Daptacel Inj, 0.5ml
It is used to prevent diphtheria, tetanus, and pertussis.
Drug Class
Vaccine, Immunizing Agent
Pharmacologic Class
Bacterial Toxoids and Acellular Pertussis Vaccine
Pregnancy Category
Not assigned (Tdap is recommended for pregnancy)
FDA Approved
Jun 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Daptacel is a vaccine given to infants and young children to protect them from three serious diseases: diphtheria, tetanus (lockjaw), and pertussis (whooping cough). It works by helping your child's body build its own protection (immunity) against these diseases without them having to get sick first.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all provided guidelines. This drug is administered via intramuscular injection.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Ensure your child completes the full vaccination series as recommended by their healthcare provider for the best protection.
- Keep a record of your child's vaccinations.
- Report any serious or unusual reactions to your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Not applicable, pediatric vaccine.
Pediatric Dosing
Neonatal:
Not established (first dose typically at 2 months of age)
Infant:
0.5 mL intramuscularly (IM) at 2, 4, and 6 months of age.
Child:
0.5 mL IM at 15-20 months of age and 4-6 years of age (total 5 doses).
Adolescent:
Not typically indicated for adolescents; Tdap (Adacel, Boostrix) is recommended for this age group.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution may be warranted in severely immunocompromised individuals.
Dialysis:
No specific dose adjustment recommended.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Confidence:
High
Pharmacology
Mechanism of Action
Daptacel is a vaccine that induces active immunity against diphtheria, tetanus, and pertussis. It contains purified diphtheria and tetanus toxoids, and five pertussis antigens (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3). These components stimulate the immune system to produce specific antibodies and cellular immune responses, providing protection against the respective diseases.
Pharmacokinetics
Absorption:
Bioavailability:
Not applicable (vaccine, immune response is the primary outcome)
Tmax:
Not applicable
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable
ProteinBinding:
Not applicable
CnssPenetration:
Not applicable
Elimination:
HalfLife:
Not applicable
Clearance:
Not applicable
ExcretionRoute:
Not applicable
Unchanged:
Not applicable
Pharmacodynamics
OnsetOfAction:
Typically within weeks after the primary series (2-3 doses) for protective antibody levels.
PeakEffect:
Achieved after completion of the primary vaccination series and booster doses, providing sustained immunity.
DurationOfAction:
Years (e.g., 5-10 years for pertussis, longer for diphtheria and tetanus, requiring booster doses).
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediately or seek medical attention:
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
Feeling confused
Changes in eyesight
Seizures
Abnormal burning, numbness, or tingling sensations
Weakness
Difficulty controlling body movements
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor right away
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild 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 persist, contact your doctor:
Common side effects for all patients taking this medication:
+ Pain, redness, or swelling at the injection site
+ Headache
+ Fatigue or weakness
+ Mild fever
+ Chills
+ Body aches
+ Upset stomach or vomiting
+ Stomach pain or diarrhea
+ Joint pain or swelling
+ Swollen glands
* Additional side effects in young children:
+ Irritability
+ Decreased appetite
+ Drowsiness
+ Excessive crying
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
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 immediately or seek medical attention:
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
Feeling confused
Changes in eyesight
Seizures
Abnormal burning, numbness, or tingling sensations
Weakness
Difficulty controlling body movements
High fever
Severe dizziness or fainting, which can occur before or after receiving a vaccine; if you feel dizzy, inform your doctor right away
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild 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 persist, contact your doctor:
Common side effects for all patients taking this medication:
+ Pain, redness, or swelling at the injection site
+ Headache
+ Fatigue or weakness
+ Mild fever
+ Chills
+ Body aches
+ Upset stomach or vomiting
+ Stomach pain or diarrhea
+ Joint pain or swelling
+ Swollen glands
* Additional side effects in young children:
+ Irritability
+ Decreased appetite
+ Drowsiness
+ Excessive crying
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS) at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.
Seek Immediate Medical Attention If You Experience:
- Signs of a severe allergic reaction: difficulty breathing, wheezing, hives, swelling of the face or throat, dizziness, or weakness.
- High fever (over 105°F or 40.5°C).
- Persistent, inconsolable crying for 3 hours or more.
- Seizures or convulsions.
- Limpness or unresponsiveness (hypotonic-hyporesponsive episode).
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 and its symptoms.
If you have a history of seizures or other brain or nervous system problems.
* If you have experienced a brain problem, including coma, decreased level of awareness, or seizures of unknown cause, within 7 days of receiving a previous vaccine that contained pertussis.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 and its symptoms.
If you have a history of seizures or other brain or nervous system problems.
* If you have experienced a brain problem, including coma, decreased level of awareness, or seizures of unknown cause, within 7 days of receiving a previous vaccine that contained pertussis.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information for All Patients Taking This Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will ensure that you receive proper care and attention.
Effectiveness and Immune System
Please note that this medication may not provide complete protection for everyone who uses it. It is essential to discuss this with your doctor to understand the potential benefits and limitations. If you have a weakened immune system or are taking medications that suppress the immune system, consult with your doctor, as this vaccine may not be as effective.
Special Considerations for Children
Not all vaccine brands are suitable for children, so it is vital to consult with your child's doctor to determine the best course of treatment.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Special Precautions for Infants
If your child is an infant born prematurely, this medication should be used with caution. There is a rare chance that your child may experience more side effects.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will ensure that you receive proper care and attention.
Effectiveness and Immune System
Please note that this medication may not provide complete protection for everyone who uses it. It is essential to discuss this with your doctor to understand the potential benefits and limitations. If you have a weakened immune system or are taking medications that suppress the immune system, consult with your doctor, as this vaccine may not be as effective.
Special Considerations for Children
Not all vaccine brands are suitable for children, so it is vital to consult with your child's doctor to determine the best course of treatment.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Special Precautions for Infants
If your child is an infant born prematurely, this medication should be used with caution. There is a rare chance that your child may experience more side effects.
Overdose Information
Overdose Symptoms:
- Overdose is unlikely with a single dose.
- Administration of more than the recommended dose may increase the risk of local reactions (e.g., pain, swelling, redness) and systemic reactions (e.g., fever, irritability).
What to Do:
Contact a healthcare professional or poison control center (1-800-222-1222) for advice. Treatment is generally supportive for symptoms.
Drug Interactions
Contraindicated Interactions
- Severe allergic reaction (e.g., anaphylaxis) to a previous dose of Daptacel or any component of the vaccine.
- Encephalopathy not attributable to another identifiable cause occurring within 7 days of a previous dose of a pertussis-containing vaccine.
Major Interactions
- Immunosuppressive therapies (e.g., corticosteroids, chemotherapy, radiation therapy): May diminish the immune response to the vaccine, leading to reduced efficacy. Vaccination should be deferred if possible, or efficacy may be compromised.
- Other vaccines: Administer at different injection sites if given concomitantly.
Moderate Interactions
- Antipyretics (e.g., acetaminophen, ibuprofen): Prophylactic use before vaccination is not recommended as it may blunt the immune response, though post-vaccination use for fever/pain is acceptable.
Confidence Interactions
Monitoring
Baseline Monitoring
Medical history (including vaccination history, allergies, previous vaccine reactions, neurological disorders)
Rationale: To identify contraindications, precautions, and assess suitability for vaccination.
Timing: Prior to vaccine administration.
Current health status (acute illness, fever)
Rationale: Vaccination should be deferred in individuals with moderate or severe acute illness with or without fever.
Timing: Prior to vaccine administration.
Routine Monitoring
Observation for immediate adverse reactions (e.g., anaphylaxis)
Frequency: For 15-20 minutes post-vaccination.
Target: Absence of severe allergic reactions.
Action Threshold: Any signs of anaphylaxis (e.g., hives, swelling, difficulty breathing, dizziness) require immediate medical intervention.
Injection site reactions (pain, redness, swelling)
Frequency: Within 48-72 hours post-vaccination.
Target: Mild to moderate, self-limiting.
Action Threshold: Severe or persistent reactions, or abscess formation, warrant medical evaluation.
Systemic reactions (fever, irritability, drowsiness, loss of appetite)
Frequency: Within 48-72 hours post-vaccination.
Target: Mild to moderate, self-limiting.
Action Threshold: High fever (>105°F), persistent inconsolable crying (>3 hours), seizures, or hypotonic-hyporesponsive episodes require medical evaluation.
Symptom Monitoring
- Fever
- Pain, redness, or swelling at the injection site
- Irritability or fussiness
- Drowsiness
- Loss of appetite
- Unusual or prolonged crying
- Vomiting
- Diarrhea
- Seizures
- Limpness or pallor (hypotonic-hyporesponsive episode)
- Signs of allergic reaction (hives, rash, swelling of face/throat, difficulty breathing, wheezing, dizziness, weakness)
Special Patient Groups
Pregnancy
Daptacel is not indicated for use in pregnant women. Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) is the recommended vaccine for pregnant women to protect against pertussis and provide passive immunity to the newborn.
Trimester-Specific Risks:
First Trimester:
Not indicated.
Second Trimester:
Not indicated.
Third Trimester:
Not indicated.
Lactation
Generally considered safe for use in breastfeeding women. The vaccine components are not expected to be excreted in breast milk, and vaccination of the mother poses no known risk to the breastfed infant.
Infant Risk:
Low risk; no adverse effects on breastfed infants have been reported.
Pediatric Use
Daptacel is specifically indicated for active immunization against diphtheria, tetanus, and pertussis in infants and children 6 weeks through 6 years of age (prior to 7th birthday). It is a cornerstone of routine childhood immunization schedules.
Geriatric Use
Not indicated for geriatric populations. Tdap is recommended for adults, including older adults, for booster immunization against tetanus, diphtheria, and pertussis.
Clinical Information
Clinical Pearls
- Daptacel is for intramuscular (IM) administration only, preferably in the anterolateral aspect of the thigh for infants or the deltoid muscle for older children.
- Ensure the full 5-dose series is completed for optimal and sustained protection against diphtheria, tetanus, and pertussis.
- Do not interchange Daptacel (DTaP) with Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine) for adolescent or adult use, as they have different antigen concentrations and indications.
- Always observe patients for 15-20 minutes after vaccination to monitor for immediate hypersensitivity reactions.
- Inform parents/guardians about common local and systemic reactions and when to seek medical attention.
Alternative Therapies
- No direct therapeutic alternatives for active immunization against diphtheria, tetanus, and pertussis. Prevention through vaccination is the primary strategy.
Cost & Coverage
Average Cost:
Varies, typically $50-$100 per 0.5 mL single-dose vial/syringe
Insurance Coverage:
Generally covered under preventive care benefits by most public and private insurance plans (e.g., ACA, Medicaid, CHIP). Often Tier 1 or 2.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for 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 otherwise, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance or inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.