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vidarabine (Ophthalmic route)

30/06/10

vye-DAR-a-been

Commonly used brand name(s):

In the U.S.

Vira-A

Available Dosage Forms:

Ointment
Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Antimetabolite

Chemical Class: Purine Nucleoside Analog

Uses For vidarabine

Vidarabine ophthalmic preparations are used to treat virus infections of the eye.

Vidarabine is available only with your doctor’s prescription.

Before Using vidarabine

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 vidarabine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vidarabine 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 vidarabine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Proper Use of vidarabine

To use:

First, wash your hands. Then pull the lower eyelid away from the eye to form a pouch. Squeeze a thin strip of ointment into the pouch. A 1.25-cm (approximately ½-inch) strip of ointment is usually enough unless otherwise directed by your doctor. Gently close the eyes and keep them closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.
To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using vidarabine eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

Do not use vidarabine more often or for a longer time than your doctor ordered. To do so may cause problems in the eyes. If you have any questions about this, check with your doctor.

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

Dosing

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

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

For ophthalmic ointment dosage forms:
- For virus eye infection:
  - Adults and children—Use in each eye every three hours (five times a day). After healing has occurred, the dose may be reduced to two times a day for seven days more.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using vidarabine

After application, eye ointments usually cause your vision to blur for a few minutes.

It is very important that you keep your appointments with your doctor. If your symptoms become worse, check with your doctor sooner.

vidarabine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

vidarabine Side Effects

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

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

Increased sensitivity of eyes to light
itching, redness, swelling, pain, burning, or other sign of irritation not present before use of vidarabine

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:

Excess flow of tears
feeling of something in the eye

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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Vicks Sinex

30/06/10

Generic Name: phenylephrine (Nasal route)

fen-il-EF-rin

Commonly used brand name(s):

In the U.S.

Neo-Synephrine
Nostril
Pretz-D
Rhinall
Tur-Bi-Cal
Vicks Sinex

Available Dosage Forms:

Solution
Gel/Jelly
Spray

Therapeutic Class: Decongestant

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Uses For Vicks Sinex

Phenylephrine is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. It may also be used in ear infections to relieve congestion.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Vicks Sinex

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

Children may be especially sensitive to the effects of nasal phenylephrine. This may increase the chance of side effects during treatment.

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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.

Rasagiline
Selegiline

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.

Amitriptyline
Amoxapine
Clomipramine
Desipramine
Dothiepin
Doxepin
Imipramine
Lofepramine
Nortriptyline
Opipramol
Protriptyline
Trimipramine

Interactions with Food/Tobacco/Alcohol

Proper Use of phenylephrine

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

To use the nose drops:

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once or twice into each nostril and wait 3 to 5 minutes to allow the medicine to work. Then, blow your nose gently and thoroughly. Repeat until the complete dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

To use the nose jelly:

Blow your nose gently. Wash your hands before applying the medicine. With your finger, place a small amount of jelly (about the size of a pea) up each nostril. Sniff it well back into the nose.
Wipe the tip of the tube with a clean, damp tissue and replace the cap right after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.

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.

For stuffy nose:
- For nose jelly dosage form:
  - Adults—Use a small amount in the nose every three or four hours as needed.
  - Children—Use is not recommended.
- For nose drops dosage form:
  - Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed.
  - Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.
  - Children 4 to 6 years of age—Use two or three drops of a 0.125 or 0.16% solution in the nose every four hours as needed.
  - Children and infants up to 4 years of age—Use is not recommended .
- For nose spray dosage form:
  - Adults and children 12 years of age and older—Use two or three sprays of a 0.25 to 0.5% solution in the nose every four hours as needed.
  - Children 6 to 12 years of age—Use two or three sprays of a 0.25% solution in the nose every four hours as needed.
  - Children 4 to 6 years of age—Use and dose must be determined by your doctor.
  - Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Vicks Sinex Side Effects

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

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

Symptoms of too much medicine being absorbed into the body

Note: The above side effects are more likely to occur in children because there is a greater chance that too much of this medicine may be absorbed into the body.

Fast, irregular, or pounding heartbeat
headache or dizziness
increased sweating
nervousness
paleness
trembling
trouble in sleeping

Increase in runny or stuffy nose

Burning, dryness, or stinging of inside of nose

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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Vicks Sinex 12 Hour

30/06/10

Generic Name: oxymetazoline (Nasal route)

ox-i-me-TAZ-oh-leen

Commonly used brand name(s):

In the U.S.

4-Way Long Lasting
Afrin
Duramist Plus
Duration
Genasal
Mucinex Full Force
Mucinex Moisture Smart
Nasacon
Nasin
Neo-Synephrine 12 Hour
Nostrilla
NRS-Nasal Relief
Sinarest Nasal
Vicks Sinex 12 Hour

Available Dosage Forms:

Solution
Spray

Therapeutic Class: Decongestant

Chemical Class: Imidazoline

Uses For Vicks Sinex 12 Hour

Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble.

This medicine may also be used for other conditions as determined by your doctor.

This medicine is available without a prescription.

Before Using Vicks Sinex 12 Hour

Allergies

Pediatric

Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment.

Geriatric

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

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of oxymetazoline

This section provides information on the proper use of a number of products that contain oxymetazoline. It may not be specific to Vicks Sinex 12 Hour. Please read with care.

To use the nose drops:

Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:

Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once into each nostril, wait 3 to 5 minutes to allow the medicine to work, then blow the nose gently and thoroughly. Repeat until the complete dose is used.
Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
To avoid spreading the infection, do not use the container for more than one person.

Dosing

For nasal dosage form (nose drops or spray):
- For nasal congestion or stuffiness:
  - Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  - Children up to 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Vicks Sinex 12 Hour Side Effects

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

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

Symptoms of too much medicine being absorbed into the body

Blurred vision
fast, irregular, or pounding heartbeat
headache, dizziness, drowsiness, or lightheadedness
high blood pressure
nervousness
trembling
trouble in sleeping
weakness.

Increase in runny or stuffy nose

The above side effects are more likely to occur in children because there is a greater chance in children that too much of this medicine may be absorbed into the body.

Burning, dryness, or stinging inside of nose
increase in nasal discharge
sneezing

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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Vibramycin Hyclate

30/06/10

Generic Name: doxycycline (Oral route)

dox-i-SYE-kleen

Commonly used brand name(s):

In the U.S.

Adoxa
Adoxa CK
Adoxa Pak
Adoxa TT
Alodox
Doryx
Monodox
Oracea
Periostat
Vibramycin Calcium
Vibramycin Hyclate
Vibramycin Monohydrate
Vibra-Tabs

Available Dosage Forms:

Tablet
Powder for Suspension
Capsule
Capsule, Extended Release
Tablet, Delayed Release
Capsule, Delayed Release
Syrup

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Uses For Vibramycin Hyclate

Doxycycline is used to treat infections and to help control acne. It is also used to treat the pimples and abscesses (usually on the face) that are caused by rosacea, also known as acne rosacea or adult acne. Doxycycline may also be used for other problems as determined by your doctor. Doxycycline will not work for colds, flu, or other virus infections.

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

Before Using Vibramycin Hyclate

Allergies

Pediatric

Doxycycline may cause permanent discoloration of teeth and slow down the growth of bones. This medicine should not be given to children 8 years of age and younger unless directed by the child’s doctor.

Geriatric

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

Pregnancy

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

Breast Feeding

Interactions with Medicines

Using 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.

Acitretin

Digoxin
Isotretinoin
Methotrexate

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.

Aluminum Carbonate, Basic
Aluminum Hydroxide
Aluminum Phosphate
Bismuth Subsalicylate
Calcium
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Ethinyl Estradiol
Fosphenytoin
Iron
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Oxide
Magnesium Trisilicate
Mestranol
Norelgestromin
Norethindrone
Norgestrel
Penicillin G
Penicillin G Procaine
Penicillin V
Rifampin
Rifapentine

Interactions with Food/Tobacco/Alcohol

Proper Use of doxycycline

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

Do not give doxycycline to infants or children 8 years of age and younger unless directed by your doctor. Doxycycline may cause permanently discolored teeth and other problems in patients in these age groups.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Take only the amount of doxycycline that is prescribed for you. If you take more than the correct dosage, you may have side effects and the medicine may not work.

Drink plenty of fluids to avoid esophageal irritation and ulceration.

For Doryx® delayed-release tablets—This medicine may be taken with food or milk if it upsets your stomach.

For Oracea™ delayed-release capsules—

You should take this medicine on an empty stomach, preferably at least one hour before or two hours after meals.
You should take this medicine with a full glass of water while sitting or standing.
To prevent throat irritation, do not lay down right after taking this medicine.

Dosing

For oral dosage form (delayed-release tablets):
- For infections:
  - Adults and children older than 8 years of age who weigh more than 100 pounds (45 kilograms or kg)—100 milligrams (mg) every 12 hours the first day, then 100 mg once a day or 50 to 100 mg every 12 hours.
  - Children older than 8 years of age who weigh 100 pounds (45 kg) or less—Dose is based on body weight. The usual dose is 2 milligrams (mg) per pound of body weight divided into two doses on the first day of treatment, followed by 1 mg per pound of body weight given as a single daily dose or divided into two doses on subsequent days.
  - Infants and children 8 years of age and younger—Doxycycline is not used in young children because it can permanently stain teeth.
- For the prevention of malaria:
  - Adults and teenagers—100 milligrams (mg) once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Children older than 8 years of age—Dose is based on body weight. The usual dose is 2 milligrams per kilogram (mg per kg) of body weight once a day. You should take the first dose one or two days before travel to an area where malaria may occur, and continue taking the medicine every day throughout travel and for 4 weeks after you leave the malarious area.
  - Infants and children 8 years of age and younger—Doxycycline is not used in young children because it can permanently stain teeth.
- For inhalation anthrax (post-exposure):
  - Adults and children weighing 100 pounds or more (45 kilograms or kg)—100 milligrams (mg) twice a day for 60 days.
  - Children weighing less than 100 pounds (45 kg)—1 milligram (mg) per pound (2.2 mg/kg) of body weight twice a day for 60 days.
For oral dosage form (delayed-release capsules):
- For the treatment of pimples from rosacea:
  - Adults—40 milligrams (mg) (one capsule) once a day in the morning.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vibramycin Hyclate

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking doxycycline. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking doxycycline. If you have any questions about this, check with your health care professional.

You should contact your doctor right away if you experience stomach cramps, high fever, and bloody diarrhea. These could be symptoms of pseudomembranous colitis, a serious condition where the colon is severely inflamed.

Doxycycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
Wear protective clothing, including a hat. Also, wear sunglasses.
Apply a sunblock product that has a skin protection factor (SPF) number of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
Do not use a sun lamp or tanning bed or booth.

Contact your doctor immediately if fever, rash, joint pain, or tiredness occurs. These could be symptoms of an autoimmune syndrome where the body attacks itself.

You should not take antacids that contain aluminum, calcium or magnesium, or any product that contains iron such as vitamin or mineral supplements.

Vibramycin Hyclate Side Effects

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

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

Frequency not known

Abdominal tenderness
bloating
clay-colored stools
cough
dark urine
decreased appetite
diarrhea
diarrhea, watery and severe, which may also be bloody
difficulty swallowing
dizziness
fast heartbeat
feeling of discomfort
fever
headache
hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
hives or welts
increased thirst
inflammation of joints
itching
joint or muscle pain
large , hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
nausea and vomiting
numbness or tingling of face, hands or feet
pain
rash
redness and soreness of eyes
redness of skin
shortness of breath
sore throat
sores in mouth
stomach cramps
stomach pain or tenderness
swelling of feet or lower legs
swollen lymph glands
tightness in chest
unusual tiredness or weakness
unusual weight loss
wheezing
yellow eyes or skin

Frequency not known

Back, leg, or stomach pains
black, tarry stools
bleeding gums
blood in urine or stools
blurred vision
bulging soft spot on head of an infant
change in ability to see colors, especially blue or yellow
chest pain, discomfort, or burning
chills
cracks in the skin
decrease in vision
difficulty breathing
discoloration of thyroid glands
double vision
general body swelling
heartburn
increased sensitivity of skin to sunlight
loss of heat from the body
lower back or side pain
nosebleeds
pain or burning in throat
pain with swallowing
painful or difficult urination
pale skin
pinpoint red spots on skin
rash with flat lesions or small raised lesions on the skin
red, swollen skin
redness or other discoloration of skin
redness, swelling, or soreness of tongue
scaly skin
severe nausea
severe stomach pain
severe sunburn
sores, ulcers, or white spots on lips or tongue or inside the mouth
unusual bleeding or bruising
vomiting blood

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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Viadur

30/06/10

Generic Name: leuprolide (Intramuscular route, Subcutaneous route, Intradermal route, Injection route)

LOO-proe-lide

Commonly used brand name(s):

In the U.S.

Eligard
Lupron
Lupron Depot
Lupron Depot-Ped
Viadur

Available Dosage Forms:

Powder for Solution
Powder for Suspension, 3 Month
Solution
Powder for Suspension, 1 Month
Kit
Powder for Suspension, 4 Month
Powder for Suspension
Powder for Suspension, 6 Month

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Viadur

Leuprolide may be used for a number of different medical problems. These include treatment of:

anemia caused by bleeding of uterine leiomyomas (tumors in the uterus);
cancer of the prostate gland in men;
central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age);
pain due to endometriosis in women.

Leuprolide is similar to a hormone normally released from the hypothalamus gland.

When given regularly to men and boys, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

When given regularly to women and girls, leuprolide decreases estrogen levels. Reducing the amount of estrogen in the body is one way of treating endometriosis. By shrinking tumors in the uterus, leuprolide helps stop anemia by decreasing the vaginal bleeding from these tumors. Iron supplements should be used to help treat the anemia.

When given to boys and girls experiencing early puberty, leuprolide slows down the development of the genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to receive it.

Suppressing estrogen can cause thinning of the bones or slowing of their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect in girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when leuprolide helps their bones grow at the proper and expected rate for children.

Leuprolide is available only with your doctor’s prescription.

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

Cancer of the breast

Before Using Viadur

Allergies

Pediatric

Leuprolide will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using leuprolide around the time of puberty causes changes in boys’ and girls’ future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child’s doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of leuprolide in the elderly to use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of leuprolide

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

Leuprolide comes with patient directions. Read these instructions carefully .

Use the syringes provided in the kit. Other syringes may not provide the correct dose. These disposable syringes and needles are already sterilized and are designed to be used one time only and then discarded. If you have any questions about the use of disposable syringes, check with your health care professional.

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much may increase the chance of side effects, while using too little may not improve your condition.

For adult patients receiving leuprolide for anemia caused by tumors of the uterus or for endometriosis :

Leuprolide sometimes causes unwanted effects such as hot flashes or decreased interest in sex. It may also cause a temporary increase in pain when you first begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checking with your doctor.

For adult patients receiving leuprolide for cancer of the prostate:

Leuprolide sometimes causes unwanted effects such as hot flashes or decreased sexual ability. It may also cause a temporary increase in pain or difficulty in urinating, as well as temporary numbness or tingling of hands or feet or weakness when you first begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checking with your doctor.

Dosing

For short-acting (daily) injection dosage forms:
- For cancer of the prostate:
  - Adults—1 milligram (mg) injected under the skin once a day.
- For central precocious puberty:
  - Children—Dose is based on body weight and must be determined by your doctor. It is injected under the skin once a day. The dose should be changed over time as weight changes.

For long-acting (1-month) injection dosage forms:
- For anemia caused by tumors of the uterus:
  - Adults—3.75 milligrams (mg) injected into a muscle once a month for up to three months.
- For cancer of the prostate:
  - Adults—7.5 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once a month.
- For central precocious puberty:
  - Children—Dose is based on body weight and must be determined by the doctor. It is injected into a muscle once a month. The dose should be changed over time as weight changes.
- For endometriosis:
  - Adults—3.75 milligrams (mg) injected into a muscle once a month for up to six months.

For long-acting (3-month) injection dosage forms:
- For anemia caused by tumors of the uterus:
  - Adults—11.25 milligrams (mg) injected into a muscle as a single injection to last for three months.
- For cancer of the prostate:
  - Adults—22.5 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once every three months.
- For endometriosis:
  - Adults—11.25 milligrams (mg) injected into a muscle once every three months for up to six months.

For long-acting (4-month) injection dosage form:
- For cancer of the prostate:
  - Adults—30 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once every four months.

For long-acting (12-month) implant dosage form:
- For cancer of the prostate:
  - Adults—one implant every 12 months.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Dispose of used syringes properly in the container provided.

Precautions While Using Viadur

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

For patients receiving leuprolide for endometriosis or for anemia caused by tumors of the uterus :

During the time you are receiving leuprolide, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 60 to 90 days after you stop receiving this medicine, check with your doctor.
During the time you are receiving leuprolide, you should use birth control methods that do not contain hormones. If you have any questions about this, check with your health care professional.
If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.

Viadur 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:

For adultsLess common

Fast or irregular heartbeat

Rare

Bone, muscle, or joint pain
fainting
fast or irregular breathing
numbness or tingling of hands or feet
puffiness or swelling of the eyelids or around the eyes
shortness of breath
skin rash, hives, and/or itching
sudden, severe decrease in blood pressure and collapse
tightness in chest or wheezing
troubled breathing

For males only (adults)Rare

Pains in chest
pain in groin or legs (especially in calves of legs)

Unknown – Observed during clinical practice, estimates of frequency can not be determined

Altered mental status
cardiovascular collapse
double vision
visual changes
vomiting

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

For females only (adults)Rare

Anxiety
deepening of voice
increased hair growth
mental depression
mood changes
nervousness

For childrenRare

Body pain
burning, itching, redness, or swelling at place of injection
skin rash

For females only (children)—expected in first few weeksRare

Vaginal bleeding (continuing)
white vaginal discharge (continuing)

For adultsMore common

Sudden sweating and feelings of warmth (also called hot flashes)

Less common

Blurred vision
bleeding, bruising, burning, itching, pain, redness, or swelling at place of injection
decreased interest in sexual intercourse
dizziness
headache
nausea
swelling of feet or lower legs
swelling or increased tenderness of breasts
trouble in sleeping
weight gain

For females only (adults)More common

Light, irregular vaginal bleeding
stopping of menstrual periods

Less common

Burning, dryness, or itching of vagina
pelvic pain

For males only (adults)Less common

Bone pain
constipation
decreased size of testicles
inability to have or keep an erection

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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Vfend I.V.

30/06/10

Generic Name: voriconazole (Oral route, Intravenous route)

vor-i-KON-a-zole

Commonly used brand name(s):

In the U.S.

Vfend
Vfend I.V.

Available Dosage Forms:

Powder for Suspension
Tablet
Powder for Solution

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For Vfend I.V.

Voriconazole is used to treat different kinds of serious fungal infections. It may also be used to treat patients with serious fungal infections who cannot tolerate other types of treatment or do not respond to other types of treatment.

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

Before Using Vfend I.V.

Allergies

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of voriconazole in children up to 12 years of age. Safety and efficacy have not been established .

Geriatric

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

Pregnancy

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

Breast Feeding

Interactions with Medicines

Using 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.

Astemizole
Carbamazepine
Cisapride
Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Mephobarbital
Methylergonovine
Methysergide
Phenobarbital
Pimozide
Quinidine
Rifabutin
Rifampin
Ritonavir
Sirolimus
St John’s Wort
Terfenadine

Acenocoumarol
Alprazolam
Amiodarone
Bretylium
Chloramphenicol
Clarithromycin
Clopidogrel
Cyclosporine
Darunavir
Dasatinib
Delavirdine
Dicumarol
Dofetilide
Efavirenz
Erythromycin
Everolimus
Fosphenytoin
Ibutilide
Ixabepilone
Lapatinib
Lopinavir
Nevirapine
Nilotinib
Pazopanib
Phenprocoumon
Phenytoin
Ranolazine
Romidepsin
Sotalol
Sunitinib
Tacrolimus
Telavancin
Temsirolimus
Triazolam
Vinblastine
Vincristine
Vincristine Liposome
Vinorelbine
Warfarin

Alfentanil
Amprenavir
Atorvastatin
Cerivastatin
Ethinyl Estradiol
Etravirine
Fosamprenavir
Glipizide
Glyburide
Lovastatin
Meloxicam
Methadone
Midazolam
Nelfinavir
Norethindrone
Omeprazole
Oxycodone
Saquinavir
Simvastatin
Tolbutamide
Tretinoin

Interactions with Food/Tobacco/Alcohol

Proper Use of voriconazole

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

Dosing

A nurse or other trained health professional will give you the IV form of this medicine. This medicine is given through a needle placed in one of your veins. It will be given slowly, so the needle will remain in place for up to 2 hours .

For the oral suspension, shake well before measuring the dose. Use the oral dispenser supplied with your medicine to measure the dose.

For oral dosage forms (oral suspension or tablets):
- For serious fungal infections:
  - Adults and children 12 years of age and above—Your dose will be determined based on your weight and other medicines you are taking. Check with your doctor for more dosage information. Oral suspension or tablets should be taken 1 hour before or after a meal.
  - Children below 12 years of age—Use and dose will be determined by your doctor .

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Throw away any unused oral suspension after the date listed on the label.

Precautions While Using Vfend I.V.

It is very important that your doctor check you at regular visits to see if the medicine is working properly and decide if you should continue to take it.

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

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. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions .

You should NOT use any of the following medicines while you are using voriconazole :

Astemizole (e.g., Hismanal®)
Carbamazepine (e.g., Tegretol®)
Cisapride (e.g., Propulsid®)
Ergot medicines (e.g., ergotamine, dihydroergotamine, methysergide, bromocriptine, Sansert®, or Parlodel®)
Phenobarbital (e.g., Luminal®)
Pimozide (e.g., Orap®)
Quinidine (e.g., Quinora®)
Rifabutin (e.g., Mycobutin®)
Rifampin (e.g., Rifadin®)
Sirolimus (e.g., Rapamune®)
St. John’s wort
Terfenadine (e.g., Seldane®)

Check with your doctor first before using efavirenz (Sustiva®) or ritonavir (Norvir®) during voriconazole treatment. Your doses of these medicines will need to be adjusted .

This medicine may cause some people to have changes in vision, such as blurred vision and seeing bright spots or wavy lines. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you have vision changes.

Using this medicine while you are pregnant can harm your unborn baby. It is important that contraception (birth control) be used during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away .

The IV form of this medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest tightness within a few hours after you receive it .

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

Vfend I.V. 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

Rash

Less common

Abdominal or stomach pain
bloating or swelling of face, arms, hands, lower legs, or feet
blurred vision
chills
clay-colored stools
confusion
convulsions
dark urine
decreased urine
dizziness
dry mouth
faintness or light-headedness when getting up from a lying or sitting position
fever
headache
increased thirst
irregular or pounding heartbeat
itching
loss of appetite
mood or mental changes
muscle pain or cramps
muscle spasms or twitching
nausea
nervousness
numbness or tingling in hands, feet, or lips
pounding in the ears
rapid weight gain
rash with flat lesions or small raised lesions on the skin
shortness of breath
slow or fast heartbeat
suddenly sweating
trembling
unpleasant breath odor
unusual tiredness or weakness
vasodilation (flushing)
vomiting of blood
yellow eyes or skin

Rare

Abnormal kidney function
black, bloody, or tarry stools
bleeding gums
blood in eye
blood in urine or stools
chest pain
eye pain
painful or difficult urination
pale skin
pinpoint red spots on skin
redness in whites of eyes
sore throat
sores, ulcers, or white spots on lips or in mouth
sudden kidney failure
swollen glands
trouble breathing with activity
unusual bleeding or bruising

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

Change in color vision
difficulty seeing at night
increased sensitivity of eyes to sunlight

More Common

Seeing things that are not there

Less common

Diarrhea
disturbance in vision
dry mouth
feeling unusually cold
shivering
vomiting

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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verteporfin (Intravenous route, Injection route)

30/06/10

ver-te-PORE-fin

Commonly used brand name(s):

In the U.S.

Visudyne

Available Dosage Forms:

Powder for Solution

Therapeutic Class: Photosensitizing Agent

Uses For verteporfin

Verteporfin is used together with a special laser light, to treat abnormal blood vessel formation in a part of the eye which, if left untreated, can lead to a loss of eyesight.

Verteporfin may also be used for the following problems:

Pathologic myopia (changes in the eyeball causing vision problems);
Ocular histoplasmosis (damage to the eye from a fungus found in the soil)

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

Before Using verteporfin

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 verteporfin, the following should be considered:

Allergies

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

Pediatric

Studies on verteporfin have been done only in adult patients, and there is no specific information comparing use of verteporfin in children with use in other age groups.

Geriatric

Studies show that the effects of verteporfin are less in patients 75 years of age or older.

Pregnancy

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

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of verteporfin

Treatment with verteporfin and laser light occurs in two steps. First, the verteporfin is injected into your body. Second, 15 minutes later, a laser light is directed at the affected eye.

Dosing

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

Precautions While Using verteporfin

For 5 days after you receive an injection of verteporfin, your eyes will be extra sensitive to light, including sunlight and bright indoor lights. Certain types of sunglasses can help protect your eyes during this time. Check with your doctor about which sunglasses to use.

For 5 days after you receive an injection of verteporfin, your skin will be extra sensitive to sunlight and to very bright indoor lights, such as tanning lamps, bright halogen lighting and lights in dental offices or operating rooms. Do not expose your skin to direct sunlight or to bright indoor lights during this time. Sunscreens will not protect your skin from a severe reaction to light (blistering, burning, and swelling of the skin). However, exposure to normal amounts of indoor light (for example, daylight or light from lamps with shades) will help clear up the verteporfin remaining in your skin. Therefore, do not protect your skin from normal amounts of indoor light. If you have any questions about whether the light in your home is too bright, check with your doctor or nurse. If you do have a severe reaction to light, call your doctor immediately.

verteporfin 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

Blurred vision or other change in vision

Less common

Decrease in vision, may be severe
dizziness
dull nervousness
eye pain
fainting
fast, slow, or irregular heartbeat
itching, redness, or other irritation of eye
pale skin
pounding in the ears
troubled breathing on exertion
unusual bleeding or bruising
unusual tiredness or weakness

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, infection, itching, numbness, pain, rash, redness, scarring, stinging, swelling, tenderness, tingling, ulceration, and/or warmth at the injection site
headache

Less common

Back pain (during infusion of verteporfin)
chills
cloudy urine
constipation
cough
decreased hearing
decreased sensitivity to touch
diarrhea
difficult or painful urination
difficulty in moving
double vision
dry eyes
feeling of constant movement of self or surroundings
fever
general feeling of discomfort or illness
hoarseness
increased sensitivity of skin to sunlight
joint pain
light headedness
loss of appetite
loss of strength or energy
muscle pain or stiffness
nausea
pain, swelling, or redness in joints
pelvic discomfort
redness or other discoloration of skin
runny nose
severe sunburn
shivering
skin rash
sore throat
sweating
tearing
tender, swollen glands in neck
throat congestion
trouble in sleeping
trouble in swallowing
trouble sleeping
varicose veins
voice changes
vomiting

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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Versel

30/06/10

Generic Name: selenium sulfide (Topical route)

se-LEE-nee-um SUL-fide

Commonly used brand name(s):

In the U.S.

Dandrex
Selenos
Selseb
Selsun Blue Medicated Treatment
Tersi Foam

In Canada

Versel

Available Dosage Forms:

Lotion
Cream
Shampoo
Foam
Suspension

Therapeutic Class: Antiseborrheic

Uses For Versel

Selenium sulfide 1% and 2.5% strengths are used on the scalp to help control the symptoms of dandruff and seborrheic dermatitis.

Selenium sulfide 2.5% strength is used also on the body to treat tinea versicolor (a type of fungus infection of the skin).

In the United States, the 2.5% strength is available only with your doctor’s prescription.

Before Using Versel

Allergies

Pediatric

There is no specific information comparing use of selenium sulfide in infants and children with use in other age groups; however, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of selenium sulfide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of selenium sulfide

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

If you are using the 2.5% strength of selenium sulfide: Use this medicine only as directed. Do not use it more often than recommended on the label, unless otherwise directed by your doctor.

If you are using the 1% strength of selenium sulfide : For best results, use this medicine at least 2 times a week or as directed by your doctor.

To use selenium sulfide for dandruff or seborrheic dermatitis of the scalp:

Before using this medicine, wet the hair and scalp with lukewarm water.
Apply enough medicine (1 or 2 teaspoonfuls) to the scalp to work up a lather. Allow the lather to remain on the scalp for 2 to 3 minutes, then rinse.
Apply the medicine again and rinse well.
If this medicine is used on light or blond, gray, or chemically treated (bleached, tinted, permanent-waved) hair, rinse your hair well for at least 5 minutes after using the medicine to lessen the chance of hair discoloration.
After treatment, wash your hands well.

To use selenium sulfide for tinea versicolor of the body:

Apply the medicine to the affected areas of your body, except for your face and genitals (sex organs).
Work up a lather using a small amount of water.
Allow the medicine to remain on your skin for 10 minutes.
Rinse your body well to remove all the medicine.

Do not use this medicine if blistered, raw, or oozing areas are present on your scalp or the area of your body that is to be treated , unless otherwise directed by your doctor.

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

Dosing

For lotion dosage form:
- For dandruff or seborrheic dermatitis:
  - Adults and children—If you are using the 1% lotion, use on the scalp two times a week. If you are using the 2.5% lotion, use on the scalp two times a week for two weeks, then use one time a week or less often.
  - Infants—Use and dose must be determined by your doctor.
- For tinea versicolor:
  - Adults and children—Use the 2.5% lotion on the body one time a day for seven days.
  - Infants—Use and dose must be determined by your doctor.

Missed Dose

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Versel

If your condition does not get better after regular use of this medicine, or if it gets worse, check with your doctor.

Versel Side Effects

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

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

Less common or rare

Skin irritation

More common

Unusual dryness or oiliness of hair or scalp

Less common

Increase in normal hair loss

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

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

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Versed

30/06/10

Generic Name: midazolam (Injection route)

MID-ay-zoe-lam

Oral routeSyrup

Midazolam hydrochloride syrup has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Midazolam hydrochloride syrup has been associated with reports of respiratory depression, airway obstruction, desaturation, hypoxia, and apnea, most often when used concomitantly with other central nervous system depressants (eg, opioids). Midazolam hydrochloride syrup should be used only in hospital or ambulatory care settings, including physicians’ and dentists’ offices, that can provide for continuous monitoring of respiratory and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure .

Injection routeSolution

Adult and Pediatric:
- Intravenous midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy has resulted. Intravenous midazolam hydrochloride should be used only in hospital or ambulatory care settings, including physicians’ and dental offices, that provide for continuous monitoring of respiratory and cardiac function, ie, pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured. For deeply sedated pediatric patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedures.
- The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult. Lower doses are necessary for older (over 60 years) or debilitated patients and in patients receiving concomitant narcotics or other central nervous system (CNS) depressants. The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation/anxiolysis/amnesia is age, procedure, and route dependent.
Neonates:
- Midazolam hydrochloride should not be administered by rapid injection in the neonatal population. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl .

Midazolam has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. Use only in settings that can provide for continuous monitoring of respiratory and cardiac function. The initial dose and all subsequent doses should always be titrated slowly. Midazolam injection should not be administered by rapid injection in the neonatal population as severe hypotension and seizures have been reported .

Commonly used brand name(s):

In the U.S.

Versed

In Canada

Midazolam

Available Dosage Forms:

Solution

Therapeutic Class: Anesthetic Adjunct

Pharmacologic Class: Benzodiazepine, Short or Intermediate Acting

Uses For Versed

Midazolam is used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures. Midazolam is also given to produce amnesia (loss of memory) so that the patient will not remember any discomfort or undesirable effects that may occur after a surgery or procedure . It is also used to produce loss of consciousness before and during surgery. Midazolam is sometimes used in patients in hospital intensive care units to cause unconsciousness. This may allow the patient to withstand the stress of being in the intensive care unit and help the patient cooperate when a machine must be used to assist with breathing.

Midazolam is given only by or under the immediate supervision of a doctor trained to use this medicine. If you will be receiving midazolam during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.

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

Epilepsy

Before Using Versed

Allergies

Pediatric

Newborn babies may be especially sensitive to the effects of midazolam. This may increase the chance of side effects during the use of this medicine. Also, the time it takes to completely recover after midazolam is given may be longer in very ill newborn babies.

Geriatric

Elderly people are especially sensitive to the effects of midazolam. This may increase the chance of side effects during the use of this medicine. Also, the time it takes to completely recover after midazolam is given may be slower in the elderly than in younger adults.

Pregnancy

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

Breast Feeding

Interactions with Medicines

Using 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.

Amprenavir
Atazanavir
Darunavir
Delavirdine
Efavirenz
Fosamprenavir
Indinavir
Itraconazole
Lopinavir
Nelfinavir
Ritonavir
Saquinavir
Tipranavir

Alfentanil
Amobarbital
Anileridine
Aprobarbital
Butabarbital
Butalbital
Carisoprodol
Chloral Hydrate
Chlorzoxazone
Codeine
Dantrolene
Ethchlorvynol
Fentanyl
Fospropofol
Hydrocodone
Hydromorphone
Ketoconazole
Levorphanol
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Morphine
Morphine Sulfate Liposome
Nilotinib
Oxycodone
Oxymorphone
Pentobarbital
Phenobarbital
Primidone
Propoxyphene
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Tapentadol
Thiopental
Zolpidem

Aprepitant
Armodafinil
Carbamazepine
Cimetidine
Clarithromycin
Conivaptan
Dalfopristin
Deferasirox
Diltiazem
Echinacea
Erythromycin
Fluconazole
Fluvoxamine
Fosaprepitant
Fosphenytoin
Ginkgo Biloba
Goldenseal
Halothane
Phenytoin
Posaconazole
Quinupristin
Roxithromycin
St John’s Wort
Telithromycin
Theophylline
Verapamil
Voriconazole

Interactions with Food/Tobacco/Alcohol

Proper Use of Versed

Dosing

Your age;
Your weight;
Your general physical condition;
The kind of surgery or other procedure you are having; and
Other medicines you are taking or will receive before and during the procedure.

Precautions While Using Versed

For patients going home within 24 hours after receiving midazolam:

Midazolam may cause some people to feel drowsy, tired, or weak for 1 or 2 days after it has been given. It may also cause problems with coordination and one’s ability to think. Therefore, do not drive, use machines, or do anything else that could be dangerous if you are not alert until the effects of the medicine have disappeared or until the day after you receive midazolam, whichever period of time is longer.
Do not drink alcoholic beverages or take other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received midazolam, unless otherwise directed by your doctor. To do so may add to the effects of the medicine. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; other sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; and muscle relaxants.

Versed Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. While you are receiving midazolam, your doctor will monitor you closely for the following side effects:

Breathing problems
confusion

Some side effects may occur that usually do not need medical attention. Most side effects will go away as the effects of midazolam wear off. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

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verapamil (Intravenous route)

30/06/10

ver-AP-a-mil

Available Dosage Forms:

Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Phenylalkylamine

Uses For verapamil

Verapamil is used to control rapid heartbeats or abnormal heart rhythms. It belongs to a group of drugs called calcium channel blocking agents. Verapamil affects the movement of calcium into the cells of the heart and blood vessels. As a result, the heart beats slower and the blood vessels relax, thus, increasing the supply of blood and oxygen to the heart while reducing its workload .

verapamil is available only with your doctor’s prescription .

Before Using verapamil

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 verapamil, the following should be considered:

Allergies

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

Pediatric

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

Geriatric

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

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

Dofetilide

Using verapamil 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.

Acebutolol
Adenosine
Alprenolol
Amiodarone
Atazanavir
Atenolol
Atorvastatin
Betaxolol
Bevantolol
Bisoprolol
Bucindolol
Bupivacaine
Carteolol
Carvedilol
Celiprolol
Clonidine
Colchicine
Dantrolene
Digoxin
Dilevalol
Dronedarone
Eplerenone
Erythromycin
Esmolol
Everolimus
Fentanyl
Labetalol
Levobunolol
Lovastatin
Mepindolol
Mepivacaine
Metipranolol
Metoprolol
Nadolol
Nebivolol
Oxprenolol
Penbutolol
Pindolol
Propranolol
Ranolazine
Simvastatin
Sotalol
Talinolol
Telithromycin
Tertatolol
Timolol
Tizanidine
Tolvaptan

Using verapamil 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.

Aspirin
Buspirone
Carbamazepine
Clarithromycin
Cyclosporine
Dalfopristin
Digitoxin
Dutasteride
Flecainide
Fosphenytoin
Indinavir
Itraconazole
Lithium
Midazolam
Nevirapine
Oxcarbazepine
Pancuronium
Phenobarbital
Phenytoin
Quinidine
Quinupristin
Rifapentine
Ritonavir
Saquinavir
Sirolimus
St John’s Wort
Tedisamil
Tubocurarine
Vecuronium

Interactions with Food/Tobacco/Alcohol

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

Ethanol

Proper Use of verapamil

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

Precautions While Using verapamil

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

verapamil Side Effects

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

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

Less common

Blurred vision
chest pain or discomfort
confusion
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fast, slow, pounding, or irregular heartbeat or pulse
lightheadedness, dizziness, or fainting
shortness of breath
sweating
unusual tiredness or weakness

Rare

Cough
difficulty breathing
noisy breathing
tightness in chest
wheezing

Incidence not known

Convulsions
loss of bladder control
muscle spasm or jerking of all extremities
sudden loss of consciousness

Less common

Headache

Rare

Hives or welts
itching
nausea
redness of skin
skin rash
stomach soreness or discomfort

Incidence not known

Discouragement
feeling of constant movement of self or surroundings
feeling sad or empty
increased sweating
irritability
lack of appetite
loss of interest or pleasure
sensation of spinning
sleepiness
tiredness
trouble concentrating
trouble sleeping
uncontrolled eye movements

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

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

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Drugs & Medications:A-Z

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30/06/10

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