PNV-DHA Capsules

Manufacturer ACELLA Active Ingredient Prenatal Vitamin Without Vitamin A(pre NAY tal VYE ta min) Pronunciation PNV-DHA: PEE-EN-VEE DEE-AYCH-AY
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
Prenatal Supplement; Vitamin/Mineral Supplement
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Pharmacologic Class
Multivitamin; Omega-3 Fatty Acid; Mineral Supplement
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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?

PNV-DHA is a daily supplement designed for women who are pregnant, breastfeeding, or trying to conceive. It provides essential vitamins and minerals, like folic acid and iron, along with DHA (an omega-3 fatty acid). These nutrients are crucial for your health and the healthy development of your baby's brain and eyes.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

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. Check with your pharmacist to determine the best way to take your medication.
Take your medication with a full glass of water.
Avoid taking antacids within 2 hours before or 2 hours after taking your medication.
Do not consume 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, away from bathrooms.
Protect it from heat.
Keep all medications in a safe and secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the capsule with food to help with absorption and reduce stomach upset, especially from the iron.
  • Take it at the same time each day to help you remember.
  • Store in a cool, dry place, away from direct light and moisture.
  • Keep out of reach of children, as accidental overdose of iron-containing products 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 capsule daily
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

pregnancy: One capsule daily, typically starting prior to conception and continuing throughout pregnancy.
lactation: One capsule daily, continuing throughout the breastfeeding period.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (unless specifically indicated for adolescent pregnancy, then adult dosing applies)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for standard doses.
Moderate: No specific adjustment needed for standard doses; monitor for electrolyte imbalances if severe renal dysfunction is present.
Severe: Use with caution; consult a healthcare provider. Accumulation of certain minerals (e.g., magnesium, potassium) could occur. Dosage adjustment may be necessary based on individual nutrient levels.
Dialysis: Consult a healthcare provider. Specific nutrient needs may vary; monitor serum levels of vitamins and minerals.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, as metabolism of most components is not primarily hepatic-dependent in a way that necessitates dose adjustment for supplementation.

Pharmacology

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Mechanism of Action

PNV-DHA capsules provide essential vitamins, minerals, and omega-3 fatty acids (specifically DHA) crucial for maternal health and fetal development. Folate (as folic acid or methylfolate) is vital for neural tube development and red blood cell formation. Iron supports increased maternal blood volume and prevents anemia. Calcium and Vitamin D are essential for bone health. DHA is critical for the development of the fetal brain, eyes, and nervous system. Other vitamins and minerals act as cofactors in various metabolic processes, support immune function, and contribute to overall maternal and fetal well-being.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, depends on specific vitamin/mineral form and presence of food. Folate: high (85-100%). Iron: 10-15% (non-heme), higher for heme iron. DHA: well-absorbed, enhanced by dietary fat.
Tmax: Variable for individual components (e.g., water-soluble vitamins typically 1-4 hours; fat-soluble vitamins and DHA absorption is slower and more prolonged).
FoodEffect: Generally recommended to take with food to enhance absorption of fat-soluble components (DHA, Vitamin D) and minimize gastrointestinal upset (especially with iron).

Distribution:

Vd: Not applicable for a multi-component supplement; individual components distribute widely to tissues.
ProteinBinding: Variable for individual components (e.g., Vitamin D metabolites are protein-bound; DHA is incorporated into cell membranes).
CnssPenetration: Limited for most water-soluble vitamins; DHA readily crosses the blood-brain barrier and placenta.

Elimination:

HalfLife: Variable for individual components (e.g., water-soluble vitamins: hours; fat-soluble vitamins: days to months; DHA: days to weeks, as it's incorporated into tissues).
Clearance: Variable; water-soluble vitamins primarily renal; fat-soluble vitamins primarily biliary/fecal.
ExcretionRoute: Renal (water-soluble vitamins, some minerals); Biliary/Fecal (fat-soluble vitamins, DHA metabolites, unabsorbed minerals).
Unchanged: Variable; some water-soluble vitamins excreted largely unchanged.
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Pharmacodynamics

OnsetOfAction: Effects are cumulative and nutritional, not acute. Benefits accrue over weeks to months.
PeakEffect: Not applicable in a pharmacological sense; reflects sustained nutritional support.
DurationOfAction: Continuous with daily supplementation; benefits persist as long as supplementation continues.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Black, tarry, or bloody stools
- Fever
- Vomiting blood or material that looks like coffee grounds
- Stomach cramps

Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
- Constipation
- Diarrhea
- Stomach pain
- Upset stomach
- Vomiting
- Heartburn
- Change in stool color to green

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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, nausea, vomiting, or diarrhea (may indicate intolerance or overdose)
  • Allergic reaction symptoms: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • Black, tarry stools (common with iron, but report if accompanied by other concerning symptoms or if very dark and sticky, as it could indicate bleeding).
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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 iron overload 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

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 medications and health conditions. 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 it. If you have been diagnosed with phenylketonuria (PKU), consult with your doctor, as some formulations of this medication 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:

  • Nausea, vomiting, diarrhea, abdominal pain (common with iron overdose)
  • Drowsiness, lethargy, pallor, cyanosis
  • Hypotension, tachycardia
  • Metabolic acidosis, liver damage (severe cases, especially with iron)
  • Hypercalcemia (rare, with excessive calcium/Vitamin D intake)
  • Hypervitaminosis (rare, with excessive intake of fat-soluble vitamins)

What to Do:

Immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is supportive and may include gastric lavage, chelation therapy for iron, or other measures depending on the specific nutrients involved and severity.

Drug Interactions

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Major Interactions

  • Tetracyclines/Quinolones (with iron/calcium): Reduced absorption of antibiotics. Separate administration by at least 2-4 hours.
  • Levothyroxine (with iron/calcium): Reduced absorption of thyroid hormone. Separate administration by at least 4 hours.
  • Bisphosphonates (with calcium/iron): Reduced absorption of bisphosphonates. Separate administration by at least 30 minutes to 2 hours.
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Moderate Interactions

  • Antacids/H2 blockers/PPIs (with iron/calcium): May reduce absorption of iron and calcium due to altered gastric pH.
  • Methotrexate (with folic acid): Folic acid supplementation may reduce the efficacy of methotrexate (a folate antagonist). However, in pregnancy, folate is essential, and specific guidance from an oncologist is needed if methotrexate is used.
  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital) (with folic acid): May reduce serum folate levels and increase seizure frequency. Folic acid supplementation may reduce anticonvulsant levels.
  • Cholestyramine/Colestipol (with fat-soluble vitamins/DHA): May reduce absorption of fat-soluble vitamins (D, E) and DHA.
  • Warfarin (with Vitamin E/DHA): High doses of Vitamin E or DHA may theoretically increase bleeding risk, though typically not significant at doses found in prenatal vitamins. Monitor INR if on warfarin.
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Minor Interactions

  • Dietary fiber/Phytates/Oxalates (with minerals): May reduce absorption of iron and calcium.
  • Caffeine/Alcohol (with vitamins/minerals): May interfere with absorption or increase excretion of some nutrients.

Monitoring

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Baseline Monitoring

General health assessment

Rationale: To establish baseline health status and identify any pre-existing conditions or nutritional deficiencies.

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.

Serum Vitamin D levels (25-OH D)

Rationale: To assess for Vitamin D deficiency, which is common and important for maternal and fetal bone health.

Timing: Baseline, especially if risk factors for deficiency are present.

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Routine Monitoring

Clinical well-being and adherence

Frequency: At each prenatal visit

Target: Patient reports feeling well, tolerating supplement, and taking it consistently.

Action Threshold: Reported side effects (e.g., nausea, constipation), non-adherence, or new symptoms warrant further investigation.

Hemoglobin/Hematocrit

Frequency: As per standard prenatal care guidelines (e.g., 28 weeks gestation)

Target: Normal ranges for pregnancy (e.g., Hb >11 g/dL in 1st/3rd trimester, >10.5 g/dL in 2nd trimester)

Action Threshold: Values below normal range may indicate need for additional iron supplementation or investigation of other causes of anemia.

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Symptom Monitoring

  • Gastrointestinal upset (nausea, constipation, diarrhea, stomach cramps)
  • Allergic reactions (rash, itching, swelling, dizziness, trouble breathing)
  • Unusual fatigue or weakness (may indicate persistent anemia)
  • Changes in stool color (dark stools are common with iron supplementation)

Special Patient Groups

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Pregnancy

PNV-DHA is specifically formulated and recommended for use before, during, and after pregnancy to support maternal health and fetal development. It is considered essential for preventing neural tube defects (due to folate) and supporting brain/eye development (due to DHA).

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folate) and organogenesis. No specific risks when taken at recommended doses; essential for healthy development.
Second Trimester: Supports continued fetal growth and development, including brain and bone formation. No specific risks.
Third Trimester: Supports rapid fetal growth, iron stores, and continued brain development. No specific risks.
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Lactation

PNV-DHA is recommended during lactation to ensure adequate nutrient intake for the breastfeeding mother and to enrich breast milk with essential vitamins, minerals, and DHA for the infant's continued development.

Infant Risk: L1 (Lowest Risk) - Compatible with breastfeeding. The nutrients are naturally present in breast milk and are beneficial for infant development.
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Pediatric Use

Not indicated for general pediatric use. Specific pediatric vitamin/mineral supplements are available if needed. Accidental overdose, especially of iron, can be fatal in young children.

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Geriatric Use

Not specifically formulated for geriatric populations. While some components (e.g., Vitamin D, calcium) are important for older adults, the overall formulation and iron content may not be appropriate for general geriatric use without specific medical indication.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily intake, especially for folate before and during early pregnancy.
  • Advise patients to take with food to minimize GI upset, particularly from iron.
  • Educate on proper storage to prevent accidental pediatric overdose, especially with iron.
  • Remind patients that this is a supplement and does not replace a healthy, balanced diet.
  • For patients experiencing significant nausea, suggest taking the supplement at bedtime or trying different brands/formulations (e.g., chewables, smaller pills).
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Alternative Therapies

  • Individual vitamin and mineral supplements (e.g., separate folic acid, iron, calcium, Vitamin D, DHA supplements) - less convenient but allows for tailored dosing.
  • Dietary intake alone (not recommended during pregnancy due to increased nutrient demands and difficulty meeting all needs through diet alone).
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Cost & Coverage

Average Cost: Variable, typically $15 - $60 per 30 capsules
Generic Available: Yes
Insurance Coverage: Often covered as a Tier 1 or Tier 2 prescription, or available OTC. Coverage varies widely by insurance plan.
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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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.