Rena-Vite Tablets

Manufacturer CYPRESS PHARMACEUTICAL Active Ingredient Vitamin B Complex Combinations Tablets and Capsules(VYE ta min bee KOM pleks kom bi NAY shuns) Pronunciation REE-nah-VITE (for Rena-Vite); VYE-ta-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
Nutritional Supplement; Vitamin
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Pharmacologic Class
Water-soluble Vitamins; B-Complex Vitamins
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Pregnancy Category
Not available (generally considered safe and often recommended, but specific product category not assigned)
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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 is a vitamin supplement containing a combination of B vitamins. These vitamins are essential for your body's energy production, nerve function, and overall health. It's often prescribed for people with kidney disease, especially those on dialysis, to replace vitamins that are lost or not adequately obtained through diet.
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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 prescription and follow the instructions closely. Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist to determine the best way to take your medication.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Protect it from heat and light to prevent degradation. Keep all medications in a secure location, out of the reach of children and pets, to avoid accidental ingestion or exposure.

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, as this can increase the risk of adverse effects.
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Lifestyle & Tips

  • Take as directed by your doctor, usually once daily.
  • Can be taken with or without food, but taking with food may reduce stomach upset.
  • Do not exceed the recommended dose unless advised by your doctor.
  • Maintain a balanced diet as much as possible, even with supplementation.
  • Store at room temperature, away from moisture and heat.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

renal_dialysis: 1 tablet daily, often post-dialysis, to replace water-soluble vitamins lost during the procedure and to supplement dietary restrictions.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing should be determined by a healthcare professional based on specific needs and age. Not typically a standard pediatric supplement.
Adolescent: Dosing should be determined by a healthcare professional based on specific needs and age. May follow adult dosing if indicated.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed; product is often specifically formulated for renal patients.
Moderate: No adjustment needed; product is often specifically formulated for renal patients.
Severe: No adjustment needed; product is often specifically formulated for renal patients.
Dialysis: Product is specifically designed for patients on dialysis to replace lost water-soluble vitamins. Dosing is typically 1 tablet daily, often after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.

Pharmacology

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Mechanism of Action

Vitamin B complex vitamins (B1, B2, B3, B5, B6, B7, B9, B12) act as coenzymes in numerous metabolic pathways essential for cellular function, energy production, DNA synthesis, red blood cell formation, and nervous system health. They are water-soluble, meaning they are not stored in large quantities in the body and excess amounts are excreted, necessitating regular intake.
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Pharmacokinetics

Absorption:

Bioavailability: High (for most B vitamins, though B12 requires intrinsic factor)
Tmax: Varies by specific vitamin, generally 1-4 hours for peak plasma concentrations.
FoodEffect: Generally minimal; some B vitamins may be better absorbed with food.

Distribution:

Vd: Widely distributed throughout body tissues.
ProteinBinding: Low to moderate, varies by specific vitamin.
CnssPenetration: Yes (most B vitamins cross the blood-brain barrier to varying degrees).

Elimination:

HalfLife: Varies by vitamin, generally short (hours to days).
Clearance: Primarily renal.
ExcretionRoute: Renal (urine)
Unchanged: Significant portion of unutilized vitamins excreted unchanged.
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Pharmacodynamics

OnsetOfAction: Not acutely measurable for chronic supplementation; effects are gradual as deficiencies are corrected.
PeakEffect: Not acutely measurable.
DurationOfAction: Not acutely measurable; continuous intake required due to water-solubility.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
If you experience any of the following symptoms, call your doctor or seek medical help right away, 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
While many people taking this medication may not experience any side effects or only minor ones, it's essential to be aware of the following:
- Stomach pain or diarrhea
- Upset stomach or vomiting
- Decreased appetite
- Gas
- Bad taste in your mouth
If any of these side effects or any others bother you or do not go away, contact your doctor for advice.

Reporting Side Effects
This list does not include all possible 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach upset
  • Diarrhea
  • Nausea
  • Skin rash or itching
  • Unusual tingling, numbness, or weakness (especially with very high B6 intake)
  • Yellowing of skin or eyes (rare, but can indicate liver issues, not typically from B vitamins)
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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 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 concerns with your doctor. This includes:

All 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. Do not start, stop, or adjust 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 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 all of 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.

Note that not all products containing this medication are suitable for pediatric use. If you are a parent or guardian, consult with your child's doctor to determine the appropriate treatment.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • For most B vitamins, excess is excreted in urine, leading to low toxicity.
  • High doses of Vitamin B6 (pyridoxine) can cause severe peripheral neuropathy (numbness, tingling, weakness) and ataxia.
  • High doses of Niacin (B3) can cause flushing, itching, gastrointestinal upset, and liver damage.
  • High doses of Folic Acid (B9) can mask Vitamin B12 deficiency, leading to irreversible neurological damage.

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 also given)
  • Methotrexate (with folic acid/B9, can reduce efficacy of methotrexate)
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Moderate Interactions

  • Phenytoin (folic acid/B9 can decrease phenytoin levels)
  • Phenobarbital (folic acid/B9 can decrease phenobarbital levels)
  • Primidone (folic acid/B9 can decrease primidone levels)
  • Isoniazid (can interfere with pyridoxine/B6 metabolism)
  • Oral contraceptives (can affect levels of several B vitamins)
  • Certain antibiotics (e.g., chloramphenicol, neomycin, colchicine can impair B12 absorption)
  • Proton pump inhibitors (can impair B12 absorption with long-term use)
  • Metformin (can impair B12 absorption with long-term use)

Monitoring

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Baseline Monitoring

Baseline vitamin levels (e.g., B12, folate)

Rationale: To assess pre-existing deficiencies, especially in at-risk populations like renal patients.

Timing: Prior to initiation, if deficiency is suspected or being treated.

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Routine Monitoring

Clinical symptoms of deficiency or toxicity

Frequency: Ongoing, at each clinical visit

Target: Resolution of deficiency symptoms; absence of toxicity symptoms

Action Threshold: Worsening symptoms or new symptoms warrant further investigation and potential dose adjustment.

Renal function (eGFR, creatinine)

Frequency: As per standard renal disease management

Target: Stable renal function

Action Threshold: Significant decline may necessitate re-evaluation of overall nutritional status.

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Symptom Monitoring

  • Fatigue
  • Weakness
  • Numbness or tingling (neuropathy)
  • Memory issues
  • Depression
  • Irritability
  • Skin changes
  • Sore tongue
  • Gastrointestinal upset
  • Peripheral neuropathy (especially with high B6 doses)

Special Patient Groups

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Pregnancy

B vitamins are essential during pregnancy and are commonly included in prenatal vitamins. Rena-Vite, as a B-complex, is generally considered safe and may be prescribed if specific deficiencies are identified or for underlying conditions like renal disease. Consult a healthcare provider.

Trimester-Specific Risks:

First Trimester: Generally safe and beneficial; folic acid (B9) is crucial for neural tube development.
Second Trimester: Generally safe and beneficial.
Third Trimester: Generally safe and beneficial.
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Lactation

B vitamins are excreted in breast milk and are essential for infant development. Rena-Vite is generally considered safe and compatible with breastfeeding. Consult a healthcare provider.

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

Use in children should be under the guidance of a healthcare professional. Dosing must be carefully adjusted based on age, weight, and specific nutritional needs or deficiencies. Not typically a general pediatric supplement.

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Geriatric Use

Generally safe for geriatric patients. Older adults may be at higher risk for certain B vitamin deficiencies (e.g., B12 due to malabsorption). Dosing typically follows adult recommendations, but monitoring for interactions with polypharmacy is important.

Clinical Information

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Clinical Pearls

  • Rena-Vite is specifically formulated for patients with renal impairment, often containing higher doses of water-soluble B vitamins to compensate for losses during dialysis and dietary restrictions, while avoiding fat-soluble vitamins (like A, D, E, K) that can accumulate in renal disease.
  • Educate patients that urine may turn bright yellow due to riboflavin (B2) excretion, which is a normal and harmless effect.
  • Emphasize the importance of adherence, especially for dialysis patients, to prevent vitamin deficiencies that can exacerbate symptoms of renal disease.
  • Advise patients to inform all healthcare providers about their vitamin supplementation, especially if they are taking other medications, due to potential interactions.
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Alternative Therapies

  • Individual B vitamin supplements (e.g., B12, Folic Acid, Pyridoxine) if only specific deficiencies are present.
  • Dietary modifications to increase B vitamin intake (though often limited in renal diets).
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Cost & Coverage

Average Cost: $15 - $40 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often not covered by standard insurance unless prescribed for a specific medical condition (e.g., renal disease, malabsorption) and deemed medically necessary. May be covered under specific Medicare Part D plans or state Medicaid programs.
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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 for more information. 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. 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 details about the medication taken, the amount, and the time it happened.