PNV-Omega Capsules
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.
Drug Class
Nutritional Supplement; Prenatal Vitamin
Pharmacologic Class
Multivitamin; Mineral Supplement; Omega-3 Fatty Acid Supplement
Pregnancy Category
Not applicable (Product is specifically for use during pregnancy)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
PNV-Omega Capsules are a special vitamin and mineral supplement designed for women who are pregnant or breastfeeding. They provide important nutrients like folic acid, iron, calcium, and omega-3 fatty acids (DHA) that are essential for your health and the healthy development of your baby's brain and eyes. This specific formula is designed to provide necessary nutrients without high levels of preformed Vitamin A, which can be a concern during pregnancy.
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. Check with your pharmacist to determine the best way to take your medication. When taking your medication, be sure to swallow it 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, as this can interfere with its effectiveness. Additionally, 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 and moisture. Avoid storing your medication in a bathroom, as the heat and humidity can affect its potency. Keep your medication in a safe place, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you forget to take 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, as this can increase the risk of side effects.
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. Check with your pharmacist to determine the best way to take your medication. When taking your medication, be sure to swallow it 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, as this can interfere with its effectiveness. Additionally, 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 and moisture. Avoid storing your medication in a bathroom, as the heat and humidity can affect its potency. Keep your medication in a safe place, out of the reach of children and pets, to prevent accidental ingestion.
What to Do If You Miss a Dose
If you forget to take 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, as this can increase the risk of side effects.
Lifestyle & Tips
- Take the capsule with food to minimize stomach upset and enhance absorption of fat-soluble vitamins and omega-3s.
- Swallow the capsule whole; do not chew or crush.
- Maintain a balanced and healthy diet in addition to taking this supplement.
- Store in a cool, dry place, away from direct light and moisture.
- Keep out of reach of children, especially due to the iron content, which can be toxic in overdose.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 capsule orally once daily, or as directed by a healthcare professional.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
pregnancy:
1 capsule orally once daily
lactation:
1 capsule orally once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (unless specifically indicated for adolescent pregnancy, then adult dose applies)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required; monitor for individual nutrient accumulation (e.g., iron, magnesium) if severe impairment.
Moderate:
No specific adjustment typically required; monitor for individual nutrient accumulation (e.g., iron, magnesium) if severe impairment.
Severe:
Use with caution; specific nutrient adjustments may be necessary based on individual lab values (e.g., iron, magnesium, phosphorus). Consult nephrologist.
Dialysis:
Use with caution; specific nutrient adjustments may be necessary based on individual lab values. Consult nephrologist.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
No specific adjustment typically required, but monitor for any signs of nutrient imbalance or toxicity if liver function is severely compromised.
Pharmacology
Mechanism of Action
PNV-Omega Capsules provide essential vitamins, minerals, and omega-3 fatty acids (DHA/EPA) necessary to support the increased nutritional demands of pregnancy and lactation. These nutrients are crucial for maternal health, fetal growth and development (especially brain and eye development), and to prevent nutrient deficiencies that can lead to adverse pregnancy outcomes. The formulation 'without Vitamin A' typically means it contains beta-carotene (a precursor) or very low levels of preformed Vitamin A to mitigate potential teratogenic risks associated with excessive preformed Vitamin A intake during pregnancy.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly by individual vitamin, mineral, and fatty acid component. Generally good for water-soluble vitamins, variable for fat-soluble vitamins and minerals.
Tmax:
Varies by component; generally within 2-6 hours for most absorbed nutrients.
FoodEffect:
Absorption of fat-soluble vitamins (D, E) and omega-3s is enhanced by food, especially fatty meals. Some minerals (e.g., iron) may have reduced absorption with certain foods (e.g., dairy, tea, coffee).
Distribution:
Vd:
Not specifically defined for the combination product; individual components distribute widely throughout body tissues.
ProteinBinding:
Varies by component (e.g., calcium, iron, fatty acids bind to proteins).
CnssPenetration:
Yes, many components (e.g., folate, DHA) cross the blood-brain barrier and placental barrier.
Elimination:
HalfLife:
Varies widely by component (e.g., hours for water-soluble vitamins, days to weeks for fat-soluble vitamins, longer for fatty acids incorporated into tissues).
Clearance:
Varies by component; primarily renal for water-soluble vitamins and some minerals, biliary/fecal for some fat-soluble vitamins and metabolites.
ExcretionRoute:
Renal (urine) for water-soluble vitamins and some minerals; Biliary/Fecal for some fat-soluble vitamins and fatty acid metabolites.
Unchanged:
Varies; excess water-soluble vitamins are largely excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Nutritional effects are gradual and cumulative, not acute. Benefits accrue over days to weeks of consistent supplementation.
PeakEffect:
Not applicable in an acute sense; reflects sustained optimal nutrient levels.
DurationOfAction:
Sustained with daily intake; reflects maintenance of adequate nutrient stores.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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 many people experience none or only mild effects. If you encounter any of the following side effects or any other unusual symptoms that 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 advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 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 many people experience none or only mild effects. If you encounter any of the following side effects or any other unusual symptoms that 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 advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Severe constipation or diarrhea
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
- Unusual fatigue or weakness (may indicate iron overload if not anemic)
- Dark, tarry stools (normal due to iron, but report if accompanied by other concerning symptoms)
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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have an excess of iron in your body (iron overload).
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12.
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 anticoagulant medications (blood thinners).
* You have bleeding disorders or problems.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have an excess of iron in your body (iron overload).
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12.
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 anticoagulant medications (blood thinners).
* You have bleeding disorders or problems.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health issues, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 phenylketonuria (PKU), consult with your doctor, as some formulations of this drug 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.
Overdose Information
Overdose Symptoms:
- Severe stomach pain
- Nausea
- Vomiting (may contain blood)
- Diarrhea
- Drowsiness
- Weak, rapid pulse
- Low blood pressure
- Bluish lips/skin
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose, especially from iron, can be fatal, particularly in young children.
Drug Interactions
Major Interactions
Moderate Interactions
- Antacids/H2 Blockers/PPIs: May reduce absorption of iron and other minerals requiring acidic environment.
- Tetracycline/Quinolone Antibiotics: Calcium, iron, and magnesium can chelate these antibiotics, reducing their absorption. Administer at least 2-4 hours apart.
- Bisphosphonates: Calcium and other minerals can interfere with absorption. Administer at least 30-60 minutes apart.
- Diuretics (Thiazide): May increase calcium reabsorption, potentially leading to hypercalcemia.
- Diuretics (Loop): May increase excretion of calcium and magnesium.
- Phenytoin/Carbamazepine/Phenobarbital: May increase metabolism of folic acid and vitamin D, potentially leading to deficiency.
- Cholestyramine/Colestipol/Orlistat: May reduce absorption of fat-soluble vitamins (D, E) and omega-3s.
Minor Interactions
- Alcohol: May impair absorption of some B vitamins and folate.
- Caffeine: May slightly reduce calcium absorption.
Monitoring
Baseline Monitoring
Nutritional status assessment
Rationale: To identify pre-existing deficiencies or specific dietary needs.
Timing: Prior to conception or early in pregnancy
Complete Blood Count (CBC)
Rationale: To assess for anemia (especially iron-deficiency anemia), which is common in pregnancy.
Timing: Baseline and periodically during pregnancy
Routine Monitoring
Patient adherence to daily dosing
Frequency: Each visit
Target: Consistent daily intake
Action Threshold: Inconsistent intake; reinforce importance
Symptoms of gastrointestinal upset (nausea, constipation)
Frequency: Each visit
Target: Absence or mild, manageable symptoms
Action Threshold: Severe or persistent symptoms; consider alternative formulation or timing of dose
Iron status (Ferritin, Transferrin Saturation) if indicated
Frequency: As per clinical guidelines or if anemia suspected
Target: Within normal limits for pregnancy
Action Threshold: Low levels; consider additional iron supplementation or dietary changes
Symptom Monitoring
- Nausea
- Constipation
- Diarrhea
- Stomach upset
- Dark stools (due to iron)
- Fishy aftertaste (due to omega-3s)
Special Patient Groups
Pregnancy
Essential for use throughout pregnancy to support maternal health and fetal development. Provides critical nutrients like folic acid (to prevent neural tube defects), iron (to prevent anemia), calcium, vitamin D, and omega-3 fatty acids (DHA for brain and eye development). The 'without Vitamin A' formulation is generally preferred to avoid potential teratogenicity from excessive preformed Vitamin A.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development (folic acid) and organogenesis. Low risk when used as directed; high doses of preformed Vitamin A are a concern, but this formulation mitigates that.
Second Trimester:
Supports rapid fetal growth and development. Continued need for iron, calcium, and DHA.
Third Trimester:
Supports continued fetal growth, bone development, and preparation for birth. Continued need for all components.
Lactation
Recommended during lactation to replenish maternal nutrient stores depleted during pregnancy and to ensure adequate nutrient content in breast milk for infant growth and development. Omega-3 fatty acids are particularly important for infant neurological development via breast milk.
Infant Risk:
Low risk; generally considered safe and beneficial for the breastfed infant.
Pediatric Use
Not indicated for general pediatric use. Specific pediatric formulations of vitamins and minerals are available if needed.
Geriatric Use
Not specifically indicated for geriatric population. Geriatric individuals have different nutritional needs and may require different multivitamin formulations.
Clinical Information
Clinical Pearls
- Emphasize the importance of consistent daily intake throughout pregnancy and lactation.
- Advise patients to take with food to reduce gastrointestinal side effects and improve absorption.
- Educate patients that dark stools are a normal side effect due to iron content.
- Stress the critical role of folic acid in early pregnancy for neural tube defect prevention.
- Highlight the benefit of omega-3s (DHA) for fetal brain and eye development.
- Remind patients that this supplement complements, but does not replace, a healthy and balanced diet.
- Counsel on potential drug interactions, especially with thyroid hormones, antibiotics, and anticoagulants.
Alternative Therapies
- Individual vitamin and mineral supplements (e.g., separate folic acid, iron, calcium, vitamin D, DHA supplements)
- Dietary intake alone (not recommended during pregnancy due to increased nutrient demands)
Cost & Coverage
Average Cost:
$15 - $40 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often covered by Flexible Spending Accounts (FSA) or Health Savings Accounts (HSA). Some insurance plans may cover prescription prenatal vitamins, but OTC supplements are generally out-of-pocket.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 substance taken, the amount, and the time it occurred.