Diphtheria and Tetanus Toxoids

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, suspension [Td, adult; preservative free]:

TDVAX: Diphtheria 2 Lf units and tetanus 2 Lf units per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde, and thimerosal]

Tenivac: Diphtheria 2 Lf units and tetanus 5 Lf units per 0.5 mL (0.5 mL) [contains aluminum, may contain natural rubber/natural latex in prefilled syringe]

Generic: Diphtheria 2 Lf units and tetanus 5 Lf units per 0.5 mL (0.5 mL)

Injection, suspension [DT, pediatric; preservative free]:

Generic: Diphtheria 25 Lf units and tetanus 5 Lf units per 0.5 mL (0.5 mL)

Pharmacology

Mechanism of Action

Promotes active immunity to diphtheria and tetanus by inducing production of specific antibodies.

Use: Labeled Indications

Diphtheria and tetanus disease prevention:

Diphtheria and tetanus toxoids adsorbed for pediatric use (DT): Infants ≥6 weeks and children through 6 years of age: Active immunization against diphtheria and tetanus when pertussis vaccine is contraindicated

Tetanus and diphtheria toxoids adsorbed for adult use (Td) (Tenivac): Children ≥7 years, adolescents, and adults: Active immunization against diphtheria and tetanus; tetanus prophylaxis in wound management

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following:

• For primary immunization against diphtheria and tetanus in infants and children 6 weeks to <7 years in whom pertussis vaccine is contraindicated (CDC/ACIP [Liang 2018])
• Children ≥7 years, adolescents, and adults should receive a booster dose of Td every 10 years; may substitute a single Td booster dose with Tdap (CDC/ACIP [Liang 2018])
• Children 7 to 10 years, adolescents, adults, and elderly (≥65 years) patients who are wounded in bombings or similar mass casualty events who have penetrating injuries or nonintact skin exposure and who cannot confirm receipt of a tetanus booster within the previous 5 years, may also receive a single dose of Td; children ≥11 years and adults may also receive Td if Tdap is unavailable (CDC [Chapman 2008])
• For patients who have recovered from tetanus or diphtheria infection: Because tetanus or diphtheria infection does not confer life-long immunity, active vaccination should be initiated at the time of recovery from the illness (according to the schedule). If the primary tetanus vaccination series has been completed, then a booster dose should be administered as soon as feasible during convalescence. Persons with unknown or uncertain previous tetanus vaccination histories should begin the 3-dose tetanus and diphtheria toxoids vaccination series (CDC/ACIP [Liang 2018]).

Contraindications

Hypersensitivity to diphtheria, tetanus toxoid, or any component of the formulation

Dosage and Administration

Dosing: Adult

Primary immunization (Td): IM:

Manufacturer labeling (Tenivac): Patients previously not immunized should receive 2 primary doses of 0.5 mL each, given at an interval of 8 weeks; third (reinforcing) dose of 0.5 mL 6 to 8 months later

ACIP recommendations: Patients previously not immunized should receive 2 primary doses of 0.5 mL each, given at an interval of at least 4 weeks; third (reinforcing) dose of 0.5 mL 6 to 12 months later. Patients not completely immunized (<3 doses) should receive the remaining doses. For patients who have not received Tdap, a dose should be included as part of primary immunization (in place of one of the Td doses) (CDC/ACIP [Liang 2018]).

Booster immunization (Td): IM: 0.5 mL every 10 years (for routine booster in patients who have completed primary immunization series). The ACIP prefers Tdap for use in in some situations if no contraindications exist (CDC/ACIP [Liang 2018]); refer to Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine monograph for additional information.

Tetanus prophylaxis in wound management (CDC/ACIP [Liang 2018]): IM: Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated, the immunization status of the patient. Wound management includes proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.

Table has been converted to the following text.

Tetanus Prophylaxis in Wound Management

History of tetanus immunization: Uncertain or <3 doses

Clean, minor wounds: Administer a tetanus toxoid-containing vaccine.

Children ≤6 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Other wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid-containing vaccine and TIG.

Children ≤6 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

History of tetanus immunization: Three or more doses

Clean, minor wounds: Administer a tetanus toxoid-containing vaccine if ≥10 years since last dose.

Children ≤6 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Other wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid-containing vaccine if ≥5 years since last dose.

Children ≤6 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Abbreviations: DT = Diphtheria and Tetanus Toxoids (formulation for age ≤6 years); DTaP = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (formulation for age ≤6 years; Daptacel, Infanrix); Td = Diphtheria and Tetanus Toxoids (formulation for age ≥7 years; Tenivac); TT= Tetanus toxoid (adsorbed [formulation for age ≥7 years]); Tdap = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (Adacel or Boostrix [formulations for age ≥7 years]); TIG = Tetanus Immune Globulin

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2017]).

Primary Immunization:

CDC (ACIP) recommendations (CDC/ACIP [Liang 2018]): Infants and Children 6 weeks to 6 years with contraindication to immunization containing pertussis: Note: Preterm infants should be vaccinated according to their chronological age from birth; Pediatric formulation (DT): IM: 0.5 mL per dose for a total of 5 doses administered as follows:

Three doses, usually given at 2-, 4-, and 6 months of age; may be given as early as 6 weeks of age and repeated every 4 to 8 weeks

Fourth dose: Given at ~15 to 18 months of age, but at least 6 months after third dose. The fourth dose may be given as early as 12 months of age, but at least 6 months must have elapsed between the third dose and the fourth dose. The fourth dose does not need to be repeated if inadvertently administered at least 4 months after the third dose.

Fifth dose: Given at 4 to 6 years of age, prior to starting school or kindergarten; if the fourth dose is given at ≥4 years of age, the fifth dose may be omitted

Catch-up immunization:

CDC (ACIP) Recommendations (CDC/ACIP [Liang 2018]): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.

Infants and Children who start primary immunization series ≥4 months of age through 6 years (prior to seventh birthday): Pediatric formulation (DT): IM: 0.5 mL per dose for a total of 4 to 5 doses based on previous vaccination doses received and ages.

Children ≥7 years and Adolescents not fully, or never vaccinated against diphtheria, or tetanus, or pertussis, or whose vaccination status is not known: IM: 0.5 mL per dose for a total of 3 to 4 doses based on number of previous vaccination doses, intervals, and patient age.

Manufacturer's labeling: Tenivac: Children ≥7 years and Adolescents: IM: Patients previously not immunized should receive 2 primary doses of 0.5 mL each, given at an interval of 8 weeks; plus a third (reinforcing) dose of 0.5 mL given 6 to 8 months later. Note: For patients who have not received Tdap, a dose should be included as part of primary immunization (in place of one of the Td doses) (CDC/ACIP [Liang 2018]).

Booster immunization: For routine booster in patients who have completed primary immunization series. The ACIP prefers Tdap for use in some situations if no contraindications exist; refer to Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine monograph for additional information.

Children 11 to 12 years: IM: 0.5 mL as a single dose when at least 5 years have elapsed since last dose of toxoid-containing vaccine. If not contraindicated, Tdap is the preferred agent for this dose. Subsequent routine doses (Td) are not recommended more often than every 10 years. Note: If Tdap is given as part of catch-up dosing at 7 to 10 years of age, the 11 to 12 year booster is not needed. Regular Td booster immunizations should begin 10 years after the last dose of the primary series.

Adolescents: IM 0.5 mL as a single dose every 10 years

Tetanus prophylaxis in wound management (CDC/ACIP [Liang 2018]): Infants, Children, and Adolescents: Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated, the immunization status of the patient. Wound management includes proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow-up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.

Table has been converted to the following text.

History of Tetanus Immunization (Doses): Uncertain or <3 doses

Clean, Minor Wounds: Administer a tetanus toxoid containing vaccine. For children ≤6 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and adolescents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine and TIG. For children ≤6 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≤7 years of age and adolescents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

History of Tetanus Immunization (Doses): 3 or more doses

Clean, Minor Wounds: Administer a tetanus toxoid containing vaccine if ≥10 years since last dose. For children ≤6 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and adolescents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine if ≥5 years since last dose. For children ≤6 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and adolescents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

Abbreviations: DT = Diphtheria and Tetanus Toxoids (formulation for age ≤6 years); DTaP = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (formulation for age ≤6 years; Daptacel, Infanrix, Tripedia); Td = Diphtheria and Tetanus Toxoids (formulation for age ≥7 years; Tenivac); TT= Tetanus toxoid (adsorbed [formulation for age ≥7 years]); Tdap = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (Adacel or Boostrix [formulations for age ≥7 years]); TIG = Tetanus Immune Globulin

Administration

IM: For IM administration only; not for IV or SubQ administration. Prior to use, shake suspension well. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

Td: Administer in the deltoid muscle; do not inject in the gluteal area

For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2017]).

Storage

Store at 2°C to 8°C (35°F to 46°F). Do not freeze; discard if product has been frozen.

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Meningococcal Polysaccharide (Groups A / C / Y and W-135) Tetanus Toxoid Conjugate Vaccine: May diminish the therapeutic effect of Tetanus Toxoids Vaccines. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) tetanus toxoid conjugate vaccine either together with or at least one month before a tetanus toxoids-containing vaccine. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

All serious adverse reactions must be reported to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Percentages noted within 2 weeks following booster dose of Decavac in persons ≥11 years of age.

>10%:

Central nervous system: Headache (34% to 40%), fatigue (21% to 27%), body pain (≤19% to 30%), myasthenia (≤19% to 30%), chills (7% to 13%)

Gastrointestinal: Nausea (8% to 12%), diarrhea (10% to 11%)

Local: Pain at injection site (63% to 71%), erythema at injection site (20% to 22%), swelling at injection site (17% to 18%)

Neuromuscular & skeletal: Arthralgia (≤7% to 12%), joint swelling (≤7% to 12%)

1% to 10%:

Dermatologic: Skin rash (2%)

Gastrointestinal: Vomiting (2% to 3%)

Hematologic & oncologic: Adenopathy (4% to 5%)

Miscellaneous: Fever (1% to 3%)

<1%, postmarketing and/or case reports: Anaphylaxis, arthralgia, dizziness, hypersensitivity reaction (includes angioedema, skin rash, urticaria), injection site reaction (includes cellulitis, induration at injection site, injection site nodule, warm sensation at injection site), limb pain, lymphadenopathy, musculoskeletal stiffness, myalgia, pain, paresthesia, peripheral edema, seizure, syncope, weakness

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2017]).
• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous diphtheria toxoid or tetanus toxoid-containing vaccine dose should not be given further routine or emergency doses of Td unless ≥10 years since most recent dose, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (CDC/ACIP [Liang 2018]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescent and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2017]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2017]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2017]).
• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP [Liang 2018]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual component. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2017]).

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).
• Pediatric: Pediatric dosage form (DT) should only be used in patients 6 weeks to ≤6 years of age. Td should be administered to children ≥7 years of age. Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2017]).

Dosage form specific issues:

• DT confused with Td: Do not confuse pediatric diphtheria and tetanus (DT) with adult tetanus and diphtheria (Td).
• Latex: Some products may contain natural latex/natural rubber.
• Thimerosal: Some products may contain thimerosal.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2017]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy

Pregnancy Considerations

Diphtheria toxoid and tetanus toxoid vaccines may be used during pregnancy (CDC/ACIP [Liang 2018]).

Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2017]). The Advisory Committee on Immunization Practices (ACIP) recommends a single Tdap vaccination during each pregnancy; ideally between 27 and 36 weeks' gestation to maximize passive antibody transfer to the fetus. Pregnant females who are not immunized or are only partially immunized should complete the primary series with Td. Tetanus immune globulin and a tetanus toxoid containing vaccine are recommended by the ACIP as part of the standard wound management to prevent tetanus in pregnant females; the use of a tetanus-toxoid containing vaccine during pregnancy is recommended for wound management if ≥5 years have passed since the last Td vaccination (CDC/ACIP [Liang 2018]).

Patient Education

What is this drug used for?

• It is used to prevent tetanus and diphtheria.

Frequently reported side effects of this drug

• Headache
• Injection site pain, redness, or swelling
• Loss of strength and energy
• Joint pain
• Joint swelling
• Nausea
• Diarrhea
• Mild fever
• Abnormal crying (children)
• Lack of appetite (children)

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Severe dizziness
• Passing out
• Muscle pain
• Muscle weakness
• Face muscle weakness
• Uneven smile
• Burning or numbness feeling
• Abnormal movements
• Severe injection site irritation
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.