Se-Natal 19 Chewable Tablets

Manufacturer SETON PHARMACEUTICALS Active Ingredient Prenatal Vitamin Chewable Tablet(pre NAY tal VYE ta min) Pronunciation See-NAY-tal NINE-teen Chee-oo-uh-bul TAB-lets
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
Nutritional Supplement; Prenatal Vitamin
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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 Chewable Tablets are a daily vitamin and mineral supplement specifically designed for women who are pregnant or breastfeeding. They provide important nutrients like folic acid, iron, and calcium to support your health and your baby's development.
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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 and read all the information provided.
Follow the instructions carefully, and if you have any questions, consult your pharmacist.
Some medications should be taken with food, 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, as this can interfere with its effectiveness.
Do not consume dairy products with your medication, as they may reduce its effectiveness.
Chew your medication thoroughly before swallowing.

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 heat sources.
Do not store your medication in a bathroom.
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 to make up for a missed one.
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Lifestyle & Tips

  • Take one tablet daily, preferably with a meal to reduce stomach upset and improve absorption.
  • Chew the tablet thoroughly before swallowing.
  • Do not exceed the recommended dose.
  • Store at room temperature, away from moisture and heat, and out of reach of children.
  • Maintain a balanced diet in addition to taking this supplement.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

Neonatal: Not established (Not indicated for this age group)
Infant: Not established (Not indicated for this age group)
Child: Not established (Not indicated for this age group)
Adolescent: Not established (Not indicated for this age group, unless specifically for adolescent pregnancy under medical supervision)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment typically needed for standard doses, but caution with iron accumulation in severe cases.
Moderate: No specific adjustment typically needed for standard doses, but caution with iron accumulation in severe cases.
Severe: Use with caution due to potential for iron accumulation; consult healthcare provider. May require monitoring of iron levels.
Dialysis: Use with caution due to potential for iron accumulation; consult healthcare provider. May require monitoring of iron levels.

Hepatic Impairment:

Mild: No specific adjustment typically needed.
Moderate: No specific adjustment typically needed.
Severe: No specific adjustment typically needed, but monitor for signs of iron overload if underlying liver disease is present.

Pharmacology

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Mechanism of Action

Se-Natal 19 Chewable Tablets provide essential vitamins and minerals necessary for maternal health and optimal fetal development during pregnancy and lactation. Each component contributes to various physiological processes: Folic acid is crucial for neural tube development and red blood cell formation. Iron supports erythropoiesis and prevents maternal anemia. Calcium and Vitamin D are vital for fetal bone development and maternal bone health. Other vitamins (e.g., B vitamins, Vitamin C) and minerals (e.g., zinc, iodine) support energy metabolism, immune function, and overall growth and development.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable depending on the specific vitamin/mineral and its form (e.g., ferrous fumarate vs. ferrous gluconate for iron).
Tmax: Highly variable (minutes to hours) depending on the specific vitamin/mineral.
FoodEffect: Absorption of some components (e.g., iron) can be enhanced by Vitamin C and reduced by calcium or phytates. Taking with food generally improves tolerability and may enhance absorption of fat-soluble vitamins.

Distribution:

Vd: Highly variable; distributed throughout body tissues and fluids.
ProteinBinding: Highly variable; some vitamins/minerals bind to plasma proteins (e.g., Vitamin D, iron).
CnssPenetration: Limited for most components, though some (e.g., folate) are actively transported into the CNS.

Elimination:

HalfLife: Highly variable (hours to days) depending on the specific vitamin/mineral.
Clearance: Highly variable; primarily renal for water-soluble vitamins, biliary/fecal for some fat-soluble vitamins and minerals.
ExcretionRoute: Renal (water-soluble vitamins, some minerals), Biliary/Fecal (fat-soluble vitamins, some minerals).
Unchanged: Varies by component.
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Pharmacodynamics

OnsetOfAction: Gradual; nutritional benefits accumulate over days to weeks of consistent use.
PeakEffect: Not applicable in the acute sense; sustained nutritional support.
DurationOfAction: Continuous with daily supplementation.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention 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 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they 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 is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 stomach pain or cramps
  • Persistent nausea or vomiting
  • Diarrhea
  • Allergic reaction symptoms (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of iron overdose (e.g., severe vomiting, bloody diarrhea, pale or bluish skin, weakness, shallow breathing, rapid heartbeat)
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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, 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.
If you are taking acitretin.

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, 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 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
  • Constipation
  • Fatigue
  • Headache
  • In severe cases (especially iron overdose): hypotension, metabolic acidosis, shock, liver damage, coma, death.

What to Do:

In case of suspected overdose, especially in children, seek immediate medical attention or call a Poison Control Center at 1-800-222-1222. Iron overdose can be fatal, particularly in young children.

Drug Interactions

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Major Interactions

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

  • Anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital - folic acid may reduce levels or efficacy)
  • Warfarin (Vitamin K can reduce anticoagulant effect, though prenatal vitamins typically contain low amounts)
  • Diuretics (thiazide diuretics can increase calcium reabsorption)
  • Proton Pump Inhibitors/H2 Blockers (may reduce absorption of some minerals like iron)
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Minor Interactions

  • Fiber supplements (may reduce absorption of some minerals if taken concurrently)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC)

Rationale: To assess baseline hemoglobin and hematocrit, and identify pre-existing anemia.

Timing: Prior to or early in pregnancy.

Serum Ferritin

Rationale: To assess iron stores, especially if anemia is suspected or high-risk.

Timing: Prior to or early in pregnancy, if indicated.

Vitamin D levels (25-hydroxyvitamin D)

Rationale: To assess baseline vitamin D status, especially in at-risk populations.

Timing: Prior to or early in pregnancy, if indicated.

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Routine Monitoring

Hemoglobin/Hematocrit

Frequency: Routinely during pregnancy (e.g., first trimester, 28 weeks)

Target: Normal for pregnancy (varies by trimester)

Action Threshold: Below normal range for gestational age, indicating potential anemia.

Patient adherence and tolerability

Frequency: At each prenatal visit

Target: Consistent daily use with minimal side effects

Action Threshold: Non-adherence or significant GI upset requiring intervention.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Se-Natal 19 Chewable Tablets are specifically formulated for use during pregnancy to provide essential nutrients for maternal health and fetal development. Adequate intake of folic acid before and during early pregnancy is critical to reduce the risk of neural tube defects. Iron helps prevent maternal anemia. Other vitamins and minerals support overall health.

Trimester-Specific Risks:

First Trimester: Crucial for neural tube development (folic acid). Generally safe and beneficial.
Second Trimester: Continued support for fetal growth and maternal health. Iron needs increase.
Third Trimester: Continued support for rapid fetal growth and preparation for delivery. Iron needs remain high.
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Lactation

Recommended during lactation to ensure adequate nutrient intake for the breastfeeding mother and to support the nutritional content of breast milk.

Infant Risk: Low risk; beneficial for infant through breast milk.
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Pediatric Use

Not indicated for general pediatric use. Specific formulations for children exist. Accidental overdose, especially of iron, can be fatal in young children.

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Geriatric Use

Not specifically indicated for geriatric population, though general multivitamin use may be appropriate. Consult a healthcare provider for specific needs.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of consistent daily intake, especially folic acid, starting at least one month prior to conception and continuing through the first trimester.
  • Advise patients to take the chewable tablet with food to minimize gastrointestinal upset, which is common with iron-containing supplements.
  • Inform patients that dark or black stools are a common and harmless side effect due to iron content.
  • Counsel on potential interactions with other medications, particularly antibiotics (tetracyclines, fluoroquinolones) and thyroid hormones, advising to separate administration times by at least 2-4 hours.
  • Stress the critical importance of keeping all iron-containing supplements out of reach of children due to the high risk of fatal overdose.
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Alternative Therapies

  • Individual vitamin and mineral supplements (e.g., separate folic acid, iron, calcium, vitamin D supplements) if specific deficiencies are identified or preferred by patient.
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Often covered by insurance plans (Rx or OTC benefit), or available OTC without prescription.
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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. 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.