PNV-Dha+docusate 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
Prenatal vitamin/mineral supplement; Omega-3 fatty acid; Stool softener
Pharmacologic Class
Multivitamin; Fatty acid supplement; Surfactant laxative
Pregnancy Category
Not applicable (product is intended for use during pregnancy); components are generally considered safe and beneficial for pregnancy.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a special vitamin supplement designed for pregnant and breastfeeding women. It provides important nutrients like folic acid, iron, and DHA (an omega-3 fatty acid) to support your health and your baby's development. It also contains a stool softener (docusate) to help prevent and relieve constipation, which is common during pregnancy.
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 must 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.
Swallow 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 sources.
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 of your medication:
Take it as soon as you remember.
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 dose.
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 must 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.
Swallow 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 sources.
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 of your medication:
Take it as soon as you remember.
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 dose.
Lifestyle & Tips
- Take with food to minimize stomach upset.
- Drink plenty of water and increase fiber intake to help with constipation, in addition to the docusate.
- Maintain a balanced diet rich in fruits, vegetables, and whole grains.
- Store in a cool, dry place, away from direct light and moisture.
- Keep out of reach of children, especially due to the iron content.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Typically 1 capsule daily, or as directed by a healthcare professional.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
pregnancy:
1 capsule daily
lactation:
1 capsule daily
Pediatric Dosing
Neonatal:
Not established (product not intended for this age group)
Infant:
Not established (product not intended for this age group)
Child:
Not established (product not intended for this age group)
Adolescent:
Not established (product not intended for this age group, unless pregnant/lactating and under medical supervision)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
Use with caution due to docusate component; consult healthcare provider. Iron and other mineral accumulation may be a concern in severe renal failure.
Dialysis:
Use with caution due to docusate component; consult healthcare provider. Iron and other mineral accumulation may be a concern.
Hepatic Impairment:
Mild:
No specific adjustment typically needed.
Moderate:
No specific adjustment typically needed.
Severe:
No specific adjustment typically needed.
Pharmacology
Mechanism of Action
PNV-Dha+docusate Capsules provide essential vitamins and minerals necessary for maternal health and fetal development during pregnancy and lactation. Key components include:
- **Folic Acid**: Essential for neural tube development and red blood cell formation. Prevents neural tube defects.
- **Iron**: Crucial for hemoglobin synthesis and oxygen transport, preventing maternal anemia and supporting fetal growth.
- **Calcium & Vitamin D**: Important for bone health in both mother and fetus.
- **DHA (Docosahexaenoic Acid)**: An omega-3 fatty acid vital for fetal brain, eye, and nervous system development.
- **Docusate**: A stool softener (surfactant laxative) that works by increasing the penetration of water and fat into the stool, making it softer and easier to pass, thereby alleviating constipation common during pregnancy.
- **Folic Acid**: Essential for neural tube development and red blood cell formation. Prevents neural tube defects.
- **Iron**: Crucial for hemoglobin synthesis and oxygen transport, preventing maternal anemia and supporting fetal growth.
- **Calcium & Vitamin D**: Important for bone health in both mother and fetus.
- **DHA (Docosahexaenoic Acid)**: An omega-3 fatty acid vital for fetal brain, eye, and nervous system development.
- **Docusate**: A stool softener (surfactant laxative) that works by increasing the penetration of water and fat into the stool, making it softer and easier to pass, thereby alleviating constipation common during pregnancy.
Pharmacokinetics
Absorption:
Bioavailability:
Varies by specific vitamin/mineral and formulation (e.g., iron absorption is ~10-15%, folic acid is high, DHA is well-absorbed).
Tmax:
Varies by component (e.g., iron ~2-4 hours, docusate ~1-3 days for full effect).
FoodEffect:
Absorption of some components (e.g., iron) can be affected by food; often recommended with food to reduce GI upset. DHA absorption is enhanced with fatty meals.
Distribution:
Vd:
Varies widely by component (e.g., water-soluble vitamins distribute in total body water, fat-soluble vitamins accumulate in adipose tissue, DHA incorporates into cell membranes).
ProteinBinding:
Varies by component (e.g., iron binds to transferrin, calcium to albumin, DHA to lipoproteins).
CnssPenetration:
Yes (DHA, some B vitamins), Limited (most minerals).
Elimination:
HalfLife:
Varies by component (e.g., water-soluble vitamins are excreted relatively quickly, fat-soluble vitamins have longer half-lives, DHA has a long half-life due to incorporation into tissues).
Clearance:
Varies by component (renal for water-soluble vitamins, fecal for unabsorbed minerals, metabolic for DHA).
ExcretionRoute:
Renal (water-soluble vitamins, some minerals), Fecal (unabsorbed minerals, docusate), Metabolic (DHA).
Unchanged:
Varies by component (e.g., some minerals are excreted unchanged if not absorbed).
Pharmacodynamics
OnsetOfAction:
Nutritional benefits are cumulative over time. Docusate: 12-72 hours (softening effect), up to 3-5 days for full laxative effect.
PeakEffect:
Nutritional benefits are cumulative. Docusate: 1-3 days.
DurationOfAction:
Nutritional benefits are ongoing with daily supplementation. Docusate: Effects persist as long as treatment continues.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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, 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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, 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.
Seek Immediate Medical Attention If You Experience:
- Severe stomach pain, nausea, vomiting, or diarrhea (may indicate overdose or severe intolerance).
- Black, tarry stools (may be normal due to iron, but report if accompanied by other symptoms of GI bleeding).
- Allergic reaction symptoms: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Persistent or worsening constipation despite taking the medication.
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 (iron overload).
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12 in the body.
If you are currently taking mineral oil.
If you are taking levodopa, a medication used to treat Parkinson's disease.
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 with bleeding.
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, 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.
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 (iron overload).
If you have certain types of anemia, such as pernicious anemia, which is characterized by a lack of vitamin B12 in the body.
If you are currently taking mineral oil.
If you are taking levodopa, a medication used to treat Parkinson's disease.
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 with bleeding.
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, 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.
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 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.
Overdose Information
Overdose Symptoms:
- **Iron overdose (most critical)**: Abdominal pain, nausea, vomiting, diarrhea (may be bloody), lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage, coma, death. Symptoms may appear to improve after initial GI upset, then worsen significantly.
- Excessive docusate: Diarrhea, abdominal cramping.
- Excessive fat-soluble vitamins (A, D, E, K - though Vitamin A is absent in this formulation, other fat-soluble vitamins can accumulate): Nausea, vomiting, headache, fatigue, bone pain (Vitamin D), bleeding (Vitamin E interfering with Vitamin K).
What to Do:
Immediately call a poison control center (1-800-222-1222) or seek emergency medical attention. For iron overdose, treatment may involve gastric lavage, chelation therapy (e.g., deferoxamine), and supportive care.
Drug Interactions
Major Interactions
- Methotrexate (high doses of folic acid can reduce efficacy)
- Levothyroxine (iron and calcium can impair absorption)
- Tetracyclines, Quinolones (iron and calcium can chelate and reduce absorption)
Moderate Interactions
- Antacids (can reduce iron absorption)
- Bisphosphonates (iron and calcium can impair absorption)
- Phenytoin, Phenobarbital, Primidone (folic acid can decrease levels of anticonvulsants)
- Cholestyramine, Colestipol (can reduce absorption of fat-soluble vitamins and DHA)
- Orlistat (can reduce absorption of fat-soluble vitamins and DHA)
Minor Interactions
- Corticosteroids (may increase calcium excretion)
- Thiazide diuretics (may increase calcium reabsorption)
Monitoring
Baseline Monitoring
Baseline nutritional status (e.g., iron levels, Vitamin D levels)
Rationale: To identify pre-existing deficiencies and guide supplementation if needed.
Timing: Prior to or early in pregnancy
Routine Monitoring
Hemoglobin/Hematocrit
Frequency: As per routine prenatal care guidelines (e.g., first trimester, 28 weeks)
Target: Normal for pregnancy (e.g., Hb >11 g/dL in 1st/3rd trimester, >10.5 g/dL in 2nd trimester)
Action Threshold: Below target range may indicate need for additional iron supplementation or investigation of anemia.
Bowel movements/Constipation relief
Frequency: Daily/Weekly
Target: Regular, soft stools
Action Threshold: Persistent constipation despite docusate may require further intervention or dietary changes.
Symptom Monitoring
- Gastrointestinal upset (nausea, constipation, diarrhea)
- Allergic reactions (rash, itching, swelling)
- Symptoms of iron overload (rare with typical dosing, but important to recognize in case of accidental overdose: abdominal pain, vomiting, diarrhea, lethargy)
- Symptoms of persistent constipation
Special Patient Groups
Pregnancy
This product is specifically formulated and indicated for use during pregnancy to provide essential nutrients for maternal health and fetal development, and to alleviate common pregnancy-related constipation.
Trimester-Specific Risks:
First Trimester:
Crucial for neural tube development (folic acid) and organogenesis. Generally safe and beneficial.
Second Trimester:
Supports continued fetal growth and development. Generally safe and beneficial.
Third Trimester:
Supports rapid fetal growth, iron stores, and bone development. Generally safe and beneficial.
Lactation
This product is 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:
Low risk. Components are generally safe and beneficial for the breastfed infant.
Pediatric Use
Not indicated for general pediatric use. Specific components (e.g., iron) can be toxic in overdose for children. Keep out of reach of children.
Geriatric Use
Not the primary target population. Generally safe, but specific needs for vitamins/minerals may differ. Docusate is generally safe for elderly, but ensure adequate hydration.
Clinical Information
Clinical Pearls
- Emphasize the importance of consistent daily dosing for optimal nutritional benefit.
- Advise patients that iron in prenatal vitamins can cause dark stools, which is normal.
- Counsel on the importance of adequate fluid and fiber intake in conjunction with docusate for effective constipation relief.
- Remind patients that while this supplement is comprehensive, it does not replace a healthy, balanced diet.
- Stress the critical importance of keeping iron-containing supplements out of reach of children due to the risk of fatal poisoning.
Alternative Therapies
- Other prenatal vitamin formulations (with or without DHA, with or without iron, etc.)
- Dietary modifications for constipation (increased fiber, fluids)
- Other stool softeners (e.g., psyllium, polyethylene glycol)
- Individual vitamin/mineral supplements based on specific deficiencies
Cost & Coverage
Average Cost:
$20 - $60 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Often covered by prescription drug plans, but may vary by specific plan and formulary tier. Some plans may require prior authorization or prefer specific brands.
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.