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Vioform Hydrocortisone Mild

30/06/10

Generic Name: clioquinol and hydrocortisone (Topical route)

klye-oh-KWIN-ol, hye-droe-KOR-ti-sone

Commonly used brand name(s):

In Canada

Vioform Hydrocortisone
Vioform Hydrocortisone Mild

Available Dosage Forms:

Cream
Ointment

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Vioform Hydrocortisone Mild

Clioquinol and hydrocortisone is a combined anti-infective and cortisone-like medicine. Clioquinol and hydrocortisone topical preparations are used to treat infections of the skin and to help provide relief from the redness, itching, and discomfort of many skin problems.

Clioquinol and hydrocortisone combination is available only with your doctor’s prescription.

Before Using Vioform Hydrocortisone Mild

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

Clioquinol and hydrocortisone combination is not recommended in children up to 2 years of age. Although there is no specific information comparing use of clioquinol and hydrocortisone combination in children over 2 years of age with use in other age groups, this medicine is not expected to cause different side effects or problems in these 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. Although there is no specific information comparing use of clioquinol and hydrocortisone combination 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

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

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rotavirus Vaccine, Live

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.

Aldesleukin
Bupropion
Quetiapine

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.

Alatrofloxacin
Alcuronium
Atracurium
Balofloxacin
Cinoxacin
Ciprofloxacin
Clinafloxacin
Colestipol
Enoxacin
Fleroxacin
Flumequine
Gallamine
Gemifloxacin
Grepafloxacin
Hexafluorenium
Itraconazole
Levofloxacin
Licorice
Lomefloxacin
Metocurine
Moxifloxacin
Norfloxacin
Ofloxacin
Pefloxacin
Primidone
Prulifloxacin
Rifapentine
Rosoxacin
Rufloxacin
Saiboku-To
Sparfloxacin
Temafloxacin
Tosufloxacin
Trovafloxacin Mesylate

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 clioquinol and hydrocortisone

This section provides information on the proper use of a number of products that contain clioquinol and hydrocortisone. It may not be specific to Vioform Hydrocortisone Mild. Please read with care.

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly.

Do not use this medicine in or around the eyes or on infants and children up to 2 years of age.

To use the cream form of this medicine:

Apply a thin layer of cream to the affected area and rub in gently until cream disappears.

To use the lotion form of this medicine:

Gently squeeze bottle and apply a few drops of lotion to the affected area. Rub in gently until lotion disappears.

To use the ointment form of this medicine:

Apply a thin layer of ointment to the affected area and rub in gently.

Do not bandage or otherwise wrap the area of the skin being treated unless directed to do so by your doctor.

Check with your doctor before using this medicine on any other skin problems. It should not be used on certain kinds of bacterial, virus, or fungus skin infections.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses. However, do not use this medicine more often or for a longer time than your doctor ordered. To do so may increase the chance of absorption through the skin and the chance of side effects. In addition, too much use, especially on thin skin areas (for example, face, armpits, groin), may result in thinning of the skin and stretch marks.

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 topical dosage forms (cream, lotion, or ointment):
- For bacterial and fungus infections:
  - Adults, teenagers, and children 2 years of age and over—Apply to the affected area(s) of the skin three or four times a day.
  - Children up to 2 years of age—Use is not recommended.

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 Vioform Hydrocortisone Mild

If your skin problem does not improve within 1 to 2 weeks, or if it becomes worse, check with your doctor.

This medicine may be absorbed through the skin, and too much use can affect growth. Children who must use this medicine should be followed closely by their doctor.

This medicine may stain clothing, skin, hair, and nails yellow. Avoid getting this medicine on your clothing. Bleaching may not remove the stain.

Vioform Hydrocortisone Mild 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

Blistering, burning, itching, peeling, skin rash, redness, swelling, or other sign of irritation not present before use of this medicine

With prolonged use

Thinning of skin with easy bruising

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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Vioform

30/06/10

Generic Name: clioquinol (Topical route)

klye-oh-KWIN-ol

Commonly used brand name(s):

In Canada

Vioform

Available Dosage Forms:

Cream

Therapeutic Class: Antifungal

Uses For Vioform

Clioquinol belongs to the family of medicines called anti-infectives. Clioquinol topical preparations are used to treat skin infections.

Clioquinol is available without a prescription.

Before Using Vioform

Allergies

Pediatric

Clioquinol is not recommended in children younger than 2 years of age. Although there is no specific information comparing use of this medicine in children 2 years of age and older 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. Although there is no specific information comparing use of this medicine 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

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 Vioform

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly.

Do not use this medicine in or around the eyes. If accidental contact occurs, flush eyes with water.

Do not bandage or apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine, since it may increase the infection and may cause unwanted drug absorption into the body. If you have any questions about this, check with your doctor.

To use the ointment form of this medicine:

Apply a thin layer of ointment to the affected area and rub in gently. The ointment is recommended for use on dry, crusted lesions.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

For topical dosage form (ointment):
- For bacterial or fungus infections:
  - Adults and children 2 years of age and older—Apply to the affected area(s) of the skin two or three times a day.
  - Children younger than 2 years of age—Use is not recommended.

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 Vioform

This medicine should not be used for more than 1 week. If your skin problem does not improve in 1 week, or if it becomes worse, check with your doctor.

Clioquinol should not be used to treat large areas of the skin or large open skin lesions. If you have any questions about this, check with your doctor.

This medicine may turn yellow in color when exposed to air. It may stain clothing, skin, hair, and nails yellow. Avoid getting this medicine on your clothing since bleaching may not remove the stain.

Before you have any medical tests, tell the doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Vioform 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

Burning, itching, rash, redness, swelling, or other sign of skin irritation not present before use of this medicine or becoming worse during treatment

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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vinorelbine (Intravenous route)

30/06/10

vin-OR-el-been

Commonly used brand name(s):

In the U.S.

Navelbine

Available Dosage Forms:

Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For vinorelbine

Vinorelbine belongs to the general group of medicines known as antineoplastics. It is used to treat some kinds of lung cancer. It may also be used to treat other kinds of cancer, as determined by your doctor.

Vinorelbine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells also may be affected by vinorelbine, other effects will occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with vinorelbine, you and your doctor should talk about the good vinorelbine will do as well as the risks of using it.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, vinorelbine is used in certain patients with the following medical condition:

Breast cancer
Cervical cancer
Ovarian cancer (epithelial)

Before Using vinorelbine

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 vinorelbine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vinorelbine 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

There is no specific information comparing use of vinorelbine in children with use in other age groups. Safety and efficacy of vinorelbine in children have not been established.

Geriatric

Vinorelbine has been studied in the elderly. Although patients older than 65 years of age have shown a slight increase in side effects compared with patients younger than 65 years of age, the overall safety and efficacy of vinorelbine are not different for older people.

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

Using vinorelbine 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.

Rotavirus Vaccine, Live

Using vinorelbine 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.

Bacillus of Calmette and Guerin Vaccine, Live
Cisplatin
Clarithromycin
Gefitinib
Influenza Virus Vaccine, Live
Itraconazole
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Posaconazole
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine
Varicella Virus Vaccine
Voriconazole
Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Proper Use of vinorelbine

Vinorelbine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving vinorelbine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

vinorelbine often causes nausea and vomiting. However, it is very important that you continue to receive it, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

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

Precautions While Using vinorelbine

It is very important that your doctor check your progress at regular visits to make sure that vinorelbine is working properly and to check for unwanted effects.

While you are being treated with vinorelbine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Vinorelbine may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral poliovirus vaccine, since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Vinorelbine 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:

If you can, avoid people with infection. 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 have painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
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 contact sports or other situations where bruising or injury can occur.

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

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.

vinorelbine Side Effects

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

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

More common

Cough or hoarseness, accompanied by fever or chills
fever or chills
lower back or side pain, accompanied by fever or chills
painful or difficult urination, accompanied by fever or chills
redness, increased warmth, pain, or discoloration of vein at place of injection
sore throat, accompanied by fever or chills

Less common

Chest pain
shortness of breath
sores in mouth and on lips

Rare

Black, tarry stools
bloating
blood in urine or stools
chills
darkened urine
fast heartbeat
fever
indigestion
loss of appetite
nausea
painful urination
pains in stomach
pinpoint red spots on skin
skin rash
unusual bleeding or bruising
vomiting
yellow eyes or skin

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

More common

Loss of strength and energy
unusual tiredness or weakness

Less common

Numbness or tingling in fingers and toes

Symptoms of overdose

Chest pain
cough or hoarseness, accompanied by fever or chills
fever or chills
heartburn
lower back or side pain, accompanied by fever or chills
mild abdominal pain and constipation
numbness or tingling in fingers and toes
painful or difficult urination, accompanied by fever or chills
sore throat, accompanied by fever or chills
unusual bleeding or bruising
unusual tiredness or weakness
vomiting

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

More common

Constipation
loss of appetite
nausea and vomiting

Less common

Diarrhea
jaw pain
joint or muscle pain

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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vindesine (Injection route)

30/06/10

VIN-de-seen

Available Dosage Forms:

Powder for Solution

Pharmacologic Class: Mitotic Inhibitor

Uses For vindesine

Vindesine belongs to the group of medicines known as antineoplastic agents. It is used to treat some kinds of cancer, including leukemia and lung cancer.

Vindesine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by vindesine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern.

Before you begin treatment with vindesine, you and your doctor should talk about the good vindesine will do as well as the risks of using it.

vindesine is available only with your doctor’s prescription.

Before Using vindesine

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 vindesine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vindesine 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

Although there is no specific information comparing use of vindesine in children with use in other age groups, vindesine 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. There is no specific information comparing use of vindesine in the elderly with use in other age groups.

Breast Feeding

Interactions with Medicines

Using vindesine 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.

Rotavirus Vaccine, Live

Using vindesine 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.

Bacillus of Calmette and Guerin Vaccine, Live
Influenza Virus Vaccine, Live
Itraconazole
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine
Varicella Virus Vaccine
Warfarin
Yellow Fever Vaccine

Using vindesine 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.

Dalfopristin
Quinupristin

Interactions with Food/Tobacco/Alcohol

Proper Use of vindesine

vindesine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor, nurse, or pharmacist for ways to lessen these effects.

Vindesine frequently causes constipation and stomach cramps. Your doctor may want you to take a laxative. However, do not decide to take these medicines on your own without first checking with your doctor.

Dosing

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

Precautions While Using vindesine

It is very important that your doctor check your progress at regular visits to make sure that vindesine is working properly and to check for unwanted effects.

While you are being treated with vindesine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Vindesine may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. Other people living in your household should not take or should not have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Vindesine 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:

If you can, 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 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 contact sports or other situations where bruising or injury could occur.

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

vindesine 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

Black, tarry stools
chest pain
chills
cough
fever
painful or difficult urination
shortness of breath
sore throat
sores, ulcers, or white spots on the lips or in the mouth
swollen glands

Less common

Blindness
blurred or double vision
convulsions (seizures)
difficulty with walking
drooping eyelids
headache
jaw pain
numbness or tingling in the fingers and toes
pain in the fingers and toes
pain in the testicles
unusual bleeding or bruising
unusual tiredness or weakness

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

Abnormal drowsiness
agitation
confusion
dazed feeling
decreased urine output
depression
dizziness
headache
hostility
irritability
muscle twitching
nausea
rapid weight gain
seizures
swelling of face, ankles, or hands

Less common

Constipation
general feeling of discomfort or illness
increase in bowel movements
loose stools
loss of appetite
muscle or bone pain
nausea and vomiting
skin rash
soft stools
weight loss

vindesine often causes a temporary loss of hair. After treatment with vindesine has ended, normal hair growth should return.

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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vincristine (Intravenous route)

30/06/10

vin-KRIS-teen

Intravenous routeSolution

Vincristine sulfate injection should be administered by individuals experienced in the administration of vincristine sulfate.

Caution- It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of vincristine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis.

Fatal if given intrathecally. For intravenous use only .

For intravenous use only; fatal if given intrathecally. Intravenous needle or catheter must be properly positioned before any vincristine is injected as leakage into the surrounding tissue may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis .

Commonly used brand name(s):

In the U.S.

Oncovin
Vincasar PFS

Available Dosage Forms:

Powder for Solution
Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For vincristine

Vincristine belongs to the group of medicines known as antineoplastic agents. It is used to treat some kinds of cancer as well as some noncancerous conditions.

Vincristine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by vincristine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with vincristine, you and your doctor should talk about the good vincristine will do as well as the risks of using it.

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

Before Using vincristine

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 vincristine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vincristine 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

vincristine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Nervous system effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of vincristine.

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

Using vincristine 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.

Rotavirus Vaccine, Live

Using vincristine 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.

Aprepitant
Asparaginase
Bacillus of Calmette and Guerin Vaccine, Live
Filgrastim
Fosaprepitant
Influenza Virus Vaccine, Live
Itraconazole
Lopinavir
Measles Virus Vaccine, Live
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Posaconazole
Ritonavir
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Sargramostim
Smallpox Vaccine
Typhoid Vaccine
Valspodar
Varicella Virus Vaccine
Voriconazole
Warfarin
Yellow Fever Vaccine
Zidovudine

Using vincristine 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.

Dalfopristin
Nifedipine
Quinupristin

Interactions with Food/Tobacco/Alcohol

Proper Use of vincristine

Vincristine is often given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are using vincristine, it may be necessary to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well. Ask your doctor if this is necessary for you.

vincristine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Vincristine frequently causes constipation and stomach cramps. Your doctor may want you to take a laxative. However, do not decide to take these medicines on your own without first checking with your doctor.

Dosing

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

Precautions While Using vincristine

It is very important that your doctor check your progress at regular visits to make sure that vincristine is working properly and to check for unwanted effects.

While you are being treated with vincristine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Vincristine may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. Other people living in your household should not take or should not have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

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

vincristine Side Effects

Along with their needed effects, medicines like vincristine can sometimes cause unwanted effects such as blood problems, nervous system problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. Discuss these possible effects with your doctor.

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

Less common

Pain or redness at place of injection

Rare

Black, tarry stools
blood in urine or stools
cough or hoarseness
fever or chills
pinpoint red spots on skin
unusual bleeding or bruising

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

More common

Blurred or double vision
constipation
difficulty in walking
drooping eyelids
headache
jaw pain
joint pain
lower back or side pain
numbness or tingling in fingers and toes
pain in fingers and toes
pain in testicles
stomach cramps
swelling of feet or lower legs
weakness

Less common

Agitation
bed-wetting
confusion
convulsions (seizures)
decrease or increase in urination
dizziness or lightheadedness when getting up from a lying or sitting position
hallucinations (seeing, hearing, or feeling things that are not there)
lack of sweating
loss of appetite
mental depression
painful or difficult urination
trouble in sleeping
unconsciousness

Rare

Sores in mouth and on lips

Less common

Bloating
diarrhea
loss of weight
nausea and vomiting
skin rash

Other side effects may occur that usually do not need medical attention. vincristine often causes a temporary loss of hair. After treatment with vincristine has ended, or sometimes even during treatment, normal hair growth should return.

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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vinblastine (Intravenous route)

30/06/10

vin-BLAS-teen

Intravenous routeSolutionPowder for Solution

Caution – This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the needle be properly positioned in the vein before this product is injected. If leakage into surrounding tissue should occur during intravenous administration of vinblastine sulfate, it may cause considerable irritation. The injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis.

Fatal if given intrathecally. For intravenous use only .

Intravenous needle or catheter must be properly positioned before any vinblastine is injected as leakage into the surrounding tissue may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis .

Commonly used brand name(s):

In the U.S.

Velban

Available Dosage Forms:

Solution
Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Mitotic Inhibitor

Uses For vinblastine

Vinblastine belongs to the group of medicines known as antineoplastic agents. It is used to treat certain kinds of cancer, including lymphoma and cancer of the breast or testicles, as well as some noncancerous conditions.

Vinblastine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by vinblastine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, such as hair loss, may not be serious but may cause concern. Some effects do not occur until months or years after the medicine is used.

Before you begin treatment with vinblastine, you and your doctor should talk about the good vinblastine will do as well as the risks of using it.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, vinblastine is used in certain patients with the following medical conditions:

Cancer of the bladder
Cancer of the kidneys
Cancer of the lungs
Cancer of the prostate
Germ cell ovarian tumors (a certain type of cancer of the ovaries)
Malignant melanoma

Before Using vinblastine

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 vinblastine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vinblastine 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

vinblastine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of vinblastine 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

Using vinblastine 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.

Rotavirus Vaccine, Live

Using vinblastine 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.

Aprepitant
Bacillus of Calmette and Guerin Vaccine, Live
Fosaprepitant
Influenza Virus Vaccine, Live
Itraconazole
Lopinavir
Measles Virus Vaccine, Live
Mitomycin
Mumps Virus Vaccine, Live
Poliovirus Vaccine, Live
Posaconazole
Ritonavir
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Smallpox Vaccine
Typhoid Vaccine
Varicella Virus Vaccine
Voriconazole
Yellow Fever Vaccine
Zidovudine

Using vinblastine 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.

Dalfopristin
Quinupristin
Tolterodine

Interactions with Food/Tobacco/Alcohol

Proper Use of vinblastine

Vinblastine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are using vinblastine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

Vinblastine sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

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

Precautions While Using vinblastine

It is very important that your doctor check your progress at regular visits to make sure that vinblastine is working properly and to check for unwanted effects.

While you are being treated with vinblastine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Vinblastine may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. Other people living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the past several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Vinblastine 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:

If you can, 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 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 contact sports or other situations where bruising or injury could occur.

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

vinblastine Side Effects

Along with their needed effects, medicines like vinblastine can sometimes cause unwanted effects such as blood problems, loss of hair, and other side effects. These and other effects are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

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 frequent

Cough or hoarseness accompanied by fever or chills
fever or chills
lower back or side pain accompanied by fever or chills
painful or difficult urination accompanied by fever or chills

Less common

Blood in urine or stools
pain or redness at place of injection
pinpoint red spots on skin
unusual bleeding or bruising

Rare

Black, tarry stools

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

Less common

Joint pain
sores in mouth and on lips
swelling of feet or lower legs

Rare

Difficulty in walking
dizziness
double vision
drooping eyelids
headache
jaw pain
mental depression
numbness or tingling in fingers and toes
pain in fingers and toes
pain in testicles
weakness

Less common

Bone or muscle pain
nausea and vomiting

vinblastine often causes a temporary loss of hair. After treatment with vinblastine has ended, or sometimes even during treatment, normal hair growth should return.

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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ViloFane-Dp 7.5

30/06/10

Generic Name: folic acid (Oral route, Injection route)

FOE-lik AS-id

Commonly used brand name(s):

In the U.S.

FA-8
Folacin-800
Nature’s Blend Folic Acid
ViloFane-Dp 7.5

Available Dosage Forms:

Tablet
Solution
Injectable
Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin B

Uses For ViloFane-Dp 7.5

Vitamins are compounds that you must have for growth and health. They are needed in small amounts only and are usually available in the foods that you eat. Folic acid (vitamin B 9) is necessary for strong blood.

Lack of folic acid may lead to anemia (weak blood). Your health care professional may treat this by prescribing folic acid for you.

Some conditions may increase your need for folic acid. These include:

Alcoholism
Anemia, hemolytic
Diarrhea (continuing)
Fever (prolonged)
Hemodialysis
Illness (prolonged)
Intestinal diseases
Liver disease
Stress (continuing)
Surgical removal of stomach

In addition, infants smaller than normal, breast-fed infants, or those receiving unfortified formulas (such as evaporated milk or goat’s milk) may need additional folic acid.

Increased need for folic acid should be determined by your health care professional.

Some studies have found that folic acid taken by women before they become pregnant and during early pregnancy may reduce the chances of certain birth defects (neural tube defects).

Claims that folic acid and other B vitamins are effective for preventing mental problems have not been proven. Many of these treatments involve large and expensive amounts of vitamins.

Injectable folic acid is given by or under the direction of your health care professional. Another form of folic acid is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Folic acid is found in various foods, including vegetables, especially green vegetables; potatoes; cereal and cereal products; fruits; and organ meats (for example, liver or kidney). It is best to eat fresh fruits and vegetables whenever possible since they contain the most vitamins. Food processing may destroy some of the vitamins. For example, heat may reduce the amount of folic acid in foods.

Vitamins alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods.

The daily amount of folic acid needed is defined in several different ways.

For U.S.—
Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person’s age, sex, and physical condition (e.g., pregnancy).
Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

For Canada—
Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes in micrograms (mcg) for folic acid are generally defined as follows:

Persons	U.S. (mcg)	Canada (mcg)
Infants and children Birth to 3 years of age	25–100	50–80
4 to 6 years of age	75–400	90
7 to 10 years of age	100–400	125–180
Adolescent and adult males	150–400	150–220
Adolescent and adult females	150–400	145–190
Pregnant females	400–800	445–475
Breast-feeding females	260–800	245–275

Before Using ViloFane-Dp 7.5

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

In deciding to use folic acid, the risks of taking it must be weighed against the good it will do. This is a decision you and your health care professional will make. For folic acid, the following should be considered:

Allergies

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

Interactions with Medicines

Using this dietary supplement 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.

Phenytoin

Interactions with Food/Tobacco/Alcohol

Proper Use of folic acid

This section provides information on the proper use of a number of products that contain folic acid. It may not be specific to ViloFane-Dp 7.5. Please read with care.

Dosing

For oral dosage form (tablets):
- To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  - For the U.S.
  - Adult and teenage males—150 to 400 micrograms (mcg) per day.
  - Adult and teenage females—150 to 400 mcg per day.
  - Pregnant females—400 to 800 mcg per day.
  - Breast-feeding females—260 to 800 mcg per day.
  - Children 7 to 10 years of age—100 to 400 mcg per day.
  - Children 4 to 6 years of age—75 to 400 mcg per day.
  - Children birth to 3 years of age—25 to 100 mcg per day.
  - For Canada
  - Adult and teenage males—150 to 220 mcg per day.
  - Adult and teenage females—145 to 190 mcg per day.
  - Pregnant females—445 to 475 mcg per day.
  - Breast-feeding females—245 to 275 mcg per day.
  - Children 7 to 10 years of age—125 to 180 mcg per day.
  - Children 4 to 6 years of age—90 mcg per day.
  - Children birth to 3 years of age—50 to 80 mcg per day.
- To treat deficiency:
  - Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement 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.

ViloFane-Dp 7.5 Side Effects

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

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

Rare

Fever
general weakness or discomfort
reddened skin
shortness of breath
skin rash or itching
tightness in chest
troubled breathing
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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Vigamox

30/06/10

Generic Name: moxifloxacin (Ophthalmic route)

mox-i-FLOX-a-sin

Oral routeTablet

Fluoroquinolones, including moxifloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants .

Fluoroquinolones, including moxifloxacin hydrochloride, are associated with an increased risk of tendinitis and tendon rupture in all ages. Risk further increases with age over 60 years, concomitant steroid therapy, and kidney, heart, or lung transplants .

Intravenous routeSolution

Commonly used brand name(s):

In the U.S.

Vigamox

Available Dosage Forms:

Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Vigamox

Moxifloxacin belongs to the family of medicines called antibiotics. Moxifloxacin ophthalmic solution (eye drops) is used to treat infections of the eye, such as bacterial conjunctivitis. Ophthalmic moxifloxacin works by killing the bacteria in your eye.

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

Before Using Vigamox

Allergies

Pediatric

Although there is no specific information comparing use of moxifloxacin eye drops 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 older adults. This medicine should not be used in children younger than one year old.

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. Moxifloxacin eye drops are not expected to cause different side effects or problems in older people than they do in younger adults.

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

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.

Cisapride
Dronedarone
Mesoridazine
Pimozide
Thioridazine
Ziprasidone

Acarbose
Acetohexamide
Acetophenazine
Ajmaline
Alfuzosin
Alosetron
Amiodarone
Amitriptyline
Amoxapine
Arsenic Trioxide
Asenapine
Benfluorex
Bretylium
Chlorpromazine
Chlorpropamide
Clomipramine
Desipramine
Disopyramide
Dofetilide
Dothiepin
Doxepin
Droperidol
Encainide
Erythromycin
Ethopropazine
Flecainide
Fluphenazine
Gliclazide
Glimepiride
Glipizide
Gliquidone
Glyburide
Guar Gum
Ibutilide
Iloperidone
Imipramine
Insulin
Insulin Aspart, Recombinant
Insulin Glulisine
Insulin Lispro, Recombinant
Lapatinib
Lidocaine
Lofepramine
Lumefantrine
Metformin
Methadone
Methotrimeprazine
Mexiletine
Miglitol
Moricizine
Nilotinib
Nortriptyline
Opipramol
Paliperidone
Pazopanib
Perphenazine
Pipotiazine
Pirmenol
Prajmaline
Procainamide
Prochlorperazine
Promazine
Promethazine
Propafenone
Propiomazine
Protriptyline
Quinidine
Ranolazine
Recainam
Sotalol
Sunitinib
Telavancin
Tetrabenazine
Thiethylperazine
Tocainide
Tolazamide
Tolbutamide
Trifluoperazine
Triflupromazine
Trimeprazine
Trimipramine
Troglitazone
Warfarin

Betamethasone
Corticotropin
Cortisone
Cosyntropin
Deflazacort
Dexamethasone
Fludrocortisone
Fluocortolone
Hydrocortisone
Methylprednisolone
Paramethasone
Prednisolone
Prednisone
Rifampin
Triamcinolone

Interactions with Food/Tobacco/Alcohol

Proper Use of Vigamox

To use:

First, wash your hands. Tilt the head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink.
If you think you did not get the drop of medicine into your eye properly, use another drop.
Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
To keep the medicine as germ free as possible, do not touch the applicator tip to any surface (including the eye).

Dosing

To keep the medicine as germ free as possible, do not touch the applicator tip to any surface (including your eye).

You should not wear your contact lenses if you have any signs or symptoms of an eye infection.

For ophthalmic solution (eye drops) dosage form:

For bacterial conjunctivitis (eye infections)
- Adults and children 1 year of age and older—One drop in your infected eye(s) three times a day for 7 days.
- Children up to 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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 Vigamox

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Check with your doctor right away if you have any of the following symptoms: cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness or wheezing. These could be symptoms of an allergic reaction.

Vigamox Side Effects

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

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

Incidence unknown

Fainting or loss of consciousness
fast or irregular breathing
itching
skin rash
swelling of eyes or eyelids
tightness in chest, and/or wheezing
trouble in breathing

More Common

Burning, dry or itching eyes
change in vision
decreased vision
dry eye
eye discharge
itching of eye
pain in eye
redness of eye
swelling of eye, eyelid, or inner lining of eyelid
tearing

Less common

Body aches or pain
congestion
cough or hoarseness
decreased hearing
dryness or soreness of throat
fever or chills
general body discomfort
lower back or side pain
painful or difficult urination
rash
rubbing or pulling of the ears (in children)
runny nose
sore throat
tender, swollen glands in neck
trouble in swallowing
voice changes
vomiting and diarrhea (in infants)

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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Videx Pediatric

30/06/10

Generic Name: didanosine (Oral route)

dye-DAN-oh-seen

Oral routeCapsule, Delayed ReleasePowder for Solution

Pancreatitis, Lactic Acidosis and Hepatomegaly with Steatosis
- Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis.
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk .

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine. Didanosine should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. 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 didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk .

Commonly used brand name(s):

In the U.S.

Videx
Videx EC
Videx Pediatric

Available Dosage Forms:

Powder for Suspension
Tablet, Chewable
Powder for Solution
Capsule, Delayed Release

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Videx Pediatric

Didanosine 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).

Didanosine will not cure or prevent HIV infection or AIDS. 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. Didanosine will not keep you 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.

The buffered tablets that are to be chewed, crushed or mixed with water are no longer available in the United States. This product was voluntarily discontinued, and it was not due to safety concerns. Didanosine delayed-release capsules (Videx® EC) and pediatric powder for oral solution are still available.

Before Using Videx Pediatric

Allergies

Pediatric

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

Geriatric

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

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

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.

Allopurinol
Ribavirin

Hydroxyurea
Stavudine
Tenofovir Disoproxil Fumarate
Zalcitabine

Atazanavir
Atevirdine
Ciprofloxacin
Delavirdine
Enoxacin
Ganciclovir
Indinavir
Itraconazole
Ketoconazole
Lomefloxacin
Methadone
Metoclopramide
Moxifloxacin
Nelfinavir
Norfloxacin
Ofloxacin
Ranitidine
Rifabutin
Ritonavir
Sulfamethoxazole
Trimethoprim
Trovafloxacin Mesylate
Valganciclovir

Interactions with Food/Tobacco/Alcohol

Proper Use of didanosine

This section provides information on the proper use of a number of products that contain didanosine. It may not be specific to Videx Pediatric. 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 first with your doctor.

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

Keep taking didanosine 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 other people.

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.

Didanosine should be taken on an empty stomach since food may keep it from working properly. Didanosine oral liquid should be taken at least 30 minutes before or 2 hours after you eat.

Swallow the delayed-release capsule whole. Do not break, crush, chew, or open it.

Shake the oral liquid before use. Measure each dose with a specially marked measuring spoon or measuring cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

For HIV infection:
- For oral dosage form (delayed-release capsules):
  - Adults, teenagers, and children who can swallow capsules—Dose is based on body weight and must be determined by your doctor.
    - For patients weighing 60 kilograms (kg) or more—400 milligrams (mg) once a day.
    - For patients weighing 25 kg to less than 60 kg—250 mg once a day.
    - For patients weighing 20 kg to less than 25 kg—200 mg once a day.
  - Children weighing less than 20 kg—The oral capsules are not given to small children.
- For oral dosage form (solution):
  - Adults weighing 60 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 200 milligrams (mg) two times a day or 400 mg once a day.
  - Adults weighing less than 60 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 125 mg two times a day or 250 mg once a day.
  - Teenagers, children, and infants 8 months of age and older—Dose is based on body size and must be determined by your doctor. The usual dose is 120 milligrams per square meter (mg/m(2)) two times a day.
  - Infants 2 weeks to 8 months old—Dose is based on body size and must be determined by your doctor. The usual dose is 100 mg/m(2) two times a day.
  - Infants younger than 2 weeks old—Use and dose must be determined by your doctor.

Missed Dose

Storage

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.

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

Store the oral liquid in the refrigerator. Throw away any unused medicine after 30 days.

Precautions While Using Videx Pediatric

It is very important that your doctor check your or your child’s 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 use didanosine if you or your child are also using allopurinol (Zyloprim®) or ribavirin (Copegus®, Rebetol®). Using these medicines together may cause serious side effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking a anti-viral medicine.

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.

This medicine may cause a life-threatening condition called pancreatitis. Stop using this medicine and check with your doctor right away if you or your child have more than one of these symptoms: bloating; chills; constipation; darkened urine; a fast heartbeat; fever; indigestion; loss of appetite; nausea; pains in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin.

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. Call your doctor right away if you or your child have more than one of these symptoms: abdominal or stomach 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 with breathing; vomiting; or yellow eyes or skin.

Stop using this medicine and check with your doctor right away if you or your child have abdominal or stomach pain; black, tarry stools; bleeding gums; blood in the urine or stools; pinpoint red spots on the skin; or unusual bleeding or bruising. These may be symptoms of a condition called non-cirrhotic portal hypertension.

Tell your doctor right away if you or your child start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

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.

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.

This medicine may cause changes in vision. Check with your doctor right away if you or your child start to see unusual colors or have blurred vision.

Do not drink alcohol while you are using this medicine.

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

Videx Pediatric 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:

Less common

Nausea and vomiting
stomach pain
tingling, burning, numbness, and pain in the hands or feet

Rare

Convulsions (seizures)
fever and chills
shortness of breath
skin rash and itching
sore throat
swelling of the feet or lower legs
unusual bleeding and bruising
unusual tiredness and weakness
yellow skin and eyes

Incidence not known

Abdominal or stomach discomfort
anxiety
black, tarry stools
bleeding gums
blindness
bloating
blood in the urine or stools
blue-yellow color blindness
blurred vision
change in the color of the eye
chest pain
clay colored stools
cold sweats
coma
confusion
constipation
cool, pale skin
cough
dark urine
decreased appetite
decreased vision
depression
diarrhea
difficulty with moving
difficulty with swallowing
dizziness
dry eyes
dry mouth
eye pain
fast heartbeat
fast, shallow breathing
flushed, dry skin
fruit-like breath odor
general feeling of discomfort
headache
hives
increased hunger
increased thirst
increased urination
indigestion
joint pain
light-colored stools
loss of appetite
loss of consciousness
muscle aching, cramping, or pain
nervousness
nightmares
painful or difficult urination
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
right upper abdominal pain and fullness
shakiness
sleepiness
slurred speech
sores, ulcers, or white spots on the lips or in the mouth
stomachache
sweating
swollen glands
swollen joints
tightness in the chest
troubled breathing with exertion
unexplained weight loss
unsteadiness or awkwardness
weakness in the arms, hands, legs, or feet
wheezing

More common

Difficulty with sleeping
irritability
restlessness

Incidence not known

Acid or sour stomach
belching
excess air or gas in the stomach or intestines
full feeling
hair loss or thinning of the hair
heartburn
indigestion
lack or loss of strength
passing gas
redistribution or accumulation of body fat

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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vigabatrin (Oral route)

30/06/10

vye-GA-ba-trin

Oral routeTablet

Vision loss:

Vigabatrin causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity.

The onset of vision loss from vigabatrin is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years.

The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

Vision testing at baseline (no later than 4 weeks after starting vigabatrin) and at least every 3 months during therapy is required for adults on vigabatrin. Vision testing is also required about 3 to 6 months after the discontinuation of vigabatrin therapy. Once detected, vision loss due to vigabatrin is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.

It is possible that vision loss can worsen despite discontinuation of vigabatrin.

Because of the risk of vision loss, vigabatrin should be withdrawn from patients who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for vigabatrin should be periodically reassessed.

Symptoms of vision loss from vigabatrin are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient, can still adversely affect function.

Vigabatrin should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from vigabatrin has not been well-characterized, but is likely adverse.

Vigabatrin should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.

The lowest dose and shortest exposure to vigabatrin should be used that is consistent with clinical objectives.

Because of the risk of permanent vision loss, vigabatrin is available only through a special restricted distribution program called SHARE, by calling 1-888-45-SHARE. Only prescribers and pharmacies registered with SHARE may prescribe and distribute vigabatrin. In addition, vigabatrin may be dispensed only to patients who are enrolled in and meet all conditions of SHARE .

Vigabatrin causes permanent vision loss which may occur at any time during therapy and the risk increases with total dose and duration of use. Periodic vision testing is required for patients receiving vigabatrin therapy. Vigabatrin should not be used concomitantly with other drugs associated with adverse ophthalmic effects or in patients at high risk for other types of irreversible vision damage. Vigabatrin is only available through a special restricted distribution program .

Oral routeSolution

Vision loss:

Vigabatrin causes permanent vision loss in infants, children and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized. For this reason, the data described below is primarily based on the adult experience.

In adults, vigabatrin causes permanent bilateral concentric visual field constriction in 30 percent or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity.

The onset of vision loss from vigabatrin is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years.

The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.

It is possible that vision loss can worsen despite discontinuing vigabatrin.

Because of the risk of vision loss, vigabatrin should be withdrawn from patients with infantile spasms who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for vigabatrin should be periodically reassessed.

In infants and children, vision loss may not be detected until it is severe. Nonetheless, vision should be assessed to the extent possible at baseline (no later than 4 weeks after starting vigabatrin) and at least every 3 months during therapy. Once detected, vision loss due to vigabatrin is not reversible. Vision testing is also required about 3 to 6 months after the discontinuation of vigabatrin therapy.

Symptoms of vision loss from vigabatrin are unlikely to be recognized by the parent or caregiver before vision loss is severe. Vision loss of milder severity, although unrecognized by the caregiver, may still adversely affect function.

Vigabatrin should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.

The lowest dose and shortest exposure to vigabatrin should be used that is consistent with clinical objectives.

The possibility that vision loss from vigabatrin may be more common, more severe or have more severe functional consequences in infants and children than in adults cannot be excluded.

Commonly used brand name(s):

In the U.S.

Sabril

Available Dosage Forms:

Tablet
Powder for Solution
Powder

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Gamma Aminobutyric Acid Transaminase Inhibitor

Chemical Class: Gamma Aminobutyric Acid (class)

Uses For vigabatrin

Vigabatrin is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. vigabatrin is used in patients with seizures who have already been treated with other medicines that did not work well.

Vigabatrin is an anticonvulsant. It increases the amount of the chemical called gamma amino butyric acid (GABA) in the brain. It is thought that epileptic seizures are the result of low levels of GABA. By increasing the amount of GABA, vigabatrin reduces the likelihood of an epileptic seizure.

vigabatrin is available only with your doctor’s prescription.

Before Using vigabatrin

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 vigabatrin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vigabatrin 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 vigabatrin oral solution to treat infantile spasms in children and infants 1 month to 2 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of vigabatrin tablets in children and teenagers younger than 16 years of age with complex partial seizures. 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 valproate sodium injection 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 vigabatrin.

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

Using vigabatrin 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.

Carbamazepine

Using vigabatrin 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.

Fosphenytoin
Ginkgo
Phenytoin

Interactions with Food/Tobacco/Alcohol

Proper Use of vigabatrin

Take vigabatrin 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. To do so may increase the chance of side effects.

It is very important that you understand the requirements of the SHARE program, and become familiar with Sabril® Medication Guide. Ask your doctor or pharmacist before starting treatment with vigabatrin.

You may take vigabatrin with or without food.

To use the oral solution:

Open the packet and empty the contents into an empty cup.
Dissolve it with 10 milliliters (mL) of cold or room temperature water.
Measure the dose with an oral syringe that comes with the package.

Vigabatrin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing

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

For oral dosage form (solution):
- For infantile spasms:
  - Children and infants 1 month to 2 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, given in smaller doses two times a day. Your doctor may adjust the dose as needed up to a maximum dose of 150 mg per kg of body weight per day.
  - Infants up to 1 month—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
- For seizures:
  - Adults—At first, 500 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of vigabatrin, 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 vigabatrin

It is very important that your doctor check your or your child’s progress at regular visits to allow for changes in the dose and to check for any unwanted effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

vigabatrin may increase your risk of permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child’s or your eyes approximately every 3 months for any visual problems.

Make sure any doctor or dentist who treats you knows that you are using vigabatrin. vigabatrin may affect the results of certain medical tests (e.g., magnetic resonance imaging or MRI).

vigabatrin 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, your child, or your caregiver notice any of these side effects, tell your doctor right away.

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

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.

Tell your doctor if you or your child have increased weight or swelling in the hands, ankles, or feet while taking vigabatrin.

Do not suddenly stop taking vigabatrin without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping vigabatrin suddenly may cause seizures.

vigabatrin 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

Blue-yellow color blindness
blurred vision
decreased vision or other vision changes
eye pain
increase in seizures
loss of memory
problems with memory

Less common or rare

Uncontrolled rolling eye movements

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

Symptoms of overdose

Mood or mental changes

More common

Abdominal or stomach pain
abnormal coordination
agitation
anxiety
burning, tingling, or prickly sensations
clumsiness
confusion
constipation
diarrhea
dizziness
double vision or seeing double
drowsiness
increased movement
joint pain
mental depression
restlessness
shakiness
sleepiness or unusual drowsiness
trembling
tremor
trouble sitting still
unsteadiness

Less common

Aggression
headache
increased saliva
muscle weakness
nausea
poor concentration
sleeplessness
speech disorder
thinking abnormal
trouble sleeping
unable to sleep
vomiting
weight gain

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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Drugs & Medications:A-Z

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30/06/10

Uses For Vioform Hydrocortisone Mild

Before Using Vioform Hydrocortisone Mild

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of clioquinol and hydrocortisone

Dosing

Missed Dose

Storage

Precautions While Using Vioform Hydrocortisone Mild

Vioform Hydrocortisone Mild Side Effects

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Before Using Vioform

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

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Proper Use of Vioform

Dosing

Missed Dose

Storage

Precautions While Using Vioform

Vioform Side Effects

30/06/10

Uses For vinorelbine

Before Using vinorelbine

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of vinorelbine

Dosing

Precautions While Using vinorelbine

vinorelbine Side Effects

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Before Using vindesine

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Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of vindesine

Dosing

Precautions While Using vindesine

vindesine Side Effects

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Before Using vincristine

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of vincristine

Dosing

Precautions While Using vincristine

vincristine Side Effects

30/06/10