Covitasa B12 may be available in the countries listed below.
Cobamamide is reported as an ingredient of Covitasa B12 in the following countries:
Cyproheptadine hydrochloride (a derivative of Cyproheptadine) is reported as an ingredient of Covitasa B12 in the following countries:
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Diclostar may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclostar in the following countries:
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Fenacop Retard may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Fenacop Retard in the following countries:
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Citogel may be available in the countries listed below.
Sucralfate is reported as an ingredient of Citogel in the following countries:
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Medoklav may be available in the countries listed below.
Amoxicillin is reported as an ingredient of Medoklav in the following countries:
Clavulanic Acid is reported as an ingredient of Medoklav in the following countries:
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Generic Name: phendimetrazine (Oral route)
fen-dye-MET-ra-zeen TAR-trate
In the U.S.
Available Dosage Forms:
Therapeutic Class: Appetite Suppressant, Centrally Acting
Chemical Class: Phendimetrazine
Phendimetrazine is used as part of a short-term plan, along with a low calorie diet, for weight reduction. It is used in obese patients who have not been able to lose weight with diet and exercise alone. Phendimetrazine belongs to the group of medicines known as appetite suppressants.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of phendimetrazine tablets in the pediatric population. Safety and efficacy have not been established.
Use of phendimetrazine slow-release capsules is not recommended in children younger than 12 years of age.
No information is available on the relationship of age to the effects of phendimetrazine in geriatric patients.
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain phendimetrazine. It may not be specific to Obezine. Please read with care.
Take this medicine only as directed by your doctor. 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. If too much is taken, it may become habit-forming (causing mental or physical dependence).
This medicine is available in two forms: slow-release capsules and tablets. Ask your doctor which dosage form is right for you.
Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.
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.
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.
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.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and does not cause any unwanted effects.
Do not use phendimetrazine if you are also using similar medicines such as benzphetamine, diethylpropion, mazindol, phentermine, Didrex®, or Suprenza™. Also, do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Using these medicines together may cause serious unwanted effects.
Make sure your doctor knows if you are pregnant or planning to become pregnant before using this medicine.
This medicine may be habit-forming. If you think this medicine is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.
Stop using this medicine and check with your doctor right away if you notice a decrease in your ability to exercise, if you faint, or if you have chest pain, swelling of your feet or lower legs, or trouble with breathing. These may be symptoms of a very serious heart or lung problem.
This medicine may cause some people to become dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
For diabetic patients: This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter) medicines, dietary supplements, herbal remedies, or medicines for appetite control, asthma, colds, cough, hay fever, and sinus problems.
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
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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Nitrest may be available in the countries listed below.
Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Nitrest in the following countries:
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Spanor may be available in the countries listed below.
Doxycycline hyclate (a derivative of Doxycycline) is reported as an ingredient of Spanor in the following countries:
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Buspirona Genfar may be available in the countries listed below.
Buspirone is reported as an ingredient of Buspirona Genfar in the following countries:
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Furosemida Denver Farma may be available in the countries listed below.
Furosemide is reported as an ingredient of Furosemida Denver Farma in the following countries:
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Cefuroksim may be available in the countries listed below.
Cefuroxime is reported as an ingredient of Cefuroksim in the following countries:
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Duovent may be available in the countries listed below.
UK matches:
Fenoterol hydrobromide (a derivative of Fenoterol) is reported as an ingredient of Duovent in the following countries:
Ipratropium Bromide is reported as an ingredient of Duovent in the following countries:
Ipratropium Bromide monohydrate (a derivative of Ipratropium Bromide) is reported as an ingredient of Duovent in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Timolo may be available in the countries listed below.
Timolol maleate (a derivative of Timolol) is reported as an ingredient of Timolo in the following countries:
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Be-Tabs Prednisone may be available in the countries listed below.
Prednisone is reported as an ingredient of Be-Tabs Prednisone in the following countries:
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Adco-Vascard may be available in the countries listed below.
Nifedipine is reported as an ingredient of Adco-Vascard in the following countries:
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Betaglau may be available in the countries listed below.
Betaxolol is reported as an ingredient of Betaglau in the following countries:
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Generic Name: benzphetamine (benz FET ah meen)
Brand Names: Didrex
Benzphetamine is a stimulant that is similar to an amphetamine. Benzphetamine is an appetite suppressant that affects the central nervous system.
Benzphetamine is used togther with diet and exercise to treat obesity (overweight).
Benzphetamine may also be used for other purposes not listed in this medication guide.
Taking benzphetamine together with other diet medications (including medicines available over the counter) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take benzphetamine with any other diet medications without your doctor's advice.
Benzphetamine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
Taking benzphetamine together with other diet medications (including medicines available over the counter) can cause a rare fatal lung disorder called pulmonary hypertension. Do not take benzphetamine with any other diet medications without your doctor's advice.
coronary artery disease (hardening of the arteries);
heart disease, heart rhythm disorder;
severe or uncontrolled high blood pressure;
overactive thyroid;
glaucoma;
if you are pregnant;
if you have a history of drug or alcohol abuse; o
if you have used any other diet pills within the past year.
If you have any of these other conditions, you may need a benzphetamine dose adjustment or special tests:
high blood pressure;
diabetes; or
a thyroid disorder.
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Benzphetamine is usually taken once each day, mid-morning or mid-afternoon.
Benzphetamine should be taken only for a short time, such as a few weeks. Tell your doctor if you have not lost any weight after 4 weeks of treatment.
Benzphetamine is only part of a complete program of treatment that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
See also: Didrex dosage (in more detail)
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include confusion, panic, feeling hostile or aggressive, nausea, vomiting, diarrhea, stomach cramps, fever, muscle pain or weakness, dark colored urine, irregular heartbeat, weak pulse, slow breathing, feeling light-headed, seizure, or fainting.
To prevent sleep problems, avoid taking this medication late in the afternoon.
feeling short of breath, even with mild exertion;
chest pain, feeling like you might pass out;
swelling in your ankles or feet;
pounding heartbeats or fluttering in your chest;
confusion or irritability, unusual thoughts or behavior; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
feeling restless or hyperactive;
headache, dizziness, tremors;
sleep problems (insomnia);
increased sweating;
dry mouth or an unpleasant taste in your mouth;
nausea, diarrhea upset stomach; or
skin rash.
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.
Tell your doctor about all other medicines you use, especially:
ammonium chloride, ascorbic acid (vitamin C), K-Phos;
blood pressure medications;
insulin or oral diabetes medication;
sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);
a stimulant or ADHD medication such as amphetamine salt combination (Adderall), dextroamphetamine (Dexedrine), or methylphenidate (Ritalin); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.
This list is not complete and other drugs may interact with benzphetamine. 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.
See also: Didrex side effects (in more detail)
Treating infections caused by certain bacteria.
Biaxin XL Extended-Release Tablets are a macrolide antibiotic. It works by stopping the growth or killing bacteria sensitive to macrolide antibiotics.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Biaxin XL Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Biaxin XL Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Biaxin XL Extended-Release Tablets 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.
Use Biaxin XL Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Biaxin XL Extended-Release Tablets.
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:
Abnormal taste; diarrhea; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; dizziness; emotional or mood changes; fast or irregular heartbeat; hallucinations; loss of taste or sense of smell; muscle weakness; nightmares; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain/cramps; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness); tremor; trouble sleeping.
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: Biaxin XL side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; stomach pain; vomiting.
Store Biaxin XL Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a well-closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from light, heat, and moisture. Do not store in the bathroom. Keep Biaxin XL Extended-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Biaxin XL Extended-Release Tablets. 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.
Meclozine Hydrochloride may be available in the countries listed below.
Meclozine Hydrochloride (BANM) is also known as Meclozine (Prop.INN)
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Glossary
| BANM | British Approved Name (Modified) |
| Prop.INN | Proposed International Nonproprietary Name (World Health Organization) |
Amitriptinova may be available in the countries listed below.
Amitriptyline is reported as an ingredient of Amitriptinova in the following countries:
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Isotretin Sandoz may be available in the countries listed below.
Isotretinoin is reported as an ingredient of Isotretin Sandoz in the following countries:
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Asozart may be available in the countries listed below.
Hydralazine hydrochloride (a derivative of Hydralazine) is reported as an ingredient of Asozart in the following countries:
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Fluoxetin Axapharm may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetin Axapharm in the following countries:
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Renor may be available in the countries listed below.
Norfloxacin is reported as an ingredient of Renor in the following countries:
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Biliepar may be available in the countries listed below.
Ursodeoxycholic Acid is reported as an ingredient of Biliepar in the following countries:
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Diarstop may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Diarstop in the following countries:
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Notiderm may be available in the countries listed below.
Gentamicin is reported as an ingredient of Notiderm in the following countries:
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Otiborin may be available in the countries listed below.
Boric Acid is reported as an ingredient of Otiborin in the following countries:
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Leka may be available in the countries listed below.
Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Leka in the following countries:
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Rec.INN
S01ED06
0039552-01-7
C16-H21-N-O4
291
ß-Adrenergic blocking agent
Glaucoma treatment
Ethanone, 1-[7-[2-hydroxy-3-[(1-methylethyl)amino]propoxy]-2-benzofuranyl]-
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Generic Name: tetanus, diphtheria, acellular pertussis vaccine (Tdap) (TET a nus, dif THEER ee a, and ay SEL yoo ler per TUS iss)
Brand Names: Adacel (Tdap), Boostrix (Tdap)
Tetanus, diphtheria, and pertussis are serious diseases caused by bacteria.
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 the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.
Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.
Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.
Diphtheria and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.
The diphtheria, tetanus acellular, and pertussis adult vaccine (also called Tdap) is used to help prevent these diseases in people who are at least 10 years old. Most people in this age group require only one Tdap shot for protection against these diseases.
This vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.
Like any vaccine, the Tdap vaccine may not provide protection from disease in every person.
In most cases, tetanus, diphtheria, acellular pertussis vaccine is given in only one dose. Follow your doctor's instructions about receiving a booster dose if needed.
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
You may not be able to receive a Tdap vaccine if you have ever received a similar vaccine that caused any of the following:
a very high fever (over 104 degrees);
a neurologic disorder or disease affecting the brain;
fainting or going into shock;
an allergy to latex rubber;
severe or uncontrolled epilepsy or other seizure disorder; or
Guillain-Barré syndrome (within 6 weeks after receiving a vaccine containing tetanus).
If you have any of these other conditions, your vaccine may need to be postponed or not given at all:
a history of seizures;
a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
if it has been less than 5 years since you last received a tetanus shot.
You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.
The adult version of this vaccine (Adacel, Boostrix) should not be given to anyone under the age of 10. Another vaccine is available for use in children younger than 10 years old.
This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.
In most cases, you will receive only one dose of the tetanus, diphtheria, acellular pertussis vaccine. Follow your doctor's instructions about receiving a booster dose if needed.
Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.
It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.
Since this vaccine is given as a one time injection, you are not likely to be on a dosing schedule.
An overdose of this vaccine is unlikely to occur.
Follow your doctor's instructions about any restrictions on food, beverages, or activity after receiving a Tdap vaccine.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.
Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Call your doctor at once if you have any of these serious side effects within 7 days after receiving this vaccine:
extreme drowsiness, fainting;
seizure (black-out or convulsions); or
high fever.
Less serious side effects include:
mild fever or chills;
redness, pain, tenderness, or swelling where the shot was given;
headache or tiredness;
joint pain, body aches; or
mild nausea, diarrhea, or vomiting.
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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:
an oral, nasal, inhaled, or injectable steroid medicine;
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or
medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
This list is not complete and other drugs may interact with tetanus, diphtheria, acellular pertussis vaccine. 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.
See also: Boostrix (Tdap) side effects (in more detail)
Fluroblastine may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluroblastine in the following countries:
Fluorouracil sodium salt (a derivative of Fluorouracil) is reported as an ingredient of Fluroblastine in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Ketamine hydrochloride (a derivative of Ketamine) is reported as an ingredient of Vetalar in the following countries:
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Ciprecu may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Ciprecu in the following countries:
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Botastin may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Botastin in the following countries:
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Broncovaleas may be available in the countries listed below.
Salbutamol is reported as an ingredient of Broncovaleas in the following countries:
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Casacin may be available in the countries listed below.
Capsaicin is reported as an ingredient of Casacin in the following countries:
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Class: Vaccines
VA Class: IM100
Brands: Rotarix, RotaTeq
Live, attenuated virus vaccine.11 12 22 Rotavirus vaccine is commercially available in the US as a monovalent vaccine derived from a human rotavirus strain (Rotarix; RV1)11 12 22 and as a pentavalent vaccine containing 5 reassortant rotaviruses derived from human and bovine hosts (RotaTeq; RV5).1 2 3 9 11 12 Rotavirus vaccine is used to stimulate active immunity to the rotavirus serotypes represented in the vaccine.1 2 3 9 11 12 22 Various other rotavirus vaccines (e.g., other monovalent or multivalent human-animal reassortant vaccines) are being investigated or may be available in other countries.3 4 9
Rotarix (RV1): Prevention of gastroenteritis caused by rotavirus serotype G1 and non-G1 types (G3, G4, G9).11 12 22 23 24 25
RotaTeq (RV5): Prevention of gastroenteritis caused by rotavirus serotypes G1, G2, G3, and G4.1 2 11 12 17 19
Rotavirus is the leading cause of severe gastroenteritis in infants and young children.9 11 12 29 Worldwide, rotavirus gastroenteritis causes approximately 500,000 deaths each year in children <5 years of age; more than 80% of these deaths occur in developing countries.9 11 Prior to licensure of rotavirus vaccine, rotavirus gastroenteritis was estimated to cause up to 70,000 hospitalizations and up to 60–70 deaths each year in the US in children <5 years of age.11 12 29
The incidence of rotavirus disease decreased in the US after rotavirus vaccine (RotaTeq) was licensed in 2006.29 Surveillance data collected by the National Respiratory and Enteric Virus Surveillance System (NREVSS) indicate that the 2007–2008 and 2008–2009 rotavirus seasons were shorter, had a later onset, and had substantially fewer reports of positive rotavirus test results compared with the 2000–2006 seasons.29 These data suggest that rotavirus vaccination may provide clinical benefits to both vaccinated and unvaccinated individuals by reducing overall rotavirus transmission (i.e., herd immunity).29 Continued surveillance is needed to further evaluate the effect of routine childhood vaccination against rotavirus disease in the US.29
USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and American Academy of Family Physicians (AAFP) recommend that all infants be vaccinated against rotavirus gastroenteritis beginning at 6 weeks of age, unless contraindicated.11 12 17 (See Contraindications under Cautions.) These experts state give the first dose at 6 through 14 weeks of age (no later than 14 weeks 6 days of age) and complete the vaccination series by 8 months 0 days of age.11 12 17
Data not available regarding the interchangeability of the commercially available rotavirus vaccines (Rotarix, RotaTeq).11 12 ACIP and AAP do not state a preference for either vaccine for primary immunization in infants.11 12 (See Dosage under Dosage and Administration.)
Data not available regarding efficacy and safety of rotavirus vaccine for postexposure prophylaxis after exposure to natural rotavirus.1 22
Rotarix (RV1) and RotaTeq (RV5) are administered orally.1 22
Do not administer by IM, IV, or sub-Q injection.1 22
Do not mix with any other vaccine or solution.1 22
Food or liquid intake (including breast milk) does not need to be restricted before or after administration of rotavirus vaccine.1 11 12 22
May be given simultaneously with other age-appropriate vaccines during the same health-care visit.1 8 11 12 22 (See Interactions.)
Reconstitute lyophilized vaccine using the diluent and transfer adapter provided by the manufacturer.22 Consult manufacturer’s information for complete reconstitution instructions.22 Reconstituted Rotarix is a white, turbid suspension.22
Following reconstitution, administer orally directly from oral applicator provided by the manufacturer.22 Administer entire contents of the oral applicator into infant’s mouth on the inside of the cheek.22
If an incomplete dose is given (e.g., infant spits or regurgitates during or after vaccine dose), the manufacturer states that a single replacement dose may be considered at the same vaccination visit.22 ACIP and AAP do not recommend a replacement dose if an incomplete dose is given since data not available on benefits or risks associated with readministration.11 12 Administer remaining dose of the 2-dose vaccination series at usually recommended interval (minimum interval 4 weeks between doses).11 12
Administer orally directly from the single-dose tubing supplied by the manufacturer.1 Do not dilute.1
Administer dose by gently squeezing entire contents of tubing into infant’s mouth toward the inner cheek.1
If an incomplete dose is given (e.g., infant spits or regurgitates vaccine during or after vaccine dose), a replacement dose is not recommended since data not available on benefits or risks associated with readministration.1 11 12 Administer remaining doses of the 3-dose vaccination series at usually recommended intervals (minimum interval 4 weeks between doses).1 11 12
Dose and dosing schedule vary depending on the specific vaccine administered.1 22 Follow dosage recommendations for the specific preparation used.1 22
The specific rotavirus vaccine (Rotarix or RotaTeq) used for the initial dose should be used to complete the vaccination series, whenever possible.11 12 22 If the specific rotavirus vaccine used for previous doses is unknown or unavailable, continue or complete the vaccination series with the currently available rotavirus vaccine; do not defer vaccination.11 12
If RotaTeq or an unknown rotavirus vaccine was administered for any dose in the vaccination series, a total of 3 doses should be administered to complete the primary vaccination series.11 12
ACIP, AAP, and AAFP state that the first dose of rotavirus vaccine should be given at 6 weeks through 14 weeks 6 days of age and should not be initiated in infants ≥15 weeks 0 days of age.11 12 17 If the first dose is inadvertently administered to an infant ≥15 weeks 0 days of age, complete the remainder of the vaccination series according to the recommended schedule.11 12 Timing of the first vaccine dose should not affect the safety and efficacy of subsequent doses.11 12 ACIP, AAP, and AAFP also state that the vaccination series should be completed by 8 months 0 days of age.11 12 17
ACIP and AAP recommend a minimum interval of 4 weeks between doses of rotavirus vaccine.11 12
In preterm infants who are medically stable, administer rotavirus vaccine at the usual chronologic age using usual dosage, provided the vaccine is administered to the age-eligible infant after or at the time of discharge from the neonatal intensive care unit (NICU) or hospital nursery.11 12 Theoretical risks of transmission of rotavirus vaccine virus to other hospitalized infants outweigh benefits of vaccination in age-eligible infants who will remain in the NICU or nursery after the dose.12 (See Pediatric Use under Cautions.)
Because natural rotavirus infection frequently provides only partial immunity, ACIP and AAP recommend that the rotavirus vaccination series be initiated or completed in infants who had rotavirus gastroenteritis before receiving the complete series.11 12 (See Individuals with GI Disorders under Cautions.)
Primary immunization consists of a series of 2 doses.11 12 22 Each dose consists of the entire contents of the reconstituted single-dose vial.22
Manufacturer recommends giving initial dose at 6 weeks of age and second dose at least 4 weeks after first dose.11 12 22 Manufacturer also recommends completing the 2-dose series by 6 months (24 weeks) of age.22
ACIP, AAP, and AAFP recommend that infants receive Rotarix at 2 and 4 months of age with a minimum interval of 4 weeks between doses.11 12 17 ACIP, AAP, and AAFP also recommend completing the 2-dose series by 8 months 0 days of age.11 12 17
Duration of immunity following the 2-dose vaccination series not fully determined.22 Need for revaccination or additional (booster) doses not determined.22 (See Duration of Immunity under Cautions.)
Primary immunization consists of a series of 3 doses.1 11 12 Each dose consists of the entire contents of the commercially available single-dose tubing.1 11
Manufacturer recommends giving initial dose at 6 to 12 weeks of age and remaining 2 doses at 4- to 10-week intervals.1 11 12 17 Manufacturer recommends administering the third dose at ≤32 weeks of age.1 11 12 17
ACIP, AAP, and AAFP recommend that RotaTeq be given at 2, 4, and 6 months of age with a minimum interval of 4 weeks between doses.11 12 17 ACIP and AAP also recommend completing the 3-dose series by 8 months 0 days of age.11 12
Duration of immunity following the 3-dose vaccination series not fully determined.1 Need for revaccination or additional (booster) doses not determined.1 (See Duration of Immunity under Cautions.)
No specific dosage recommendations.1 22
No specific dosage recommendations.1 22
Not indicated in adults, including geriatric adults.1 22
Known hypersensitivity to Rotarix or any vaccine component (e.g., latex).22 (See Latex Sensitivity under Cautions.)
Do not give additional doses to infants who experienced symptoms suggestive of hypersensitivity following any previous dose.11 12 22
History of uncorrected congenital malformation of the GI tract (e.g., Meckel’s diverticulum) that would predispose infant to intussusception.22
Severe combined immunodeficiency disease (SCID).22 (See Individuals with Altered Immunocompetence under Cautions.)
Known hypersensitivity to RotaTeq or any vaccine component.1 11 12
Do not give additional doses to infants who experienced symptoms suggestive of hypersensitivity following any previous dose.1 11 12
SCID.1 34 (See Individuals with Altered Immunocompetence under Cautions.)
Review infant immunization history to determine whether there is a history of hypersensitivity or other reactions to any vaccine components.1 22
Rotarix: Packaging components (tip cap and rubber plunger of oral applicator) contain dry natural latex.11 12 22
Some individuals may be hypersensitive to natural latex proteins.8 Take appropriate precautions if Rotarix is administered to individuals with a history of latex sensitivity.8
ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex, unless the benefits of vaccination outweigh the risk of a potential allergic reaction.8 11
Consider use of RotaTeq (latex-free) as an alternative to Rotarix. in infants with severe allergy to latex.11 Some experts prefer that infants with spina bifida or bladder exstrophy, who are at high risk for acquiring latex allergy, receive RotaTeq (latex-free) as an alternative to Rotarix to minimize latex exposure.11 12 Administer Rotarix if it is the only rotavirus vaccine available since the benefit of rotavirus vaccination is considered to be greater than the risk for latex sensitization.11 12
Safety and efficacy not established in immunocompromised or potentially immunocompromised infants.1 11 12 22 30 Examples include infants with blood dyscrasias, leukemia, lymphoma, or other malignant neoplasms affecting bone marrow or the lymphatic system; those receiving immunosuppressive therapy (see Interactions); those with primary and acquired immunodeficiency states such as HIV/AIDS or other clinical manifestations of HIV infection, cellular immune deficiencies, or hypogammaglobulinemic and dysgammaglobulinemic states; and those of indeterminate HIV status born to HIV-infected mothers (HIV-exposed).1 11 12 22 30
There have been postmarketing reports of vaccine-acquired rotavirus gastroenteritis, with severe diarrhea and prolonged vaccine virus shedding, in infants who received Rotarix or RotaTeq and were subsequently diagnosed with SCID.1 22 33 34 Some of these infants continued to shed vaccine virus for 5–12 months.33 Do not use Rotarix or RotaTeq in infants with SCID.1 22 33 34
Consider the potential risks and benefits of administering rotavirus vaccine to infants with known or suspected altered immunocompetence.11 12 30 Consultation with an immunologist or infectious diseases specialist is advised.11 12 30
ACIP, AAP, CDC, National Institutes of Health (NIH), HIV Medicine Association of IDSA, and Pediatric Infectious Diseases Society state that use of rotavirus vaccine in HIV-infected or HIV-exposed infants is supported since HIV diagnosis in infants born to HIV-infected mothers may not be established before the recommended age for the first dose of the vaccine, only 1.5–3% of HIV-exposed infants in the US will eventually be determined to be HIV infected, and the rotavirus strains used in the vaccines are considerably attenuated.11 12 30
Rotarix: Manufacturer states the vaccine is contraindicated in infants with a history of uncorrected congenital malformation of the GI tract (e.g., Meckel’s diverticulum) that would predispose to intussusception.22 Manufacturer states safety and efficacy not evaluated in infants with chronic GI disorders;22 delay administration of the vaccine in infants with acute diarrhea or vomiting.22
RotaTeq: Manufacturer states use caution in infants with a history of GI disorders (e.g., active acute GI illness, chronic diarrhea and failure to thrive, history of congenital abdominal disorders, abdominal surgery, intussusception); safety and efficacy data not available in these infants.1 11 Manufacturer states the vaccine may be used in infants with controlled gastroesophageal reflux disease (GERD).1
Although safety and efficacy of rotavirus vaccine not evaluated in infants with preexisting chronic GI disorders, ACIP and AAP state that the benefits of the vaccine outweigh theoretical risks in those with preexisting GI tract conditions (e.g., congenital malabsorption syndrome, Hirschsprung disease, short-gut syndrome) if they are not receiving immunosuppressive therapy.11 12
Data not available regarding use of rotavirus vaccine in infants with concurrent acute gastroenteritis; immunogenicity and efficacy may be compromised in these infants.11 12 ACIP and AAP state that the vaccine can be administered to infants with mild acute gastroenteritis (particularly if a delay in vaccination may result in the child becoming ineligible to receive the vaccine based on age at first dose), but recommend that the vaccine not be administered to infants with acute, moderate-to-severe gastroenteritis until improvement of the condition is noted.11 12
Hematochezia reported rarely within 42 days after a dose of RotaTeq; incidence was similar to that observed in those receiving placebo during clinical trials.1 11 12 Data from postmarketing surveillance include reports of hematochezia following use of Rotarix or RotaTeq.1 22 Causal relationship between administration of rotavirus vaccine and occurrence of hematochezia not established.1
A previously available rotavirus vaccine live oral (RotaShield; Wyeth) was voluntarily withdrawn from US market in 1999 following postmarketing reports of intussusception in infants receiving the vaccine.1 2 6 7 9 11 12 13 14 27 Data indicated the period of highest risk of intussusception associated with RotaShield was the first 42 days following the initial vaccine dose.1 2 6
Although some cases of intussusception have been reported in temporal association with Rotarix or RotaTeq, data to date from clinical trials do not indicate an increased risk of intussusception with these currently available rotavirus vaccines compared with placebo.1 2 11 12 19 22 24
Because of possible underreporting, limitations and assumptions in the analysis of data from the Vaccine Adverse Event Reporting System (VAERS), and the limited number of infants vaccinated with rotavirus vaccine to date, the possibility of a small increased risk of intussusception cannot be excluded.13 26 27 Closely monitor infants receiving rotavirus vaccine for intussusception, particularly during the first week following vaccination.10 36 Report any cases of intussusception or other serious events possibly associated with the vaccine to VAERS at 800-822-7967 or .13 14 36 For more information, see the FDA website at .14
Infants with a history of intussusception may be at higher risk for another episode, but data not available regarding administration of rotavirus vaccine to infants with a history of intussusception.11 12 Consider potential risks and benefits of vaccination in infants with a previous episode.11 12
Data to date from clinical trials of Rotarix do not indicate an increased risk of intussusception compared with placebo.11 12 22 24 In one randomized study conducted in Latin America and Finland, 63,225 infants received a 2-dose regimen of Rotarix or placebo and were monitored for intussusception for 31 days after each dose and for a median duration of 100 days after the first dose.22 24 There were 6 cases of confirmed intussusception in vaccine recipients and 7 cases in placebo recipients within 31 days following administration of either dose.22 24 After the 31-day observation period, there were 3 additional cases of intussusception in those who received vaccine and 9 cases in those who received placebo.22 24 There were no confirmed cases of intussusception in vaccine recipients within the first 14 days after the initial vaccine dose.22 In a subset of infants followed up to 1 year after the first vaccine dose, there were 4 cases of intussusception in vaccine recipients compared with 14 cases in placebo recipients.22 All infants who developed intussusception recovered without sequelae.22 24
Interim data from a hospital-based, postmarketing active surveillance study in a birth cohort of infants in Mexico suggest an increased risk of intussusception in the 31-day period following administration of the first dose of Rotarix.22 36 Most cases of intussusception in this study occurred during the first 7 days following vaccination;22 36 worldwide passive postmarketing surveillance data also suggest that most cases of intussusception occur during the 7-day period following the first dose of Rotarix.22 When the relative risk of intussusception observed in the interim analysis of this Mexican study (i.e., 1.8) is applied to estimates of background rates of hospitalizations due to intussusception in infants <1 year of age in the US (i.e., 34 cases per 100,000 infants), the estimated increase is approximately 0–4 additional cases per 100,000 vaccinated infants within the 31 days following the first vaccine dose.22 36 37 FDA will review the final study report of the Mexican postmarketing surveillance study and is continuing to evaluate the association between Rotarix and intussusception using other ongoing studies.36
Data accumulated to date regarding RotaTeq do not indicate an increased risk of intussusception compared with placebo.1 2 11 12 19 In one randomized study, >60,000 infants received a 3-dose regimen of RotaTeq or placebo and were monitored for intussusception at 7, 14, and 42 days after each dose and every 6 weeks for 1 year after the initial dose.1 2 A total of 13 vaccine recipients and 15 placebo recipients developed confirmed cases of intussusception within 1 year following the first dose.1 There were 6 or 5 confirmed cases of intussusception that occurred within 42 days following any dose of vaccine or placebo, respectively; there were no confirmed cases of intussusception reported within the first 42 days following the initial vaccine dose.1 2 All infants who developed intussusception recovered without sequelae, except one child who died from postoperative sepsis.1 2
Postmarketing surveillance has identified some cases of intussusception (including a death) in temporal association with RotaTeq.1 13 14 26 27 A total of 160 confirmed cases of intussusception (but no related fatalities) were reported to VAERS during the first 19 months of postmarketing surveillance (February 1, 2006 to September 25, 2007).27 Of these 160 cases, 47 occurred within 21 days following vaccination, including 27 that occurred within the first 7 days.27 Twenty-two of these infants required surgery; intussusception in the other 25 infants resolved through use of enema reduction.27 Updated surveillance data from VAERS indicate that a total of 267 confirmed cases of intussusception were reported between February 1, 2006 and March 31, 2008.26 Of these 267 cases, 91 occurred within 21 days following vaccination, including 48 that occurred within the first 7 days.26 One fatality was reported in an infant 18 days following administration of the second dose of RotaTeq .26 Among the VAERS reports of intussusception, more cases have been reported within 7 days than within 14 or 21 days following the first dose of RotaTeq.11 26
Based on the assumption that 75% of intussusception cases were reported to VAERS and that 75% of rotavirus vaccine doses distributed were administered, the reported number of intussusception cases in RotaTeq recipients during the first 2 years of postmarketing surveillance did not exceed the number of expected cases during 1–7 or 1–21 days following vaccination.27 After 2 years of postmarketing surveillance, VAERS data did not show an increased risk of intussusception within 21 days following any dose of RotaTeq.26
FDA states that currently available evidence does not suggest an increased risk of intussusception in infants following vaccination with RotaTeq; however, studies are ongoing and additional information is being evaluated.36 Preliminary analysis of data from the Vaccine Safety Datalink (VSD) project does not show a significant increased risk of intussusception with RotaTeq.36 However, the VSD study is not large enough to date to rule out the increased level of risk for intussusception suggested by the preliminary data from the postmarketing study of Rotarix in Mexico.36 (See Rotarix [RV1] under Cautions: Intussusception.)
Because postmarketing reports to date do not suggest an association between RotaTeq and intussusception,13 26 27 36 CDC recommends routine vaccination of infants at 2, 4, and 6 months of age.13
Rotarix contains live, attenuated rotavirus1 and RotaTeq contains live reassortant rotaviruses.22
Viral shedding occurs in vaccine recipients.1 11 12 22 Up to 26% of those receiving Rotarix shed vaccine virus in their stools after the first dose; peak shedding occurs at approximately day 7 after the first dose.22 Up to 9% of infants receiving RotaTeq shed vaccine virus in their stools after the first dose (as early as day 1 and as late as day 15 following the dose); viral shedding occurs rarely after subsequent doses of RotaTeq.1
Although not specifically studied, rotavirus vaccine virus could potentially be transmitted between vaccinees and susceptible contacts.1 11 12 22 There have been postmarketing reports of vaccine virus transmission to unvaccinated contacts of infants who received RotaTeq.1
Caution advised when considering whether to administer rotavirus vaccine to infants with close contacts who are immunocompromised (e.g., individuals who have malignancies, primary immunodeficiencies, or are receiving immunosuppressive therapy).1 Manufacturers state weigh risk of possible vaccine virus transmission against risk of infant developing natural rotavirus infection that could be transmitted to susceptible contacts.1 22
ACIP and AAP state that infants living in households with individuals who are immunocompromised may be vaccinated with rotavirus vaccine.8 11 12 Protection of immunocompromised household contacts afforded by rotavirus vaccination of infants in the household and prevention of wild-type rotavirus disease outweighs the small risk of transmitting vaccine virus to the susceptible individual and any subsequent theoretical risk of vaccine virus-associated disease.11 12
To minimize potential vaccine virus transmission from the vaccinee, advise all household contacts to use hygienic measures (e.g., good hand washing) following contact with feces from a vaccinated infant (e.g., diaper changing) for at least 1 week after each vaccine dose.11 12
If hospitalization of an infant recently vaccinated with rotavirus vaccine occurs for any reason, use standard precautions to prevent the spread of vaccine virus in the hospital setting.11 12 Because of the possible risk of transmission of rotavirus vaccine virus to other hospitalized infants, if a preterm infant previously vaccinated with rotavirus vaccine requires readmission to the NICU or hospital nursery within 2 weeks following a dose of the vaccine, initiate contact precautions for the preterm infant and maintain these precautions for 2–3 weeks following the dose.12 (See Pediatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Kawasaki disease reported during phase 3 clinical trials of RotaTeq in 5 out of 36,150 infants who received the vaccine and in 1 out of 35,536 infants who received placebo.1 15 Additional 3 cases in vaccinated infants reported to VAERS and 1 unconfirmed case reported through the VSD Project.15
Kawasaki disease also has been reported in 18 infants who received Rotarix during clinical trials.22
Causal relationship between rotavirus vaccine or any vaccine and the occurrence of Kawasaki disease not established.15 To date, the number of reported cases of Kawasaki disease occurring in association with use of RotaTeq does not exceed the number of expected cases occurring randomly in this population.15 Postmarketing surveillance data to date do not indicate that RotaTeq is associated with an increased risk of Kawasaki disease.11
Report any case of Kawasaki disease occurring following administration of rotavirus vaccine (or any other vaccine) to VAERS at 800-822-7967 or .15 For more information, see FDA website at .15
A decision to administer or delay administration of rotavirus vaccine in an infant with current or recent febrile illness depends on the severity of symptoms and etiology of the illness.1 Manufacturer of RotaTeq states presence of low-grade fever (<38.1°C) or mild upper respiratory infection does not preclude vaccination.1
ACIP and AAP state that rotavirus vaccine may be administered to infants with transient, mild illnesses (with or without low-grade fever),8 11 12 but defer vaccination of individuals with moderate or severe acute illness until after recovery from the acute phase of illness.8 11 12
May not protect all vaccine recipients against rotavirus infection.1
Data not available to determine the level of protection provided against rotavirus infection in infants who have not received the complete vaccination series (i.e., have received only a single dose of Rotarix or only 1 or 2 doses of RotaTeq).1 22
Duration of protection against rotavirus gastroenteritis following the 2-dose vaccination series of Rotarix or 3-dose vaccination series of RotaTeq not fully determined.1 22 Efficacy beyond the second rotavirus season after vaccination has not been evaluated to date.1 22
Porcine-derived materials are used in the manufacture of Rotarix and Rotateq; DNA from porcine circoviruses is present in the vaccines.1 22 31 32
In March 2010, after becoming aware that DNA from porcine circovirus type 1 (PCV1) was present in Rotarix, FDA advised that use of the vaccine be temporarily suspended as a safety precaution pending further investigation.31 32 In May 2010, FDA provided additional information that DNA fragments from PCV1 and porcine circovirus type 2 (PCV2) were detected in RotaTeq.31 32 After careful evaluation, FDA decided that it was appropriate to resume use of Rotarix and continue use of RotaTeqfor prevention of rotavirus infection in infants.31 32
FDA states that there is no evidence to date that PCV1 or PCV2 can cause clinical infection or disease in humans or that either virus poses a safety risk in humans.31 32 Because available evidence supports the safety of Rotarix and RotaTeq in infants, FDA states that clinical benefits of vaccination against rotavirus infection outweigh any theoretical risks from the presence of PCV1 or PCV2 in rotavirus vaccines.31 32 FDA and the manufacturers will continue to investigate the presence of porcine virus in Rotarix and RotaTeq and evaluate safety data from ongoing studies.31 32
Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.8
Do not administer rotavirus vaccine that has been mishandled or has not been stored at the recommended temperature.8 (See Storage under Stability.)
Protect the vaccine from light at all times;1 8 20 22 exposure to light may inactivate the vaccine virus.20
Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.8 If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.8 20
Category C.1 22
Not indicated for use in adults, including pregnant women.1 22
ACIP and AAP state that infants living in households with pregnant women may receive rotavirus vaccine.11 12 Risk of acquiring rotavirus infection from potential exposure to vaccine virus considered very low since most women of childbearing age would be expected to have preexisting immunity to rotavirus.11 12
No evidence to date that rotavirus infection during pregnancy poses any fetal risk.11 Vaccination of infants against rotavirus would avoid potential exposure of pregnant women to natural rotavirus from unvaccinated infants with rotavirus gastroenteritis.11 12
Not indicated for use in adults, including nursing women.1 22
ACIP and AAP state that breast-feeding infants may receive the rotavirus vaccine since efficacy in breast-feeding infants appears to be similar to that in infants not breast-feeding.11 12
Rotarix: Manufacturer states that safety and efficacy not established in infants <6 weeks or >24 weeks of age.22 Efficacy in preterm infants not established;22 safety data to date in preterm infants indicate serious adverse events in 5.2% of vaccine recipients compared with 5% of placebo recipients.22 No deaths or cases of intussusception reported in this patient population to date.22
RotaTeq: Manufacturer states that safety and efficacy not established in infants <6 weeks or >32 weeks of age.1 Data support use of RotaTeq in preterm infants (i.e., gestational age 25–36 weeks) according to age in weeks since birth.1
Pending additional data, ACIP and AAP state that the benefits of routine vaccination with rotavirus vaccine outweigh theoretical risks in medically stable preterm infants.11 12 These experts state that clinically stable preterm infants who meet age requirements (at least 6 weeks and not greater than 14 weeks 6 days of age) may receive the first dose of rotavirus vaccine after or at the time of discharge from the NICU or hospital nursery.11 12 However, the possible risk of transmission of rotavirus vaccine virus to other hospitalized infants outweigh benefits of vaccination in age-eligible infants who will remain in the NICU or nursery after the dose.
