Idasal may be available in the countries listed below.
Xylometazoline hydrochloride (a derivative of Xylometazoline) is reported as an ingredient of Idasal in the following countries:
International Drug Name Search
Generic Name: fluoride topical (FLOR ide TOP i kal)
Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N
Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.
Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.
Fluoride may also be used for other purposes not listed in this medication guide.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.
Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.
Swish this medication in your mouth without swallowing. Then spit it out.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
discolored teeth;
weakened tooth enamel; or
any changes in the appearance of your teeth.
Less serious side effects may include:
stomach upset;
headache; or
weakness.
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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: NaFrinse Daily/Acidulated side effects (in more detail)
Generic Name: carbinoxamine (car bi NOX a meen)
Brand Names: Palgic
Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Carbinoxamine is used to treat sneezing, runny nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Carbinoxamine may also be used for other purposes not listed in this medication guide.
Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take carbinoxamine:
glaucoma;
a stomach ulcer;
a blockage in your stomach or intestines;
an enlarged prostate or urination problems;
overactive thyroid;
heart disease, high blood pressure; or
asthma.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Carbinoxamine can be taken with or without food.
Measure the liquid form of carbinoxamine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include extreme drowsiness, confusion, blurred vision, dry mouth, hallucinations, fainting, and seizure (convulsions).
feeling light-headed, fainting;
urinating less than usual or not at all;
wheezing, tightness in your chest;
fast or pounding heartbeat; or
pale skin, easy bruising or bleeding.
Less serious side effects may include:
drowsiness, dizziness;
lack of coordination;
upset stomach;
stuffy nose, chest congestion;
sleep problems (insomnia);
feeling restless or excited (especially in children);
dry mouth or nose; or
blurred vision.
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.
This list is not complete and there may be other drugs that can interact with carbinoxamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Histex Pd2 side effects (in more detail)
Generic Name: imipramine (im IP ra meen)
Brand Names: Tofranil, Tofranil-PM
Imipramine is in a group of drugs called tricyclic antidepressants. Imipramine affects chemicals in the brain that may become unbalanced.
Imipramine is used to treat symptoms of depression.
Imipramine may also be used for purposes other than those listed in this medication guide.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Treatments for depression are getting better everyday and there are things you can start doing right away.
Before taking imipramine, tell your doctor if you are allergic to any drugs, or if you have:
heart disease;
a history of heart attack, stroke, or seizures;
bipolar disorder (manic-depression);
overactive thyroid;
diabetes (imipramine may raise or lower blood sugar);
adrenal gland tumor (pheochromocytoma);
glaucoma; or
problems with urination.
If you have any of these conditions, you may not be able to use imipramine, or you may need a dosage adjustment or special tests during treatment.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.
Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.
If you need to have any type of surgery, tell the surgeon ahead of time that you are taking imipramine. You may need to stop using the medicine for a short time.
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Symptoms of an imipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, sweating, muscle stiffness, swelling, shortness of breath, blue lips or fingernails, feeling light-headed, fainting, seizure (convulsions), or coma.
Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by imipramine.
Grapefruit and grapefruit juice may interact with imipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
fast, pounding, or uneven heart rate;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
feeling short of breath, even with mild exertion;
swelling, rapid weight gain;
confusion, hallucinations, or seizure (convulsions);
easy bruising or bleeding, unusual weakness;
restless muscle movements in your eyes, tongue, jaw, or neck;
urinating more or less than usual;
extreme thirst with headache, nausea, vomiting, and weakness;
skin rash, bruising, severe tingling, numbness, pain, or muscle weakness.
Less serious side effects may be more likely to occur, such as:
nausea, vomiting, stomach pain, loss of appetite;
constipation or diarrhea;
dry mouth, unpleasant taste;
weight changes;
weakness, lack of coordination;
feeling dizzy, drowsy, or tired;
nightmares;
blurred vision, headache, ringing in your ears;
breast swelling (in men or women); or
decreased sex drive, impotence, or difficulty having an orgasm.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Before taking imipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).
Before taking imipramine, tell your doctor if you are currently using any of the following drugs:
cimetidine (Tagamet);
clonidine (Catapres);
guanethidine (Ismelin);
methylphenidate (Concerta, Ritalin, Daytrana); or
heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).
If you are using any of these drugs, you may not be able to use imipramine, or you may need dosage adjustments or special tests during treatment.
There are many other medicines that can interact with imipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
See also: Tofranil side effects (in more detail)
Woodward's Gripe Water- Alcohol Free & Sugar Free.
Terpeneless Dill Seed Oil 2.3mg/5ml; Sodium Hydrogen Carbonate 52.5mg/5ml.
Oral solution.
For the symptomatic relief of distress associated with wind in infants up to one year old.
For oral use.
Adults including the elderly: not applicable.
Children 1-6 months: one 5ml spoonful.
Children 6-12 months: two 5ml spoonsful.
Children under 1 month: not to be used.
These doses may be given during or after each feed or up to six times in 24 hours.
Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists.
If symptoms persist, medical advice should be sought. Keep all medicines out of the reach of children.
None known.
Not applicable.
Not applicable.
None known.
Symptoms following overdose are rare and are generally due to the effects of sodium hydrogen carbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe overdosing, medical advice should be sought immediately.
Symptoms of hypernatraemia may include drowsiness and irritability, pyrexia and tachypnoea. In more severe instances of acute sodium overload, signs of dehydration and convulsions may occur.
The treatment of hypernatraemia includes repair of any dehydration present and gradual reduction of the plasma sodium. The alkalosis, if present, will respond usually to the treatment of hypernatraemia. At all times intensive monitoring of the electrolytes, and patients circulatory and central nervous system are necessary.
Sodium hydrogen carbonate has a well established antacid action. Dill seed oil is a widely used aromatic carminative especially for use in the treatment of flatulence in children.
Not applicable.
Not applicable.
Glycerol;
Antifoam M Compound
Polysorbate 80
Maltitol Liquid;
Sodium Methyl Parahydroxybenzoate
Sodium Propyl Parahydroxybenzoate
Disodium Edetate
Purified Water.
None known.
18 months unopened.
14 days after opening.
Do not store above 25°C.
Clear, soda-lime-silica Type III pharmaceutical grade glass bottle with an expanded polyethylene wadded cap containing 150 of product.
None.
Seton Products Limited, Tubiton House, Oldham, Lancashire, OL1 3HS.
PL 11314/0139.
30/11/99
March 2004
his-TREL-in
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Gonadotropin Releasing Hormone Agonist
Histrelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It works in the brain to reduce the blood levels of sex hormones, such as testosterone and estrogen. The histrelin implant is placed under the skin. The implant releases small amounts of histrelin in the body every day for 12 months.
Histrelin (Vantas®) is used to treat advanced prostate cancer in adults. It will reduce the level of testosterone, a male hormone, in the blood. Testosterone makes most prostate cancers grow. Histrelin is not a cure for prostate cancer, but it may help relieve the symptoms.
Histrelin (Supprelin® LA) is used to treat central precocious puberty (CPP) in children. CPP is a condition where puberty begins at an unusually early age. This usually means puberty occurs before 8 years of age in girls and before 9 years of age in boys. Histrelin works by reducing the amount of sex hormones (eg, estrogen and testosterone) in the blood.
histrelin acetate 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 histrelin acetate, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to histrelin acetate 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.
The Vantas® form of histrelin should not be used in children.
Appropriate studies have not been performed on the relationship of age to the effects of the Supprelin® LA form of histrelin in children younger than 2 years of age. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of histrelin (eg, Supprelin® LA, Vantas®) in geriatric patients.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | X | Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 histrelin acetate. Make sure you tell your doctor if you have any other medical problems, especially:
A doctor or other trained health professional will give you or your child histrelin acetate. The histrelin implant will be placed under the skin of the upper arm.
Your doctor will treat the upper arm with a numbing medicine and then cut a small incision to insert the implant. The incision will be closed with either stitches or surgical strips. A pressure bandage will be placed over the arm and left in place for 24 hours.
Do not remove the surgical strips. Allow them to fall off on their own after several days. If the incision has been stitched, your doctor will remove the stitches or they will dissolve after several days.
After the implant is inserted, you or your child should keep the arm clean and dry. Do not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for the first 7 days after the implant is inserted.
You or your child may have some pain, redness, or bruising at the site where the implant is placed. If your arm has not healed within 2 weeks after you received the implant or if you continue to have redness or pain, call your doctor.
The implant will be left in place for one year (12 months) and then removed. If needed, your doctor will insert a new implant to continue treatment for another year.
histrelin acetate comes with patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the implant is in the proper place and if it is working properly.
For female patients: You should not receive histrelin acetate if you are pregnant or may become pregnant. Using histrelin acetate 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.
For children using Supprelin® LA: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.
For male patients:
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
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.
See also: histrelin acetate Subcutaneous side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Class: Serums
ATC Class: J06BB04
VA Class: IM100
Brands: HepaGam B, HyperHEP B, Nabi-HB
Specific immune globulin (hyperimmune globulin).110 Hepatitis B immune globulin (HBIG) contains antibody to hepatitis B surface antigen (anti-HBs) prepared from plasma of donors with high titers of anti-HBs and is used to provide temporary passive immunity to hepatitis B virus (HBV).101 112 116 128 129 132
Prevention of perinatal HBV infection in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) women.101 128 129 132
A combined regimen that includes active immunization with hepatitis B vaccine (HepB vaccine) and passive immunization with hepatitis B immune globulin (HBIG) is 85–95% effective in preventing acute and chronic HBV infection in infants born to women positive for both HBsAg and HBeAg.101 112 128
HBIG has been used alone for prevention of perinatal HBV infection in neonates born to HBsAg-positive women, but use of passive immunization alone is no longer recommended since a regimen that includes both HBIG and HepB vaccine is more effective.112 a
ACIP and AAP recommend routine serologic screening of all pregnant women during an early prenatal visit (e.g., first trimester) to determine their HBsAg status, even if they were tested previously or have already been vaccinated against HBV.101 128 129 Women who were not tested prenatally, those who engage in behaviors that put them at high risk for HBV (e.g., >1 sex partner in the previous 6 months, HBsAg-positive sex partner, evaluation or treatment for sexually transmitted diseases (STDs), recent or current injection drug abuse) and those with clinical hepatitis should be tested for HBsAg status when admitted to the hospital for delivery.101 128
To prevent perinatal HBV infection, ACIP and AAP recommend that all neonates born to HBsAg-positive women receive a dose of HBIG and a dose of HepB vaccine as soon as possible after birth (within 12 hours of birth), regardless of gestational age or birthweight.101 124 126 127 128 For neonates <2 kg, do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.101 128 127
If maternal HBsAg status is unknown at birth, give infant the first dose of HepB vaccine (within 12 hours of birth).101 124 127 128 Determine mother's HBsAg status as quickly as possible and, if positive, give infant a dose of HBIG as soon as possible (no later than 7 days of age).101 124 127 For neonates weighing <2 kg, if the mother's HBsAg status cannot be determined within 12 hours of birth, give a dose of HBIG as soon as possible (within 12 hours of birth) and do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.101 127 128
HBV postexposure prophylaxis (PEP) in certain individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of HBsAg-positive individuals).100 109 112 116 122 128 129 132
Depending on exposure circumstances, PEP regimen may include combined passive immunization with HBIG and active immunization with HepB vaccine to provide both short- and long-term protection.100 109 122 129
Multiple-dose regimen of HBIG alone (e.g., first dose at time of exposure and second dose 1 month later) is about 75% effective in preventing HBV infection following percutaneous exposure.10 22 100 112 122 However, since health-care personnel and others at risk of HBV exposure are candidates for preexposure vaccination with HepB vaccine and since combined passive and active immunization is more effective than HBIG alone following perinatal HBV exposure, combined active and passive immunization is preferred when PEP is indicated following an exposure to HBsAg-positive material.109 112 122 129
HBIG is most effective when administered as soon as possible after exposure (preferably within 24 hours) and may be ineffective if administered >7 days after a percutaneous exposure or >14 days after a sexual exposure.109 122 129
HBIG not indicated for treatment of acute or chronic HBV infection.101
PEP may be indicated in susceptible, unvaccinated health-care personnel following occupational exposure to blood and other body fluids that might contain HBV.122 If an occupational exposure to HBV occurs, review vaccination status and vaccine-response status (if known) of exposed individual and HBsAg status of source.122 (See Table 1.)
If exposed individual was not previously vaccinated against HBV, initiate HepB vaccine series as soon as possible (preferably within 24 hours).122 In addition, if source is found to be HBsAg-positive, give a dose of HBIG as soon as possible (preferably within 24 hours).122
If exposed individual was previously vaccinated against HBV and is a known responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.122 If exposed individual was previously vaccinated but is a known nonresponder (serum anti-HBs <10 mIU/mL), PEP is not necessary if source is HBsAg-negative.122 However, if source is HBsAg-positive or known to be high-risk for HBV, give exposed individual a dose of HBIG and initiate a second HepB vaccine series as soon as possible after exposure.122 A 2-dose regimen of HBIG (without HepB vaccine) is preferred in individuals who already previously failed to respond to a second vaccine series.122
If antibody status of exposed individual is unknown, test them for anti-HBs prior to initiation of PEP.122 If exposed individual is found to be a responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary.122 If exposed individual is found to be a nonresponder (anti-HBs levels <10 mIU/mL) and source is HBsAg-positive, give a dose of HBIG and a booster dose of HepB vaccine.122 If exposed individual is found to be a nonresponder and source is unknown or not available for testing, give a booster dose of HepB vaccine and recheck antibody titer in 1–2 months.122
| Treatment when Source Is: | ||
|---|---|---|---|
Vaccination and Antibody Status of Exposed Individual | HBsAg-positive | HBsAg-negative | Source Unknown or Not Available for Testing |
Unvaccinated | Single HBIG dose (within 24 hours) and initiate HepB vaccine series (within 24 hours) | Initiate HepB vaccine series | Initiate HepB vaccine series |
Previously vaccinated |
|
|
|
Known responder (anti-HBs ≥10 mIU/mL) | No treatment | No treatment | No treatment |
Known nonresponder (anti-HBs <10 mIU/mL) | Single HBIG dose and initiate HepB revaccination series or 2 HBIG doses (first dose as soon as possible; second dose 1 month later) | No treatment | If known high-risk source, treat as if source were HBsAg-positive |
Antibody response unknown | Test exposed individual for anti-HBs | No treatment | Test exposed individual for anti-HBs |
| 1. If inadequate, single dose of HBIG and a booster dose of HepB vaccine |
| 1. If inadequate, give a booster dose of HepB vaccine and recheck titer in 1–2 months |
| 2. If adequate, no treatment |
| 2. If adequate, no treatment |
ACIP and CDC recommend PEP with HepB vaccine with or without HBIG for victims of sexual assault (adult, adolescent, child) who are susceptible to HBV.109 129 PEP after a sexual assault is not necessary in those who previously received the complete HepB vaccine series.109 If victim is unvaccinated or incompletely vaccinated and perpetrator is HBsAg-positive, give a dose of HBIG within 14 days of the assault (preferably within 24 hours) and initiate or complete HepB vaccine series.109 129
ACIP and CDC recommend that previously unvaccinated sexual partners of individuals HbsAg-positive individuals receive PEP with a dose of HBIG and the initial dose of the HepB vaccine series (within 14 days of the most recent sexual contact).109 129 Completion of the vaccine series confers long-term protection in case the individual with acute HBV infection becomes chronically infected.109 129
AAP recommends that unvaccinated infants <12 months of age in close contact with a mother or other primary care-giver who has acute HBV infection receive combined passive immunization with HBIG and active immunization with HepB vaccine.101 If the infant previously received a single dose of HepB vaccine, give the second vaccine dose if the interval is appropriate or, if it is too soon to give a vaccine dose, give a dose of HBIG.101 HBIG is not required if, at the time of exposure, the infant has already received ≥2 doses of HepB vaccine.101
Other nonsexual household contacts of individuals with acute HBV infection are not at increased risk for infection unless they have other risk factors or are exposed to the blood of the infected patient (e.g., by sharing a toothbrush or razor).101 109 However, encourage all household contacts of patients with acute HBV infection to receive HepB vaccine.101 109 If the patient with acute HBV infection becomes chronically infected (i.e., remains HBsAg-positive after 6 months), all household contacts should be vaccinated with HepB vaccine.109
ACIP and CDC recommend PEP with HepB vaccine for sexual or needle-sharing partners and nonsexual household contacts of individuals with chronic HBV infection.109 129 Because most HBsAg-positive individuals are identified during routine screening (e.g., blood donation, prenatal evaluation) or clinical evaluation and it may be difficult to identify the time of last contact, HBIG is not considered necessary for PEP in contacts of such individuals.129 A dose of HBIG may be indicated if the most recent sexual exposure to an HBsAg-positive individual occurred within the last 14 days.109
CDC recommends that individuals wounded in bombings or other mass casualty settings who are unvaccinated or have an uncertain vaccination history receive postexposure vaccination with HepB vaccine (without HBIG).144 Responders and other personnel in mass casualty settings should be managed using PEP regimens recommended for occupational exposures to HBV.144 (See Table 1.)
PEP not necessary in individuals who previously received primary immunization with HepB vaccine and have serologic evidence of adequate levels of anti-HBs (≥10 mIU/mL).122
PEP not necessary in individuals previously infected with HBV; such individuals are immune to reinfection.122 134
Prevention of HBV recurrence in liver transplant recipients who are HBsAg-positive.132 135 136 137 138 139 140 141 142
HBIG has been used alone or in conjunction with an antiviral (e.g., lamivudine, adefovir) to suppress HBV replication and prevent recurrence of HBV infection in patients with chronic HBV infection undergoing liver transplantation.132 135 136 137 138 139 140 141 142 Optimum regimens for such prophylaxis (i.e., dosage, route, and duration of HBIG; specific antiviral for a combined regimen) not established.135 137 138 139 140 141 142
HepaGam B given by IV infusion is labeled by the FDA for prevention of HBV recurrence in liver transplant recipients based on interim results of a clinical study in HBsAg-positive, HBeAg-negative transplant recipients who had only low or undetectable levels of HBV replication at time of transplant.132
Although safety and efficacy not established, other HBIG preparations have been administered IM or IV† for prevention of HBV recurrence in liver transplant recipients and have been used alone or in conjunction with an antiviral active against HBV.135 136 137 138 139 140 141 142
HepaGam B, HyperHEP B, and Nabi-HB: Administer by IM injection for prevention of perinatal HBV infection and for postexposure prophylaxis of HBV infection.112 116 128 132 Do not administer IV for this indication.112 116
Inspect visually for particulate matter and discoloration.112 116 132
Administer undiluted.116 132 Do not mix with any other drug or solution.116 132
Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh.110 112 116 128 129 To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual's age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.110 128 129
For neonates and young children (up to 12 months of age), IM injections should be made into the anterolateral aspect of the thigh.110 128 For children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; deltoid muscle is an alternative if muscle mass is adequate.110 128 For children and adolescents 3–18 years of age and adults, deltoid muscle is preferred, although anterolateral thigh is an alternative.110 128 129
Because of the risk of injection-associated injury to the sciatic nerve, use gluteal region only when necessary (e.g., when a large volume or multiple doses are indicated).110 112 116 If use of gluteal area is considered necessary, use only the upper, outer quadrant; avoid central region.112 116
Although some manufacturers recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) should be performed to ensure that a blood vessel has not been entered,112 ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.101 110
May be given simultaneously with HepB vaccine (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to HBsAg-positive women, PEP regimen in certain individuals exposed to HBV or HBsAg-positive materials).101 110 112 124 128 129 132
HepaGam B: Administer by IV infusion for prevention of HBV recurrence in liver transplant recipients.132 Although safety and efficacy not established, other HBIG preparations have been administered by IV infusion† for this use.135 136 137 140 141
Do not mix with any other drug or solution.132 Administer using a separate IV line using an IV administration set via infusion pump.132
Do not shake vial; avoid foaming.132
HepaGam B: Administer by IV infusion at a rate of 2 mL/minute.132 Decrease to ≤1 mL/minute if patient develops discomfort or infusion-related adverse effects or if there is concern about the rate of infusion.132
Combined passive immunization with HBIG and active immunization with HepB vaccine is indicated.101 124 127 128
Give 0.5 mL of HBIG and a dose of monovalent HepB vaccine within 12 hours of birth (using different syringes and different injection sites).101 112 116 124 127 128 132
If first dose of HepB vaccine is delayed for ≥3 months, manufacturer of HyperHEP B recommends a second 0.5-mL dose of HBIG at 3 months of age.112 If HepB vaccine is contraindicated or not available, this manufacturer recommends second and third 0.5-mL doses of HBIG at 3 and 6 months of age, respectively.112
Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.100 101 124 127 128
Give a dose of monovalent HepB vaccine within 12 hours of birth.101 124 127 128 Determine HBsAg status of the mother as soon as possible.101 124 127 128
If mother is found to be HBsAg-positive, give neonate 0.5 mL of HBIG as soon as possible (no later than 1 week of age).101 124 127 128
If neonate was preterm and weighed <2 kg at birth, give neonate 0.5 mL of HBIG within 12 hours of birth if mother is found to be HBsAg-positive or if results are not available.101 127 128
Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.101 112
If mother or other primary care-giver has acute HBV infection, give 0.5 mL of HBIG and initiate or complete primary immunization with HepB vaccine.101 112 HBIG is not necessary if infant already received ≥2 doses of HepB vaccine.101
Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.109 129
If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours).109 129 Initiate or complete primary immunization with HepB vaccine.109 129
When source is known to be HBsAg-positive and exposed individual is unvaccinated or a known nonresponder to HepB vaccine (anti-HBs <10 mIU/mL), combined active immunization with HepB vaccine and passive immunization with HBIG is indicated.122 129 (See Table 1 under Uses.)
Give 0.06 mL/kg of HBIG within 24 hours of the exposure and initiate or complete primary immunization with HepB vaccine.122 129
In those who previously failed to respond to a second HepB vaccine series, give 0.06 mL/kg of HBIG within 24 hours of the exposure and 0.06 mL/kg 1 month later.122
Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.109 129
If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours).109 129 Initiate or complete primary immunization with HepB vaccine.109 129
Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.101 129
Give 0.06 mL/kg of HBIG within 14 days of the last sexual or intimate exposure and initiate or complete primary immunization with HepB vaccine.109 129
Give initial dose of 20,000 international units concurrently with grafting of transplanted liver (anhepatic phase).132 Give 20,000 international units once daily on postoperative days 1–7, once every 2 weeks during postoperative weeks 2–12, and once monthly beginning at postoperative month 4.132
Track treatment response by monitoring serum HBsAg and anti-HBs antibody levels.132
Dosage is designed to provide serum anti-HBs levels >500 international units/L.132 Adjust dosage if anti-HBs levels do not increase to ≥500 international units/L within the first postoperative week.132 In such cases, increase dosage to 10,000 international units every 6 hours until target anti-HBs level is reached.132 Individuals with surgical bleeding or abdominal fluid drainage (>500 mL) and those undergoing plasmapheresis are particularly susceptible to extensive loss of circulating anti-HBs.132
HepaGam B: Individuals with history of anaphylactic or severe systemic reactions to parenteral human immune globulin.132
HyperHEP B: Manufacturer states no known contraindications.112
Nabi-HB: Individuals with history of anaphylactic or severe systemic reactions to human immune globulin.116
Because HBIG is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).112 116 117 132
Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.100 104 112 116 132
Solvent/detergent inactivation processes apparently can inactivate lipid-enveloped viruses (e.g., HBV, hepatitis C virus [HCV], HIV type 1 and type 2 [HIV-1 and HIV-2]), but are less effective against viruses that do not have a lipid envelope (e.g., hepatitis A virus [HAV], parvovirus B-19).116 132 Certain filtering procedures are effective in reducing levels of some enveloped and non-enveloped viruses.132
Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge which may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, administer HBIG only when a benefit is expected.112 116 132
Any infection believed to have been transmitted by HBIG should be reported to the manufacturer.112 116 132
Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals.110 112 116 132 Administer IM in these patients only if expected benefits outweigh potential risks.112 116 132
ACIP states that IM injections can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient's bleeding risk determines that the injection can be administered with reasonable safety.110 In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.110 If patient is receiving antihemophilia therapy, administer the IM dose shortly after a scheduled dose of such therapy.110
Advise individual and/or their family about the risk of hematoma from IM injections.110
HBIG preparations that contain maltose (HepaGam B) may cause falsely elevated results in blood glucose determinations that use glucose dehydrogenase pyrroloquinequinone (GDH-PQQ).132 133 (See Specific Drugs and Laboratory Tests under Interactions.)
Although not reported to date with HBIG, anaphylaxis has been reported rarely following administration of human immune globulins.112 116 132
Use caution in individuals with history of systemic allergic reactions to immune globulins.112
Epinephrine should be readily available in case anaphylaxis occurs.112 132 If hypotension or a hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately discontinue HBIG and institute appropriate therapy as indicated.132
Use caution in individuals with specific IgA deficiency; these individuals may have antibodies to IgA or may develop such antibodies following administration of HBIG preparations containing IgA.116 132 Anaphylaxis could occur.116 132
HepaGam B contains <40 mcg/mL and Nabi-HB contains <100 mcg/mL of IgA.116 132 Weigh potential benefits against potential for hypersensitivity reaction.116 132
May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.110 130
Recommendations regarding use in HIV-infected individuals or use in neonates born to HIV-infected women are the same as those for individuals who are not infected with HIV.110 126 127 130
HyperHEP B administered by IV infusion may be associated with certain adverse effects related to the rate of infusion.132 Do not exceed recommended infusion rate (2 mL/minute).132 Monitor closely during and immediately following infusion.132
All infants born to HBsAg-positive women should undergo serologic testing at 9–18 months of age (usually at next well-child visit) to document whether the combined regimen of active immunization with HepB vaccine and passive immunization with HBIG prevented perinatal HBV infection.101 128 Do not test before 9 months of age to avoid detecting anti-HBs passively acquired from the HBIG dose administered at birth and to maximize the likelihood of detecting late HBV infections.101 This follow-up serologic testing not necessary in infants born to HBsAg-negative women.101 128
Prior to initiation of HBV postexposure prophylaxis, serologic testing usually is indicated to determine immune status of individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of individuals with acute HBV infection).122 In those who have had sexual or intimate exposure to individuals with acute HBV infection, such testing should be done only if it will not delay administration of HBIG beyond 14 days.109
If a combined regimen of HBIG and HepB vaccine is used for postexposure prophylaxis following exposure to HBV or HBsAg-positive materials, postvaccination testing for anti-HBs should not be performed until 3–4 months after the HBIG dose.122 (See Specific Drugs and Laboratory Tests under Interactions.)
Category C.112 116 132
Because of potential risks to the neonate from exposure to HBV infection, pregnancy is not considered a contraindication to use of HBIG when indicated.122
ACIP states there are no known risks associated with use of immune globulins for passive immunization in pregnant women.110
Not known whether HBIG is distributed into milk; use caution.116 132
HepaGam B: Labeled by the FDA for use in neonates and children.132
HyperHEP B and Nabi-HB: Although safety and efficacy not established in infants and children,112 116 safety and efficacy of similar HBIG preparations have been demonstrated in infants and children.116
HBIG is used in conjunction with HepB vaccine for postexposure prophylaxis in neonates born to HBsAg-positive mothers and for postexposure prophylaxis in unvaccinated children <12 months of age whose mother or primary care-giver has acute HBV infection.101 112 132 (See Uses.)
Nabi-HB: Clinical studies did not include sufficient numbers of adults ≥65 years of age to determine whether geriatric adults respond differently than younger individuals.116 Other reported clinical experience has not identified differences in responses between geriatric and younger individuals.116
IM injection: Injection site reactions (pain, tenderness, swelling, erythema),112 116 122 headache,116 132 myalgia,116 malaise,116 GI effects (nausea, vomiting),116 132 flu or cold symptoms,132 lightheadedness/fainting.132
IV infusion: Tremor and hypotension reported with HepaGam B given by IV infusion.132 Chills, fever, headache, vomiting, allergic reactions, nausea, arthralgia, moderate low back pain have been reported with other IV immune globulins.132
Immune globulins, including HBIG, are not expected to have a clinically important effect on the immune response to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, or toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after HBIG.101 110 Neonates born to HBsAg-positive women who receive combined passive immunization with HBIG and active immunization with HepB vaccine at birth can receive other age-appropriate vaccines according to the usually recommend childhood immunization schedule.110
Antibodies present in immune globulins, including HBIG, may interfere with the immune response to certain live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rotavirus vaccine live oral, rubella virus vaccine live, varicella virus vaccine live); these vaccines should not be administered simultaneously with or for specified intervals before or after HBIG.101 110 128 131 132 (See Specific Drugs and Laboratory Tests under Interactions.) There is no evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live, typhoid vaccine live oral, influenza virus vaccine live intranasal, or poliovirus vaccine live oral (OPV; no longer commercially available in the US).101 110
Drug or Test | Interaction | Comments |
|---|---|---|
Hepatitis B (HepB) vaccine | Passively acquired antibody to hepatitis B surface antigen (anti-HBs), which is present in HBIG, does not appear to interfere with the active immune response to HepB vaccine112 | When combined active immunization with HepB vaccine and passive immunization with HBIG is indicated, the first dose of vaccine should be administered simultaneously with HBIG (using different syringes and injection sites)122 128 129 132 HepaGam B: May be given concurrently with (at a different site) or up to 1 month preceding HepB vaccine without impairing the active immune response to the vaccine132 |
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation) | Recommendations for use of immune globulins in patients receiving immunosuppressive agents are the same as those for patients not receiving such agents130 | |
Influenza vaccine | Intranasal live influenza vaccine: No evidence that immune globulin preparations interfere with the immune response to the vaccine110 Parenteral inactivated influenza vaccine: Interference with the immune response to this inactivated vaccine is not expected110 | Intranasal live influenza vaccine or parenteral inactivated influenza vaccine may be given simultaneously with or at any interval before or after HBIG110 |
Measles, mumps, and rubella vaccine (MMR) | HBIG may interfere with the immune response to measles virus vaccine live and rubella virus vaccine live; the effect of HBIG on the immune response to mumps virus vaccine live is unknown101 110 128 132 | MMR (or its individual components) should not be administered simultaneously with or within 3 months before or after HBIG101 110 128 132 If a dose of MMR (or its individual components) is given simultaneously with or within 14 days before or after a dose of HBIG, the MMR dose (or its individual components) should be repeated >3 months after the HBIG dose unless serologic testing is feasible and indicates a response to the vaccine was attained101 110 132 |
Rotavirus vaccine | Safety and efficacy data not available regarding use of rotavirus vaccine in infants who have received an immune globulin within 42 days131 | If possible, defer dose of rotavirus vaccine until 42 days (6 weeks) after the immune globulin; use a shorter interval if the 42-day deferral would result in the first dose of rotavirus vaccine being scheduled at ≥13 weeks of age110 |
Tests for anti-HBs | Anti-HBs present in serum for 2–6 months following a dose of HBIG and may result in positive tests for anti-HBs that reflect passively-acquired antibody rather than an immune response to HepB vaccine122 128 129 | In neonates who receive postexposure prophylaxis with both HBIG and HepB vaccine (i.e., those born to HBsAg-positive mothers), do not perform postvaccination testing for anti-HBs to confirm an immunologic response to the vaccine until ≥9 months of age to avoid detecting passively-acquired antibody from HBIG128 If a combined regimen of HBIG and HepB vaccine is used for postexposure prophylaxis following exposure to HBV or HBsAg-positive materials, do not perform postvaccination testing for anti-HBs until 3–4 months after the HBIG dose122 |
Tests for glucose | Maltose contained in HepaGam B may interfere with blood glucose monitoring systems based on glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) and cause falsely elevated blood glucose results; this may result in inappropriate insulin administration and life-threatening hypoglycemia or may mask true hypoglycemia132 133 | Use only glucose-specific test methods not affected by maltose (e.g., glucose dehydrogenase nicotine adenine dinucleotide [GDH-NAD], glucose oxidase, glucose hexokinase) in patients receiving HepaGam B132 133 Carefully review product information for the blood glucose testing meter and test strips to determine if the testing system is appropriate;132 133 if any uncertainty exi |
