Rena-Vite Rx Tablets

Manufacturer CYPRESS Active Ingredient Vitamin B Complex Combinations Tablets and Capsules(VYE ta min bee KOM pleks kom bi NAY shuns) Pronunciation REE-nuh-VITE R-X; VYE-tuh-min BEE KOM-pleks KOM-bi-NAY-shuns
It is used to help growth and good health.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Vitamin Supplement; Nutritional Supplement
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Pharmacologic Class
Water-soluble vitamins; Coenzymes
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Pregnancy Category
Not assigned (Generally considered safe, consult physician)
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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?

Rena-Vite Rx Tablets are a vitamin supplement containing a combination of B vitamins. These vitamins are essential for many body functions, including energy production, nerve health, and red blood cell formation. They help your body convert food into energy and maintain overall health.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

Store it at room temperature in a dry place, avoiding bathrooms.
Protect it from heat and light.
Keep all medications in a secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's 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 one.
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Lifestyle & Tips

  • Take with food to minimize stomach upset and potentially enhance absorption.
  • Maintain a balanced diet rich in fruits, vegetables, and whole grains.
  • Inform your doctor about all other medications and supplements you are taking.
  • Store at room temperature, away from light and moisture.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 tablet daily, or as directed by a healthcare professional
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

deficiency: Higher doses may be prescribed for specific vitamin deficiencies under medical supervision.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Consult pediatrician for specific dosing)
Adolescent: Typically adult dose, or as directed by a healthcare professional
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustments typically required for supplementation doses.
Moderate: No specific adjustments typically required for supplementation doses.
Severe: No specific adjustments typically required for supplementation doses; however, caution with high doses of certain B vitamins (e.g., B6) in severe renal failure.
Dialysis: Supplementation may be beneficial due to loss during dialysis; consult nephrologist for specific recommendations.

Hepatic Impairment:

Mild: No specific adjustments typically required.
Moderate: No specific adjustments typically required.
Severe: No specific adjustments typically required.

Pharmacology

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Mechanism of Action

Vitamin B complex vitamins (B1, B2, B3, B5, B6, B7, B9, B12) are water-soluble vitamins that serve as essential coenzymes in numerous metabolic pathways. They are crucial for cellular energy production, DNA synthesis and repair, nerve function, red blood cell formation, and various other physiological processes. They do not exert a direct pharmacological action in the same way as drugs, but rather support normal biochemical functions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly by individual B vitamin (e.g., B12 requires intrinsic factor, B9 is well-absorbed). Generally good for most B vitamins from oral supplements.
Tmax: Not precisely defined for the combination; individual B vitamins peak at varying times (e.g., 1-4 hours).
FoodEffect: Generally enhanced absorption with food for some B vitamins, or no significant impact. B12 absorption can be reduced by certain foods or medications.

Distribution:

Vd: Not precisely defined for the combination; water-soluble vitamins distribute widely in body water.
ProteinBinding: Minimal for most B vitamins; some may bind to specific transport proteins (e.g., transcobalamin for B12).
CnssPenetration: Yes, most B vitamins cross the blood-brain barrier to varying degrees.

Elimination:

HalfLife: Varies significantly by individual B vitamin (e.g., B1: ~18 days tissue half-life, B6: ~15-20 days, B12: very long tissue retention). Excess water-soluble vitamins are generally excreted rapidly.
Clearance: Renal clearance for excess amounts.
ExcretionRoute: Renal (urine)
Unchanged: Significant portion of excess unutilized vitamins.
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Pharmacodynamics

OnsetOfAction: Gradual, supportive effect; not a rapid pharmacological onset. Clinical effects for deficiency may take weeks to months.
PeakEffect: Not applicable in a typical pharmacological sense; sustained support of metabolic processes.
DurationOfAction: Sustained as long as supplementation continues and body stores are maintained.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening 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, or swelling of the mouth, face, lips, tongue, or throat.

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 if you experience any of the following side effects or if they persist or bother you:
- Stomach pain or diarrhea
- Upset stomach or vomiting
- Decreased appetite
- Gas
- Bad taste in your mouth

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 stomach upset or nausea (rare)
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing - rare but serious)
  • Unusual tingling, numbness, or weakness (especially with very high doses of B6)
  • Darkening of urine (common and harmless with B2/riboflavin)
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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 symptoms you experienced.
If you are currently taking levodopa, as this may interact with the medication.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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Precautions & Cautions

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and laboratory personnel that you are taking it.

If you have a known allergy to tartrazine (also referred to as FD&C Yellow No. 5), consult with your doctor before taking this medication, as some formulations may contain this ingredient.

Not all formulations of this medication are suitable for pediatric use, so it is crucial to discuss its use with your doctor if you are considering administering it to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, you must consult with your doctor to weigh the potential benefits and risks of taking this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Generally, water-soluble B vitamins are considered safe even at higher doses as excess is excreted in urine.
  • However, very high doses of Pyridoxine (B6) over prolonged periods can cause peripheral neuropathy (nerve damage) characterized by numbness, tingling, and weakness.
  • Very high doses of Niacin (B3) can cause flushing, itching, liver damage, and gastrointestinal upset.

What to Do:

Discontinue use and seek immediate medical attention. Call a poison control center (1-800-222-1222) or emergency services.

Drug Interactions

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Major Interactions

  • Levodopa (with high doses of Pyridoxine/B6, unless carbidopa is co-administered)
  • Methotrexate (with Folic Acid/B9, can reduce efficacy of methotrexate; requires careful monitoring and specific dosing strategies)
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Moderate Interactions

  • Phenytoin (Folic acid can decrease phenytoin levels)
  • Phenobarbital (Folic acid can decrease phenobarbital levels)
  • Primidone (Folic acid can decrease primidone levels)
  • Isoniazid (can interfere with B6 metabolism)
  • Oral Contraceptives (may affect B6 and B9 status)
  • Certain antibiotics (e.g., chloramphenicol, neomycin) and proton pump inhibitors (can impair B12 absorption)
  • Colchicine (can impair B12 absorption)
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Minor Interactions

  • Alcohol (can impair absorption and increase excretion of several B vitamins)
  • Diuretics (may increase excretion of some B vitamins)

Monitoring

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Baseline Monitoring

Clinical assessment of nutritional status

Rationale: To identify signs of vitamin deficiency or excess, and to determine the need for supplementation.

Timing: Prior to initiation, especially if deficiency is suspected.

Relevant laboratory tests (e.g., B12, folate levels)

Rationale: If specific vitamin deficiencies are suspected or confirmed, to guide dosing and assess severity.

Timing: Prior to initiation of high-dose therapy for deficiency.

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Routine Monitoring

Clinical symptoms (e.g., energy levels, neurological symptoms)

Frequency: Periodically, as needed

Target: Improvement or resolution of deficiency symptoms

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

Adverse effects (e.g., gastrointestinal upset, skin reactions)

Frequency: As needed, especially with new initiation or dose changes

Target: Absence of adverse effects

Action Threshold: Presence of adverse effects may require dose reduction or discontinuation.

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Symptom Monitoring

  • Improved energy levels
  • Reduced fatigue
  • Improved mood
  • Resolution of neurological symptoms (e.g., tingling, numbness)
  • Improved skin, hair, and nail health
  • Absence of gastrointestinal upset
  • Absence of allergic reactions (rare)

Special Patient Groups

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Pregnancy

B vitamins are essential during pregnancy for fetal development and maternal health. Folic acid (B9) is particularly crucial to prevent neural tube defects. Generally considered safe and often recommended as part of prenatal vitamins. Consult a healthcare provider for appropriate dosing.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (Folic Acid).
Second Trimester: Continued support for fetal growth and maternal metabolic needs.
Third Trimester: Continued support for fetal growth and maternal metabolic needs.
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Lactation

B vitamins are excreted in breast milk and are essential for infant growth and development. Supplementation is generally considered safe and often recommended for lactating mothers. Consult a healthcare provider.

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

Specific pediatric formulations and dosing are available for children. Rena-Vite Rx is typically for adult use or as directed by a pediatrician for specific conditions. High doses of certain B vitamins should be avoided without medical supervision.

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Geriatric Use

Older adults may have increased needs for certain B vitamins (e.g., B12 due to malabsorption) or may be at higher risk for deficiencies due to diet, medications, or underlying conditions. Supplementation can be beneficial. No specific dose adjustments are typically required for the combination, but individual needs should be assessed.

Clinical Information

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Clinical Pearls

  • Rena-Vite Rx is a prescription-strength B-complex vitamin, often used in patients with specific nutritional needs, such as those with renal disease or malabsorption.
  • Water-soluble vitamins are not stored in large amounts in the body, so regular intake is important.
  • Urine may turn bright yellow due to riboflavin (B2) excretion; this is a harmless effect.
  • While generally safe, very high doses of certain B vitamins (especially B6 and B3) can lead to adverse effects. Always adhere to prescribed or recommended doses.
  • Patients on certain medications (e.g., levodopa, methotrexate, anticonvulsants) should discuss B vitamin supplementation with their doctor due to potential interactions.
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Alternative Therapies

  • Dietary modifications to increase intake of B vitamin-rich foods (e.g., whole grains, meat, fish, eggs, dairy, leafy greens, legumes).
  • Individual B vitamin supplements if only a specific deficiency is present (e.g., B12 injections for pernicious anemia).
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often available over-the-counter (OTC) or as a prescription. If prescribed, coverage varies by plan (e.g., Tier 3 or 4, or not covered if considered OTC equivalent).
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.