Infanrix

Generic Name: diphtheria, tetanus, and pertussis (DTaP) vaccines (DIF thee ree ah, TET ah nus, per TUH sis)

Brand Names: Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia

What are diphtheria, tetanus, and pertussis vaccines?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, and even death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Pertussis (whooping cough) causes coughing so severe that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Vaccines for these diseases expose the individual to a small amount of the bacteria, helping the body develop immunity to the disease.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood.

What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose. Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

What should I discuss with my healthcare provider before receiving diphtheria, tetanus, and pertussis vaccines?

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose. Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Before receiving DTaP vaccine, talk to your doctor if your child:

• 
  

  had a seizure or collapsed after a dose of DTaP;

  
  


• 
  

  cried non-stop for 3 hours or more after a dose of DTaP;

  
  


• 
  

  had a fever over 105 degrees after a dose of DTaP;

  
  


• 
  

  developed Guillian-Barre syndrome within 6 weeks after a prior tetanus shot;

  
  


• 
  

  has HIV or AIDS or another disease that affects the immune system;

  
  


• 
  

  is taking a medication that affects the immune system (steroids, anti-rejection medications after a transplant);

  
  


• 
  

  has a bleeding disorder or takes blood thinners (such as warfarin or Coumadin);

  
  


• 
  

  has cancer; or

  
  


• 
  

  is receiving cancer treatment with x-rays, radiation, or medication.

  
  

If the child has any of these conditions, he or she may not be able to receive DTaP.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

FDA pregnancy category C: This medication may be harmful to an unborn baby and should not be given to a woman who is pregnant.

How are diphtheria, tetanus, and pertussis vaccines administered?

This vaccine is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give this injection.

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Your doctor may recommend reducing fever and pain by giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications. Controlling fever is especially important for children who have had seizures for any reason, or if a family member has had seizures.

What happens if I miss a dose?

Contact your doctor if a dose of DTaP vaccine is missed.

What happens if I overdose?

An overdose of DTaP vaccine is unlikely to occur.

What should I avoid before or after getting diphtheria, tetanus, and pertussis vaccines?

There are no restrictions on food, beverages, or activity before or after receiving DTaP vaccine unless your doctor has told you otherwise.

Diphtheria, tetanus, and pertussis vaccines side effects

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if the child has any of the following serious side effects:

• 
  

  loss of consciousness;

  
  


• 
  

  seizure (black-out or convulsions);

  
  


• 
  

  high fever, over 105 degrees; or

  
  


• 
  

  non-stop crying for 3 hours or more.

  
  

Other less serious side effects may be more likely to occur. Talk to your doctor if your child has:

• 
  

  mild fever;

  
  


• 
  

  redness, pain, tenderness, or swelling where the shot was given;

  
  


• 
  

  fussiness for 1-3 days after the shot;

  
  


• 
  

  tiredness or poor appetite for 1-3 days after the shot; or

  
  


• 
  

  vomiting for 1-3 days after the shot.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

To help reduce fever and pain, your doctor may recommend giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil). This may be given at the time of the shot and over the next 24 hours. Your doctor will tell you the correct dose to use. Controlling fever is especially important if the child has a history of seizures.

What other drugs will affect diphtheria, tetanus, and pertussis vaccines?

Before receiving the DTaP vaccine, tell the doctor if the child is using any of the following medications:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  cancer chemotherapy or radiation;

  
  


• 
  

  azathioprine (Imuran);

  
  


• 
  

  basiliximab (Simulect);

  
  


• 
  

  cyclosporine (Sandimmune, Neoral, Gengraf);

  
  


• 
  

  etanercept (Enbrel);

  
  


• 
  

  leflunomide (Arava);

  
  


• 
  

  muromonab-CD3 (Orthoclone);

  
  


• 
  

  mycophenolate mofetil (CellCept);

  
  


• 
  

  sirolimus (Rapamune); or

  
  


• 
  

  tacrolimus (Prograf).

  
  

There may be other drugs not listed that can affect the DTaP vaccine. Tell your doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Where can I get more information?

• Your doctor or pharmacist may have additional information or suggest additional resources regarding DTaP vaccine.

Indocin Intravenous

Generic Name: indomethacin (Intravenous route)

in-doe-METH-a-sin

Commonly used brand name(s)

In the U.S.

• Indocin

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Indocin

Indomethacin injection is used to treat patent ductus arteriosus (PDA) in premature infants (babies born too early) who weigh between 500 and 1750 grams. PDA is a heart problem where a blood vessel, the ductus arteriosus, fails to close normally after birth. This blood vessel is only used before birth, and is no longer needed after the baby is born. Indomethacin injection works by causing the PDA to constrict, and this closes the blood vessel. This medicine is used when other medical treatment for PDA fails after 48 hours.

This medicine is available only with your doctor's prescription.

Before Using Indocin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of indomethacin injection in premature babies.

Geriatric

No information is available on the relationship of age to the effects of indomethacin injection in geriatric patients.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Digoxin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Potassium


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Dipyridamole


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gentamicin


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Warfarin


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Active bleeding (e.g., brain hemorrhage or stomach bleeding) or


• Bleeding problems (e.g., thrombocytopenia) or


• Congenital heart disease or


• Infection, untreated or


• Kidney problem or


• Necrotizing enterocolitis, known or suspected (an inflamed intestine)—Should not be used in babies with these conditions.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Indocin

A nurse or other trained health professional will give this medicine to your baby. This medicine is given through a needle placed in one of your baby's veins.

Precautions While Using Indocin

Indomethacin injection may change how the body reacts during an infection. Your baby's doctor will monitor your baby for any signs of infection (e.g., fever, chills, or other unusual behavior).

This medicine may affect the action of platelets, which are necessary for clotting the blood. This may increase the chance of bleeding for your baby. Your baby's doctor will monitor your baby for any unusual bleeding or bruising, any dark-colored urine or stools, or other signs of bleeding in your baby.

This medicine may decrease your baby's urine volume. This may increase your baby's chance of having kidney problems or low sodium in the blood (hyponatremia). Blood and urine tests will be needed to check for any signs of these risks.

Liver problems may occur while your baby is receiving this medicine. Stop using this medicine and check with your baby's doctor right away if your baby is having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Indocin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• ammonia-like breath odor


• bloody or black, tarry stools


• coma


• confusion


• constipation


• convulsions


• decreased urine output


• difficult breathing


• dizziness


• fast or irregular heartbeat


• headache, sudden, severe


• increased thirst


• irregular heartbeat


• loss of appetite


• muscle pain or cramps


• nausea and vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• severe stomach pain


• shortness of breath


• swelling of the face, ankles, or hands


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• weakness or heaviness of the legs


• weight loss

Less common

• Anxiety


• blurred vision


• chills


• cold sweats


• cool, pale skin


• depression


• full or bloated feeling


• heartburn


• increased hunger


• indigestion


• nightmares


• noisy, rattling breathing


• pressure in the stomach


• seizures


• severe abdominal or stomach pain, cramping, or burning


• severe constipation


• severe vomiting


• shakiness


• slurred speech


• swelling of the abdominal or stomach area


• swelling of the fingers, hands, feet, or lower legs


• troubled breathing at rest


• unusual bruising or bleeding


• vomiting of material that looks like coffee grounds, severe and continuing


• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Indocin Intravenous side effects (in more detail)

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More Indocin Intravenous resources

• Indocin Intravenous Side Effects (in more detail)
• Indocin Intravenous Use in Pregnancy & Breastfeeding
• Drug Images
• Indocin Intravenous Drug Interactions
• Indocin Intravenous Support Group
• 14 Reviews for Indocin Intravenous - Add your own review/rating

Compare Indocin Intravenous with other medications

• Ankylosing Spondylitis
• Back Pain
• Bartter Syndrome
• Bursitis
• Cluster Headaches
• Frozen Shoulder
• Gitelman Syndrome
• Gout, Acute
• Langerhans' Cell Histiocytosis
• Osteoarthritis
• Pain
• Patent Ductus Arteriosus
• Rheumatoid Arthritis
• Sciatica
• Tendonitis

indomethacin Rectal

in-doe-METH-a-sin

Rectal route(Suppository)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Indocin

In Canada

• Indocid


• Novo-Methacin Suppositories


• Ratio-Indomethacin


• Rhodacine

Available Dosage Forms:

• Suppository

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For indomethacin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, indomethacin does not cure arthritis and will help you only as long as you continue to take it.

Indomethacin is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. indomethacin may also be used to treat painful shoulder caused by bursitis or tendinitis.

indomethacin is available only with your doctor's prescription.

Before Using indomethacin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For indomethacin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to indomethacin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of indomethacin in children below 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (e.g., stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking indomethacin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using indomethacin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

Using indomethacin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Digoxin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Potassium


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

Using indomethacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Dipyridamole


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gentamicin


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Warfarin


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of indomethacin. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or


• Bleeding problems or


• Blood clots or


• Depression or other mental changes or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hepatitis or jaundice, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Parkinsonism or


• Seizures or epilepsy, history of or


• Stomach ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history of or


• Proctitis (inflammation of the rectum), history of or


• Rectal bleeding, recent—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of indomethacin

For safe and effective use of indomethacin, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of indomethacin may increase the chance of unwanted effects.

indomethacin should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, indomethacin must be taken regularly as ordered by your doctor in order for it to help you. indomethacin usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of indomethacin.

Do not take rectal suppositories by mouth.

To use the suppository:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• Remove the foil wrapper and moisten the suppository with cold water.


• Lie down on your side and use your finger to push the suppository well up into the rectum


• Remain lying down for about 15 minutes to keep the suppository from coming out before it melts.


• Make sure to wash your hands with soap and water before and after inserting indomethacin.

Dosing

The dose of indomethacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of indomethacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For rectal dosage form (suppositories):
  
  • For ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, bursitis, tendinitis, or gout:
    
    • Adults and teenagers older than 14 years of age—One 50-milligram (mg) suppository, inserted into the rectum up to four times a day.
    
    
    • Teenagers and children 14 years of age or younger—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of indomethacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using indomethacin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

indomethacin may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use indomethacin for a long time might also have a higher risk.

indomethacin may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with indomethacin. Check with your doctor right away if you have any of the following symptoms while using indomethacin: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with indomethacin may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop using indomethacin and check with your doctor right away if you notice any of these warning signs.

indomethacin may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using indomethacin in the last few months of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

indomethacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to indomethacin before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are using indomethacin. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. .

indomethacin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Acid or sour stomach


• belching


• diarrhea


• heartburn


• indigestion


• nausea


• stomach discomfort, upset, or pain


• vomiting

Rare

• Abdominal or stomach cramping, burning, or tenderness


• back or leg pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody or black, tarry stools


• blue lips and fingernails


• blurred vision


• breast enlargement and tenderness


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning upper abdominal pain


• canker sores


• change in consciousness


• change in hearing


• chest pain, discomfort, or burning


• clay colored stools


• cloudy or bloody urine


• confusion


• continuing diarrhea


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• cracks in the skin


• dark urine


• decreased appetite


• decreased vision or any change in vision


• depression


• difficult or labored breathing


• difficulty with swallowing


• dilated neck veins


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• double vision


• dry mouth


• extreme fatigue


• false sense of well-being


• feeling of unreality


• feeling of warmth


• fever with or without chills


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• greatly decreased frequency of urination or amount of urine


• hair loss


• headache


• heavier menstrual periods


• hives or welts


• increased hunger


• increased sweating


• increased thirst


• increased urination


• irregular breathing


• irritation and swelling of the eye


• itching skin


• jerky movements of the head, face, mouth, and neck


• joint pain


• large, flat, blue or purplish patches in the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of balance control


• loss of bladder control


• loss of consciousness


• loss of hearing


• loss of heat from the body


• lower back or side pain


• mask-like face


• mental confusion


• mood swings


• muscle aches, pains, or weakness


• muscle spasm or jerking of all extremities


• nervousness


• noisy, rattling breathing


• nosebleeds


• numbness or tingling in the hands, feet, or lips


• pain in ankles or knees


• pain or discomfort in upper stomach or throat


• pain with swallowing


• painful or difficult urination


• painful, red lumps under the skin, mostly on the legs


• pale skin


• persistent bleeding or oozing from puncture sites, mouth, or nose


• personality changes


• pinpoint red or purple spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness of the face, neck, arms and occasionally, upper chest


• scaly skin


• seeing double


• seeing, hearing, or feeling things that are not there


• seizures


• sense of detachment from self or body


• severe constipation


• severe mental changes


• severe or continuing stomach pain


• shortness of breath


• shuffling walk


• skin rash


• slow, fast, irregular, pounding, or racing heartbeat or pulse


• slowed movements


• slurred speech


• small red or purple spots on the skin


• sore throat


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stiffness of the arms and legs


• sudden loss of consciousness


• sugar in the urine


• swelling in the legs and ankles


• swelling of the face, fingers, feet, or lower legs


• swelling of the breasts or breast soreness in both females and males


• swollen or painful glands


• tightness in the chest


• trembling and shaking of the fingers and hands


• troubled breathing at rest


• troubled breathing with exertion


• unexplained weight loss


• unpleasant breath odor


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• vaginal bleeding


• vomiting of blood or material that looks like coffee grounds


• weakness in the arms, hands, legs, or feet


• weight gain


• wheezing


• yellow eyes or skin

Incidence not known

• Frequent urge to defecate


• rectal bleeding, burning, dryness, itching, or pain


• straining while passing stool

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion about identity, place, and time


• severe headache


• unusual drowsiness, dullness, or feeling of sluggishness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Mild headache

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears


• difficulty having a bowel movement (stool)


• discouragement


• feeling sad or empty


• general feeling of discomfort or illness


• hearing loss


• irritability


• loss of interest or pleasure


• sleepiness


• trouble with concentrating

Rare

• Anxiety


• bloated full feeling


• changes in patterns and rhythms of speech


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• involuntary muscle movements


• lightheadedness


• passing gas


• sensation of spinning


• sleeplessness


• tiredness


• trouble with speaking


• trouble sleeping


• unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: indomethacin Rectal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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Influenza A (H1N1) 2009 Monovalent Vaccine Inactivated

Class: Vaccines
VA Class: IM100

Introduction

Inactivated virus vaccine.^{97 98 99} Influenza A (H1N1) 2009 monovalent vaccine inactivated contains noninfectious, suitably inactivated 2009 influenza type A (H1N1) virus and is used to stimulate active immunity to the influenza virus strain contained in the vaccine.^{97 98 99}

Uses for Influenza A (H1N1) 2009 Monovalent Vaccine Inactivated

Prevention of 2009 Influenza A (H1N1) Virus Infection

Prevention of 2009 pandemic influenza A (H1N1) virus infection in adults,^{97 98 99} adolescents,^{97 98} and children ≥6 months of age.⁹⁷

Influenza outbreaks caused by the 2009 influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus, were initially reported in several countries, including the US, beginning in March and April 2009.^{100 508 513 514 515 516 517 532} On June 11, 2009, the WHO declared that the first global influenza pandemic in 41 years was occurring and issued a phase 6 pandemic alert regarding 2009 influenza A (H1N1).^{513 529} A phase 6 pandemic is characterized by human-to-human transmission of an animal or human-animal reassortant virus and sustained community level outbreaks of the virus in 2 or more countries in a single WHO region and sustained community level outbreaks in at least one other country in a different WHO region.⁵²¹

Influenza viruses can cause seasonal epidemics and, occasionally, global pandemics (an epidemic that affects the whole population).^{100 437 521} Prior to 2009, the 3 most recent influenza pandemics were the 1918 Spanish flu pandemic (caused 20–50 million deaths worldwide including about 500,000 deaths in the US), the 1957 Asian flu pandemic (caused 1–4 million deaths worldwide including about 70,000 deaths in the US), and the 1968 Hong Kong flu pandemic (1–4 million deaths worldwide including about 34,000 deaths in the US).^{437 521}

The 2009 influenza A (H1N1) virus appears to be a triple-reassortant swine influenza virus containing genes from human, swine, and avian influenza A viruses.^{517 522 532} The virus contains a unique combination of gene segments not previously reported among human or swine influenza A in the US or elsewhere.^{514 517 522 532} The virus, however, may be antigenically similar to classical swine influenza A (H1N1) viruses and triple reassortant swine influenza A (H1N1) viruses that circulate in pigs and have been associated with sporadic human infections.^{522 532}

The 2009 influenza A (H1N1) virus is antigenically and genetically distinct from circulating seasonal human influenza A (H1N1) viruses, and preliminary studies indicate that a majority of the population may be susceptible to the virus.^{508 522} This virus is expected to continue to circulate worldwide, including in the US, during the 2009–2010 influenza season in addition to strains of seasonal influenza A and B.^{100 465 508 512 513 526}

Vaccination using an appropriate vaccine is the most effective strategy for preventing influenza and its complications.^{100 508}

Seasonal influenza virus vaccines used for prevention of seasonal influenza are reformulated each year to contain antigens representative of the strains of influenza A and B viruses likely to circulate in the US during the upcoming influenza season.^{100 510 511} Seasonal influenza vaccines for the 2009–2010 influenza season are not expected to provide protection against 2009 influenza A (H1N1) virus infection.^{100 508}

For prevention of 2009 influenza A (H1N1) virus infection, 2 different types of monovalent influenza vaccine are commercially available in the US: parenteral vaccine containing inactivated virus^{97 98 99} and intranasal vaccine containing live, attenuated virus.⁵²³ Both vaccine types are produced using an A/California/7/2009 (H1N1)v-like strain.^{97 98 99 508 523} (See Actions.)

Initial FDA approval of each of the commercially available inactivated influenza A (H1N1) 2009 monovalent vaccines was based on safety and efficacy data for the seasonal inactivated trivalent influenza vaccine produced by the same manufacturer (Afluria, manufactured by CSL; Fluvirin, manufactured by Novartis; Fluzone, manufactured by Sanofi Pasteur) and was considered a strain change to each manufacturer's FDA-approved seasonal inactivated influenza vaccine.^{97 98 99 528} Studies are ongoing to evaluate safety and efficacy of monovalent influenza A (H1N1) 2009 vaccines.^{97 98 508 524 528}

Although influenza vaccination using an appropriate vaccine is the most effective method for preventing influenza and influenza-related complications,^{100 508} there may be some situations, including during influenza pandemics, when use of antiviral agents may be indicated for prevention or treatment of influenza.^{100 437 465 512 513 520 521} CDC has issued updated interim recommendations concerning the use of antiviral agents for prevention and treatment of influenza, including 2009 influenza A (H1N1) and seasonal influenza.⁵¹² The CDC recommendations are available at and should be used to guide selection of the most appropriate antivirals for prevention and treatment of influenza and to prioritize use of such agents in patients at higher risk for influenza-related complications.⁵¹²

Because initial supplies of influenza A (H1N1) 2009 vaccine may not be sufficient to meet demands for the vaccine, the USPHS Advisory Committee on Immunization Practices (ACIP) identified initial target groups for priority vaccination.⁵⁰⁸ These individuals are at higher risk for influenza or influenza-related complications, are likely to come in contact with influenza viruses as part of their occupation and could transmit the viruses to others in medical care settings, or are close contacts of infants too young to be vaccinated (<6 months of age).⁵⁰⁸ (See table.) As supplies of the vaccine increase and demand for vaccine among individuals in initial priority target groups is met, CDC or ACIP is likely to revise recommendations to include additional target groups (e.g., all individuals 25 through 64 years of age, adults ≥65 years of age).^{508 533}

ACIP Recommendations for Priority Vaccination Against 2009 Pandemic Influenza A (H1N1) Virus:508

Initial Target Groups for Vaccine Supplies

Pregnant women

Individuals who live with or provide care for infants <6 months of age (e.g., parents, siblings, day-care providers)

Health-care and emergency medical services personnel

Individuals 6 months through 24 years of age

Adults 25 through 64 years of age with medical conditions that put them at higher risk for influenza-related complications, including chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic (including diabetes mellitus) disorders

Adults 25 through 64 years of age who are immunosuppressed, including those receiving immunosuppressive drugs and those with HIV infection

Subset of Initial Target Groups for Priority Vaccination if Vaccine Supplies are Limited

Pregnant women

Individuals who live with or provide care for infants <6 months of age (e.g., parents, siblings, day-care providers)

Health-care and emergency medical services personnel who have direct contact with patients or infectious materials

Children 6 months through 4 years of age

Children and adolescents 5–18 years of age who have medical conditions that put them at higher risk for influenza complications, including chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic (including diabetes mellitus) disorders

Based on current prescribing information, parenteral inactivated influenza A (H1N1) 2009 vaccine can be used for prevention of 2009 influenza A (H1N1) virus infection in any of the target groups identified for priority vaccination, unless contraindicated.^{97 98 99} Based on current prescribing information, the intranasal live influenza A (H1N1) 2009 vaccine may be used in some (but not all) of the target groups.⁵²³

Information regarding influenza surveillance and updated recommendations for prevention and treatment of 2009 influenza A (H1N1) virus infection is available at . CDC information on treatment and prevention of seasonal influenza is available at .

Influenza A (H1N1) 2009 Monovalent Vaccine Inactivated Dosage and Administration

Administration

IM Administration

Administer by IM injection.^{97 98 99}

Shake vaccine vial before withdrawing a dose.^{97 98 99} Shake prefilled syringe immediately before administering a dose.^{97 98 99} Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.^{97 98 99}

Do not mix with any other vaccine or solution.^{97 98 99}

To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass.⁴⁷⁵ For adults and adolescents, administer IM into the deltoid muscle.^{97 98 99 475} In children ≥3 years of age, IM injections should be made into the deltoid muscle if muscle mass is adequate; alternatively, the anterolateral thigh can be used.^{97 98 475} In children 6 months to 2 years of age, IM injections should preferably be made in the anterolateral aspect of the thigh.^{97 475}

Do not administer into buttock muscle because of potential for injection-associated injury to sciatic nerve.^{97 98 475} Do not administer into any area where there may be a major nerve trunk.^{97 98}

ACIP states that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) is not required because large blood vessels are not present at recommended IM injection sites.⁴⁷⁵

Since syncope may occur following vaccination, observe vaccinees for approximately 15 minutes after the dose.^{112 475} Syncope occurs most frequently in adolescents and young adults,^{112 475} and may be averted if vaccinees sit or lie down for 15 minutes after vaccination.¹¹² If syncope occurs, observe patient until symptoms resolve.^{112 475}

May be administered simultaneously with other age-appropriate vaccines.⁵³³ If given at the same time as other parenteral vaccines during a single health-care visit, each vaccine should be given with a different syringe and at different injection sites.⁹⁷ (See Other Vaccines under Interactions.)

ACIP has identified specific target groups who should receive influenza A (H1N1) 2009 vaccine beginning as soon as initial supplies become available in October, unless contraindicated.⁵⁰⁸ These individuals are at higher risk for influenza or influenza-related complications, are likely to come in contact with influenza viruses as part of their occupation and could transmit influenza viruses to others in medical care settings, or are close contacts of infants too young to be vaccinated (<6 months of age).⁵⁰⁸ (See Uses.)

Dosage

Clinical studies are ongoing to determine the optimal dosage, number of doses, and vaccination schedule for parenteral inactivated influenza A (H1N1) 2009 monovalent vaccine.^{97 98 99 508 528} The following dosages are based on available data to date.^{97 98}

A single-dose regimen is recommended for adults and children ≥10 years of age.^{97 98 99} A 2-dose regimen is recommended for children 6 months through 9 years of age.^{97 98}

Influenza A (H1N1) 2009 vaccine inactivated manufactured by CSL is used only in adults ≥18 years of age.⁹⁹

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Sanofi Pasteur may be used in adults, adolescents, and children ≥6 months of age.⁹⁷

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Novartis may be used in adults, adolescents, and children ≥4 years of age.⁹⁸

Pediatric Patients

Prevention of 2009 Influenza A (H1N1) Virus Infection

Children and Adolescents 6 Months through 17 Years of Age (Influenza A (H1N1) 2009 Vaccine Inactivated Manufactured by Sanofi Pasteur)

IM

Children 6 through 35 months of age: Two 0.25-mL doses administered approximately 1 month apart.⁹⁷

Children 36 months through 9 years of age: Two 0.5-mL doses administered approximately 1 month apart.⁹⁷

Children and adolescents 10 through 17 years of age: Single 0.5-mL dose.⁹⁷

Children and Adolescents 4 through 17 Years of Age (Influenza A (H1N1) 2009 Vaccine Inactivated Manufactured by Novartis)

IM

Children 4 through 9 years of age: Two 0.5-mL doses administered approximately 1 month apart.⁹⁸

Children and adolescents 10 through 17 years of age: Single 0.5-mL dose.⁹⁸

Adults

Prevention of 2009 Influenza A (H1N1)Virus Infection

Adults 18 Years of Age or Older

IM

Single 0.5-mL dose.^{97 98 99}

Special Populations

Hepatic Impairment

No specific dosage recommendations.^{97 98 99}

Renal Impairment

No specific dosage recommendations.^{97 98 99}

Geriatric Patients

No specific dosage recommendations.^{97 98 99} (See Geriatric Use under Cautions.)

Cautions for Influenza A (H1N1) 2009 Monovalent Vaccine Inactivated

Contraindications

• 
  

  Hypersensitivity to eggs,^{98 99} egg protein,^{97 98} chicken protein,⁹⁹ or any vaccine component.^{97 98} (See Sensitivity Reactions under Cautions.)

  
  


• 
  

  Life-threatening reaction to previous dose of any influenza vaccine.^{97 98 99}

  
  


• 
  

  Influenza A (H1N1) 2009 vaccine inactivated manufactured by CSL: Hypersensitivity to neomycin or polymyxin.⁹⁹ (See Neomycin and/or Polymyxin B Allergy under Cautions.)

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Studies using seasonal parenteral inactivated influenza vaccine indicate rare reports of immediate, presumably allergic reactions (e.g., urticaria, angioedema, anaphylaxis, allergic asthma).^{97 98 99 103 143 441 463 473} Reactions may result from sensitivity to some vaccine component, including residual egg protein.^{97 98 99 103 143 441 463 473}

Parenteral inactivated influenza A (H1N1) 2009 vaccine is produced using embryonated chicken eggs (the same process used for manufacture of seasonal parenteral inactivated influenza vaccine) and can contain residual egg protein that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.^{97 98 99} CDC and ACIP state that asking patients if they can eat eggs without adverse effects is a reasonable way to identify those who may be at risk for allergic reactions if they receive the vaccine.^{475 533} Those who are able to eat eggs or egg products safely usually can receive vaccines produced using chicken eggs; those with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins should not receive such vaccines.⁴⁷⁵ (See Contraindications under Cautions.)

Prior to administration, review patient’s history with respect to possible hypersensitivity to vaccine components, including egg and egg products.⁹⁸ Epinephrine and other appropriate agents should be readily available in case anaphylaxis occurs.^{97 98 99}

Do not administer additional vaccine doses to any individual who experienced life-threatening reactions to a previous dose.^{97 98 99} (See Contraindications under Cautions.)

Neomycin and/or Polymyxin B Allergy

Influenza A (H1N1) 2009 vaccine inactivated manufactured by CSL: Contains trace amounts of neomycin sulfate (≤0.2 picograms) and polymyxin B (≤0.03 picograms).⁹⁹ Manufacturer states the vaccine is contraindicated in individuals hypersensitive to neomycin or polymyxin.⁹⁹

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Novartis: Contains neomycin sulfate (≤2.5 mcg) and polymyxin B (≤3.75 mcg).⁹⁸

Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis.⁴⁷⁵ ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with a history of anaphylactic reaction to neomycin, but may be considered in those with a history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks.^{112 475}

Thimerosal Allergy

All multiple-dose vials of influenza A (H1N1) 2009 vaccine inactivated contain thimerosal as a preservative;^{97 98 99} some preparations of the vaccine in prefilled syringes are preservative-free but contain trace amounts of thimerosal from the manufacturing process.⁹⁸ (See Thimerosal Precautions under Cautions.) Hypersensitivity reactions to thimerosal contained in vaccines have been reported in some individuals.^{100 140 427 498 500} These reactions usually manifest as local, delayed-type hypersensitivity reactions (e.g., erythema, swelling),^{100 140 427 475} but a generalized reaction manifested as pruritus and an erythematous, maculopapular rash on all 4 extremities has been reported rarely.⁵⁰⁰ Even when patch or intradermal tests for thimerosal sensitivity are positive, most individuals do not develop hypersensitivity reactions to thimerosal administered as a component of vaccines.^{100 140 475}

ACIP states that a history of delayed-type hypersensitivity to thimerosal is not a contraindication to use of vaccines that contain thimerosal.⁴⁷⁵

Ongoing Safety Review

Safety and adverse effects reported with parenteral inactivated influenza A (H1N1) 2009 vaccine are expected to be similar to those reported for seasonal parenteral inactivated influenza vaccines (e.g., mild fever, body aches, fatigue, soreness at injection site).⁵²⁸ However, as with any medical product, serious adverse events may occur.⁵²⁸

FDA and CDC are closely monitoring safety of influenza A (H1N1) 2009 vaccines through a collaborative effort between CDC, US Department of Health and Human Services (HHS), and other government agencies.⁵²⁸ Only limited data are available to date regarding adverse effects reported with influenza A (H1N1) 2009 vaccine.⁵²⁴ (See Common Adverse Effects.)

Guillain-Barré Syndrome

In 1976, a temporal association was noted between administration of A/New Jersey/76 (swine) influenza vaccine and Guillain-Barré syndrome (GBS, polyradiculoneuritis).^{97 98 99 100 278 279 364 365} The annual incidence of GBS is 10–20 cases per million in adults; the increased risk of GBS in individuals who received A/New Jersey/76 (swine) influenza vaccine was estimated to be 1 additional case of GBS per 100,000 vaccinees.^{100 192 275 276 277 278 279} Epidemiologic evidence indicates that the associated risk between administration of the A/New Jersey/76 (swine) influenza vaccine and GBS did not extend beyond 6 weeks after vaccination,¹⁹¹ and vaccinees who received the 1976 swine influenza vaccine have not been shown to exhibit an increased risk of GBS with subsequent vaccine formulations.²⁸⁰

Evidence for an increased risk of developing GBS with subsequent influenza vaccine formulations prepared from other virus strains is unclear;^{97 98 99 100 192 275 276 277 280} however, it is difficult to estimate precisely the risk for a condition as rare as GBS.^{100 192 275 276 277 280}

If influenza vaccine does pose a risk, the estimated risk for GBS probably is slightly more than 1 additional case per million vaccinees.^{97 98 99 100 152 364 365} ACIP states that there is no evidence that the case-fatality ratio for GBS differs among vaccinated and unvaccinated individuals.¹⁰⁰

Carefully consider possible benefits and potential risks of influenza A (H1N1) 2009 vaccine in individuals who experienced GBS within 6 weeks of previous influenza vaccination.^{97 98 99 441 463}

AAP states that influenza vaccines should not be used in children who developed GBS within 6 weeks after a dose of any influenza vaccine.⁴⁶⁵ ACIP states that benefits of influenza vaccine may outweigh risks in individuals with a history of GBS who are at high risk for severe influenza-related complications.¹⁰⁰ However, it may be prudent to avoid influenza vaccine in individuals who are not at high risk for severe influenza complications if they experienced GBS within 6 weeks after previous influenza vaccination.¹⁰⁰

Other Neurologic Effects

Neurologic disorders (not defined as GBS) have been temporally associated with seasonal inactivated influenza vaccine, including encephalopathy,^{97 98 99 103 143 441 463 473} encephalomyelitis,⁴⁴¹ neuralgia,^{99 143 473} optic neuritis/neuropathy,^{97 98 99 103 143 441 463 473} partial facial paralysis,^{97 98 99 103 143 441 463 473} Bell's palsy,^{97 98 103 143} neuritis or neuropathy,^{98 99 143 473} paresthesia,^{99 103 143 463 473} hypoesthesia,⁴⁶³ and brachial plexus neuropathy.^{97 98 99 103 143 203 204 205 206 207 208 441 463 473} Seizures^{97 98 103 143 463 473} and myelitis (including encephalomyelitis and transverse myelitis)^{97 98 99 103 143 473 358} also reported rarely with seasonal inactivated influenza vaccine.

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.⁵⁰⁸ Immunocompromised individuals may be at increased risk of severe infections and should be vaccinated against influenza A (H1N1) infection.⁵⁰⁸ Consider possibility that immune response to the vaccine may be reduced in these individuals.^{97 98 99}

In recommendations regarding seasonal influenza, CDC, National Institutes of Health (NIH), IDSA, AAP, and other experts state that HIV-infected children, adolescents, and adults should be vaccinated against influenza; however, parenteral inactivated influenza vaccine (not intranasal live vaccine) should be used in HIV-infected individuals.^{378 509} Studies using seasonal influenza virus vaccine inactivated indicate antibody response may be inversely correlated with severity of the disease.^{100 101 106 109 110 112 116 232 233 255 260 310 375 376 428} Although seasonal parenteral inactivated influenza vaccine has been highly effective in preventing symptomatic, laboratory-confirmed influenza infection in HIV-infected individuals with mean CD4⁺ T-cell counts of 400/mm³, the vaccine may be less effective in those with more advanced disease and lower CD4⁺ T-cell counts (e.g., <100/mm³).¹⁰⁰ A second dose of seasonal influenza vaccine does not appear to improve immune response in these individuals.¹⁰⁰

Individuals with a History of Influenza

May be administered to individuals who have had an influenza-like illness.^{531 533} The vaccine is not harmful in individuals who previously had diagnosed or undiagnosed influenza illness, including 2009 influenza A (H1N1) infection,^{531 533} and is not harmful in individuals who already have some existing immunity to the 2009 influenza A (H1N1) virus.⁵³³

If influenza A (H1N1) 2009 vaccine is indicated (see Uses), CDC recommends that the vaccine be administered even in individuals who have had an influenza-like illness previously, unless such individuals had a confirmed diagnosis of 2009 influenza A (H1N1) infection based on results of a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test for 2009 influenza A (H1N1) virus.^{531 533} Individuals who had an influenza-like illness and were tested using a less specific test (e.g., rapid antigen detection assay) should not assume they had 2009 influenza A (H1N1) infection, even if they became ill after being exposed to an individual with confirmed 2009 influenza A (H1N1) infection.⁵³³

Thimerosal Precautions

Although it was suggested that thimerosal in vaccines theoretically could have adverse effects in vaccine recipients, there is no conclusive evidence that the low levels of thimerosal contained in vaccines cause harm in vaccine recipients.^{100 475 492 493 494 499 501 502 503 504 505 506} A link between thimerosal in vaccines and neurodevelopmental disorders in children (autism, attention deficit/hyperactivity disorder [AHDH], speech or language delay) possibly related to mercury neurotoxicity has been theorized; however, considerable evidence has accumulated that supports the absence of substantial risk for neurodevelopmental disorders or other harm resulting from exposure to thimerosal-containing vaccines.^{100 493 494 499 501 502 503 504 505 506} In 2004, the Immunization Safety Review Committee of the Institute of Medicine (IOM) examined the hypothesis that thimerosal-containing vaccines are causally associated with autism and concluded that the body of epidemiologic evidence favors rejection of a causal relationship between these vaccines and autism.⁵⁰⁶

Analysis of adverse effects reported to the Vaccine Adverse Event Reporting System (VAERS) indicates that there is no difference in the incidence of injection site reactions, rash, or infections in infants 6–23 months of age who received preservative-containing (thimerosal-containing) seasonal inactivated influenza vaccine compared with those who received preservative-free preparations of the vaccine.^{100 497} To date, the only adverse effects known to be caused by thimerosal contained in vaccines are hypersensitivity reactions.^{100 140 427 475 493} (See Thimerosal Allergy under Cautions.)

USPHS, ACIP, AAP, American Association of Family Physicians (AAFP), and other experts state that use of vaccines that contain thimerosal is preferable to withholding vaccination since failure to provide protection against vaccine-preventable diseases may represent an immediate threat, especially in infants.^{100 401 402 403 465} ACIP states that benefits of influenza vaccination for all recommended groups (including pregnant women and young children) outweigh concerns related to theoretical risks of thimerosal exposure from vaccination with preparations containing thimerosal.¹⁰⁰ AAP states that the benefits of protecting children (including children at high risk with underlying CNS disorders) outweigh the hypothetical risks associated with the minute amounts of thimerosal contained in some currently available influenza vaccine preparations.⁴⁶⁵

Influenza A (H1N1) 2009 vaccine inactivated manufactured by CSL: Commercially available in 0.5-mL prefilled syringes as a preservative-free formulation (thimerosal not used in manufacturing process).⁹⁹ Also available in multiple-dose vials containing thimerosal as a preservative (24.5 mcg of mercury per 0.5-mL dose).⁹⁹

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Novartis: Commercially available in prefilled syringes in a preservative-free formulation containing only trace amounts of thimerosal from the manufacturing process (≤1 mcg of mercury per 0.5 mL).⁹⁸ Also available in multiple-dose vials containing thimerosal as a preservative (25 mcg of mercury per 0.5-mL dose).⁹⁸

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Sanofi Pasteur: Commercially available in 0.25- and 0.5-mL prefilled syringes and single-dose 0.5-mL vials as a preservative-free formulation (thimerosal not used in manufacturing process).⁹⁷ Also available in multiple-dose vials containing thimerosal as a preservative (25 mcg of mercury per 0.5-mL dose).⁹⁷

Limitations of Vaccine Effectiveness

Studies using seasonal influenza vaccines indicate up to 2 weeks may be required for protection to develop following influenza vaccination.¹⁰⁰ Preliminary studies using parenteral inactivated influenza A (H1N1) 2009 vaccine indicate an immune response can occur as early as 8–10 days after vaccination.⁵³⁰

May not protect all vaccine recipients against 2009 influenza A (H1N1) virus infection.^{97 98 99}

Does not provide protection against seasonal influenza A and B viruses;⁵⁰⁸ seasonal influenza vaccine for the 2009–2010 influenza season is indicated to provide protection against seasonal influenza.^{100 508 531}

Duration of Immunity

Studies using seasonal influenza vaccines indicate that immunity declines during the year after influenza vaccination.^{100 488} Data are not available to date regarding the duration of protection following vaccination with parenteral inactivated influenza A (H1N1) 2009 vaccine.

Concomitant Illness

Vaccination generally should be delayed in individuals with moderate to severe acute febrile illness until symptoms have subsided.^{100 475} ACIP states that minor acute illness (with or without fever), generally does not preclude vaccination.^{100 475}

Individuals with Bleeding Disorders

ACIP states that vaccines may be given IM to individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the preparation can be administered with reasonable safety.⁴⁷⁵ In these cases, use a fine needle (23 gauge) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.⁴⁷⁵ If patient is receiving antihemophilia therapy, administer the IM vaccine shortly after a scheduled dose of such therapy.⁴⁷⁵

Advise individual and/or their family about the risk of hematoma from IM injections.⁴⁷⁵

Improper Storage and Handling

Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.⁴⁷⁵

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.^{99 475 476}

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.^{99 475} (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.^{475 476}

Specific Populations

Pregnancy

Category C.^{97 98 99}

Manufacturers state that parenteral inactivated influenza A (H1N1) 2009 vaccine should be used in pregnant women only when clearly needed.^{97 98 99}

CDC, ACIP, American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), NIH, IDSA, and other experts state that parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) should be used for prevention of seasonal influenza in pregnant women.^{100 378 479 531}

Because pregnant women are at risk for influenza complications, CDC and ACIP recommend that pregnant women receive priority vaccination against 2009 influenza A (H1N1) virus infection, unless contraindicated.^{508 531} (See Uses.)

ACIP states that benefits of influenza vaccination for pregnant women outweigh theoretical risks from thimerosal exposure by vaccination with preparations containing thimerosal;¹⁰⁰ CDC states that pregnant women may receive influenza A (H1N1) 2009 vaccine with or without thimerosal.⁵³¹ (See Thimerosal Precautions under Cautions.)

Lactation

Safety and efficacy not established in breastfeeding mothers.^{97 98 99}

Not known whether parenteral inactivated influenza A (H1N1) vaccine is distributed into milk.^{97 98 99} Manufacturers recommend caution.^{97 98 99}

Inactivated vaccines do not affect safety of breastfeeding for lactating women or their infants.⁴⁷⁵ ACIP and CDC state that breastfeeding does not adversely affect immune response and is not a contraindication to vaccination.^{100 117 475}

Pediatric Use

Influenza A (H1N1) 2009 vaccine inactivated manufactured by CSL: Safety and efficacy not established in children <18 years of age.⁹⁹

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Novartis: Safety and efficacy not established in children <4 years of age.⁹⁸

Influenza A (H1N1) 2009 vaccine inactivated manufactured by Sanofi Pasteur: Safety and efficacy not established in infants <6 months of age.⁹⁷

ACIP states t