PNV-Select Tablets

Manufacturer ACELLA Active Ingredient Prenatal Vitamin Pronunciation P-N-V Select (P-N-V as in the letters, Select as in 'suh-LEKT')
WARNING: Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away. @ COMMON USES: This vitamin is used to aid the diet needs before, during, and after pregnancy.
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Drug Class
Vitamin/Mineral Supplement
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Pharmacologic Class
Multivitamin; Mineral Supplement
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Pregnancy Category
Not applicable; indicated for pregnancy
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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?

PNV-Select Tablets are a daily vitamin and mineral supplement specifically designed for women who are pregnant, planning to become pregnant, or breastfeeding. They provide essential nutrients like folic acid, iron, and calcium to support your health and the healthy development of your baby.
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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 work best when taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your medication. Always take your medication with a full glass of water.

There are some important precautions to keep in mind when taking this medication:
- Do not take antacids within 2 hours before or 2 hours after taking your medication.
- Avoid consuming dairy products with your medication, as they may reduce its effectiveness.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:
- Store it at room temperature, protected from light.
- Keep it in a dry place, avoiding storage in a bathroom.
- Protect it from heat sources.
- Keep all medications in a safe 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 continue with 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.
  • Do not take with milk, antacids, or calcium supplements, as these can reduce iron absorption. Separate by at least 2 hours.
  • Maintain a balanced diet in addition to taking the supplement.
  • Store in a cool, dry place, out of reach of children. Iron overdose is a leading cause of fatal poisoning in children under 6.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

pregnancy: One tablet orally daily, or as directed by a healthcare professional.
lactation: One tablet orally daily, or as directed by a healthcare professional.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (unless specifically formulated for adolescent pregnancy, then consult physician)
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Dose Adjustments

Renal Impairment:

Mild: Generally no specific adjustment for standard prenatal vitamins.
Moderate: Generally no specific adjustment for standard prenatal vitamins; monitor for specific mineral accumulation (e.g., iron, potassium) if present in high doses.
Severe: Use with caution; consult physician. Specific mineral components (e.g., iron, vitamin A, potassium) may accumulate. Dosage adjustment or alternative formulations may be necessary.
Dialysis: Consult physician. Specific mineral components may require careful monitoring and adjustment.

Hepatic Impairment:

Mild: Generally no specific adjustment.
Moderate: Generally no specific adjustment.
Severe: Generally no specific adjustment, but caution with fat-soluble vitamins (A, D, E, K) if cholestasis is present.

Pharmacology

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Mechanism of Action

PNV-Select Tablets provide essential vitamins and minerals necessary to meet the increased nutritional demands of pregnancy and lactation, supporting both maternal health and fetal/infant development. Key components like folic acid prevent neural tube defects, iron prevents maternal anemia, and calcium supports bone development.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (component-dependent, e.g., iron absorption is 5-15%, folic acid is high)
Tmax: Variable (component-dependent, generally 1-4 hours for most water-soluble vitamins)
FoodEffect: Absorption of some components (e.g., iron) may be enhanced by vitamin C and reduced by calcium or phytates. Best taken with food to minimize GI upset.

Distribution:

Vd: Variable (component-dependent)
ProteinBinding: Variable (component-dependent, e.g., vitamin D binds to DBP, vitamin B12 to transcobalamins)
CnssPenetration: Limited (most components distribute widely, but specific CNS penetration varies)

Elimination:

HalfLife: Variable (component-dependent, ranging from hours to days)
Clearance: Variable (component-dependent)
ExcretionRoute: Renal (water-soluble vitamins, some minerals); Biliary/Fecal (fat-soluble vitamins, some minerals)
Unchanged: Variable (component-dependent)
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Pharmacodynamics

OnsetOfAction: Not acutely defined; benefits accrue over time with consistent supplementation.
PeakEffect: Not acutely defined; sustained nutritional support.
DurationOfAction: Not acutely defined; continuous supplementation required for ongoing benefit.

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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

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
Black, tarry, or bloody stools
Fever
Vomiting blood or coffee ground-like material
Stomach cramps

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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Change in stool color to green

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain
  • Vomiting
  • Diarrhea
  • Black, tarry stools (beyond normal iron-induced darkening)
  • Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
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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 conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have an excessive amount of iron in your body.
If you have certain types of anemia, such as pernicious anemia, which is characterized by a vitamin B12 deficiency.
If you are currently taking mineral oil.
If you are taking levodopa.
If you are taking acitretin.

Additionally, if your medication contains omega-3 fatty acids, you should also inform your doctor if:
You are taking a blood thinner.
You have bleeding problems.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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 this medication. If you have been diagnosed with phenylketonuria (PKU), consult with your doctor, as some formulations of this product may contain phenylalanine. Additionally, if you are breastfeeding, discuss the potential risks to your baby with your doctor to determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe nausea
  • Vomiting (may be bloody)
  • Diarrhea
  • Abdominal pain
  • Drowsiness
  • Pale, clammy skin
  • Weak, rapid pulse
  • Low blood pressure
  • Metabolic acidosis
  • Liver damage
  • Coma
  • Seizures

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Iron overdose is particularly dangerous, especially in young children.

Drug Interactions

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Major Interactions

  • Levothyroxine (iron and calcium can impair absorption)
  • Tetracycline antibiotics (iron and calcium can chelate, reducing absorption)
  • Quinolone antibiotics (iron and calcium can chelate, reducing absorption)
  • Bisphosphonates (calcium can impair absorption)
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Moderate Interactions

  • Antacids (calcium and iron absorption may be affected)
  • Proton Pump Inhibitors/H2 Blockers (may reduce absorption of vitamin B12)
  • Phenytoin (folic acid may reduce phenytoin levels)
  • Warfarin (vitamin K can reduce anticoagulant effect, though prenatal vitamins typically contain low amounts)
  • Thiazide diuretics (may increase calcium levels)
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Minor Interactions

  • Dietary fiber (may slightly reduce mineral absorption)

Monitoring

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Baseline Monitoring

Nutritional status assessment

Rationale: To identify pre-existing deficiencies and tailor supplementation if needed.

Timing: Prior to conception or at first prenatal visit.

Hemoglobin/Hematocrit

Rationale: To assess for anemia, especially iron-deficiency anemia, which is common in pregnancy.

Timing: Baseline and periodically throughout pregnancy.

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Routine Monitoring

Adherence to regimen

Frequency: At each prenatal visit

Target: Consistent daily intake

Action Threshold: Inconsistent intake may lead to suboptimal nutritional status; reinforce importance.

Gastrointestinal symptoms (nausea, constipation)

Frequency: At each prenatal visit

Target: Minimal to no symptoms

Action Threshold: Persistent symptoms may indicate intolerance to specific components (e.g., iron) and require dosage adjustment or alternative formulation.

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Symptom Monitoring

  • Nausea
  • Constipation
  • Stomach upset
  • Dark stools (due to iron)
  • Allergic reactions (rare, e.g., rash, itching, swelling)

Special Patient Groups

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Pregnancy

PNV-Select Tablets are specifically indicated and formulated for use during pregnancy to provide essential nutrients for maternal health and fetal development. Folic acid is crucial for neural tube development, especially in the first trimester.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folic acid). No known risks when taken at recommended doses; overdose of certain components (e.g., Vitamin A) can be teratogenic.
Second Trimester: Continued need for iron, calcium, and other vitamins/minerals to support rapid fetal growth and maternal physiological changes.
Third Trimester: Continued need for all components, particularly iron to prevent anemia and prepare for delivery, and calcium for fetal bone mineralization.
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Lactation

PNV-Select Tablets are indicated for use during lactation to ensure adequate nutrient intake for the breastfeeding mother and to support the nutritional content of breast milk.

Infant Risk: L1 (Compatible). No known adverse effects on the breastfed infant when taken at recommended doses. Provides beneficial nutrients to the infant via breast milk.
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Pediatric Use

Not indicated for general pediatric use. Accidental overdose, particularly of iron, is a leading cause of fatal poisoning in children under 6 years of age. Keep out of reach of children.

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Geriatric Use

Not specifically indicated for geriatric use, as the formulation is tailored for pregnancy/lactation. Geriatric patients requiring vitamin/mineral supplementation should use products formulated for their specific needs.

Clinical Information

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Clinical Pearls

  • Advise patients to take prenatal vitamins with food to minimize gastrointestinal upset, which is common due to iron content.
  • Emphasize the critical role of folic acid, especially in the periconceptional period (before and during early pregnancy), to prevent neural tube defects.
  • Educate patients about potential interactions, particularly with iron and calcium, which can interfere with the absorption of certain medications (e.g., thyroid hormones, some antibiotics). Advise separating doses by at least 2 hours.
  • Stress the importance of keeping prenatal vitamins, especially those containing iron, out of reach of children due to the risk of accidental overdose and poisoning.
  • Some patients may experience constipation due to iron; recommend increasing fluid and fiber intake, or discuss stool softeners if necessary.
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Alternative Therapies

  • Individual vitamin and mineral supplements (e.g., separate folic acid, iron, calcium supplements, though less convenient)
  • Dietary modifications (while important, typically insufficient to meet all increased demands of pregnancy/lactation alone)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often covered by most insurance plans, sometimes without a co-pay under preventive care benefits. May be available over-the-counter.
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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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication taken, the amount, and the time it happened.