Generic Name: vaccinia immune globulin, human (Intravenous route)

Commonly used brand name(s):

In the U.S.

• Vaccinia IVIG

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Serum

Uses For Vaccinia IVIG

Vaccinia immune globulin is used to treat infections caused by the vaccinia virus.

Before Using Vaccinia IVIG

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

Allergies

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

Pediatric

Studies on this medicine have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin in children with use in other age groups.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Vaccinia keratitis—Use is not recommended.

• Hyperviscosity, known or suspected—May increase chance for serious side effects

• Immunoglobulin A (IgA) deficiency—Increased risk for allergic reaction

Proper Use of Vaccinia IVIG

Make sure you discuss the risks and benefits of this medicine with your doctor.

Report all infections thought to have been possibly transmitted by this product by having your doctor call Cangene Corporation at 1-877-CANGENE.

Dosing

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

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

• For injectable dosage form:
  • For treatment and/or medical problems due to vaccinia virus:
    • Adults—Dose is based on weight and will be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Precautions While Using Vaccinia IVIG

Tell your healthcare provider if you have ever had a reaction to a vaccination.

Vaccinia IVIG Side Effects

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

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

Incidence unknown

• Fever
• headache
• nausea
• stiff neck or back

Observed postmarketing

• Back, leg or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, loosening of skin
• bluish color of fingernails, lips, skin, palms, or nail beds
• blurred vision
• change in consciousness
• chest pain
• chills
• cold, clammy, pale skin
• confusion
• convulsions
• cough
• coughing that produces a pink frothy sputum
• dark urine
• decreased urination
• diarrhea
• difficulty or labored breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fatigue
• general body swelling
• itching
• irregular heartbeats
• joint or muscle pain
• light-colored stools
• loss of appetite
• loss of bladder control
• loss of consciousness
• muscle spasms or jerking of all extremities
• nausea or vomiting
• no blood pressure or pulse
• noisy breathing
• nosebleeds
• not breathing
• pain in chest, groin, or legs, especially the calves
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• severe, sudden headache
• severe weakness or numbness in arm or leg
• shortness of breath
• slow heart rate
• slurred speech
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stopping of heart
• sudden loss of coordination
• suddenly sweating
• swelling in legs and ankles
• swollen glands
• tightness in chest
• troubled breathing
• unconsciousness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• wheezing
• yellowing of the eyes or skin

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

More common

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• eye disorder
• energy increased
• feeling unusually cold
• feeling hot
• lack or loss of strength
• lip dry
• muscle pain
• shakiness in legs, arms, hands, feet
• shivering
• trembling or shaking of hands or feet

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.

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

Generic Name: estradiol vaginal (local) (ess tra DYE ole VAJ in ul (LO kul))
Brand Names: Estrace Vaginal Cream, Estring, Vagifem

What is estradiol vaginal (local)?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

Estradiol vaginal (local) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol vaginal also reduces urgency or irritation of urination.

Estradiol vaginal (local) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about estradiol vaginal (local)?

Some estradiol products placed directly into the vagina are used for “local” treatment of vaginal menopause symtoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has “systemic” effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol.

What should I discuss with my healthcare provider before using estradiol vaginal (local)?

Do not use estradiol vaginal if you have:

• a bleeding or blood-clotting disorder;

• a history of stroke or circulation problems;

• abnormal vaginal bleeding that a doctor has not checked; or

• any type of breast, uterine, or hormone-dependent cancer.

Before using estradiol vaginal, tell your doctor if you have:

• high blood pressure, angina, or heart disease;

• high cholesterol or triglycerides;

• liver disease;
• kidney disease;

• asthma;

• epilepsy or other seizure disorder;

• migraines;

• diabetes;

• depression;

• gallbladder disease; or

• if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may not be able to use estradiol vaginal, or you may need a dosage adjustment or special tests during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol vaginal.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol vaginal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estradiol may decrease breast milk flow and have other effects on milk composition. Do not use estradiol without first talking to your doctor if you are breast-feeding a baby.

How should I use estradiol vaginal (local)?

Some estradiol products placed directly into the vagina are used for “local” treatment of vaginal menopause symtoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has “systemic” effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

To use the estradiol vaginal ring:

• Squeeze the sides of the ring together and insert it into the vagina as far as possible. You should not be able to feel the ring once it is in place. If you can feel it, use a finger to push it in farther. It is not possible for the ring to go too far in or become lost.

• Leave the ring in place for 90 days. If the ring ever falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. After 90 days, remove the ring. Your doctor may want you to replace it with a new ring.

• The ring does not need to be removed during sexual intercourse. Neither partner should be able to feel the ring when it is in place. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.

• To remove the ring, loop a finger through the ring and gently pull it from the vagina.

To use the estradiol vaginal cream:

• Using the marked applicator provided, measure the prescribed dose of cream.

• Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the cream from the applicator into the vagina.

• Take apart the applicator and wash it with mild soap and warm water. Allow the applicator to dry completely before using it again.

To use the estradiol vaginal tablets:

• Each vaginal tablet is supplied in a disposable applicator.

• Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the tablet into the vagina.

• Throw the applicator away.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an estradiol vaginal overdose may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using estradiol vaginal (local)?

Avoid using other vaginal products without your doctor’s advice.

Estradiol vaginal (local) side effects

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

• 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;

• pain or swelling in your lower leg;

• abnormal vaginal bleeding;

• pain, swelling, or tenderness in your stomach;

• jaundice (yellowing of the skin or eyes); or

• a lump in your breast.

Other less serious side effects are more likely to occur, such as:

• nausea, vomiting, loss of appetite;

• swollen breasts;

• acne or skin color changes;

• decreased sex drive, impotence, or difficulty having an orgasm;

• migraine headaches or dizziness;

• vaginal pain, dryness, or discomfort;

• swelling of your ankles or feet;

• depression; or

• changes in your menstrual periods, break-through bleeding.

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.

What other drugs will affect estradiol vaginal (local)?

Before using estradiol vaginal, tell your doctor if you are using any of the following drugs:

• St. John’s wort;

• phenobarbital (Luminal, Solfoton);

• a blood thinner such as warfarin (Coumadin);

• ritonavir (Norvir);

• carbamazepine (Carbatrol, Tegretol);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estradiol vaginal or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estradiol vaginal. 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.

Where can I get more information?

• Your pharmacist has more information about estradiol vaginal (local) written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:42:54 PM.

Generic Name: isometheptene, dichloralphenazone, and acetaminophen (Oral route)

eye-soe-meth-EP-teen MUE-kate, dye-klor-al-FEN-a-zone, a-seet-a-MIN-oh-fen

Commonly used brand name(s):

In the U.S.

• Amidrine
• Diacetazone
• Duradrin
• Epidrin
• Iso-Acetazone
• Midrin
• Migquin
• Migratine
• Migrazone
• Migrin-A
• Va-Zone

Available Dosage Forms:

• Capsule

Therapeutic Class: Acetaminophen Combination

Pharmacologic Class: Isometheptene

Uses For Va-Zone

Isometheptene, dichloralphenazone, and acetaminophen combination is used to treat certain kinds of headaches, such as “tension” headaches and migraine headaches. This combination is not used regularly (for example, every day) to prevent headaches. It should be taken only after headache pain begins, or after a warning sign that a migraine is coming appears. Isometheptene helps to relieve throbbing headaches, but it is not an ordinary pain reliever. Dichloralphenazone helps you to relax, and acetaminophen relieves pain.

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

Before Using Va-Zone

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

Allergies

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

Pediatric

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

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.

• Clorgyline
• Iproniazid
• Isocarboxazid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Selegiline
• Toloxatone
• Tranylcypromine

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

• Bromocriptine
• Fospropofol

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

• Acenocoumarol
• Carbamazepine
• Isoniazid
• Phenytoin
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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

• Cabbage

Other Medical Problems

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

• Alcohol abuse or
• Heart attack (recent) or
• Heart or blood vessel disease or
• Kidney disease or
• Liver disease or
• Stroke (recent) or
• Virus infection of the liver (viral hepatitis)—The chance of side effects may be increased

• Glaucoma, not well controlled, or
• High blood pressure (hypertension), not well controlled—The isometheptene in this combination medicine may make these conditions worse

Proper Use of isometheptene, dichloralphenazone, and acetaminophen

This section provides information on the proper use of a number of products that contain isometheptene, dichloralphenazone, and acetaminophen. It may not be specific to Va-Zone. 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 than directed, and do not take it every day for several days in a row. If the amount you are to take does not relieve your headache, check with your doctor. If a headache medicine is used too often, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse. Also, taking too much acetaminophen can cause liver damage.

This medicine works best if you:

• Take it as soon as the headache begins. If you get warning signals of a migraine, take this medicine as soon as you are sure that the migraine is coming. This may even stop the headache pain from occurring.
• Lie down in a quiet, dark room until you are feeling better.

People who get a lot of headaches may need to take a different medicine to help prevent headaches. It is important that you follow your doctor’s directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve, than before. This will reduce the amount of headache relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

Dosing

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

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

• For “tension” headaches:
  • Adults: 1 or 2 capsules every 4 hours, as needed. Not more than 8 capsules a day.
  • Children: Dose must be determined by the doctor.
• For migraine headaches:
  • Adults: 2 capsules for the first dose, then 1 capsule every hour, as needed. Not more than 5 capsules in 12 hours.
  • Children: Dose must be determined by the doctor.

Precautions While Using Va-Zone

Check with your doctor:

• If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not try to get better relief by increasing the dose.
• If you are having headaches more often than you did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Check the labels of all nonprescription (over-the-counter [OTC]) and prescription medicines you now take. Taking other medicines that contain acetaminophen together with this medicine may lead to an overdose. If you have any questions about this, check with your health care professional.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with this medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; antiemetics (medicines that prevent or relieve nausea or vomiting), and anesthetics. If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are drowsy or dizzy or are not alert.

Do not drink alcoholic beverages while taking this medicine. To do so may increase the chance of liver damage caused by acetaminophen, especially if you drink large amounts of alcoholic beverages regularly. Also, because drinking alcoholic beverages may make your headaches worse or cause new headaches to occur, people who often get headaches should probably avoid alcohol.

Va-Zone Side Effects

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

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

Less common

• Unusual tiredness or weakness

Rare

• Black, tarry stools
• blood in urine or stools
• pinpoint red spots on skin
• skin rash, hives, or itching
• sore throat and fever
• unusual bleeding or bruising
• yellow eyes or skin

Symptoms of dependence on this medicine

• Headaches, more severe and/or more frequent than before

Symptoms of acetaminophen overdose

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• pain, tenderness, and/or swelling in the upper abdominal (stomach) area
• stomach cramps or pain

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

More common

• Drowsiness

Rare

• Dizziness
• fast or irregular heartbeat

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.

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

Pronunciation: (vax-IN-ee-ah ih-MYOON GLAH-byoo-lin)
Class: Immune globulin

Trade Names:
Vaccinia Immune Globulin Intravenous (Human)
- Solution for injection 50 mg/mL (immunoglobulin 2,500 mg/vial)

Pharmacology

Vaccinia-specific immunoglobulin G (IgG) that directly neutralizes vaccinia virus.

Pharmacokinetics

Elimination

Serum t _½ is about 22 days.

Indications and Usage

Treatment and/or modification of aberrant infections induced by vaccinia virus (including accidental implantation in eyes, mouth, or other areas where vaccinia infection would constitute a special hazard), eczema vaccinatum, progressive vaccinia, severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy, or in individuals with eczematous skin lesions. Treat complications that include vaccinia keratitis with caution.

Contraindications

Isolated vaccinia keratitis; prior severe reactions associated with parenteral use of vaccinia immune globulin IV or other human immunoglobulin preparations; people with selective IgA deficiency.

Dosage and Administration

Adults

IV 2 mL/kg (100 mg/kg) as IV infusion. Dose may be repeated, depending on severity of symptoms and response to treatment.

Higher doses (200 or 500 mg/kg) may be considered in the event the patient does not respond to the initial 100 mg/kg dose. Do not use doses greater than 400 mg/kg in patients predisposed to renal complications.

General Advice

• For IV infusion only. Not for oral, intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Remove tab portion of vial cap and clean rubber stopper with 70% alcohol or equivalent. Do not shake vial to avoid foaming. Withdraw prescribed dose. Administer without further dilution within 6 h of entering the vial. Complete dose within 12 h of entering the vial.
• Visually inspect solution before use. Do not use if particulate matter, cloudiness, or discoloration noted.
• Administer with a constant infusion pump through a dedicated IV catheter with administration set that contains an in-line filter (0.22 mcm pore size). May be piggybacked into a preexisting catheter if the catheter contains either sodium chloride 0.9% injection or one of the following dextrose solutions (with or without sodium chloride): 2.5%, 5%, 10%, or 20% dextrose in water. Flush the line before use and do not dilute the vaccinia immune globulin IV more than 1:2 (v/v).
• Administer by IV infusion at rate of 1 mL/kg/h for first 30 min, increased to 2 mL/kg/h for the next 30 min, and then to 3 mL/kg/h for the remainder of the infusion, as tolerated. Do not exceed these rates of administration.
• Monitor patient closely during and after each infusion rate change for minor (flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, wheezing) and serious (anaphylaxis, hypotension, respiratory distress) infusion-related reactions. If patient develops a minor adverse reaction, slow the rate of infusion or temporarily interrupt the infusion. For serious adverse reactions, discontinue the infusion and be prepared to treat appropriately.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F).

Drug Interactions

Live virus vaccines

To avoid interference with immune response to live virus vaccines, defer vaccination with live virus vaccines for about 6 mo after giving vaccinia immune globulin IV.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness, headache, somnolence (at least 5%).

Dermatologic

Contact dermatitis, erythema, flushing, skin lacerations, urticaria (at least 5%).

EENT

Nasal congestion, sore throat (at least 5%).

GI

Abdominal pain, nausea, toothache (at least 5%).

Local

Injection site reaction (at least 5%).

Musculoskeletal

Arthralgia, back pain (at least 5%).

Respiratory

Dyspnea, upper respiratory tract infection (at least 5%).

Precautions

Warnings Immune globulin IV (Human) products have been reported to be associated with renal function impairment, acute renal failure, osmotic nephrosis, proximal tubular nephropathy, and death. Although many immune globulin IV products have been associated with renal function impairment and acute renal failure, a disproportionate share of the cases were associated with immune globulin IV products that contained sucrose as a stabilizer and were administered at daily doses of 400 mg/kg or more. Immune globulin IV contains sucrose (5%) as a stabilizer, and the recommended dose is 100 mg/kg. Risk factors that predispose to acute renal failure include: any degree of preexisting renal function impairment, diabetes mellitus, volume depletion, sepsis, paraproteinemia, older than 65 yr of age, and concurrent treatment with nephrotoxic drugs. Immune globulin IV should be administered at the minimum concentration available and at the minimum rate of infusion practical, especially in patients predisposed to renal failure.

Monitor Monitor vital signs continuously during administration and observe for any symptoms throughout the infusion.

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Safety and efficacy not established.

Hypersensitivity

Serious reactions can occur. Have epinephrine and resuscitation equipment readily available. Monitor patient for signs and symptoms of allergic reaction. Discontinue therapy immediately severe or anaphylactic reaction noted.

Renal Function

Use with caution in patients with renal function impairment and patients with increased risk of developing renal function impairment. Ensure that such patients are not volume depleted before infusion. Do not exceed recommended infusion rate.

Aseptic meningitis syndrome

Occurs infrequently and usually begins several h to 2 days after treatment. Signs and symptoms of aseptic meningitis include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting.

Hemolysis

Immune globulin IV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin, causing a positive direct antiglobulin reaction and, rarely, hemolysis. Monitor patients for signs and symptoms of hemolysis (unexplained fatigue, jaundice, splenomegaly).

Transfusion-Related Acute Lung Injury (TRALI)

Noncardiogenic pulmonary edema has been reported in patients administered immune globulin IV, usually within 1 to 6 h following infusion. Monitor patients for adverse pulmonary reactions (eg, severe respiratory distress, pulmonary edema, hypoxemia, fever, normal left ventricular function). Be prepared to provide oxygen therapy and ventilatory support. Ensure that tests for antineutrophil antibodies in the immune globulin IV and patient are performed and evaluated.

Thrombotic events

Thrombotic events have been reported in association with IGIV. Risk factors may include: history of atherosclerosis, multiple CV risk factors, advanced age, impaired cardiac output, and/or known or suspected hyperviscosity. Ensure that baseline blood viscosity is assessed in patients at risk for hyperviscosity (eg, cryoglobulins, monoclonal gammopathy, fasting chylomicronemia, markedly high triglycerides). Monitor patients for signs and symptoms of thromboembolic events (eg, venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, arterial occlusion).

Overdosage

Symptoms

Manifestations would be related to volume overload.

Patient Information

• Review benefits of therapy and risks, including potential to transmit disease and unknown infectious agents.
• Advise patient or caregiver that medication will be prepared and administered by a health care professional in a health care setting.
• Instruct patient to immediately report any of the following to health care provider: decreased urine output, sudden weight gain, fluid retention or swelling, unexplained shortness of breath, fever, severe headache, stiff neck, unexplained drowsiness or fatigue, painful eye movements, sensitivity to bright light, persistent or worsening nausea and vomiting.

Copyright © 2009 Wolters Kluwer Health.