Ipol

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Not all drug interactions are known or reported and new drug interactions aare continually being reported. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ipol falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Ipol should only be given to a pregnant woman if clearly needed. 

Ipol is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention. 

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.

Other drugs may interact with polio vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative as required by the National Childhood Vaccine Injury Act (VISs are available at ).1 106 162 163 223 224

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with IPV.1 106 223 224

• Importance of receiving the complete primary immunization series to ensure the highest level of protection, unless contraindicated.1 106 223 224

• Importance of informing clinicians if any adverse reactions occur.1 106 223 224 Clinicians or individuals can report any adverse reactions that occur following vaccination to Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or .106 224

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 106 223 224

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 106 223 224 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• Tell all of your health care providers that you take IPOL. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not protect all people who use it. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling confused.
• Very bad dizziness or passing out.
• Change in eyesight.
• Seizures.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble controlling body movements.

AHFS Category 80:12     IPV

Rx only

Before administration, parenteral drug products should be checked visually for any deviation from normal appearance including container integrity. The syringe or vial and its packaging should be inspected prior to use for evidence of leakage, premature activation of the plunger, or a faulty tip seal. If evidence of such defects are observed, the syringe should not be used.

After preparation of the injection site, immediately administer IPOL vaccine intramuscularly or subcutaneously. In infants and small children, the mid-lateral aspect of the thigh is the preferred site. In older children and adults IPOL vaccine should be administered intramuscularly or subcutaneously in the deltoid area.

The syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.

To help avoid HIV (AIDS), HBV (Hepatitis), and other infectious diseases due to accidental needlesticks, contaminated needles should not be recapped or removed, unless there is no alternative or that such action is required by a specific medical procedure.

Care should be taken to avoid administering the injection into or near blood vessels and nerves. If blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedures using a new dose of vaccine administered at a different site.

DO NOT ADMINISTER VACCINE INTRAVENOUSLY.

Children

The primary series of IPOL vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. Under no circumstances should the vaccine be given more frequently than four weeks apart. The first immunization may be administered as early as six weeks of age. For this series, a booster dose of IPOL vaccine is administered at 4 to 6 years of age.41

From historical data on the antibody responses to diphtheria, tetanus, whole-cell or acellular pertussis, Hib, or hepatitis B vaccines used concomitantly with IPOL vaccine, no interferences have been observed on the immunological end points accepted for clinical protection.11,16,36 (See DRUG INTERACTIONS section.)

If the third dose of IPOL vaccine is given between 12 to 18 months of age, it may be desirable to administer this dose with Measles, Mumps, and Rubella (MMR) vaccine and/or other vaccines using separate syringes at separate sites,28 but no data on the immunological interference between IPOL vaccine and these vaccines exist.

Children and adolescents with a previously incomplete series of polio vaccine should receive sufficient additional doses of IPOL vaccine to complete the series. OPV is no longer recommended for routine immunization and is recommended only in special circumstances7 (see General Recommendations section).

Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity. There is no need to start the series over again, regardless of the time elapsed between doses.

The need to routinely administer additional doses is unknown at this time.28

Adults

A primary series of IPOL vaccine is recommended for unvaccinated adults at increased risk of exposure to poliovirus. While the responses of adults to primary series have not been studied, the recommended schedule for adults is two doses given at a 1 to 2 month interval and a third dose given 6 to 12 months later. If less than 3 months but more than 2 months are available before protection is needed, three doses of IPOL vaccine should be given at least 1 month apart. Likewise, if only 1 or 2 months are available, two doses of IPOL vaccine should be given at least 1 month apart. If less than 1 month is available, a single dose of IPOL vaccine is recommended.28

Adults who are at an increased risk of exposure to poliovirus and who have had at least one dose of OPV, fewer than three doses of conventional IPV or a combination of conventional IPV or OPV totaling fewer than three doses should receive at least one dose of IPOL vaccine. Additional doses needed to complete a primary series should be given if time permits.28

Adults who are at an increased risk of exposure to poliovirus and who have previously completed a primary series with one or a combination of polio vaccines can be given a dose of IPOL vaccine.

The preferred injection site of IPOL vaccine for adults is in the deltoid area.

Syringe, without needle, 0.5 mL (10 per package).
Product No. 49281-860-55

Vial, 10 Dose – Product No. 49281-860-10

CPT® Code: 90713

CPT is a registered trademark of the American Medical Association.

STORAGE

The vaccine is stable if stored in the refrigerator at 2°C to 8°C (35°F to 46°F). The vaccine must not be frozen.

Applies to poliovirus vaccine, inactivated: injectable suspension

Local

Very common (10% or more): Injection site pain (34%), local tenderness (29.4%), local swelling (11.4%)
Common (1% to 10%): Local erythema
Uncommon (0.1% to 1%): Injection site mass
Postmarketing reports: Injection site reaction (including injection site rash)[Ref]

Other

Very common (10% or more): Temperature over 102F (38%)
Common (1% to 10%): Persistent crying
Frequency not reported: Death
Postmarketing reports: Pyrexia[Ref]

Psychiatric

Very common (10% or more): Irritability (64.5%), tiredness (60.7%) fussiness, sleepiness
Postmarketing reports: Agitation[Ref]

Metabolic

Very common (10% or more): Anorexia (16.6%)[Ref]

Gastrointestinal

Common (1% to 10%): Vomiting, diarrhea[Ref]

Nervous system

Frequency not reported: Guillain-Barre syndrome
Postmarketing reports: Convulsion, febrile convulsion, headache, paresthesia[Ref]

Hypersensitivity

Postmarketing reports: Type I hypersensitivity reaction (including allergic reaction, anaphylactic reaction, and anaphylactic shock)[Ref]

Musculoskeletal

Postmarketing reports: Arthralgia, myalgia[Ref]

Hematologic

Postmarketing reports: Lymphadenopathy[Ref]

Dermatologic

Postmarketing reports: Rash, urticaria[Ref]

Some side effects of Ipol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.