Westab Max 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 WES-tab MAX (FOH-lik AS-id, SYE-an-oh-KOH-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
Nutritional Supplement; Vitamin
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Pharmacologic Class
Water-soluble Vitamins
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Pregnancy Category
Category A (Folic Acid), Category B (Cyanocobalamin), Category C (Pyridoxine in high doses)
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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 Max Tablets are a vitamin supplement containing Folic Acid (Vitamin B9), Cyanocobalamin (Vitamin B12), and Pyridoxine (Vitamin B6). These vitamins are essential for many body functions, including making red blood cells, maintaining a healthy nervous system, and supporting metabolism. It is often prescribed to prevent or treat deficiencies of these vitamins, which can lead to conditions like anemia or nerve problems.
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How to Use This Medicine

Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication 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 safe location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best way to dispose of your medication, or look into 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 or without food as directed by your doctor.
  • Do not exceed the recommended dose unless advised by a healthcare professional.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential interactions.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Typically 1 tablet orally once daily, or as directed by a healthcare professional.

Condition-Specific Dosing:

Nutritional Deficiency: Dosage may vary based on the severity of deficiency and specific medical conditions (e.g., megaloblastic anemia, hyperhomocysteinemia).
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Pediatric Dosing

Neonatal: Not established for this combination product. Individual vitamin doses are used.
Infant: Not established for this combination product. Individual vitamin doses are used.
Child: Not established for this combination product. Individual vitamin doses are used.
Adolescent: Not established for this combination product. Individual vitamin doses are used, or adult dose may be considered for older adolescents under medical supervision.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required.
Severe: No specific adjustment typically required, but monitor for potential accumulation of pyridoxine in very severe cases. Consult physician.
Dialysis: Water-soluble vitamins are dialyzable; supplementation may be necessary. Consult physician.

Hepatic Impairment:

Mild: No specific adjustment typically required.
Moderate: No specific adjustment typically required.
Severe: No specific adjustment typically required.
Confidence: Medium

Pharmacology

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Mechanism of Action

Westab Max Tablets provide essential B vitamins: Folic Acid (Vitamin B9), Cyanocobalamin (Vitamin B12), and Pyridoxine (Vitamin B6). These vitamins act as coenzymes in various metabolic processes critical for cellular function, particularly in hematopoiesis and nervous system health. Folic acid is crucial for DNA synthesis, repair, and methylation, and is essential for the production of red blood cells. Cyanocobalamin is a coenzyme for methionine synthase (involved in the folate cycle and myelin synthesis) and methylmalonyl-CoA mutase (involved in fatty acid metabolism). Pyridoxine, in its active form pyridoxal phosphate (PLP), is a coenzyme for over 100 enzymes involved in amino acid metabolism, neurotransmitter synthesis (e.g., serotonin, dopamine, GABA), and glycogenolysis.
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Pharmacokinetics

Absorption:

Bioavailability: Folic Acid: High (nearly 100% for synthetic folic acid). Cyanocobalamin: Varies, typically 1-5% for oral doses, requires intrinsic factor for active absorption. Pyridoxine: Readily absorbed from the GI tract.
Tmax: Folic Acid: 1-2 hours. Cyanocobalamin: 8-12 hours (for peak plasma levels after oral dose). Pyridoxine: 1-2 hours.
FoodEffect: Folic Acid: Food may slightly delay absorption but does not significantly affect bioavailability. Cyanocobalamin: Food may slightly impair absorption. Pyridoxine: No significant food effect.

Distribution:

Vd: Folic Acid: Approximately 17 L. Cyanocobalamin: Widely distributed, stored in the liver. Pyridoxine: Widely distributed, primarily in liver, muscle, and brain.
ProteinBinding: Folic Acid: Highly protein bound (to albumin and specific folate-binding proteins). Cyanocobalamin: Highly protein bound (to transcobalamins). Pyridoxine: Pyridoxal phosphate is highly protein bound to albumin.
CnssPenetration: Yes (all three vitamins cross the blood-brain barrier).

Elimination:

HalfLife: Folic Acid: Approximately 3-6 hours. Cyanocobalamin: 6 days (for total body stores, plasma half-life is shorter). Pyridoxine: 15-20 days (for PLP).
Clearance: Not typically quantified for vitamins in this context.
ExcretionRoute: Folic Acid: Primarily renal, some biliary. Cyanocobalamin: Primarily renal, some biliary. Pyridoxine: Primarily renal (as pyridoxic acid).
Unchanged: Folic Acid: Minimal. Cyanocobalamin: Small amounts. Pyridoxine: Minimal.
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Pharmacodynamics

OnsetOfAction: Not acutely defined for vitamin supplementation; therapeutic effects develop gradually over days to weeks.
PeakEffect: Not acutely defined; depends on repletion of body stores.
DurationOfAction: Depends on body stores and ongoing intake; effects persist as long as adequate levels are maintained.
Confidence: Medium

Safety & Warnings

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

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's 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 persist, contact your doctor for advice:

Diarrhea
Itching
Drowsiness
Upset stomach
Headache

Note: 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:

  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing) - rare but seek immediate medical attention.
  • Unusual tingling, numbness, or weakness (especially with very high doses of pyridoxine over time).
  • Severe stomach upset or diarrhea (rare).
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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, health conditions, and supplements with your doctor. This includes:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Your doctor and pharmacist need to be aware of all your medications and health problems to ensure safe use of this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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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. In the event that you or someone else accidentally takes this drug, seek immediate medical attention. 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.
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Overdose Information

Overdose Symptoms:

  • Folic Acid: Generally non-toxic, even at high doses. Rarely, GI upset, irritability, sleep disturbances.
  • Cyanocobalamin: Generally non-toxic, even at high doses.
  • Pyridoxine: High doses (typically >200 mg/day long-term) can cause severe peripheral neuropathy (numbness, tingling, pain, weakness in hands/feet), ataxia, and skin lesions.

What to Do:

Discontinue the supplement. For severe pyridoxine toxicity, symptomatic and supportive care. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.

Drug Interactions

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Major Interactions

  • Folic Acid + Methotrexate: Folic acid can reduce the efficacy of methotrexate (a folate antagonist).
  • Pyridoxine + Levodopa: High doses of pyridoxine can reverse the effects of levodopa (unless co-administered with a dopa decarboxylase inhibitor like carbidopa).
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Moderate Interactions

  • Folic Acid + Anticonvulsants (e.g., Phenytoin, Carbamazepine, Phenobarbital): Folic acid may decrease anticonvulsant levels, potentially increasing seizure risk. Anticonvulsants can also decrease 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: Long-term use can reduce vitamin B12 absorption.
  • Pyridoxine + Isoniazid: Isoniazid can cause pyridoxine deficiency.
  • Pyridoxine + Oral Contraceptives: May increase pyridoxine requirements.
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Minor Interactions

  • Folic Acid + Trimethoprim: Trimethoprim is a weak folate antagonist.
  • Cyanocobalamin + Colchicine: Colchicine may impair vitamin B12 absorption.

Monitoring

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Baseline Monitoring

Serum Folic Acid, Vitamin B12, and Pyridoxine levels

Rationale: To assess baseline deficiency status, especially if symptoms are present or risk factors exist.

Timing: Prior to initiation, if deficiency is suspected.

Complete Blood Count (CBC) with differential

Rationale: To assess for megaloblastic anemia (due to B12 or folate deficiency).

Timing: Prior to initiation, if deficiency is suspected.

Homocysteine levels

Rationale: Elevated homocysteine can indicate B6, B9, or B12 deficiency.

Timing: Prior to initiation, if hyperhomocysteinemia is suspected or for cardiovascular risk assessment.

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Routine Monitoring

Clinical symptom assessment (e.g., fatigue, neurological symptoms, paresthesias)

Frequency: Regularly, as clinically indicated.

Target: Resolution or improvement of deficiency symptoms.

Action Threshold: Persistent or worsening symptoms may indicate inadequate dosing or alternative diagnosis.

Serum Folic Acid, Vitamin B12, and Pyridoxine levels

Frequency: Periodically (e.g., every 3-6 months) if treating a deficiency or if symptoms recur.

Target: Within normal reference ranges.

Action Threshold: Levels below target may require dose adjustment or investigation of malabsorption.

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Symptom Monitoring

  • Fatigue
  • Weakness
  • Pale skin
  • Shortness of breath
  • Sore tongue (glossitis)
  • Numbness or tingling in hands and feet (paresthesias)
  • Difficulty walking
  • Memory problems
  • Mood changes (irritability, depression)
  • Muscle weakness
  • Loss of appetite
  • Nausea
  • Diarrhea

Special Patient Groups

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Pregnancy

Folic acid is critically important during pregnancy, especially in the periconceptional period, to prevent neural tube defects. Cyanocobalamin and Pyridoxine are also important for fetal development. Generally considered safe and beneficial when used at recommended doses during pregnancy.

Trimester-Specific Risks:

First Trimester: Folic acid is crucial for neural tube development. Pyridoxine may help with morning sickness. All generally safe and beneficial.
Second Trimester: Continued importance for fetal growth and development. Generally safe.
Third Trimester: Continued importance for fetal growth and development. Generally safe.
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Lactation

All three vitamins are excreted in breast milk. They are generally considered safe and compatible with breastfeeding at recommended doses, as they are essential nutrients for the infant.

Infant Risk: Low risk; beneficial for infant nutrition.
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Pediatric Use

Not typically formulated for routine pediatric use as a combination product. Individual vitamin supplementation is preferred for specific deficiencies in children, with doses adjusted by age and weight. Consult a pediatrician.

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Geriatric Use

Older adults are at higher risk for deficiencies of B12 (due to malabsorption, e.g., atrophic gastritis) and sometimes B6 and folate. Supplementation can be particularly beneficial in this population. No specific dose adjustments are typically needed, but monitor for potential interactions with polypharmacy.

Clinical Information

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Clinical Pearls

  • This combination is commonly used to address hyperhomocysteinemia, a risk factor for cardiovascular disease and neurological disorders, as all three vitamins are involved in homocysteine metabolism.
  • While generally safe, high doses of pyridoxine (Vitamin B6) over prolonged periods can lead to peripheral neuropathy. Patients should be advised not to exceed recommended doses without medical supervision.
  • Patients with pernicious anemia or other causes of severe B12 malabsorption may require injectable cyanocobalamin, as oral supplementation may not be sufficient.
  • Folic acid supplementation can mask the hematological symptoms of vitamin B12 deficiency, potentially allowing neurological damage to progress. It is crucial to rule out B12 deficiency before initiating high-dose folic acid, especially in at-risk individuals.
  • Advise patients that urine may turn bright yellow due to riboflavin (another B vitamin often included in B-complex formulations, though not explicitly listed here, it's a common observation with B vitamins).
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Alternative Therapies

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

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often covered as a prescription vitamin or supplement, coverage varies by insurance plan (Tier 1-3 or not covered).
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.