Rotateq

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Rotateq (Rotavirus-vaccine). If you are concerned about side effects, discuss the risks and benefits of Rotateq (Rotavirus-vaccine) with your doctor.

The following side effects have been reported by at least 1% of people taking Rotateq (Rotavirus-vaccine). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea
• gas
• irritability
• skin irritation
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• blood in the stools

Seek immediate medical attention if any of the following occur:

• signs of blocked intestine (e.g., severe stomach pain, vomiting, blood in stools, swollen belly, high Fever)
• signs of a serious allergic reaction (shortness of breath; wheezing; trouble breathing; Hives; swelling of the lips, tongue, or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Rotateq (Rotavirus-vaccine).

Each 2 mL dose of sterile, pale yellow, clear liquid that may have a pink tint, contains human-bovine rotavirus reassortants G1, G2, G3, G4, and P1A[8]. The single dose tube has a minimum of the following dose levels: G1 - 2.2 x 106 infectious units; G2 - 2.8 x 106 infectious units; G3 - 2.2 x 106 infectious units; G4 - 2.0 x 106 infectious units; P1A[8] - 2.3 x 106 infectious units. Nonmedicinal ingredients: sucrose, sodium citrate dehydrate, sodium phosphate monobasic monohydrate, polysorbate 80, diluents and cell culture media. Latex-free.

Do not give the rotavirus vaccine to someone who:

• is allergic to rotavirus vaccine or any ingredients of the medication
• has severe combined immunodeficiency disorder (SCID)
• has a history of intussusception (a condition where part of the intestine is pulled into itself)
• has a medical condition that may make intussusceptions more likely to occur

This vaccine is intended for children only and should not be taken by adults.

Do not give Rotateq (Rotavirus-vaccine) to infants under 6 weeks of age.

There may be an interaction between rotavirus vaccine and any of the following:

• Acetaminophen
• immune globulin
• immunosuppressants
• Azathioprine
• Belimumab
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Fingolimod
• Golimumab
• hydroxychloroquine
• Leflunomide
• Infliximab
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Rituximab
• Tacrolimus
• tuberculin skin tests

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Rotateq (Rotavirus-vaccine).

Fever: Your child's doctor may decide to delay this vaccine if your child has an acute infection or fever. Mild infections without fever, such as colds, usually do not require delay of the vaccine.

Immune problems: As with any vaccine, rotavirus vaccine may not provide complete protection against rotavirus for all people. When used for children with impaired immune systems, rotavirus vaccine may not create enough of an antibody response to protect against infections caused by these bacteria. Also, this vaccine may not be effective for people receiving immunosuppressive therapy (e.g., some medications used to treat cancer or for transplant recipients).

Other vaccines: Rotavirus vaccine may be given in the doctor's office at the same time as your child receives other routine infant vaccinations.

Pregnancy: This vaccine is intended for infants and young children only and should not be used by pregnant women.

Breast-feeding: This vaccine is intended for infants and young children only and should not be used by breast-feeding women.