Cordarone

Generic Name: amiodarone (Oral route)

a-mee-OH-da-rone

Oral route(Tablet)

Amiodarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis). Liver injury is common, but is usually mild and evidenced only by abnormal liver enzymes. Overt liver disease can occur, however, and has been fatal in a few cases. Amiodarone can exacerbate the arrhythmia, e.g., by making the arrhythmia less well tolerated or more difficult to reverse. Patients with the indicated arrhythmias must be hospitalized while the loading dose is given, and a response generally requires at least one week, usually two or more .

Commonly used brand name(s)

In the U.S.

• Cordarone


• Pacerone

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiarrhythmic, Group III

Chemical Class: Benzofuran

Uses For Cordarone

Amiodarone is used to treat life-threatening heart rhythm problems called ventricular arrhythmias. This medicine is used in patients who have already been treated with other medicines that did not work.

Amiodarone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.

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

Before Using Cordarone

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 have not been performed on the relationship of age to the effects of amiodarone in the pediatric population. 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 amiodarone in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving amiodarone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 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.

• Bepridil


• Cisapride


• Dronedarone


• Grepafloxacin


• Indinavir


• Levomethadyl


• Mesoridazine


• Nelfinavir


• Pimozide


• Posaconazole


• Ritonavir


• Saquinavir


• Sparfloxacin


• Terfenadine


• Thioridazine


• Tipranavir


• Ziprasidone

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.

• Acebutolol


• Acecainide


• Alprenolol


• Amiodarone


• Amisulpride


• Amitriptyline


• Amlodipine


• Amoxapine


• Amprenavir


• Apomorphine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Atenolol


• Azimilide


• Azithromycin


• Betaxolol


• Bevantolol


• Bisoprolol


• Boceprevir


• Bretylium


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Darunavir


• Dasatinib


• Delavirdine


• Desipramine


• Dibenzepin


• Digoxin


• Dilevalol


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Eletriptan


• Enflurane


• Erythromycin


• Esmolol


• Etravirine


• Felodipine


• Fentanyl


• Fingolimod


• Flecainide


• Fluconazole


• Flunarizine


• Fluoxetine


• Fosamprenavir


• Foscarnet


• Gallopamil


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Ibutilide


• Iloperidone


• Imipramine


• Iohexol


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Labetalol


• Lacidipine


• Lapatinib


• Lercanidipine


• Levobunolol


• Levofloxacin


• Lidocaine


• Lidoflazine


• Lopinavir


• Loratadine


• Lorcainide


• Lovastatin


• Lumefantrine


• Manidipine


• Mefloquine


• Mepindolol


• Methadone


• Metipranolol


• Metoprolol


• Metronidazole


• Mibefradil


• Moricizine


• Moxifloxacin


• Nadolol


• Nebivolol


• Nicardipine


• Nifedipine


• Nilotinib


• Nilvadipine


• Nimodipine


• Nisoldipine


• Nitrendipine


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxprenolol


• Paliperidone


• Pazopanib


• Penbutolol


• Pentamidine


• Perflutren Lipid Microsphere


• Perhexiline


• Pindolol


• Pranidipine


• Prilocaine


• Probucol


• Prochlorperazine


• Promethazine


• Propafenone


• Propranolol


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Rifampin


• Risperidone


• Salmeterol


• Sematilide


• Sertindole


• Simvastatin


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• St John's Wort


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tacrolimus


• Talinolol


• Tedisamil


• Telaprevir


• Telithromycin


• Tertatolol


• Tetrabenazine


• Timolol


• Tizanidine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Vandetanib


• Vardenafil


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Warfarin


• Ziprasidone


• Zolmitriptan


• Zotepine

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.

• Abarelix


• Acenocoumarol


• Aprindine


• Cholestyramine


• Clonazepam


• Clopidogrel


• Cyclosporine


• Dicumarol


• Digitoxin


• Flecainide


• Fosphenytoin


• Methotrexate


• Nevirapine


• Phenytoin


• Procainamide


• Rifapentine


• Rosuvastatin


• Theophylline


• Tolterodine

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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:

• AV block (type of abnormal heart rhythm), with no pacemaker or


• Bradycardia (slow heartbeat) or


• Cardiogenic shock or


• Sick sinus syndrome (type of abnormal heart rhythm), with no pacemaker—Should not be used in patients with these conditions.

• Eye or vision problems or


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


• Heart rhythm problems (e.g., QT prolongation) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Hypotension (low blood pressure) or


• Lung disease or other breathing problems (e.g., interstitial pneumonitis) or


• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of amiodarone

This section provides information on the proper use of a number of products that contain amiodarone. It may not be specific to Cordarone. Please read with care.

You will receive your first dose of this medicine in a hospital. Your doctor will watch you closely after you take this medicine to make sure you do not have any serious side effects.

Take amiodarone exactly as directed by your doctor even though you may feel well. Do not take more medicine than your doctor ordered and do not miss any doses. It may take one or two weeks before your body responds to this medicine.

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

You may take this medicine with or without food, but take amiodarone the same way each time.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (tablets):
  
  • For ventricular arrhythmias:
    
    • Adults—At first, 800 to 1600 milligrams (mg) per day taken in divided doses. Your doctor may adjust your dose as needed and tolerated.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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 Cordarone

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you are having shortness of breath, chest tightness, wheezing, or any type of breathing problem while using this medicine.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are 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.

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).

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

You may need to carry a medical identification card or bracelet showing that you are taking this medicine. Ask your doctor about this.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Amiodarone increases the sensitivity of your skin to sunlight; too much sun exposure could cause a serious sunburn. Your skin may continue to be sensitive to sunlight for several months after treatment is stopped. Use a sunscreen when you are outdoors. Wear protective clothing and hats. Avoid sunlamps and tanning beds.

After you have taken this medicine for a long time, it may cause a blue-gray color to appear on your skin, especially in areas exposed to the sun, such as your face, neck, and arms. This color will usually fade after treatment with amiodarone has ended, although it may take several months. Check with your doctor if this color change occurs.

Grapefruits and grapefruit juice may increase the side effects from amiodarone by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

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 (e.g., St. John's wort) or vitamin supplements.

Cordarone 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:

More common

• Cough


• dizziness, lightheadedness, or fainting


• fever (slight)


• numbness or tingling in the fingers or toes


• painful breathing


• sensitivity of the skin to sunlight


• shortness of breath


• trembling or shaking of the hands


• trouble with walking


• unusual and uncontrolled movements of the body


• weakness of the arms or legs

Less common

• Blue-gray coloring of the skin on the face, neck, and arms


• blurred vision or blue-green halos seen around objects


• coldness


• dry eyes


• dry, puffy skin


• fast or irregular heartbeat


• nervousness


• pain and swelling in the scrotum


• sensitivity of the eyes to light


• sensitivity to heat


• slow heartbeat


• sweating


• swelling of the feet or lower legs


• trouble with sleeping


• unusual tiredness


• weight gain or loss

Rare

• Skin rash


• yellow eyes or skin

Incidence not known

• Abdominal or stomach pain


• agitation


• back, leg, or stomach pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine


• bloody, black, or tarry stools


• blue lips, fingernails, or skin


• blurred or double vision


• chest pain


• chills


• clay-colored stools


• coma


• confusion


• confusion as to time, place, or person


• coughing or spitting up blood


• cracks in the skin


• dark urine


• decreased urine output


• depression


• diarrhea


• difficult or labored breathing


• difficult urination


• dry cough


• eye pain


• fast heartbeat


• fatigue


• general body swelling


• high fever


• holding false beliefs that cannot be change by fact


• hostility


• inability to have or keep an erection


• indigestion


• irregular, fast or slow, or shallow breathing


• irritability


• itching


• joint or muscle pain


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


• lethargy


• loss in sexual ability, desire, drive, or performance


• loss of heat from the body


• lower back or side pain


• mood or mental change


• muscle cramps or spasms


• muscle pain or stiffness


• muscle twitching


• no breathing


• noisy breathing


• nosebleeds


• pain in the abdomen, groin, or scrotum


• pain or burning with urination


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on the skin


• rapid weight gain


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


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


• seizures


• severe headache


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips or in mouth


• stupor


• swelling of the face, ankles, or hands


• swelling of the scrotum


• swollen or painful glands


• tightness in the chest


• troubled breathing


• unpleasant breath odor


• unusual bleeding or bruising


• unusual excitement, nervousness, or restlessness


• unusual tiredness or weakness


• vomiting of blood


• wheezing

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

• Constipation


• headache


• loss of appetite


• nausea and vomiting

Less common

• Bitter or metallic taste


• decrease in sexual interest


• decreased sexual ability in males


• dizziness


• flushing of the face

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: Cordarone side effects (in more detail)

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More Cordarone resources

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

• Cordarone Prescribing Information (FDA)


• Cordarone MedFacts Consumer Leaflet (Wolters Kluwer)


• Amiodarone Prescribing Information (FDA)


• Amiodarone Professional Patient Advice (Wolters Kluwer)


• Amiodarone Hydrochloride Monograph (AHFS DI)


• Nexterone Prescribing Information (FDA)


• Nexterone Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Nexterone Consumer Overview


• Pacerone Prescribing Information (FDA)

Compare Cordarone with other medications

• Arrhythmia
• Supraventricular Tachycardia
• Ventricular Fibrillation
• Ventricular Tachycardia

Pentacel

Dosage Form: injection
FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday).

2. DOSAGE AND ADMINISTRATION

. Immunization Series

Pentacel vaccine is to be administered as a 4 dose series at 2, 4, 6 and 15-18 months of age. The first dose may be given as early as 6 weeks of age. Four doses of Pentacel vaccine constitute a primary immunization course against pertussis. Three doses of Pentacel vaccine constitute a primary immunization course against diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis; the fourth dose is a booster for diphtheria, tetanus, H influenzae type b invasive disease, and poliomyelitis immunizations. [See 14 Clinical Studies (14.1, 14.2, 14.3, 14.4, 14.5).]

Mixed Sequences of Pentacel Vaccine and DTaP Vaccine

While Pentacel and DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed [DTaP], Sanofi Pasteur Limited) vaccines contain the same pertussis antigens, manufactured by the same process, Pentacel vaccine contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as DAPTACEL vaccine. Pentacel vaccine may be used to complete the first 4 doses of the 5-dose DTaP series in infants and children who have received 1 or more doses of DAPTACEL vaccine and are also scheduled to receive the other antigens of Pentacel vaccine. Children who have completed a 4-dose series with Pentacel vaccine should receive a fifth dose of DTaP vaccine using DAPTACEL at 4-6 years of age. However, data are not available on the safety and immunogenicity of mixed sequences of Pentacel vaccine and DAPTACEL vaccine for successive doses of the DTaP series.

Data are not available on the safety and immunogenicity of using mixed sequences of Pentacel vaccine and DTaP vaccine from different manufacturers.

Mixed Sequences of Pentacel Vaccine and IPV Vaccine

Pentacel vaccine may be used in infants and children who have received 1 or more doses of another licensed IPV vaccine and are scheduled to receive the antigens of Pentacel vaccine. However, data are not available on the safety and immunogenicity of Pentacel vaccine in such infants and children.

The Advisory Committee on Immunization Practices (ACIP) recommends that the final dose in the 4-dose IPV series be administered at age ≥4 years. (1) When Pentacel vaccine is administered at ages 2, 4, 6, and 15-18 months, an additional booster dose of IPV vaccine should be administered at age 4-6 years, resulting in a 5-dose IPV series. (1)

Mixed Sequences of Pentacel Vaccine and Haemophilus b Conjugate Vaccine

Pentacel vaccine may be used to complete the vaccination series in infants and children previously vaccinated with one or more doses of Haemophilus b Conjugate Vaccine (either separately administered or as part of another combination vaccine), who are also scheduled to receive the other antigens of Pentacel vaccine. However, data are not available on the safety and immunogenicity of Pentacel vaccine in such infants and children. If different brands of Haemophilus b Conjugate Vaccines are administered to complete the series, three primary immunizing doses are needed, followed by a booster dose.

. Administration

Just before use, thoroughly but gently shake the vial of DTaP-IPV component, withdraw the entire liquid content and inject into the vial of the lyophilized ActHIB vaccine component. Shake the vial now containing Pentacel vaccine thoroughly until a cloudy, uniform, white to off-white (yellow tinge) suspension results. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If these conditions exist, Pentacel vaccine should not be administered.

Withdraw and administer a 0.5 mL dose of Pentacel vaccine intramuscularly. Pentacel vaccine should be used immediately after reconstitution. Refer to Figures 1, 2, 3, 4 and 5.

Pentacel Vaccine: Instructions For Reconstitution of ActHIB Vaccine Component With DTaP-IPV Component

In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Pentacel vaccine should not be mixed in the same syringe with other parenteral products.

3. DOSAGE FORMS AND STRENGTHS

Pentacel vaccine is a suspension for injection (0.5-mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single dose vials. [See Dosage and Administration (2.2) and How Supplied/Storage and Handling (16).]

4. CONTRAINDICATIONS

. Hypersensitivity

A severe allergic reaction (eg, anaphylaxis) after a previous dose of Pentacel vaccine or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or H influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of Pentacel vaccine. [See Description (11).]

. Encephalopathy

Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including Pentacel vaccine.

. Progressive Neurologic Disorder

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine including Pentacel vaccine. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

5. WARNINGS AND PRECAUTIONS

. Management of Acute Allergic Reactions

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

. Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events occur within the specified period after administration of a pertussis vaccine, the decision to administer Pentacel vaccine should be based on careful consideration of potential benefits and possible risks.

• Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.


• Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours.


• Persistent, inconsolable crying lasting ≥3 hours within 48 hours.


• Seizures with or without fever within 3 days.

. Guillain-Barré Syndrome and Brachial Neuritis

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (2) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give Pentacel vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

. Infants and Children with a History of Previous Seizures

For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing acellular pertussis antigens (including Pentacel vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever.

. Limitations of Vaccine Effectiveness

Vaccination with Pentacel vaccine may not protect all individuals.

. Altered Immunocompetence

If Pentacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Drug Interactions (7.2).]

6. ADVERSE REACTIONS

. Data from Clinical Studies

Rates of adverse reactions varied by dose number. The most frequent (>50% of participants) systemic reactions following any dose were fussiness/irritability and inconsolable crying. The most frequent (>30% of participants) injection site reactions following any dose were tenderness and increased circumference of the injected arm.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

The safety of Pentacel vaccine was evaluated in four clinical studies in which a total of 5,980 participants received at least one dose of Pentacel vaccine. In three of the studies, conducted in the US, a total of 4,198 participants were enrolled to receive four consecutive doses of Pentacel vaccine. In the fourth study, conducted in Canada, 1,782 participants previously vaccinated with three doses of Pentacel vaccine received a fourth dose. The vaccination schedules of Pentacel vaccine, Control vaccines, and concomitantly administered vaccines used in these studies are provided in Table 1.

Across the four studies, 50.8% of participants were female. Among participants in the three US studies, 64.5% were Caucasian, 9.2% were Black, 12.9% were Hispanic, 3.9% were Asian, and 9.5% were of other racial/ethnic groups. In the two controlled studies, the racial/ethnic distribution of participants who received Pentacel and Control vaccines was similar. In the Canadian fourth dose study, 86.0% of participants were Caucasian, 1.9% were Black, 0.8% were Hispanic, 4.3% were Asian, 2.0% were East Indian, 0.5% were Native Indian, and 4.5% were of other racial/ethnic groups.

Table 1: Clinical Safety Studies of Pentacel Vaccine: Vaccination Schedules

Study	Pentacel	Control Vaccines	Concomitantly Administered Vaccines
HCPDT: non-US licensed DTaP vaccine that is identical to the DTaP component of Pentacel vaccine. POLIOVAX: US licensed Poliovirus Vaccine Inactivated, Sanofi Pasteur Limited. IPOL: US licensed Poliovirus Vaccine Inactivated, Sanofi Pasteur SA.
* PCV7 manufactured by Wyeth Laboratories. † PCV7 was introduced after the study was initiated, and thus, administered concomitantly with Pentacel vaccine in a subset of participants. ‡ The first dose of hepatitis B vaccine (manufacturer not specified) was administered prior to study initiation, from birth to 21 days of age. Subsequent doses were with hepatitis B vaccine manufactured by Merck and Co. § MMR and varicella vaccines were both manufactured by Merck and Co. ¶ Study participants previously had received three doses of Pentacel vaccine by 8 months of age.
494-01	2, 4, 6 and 15 months	HCPDT + POLIOVAX + ActHIB at 2, 4, 6, and 15 months	7-valent pneumococcal conjugate vaccine* (PCV7) at 2, 4, and 6 months in a subset of participants†   Hepatitis B vaccine at 2 and 6 months‡
P3T06	2, 4, 6, and 15-16 months	DAPTACEL + IPOL + ActHIB at 2, 4, and 6 months; and DAPTACEL + ActHIB at 15-16 months	PCV7* at 2, 4, and 6 months   Hepatitis B vaccine at 2 and 6 months‡
494-03	2, 4, 6, and 15-16 months	None	PCV7* at 2, 4, and 6 months in all participants; and at 15 months in a random subset of participants   Hepatitis B vaccine at 2 and 6 months (if a dose was previously administered)‡ or at 2, 4, and 6 months (if no previous dose)   Measles, mumps, rubella vaccine§ (MMR) and varicella§ vaccine at 12 or 15 months in random subsets of participants
5A9908	15-18 months¶	None	None

Solicited Adverse Reactions

The incidence and severity of selected solicited injection site and systemic adverse reactions that occurred within 3 days following each dose of Pentacel or Control vaccines in Study P3T06 is shown in Table 2. Information on these reactions was recorded daily by parents or guardians on diary cards. In Table 2, injection site reactions are reported for the Pentacel vaccine and DAPTACEL vaccine injection sites.

Table 2: Number (Percentage) of Children with Selected Solicited Adverse Reactions by Severity Occurring within 0-3 days of Pentacel Vaccine or Control Vaccines in Study P3T06

* Any: Mild, Moderate or Severe; Mild: subject whimpers when site is touched; Moderate: subject cries when site is touched; Severe: subject cries when leg or arm is moved. † Fever is based upon actual temperatures recorded with no adjustments to the measurement route. ‡ Following Doses 1-3 combined, the proportion of temperature measurements that were taken by axillary, rectal or other routes, or not recorded were 46.0%, 53.0%, 1.0%, and 0% respectively, for Pentacel vaccine and 44.8%, 54.0%, 1.0%, and 0.1%, respectively, for DAPTACEL + IPOL + ActHIB vaccines. Following Dose 4, the proportion of temperature measurements that were taken by axillary, rectal or other routes, or not recorded were 62.7%, 34.4%, 2.4% and 0.5%, respectively, for Pentacel vaccine, and 61.1%, 36.6%, 1.7% and 0.5%, respectively, for DAPTACEL + ActHIB vaccines. § Moderate: interferes with or limits usual daily activity; Severe: disabling, not interested in usual daily activity.
Injection Site Reactions	Pentacel Vaccine				DAPTACEL Vaccine
	Dose 1 N = 465-467 %	Dose 2 N = 451 %	Dose 3 N = 438-440 %	Dose 4 N = 387-396 %	Dose 1 N = 1,400-1,404 %	Dose 2 N = 1,358-1,359 %	Dose 3 N = 1,311-1,312 %	Dose 4 N = 376-380 %
Redness
>5 mm	7.1	8.4	8.7	17.3	6.2	7.1	9.6	16.4
>25 mm	2.8	1.8	1.8	9.2	1.0	0.6	1.9	7.9
>50 mm	0.6	0.2	0.0	2.3	0.4	0.1	0.0	2.4
Swelling
>5 mm	7.5	7.3	5.0	9.7	4.0	4.0	6.5	10.3
>25 mm	3.0	2.0	1.6	3.8	1.6	0.7	1.1	4.0
>50 mm	0.9	0.0	0.0	0.8	0.4	0.1	0.1	1.3
Tenderness*
Any	47.5	39.2	42.7	56.1	48.8	38.2	40.9	51.1
Moderate or Severe	19.6	10.6	11.6	16.7	20.7	12.2	12.3	15.8
Severe	5.4	1.6	1.4	3.3	4.1	2.3	1.7	2.4
Increase in Arm Circumference
>5 mm				33.6				30.6
>20 mm	–	–	–	4.7	–	–	–	6.9
>40 mm				0.5				0.8
Systemic Reactions	Pentacel Vaccine				DAPTACEL + IPOL + ActHIB Vaccines			DAPTACEL + ActHIB Vaccines
	Dose 1 N = 466-467 %	Dose 2 N = 451-452 %	Dose 3 N = 435-440 %	Dose 4 N = 389-398 %	Dose 1 N = 1,390-1,406 %	Dose 2 N = 1,346-1,360 %	Dose 3 N = 1,301-1,312 %	Dose 4 N = 379-381 %
Fever†‡
≥38.0°C	5.8	10.9	16.3	13.4	9.3	16.1	15.8	8.7
>38.5°C	1.3	2.4	4.4	5.1	1.6	4.3	5.1	3.2
>39.5°C	0.4	0.0	0.7	0.3	0.1	0.4	0.3	0.8
Decreased Activity/Lethargy§
Any	45.8	32.7	32.5	24.1	51.1	37.4	33.2	24.1
Moderate or Severe	22.9	12.4	12.7	9.8	24.3	15.8	12.7	9.2
Severe	2.1	0.7	0.2	2.5	1.2	1.4	0.6	0.3
Inconsolable Crying
Any	59.3	49.8	47.3	35.9	58.5	51.4	47.9	36.2
≥1 hour	19.7	10.6	13.6	11.8	16.4	16.0	12.2	10.5
>3 hours	1.9	0.9	1.1	2.3	2.2	3.4	1.4	1.8
Fussiness/Irritability
Any	76.9	71.2	68.0	53.5	75.8	70.7	67.1	53.8
≥1 hour	34.5	27.0	26.4	23.6	33.3	30.5	26.2	19.4
>3 hours	4.3	4.0	5.0	5.3	5.6	5.5	4.3	4.5

Hypotonic Hyporesponsive Episodes

In Study P3T06, the diary cards included questions pertaining to HHEs. In Studies 494-01, 494-03, and 5A9908, a question about the occurrence of fainting or change in mental status was asked during post-vaccination phone calls. Across these 4 studies, no HHEs, as defined in a report of a US Public Health Service workshop (3) were reported among participants who received Pentacel vaccine (N = 5,979), separately administered HCPDT + POLIOVAX + ActHIB vaccines (N = 1,032) or separately administered DAPTACEL + IPOL + ActHIB vaccines (N = 1,455). Hypotonia not fulfilling HHE criteria within 7 days following vaccination was reported in 4 participants after the administration of Pentacel vaccine (1 on the same day as the 1st dose; 3 on the same day as the 3rd dose) and in 1 participant after the administration of DAPTACEL + IPOL + ActHIB vaccines (4 days following the 1st dose).

Seizures

Across Studies 494-01, 494-03, 5A9908 and P3T06, a total of 8 participants experienced a seizure within 7 days following either Pentacel vaccine (4 participants; N = 4,197 for at least one of Doses 1-3; N = 5,033 for Dose 4), separately administered HCPDT + POLIOVAX + ActHIB vaccines (3 participants; N = 1,032 for at least one of Doses 1-3, N = 739 for Dose 4), separately administered DAPTACEL + IPOL + ActHIB vaccines (1 participant; N = 1,455 for at least one of Doses 1-3), or separately administered DAPTACEL + ActHIB vaccines (0 participants; N = 418 for Dose 4). Among the four participants who experienced a seizure within 7 days following Pentacel vaccine, one participant in Study 494-01 had an afebrile seizure 6 days after the first dose, one participant in Study 494-01 had a possible seizure the same day as the third dose, and two participants in Study 5A9908 had a febrile seizure 2 and 4 days, respectively, after the fourth dose. Among the four participants who experienced a seizure within 7 days following Control vaccines, one participant had an afebrile seizure the same day as the first dose of DAPTACEL + IPOL + ActHIB vaccines, one participant had an afebrile seizure the same day as the second dose of HCPDT + POLIOVAX + ActHIB vaccines, and two participants had a febrile seizure 6 and 7 days, respectively, after the fourth dose of HCPDT + POLIOVAX + ActHIB vaccines.

Serious Adverse Events

In Study P3T06, within 30 days following any of Doses 1-3 of Pentacel or Control vaccines, 19 of 484 (3.9%) participants who received Pentacel vaccine and 50 of 1,455 (3.4%) participants who received DAPTACEL + IPOL + ActHIB vaccines experienced a serious adverse event. Within 30 days following Dose 4 of Pentacel or Control vaccines, 5 of 431 (1.2%) participants who received Pentacel vaccine and 4 of 418 (1.0%) participants who received DAPTACEL + ActHIB vaccines experienced a serious adverse event. In Study 494-01, within 30 days following any of Doses 1-3 of Pentacel or Control vaccines, 23 of 2,506 (0.9%) participants who received Pentacel vaccine and 11 of 1,032 (1.1%) participants who received HCPDT + POLIOVAX + ActHIB vaccines experienced a serious adverse event. Within 30 days following Dose 4 of Pentacel or Control vaccines, 6 of 1,862 (0.3%) participants who received Pentacel vaccine and 2 of 739 (0.3%) participants who received HCPDT + POLIOVAX + ActHIB vaccines experienced a serious adverse event.

Across Studies 494-01, 494-03 and P3T06, within 30 days following any of Doses 1-3 of Pentacel or Control vaccines, overall, the most frequently reported serious adverse events were bronchiolitis, dehydration, pneumonia and gastroenteritis. Across Studies 494-01, 494-03, 5A9908 and P3T06, within 30 days following Dose 4 of Pentacel or Control vaccines, overall, the most frequently reported serious adverse events were dehydration, gastroenteritis, asthma, and pneumonia.

Across Studies 494-01, 494-03, 5A9908 and P3T06, two cases of encephalopathy were reported, both in participants who had received Pentacel vaccine (N = 5,979). One case occurred 30 days post-vaccination and was secondary to cardiac arrest following cardiac surgery. One infant who had onset of neurologic symptoms 8 days post-vaccination was subsequently found to have structural cerebral abnormalities and was diagnosed with congenital encephalopathy.

A total of 5 deaths occurred during Studies 494-01, 494-03, 5A9908 and P3T06: 4 in children who had received Pentacel vaccine (N = 5,979) and one in a participant who had received DAPTACEL + IPOL + ActHIB vaccines (N = 1,455). There were no deaths reported in children who received HCPDT + POLIOVAX + ActHIB vaccines (N = 1,032). Causes of death among children who received Pentacel vaccine were asphyxia due to suffocation, head trauma, Sudden Infant Death syndrome, and neuroblastoma (8, 23, 52 and 256 days post-vaccination, respectively). One participant with ependymoma died secondary to aspiration 222 days following DAPTACEL + IPOL + ActHIB vaccines.

. Data from Post-Marketing Experience

The following additional adverse events have been spontaneously reported during the post-marketing use of Pentacel vaccine worldwide, since 1997. Between 1997 and 2007, Pentacel vaccine was primarily used in Canada. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Pentacel vaccine.

• Cardiac disorders
  
  Cyanosis


• Gastrointestinal disorders
  
  Vomiting, diarrhea


• General disorders and administration site conditions
  
  Injection site reactions (including inflammation, mass, abscess and sterile abscess), extensive swelling of the injected limb (including swelling that involved adjacent joints), vaccination failure/therapeutic response decreased (invasive H influenzae type b disease)


• Immune system disorders
  
  Hypersensitivity (such as rash and urticaria)


• Infections and infestations
  
  Meningitis, rhinitis, viral infection


• Metabolism and nutrition disorders
  
  Decreased appetite


• Nervous system disorders
  
  Somnolence, HHE, depressed level of consciousness


• Psychiatric disorders
  
  Screaming


• Respiratory, thoracic and mediastinal disorders
  
  Apnea, cough


• Skin and subcutaneous tissue disorders
  
  Erythema, skin discoloration


• Vascular disorders
  
  Pallor

7. DRUG INTERACTIONS

. Concomitant Administration with Other Vaccines

In clinical trials, Pentacel vaccine was administered concomitantly with one or more of the following US licensed vaccines: hepatitis B vaccine, 7-valent pneumococcal conjugate vaccine, MMR and varicella vaccines. [See Adverse Reactions (6) and Clinical Studies (14).] When Pentacel vaccine is given at the same time as another injectable vaccine(s), the vaccine(s) should be administered with different syringes and at different injection sites.

. Immunosuppressive Treatments

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to Pentacel vaccine. [See Warnings and Precautions (5.6).]

. Drug/Laboratory Test Interactions

Antigenuria has been detected in some instances following receipt of ActHIB vaccine. Urine antigen detection may not have definite diagnostic value in suspected H influenzae type b disease within one week following receipt of Pentacel vaccine. (4)

8. USE IN SPECIFIC POPULATIONS

. Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Pentacel vaccine. It is also not known whether Pentacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

. Pediatric Use

The safety and effectiveness of Pentacel vaccine was established in the age group 6 weeks through 18 months on the basis of clinical studies. [See Adverse Reactions (6.1) and Clinical Studies (14).] The safety and effectiveness of Pentacel vaccine in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. The safety and effectiveness of Pentacel vaccine in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.

11. DESCRIPTION

Pentacel vaccine consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component combined through reconstitution for intramuscular injection. ActHIB vaccine (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), consists of H influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) covalently bound to tetanus toxoid (PRP-T). The DTaP-IPV component is supplied as a sterile liquid used to reconstitute the lyophilized ActHIB vaccine component to form Pentacel vaccine. Pentacel vaccine is a uniform, cloudy, white to off-white (yellow tinge) suspension.

Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)] and 10 mcg PRP of H influenzae type b covalently bound to 24 mcg of tetanus toxoid (PRP-T).

Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, polysorbate 80 (approximately 10 ppm by calculation), ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde, ≤50 ng residual bovine serum albumin, 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative), <4 pg of neomycin and <4 pg polymyxin B sulfate.

Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (5) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered.

Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (6) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (7) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate.

Poliovirus Type 1, Type 2 and Type 3 are each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells, by the microcarrier method. (8) (9) The cells are grown in CMRL (Connaught Medical Research Laboratories) 1969 medium, supplemented with calf serum. For viral growth, the culture medium is replaced by Medium 199, without calf serum. After clarification and filtration, the viral suspensions are concentrated by ultrafiltration, and purified by liquid chromatography steps. The monovalent viral suspensions are inactivated with formaldehyde. Monovalent concentrates of each inactivated poliovirus are combined to produce a trivalent poliovirus concentrate.

The adsorbed diphtheria, tetanus and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection, into an intermediate concentrate. The trivalent poliovirus concentrate is added and the DTaP-IPV component is diluted to its final concentration. The DTaP-IPV component does not contain a preservative.

Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL in the guinea pig potency test. The potency of the acellular pertussis antigens is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA). The immunogenicity of the inactivated polioviruses is evaluated by the antibody response in monkeys measured by virus neutralization.

PRP, a high molecular weight polymer, is prepared from the Haemophilus influenzae type b strain 1482 grown in a semi-synthetic medium. (10) The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. (11) The toxoid is filter sterilized prior to the conjugation process. The ActHIB vaccine component does not contain a preservative. Potency of the ActHIB vaccine component is specified on each lot by limits on the content of PRP polysaccharide and protein per dose and the proportion of polysaccharide and protein that is characterized as high molecular weight conjugate.

The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel vaccine do not contain natural latex rubber.

12. CLINICAL PHARMACOLOGY

. Mechanism of Action

Diphtheria

Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (12) Levels of 1.0 IU/mL have been associated with long-term protection. (13)

Tetanus

Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (12) (14) A tetanus antitoxoid level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of Pentacel vaccine is considered protective.

Pertussis

Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.

Poliomyelitis

Polioviruses, of which there are three serotypes (Types 1, 2, and 3) are enteroviruses. The presence of poliovirus type-specific neutralizing antibodies has been correlated with protection against poliomyelitis. (15)

Invasive Disease Due to H influenzae Type b

H influenzae type b can cause invasive disease such as meningitis and sepsis. Anti-PRP antibody has been shown to correlate with protection against invasive disease due to H influenzae type b.

Based on data from passive antibody studies (16) and an efficacy study with H influenzae type b polysaccharide vaccine in Finland, (17) a post-vaccination anti-PRP level of 0.15 mcg/mL has been accepted as a minimal protective level. Data from an efficacy study with H influenzae type

Pediarix

Generic Name: diphtheria, tetanus, acellular pertussis, hepatitis b, and polio vaccine (Intramuscular route)

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-n-us TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, hep-a-TYE-tis B VAX-een re-KOM-bin-ant, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated

Commonly used brand name(s)

In the U.S.

• Pediarix

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

Uses For Pediarix

Diphtheria and tetanus toxoids and pertussis vaccine (also known as DTP vaccine) combined with hepatitis B and poliovirus vaccine (also known as HepB and IPV) is a combination immunizing agent used to prevent illness caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is given only to infants and children who are 6 weeks to 6 years of age, and is given before the child’s 7th birthday.

This vaccine combines five agents into one vaccine. In order to complete the series, you must get three injections of this vaccine at separate intervals. Because there are many different diseases you will need to be vaccinated against, make sure to follow your doctor's directions about your vaccination schedule.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications is greater in very young children and the elderly.

Tetanus (also known as lockjaw) is a very serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30% to 40% of cases. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis can also cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Hepatitis B infection is a major cause of serious liver diseases, including liver cancer. You get hepatitis B by being exposed to someone else's body fluids. Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease. People who have the virus can give it to others without them knowing it.

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This vaccine is to be administered only by or under the direct supervision of your doctor.

Before Using Pediarix

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, 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 have not been performed on the relationship of age to the effects of this vaccine in infants younger than 6 weeks of age and children 7 years of age and older. Safety and efficacy have not been established.

Geriatric

This vaccine is not recommended for use in adult patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Encephalopathy (a brain disease), history of after a vaccine with pertussis—Should not be used in patients with this condition.

• Fever, high or


• Moderate or severe illness, with or without fever—This vaccine may make these conditions worse or may increase the chance of side effects.

• Guillain-Barre syndrome (nerve disease that causes paralysis), history of—If your child had this condition after getting a vaccine with tetanus in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine.

• Immunodeficiency disorder—If you have an immune system disorder, this vaccine may not work well for you.

• Previous side effects, history of after a vaccine with pertussis—If your child has had certain side effects to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that is 105 degrees F or higher.

• Progressive neurologic disorders—This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). This vaccine should not be given until these conditions are under control.

Proper Use of Pediarix

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child’s muscles, usually in the shoulder muscle or thighs.

This vaccine is usually given as three shots. The first dose may be given as early as 6 weeks of age. You will need another dose at 4 and 6 months after the first dose, unless your doctor tells you otherwise.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, such as fever and soreness.

It is important that your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Precautions While Using Pediarix

It is very important that your child return to your doctor's office for the second and third dose of this vaccine. Be sure to notify your doctor or clinic of any side effects that may occur after your child has received the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your child's doctor right away.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

Make sure your doctor knows if your child is allergic to latex rubber. One of the prefilled syringes for this vaccine contains dry natural latex rubber. This may cause an allergic reaction in children who are sensitive to latex.

This vaccine may cause apnea (breathing problem) in some premature infants. The doctor will decide if your child should receive this vaccine.

This vaccine will not treat an active infection. If your child have a diphtheria, tetanus, pertussis, hepatitis B, or polio infection, you will need medicine to treat the infection.

Be sure to tell your child’s doctor about any serious side effects that occur after your child receives the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Pediarix Side Effects

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

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

Incidence not known

• Abdominal or stomach pain


• agitation


• back pain


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• bluish color of the fingernails, lips, skin, palms, or nail beds


• blurred vision


• chills


• clay colored stools


• collapse or shock-like state


• coma


• confusion


• cough


• dark urine


• diarrhea


• difficulty with swallowing


• dizziness


• drowsiness


• fast heartbeat


• fever


• hallucinations


• headache


• heavier menstrual periods


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


• hoarseness


• irritability


• irritation


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


• itching


• joint pain


• loosening of the skin


• mood or mental changes


• nausea


• pain or cramping in the abdomen or stomach


• pinpoint red spots on the skin


• redness of the skin


• red, irritated eyes


• seizures


• shortness of breath


• skin rash


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• stiff neck


• stiffness or swelling


• Sudden Infant Death Syndrome (SIDS)


• swelling


• tightness in the chest


• troubled breathing


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting or vomiting of blood


• weight loss


• wheezing


• yellow eyes or skin

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

• Bleeding


• blistering


• burning


• coldness


• discoloration of the skin


• fussiness


• feeling of pressure


• infection


• inflammation


• lumps


• numbness


• pain


• restlessness


• scarring


• sleeping more than usual


• soreness


• stinging


• tenderness


• tingling


• ulceration


• unusual cry


• warmth on the skin

Incidence not known

• Arm or leg swelling


• difficulty with moving


• dullness, tiredness, weakness, or feeling of sluggishness


• feeling of warmth


• general feeling of discomfort or illness


• hair loss


• itching skin


• lack or loss of strength


• loss of appetite


• loss of strength or energy


• muscle pain, weakness, or stiffness


• pain in the joints


• paleness of the skin


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


• sneezing


• sores, ulcers, or white spots in the mouth or on the lips


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• thinning of the hair

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: Pediarix 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pediarix resources

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

• Pediarix Prescribing Information (FDA)


• Pediarix MedFacts Consumer Leaflet (Wolters Kluwer)


• Pediarix Consumer Overview

Compare Pediarix with other medications

• Diphtheria Prophylaxis
• Haemophilus influenzae Prophylaxis
• Hepatitis B Prevention
• Pertussis Prophylaxis
• Poliomyelitis Prophylaxis
• Tetanus Prophylaxis

Metagonimus yokogawai, Intestinal Fluke Medications

Drugs associated with Metagonimus yokogawai, Intestinal Fluke

The following drugs and medications are in some way related to, or used in the treatment of Metagonimus yokogawai, Intestinal Fluke. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Biltricide

Epifoam Foam

Pronunciation: hye-droe-KOR-ti-sone ASS-eh-tate/pra-MOX-een
Generic Name: Hydrocortisone Acetate/Pramoxine
Brand Name: Epifoam

Epifoam Foam is used for:

Treating inflammation and itching of the skin due to certain skin conditions.

Epifoam Foam is a combination topical corticosteroid and local anesthetic. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not exactly understood. It also decreases pain in the affected area.

Do NOT use Epifoam Foam if:

• you are allergic to any ingredient in Epifoam Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Epifoam Foam:

Some medical conditions may interact with Epifoam Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin in the affected area


• if you have a parasitic, bacterial, fungal, or viral infection; diabetes; measles; tuberculosis (TB); a positive TB skin test; chickenpox; shingles; herpes infection of the eye; kidney problems; or you have received a recent vaccination


• if you have a history of congestive heart failure or heart attack

Some MEDICINES MAY INTERACT with Epifoam Foam. Because little, if any, of Epifoam Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Epifoam Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Epifoam Foam:

Use Epifoam Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Epifoam Foam is for external use only.


• Shake well for 5 to 10 seconds before each use.


• Prime the container before the first use as directed. It usually requires several pumps for foam to appear.


• Apply a small amount to the affected areas as directed by your doctor.


• Rinse the container and cap with warm water after each use.


• If you miss a dose of Epifoam Foam, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Epifoam Foam.

Important safety information:

• Avoid getting Epifoam Foam in your eyes. If you get Epifoam Foam in your eyes, immediately flush them with cool tap water.


• Check with your doctor before having vaccinations while you are using Epifoam Foam.


• The contents of this can are under pressure. Do not burn or puncture the container even if it appears to be empty.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Epifoam Foam.


• Caution is advised when using Epifoam Foam in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epifoam Foam while you are pregnant. It is not known if Epifoam Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Epifoam Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Epifoam Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry skin; itching.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; rectal pain, burning, cracking, itching, bleeding, peeling, or irritation not present before using Epifoam Foam; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Epifoam side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face. Epifoam Foam may be harmful if swallowed.

Proper storage of Epifoam Foam:

Store Epifoam Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in an upright position. Store away from heat, moisture, and light. Do not refrigerate. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120 degrees F (49 degrees C). Do not store in the bathroom. Keep Epifoam Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Epifoam Foam, please talk with your doctor, pharmacist, or other health care provider.


• Epifoam Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Epifoam Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Epifoam resources

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

Compare Epifoam with other medications

• Dermatitis
• Dermatological Disorders
• Hemorrhoids
• Psoriasis

Trusopt

Generic Name: dorzolamide ophthalmic (dor ZOL a mide)

Brand Names: Trusopt

What is Trusopt (dorzolamide ophthalmic)?

Dorzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Dorzolamide ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Dorzolamide ophthalmic may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Trusopt (dorzolamide ophthalmic)?

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using dorzolamide ophthalmic. Do not use the medications at the same time.

Dorzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

What should I discuss with my healthcare provider before using Trusopt (dorzolamide ophthalmic)?

You should not use this medication if you are allergic to dorzolamide (Trusopt or Cosopt).

To make sure you can safely use dorzolamide ophthalmic, tell your doctor if you have any of these other conditions:

• 
  

  narrow-angle glaucoma;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  liver disease.

  
  

FDA pregnancy category C. It is not known whether dorzolamide ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dorzolamide ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Trusopt (dorzolamide ophthalmic)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use this medication while wearing contact lenses. Dorzolamide ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using dorzolamide before putting your contact lenses in.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before using the eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  


• 
  

  If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

  
  

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery. You may need to stop using dorzolamide ophthalmic for a short time.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dry mouth, increased thirst, drowsiness, restless feeling, confusion, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while using Trusopt (dorzolamide ophthalmic)?

Dorzolamide ophthalmic may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use other eye medications during treatment with dorzolamide ophthalmic unless your doctor tells you to.

Trusopt (dorzolamide ophthalmic) side effects

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.

Although the risk of serious side effects is low when dorzolamide is used in the eyes, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using dorzolamide ophthalmic and call your doctor at once if you have a serious side effect such as:

• 
  

  swelling or redness of your eyelids;

  
  


• 
  

  eye redness, pain, discomfort, or sensitivity to light;

  
  


• 
  

  drainage, crusting, or oozing of your eyes or eyelids;

  
  


• 
  

  severe skin reaction: fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or

  
  


• 
  

  stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  burning or stinging in your eye;

  
  


• 
  

  bitter or unusual taste in your mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dry or watery eyes;

  
  


• 
  

  headache;

  
  


• 
  

  weakness, tired feeling;

  
  


• 
  

  nausea; or

  
  


• 
  

  dry mouth, sore throat.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trusopt (dorzolamide ophthalmic)?

Tell your doctor about all other medicines you use, especially:

• 
  

  acetazolamide (Diamox);

  
  


• 
  

  brinzolamide (Azopt); or

  
  


• 
  

  methazolamide (Neptazane).

  
  

This list is not complete and other drugs may interact with dorzolamide ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Trusopt resources

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

• Trusopt Prescribing Information (FDA)


• Trusopt Monograph (AHFS DI)


• Trusopt Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Trusopt with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Where can I get more information?

• Your pharmacist can provide more information about dorzolamide ophthalmic.

See also: Trusopt side effects (in more detail)

Synvisc Hylan G-F

Generic Name: hylan polymers a and b (Injection route)

HYE-lan POL-a-mers A and B

Commonly used brand name(s):

In the U.S.

• Synvisc


• Synvisc Hylan G-F


• Synvisc One

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Cartilaginous Defect Repair Agent

Uses For Synvisc Hylan G-F

Hyaluronate sodium derivative is similar to a substance that occurs naturally in joints that helps joints work properly by acting like a lubricant and shock absorber. This medicine is injected into the knee to relieve pain caused by osteoarthritis.

This medicine is to be administered only by or under the immediate supervision of your doctor. It is available only with your doctor's prescription.

Before Using Synvisc Hylan G-F

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of hyaluronate sodium derivative in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of hyaluronate sodium derivative in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Skin or knee joint infections or other problems at the place where the injection is to be given—This medicine should not be injected there

Proper Use of hylan polymers a and b

This section provides information on the proper use of a number of products that contain hylan polymers a and b. It may not be specific to Synvisc Hylan G-F. Please read with care.

Dosing

The dose of this medicine 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 this medicine. 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 parenteral dosage form (injection):
  
  • For knee pain caused by osteoarthritis:
    
    • Adults—By injection into the knee, 16 milligrams (mg) once a week (one week apart) for a total of three injections.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using Synvisc Hylan G-F

For the first 48 hours after you receive this medicine, avoid strenuous activities or prolonged (more than 1 hour) activities that put a lot of weight on your legs, such as jogging, heavy lifting, playing tennis, or standing on your feet for a long period of time.

Synvisc Hylan G-F 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 as soon as possible if any of the following side effects occur:

Rare

• Difficulty breathing


• hives


• shortness of breath

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

• Knee pain


• pain at the injection site


• swelling of the knee

Rare

• Calf cramps


• dizziness


• facial flushing with swelling of the lips


• headache


• infection of the joint


• itching of the skin


• muscle pain


• nausea


• pain on one side of the body with anxiety, nausea, and tiredness


• rapid heartbeat


• skin rash

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: Synvisc Hylan G-F 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Synvisc Hylan G-F resources

• Synvisc Hylan G-F Side Effects (in more detail)
• Synvisc Hylan G-F Use in Pregnancy & Breastfeeding
• Synvisc Hylan G-F Drug Interactions
• Synvisc Hylan G-F Support Group
• 11 Reviews for Synvisc Hylan G-F - Add your own review/rating

Compare Synvisc Hylan G-F with other medications

• Osteoarthritis