Ipol 0.5ml Im/sq Mdv (10 Dose)

Manufacturer SANOFI PASTEUR Active Ingredient Poliovirus Vaccine (Inactivated)(POE lee oh VYE rus vak SEEN, in ak ti VAY ted) Pronunciation POE-lee-oh VYE-rus vak-SEEN, in-ak-ti-VAY-ted
It is used to prevent polio.
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Drug Class
Vaccine, Immunizing agent
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Pharmacologic Class
Viral vaccine, Inactivated vaccine
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Pregnancy Category
Not assigned by FDA, generally considered safe and recommended if indicated
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FDA Approved
Jun 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This vaccine helps protect you or your child from polio, a serious disease that can cause paralysis (inability to move parts of the body) or even death. It contains inactivated (killed) polioviruses, so it cannot cause polio. It works by teaching your body's immune system to fight off the real virus if you are exposed to it.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered via injection into the fatty tissue under the skin or into a muscle.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • No specific lifestyle changes are required after receiving the vaccine.
  • Continue to follow recommended hygiene practices to prevent other infections.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 mL IM or SC
Dose Range: 0.5 - 0.5 mg

Condition-Specific Dosing:

primary_series: 3 doses: 0.5 mL IM or SC at 0, 1-2 months, and 6-12 months after the first dose. For accelerated schedules, doses can be given at 0, 1, and 6 months.
booster_dose: 0.5 mL IM or SC for adults at increased risk of exposure (e.g., travelers to endemic areas, laboratory workers handling poliovirus) if primary series completed.
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Pediatric Dosing

Neonatal: Not typically given to neonates unless specific high-risk situations (e.g., travel to endemic areas) and in consultation with public health authorities. Standard schedule begins at 2 months.
Infant: 0.5 mL IM or SC at 2 months and 4 months of age.
Child: 0.5 mL IM or SC at 6-18 months of age (third dose) and 4-6 years of age (fourth dose/booster).
Adolescent: 0.5 mL IM or SC if primary series incomplete or for booster if indicated (e.g., travel to endemic areas).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific adjustment needed; vaccine efficacy should be monitored in immunocompromised patients.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Inactivated Poliovirus Vaccine (IPV) contains inactivated poliovirus types 1, 2, and 3. Administration of the vaccine stimulates the immune system to produce neutralizing antibodies against these poliovirus types. These antibodies provide humoral immunity, preventing the poliovirus from replicating in the central nervous system and causing paralytic disease.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (vaccine, not a drug with systemic absorption in typical PK sense)
Tmax: Not applicable (immune response develops over weeks)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable
ProteinBinding: Not applicable
CnssPenetration: Not applicable (induces systemic immunity)

Elimination:

HalfLife: Not applicable (antigens are cleared by immune system, antibodies persist)
Clearance: Not applicable
ExcretionRoute: Not applicable
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Protective antibody levels typically achieved within 2-4 weeks after the second dose of the primary series.
PeakEffect: Peak antibody titers usually observed 1-2 months after the last dose of the primary series.
DurationOfAction: Long-lasting immunity, generally considered lifelong after a complete primary series and booster, though specific duration can vary.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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
Muscle weakness
Abnormal sensations, such as burning, numbness, or tingling
Difficulty controlling body movements, twitching, changes in balance, trouble swallowing or speaking
Severe dizziness or fainting

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, contact your doctor for advice:

For all patients taking this medication:
+ Pain, redness, or swelling at the injection site
+ Mild fever
* In young children:
+ Irritability
+ Feeling tired or weak
+ Decreased appetite

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/CDC Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
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Seek Immediate Medical Attention If You Experience:

  • Signs of a severe allergic reaction (anaphylaxis) such as difficulty breathing, wheezing, hives, swelling of the face or throat, dizziness, or a fast heartbeat. Seek immediate medical attention if these occur.
  • High fever (above 102°F or 39°C) that does not respond to fever reducers.
  • Severe pain, redness, or swelling at the injection site that worsens or does not improve within a few days.
  • Any unusual or severe symptoms that concern you.
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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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have an infection or are ill with a fever.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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. As with any vaccine, this vaccine may not provide complete protection for everyone who receives it. If you have any questions or concerns, be sure to discuss them with your doctor.

Individuals with a weakened immune system or those taking immunosuppressive medications should consult their doctor, as this vaccine may be less effective.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to carefully weigh the benefits and risks of this vaccine to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Overdose of vaccine is not typically associated with specific toxic symptoms beyond exaggerated local or systemic reactions (e.g., increased injection site pain, fever, malaise).
  • There is no specific antidote for vaccine overdose.

What to Do:

Management is supportive, focusing on alleviating symptoms. In case of accidental administration of a larger than recommended dose, monitor for adverse reactions. For any concerns, contact a healthcare professional or poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Contraindicated Interactions

  • Severe allergic reaction (e.g., anaphylaxis) to a previous dose of IPV or to any component of the vaccine (e.g., streptomycin, neomycin, polymyxin B, 2-phenoxyethanol, formaldehyde).
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Major Interactions

  • Immunosuppressive therapies (e.g., high-dose corticosteroids, chemotherapy, radiation therapy, biologics): May reduce the immune response to the vaccine, leading to suboptimal protection. Vaccination should ideally be deferred until immunosuppression resolves or is minimized. If vaccination is necessary, antibody response should be monitored if possible.
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Moderate Interactions

  • Moderate or severe acute illness with or without fever: Vaccination should generally be deferred until recovery. Minor illnesses (e.g., mild upper respiratory infection) are not contraindications.

Monitoring

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Baseline Monitoring

Allergy history (especially to vaccine components)

Rationale: To identify potential contraindications or precautions.

Timing: Prior to vaccination

Current health status (acute illness, fever)

Rationale: To determine if vaccination should be deferred.

Timing: Prior to vaccination

Immunocompromised status

Rationale: To assess potential for reduced vaccine efficacy.

Timing: Prior to vaccination

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Routine Monitoring

Observation for immediate adverse reactions (e.g., anaphylaxis)

Frequency: For 15-20 minutes post-vaccination

Target: Absence of severe reactions

Action Threshold: Any signs of anaphylaxis (e.g., rash, swelling, difficulty breathing, hypotension) require immediate medical intervention.

Local injection site reactions (pain, redness, swelling)

Frequency: Patient self-monitoring for 24-48 hours post-vaccination

Target: Mild to moderate, self-limiting

Action Threshold: Severe or persistent reactions, or signs of infection, warrant medical evaluation.

Systemic reactions (fever, headache, myalgia)

Frequency: Patient self-monitoring for 24-48 hours post-vaccination

Target: Mild to moderate, self-limiting

Action Threshold: High fever, severe symptoms, or symptoms lasting more than 48 hours warrant medical evaluation.

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Symptom Monitoring

  • Signs of allergic reaction (hives, rash, swelling of face/throat, difficulty breathing, wheezing, dizziness, weakness, rapid heartbeat)
  • Injection site pain, redness, swelling, tenderness
  • Fever
  • Headache
  • Muscle aches (myalgia)
  • Fatigue
  • Irritability (in infants/young children)

Special Patient Groups

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Pregnancy

IPV is generally considered safe and can be administered to pregnant women if there is an increased risk of exposure to poliovirus (e.g., travel to endemic areas, outbreak situations). The benefits of vaccination outweigh the theoretical risks.

Trimester-Specific Risks:

First Trimester: No evidence of adverse effects on the fetus during the first trimester.
Second Trimester: No evidence of adverse effects on the fetus during the second trimester.
Third Trimester: No evidence of adverse effects on the fetus during the third trimester.
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Lactation

IPV is considered safe for breastfeeding women and their infants. The vaccine antigens are not excreted in breast milk, and vaccination poses no risk to the nursing infant.

Infant Risk: L1 (Safest - no increase in adverse effects in infants)
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Pediatric Use

IPV is the recommended vaccine for routine polio immunization in infants and children in countries that use IPV. The standard schedule begins at 2 months of age. It is highly effective and well-tolerated in this population.

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Geriatric Use

IPV is not routinely recommended for adults over 18 years of age in countries with no endemic polio, unless they are at increased risk of exposure (e.g., travel to polio-endemic regions, healthcare workers, laboratory workers handling poliovirus). The immune response may be slightly diminished in older adults compared to younger adults, but it still provides protection.

Clinical Information

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Clinical Pearls

  • IPV is an inactivated vaccine and cannot cause polio.
  • It is the only polio vaccine recommended for routine immunization in the United States.
  • IPV is safe and effective for immunocompromised individuals, though the immune response may be suboptimal.
  • Administer IM or SC; do not administer intravenously.
  • Ensure proper storage (refrigerated, not frozen) to maintain vaccine potency.
  • Always check the expiration date before administration.
  • A complete primary series of IPV provides long-lasting protection against all three types of poliovirus.
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Alternative Therapies

  • Oral Poliovirus Vaccine (OPV): Live-attenuated vaccine, used in some parts of the world, but carries a very small risk of vaccine-associated paralytic polio (VAPP) and circulating vaccine-derived poliovirus (cVDPV). Not used for routine immunization in the US due to VAPP risk.
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Cost & Coverage

Average Cost: Varies widely, typically $25-$75 per dose per 0.5 mL dose
Insurance Coverage: Generally covered by most public and private health insurance plans as a preventive vaccine. Often covered under the Affordable Care Act (ACA) without cost-sharing.
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide details about the medication taken, the amount, and the time it occurred.