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zidovudine (Intravenous route)

30/06/10

zye-DOE-vue-deen

Intravenous routeSolution

Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV disease. Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported .

Oral routeCapsuleTabletSyrup

Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV disease.

Prolonged use of zidovudine has been associated with symptomatic myopathy.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur .

Commonly used brand name(s):

In the U.S.

Retrovir

Available Dosage Forms:

Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For zidovudine

Zidovudine (also known as AZT) injection is used in combination with other anti-virus medicines in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). Zidovudine injection is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all. zidovudine also is used to help prevent pregnant women who have HIV from passing the virus to their babies during pregnancy and at birth.

Zidovudine injection will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Zidovudine injection will not keep you from spreading HIV to other people. People who receive zidovudine may continue to have the problems usually related to AIDS or HIV disease.

zidovudine is available only with your doctor’s prescription.

Before Using zidovudine

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 zidovudine, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

Although appropriate studies on the relationship of age to the effects of zidovudine injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment of dosage in patients receiving zidovudine injection.

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

Using zidovudine 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.

Dapsone
Doxorubicin Hydrochloride
Flucytosine
Ganciclovir
Interferon Alfa
Pyrazinamide
Pyrimethamine
Ribavirin
Stavudine
Vinblastine
Vincristine
Vincristine Liposome

Using zidovudine 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.

Acetaminophen
Interferon Beta-1a
Methadone
Nelfinavir
Probenecid
Rifabutin
Rifampin
Rifapentine
Tipranavir
Valproic Acid

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.

Proper Use of zidovudine

A nurse or other trained health professional will give you zidovudine. zidovudine is given through a needle placed in one of your veins.

Your doctor may give you a few doses of zidovudine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using zidovudine

It is very important that your doctor check you or your child’s progress at regular visits to make sure that zidovudine is working properly. Blood tests may be needed to check for unwanted effects.

Do not receive zidovudine if you are also using any combination medicines that also contain zidovudine (e.g., Combivir® or Trizivir®). To do so may increase the amount of zidovudine in your body which may cause serious side effects. Also, do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zidovudine injection may cause blood problems. These problems may result in a greater chance of certain infections and slow healing. Therefore, you or your child should be careful when using regular toothbrushes, dental floss, and toothpicks not to damage your gums. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Check with your doctor if you have muscle pain, tenderness, wasting, or unusual tiredness or weakness while you are receiving zidovudine.

Two rare but serious reactions to zidovudine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

Zidovudine injection does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles with anyone or use dirty needles. If you have any questions about this, check with your doctor.

zidovudine Side Effects

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

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

More common

Abdominal pain
black, tarry stools
chills
cough
feeling of fullness
fever
lower back or side pain
painful or difficult urination
pale skin
right upper abdominal pain and fullness
shortness of breath
sore throat
swelling or inflammation of the mouth
swollen lymph nodes
ulcers, sores, or white spots in the mouth
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Less common

Troubled breathing with exertion

Incidence not known

Abdominal discomfort
back, leg, or stomach pains
bleeding gums
blistering, peeling, or loosening of the skin
bloating
blood in the urine
blurred vision or other change in vision
bone pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
burning, tingling, numbness or pain in the hands, arms, feet, or legs
clay-colored stools
constipation
cough or hoarseness
convulsions
dark-colored urine
decreased appetite
decreased urine output
diarrhea
difficult or labored breathing
difficulty in moving
difficulty in swallowing
dilated neck veins
dizziness
extreme fatigue
fainting
fast, irregular, or pounding heartbeat
fast, shallow breathing
general body swelling
general feeling of discomfort or illness
general tiredness and weakness
headache
high fever
hives
increased need to urinate
indigestion
irregular breathing
irritation or soreness of the mouth
joint or muscle pain
lack of coordination
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
muscle pain or cramping
muscle spasm or stiffness
muscular pain, tenderness, wasting, or weakness
nausea or vomiting
nosebleeds
pain
pains in the stomach, side, or abdomen, possibly radiating to the back
passing urine more often
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red skin lesions, often with a purple center
red, irritated eyes
redness, soreness, or itching skin
runny nose
sensation of pins and needles
shakiness in the legs, arms, hands, or feet
shivering
skin rash
sleepiness
sores, welting, or blisters
stabbing pain
sweating
swollen joints
swollen or painful glands
tightness in the chest
trembling or shaking of the hands or feet
trouble sleeping
unexplained bleeding or bruising
unpleasant breath odor
vomiting of blood
weight gain
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

Lack or loss of strength

Incidence not known

Acid or sour stomach
actions that are out of control
belching
bloated
change in taste or bad, unusual, or unpleasant (after) taste
changes in skin color
difficulty seeing at night
discouragement
dizziness or lightheadedness
excess air or gas in the stomach or intestines
fear or nervousness
feeling of constant movement of self or surroundings
feeling sad or empty
hearing loss
heartburn
impaired vision
increased sensitivity of the eyes to sunlight
irritability
itching skin
loss of interest or pleasure
mood or mental changes
pain or tenderness around the eyes and cheekbones
passing gas
redness of the skin
sensation of spinning
sleepiness or unusual drowsiness
sleeplessness
sneezing
stuffy nose
swelling of the breasts or breast soreness in both females and males
talking, feeling, and acting with excitement
trouble concentrating
unable to sleep
weight loss

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.

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Zide

30/06/10

Generic Name: hydrochlorothiazide (Oral route)

hye-droe-klor-oh-THYE-a-zide

Commonly used brand name(s):

In the U.S.

Aquazide H
Hydrocot
Microzide
Zide

Available Dosage Forms:

Tablet
Capsule
Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Zide

Hydrochlorothiazide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Hydrochlorothiazide is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine .

Hydrochlorothiazide is a thiazide diuretic (water pill). It is used to help reduce the amount of water in the body by increasing the flow of urine. It may also be used for other conditions as determined by your doctor .

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

Before Using Zide

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hydrochlorothiazide capsules or tablets in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of hydrochlorothiazide capsules in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving hydrochlorothiazide capsules .

No information is available on the relationship of age to the effects of hydrochlorothiazide tablets in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving hydrochlorothiazide tablets .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

Dofetilide

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.

Acetyldigoxin
Arsenic Trioxide
Deslanoside
Digitalis
Digitoxin
Digoxin
Droperidol
Flecainide
Ketanserin
Levomethadyl
Lithium
Metildigoxin
Ouabain
Proscillaridin
Sotalol

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.

Aceclofenac
Acemetacin
Alacepril
Alclofenac
Apazone
Benazepril
Benoxaprofen
Bepridil
Bromfenac
Bufexamac
Calcium Carbonate
Captopril
Carbamazepine
Carprofen
Celecoxib
Chlorpropamide
Cholestyramine
Cilazapril
Clometacin
Clonixin
Cyclophosphamide
Delapril
Dexketoprofen
Diclofenac
Diflunisal
Dipyrone
Droxicam
Enalaprilat
Enalapril Maleate
Etodolac
Etofenamate
Felbinac
Fenbufen
Fenoprofen
Fentiazac
Floctafenine
Flufenamic Acid
Flurbiprofen
Fosinopril
Ginkgo
Glipizide
Gossypol
Ibuprofen
Imidapril
Indomethacin
Indoprofen
Isoxicam
Ketoprofen
Ketorolac
Licorice
Lisinopril
Lornoxicam
Meclofenamate
Mefenamic Acid
Meloxicam
Moexipril
Nabumetone
Naproxen
Niflumic Acid
Nimesulide
Oxaprozin
Oxyphenbutazone
Pentopril
Perindopril
Phenylbutazone
Pirazolac
Piroxicam
Pirprofen
Propyphenazone
Proquazone
Quinapril
Ramipril
Rofecoxib
Spirapril
Sulindac
Suprofen
Temocapril
Tenidap
Tenoxicam
Tiaprofenic Acid
Ticrynafen
Tolmetin
Topiramate
Trandolapril
Zofenopril
Zomepirac

Interactions with Food/Tobacco/Alcohol

Proper Use of hydrochlorothiazide

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

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium or potassium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to receive it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

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 fluid retention (edema):
- For oral dosage forms (tablets):
  - Adults—The usual dose is 25 to 100 milligrams (mg) daily as a single or divided dose. Your doctor may want you to take this dose every other day or on three to five days each week.
  - Children—Dose is based on body weight and must be determined by your doctor .
For high blood pressure:
- For oral dosage forms (capsule):
  - Adults—At first, 12. 5 milligrams (mg) or one capsule once a day. Your doctor may want you to take this alone or together with other blood pressure medicines.
  - Children—Use and dose must be determined by your doctor .
- For oral dosage forms (tablets):
  - Adults—At first, 25 milligrams (mg) once a day. This may be increased by your doctor and may be taken as a single dose or divided into two doses.
  - Children—Dose is based on body weight and must be determined by your doctor .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Zide

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

Check with your doctor right away if you have any of the following symptoms while taking this medicine: convulsions or seizures; decreased urine; drowsiness; dry mouth; excessive thirst; muscle pains or cramps; nausea or vomiting; increased heart rate or pulse; or unusual tiredness or weakness. These may be symptoms of a condition called hypokalemia or potassium loss .

This medicine may cause some people to become dizzy. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy.

Drinking alcoholic beverages may also make the dizziness worse. While you are taking this medicine, be careful to limit the amount of alcohol you drink .

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests (e.g., tests for parathyroid function) may be affected by this medicine .

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

Zide 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 not known

Abdominal or stomach pain
back, leg, or stomach pains
black, tarry stools
bleeding gums
blistering, peeling, or loosening of skin
bloating
blood in urine or stools
bloody urine
blue lips and fingernails
blurred vision
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
chest pain
chills
clay-colored stools
cloudy urine
cold sweats
confusion
constipation
cough or hoarseness
coughing that sometimes produces a pink frothy sputum
coughing up blood
cracks in the skin
darkened urine
decrease in urine output or decrease in urine-concentrating ability
decreased frequency or amount of urine
diarrhea
difficult, fast, or noisy breathing, sometimes with wheezing
difficulty breathing
difficulty swallowing
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
dry mouth
fast or irregular heartbeat
fever
flushed, dry skin
fruit-like breath odor
general body swelling
general feeling of discomfort or illness
general feeling of tiredness or weakness
greatly decreased frequency of urination or amount of urine
headache
hives
increased blood pressure
increased hunger
increased sweating
increased thirst
increased urination
indigestion
itching
joint pain, stiffness, or swelling
loss of appetite
loss of heat from the body
lower back or side pain
muscle cramps or pain
nausea or vomiting
nosebleeds
numbness, tingling, pain, or weakness in hands or feet
pain in joints or muscles
painful or difficult urination
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rash
red, irritated eyes
red skin lesions, often with a purple center
red, swollen skin
redness, soreness, or itching skin
scaly skin
seizures
shortness of breath
sore throat
sores, ulcers, or white spots on lips or in mouth
sores, welting, or blisters
sugar in the urine
swelling of face, fingers, legs, ankles, feet, or lower legs
swollen or painful glands
tenderness of salivary glands
thickening of bronchial secretions
tightness in chest
trembling
troubled breathing
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
unusual weight loss
vomiting of blood
weakness and heaviness of legs
weight gain
wheezing
yellow eyes or skin

Incidence not known

Cramping
decreased interest in sexual intercourse
difficulty having a bowel movement (stool)
feeling of constant movement of self or surroundings
hair loss, thinning of hair
inability to have or keep an erection
increased sensitivity of skin to sunlight
loss in sexual ability, desire, drive, or performance
muscle spasm
pinpoint red or purple spots on skin
redness or other discoloration of skin
restlessness
sensation of spinning
severe sunburn
weakness

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.

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ziconotide (Intrathecal route)

30/06/10

zye-KON-oh-tide

Intrathecal routeSolution

Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. Patients with a pre-existing history of psychosis should not be treated with ziconotide. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Ziconotide therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms .

Commonly used brand name(s):

In the U.S.

Prialt

Available Dosage Forms:

Solution

Therapeutic Class: Analgesic

Pharmacologic Class: Calcium Channel Blocker

Uses For ziconotide

Ziconotide is a medicine that reduces chronic pain in the body.

Intrathecal ziconotide is given by or under the direct supervision of a doctor.

Before Using ziconotide

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 ziconotide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ziconotide 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 ziconotide have been done only in adult patients, and there is no specific information comparing use of ziconotide 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. Confusion may be especially likely to occur in older adults who are usually more sensitive than younger adults to the effects of ziconotide.

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

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

Proper Use of ziconotide

Dosing

The dose of ziconotide 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 ziconotide. If your dose is different, do not change it unless your doctor tells you to do so.

Storage

Store in the refrigerator. Do not freeze.

Protect from light.

Precautions While Using ziconotide

It is very important that your doctor check your progress at regular visits.

Contact your doctor right away if you are confused, less alert, or unusually tired

Tell your doctor right away if you have changes in mood, hallucinations, or unusual sensations in your mouth.

Ziconotide may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Serious infection or meningitis can occur if the catheter becomes disconnected. It is very important that you follow your doctor’s instructions about the care of the catheter and the use of the infusion pump.

If you or your caregiver notice signs of meningitis such as nausea, vomiting, seizures, fever, headache, and/or stiff neck, tell your doctor right away.

ziconotide may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to ziconotide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

ziconotide Side Effects

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

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

More common

Seeing, hearing, or feeling things that are not there
thoughts of killing oneself

Less common

Chest pain
chills
confusion
convulsions
cough
dark-colored urine
dizziness
drowsiness
fainting
fast heartbeat
fever
general feeling of illness
lightheadedness
muscle spasm or jerking of all extremities
muscle stiffness
rapid, shallow breathing
shortness of breath
sneezing
sore throat
stiff neck or back
tightness in chest
troubled breathing
trouble concentration
trouble sleeping
unusual tiredness or weakness
wheezing

Symptoms of overdose

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

Decreased awareness or responsiveness
severe sleepiness
shakiness and unsteady walk
trembling or other problems with muscle control or coordination
uncontrolled eye movements
unsteadiness

More common

Burning
change in walking and balance
clumsiness or unsteadiness
confusion
crawling feelings
diarrhea
dizziness
excessive muscle tone, muscle tension or tightness
fear
feeling of constant movement of self or surroundings
fever
headache
itching
lack or loss of strength
lightheadedness
loss of appetite
nausea
nervousness
numbness
problems with speech or speaking
sensation of spinning
trembling, or other problems with muscle control or coordination
uncontrolled eye movements
urinary retention
vomiting
weight loss

Less common

Acid or sour stomach
back pain
bad, unusual or unpleasant (after)taste
belching
bladder pain
bloody or cloudy urine
bruising
cerebrospinal fluid abnormal
change in taste
congestion
constipation
continuing ringing or buzzing or other unexplained noise in ears
crying
decreased awareness or responsiveness
dehydration
depersonalization
depression
difficult, burning or painful urination
difficulty in moving
difficulty seeing at night
double vision
dry mouth
dry skin
dryness or soreness of throat
dysphoria
euphoria
fainting
fast or irregular heartbeat
feeling that others can hear your thoughts, are watching you, or can control your behavior
frequent urge to urinate
hearing loss
heartburn
hoarseness
hostility
increased sensitivity of eyes to sunlight
increased sensitivity to pain or touch
indigestion
loss of bladder control
loss of memory or problems with memory
lung disorder
neck pain
nerve pain
pain in joints
pale skin
pounding in ears
quick to react or overreact emotionally
rapidly changing moods
red, scaly, swollen or peeling areas of skin
redness or pain at catheter site
runny nose
severe muscle stiffness
sleeplessness
slow or fast heartbeat
stomach discomfort, upset or pain
sweating
swelling or redness in joints
tender, swollen glands in neck
trouble in swallowing
unusual bleeding or bruising
unusual tiredness or weakness
voice changes
warmth on skin
weakness or heaviness in legs

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.

Advanced,Z

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Zevalin In-111

30/06/10

Generic Name: ibritumomab (Intravenous route)

eye-bri-TOOM-oh-mab tye-UX-e-tan

Intravenous routeSolution

Serious Infusion Reactions
- Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab, In-111 ibritumomab tiuxetan, and Y-90 ibritumomab tiuxetan infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias
- Y-90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients. Do not administer the ibritumomab tiuxetan therapeutic regimen to patients with greater than or equal to 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Severe Cutaneous and Mucocutaneous Reactions
- Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ibritumomab tiuxetan therapeutic regimen. Discontinue rituximab, In-111 ibritumomab tiuxetan, and Y-90 ibritumomab tiuxetan infusions in patients experiencing severe cutaneous or mucocutaneous reactions.
Dosing
- The dose of Y-90 ibritumomab tiuxetan should not exceed 32 millicurie (1184 megabecquerels). Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution as determined by imaging with In-111 ibritumomab tiuxetan .

Serious infusion reactions, including fatalities, have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. Most fatal infusion reactions (80%) occurred with the first rituximab infusion. Administration also results in severe and prolonged cytopenias in most patients. The ibritumomab tiuxetan therapeutic regimen should not be administered to patients with 25% or greater lymphoma marrow involvement and/or impaired bone marrow reserve. Severe cutaneous and mucocutaneous reactions, some with fatal outcome, can occur with therapy. The dose of Y-90 ibritumomab tiuxetan should not exceed the absolute maximum allowable dose of 32 millicurie (1184 megabecquerels) and should not be administered to patients with altered biodistribution as determined by In-111 ibritumomab tiuxetan imaging .

Commonly used brand name(s):

In the U.S.

Zevalin In-111
Zevalin Y-90

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Zevalin In-111

Ibritumomab is a monoclonal antibody. It is used together with another monoclonal antibody (rituximab) and two radioactive medications (In-111 and Y-90). Ibritumomab is used to treat a type of cancer called non-Hodgkin’s lymphoma (NHL) in patients who have never received any treatment and for those who have received other cancer medicines.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Zevalin In-111

Allergies

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab in the elderly.

Pregnancy

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

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of ibritumomab tiuxetan

This section provides information on the proper use of a number of products that contain ibritumomab tiuxetan. It may not be specific to Zevalin In-111. Please read with care.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Zevalin In-111

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

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

If you have a severe skin reaction with this medicine, you should seek medical attention right away. Symptoms may include blistering or loosening of the skin; red, swollen, irritated, or scaly skin; fever; chills; headache; or diarrhea.

This medicine may cause a rare but serious type of allergic reaction. Tell your doctor right away if you start to have a cough; difficulty with swallowing; dizziness; a fast heartbeat; wheezing; trouble with breathing; chest tightness; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; fever; chills; itching or hives; or lightheadedness or faintness while you are receiving this medicine.

While you are being treated with ibritumomab, and after you stop treatment with it, do not have any immunizations (live vaccinations) without your doctor’s approval. Ibritumomab may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent.

Ibritumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
Avoid sports or other situations where bruising or injury could occur.

If ibritumomab accidentally seeps out of the vein where it is injected, it may damage the tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

This medicine contains albumin, which is derived from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Zevalin In-111 Side Effects

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

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

More common

Black, tarry stools
bleeding gums
blood in the urine or stools
cough or hoarseness
coughing up blood
difficulty with breathing or swallowing
dizziness
fever or chills
headache
increased menstrual flow or vaginal bleeding
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lower back or side pain
noisy breathing
nosebleeds
painful or difficult urination
pale skin
paralysis
pinpoint red spots on the skin
prolonged bleeding from cuts
red or dark brown urine
red stools
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Less common

Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes
bluish lips or skin
chest pain or discomfort
confusion
diarrhea
fainting
fast heartbeat
hives
itching
lightheadedness
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, shallow breathing
skin rash
small red or purple spots on the skin
unusual vaginal bleeding
vomiting blood or material that looks like coffee grounds

Rare

Agitation
anxiety
back pain
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
blurred vision
coma
drowsiness
fast, pounding, or irregular heartbeat or pulse
hallucinations
inability to speak
irritability
mood or mental changes
nausea
redness of the skin
seizures
severe headache
slurred speech
stiff neck
temporary blindness
vomiting
weakness in the arm or leg on one side of the body, sudden and severe
welts

Incidence not known

Blistering, peeling, or loosening of the skin
cracks in the skin
joint or muscle pain
loss of heat from the body
red irritated eyes
red skin lesions, often with a purple center
red, swollen skin
scaly skin
skin blisters

More common

Abdominal or stomach pain
bruising
constipation
difficult or labored breathing
difficulty with moving
faintness or lightheadedness when getting up from a lying or sitting position
fear
feeling of warmth
full or bloated feeling or pressure in the stomach
joint pain
lack or loss of strength
large, flat, blue or purplish patches in the skin
loss of appetite
muscle aching or cramping
muscle pain or stiffness
nervousness
pain
rash
redness of the face, neck, arms and occasionally, upper chest
runny nose
sleeplessness
sneezing
stuffy nose
sudden or increased sweating
swelling of the abdominal or stomach area
swelling of the hands, ankles, feet, or lower legs
swollen joints
throat irritation
trouble with sleeping
unable to sleep
weight loss

Less common

Acid or sour stomach
belching
heartburn
indigestion
stomach discomfort, upset, or pain
swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

Bleeding gums
bone pain
headache, sudden and severe
inability to speak
increased menstrual flow or vaginal bleeding
red or black, tarry stools
red or dark brown urine
temporary blindness

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.

Advanced,Z

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Zevalin Y-90

30/06/10

Generic Name: ibritumomab (Intravenous route)

eye-bri-TOOM-oh-mab tye-UX-e-tan

Intravenous routeSolution

Serious Infusion Reactions
- Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. Discontinue rituximab, In-111 ibritumomab tiuxetan, and Y-90 ibritumomab tiuxetan infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias
- Y-90 ibritumomab tiuxetan administration results in severe and prolonged cytopenias in most patients. Do not administer the ibritumomab tiuxetan therapeutic regimen to patients with greater than or equal to 25% lymphoma marrow involvement and/or impaired bone marrow reserve.
Severe Cutaneous and Mucocutaneous Reactions
- Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ibritumomab tiuxetan therapeutic regimen. Discontinue rituximab, In-111 ibritumomab tiuxetan, and Y-90 ibritumomab tiuxetan infusions in patients experiencing severe cutaneous or mucocutaneous reactions.
Dosing
- The dose of Y-90 ibritumomab tiuxetan should not exceed 32 millicurie (1184 megabecquerels). Do not administer Y-90 ibritumomab tiuxetan to patients with altered biodistribution as determined by imaging with In-111 ibritumomab tiuxetan .

Commonly used brand name(s):

In the U.S.

Zevalin In-111
Zevalin Y-90

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Zevalin Y-90

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Zevalin Y-90

Allergies

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab in the elderly.

Pregnancy

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

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of ibritumomab tiuxetan

This section provides information on the proper use of a number of products that contain ibritumomab tiuxetan. It may not be specific to Zevalin Y-90. Please read with care.

Precautions While Using Zevalin Y-90

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

Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
Avoid sports or other situations where bruising or injury could occur.

Zevalin Y-90 Side Effects

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

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

More common

Black, tarry stools
bleeding gums
blood in the urine or stools
cough or hoarseness
coughing up blood
difficulty with breathing or swallowing
dizziness
fever or chills
headache
increased menstrual flow or vaginal bleeding
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
lower back or side pain
noisy breathing
nosebleeds
painful or difficult urination
pale skin
paralysis
pinpoint red spots on the skin
prolonged bleeding from cuts
red or dark brown urine
red stools
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Less common

Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes
bluish lips or skin
chest pain or discomfort
confusion
diarrhea
fainting
fast heartbeat
hives
itching
lightheadedness
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, shallow breathing
skin rash
small red or purple spots on the skin
unusual vaginal bleeding
vomiting blood or material that looks like coffee grounds

Rare

Agitation
anxiety
back pain
bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
blurred vision
coma
drowsiness
fast, pounding, or irregular heartbeat or pulse
hallucinations
inability to speak
irritability
mood or mental changes
nausea
redness of the skin
seizures
severe headache
slurred speech
stiff neck
temporary blindness
vomiting
weakness in the arm or leg on one side of the body, sudden and severe
welts

Incidence not known

Blistering, peeling, or loosening of the skin
cracks in the skin
joint or muscle pain
loss of heat from the body
red irritated eyes
red skin lesions, often with a purple center
red, swollen skin
scaly skin
skin blisters

More common

Abdominal or stomach pain
bruising
constipation
difficult or labored breathing
difficulty with moving
faintness or lightheadedness when getting up from a lying or sitting position
fear
feeling of warmth
full or bloated feeling or pressure in the stomach
joint pain
lack or loss of strength
large, flat, blue or purplish patches in the skin
loss of appetite
muscle aching or cramping
muscle pain or stiffness
nervousness
pain
rash
redness of the face, neck, arms and occasionally, upper chest
runny nose
sleeplessness
sneezing
stuffy nose
sudden or increased sweating
swelling of the abdominal or stomach area
swelling of the hands, ankles, feet, or lower legs
swollen joints
throat irritation
trouble with sleeping
unable to sleep
weight loss

Less common

Acid or sour stomach
belching
heartburn
indigestion
stomach discomfort, upset, or pain
swelling or redness in the joints

Bleeding gums
bone pain
headache, sudden and severe
inability to speak
increased menstrual flow or vaginal bleeding
red or black, tarry stools
red or dark brown urine
temporary blindness

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.

Advanced,Z

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Zetts

30/06/10

Generic Name: benzocaine (Oral route, Oromucosal route)

BEN-zoe-kane

Commonly used brand name(s):

In the U.S.

Anbesol
Babee Teething
Benzodent
Benz-O-Sthetic
Bi-Zets/Benzo-Troches
Dentemp’s
Dent-O-Kain/20
Detane
Gumsol
HAD
Hurricaine
Hurricane Spray Kit
Kank-A Soft Brush
Larynex
Miradyne-3
Mycinette
Orabase-B
Oracaine
Ora film
Orajel
OraMagic Plus
Orasol
Red Cross Canker Sore
Thorets
Trocaine
Zetts
Zilactin
Zilactin-B

In Canada

Anbesol Extra Strength
Anbesol Liquid
Baby Anbesol
Baby Orajel
Baby Orajel Liquid
Maximum Strength Orajel Pm
Orajel Extra Strength

Available Dosage Forms:

Liquid
Gel/Jelly
Solution
Lozenge/Troche
Lotion
Ointment
Powder for Suspension
Cream
Tablet, Disintegrating
Film
Swab
Spray
Gum
Paste

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Ester

Uses For Zetts

Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

Before Using Zetts

Allergies

Pediatric

No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.

Geriatric

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of benzocaine

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

Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.

Do not use this medicine for more than 2 days without checking first with your doctor.

Dosing

For oral dosage form (lozenges):
- For sore throat and mouth pain:
  - Adults, teenagers, and children 5 years of age and older—One lozenge, dissolved slowly in the mouth every 2 hours as needed.
  - Children younger than 5 years of age—Use is not recommended.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Zetts

If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.

Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.

Zetts 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 not known

Headache
high fever
nausea
vomiting
worsening of pain, redness, swelling, or irritation in or around the mouth

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.

Advanced,Z

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Zerit Pediatrics

30/06/10

Generic Name: stavudine (Oral route)

STAV-ue-deen

Oral routeCapsulePowder for Solution

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine, with or without hydroxyurea, in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine .

Commonly used brand name(s):

In the U.S.

Zerit

In Canada

Zerit Pediatrics

Available Dosage Forms:

Capsule
Powder for Suspension
Powder for Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Zerit Pediatrics

Stavudine is used in combination with other medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Stavudine will not cure or prevent HIV infection or AIDS. It helps to keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease.

Stavudine will not keep you or your child from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

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

Before Using Zerit Pediatrics

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of stavudine in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of stavudine in the elderly. However, elderly patients are more likely to have age-related kidney problems which may require an adjustment in the dose for patients receiving stavudine.

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

Interactions with Medicines

Didanosine
Doxorubicin Hydrochloride
Hydroxyurea
Ribavirin
Zidovudine

Methadone

Interactions with Food/Tobacco/Alcohol

Proper Use of stavudine

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking with your doctor first.

Keep taking stavudine for the full time of treatment , even if you begin to feel better. Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

The capsule should be swallowed whole. Do not chew, crush or dissolve.

You may take this medicine with or without food.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Talk to your doctor if you have any questions.

Dosing

For short-acting oral dosage forms (capsules, oral solution):
- For treatment of HIV infection:
  - Adults and teenagers weighing 60 kilograms (kg) or more—40 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
  - Adults and teenagers weighing up to 60 kg—30 milligrams (mg) every 12 hours. Your doctor may adjust your dose if needed.
  - Children weighing 30 kg or more—30 milligrams (mg) every 12 hours.
  - Infants and children at least 14 days old and weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. However, the usual dose is 1 milligram (mg) per kilogram (kg) of body weight every 12 hours.
  - Infants from birth to 13 days old—Dose is based on body weight and must be determined by your doctor. However, the usual dose is 0.5 milligram (mg) per kilogram (kg) of body weight every 12 hours.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the oral solution in the refrigerator. Throw away any unused medicine after 30 days, but do not throw it in the trash. Flush it down the toilet or take it to a community take-back program when available.

Ask your healthcare professional how to dispose of any capsules you do not use.

Precautions While Using Zerit Pediatrics

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

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from stavudine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Stop taking the medicine and call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble breathing; vomiting; or yellow eyes or skin.

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

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

Zerit Pediatrics Side Effects

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

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

More common

Burning, numbness, tingling, or painful sensations
chills with fever
tingling, burning, numbness, or pain in the hands or feet
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet

Less common

Cough
difficulty with swallowing
dizziness
fast heartbeat
hives
itching
joint pain
muscle pain
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash
tightness in the chest
unusual tiredness or weakness
wheezing

Rare

Nausea and vomiting
stomach pain (severe)

Incidence not known

Abdominal or stomach discomfort
abdominal pain
black, tarry stools
bleeding gums
bloating
blood in the urine or stools
blurred vision
chest pain
constipation
darkened urine
decreased appetite
diarrhea
difficulty with moving
dry mouth
fast, shallow breathing
fever
flushed, dry skin
fruit-like breath odor
general feeling of discomfort
general tiredness and weakness
increased hunger
increased thirst
increased urination
indigestion
light-colored stools
loss of appetite
loss of consciousness
muscle cramping, pains, or stiffness
painful or difficult urination
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
shakiness and unsteady walk, unsteadiness, trembling, or other problems with muscle control or coordination
sleepiness
sore throat
sores, ulcers, or white spots on the lips or in the mouth
sweating
swollen glands
swollen joints
troubled breathing
troubled breathing with exertion
unexplained weight loss
unusual bleeding or bruising
yellow eyes or skin

More common

Headache
loss of appetite
weight loss

Less common

Difficulty in sleeping
lack of strength or energy
stomach pain (mild)

Incidence not known

Gaining weight around your neck, upper back, breast, face, or waist
sleeplessness
unable to sleep

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

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

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Zapzyt

30/06/10

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s):

In the U.S.

Akurza
Aliclen
Avosil
Betasal
Compound W
Corn Removing
Dermarest Psoriasis
DHS Sal
Drytex
Duofilm
Duoplant
Freezone
Fung-O
Gets-It Corn/Callus Remover
Gordofilm
Hydrisalic
Ionil
Ionil Plus
Keralyt
Keralyt Scalp
Lupicare
Mediplast
Mg217 Sal-Acid
Mosco Corn & Callus Remover
Neutrogena
Occlusal-HP
Off-Ezy
Oxy Balance
P & S
Palmer’s Skin Success Acne Cleanser
Propa pH
Salac
Sal-Acid Plaster
Salactic Film
Salex
Salitop
Salkera
Sal-Plant Gel
Salvax
Seba-Clear
Stri-Dex
Thera-Sal
Therasoft Anti-Acne
Tinamed
Ti-Seb
Wart-Off Maximum Strength
Zapzyt

In Canada

Acnex
Acnomel Acne Mask
Clear Away Wart Removal System
Compound W One-Step Wart Remover
Compound W Plus
Dr. Scholl’s Clear Away One Step Plantar Wart Remover
Dr. Scholl’s Cushlin Ultra Slim Callus Removers
Dr. Scholl’s Cushlin Ultra Slim Corn Removers
Duoforte 27
Freezone – One Step Callus Remover Pad
Freezone – One Step Corn Remover Pad

Available Dosage Forms:

Soap
Lotion
Liquid
Ointment
Foam
Gel/Jelly
Cream
Pad
Shampoo
Solution
Dressing
Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Zapzyt

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor’s prescription.

Before Using Zapzyt

Allergies

Pediatric

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

Interactions with Medicines

Acenocoumarol
Anisindione
Ardeparin
Certoparin
Dalteparin
Danaparoid
Dicumarol
Enoxaparin
Nadroparin
Parnaparin
Phenindione
Phenprocoumon
Probenecid
Reviparin
Tamarind
Tinzaparin
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of salicylic acid

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

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.
Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

Wipe the pad over the affected areas.
Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

This medicine comes with patient instructions. Read them carefully before using.
Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.
Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.
Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
Cut the plaster to fit the wart, corn, or callus and apply.
For corns and calluses:
- Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
- Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
For warts:
- Depending on the product, either:
  - Apply plaster and repeat every 48 hours as needed, or
    - Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
- Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.
If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

Wet a cotton ball or pad with the topical solution and wipe the affected areas.
Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

This medicine comes with patient instructions. Read them carefully before using.
This medicine is flammable. Do not use it near heat or open flame or while smoking.
Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.
Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.
Avoid breathing in the vapors from the medicine.
Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.
Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.
For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.
For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.
If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

Dosing

For cream dosage form:
- For corns and calluses:
  - Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
For gel dosage form:
- For acne:
  - Adults and children—Use the 0.5 to 5% gel one time a day.
- For psoriasis:
  - Adults and children—Use the 5% gel one time a day.
- For common warts:
  - Adults and children—Use the 5 to 26% gel one time a day.
For lotion dosage form:
- For acne:
  - Adults and children—Use the 1 to 2% lotion one to three times a day.
- For dandruff and antiseborrhic dermatitis of the scalp:
  - Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
For ointment dosage form:
- For acne:
  - Adults and children—Use the 3 to 6% ointment as needed.
- For psoriasis and seborrheic dermatitis:
  - Adults and children—Use the 3 to 10% ointment as needed.
- For common warts:
  - Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
For pads dosage form:
- For acne:
  - Adults and children—Use one to three times a day.
For plaster dosage form:
- For corns, calluses, common warts, or plantar warts:
  - Adults and children—Use one time a day or one time every other day.
For shampoo dosage form:
- For dandruff or seborrheic dermatitis of the scalp:
  - Adults and children—Use on the scalp one or two times a week.
For soap dosage form:
- For acne:
  - Adults and children—Use as needed.
For topical solution dosage form:
- For acne:
  - Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
- For common warts and plantar warts:
  - Adults and children—Use the 5 to 27% topical solution one or two times a day.
- For corns and calluses:
  - Adults and children—Use the 12 to 27% topical solution one or two times a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Zapzyt

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

Abrasive soaps or cleansers
Alcohol-containing preparations
Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])
Cosmetics or soaps that dry the skin
Medicated cosmetics
Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Zapzyt 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 or rare

Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

Dryness and peeling of skin
flushing
redness of skin
unusually warm skin

Symptoms of salicylic acid poisoning

Confusion
diarrhea
dizziness
fast or deep breathing
headache (severe or continuing)
hearing loss
lightheadedness
nausea
rapid breathing
ringing or buzzing in ears (continuing)
severe drowsiness
stomach pain
vomiting

More common

Skin irritation not present before use of this medicine (mild)
stinging

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.

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Zapzyt Cleansing

30/06/10

Generic Name: sulfur (Topical route)

SUL-fur

Commonly used brand name(s):

In the U.S.

Liquimat
Sastid Soap
Sulfoam
Sulfo-Lo
Sulmasque
Sulpho-Lac
Sul-Ray Aloe Vera Acne
Thylox Acne Treatment
Zapzyt Cleansing

Available Dosage Forms:

Soap
Ointment
Shampoo
Liquid
Lotion
Cream
Gel/Jelly

Therapeutic Class: Antiacne

Uses For Zapzyt Cleansing

Sulfur is used to treat many kinds of skin disorders. Sulfur cream, lotion, ointment, and bar soap are used to treat acne. Sulfur ointment is used to treat seborrheic dermatitis and scabies. Sulfur may also be used for other conditions as determined by your doctor.

Some of these preparations are available only with your doctor’s prescription.

Before Using Zapzyt Cleansing

Allergies

Pediatric

Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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. Although there is no specific information comparing use of sulfur in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of sulfur

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

Use this medicine only as directed. Do not use it more often and do not use it for a longer period of time than recommended on the label, unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

To use the cream or lotion form of this medicine:

Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for seborrheic dermatitis:

Before applying the medicine, wash the affected areas with soap and water and dry thoroughly. Then apply enough medicine to cover the affected areas and rub in gently.

To use the ointment form of this medicine for scabies:

Before applying the medicine, wash your entire body with soap and water and dry thoroughly.
At bedtime, apply enough medicine to cover your entire body from the neck down and rub in gently. Leave the medicine on your body for 24 hours.
Before applying the medicine again, you may wash your entire body.
24 hours after the last treatment with this medicine, it is important that you thoroughly wash your entire body again.

To use the soap form of this medicine:

Work up a rich lather with the soap, using warm water. Wash the affected areas and rinse thoroughly. Apply again, and rub in gently for a few minutes. Remove excess lather with a towel or tissue without rinsing.

Dosing

For acne:
- For cream and bar soap dosage forms:
  - Adults and children—Use on the skin as needed.
- For lotion dosage form:
  - Adults and children—Use two or three times a day.
- For ointment dosage form:
  - Adults and children—Use the 0.5% ointment on the skin as needed.
For seborrheic dermatitis:
- For ointment dosage form:
  - Adults and children—Use the 5 to 10% ointment one or two times a day.
For scabies:
- For ointment dosage form:
  - Adults and children—Use the 6% ointment each night for three nights.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Zapzyt Cleansing

When using sulfur, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

Abrasive soaps or cleansers
Alcohol-containing preparations
Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, salicylic acid, or tretinoin [vitamin A acid])
Cosmetics or soaps that dry the skin
Medicated cosmetics
Other topical medicine for the skin

To use any of the above preparations on the same affected area as sulfur may cause severe irritation of the skin.

Do not use any topical mercury-containing preparation, such as ammoniated mercury ointment, on the same area as this medicine. To do so may cause a foul odor, may be irritating to the skin, and may stain the skin black. If you have any questions about this, check with your health care professional.

Zapzyt Cleansing 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:

Skin irritation not present before use of this medicine

Redness and peeling of skin (may occur after a few days)

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.

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zanamivir (Inhalation route)

30/06/10

zan-AM-i-vir

Commonly used brand name(s):

In the U.S.

Relenza

Available Dosage Forms:

Disk

Therapeutic Class: Antiviral

Pharmacologic Class: Neuraminidase Inhibitor, Influenza A&B Virus

Uses For zanamivir

Zanamivir is used in the treatment of the infection caused by the flu virus (influenza A and influenza B). Zanamivir may also be used to prevent and treat swine influenza A . Zanamivir may reduce flu symptoms (weakness, headache, fever, cough, and sore throat) by 1 to 1.5 days. Zanamivir may also be used to prevent influenza infection .

zanamivir must be started within 2 days of having flu symptoms (weakness, headache, fever, cough, and sore throat). Zanamivir will not keep you from spreading the flu virus to other people. Zanamivir may not work for everybody. Zanamivir may not be for you if you are severely sick or have a breathing problem (like asthma or chronic obstructive pulmonary disease). If you receive the flu vaccine every year, continue to do so.

Before Using zanamivir

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 zanamivir, the following should be considered:

Allergies

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

Pediatric

Appropriate studies for the treatment of influenza infection in children up to 7 years of age have not been performed. Appropriate studies for the prevention of influenza infection in children up to 5 years of age have also not been performed. Safety and efficacy of zanamivir for the treatment and prevention of influenza infection have not been established in these age groups .

Note: zanamivir is available in Canada. It is not recommended in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of zanamivir in the elderly. However, elderly patients may be more sensitive to the effects of zanamivir than younger adults, which may require caution in patients receiving zanamivir .

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of zanamivir

Talk to your doctor about the possibility of getting a flu shot if you have not had one yet. zanamivir works best if taken as soon as possible after exposure to people who have the flu. If you already have the flu, continue taking zanamivir for the full time of treatment even if you begin to feel better after a few days. This will help to clear up your infection completely. If you stop taking zanamivir too soon, your symptoms may return. zanamivir should be taken for 5 days.

Inhaled zanamivir is to be used ONLY with a special inhaler (Diskhaler). Do NOT mix zanamivir with other solutions. Do NOT use zanamivir in any nebulizer or mechanical ventilator. Read the directions carefully before using zanamivir. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do.

To load the inhaler:

Pull off the blue cover. Make sure the mouthpiece is clean and free of foreign objects.
Pull the white mouthpiece until the tray is extended.
Hold the corners of the white tray and pull out gently until you can see all the raised ridges on the sides of the tray.
Put your finger and thumb on the ridges, squeeze inward, and gently pull the tray out of the body of the inhaler.
Place a disk on the wheel and then slide the tray back into the inhaler
To replace the empty disk with a full disk, follow the same steps you used to load the inhaler.

To use the inhaler:

Hold the inhaler flat in your hand.
A plastic needle will break the blister containing one inhalation of medicine. When the flap is raised as far as it will go, the blister will be pierced. Do not lift the flap if the cartridge is not in the inhaler. Doing this will break the needle and you will need a new inhaler.
After the blister is broken open, close the lid. Keeping the inhaler flat and well away from your mouth, breathe out to the end of a normal breath.
Raise the inhaler to your mouth, and place the mouthpiece in your mouth.
Close your lips around the mouthpiece and tilt your head slightly back. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue. Do not cover the air holes on the side of the mouthpiece.
Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath.
Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
Prepare the cartridge for your next inhalation. Pull the mouthpiece to extend the tray then push it in until it clicks. The disk will turn to the next dose. Do not pierce the blister until just before the inhalation.
Take the second puff following exactly the same steps you used for the first puff.
When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.

Dosing

The dose of zanamivir 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 zanamivir. If your dose is different, do not change it unless your doctor tells you to do so.

For inhalation dosage form (powder):
- For prevention of flu (influenza A and influenza B) in a household:
  - Adults and children 5 years of age and older—Two puffs twice daily for 10 days. Doses should be taken at the same time each day. Zanamivir must be started within 36 hours after the onset of signs and symptoms of the flu in a household.
  - Children below 5 years of age—Use and dose must be determined by your doctor .
- For prevention of flu (influenza A and influenza B) during community outbreaks:
  - Adults and children 5 years of age and older—Two puffs twice daily for 28 days. Doses should be taken at the same time each day. Zanamivir must be started within 5 days after the outbreak was identified in the community.
  - Children below 5 years of age—Use and dose must be determined by your doctor .
- For treatment of flu (influenza A and influenza B):
  - Adults and children 7 years of age and older—Two puffs twice daily (approximately 12 hours apart in the morning and evening) for 5 days. Two doses should be taken on the first day of treatment whenever possible provided there are at least 2 hours between doses. Zanamivir must be started within 48 hours after the onset of signs and symptoms of the flu.
  - Children below 7 years of age—Use and dose must be determined by your doctor .
- Canada: For treatment of flu (influenza A and influenza B):
  - Adults and children 12 years of age and older—Two puffs twice daily (approximately 12 hours apart in the morning and evening) for 5 days. Two doses should be taken on the first day of treatment whenever possible provided there are at least 2 hours between doses. Zanamivir must be started within 48 hours after the onset of signs and symptoms of the flu.
  - Children below 12 years of age—Use and dose must be determined by your doctor .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using zanamivir

Zanamivir may cause people with lung disease (chronic obstructive lung disease or asthma) to experience trouble breathing. If this should happen contact your doctor immediately. Zanamivir may not work in patients with lung disease, heart disease, or serious medical conditions.

Bronchospasm (wheezing) is a risk for patients with asthma or chronic respiratory disease. Always have a fast-acting inhaled bronchodilator available for your use.

zanamivir may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using zanamivir and call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using zanamivir .

zanamivir contains lactose. Tell your doctor if you are allergic to lactose before you start using zanamivir .

Before using zanamivir, tell your doctor if you have received a live, attenuated intranasal influenza vaccine (FluMist®) in the past two weeks .

zanamivir 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:

Rare

Convulsions
dizziness and fainting
heartbeat, fast, slow, or irregular
increased sensitivity to sunlight
itching, pain, redness, swelling or watering of eye or eyelid
flushing or reddening of skin
joint pain
severe skin rash or hives
shortness of breath or troubled breathing
swelling or puffiness of face
swollen glands or tightness in throat
tightness in chest or wheezing

Less common

Change in hearing
cough
cough producing mucus
diarrhea
dizziness
ear drainage
ear, nose and throat infections
earache
fever or chills
headache
nasal signs and symptoms
nausea
pain and pressure over cheeks
pain in ear
shortness of breath
tightness in chest
vomiting
wheezing

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.

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