Se-Natal 19 Tablets

Manufacturer SETON PHARMACEUTICALS Active Ingredient Prenatal Vitamin Pronunciation See-NAY-tal
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
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?

Se-Natal 19 is a daily multivitamin and mineral supplement specifically formulated to meet the increased nutritional needs of women before, during, and after pregnancy, including while breastfeeding. It helps ensure adequate intake of essential nutrients like folic acid, iron, and calcium for both the mother and developing baby, supporting healthy growth and preventing deficiencies.
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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 guidelines:

Take your medication exactly as directed by your doctor and carefully read all the information provided.
Follow the instructions closely, and if you have any questions, consult your pharmacist.
Some medications require food in the stomach, while others should be taken on an empty stomach. Check with your pharmacist to determine the best approach for your specific 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 interfere with 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 bathrooms and areas with high humidity.
Protect your medication from heat sources.
Keep all medications in a 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 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 the missed one.
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Lifestyle & Tips

  • Maintain a balanced and healthy diet rich in fruits, vegetables, whole grains, and lean proteins.
  • Stay well-hydrated by drinking plenty of water throughout the day.
  • Engage in moderate exercise as advised by your healthcare provider.
  • Avoid alcohol, smoking, and illicit drugs during pregnancy and lactation.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

pregnancy: One tablet daily
lactation: One tablet daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: Generally no specific adjustment for standard doses.
Moderate: Generally no specific adjustment for standard doses.
Severe: Caution advised with individual mineral components (e.g., iron, potassium) due to potential for accumulation. Consult a healthcare professional.
Dialysis: Consult a healthcare professional; specific adjustments may be needed for individual components.

Hepatic Impairment:

Mild: Generally no specific adjustment.
Moderate: Generally no specific adjustment.
Severe: Generally no specific adjustment.

Pharmacology

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Mechanism of Action

Se-Natal 19 provides a comprehensive blend of essential vitamins and minerals (e.g., folic acid, iron, calcium, vitamin D, B vitamins) necessary to meet the increased nutritional demands of pregnancy and lactation. These nutrients support maternal health, fetal growth and development, and help prevent common nutritional deficiencies such as neural tube defects (folic acid) and iron-deficiency anemia (iron).
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly by individual vitamin and mineral component (e.g., fat-soluble vitamins require dietary fat for absorption; iron absorption is regulated by body stores and dietary factors).
Tmax: Varies by component; not typically defined for a multi-vitamin supplement.
FoodEffect: Absorption of some components (e.g., iron) may be enhanced or inhibited by food. Taking with food can reduce gastrointestinal upset.

Distribution:

Vd: Varies by component; distributed to various tissues and organs, including the placenta and breast milk.
ProteinBinding: Varies by component.
CnssPenetration: Limited for most components, but essential for neurological development.

Elimination:

HalfLife: Varies by component (e.g., hours for water-soluble vitamins, days to months for fat-soluble vitamins).
Clearance: Varies by component.
ExcretionRoute: Varies by component; water-soluble vitamins are primarily renally excreted; fat-soluble vitamins are eliminated via bile/feces or stored.
Unchanged: Varies by component.
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Pharmacodynamics

OnsetOfAction: Not applicable for a multi-vitamin supplement in terms of typical drug onset; effects are cumulative over time to correct or prevent deficiencies.
PeakEffect: Not applicable.
DurationOfAction: Not applicable.

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
+ 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe nausea or vomiting that prevents you from keeping the tablet down.
  • Severe constipation or diarrhea.
  • Symptoms of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Symptoms of iron overdose (especially in children): severe stomach pain, vomiting, diarrhea (possibly bloody), lethargy, pale or bluish skin, weakness, shallow breathing, shock. Seek immediate medical attention.
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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 treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have an excessive amount of iron in your body (iron overload).
Certain types of anemia, including 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.
If you are taking acitretin, a medication used to treat severe psoriasis.

Additional Considerations for Products Containing Omega-3 Fatty Acids:

If you are taking anticoagulant medications (blood thinners) to prevent blood clots.
If you have a history of bleeding problems or disorders that affect blood clotting.

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 existing treatments and health conditions. Never start, stop, or adjust the dosage 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 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:

  • Severe stomach pain
  • Nausea
  • Vomiting (may contain blood)
  • Diarrhea (may be bloody)
  • Lethargy
  • Pale or bluish skin
  • Weakness
  • Shallow breathing
  • Drowsiness
  • Coma
  • Shock

What to Do:

In case of suspected overdose, especially in children, seek immediate emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Iron overdose is a leading cause of poisoning fatalities in young children.

Drug Interactions

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Major Interactions

  • Iron: Reduced absorption with tetracyclines, fluoroquinolones, levothyroxine, antacids. Separate administration by several hours.
  • Calcium: Reduced absorption with tetracyclines, fluoroquinolones. Separate administration by several hours.
  • Folic Acid: May mask vitamin B12 deficiency in pernicious anemia, potentially leading to neurological damage if B12 deficiency is not diagnosed and treated.
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Moderate Interactions

  • Vitamin D: Interactions with thiazide diuretics (increased risk of hypercalcemia), corticosteroids (reduced vitamin D absorption).
  • Vitamin K: May interfere with warfarin (though prenatal vitamins usually contain low amounts of Vitamin K).
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Minor Interactions

  • General interactions with food or other supplements (e.g., high fiber intake may reduce mineral absorption).

Monitoring

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Baseline Monitoring

Nutritional status assessment

Rationale: To identify pre-existing deficiencies and guide supplementation.

Timing: Prior to conception or at first prenatal visit.

Complete Blood Count (CBC)

Rationale: To assess for anemia (especially iron deficiency anemia).

Timing: Prior to conception or at first prenatal visit.

Serum Vitamin D levels

Rationale: If deficiency is suspected or patient is at high risk.

Timing: Prior to conception or at first prenatal visit.

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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 nutrient levels.

Monitoring for common side effects (e.g., constipation, nausea)

Frequency: At each prenatal visit.

Target: Minimal or manageable side effects.

Action Threshold: Severe or persistent side effects may require dose adjustment or change in formulation.

General well-being and energy levels

Frequency: Ongoing.

Target: Improved or stable.

Action Threshold: Persistent fatigue or other symptoms may indicate ongoing deficiency or other issues.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Essential for healthy fetal development and maternal well-being. Folic acid is crucial for preventing neural tube defects, and iron prevents maternal anemia. Recommended for all women who are pregnant or planning to become pregnant.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folic acid) and organogenesis. Adequate intake helps prevent birth defects.
Second Trimester: Supports rapid fetal growth and development, and continued maternal health.
Third Trimester: Supports continued fetal growth, bone development (calcium, vitamin D), and prepares mother for delivery.
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Lactation

Recommended to support the increased nutritional needs of the breastfeeding mother and to ensure adequate nutrient content in breast milk for infant growth and development.

Infant Risk: L1 (Safest) - When taken at recommended doses, essential vitamins and minerals are considered safe and beneficial for the breastfed infant. Excessive doses of certain fat-soluble vitamins (A, D) could theoretically pose a risk, but this is rare with standard prenatal formulations.
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Pediatric Use

Not indicated for pediatric use as a prenatal vitamin. However, accidental overdose, particularly of iron, is a leading cause of poisoning fatalities in young children. Store out of reach of children.

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Geriatric Use

Not indicated for geriatric use as a prenatal vitamin. Specific vitamin/mineral needs for geriatric populations differ.

Clinical Information

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Clinical Pearls

  • Take prenatal vitamins with food to minimize gastrointestinal upset, especially nausea and constipation, which are common side effects due to iron content.
  • Iron in prenatal vitamins can cause dark or black stools, which is a normal and harmless side effect.
  • To alleviate constipation, increase fiber intake (fruits, vegetables, whole grains) and drink plenty of water.
  • Folic acid supplementation is most critical in the periconceptional period (at least one month before conception and through the first trimester) to prevent neural tube defects.
  • Always store prenatal vitamins, especially those containing iron, in a child-resistant container and out of reach of children due to the high risk of accidental iron poisoning.
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Alternative Therapies

  • Dietary modifications (though often insufficient to meet all prenatal needs)
  • Individual vitamin/mineral supplements tailored to specific deficiencies (e.g., separate folic acid, iron, calcium supplements)
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often covered by insurance plans, sometimes as a prescription or over-the-counter benefit. Coverage tier varies.
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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 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.