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Vigabatrin Oral Solution

30/06/10

Generic Name: Vigabatrin (vye-GA-ba-trin)
Brand Name: Sabril

Vigabatrin Oral Solution may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping Vigabatrin Oral Solution.

Vision loss may not be detected until it is severe. Parents or caregivers may not be able to recognize the symptoms of vision loss. Eye exams will be performed at the start of treatment and at least every 3 months during treatment. They will also be performed for 3 to 6 months after treatment stops. Some patients may develop severe vision loss even with monitoring.

Tell the doctor if the patient has or is at risk for developing another type of permanent vision loss. Tell the doctor if the patient uses other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Vigabatrin Oral Solution should not be used in these patients unless the benefit outweighs the risks.

Use the lowest dose of Vigabatrin Oral Solution for the shortest time needed. Vigabatrin Oral Solution should not be used for longer than 2 to 4 weeks if no improvement is seen in the patient’s condition.

Vigabatrin Oral Solution is used for:

Treating infantile spasms in children 1 month to 2 years old. It may also be used for other conditions as determined by your doctor.

Vigabatrin Oral Solution is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.

Do NOT use Vigabatrin Oral Solution if:

you are allergic to any ingredient in Vigabatrin Oral Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vigabatrin Oral Solution:

Some medical conditions may interact with Vigabatrin Oral Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have vision problems, kidney problems, or certain blood problems (eg, anemia, porphyria)
if you have a history of depression, other mental or mood problems, or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Vigabatrin Oral Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) because their effectiveness may decreased by Vigabatrin Oral Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vigabatrin Oral Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vigabatrin Oral Solution:

Use Vigabatrin Oral Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vigabatrin Oral Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vigabatrin Oral Solution refilled.
Take Vigabatrin Oral Solution by mouth with or without food.
Follow your doctor’s instructions for how many packets to use per dose.
Follow the instructions provided for how to mix Vigabatrin Oral Solution. Do not mix Vigabatrin Oral Solution with food. It can only be mixed with water. You will need to use 10 mL of water (cold or room temperature) for each packet used.
Vigabatrin Oral Solution should be taken right away after it is mixed. Do not store for use at a later time. Throw away any mixture that is left after you use a dose.
To give Vigabatrin Oral Solution, place the tip of the oral syringe into the child’s mouth. Point it toward either of the child’s cheeks. Push on the plunger slowly, a small amount at a time, until the entire dose is given.
Wash the oral syringes and mixing cups in warm water. To clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. Wash the barrel and plunger by hand with soap and water, rinse, and allow to dry. The barrel and plunger may also be washed in the dishwasher utensil rack.
Do not suddenly stop taking Vigabatrin Oral Solution. There may be an increased risk of side effects (eg, seizures). If you need to stop Vigabatrin Oral Solution, your doctor will gradually lower your dose.
Talk with your doctor about what to do if your child vomits or spits up Vigabatrin Oral Solution, only takes part of the dose, or misses a dose.

Ask your health care provider any questions you may have about how to use Vigabatrin Oral Solution.

Important safety information:

Vigabatrin Oral Solution may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use Vigabatrin Oral Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
Vigabatrin Oral Solution may cause weight gain. If you notice unusual weight gain, contact your doctor.
Vigabatrin Oral Solution may cause abnormal magnetic resonance imaging (MRI) changes in infants. It is not known if these changes may be harmful. Discuss any questions or concerns with your doctor.
Patients who take Vigabatrin Oral Solution may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Vigabatrin Oral Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Vigabatrin Oral Solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vigabatrin Oral Solution.
Lab tests, including eye exams, may be performed while you use Vigabatrin Oral Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Vigabatrin Oral Solution with caution in the ELDERLY; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: It is not known if Vigabatrin Oral Solution may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vigabatrin Oral Solution while you are pregnant. Vigabatrin Oral Solution is found in breast milk. Do not breast-feed while taking Vigabatrin Oral Solution.

Possible side effects of Vigabatrin Oral Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; decreased appetite; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach upset; stuffy nose; tiredness; trouble sleeping; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; confusion; decreased coordination; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; mental or mood changes (eg, depression); new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; new or worsening seizures;painful menstrual period; suicidal thoughts or actions; symptoms of ear infection (eg, ear pain); tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include abnormal behavior; coma; confusion; mental or mood changes; new or worsening seizures; severe drowsiness; severe or persistent dizziness or headache; shortness of breath; slow heartbeat; speech problems.

Proper storage of Vigabatrin Oral Solution:

Store Vigabatrin Oral Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vigabatrin Oral Solution out of the reach of children and away from pets

General information:

If you have any questions about Vigabatrin Oral Solution, please talk with your doctor, pharmacist, or other health care provider.
Vigabatrin Oral Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vigabatrin Oral Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

Comments (0)

Vigabatrin Tablets

30/06/10

Generic Name: Vigabatrin (vye-GA-ba-trin)
Brand Name: Sabril

Vigabatrin Tablets may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping Vigabatrin Tablets.

Vision loss may not be detected until it is severe. Patients or caregivers may not be able to recognize the symptoms of vision loss. Eye exams will be performed at the start of treatment and at least every 3 months during treatment. They will also be performed for 3 to 6 months after treatment stops. Some patients may develop severe vision loss even with monitoring.

Tell your doctor if you have or are at risk for developing another type of permanent vision loss. Tell your doctor if you use other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Vigabatrin Tablets should not be used in these patients unless the benefit outweighs the risks.

Use the lowest dose of Vigabatrin Tablets for the shortest time needed. Vigabatrin Tablets should not be used for longer than 3 months if no improvement is seen in your condition.

Vigabatrin Tablets is used for:

Treating refractory complex partial seizures (CPS) that have not responded to several other treatments. It may also be used for other conditions as determined by your doctor.

Vigabatrin Tablets is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.

Do NOT use Vigabatrin Tablets if:

you are allergic to any ingredient in Vigabatrin Tablets

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vigabatrin Tablets:

Some medical conditions may interact with Vigabatrin Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have vision problems, kidney problems, or certain blood problems (eg, anemia, porphyria)
if you have a history of depression, other mental or mood problems, or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Vigabatrin Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) because their effectiveness may decreased by Vigabatrin Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vigabatrin Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vigabatrin Tablets:

Use Vigabatrin Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vigabatrin Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vigabatrin Tablets refilled.
Take Vigabatrin Tablets by mouth with or without food.
Do not suddenly stop taking Vigabatrin Tablets. There may be an increased risk of side effects (eg, seizures). If you need to stop Vigabatrin Tablets, your doctor will gradually lower your dose.
Talk with your doctor about what to do if you miss a dose of Vigabatrin Tablets.

Ask your health care provider any questions you may have about how to use Vigabatrin Tablets.

Important safety information:

Vigabatrin Tablets may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use Vigabatrin Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If symptoms do not get better within 3 months or if they get worse, check with your doctor.
Vigabatrin Tablets may cause weight gain. If you notice unusual weight gain, contact your doctor.
Vigabatrin Tablets may cause abnormal magnetic resonance imaging (MRI) changes in infants. These changes have not been seen in adults. Discuss any questions or concerns with your doctor.
Patients who take Vigabatrin Tablets may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Vigabatrin Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Vigabatrin Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vigabatrin Tablets.
Lab tests, including eye exams, may be performed while you use Vigabatrin Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Vigabatrin Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Vigabatrin Tablets should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Vigabatrin Tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vigabatrin Tablets while you are pregnant. Vigabatrin Tablets is found in breast milk. Do not breast-feed while taking Vigabatrin Tablets.

Possible side effects of Vigabatrin Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach pain or upset; tiredness; trouble sleeping; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; chest pain; confusion; decreased coordination; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; mental or mood changes (eg, depression); new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; new or worsening seizures;painful menstrual period; suicidal thoughts or actions; symptoms of ear infection (eg, ear pain); tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).

If OVERDOSE is suspected:

Proper storage of Vigabatrin Tablets:

Store Vigabatrin Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vigabatrin Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Vigabatrin Tablets, please talk with your doctor, pharmacist, or other health care provider.
Vigabatrin Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vigabatrin Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

Comments (0)

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

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

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

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.

Cisapride
Dronedarone
Mesoridazine
Pimozide
Thioridazine
Ziprasidone

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.

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

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.

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

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 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

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.

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

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

More Common

Burning, 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.

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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Vigabatrin Solution

30/06/10

Generic Name: Vigabatrin (vye-GA-ba-trin)
Brand Name: Sabril

Vigabatrin Solution may cause permanent vision loss in a high percentage of patients. This effect may occur within weeks or sooner after starting treatment. It may also occur after months or years. The risk may increase with higher doses and prolonged use, but it may occur with any dose or length of use. Vision loss may continue to worsen after stopping Vigabatrin Solution.

Tell the doctor if the patient has or is at risk for developing another type of permanent vision loss. Tell the doctor if the patient uses other medicines that may cause serious vision problems (eg, retinopathy, glaucoma). Vigabatrin Solution should not be used in these patients unless the benefit outweighs the risks.

Use the lowest dose of Vigabatrin Solution for the shortest time needed. Vigabatrin Solution should not be used for longer than 2 to 4 weeks if no improvement is seen in the patient’s condition.

Vigabatrin Solution is used for:

Treating infantile spasms in children 1 month to 2 years old. It may also be used for other conditions as determined by your doctor.

Vigabatrin Solution is an antiepileptic. Exactly how it works is not known, but it may work by blocking certain enzymes in the brain.

Do NOT use Vigabatrin Solution if:

you are allergic to any ingredient in Vigabatrin Solution

Contact your doctor or health care provider right away if any of these apply to you.

Before using Vigabatrin Solution:

Some medical conditions may interact with Vigabatrin Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have vision problems, kidney problems, or certain blood problems (eg, anemia, porphyria)
if you have a history of depression, other mental or mood problems, or suicidal thoughts or actions

Some MEDICINES MAY INTERACT with Vigabatrin Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydantoins (eg, phenytoin) because their effectiveness may decreased by Vigabatrin Solution

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vigabatrin Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vigabatrin Solution:

Use Vigabatrin Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Vigabatrin Solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vigabatrin Solution refilled.
Take Vigabatrin Solution by mouth with or without food.
Follow your doctor’s instructions for how many packets to use per dose.
Follow the instructions provided for how to mix Vigabatrin Solution. Do not mix Vigabatrin Solution with food. It can only be mixed with water. You will need to use 10 mL of water (cold or room temperature) for each packet used.
Vigabatrin Solution should be taken right away after it is mixed. Do not store for use at a later time. Throw away any mixture that is left after you use a dose.
To give Vigabatrin Solution, place the tip of the oral syringe into the child’s mouth. Point it toward either of the child’s cheeks. Push on the plunger slowly, a small amount at a time, until the entire dose is given.
Wash the oral syringes and mixing cups in warm water. To clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. Wash the barrel and plunger by hand with soap and water, rinse, and allow to dry. The barrel and plunger may also be washed in the dishwasher utensil rack.
Do not suddenly stop taking Vigabatrin Solution. There may be an increased risk of side effects (eg, seizures). If you need to stop Vigabatrin Solution, your doctor will gradually lower your dose.
Talk with your doctor about what to do if your child vomits or spits up Vigabatrin Solution, only takes part of the dose, or misses a dose.

Ask your health care provider any questions you may have about how to use Vigabatrin Solution.

Important safety information:

Vigabatrin Solution may cause drowsiness, dizziness, or vision problems. These effects may be worse if you take it with alcohol or certain medicines. Use Vigabatrin Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If symptoms do not get better within 2 to 4 weeks or if they get worse, check with your doctor.
Vigabatrin Solution may cause weight gain. If you notice unusual weight gain, contact your doctor.
Vigabatrin Solution may cause abnormal magnetic resonance imaging (MRI) changes in infants. It is not known if these changes may be harmful. Discuss any questions or concerns with your doctor.
Patients who take Vigabatrin Solution may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Vigabatrin Solution closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Vigabatrin Solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Vigabatrin Solution.
Lab tests, including eye exams, may be performed while you use Vigabatrin Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Vigabatrin Solution with caution in the ELDERLY; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: It is not known if Vigabatrin Solution may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vigabatrin Solution while you are pregnant. Vigabatrin Solution is found in breast milk. Do not breast-feed while taking Vigabatrin Solution.

Possible side effects of Vigabatrin Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; decreased appetite; diarrhea; dizziness; drowsiness; headache; irritability; joint pain; nausea; sore throat; stomach upset; stuffy nose; tiredness; trouble sleeping; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling of the hands or feet; confusion; decreased coordination; fever, chills, or persistent sore throat; increased or painful urination; memory or attention problems; mental or mood changes (eg, depression); new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; new or worsening seizures;painful menstrual period; suicidal thoughts or actions; symptoms of ear infection (eg, ear pain); tremor; trouble walking; uncontrolled eye movements; unusual swelling (eg, of the hands or feet); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision); vision loss (eg, loss of the outer edges of your vision).

If OVERDOSE is suspected:

Proper storage of Vigabatrin Solution:

Store Vigabatrin Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vigabatrin Solution out of the reach of children and away from pets

General information:

If you have any questions about Vigabatrin Solution, please talk with your doctor, pharmacist, or other health care provider.
Vigabatrin Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vigabatrin Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

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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.

Advanced,V

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vigabatrin

30/06/10

Generic Name: vigabatrin (vye GA ba trin)
Brand Names: Sabril

What is vigabatrin?

Vigabatrin is an anti-epileptic medication, also called an anticonvulsant.

Vigabatrin is used in combination with other medications to treat complex partial seizures in adults and adolescents who are at least 16 years old. Vigabatrin is usually given after other anti-epileptic medications have been tried without successful control of seizures.

The powder form of vigabatrin is used to treat infantile spasms in babies and children between the ages of 1 month and 2 years.

Vigabatrin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about vigabatrin?

Before you take vigabatrin, tell your doctor if you have any vision problems, such as retinitis or glaucoma. Some people taking vigabatrin have developed mild to severe vision problems. Vision loss caused by vigabatrin may be permanent, and you must have eye exams on a regular basis while taking this medication.

To be sure vigabatrin is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking the medication and then every 3 months during treatment. If you ever stop taking vigabatrin, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

You may have thoughts about suicide while taking vigabatrin. Your doctor will need to check your progress at regular visits. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, or thoughts about suicide or hurting yourself.

Vigabatrin is available only under a special program called SHARE. You must be enrolled in the program and sign documents stating that you understand the dangers of this medication and that you agree to have vision exams on a regular basis while you are taking vigabatrin.

What should I discuss with my health care provider before taking vigabatrin?

Some people taking vigabatrin have developed mild to severe vision problems. Vision problems may occur within weeks to years after you start taking vigabatrin. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms of the onset of vision loss. You must have eye exams on a regular basis while taking this medication.

Vigabatrin is available only under a special program called SHARE. You must be enrolled in the program and sign documents stating that you understand the dangers of this medication and that you agree to have vision exams every 3 months while you are taking vigabatrin. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.

You should not use this medication if you are allergic to vigabatrin.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

kidney disease; or
vision problems, such as retinitis or glaucoma.

You may have thoughts about suicide while taking this medication. Your doctor will need to check your progress at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether vigabatrin is harmful to an unborn baby, but having a seizure during pregnancy could harm both the mother and the baby. Do not start taking vigabatrin during pregnancy without telling your doctor you are pregnant.

If you become pregnant while taking vigabatrin for seizures, do not stop taking it without your doctor’s advice. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by taking vigabatrin.

Your name may need to be listed on a pregnancy registry if you become pregnant while using this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether vigabatrin had any effect on the baby.

Vigabatrin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take vigabatrin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Vigabatrin may be taken with or without food.

Vigabatrin powder must be mixed with water before you give it to your child. Empty the packet of powder into an empty cup and add 10 milliliters (2 teaspoons) of water that is cold or room temperature. If your doctor has prescribed more than 1 packet per dose, use 2 teaspoons of water for each packet of powder you are mixing.

Do not mix the powder and water until you are ready to give a dose. Stir the mixture until the powder dissolves completely. Give the liquid mixture to your child using the 10 mL oral syringe that comes with the medicine. If your child’s dose is more than 1 packet, you will need to fill the syringe once for each packet mixed.

Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.

To be sure this medication is not causing harmful effects on your vision, you will need a thorough eye exam when you start taking vigabatrin and then every 3 months during treatment. If you ever stop taking vigabatrin, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Do not stop using vigabatrin without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using vigabatrin suddenly. You will need to use less and less before you stop the medication completely. It may take up to 3 months before your seizure control improves. Contact your doctor if your seizures get worse or you have them more often while taking vigabatrin. Store vigabatrin at room temperature away from moisture and heat.

See also: Vigabatrin dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What should I avoid while taking vigabatrin?

Vigabatrin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Vigabatrin side effects

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

any change in your vision, no matter how mild;
back and forth eye movements you cannot control;
confusion, mood or behavior changes, depression, thoughts about suicide or hurting yourself;
pale skin, easy bruising; or
worsening seizures.

Less serious side effects may include:

drowsiness, dizziness; tired feeling;
numbness or tingly feeling in your toes or feet;
runny or stuffy nose, fever, sore throat, cough;
nausea, vomiting, diarrhea, constipation;
memory problems;
weight gain;
headache, sleep problems (insomnia);
joint pain; or
loss of coordination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Vigabatrin Dosing Information

Usual Adult Dose for Seizure Prophylaxis:

Initial dose: 1 g/day (administered as one 500 mg tablet orally twice daily) with or without food

The total daily dose may be increased in 500 mg increments at weekly intervals depending on response.

Recommended dose: 3 g/day (1.5 g twice daily)

A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events.

Usual Pediatric Dose for Epilepsy:

Infantile Spasms:
1 Month to 2 Years of Age:
Initial dose: 50 mg/kg/day of vigabatrin oral solution given in two divided doses with or without food. The dose may be titrated by 25 to 50 mg/kg/day increments every 3 days up to a maximum of 150 mg/kg/day.

The entire contents of the appropriate number of packets (500 mg/packet) of powder should be emptied into an empty cup, and should be dissolved in 10 mL of cold or room temperature water per packet using the 10 mL oral syringe supplied with the medication. The concentration of the final solution is 50 mg/mL.

Each individual dose should be prepared immediately before use and administered cold or at room temperature.

What other drugs will affect vigabatrin?

Tell your doctor about all other medications you use, especially:

clonazepam (Klonopin);
hydroxychloroquine (Plaquenil);
phenytoin (Dilantin);
thioridazine (Mellaril);
steroids such as prednisone and others (especially if taken daily over a long period of time); or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with vigabatrin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about vigabatrin.

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

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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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Videx EC Delayed-Release Enteric-Coated Capsules

30/06/10

Generic Name: Didanosine (dye-DAN-oh-seen)
Brand Name: Videx EC

Videx EC Delayed-Release Enteric-Coated Capsules may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Videx EC Delayed-Release Enteric-Coated Capsules and in patients who have already been taking it. Contact your doctor right away if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Videx EC Delayed-Release Enteric-Coated Capsules may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Videx EC Delayed-Release Enteric-Coated Capsules along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or planning to become pregnant.

Videx EC Delayed-Release Enteric-Coated Capsules are used for:

Treating HIV infection when used in combination with other medicines.

Videx EC Delayed-Release Enteric-Coated Capsules are a nucleoside analogue reverse transcriptase inhibitor. It works by stopping the growth of HIV-1, the virus that causes AIDS.

Do NOT use Videx EC Delayed-Release Enteric-Coated Capsules if:

you are allergic to any ingredient in Videx EC Delayed-Release Enteric-Coated Capsules
you have pancreas inflammation (pancreatitis), certain liver problems (eg, enlarged liver, portal hypertension), abnormal liver function tests, or lactic acidosis
you are taking allopurinol or ribavirin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Videx EC Delayed-Release Enteric-Coated Capsules:

Some medical conditions may interact with Videx EC Delayed-Release Enteric-Coated Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of heart problems (eg, heart attack)
if you have advanced HIV infection (AIDS), kidney problems, liver problems (eg, hepatitis), gallstones, nerve problems (neuropathy), high blood cholesterol or lipid levels, or high blood amylase levels
if you are overweight or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Videx EC Delayed-Release Enteric-Coated Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Hydroxyurea because the risk of pancreatitis may be increased
Allopurinol, ganciclovir, nucleotide reverse transcriptase inhibitors (eg, tenofovir), or ribavirin because they may increase the risk of Videx EC Delayed-Release Enteric-Coated Capsules’s side effects
Methadone because it may decrease Videx EC Delayed-Release Enteric-Coated Capsules’s effectiveness
Aluminum salts (eg, aluminum hydroxide) because the risk of their side effects may be increased by Videx EC Delayed-Release Enteric-Coated Capsules
Azole antifungals (eg, itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (eg, indinavir, lopinavir, nelfinavir), lithium, quinolones (eg, ciprofloxacin, levofloxacin), sulfones (eg, dapsone), or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Videx EC Delayed-Release Enteric-Coated Capsules
Stavudine because the risk of pancreatitis or fatal lactic acidosis in pregnant women may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Videx EC Delayed-Release Enteric-Coated Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Videx EC Delayed-Release Enteric-Coated Capsules:

Use Videx EC Delayed-Release Enteric-Coated Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Videx EC Delayed-Release Enteric-Coated Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Videx EC Delayed-Release Enteric-Coated Capsules refilled.
Take Videx EC Delayed-Release Enteric-Coated Capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Videx EC Delayed-Release Enteric-Coated Capsules whole. Do not break, crush, or chew before swallowing.
Videx EC Delayed-Release Enteric-Coated Capsules may reduce the effectiveness of certain other medicines when taken together. Ask your doctor or pharmacist if you should separate Videx EC Delayed-Release Enteric-Coated Capsules from any other medicine that you are taking.
Continue to take Videx EC Delayed-Release Enteric-Coated Capsules even if you feel well. Do not miss any doses.
If you miss a dose of Videx EC Delayed-Release Enteric-Coated Capsules, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Videx EC Delayed-Release Enteric-Coated Capsules. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Videx EC Delayed-Release Enteric-Coated Capsules.

Important safety information:

Do not drink alcohol while you are taking Videx EC Delayed-Release Enteric-Coated Capsules.
Videx EC Delayed-Release Enteric-Coated Capsules are not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
Videx EC Delayed-Release Enteric-Coated Capsules does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Videx EC Delayed-Release Enteric-Coated Capsules, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Tell your doctor or dentist that you take Videx EC Delayed-Release Enteric-Coated Capsules before you receive any medical or dental care, emergency care, or surgery.
The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are overweight (obese), and patients who have taken reverse transcriptase inhibitors (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk of severe side effects from Videx EC Delayed-Release Enteric-Coated Capsules.
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Videx EC Delayed-Release Enteric-Coated Capsules. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Videx EC Delayed-Release Enteric-Coated Capsules may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Videx EC Delayed-Release Enteric-Coated Capsules.
Lab tests, including eye exams, liver function, complete blood cell counts, and blood clotting (eg, international normalized ratio [INR]), may be performed while you use Videx EC Delayed-Release Enteric-Coated Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Videx EC Delayed-Release Enteric-Coated Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
Use Videx EC Delayed-Release Enteric-Coated Capsules with extreme caution in CHILDREN weighing less than 44 lb; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Videx EC Delayed-Release Enteric-Coated Capsules while you are pregnant. It is not known if Videx EC Delayed-Release Enteric-Coated Capsules are found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Videx EC Delayed-Release Enteric-Coated Capsules to the baby.

Possible side effects of Videx EC Delayed-Release Enteric-Coated Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness of breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in the hands or feet; pale stools; seizures; severe muscle pain or cramping; stomach pain or swelling; tiredness; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include dark urine; diarrhea; pale stools; severe stomach pain with nausea and vomiting; tingling, burning, or numbness in the hands or feet; unusual fatigue; yellowing of the skin or eyes.

Proper storage of Videx EC Delayed-Release Enteric-Coated Capsules:

Store Videx EC Delayed-Release Enteric-Coated Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Brief storage at temperatures of up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Videx EC Delayed-Release Enteric-Coated Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Videx EC Delayed-Release Enteric-Coated Capsules, please talk with your doctor, pharmacist, or other health care provider.
Videx EC Delayed-Release Enteric-Coated Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Videx EC Delayed-Release Enteric-Coated Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

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Videx EC

30/06/10

Generic Name: didanosine (dye DAN oh seen)
Brand Names: Videx, Videx EC

What is Videx EC (didanosine)?

Didanosine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Didanosine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS.

Didanosine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Videx EC (didanosine)?

Do not use didanosine if you are allergic to it. Do not take didanosine together with allopurinol (Zyloprim) or ribavirin (Rebetol, Ribasphere, Copegus Virazole).

There are many other medicines that can interact with didanosine. Tell your doctor about all medications you use.

Didanosine can cause life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms: severe pain in your upper stomach spreading to your back, swelling around your stomach, feeling of fullness, feeling short of breath, coughing up blood, fast heart rate, nausea and vomiting, loss of appetite, low fever, dark urine or stools, or jaundice (yellowing of the skin or eyes). Do not take didanosine without telling your doctor if you are pregnant. Some people develop lactic acidosis while taking didanosine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What should I discuss with my healthcare provider before taking Videx EC (didanosine)?

Do not use didanosine if you are allergic to it. Do not take didanosine together with allopurinol (Zyloprim) or ribavirin (Rebetol, Ribasphere, Copegus Virazole). Didanosine can cause severe or life-threatening effects on your liver or pancreas.

If you have any of these conditions, you may need a dose adjustment or special tests:

liver disease;
kidney disease (or if you are on dialysis);
a history of pancreatitis; or
a history of peripheral neuropathy (numbness or tingling in your hands or feet).

Some people develop a life-threatening condition called lactic acidosis while taking didanosine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. Do not take didanosine without telling your doctor if you are pregnant. Didanosine may be more likely to cause pancreatitis or liver problems in a pregnant woman.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of didanosine on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Videx EC (didanosine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take didanosine on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

HIV/AIDS is usually treated with a combination of different drugs. Certain HIV medications or antibiotics should not be taken at the same time as didanosine because they can affect the levels of this medicine in your blood stream:

ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after you take didanosine.
delavirdine (Rescriptor) or indinavir (Crixivan) should be taken at least 1 hour before you take didanosine.
nelfinavir (Viracept) should be taken at least 1 hour after you take didanosine.
itraconazole (Sporanox) or ketoconazole (Nizoral) should be taken at least 2 hours before you take didanosine.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your vision and liver function may also need to be tested. Visit your doctor regularly.

Store at room temperature in a tightly closed container, away from moisture and heat. Store the liquid form of didanosine in the refrigerator. Throw away any leftover didanosine liquid that is more than 30 days old.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Videx EC (didanosine)?

Do not drink alcohol. It may increase your risk of liver damage or pancreatitis.

Avoid using antacids without your doctor’s advice while taking didanosine. Use only the specific type of antacid your doctor recommends.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Videx EC (didanosine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Didanosine may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

muscle pain or weakness;
numb or cold feeling in your arms and legs;
trouble breathing;
feeling dizzy, light-headed, tired, or very weak;
stomach pain, nausea with vomiting; or
fast or uneven heart rate.

Stop using didanosine and call your doctor at once if you have any of these other serious side effects:

liver damage – nausea, stomach pain, low fever, loss of appetite, dark urine or stools, jaundice (yellowing of the skin or eyes);
pancreatitis – severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
swelling around your stomach, feeling of fullness, feeling short of breath, coughing up blood;
numbness, tingling, or pain in your hands or feet;
pale skin, easy bruising or bleeding, feeling light-headed, rapid heart rate, trouble concentrating;
fever, chills, body aches, flu symptoms; or
any other signs of new infection.

Less serious side effects may include:

mild stomach pain, diarrhea;
headache;
mild rash; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Videx EC (didanosine)?

Tell your doctor about all other medicines you use, especially:

ganciclovir (Cytovene);
hydroxyurea (Droxie, Hydrea);
methadone (Dolophine, Methadose);
stavudine (Zerit); or
tenofovir (Viread).

This list is not complete and there are many other drugs that can interact with didanosine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about didanosine.

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

Concise,V

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30/06/10

Videx Chewable/

Dispersible Buffered Tablets

Generic Name: Didanosine (dye-DAN-oh-seen)
Brand Name: Videx

Videx Chewable/Dispersible Buffered Tablets may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Videx Chewable/Dispersible Buffered Tablets and in patients who have already been taking it. Contact your doctor immediately if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Videx Chewable/Dispersible Buffered Tablets may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Videx Chewable/Dispersible Buffered Tablets along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or plan to become pregnant.

Videx Chewable/Dispersible Buffered Tablets are used for:

Treating HIV infection when used in combination with other medicines.

Videx Chewable/Dispersible Buffered Tablets are a nucleoside analogue reverse transcriptase inhibitor that stops the growth of HIV-1, the virus that causes AIDS.

Do NOT use Videx Chewable/Dispersible Buffered Tablets if:

you are allergic to any ingredient in Videx Chewable/Dispersible Buffered Tablets
you have pancreas problems (pancreatitis), an enlarged liver, abnormal liver function tests, or lactic acidosis
you are taking allopurinol, aluminum salts (eg, aluminum hydroxide), or ribavirin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Videx Chewable/Dispersible Buffered Tablets:

Some medical conditions may interact with Videx Chewable/Dispersible Buffered Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of heart problems (eg, heart attack)
if you have advanced HIV infection (AIDS), kidney problems, liver problems, gallstones, nerve problems (neuropathy), high blood cholesterol or lipid levels, high blood amylase levels, or phenylketonuria
if you are overweight or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Videx Chewable/Dispersible Buffered Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Allopurinol, ganciclovir, nucleotide reverse transcriptase inhibitors (eg, tenofovir), or ribavirin because they may increase the risk of Videx Chewable/Dispersible Buffered Tablets’s side effects
Aluminum salts (eg, aluminum hydroxide), anorexiants (eg, phentermine), or sympathomimetics (eg, albuterol, pseudoephedrine) because the risk of their side effects may be increased by Videx Chewable/Dispersible Buffered Tablets
Azole antifungals (eg, itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (eg, indinavir, lopinavir, nelfinavir), lithium, quinolones (eg, ciprofloxacin, levofloxacin), sulfones (eg, dapsone), or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Videx Chewable/Dispersible Buffered Tablets
Hydroxyurea because the risk of pancreatitis may be increased
Methadone because it may decrease Videx Chewable/Dispersible Buffered Tablets’s effectiveness
Stavudine because the risk of pancreatitis or fatal lactic acidosis in pregnant women may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Videx Chewable/Dispersible Buffered Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Videx Chewable/Dispersible Buffered Tablets:

Use Videx Chewable/Dispersible Buffered Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Videx Chewable/Dispersible Buffered Tablets. Talk to your pharmacist if you have questions about this information.
Take Videx Chewable/Dispersible Buffered Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Do not swallow tablets whole. Chew tablets thoroughly or crush the tablets and mix in at least 1 oz (30 mL) of water. This mixture may be added to 1 ounce (30 mL) clear apple juice to improve taste. Make sure to stir well and drink the entire solution immediately.
Videx Chewable/Dispersible Buffered Tablets may reduce the effectiveness of certain other medicines when taken together. Ask your doctor or pharmacist if you should separate Videx Chewable/Dispersible Buffered Tablets from any other medicines that you are taking.
Continue taking Videx Chewable/Dispersible Buffered Tablets even if you feel better. Do not miss any doses.
If you miss a dose of Videx Chewable/Dispersible Buffered Tablets, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Videx Chewable/Dispersible Buffered Tablets. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Videx Chewable/Dispersible Buffered Tablets.

Important safety information:

Do not drink alcohol while you are taking Videx Chewable/Dispersible Buffered Tablets.
Videx Chewable/Dispersible Buffered Tablets are not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
Videx Chewable/Dispersible Buffered Tablets does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
Tell your doctor or dentist that you take Videx Chewable/Dispersible Buffered Tablets before you receive any medical or dental care, emergency care, or surgery.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Videx Chewable/Dispersible Buffered Tablets, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Videx Chewable/Dispersible Buffered Tablets. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
Phenylketonurics – Videx Chewable/Dispersible Buffered Tablets has phenylalanine in it.
Lab tests, including periodic eye exams, may be performed while you use Videx Chewable/Dispersible Buffered Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Videx Chewable/Dispersible Buffered Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Use Videx Chewable/Dispersible Buffered Tablets with extreme caution in CHILDREN younger than 2 weeks old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Videx Chewable/Dispersible Buffered Tablets while you are pregnant. It is not known if Videx Chewable/Dispersible Buffered Tablets are found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Videx Chewable/Dispersible Buffered Tablets to the baby.

Possible side effects of Videx Chewable/Dispersible Buffered Tablets:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness or breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever or chills; lightheadedness; low body temperature; nausea and vomiting; numbness, tingling, or pain in hands or feet; seizures; severe muscle pain or cramping; stomach pain; tiredness; weakness; yellowing of skin or eyes.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include dark urine; diarrhea; pale stools; severe stomach pain with nausea and vomiting; tingling, burning, or numbness in hands or feet; unusual fatigue; yellowing of skin or eyes.

Proper storage of Videx Chewable/Dispersible Buffered Tablets:

Store Videx Chewable/Dispersible Buffered Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store the tablets in a damp place, such as the bathroom, medicine cabinet, or near the kitchen sink. If the tablets are dispersed in water, the dose may be held for up to 1 hour at room temperature. Keep Videx Chewable/Dispersible Buffered Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Videx Chewable/Dispersible Buffered Tablets, please talk with your doctor, pharmacist, or other health care provider.
Videx Chewable/Dispersible Buffered Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Videx Chewable/Dispersible Buffered Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

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