To establish the need for supplementation and guide therapy.

Timing: Prior to initiation of therapy for suspected deficiency.

Complete Blood Count (CBC) with differential

Rationale: To assess for macrocytic anemia (common in B12/folate deficiency).

Timing: Prior to initiation of therapy for suspected deficiency.

Serum Folic Acid, Serum Vitamin B12, Serum Homocysteine, Methylmalonic Acid (MMA)

Rationale: To confirm specific vitamin deficiencies and assess metabolic impact.

Timing: Prior to initiation of therapy for suspected deficiency.

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Routine Monitoring

Clinical symptom improvement

Frequency: Ongoing, at follow-up visits

Target: Resolution or significant improvement of deficiency symptoms.

Action Threshold: Lack of improvement or worsening symptoms may indicate inadequate dosing, malabsorption, or alternative diagnosis.

Complete Blood Count (CBC)

Frequency: Every 3-6 months initially, then annually if stable.

Target: Normalization of red blood cell indices (e.g., MCV).

Action Threshold: Persistent macrocytosis or anemia.

Serum Folic Acid, Serum Vitamin B12

Frequency: Every 6-12 months, or as clinically indicated.

Target: Within normal reference ranges.

Action Threshold: Levels remaining low despite supplementation.

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Symptom Monitoring

  • Fatigue
  • Weakness
  • Pale skin
  • Sore tongue (glossitis)
  • Neurological symptoms (numbness, tingling, balance problems, memory issues)
  • Mood changes (irritability, depression)
  • Gastrointestinal disturbances (diarrhea, constipation)
  • Skin rashes (rare, high dose B6)

Special Patient Groups

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Pregnancy

Category A. Folic acid is crucial during pregnancy to prevent neural tube defects. B6 can help with morning sickness. B12 is also essential for fetal development. This combination is generally considered safe and often recommended during pregnancy.

Trimester-Specific Risks:

First Trimester: Folic acid is most critical during the first trimester (and preconception) for neural tube development. B6 and B12 are also important.
Second Trimester: Continued importance for fetal growth and maternal health.
Third Trimester: Continued importance for fetal growth and maternal health.
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Lactation

L1 (Safest). All three vitamins are excreted in breast milk and are essential for infant development. Supplementation is generally considered safe and beneficial for nursing mothers.

Infant Risk: Low risk to infant. Benefits of supplementation for the mother and infant generally outweigh any theoretical risks.
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Pediatric Use

While individual vitamins are essential for children, this specific combination product's dosing is not typically established for routine pediatric use. Pediatricians guide supplementation based on individual needs and deficiencies. Generally safe at appropriate doses.

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Geriatric Use

Older adults are at higher risk for B12 deficiency due to malabsorption (e.g., atrophic gastritis, PPI use) and may also have suboptimal folate and B6 levels. This combination can be particularly beneficial in this population. No specific dose adjustments are typically needed, but monitoring for B12 deficiency is important.

Clinical Information

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Clinical Pearls

  • This combination is often used to lower homocysteine levels, which is a risk factor for cardiovascular disease and cognitive decline, although clinical outcomes from homocysteine lowering are debated.
  • Patients with pernicious anemia or severe B12 malabsorption may require injectable B12, as oral forms may not be sufficient.
  • High doses of pyridoxine (B6) can cause peripheral neuropathy; patients should be advised not to exceed recommended doses without medical supervision.
  • Folic acid supplementation can mask the hematological symptoms of B12 deficiency (macrocytic anemia) while neurological damage progresses. Always rule out B12 deficiency before initiating high-dose folic acid.
  • These vitamins are water-soluble, meaning excess amounts are generally excreted in urine, reducing the risk of accumulation compared to fat-soluble vitamins (except for high-dose B6).
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Alternative Therapies

  • Individual Folic Acid supplements
  • Individual Cyanocobalamin (B12) supplements (oral, sublingual, injectable)
  • Individual Pyridoxine (B6) supplements
  • Dietary modifications to increase intake of these vitamins.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often Over-The-Counter (OTC) and not covered by insurance. If prescribed for specific medical conditions (e.g., high-dose folate), it may be covered as a Tier 3 or 4 medication.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.