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Zometa

30/06/10

Generic Name: zoledronic acid (Intravenous route)

zoe-le-DRON-ik AS-id

Commonly used brand name(s):

In the U.S.

Reclast
Zometa

Available Dosage Forms:

Solution
Powder for Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For Zometa

Zoledronic acid injection is used to treat hypercalcemia (high levels of calcium in the blood) that may occur in patients with some types of cancer. It is also used to treat a cancer called multiple myeloma (tumors formed by the cells of the bone marrow) or certain types of bone metastases (the spread of cancer to the bone).

Zoledronic acid injection is used to treat Paget’s disease of the bone in men and women. It is also used in men with osteoporosis and in women with osteoporosis who have gone through menopause. This medicine is used to reduce the risk of having more fractures in patients who have had a recent hip fracture.

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

This medicine 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 these uses are not included in product labeling, zoledronic acid is used in certain patients with the following medical conditions:

Bone loss, in men, from taking certain medicines for prostate cancer.
Bone loss, in breast cancer patients, from hormone therapy (prevention).

Before Using Zometa

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of zoledronic acid injection in the pediatric population. However, 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 zoledronic acid injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving zoledronic acid injection.

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

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Proper Use of zoledronic acid

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

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes.

Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

Precautions While Using Zometa

It is important that your doctor check your progress at regular visits after you have received zoledronic acid injection. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed. You will need a yearly dose of this medicine if you are being treated for postmenopausal osteoporosis, so check with your doctor regularly.

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

This medicine may cause low calcium in your blood. Check with your doctor immediately if you have numbness or tingling around the mouth, or if you have muscle spasms.

Tell your doctor right away if you have agitation; blood in the urine; confusion; decreased urine output; depression; dizziness; headache; irritability; lethargy; muscle twitching; nausea; rapid weight gain; seizures; stupor; swelling of the face, ankles, or hands; or unusual tiredness or weakness. These could be symptoms of serious kidney problems.

It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving zoledronic acid. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe problem of your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.

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

Zometa Side Effects

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

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

More common

Agitation
black, tarry stools
blurred vision
chest pain
chills
coma
confusion
convulsions
cough
depression
difficult or labored breathing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever
irregular heartbeat
irritability
lack or loss of strength
lethargy
lower back or side pain
mood or mental changes
muscle pain or cramps
muscle trembling or twitching
nausea or vomiting
numbness and tingling around the mouth, fingertips, or feet
painful or difficult urination
pale skin
rapid weight gain
seizures
shaking of the hands, arms, feet, legs, or face
shortness of breath
skin rash, cracks in the skin at the corners of the mouth, or soreness or redness around the fingernails and toenails
sore throat
sores, ulcers, or white spots on the lips or mouth
stupor
sudden sweating
swollen glands
tightness in the chest
trouble breathing with exercise
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Less common

Feeling of constant movement of self or surroundings
muscle cramps in the hands, arms, feet, legs, or face
muscle spasms
neck pain
pounding in the ears
rapid breathing
sensation of spinning
slow or fast heartbeat
sunken eyes
tingling of the hands or feet
tremor

Incidence not known

Blurred vision or other change in vision
decreased frequency or amount of urine
decreased vision
eye pain
eye tenderness
heavy jaw feeling
increased blood pressure
increased tearing
increased thirst
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loosening of a tooth
pain, swelling, or numbness in the mouth or jaw
redness of the eye
sensitivity of the eye to light
severe eye pain
swelling of the face, hands, fingers, lower legs, or ankles
tearing
troubled breathing
weight gain

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

Abdominal or stomach pain
anxiety, nervousness, restlessness, or irritability
back pain
bad, unusual, or unpleasant (after) taste
bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
bone pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
constipation
cracked lips
cracked, dry, or scaly skin
diarrhea
difficulty with swallowing
discouragement
dry mouth
ear congestion
fear or nervousness
feeling sad or empty
frequent urge to urinate
hair loss or thinning hair
headache
hyperventilation
joint pain or swollen joints
loss of appetite
loss of interest or pleasure
loss of voice
muscle stiffness or difficulty with moving
nasal congestion or runny nose
pain, swelling, or redness in the joints
partial loss of feeling
seeing, hearing, or feeling things that are not there
sleepiness or unusual drowsiness
sleeplessness, trouble sleeping, or unable to sleep
swelling or inflammation of the mouth
thirst
trouble with concentrating
unusually cold, shivering
vomiting
weight loss

Less common

Acid or sour stomach
belching
heartburn
indigestion
stomach discomfort, upset, or pain
unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
wrinkled skin

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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zolpidem (Oral route, Oromucosal route, Sublingual route)

30/06/10

zole-PI-dem

Commonly used brand name(s):

In the U.S.

Ambien
Ambien CR
Edluar

Available Dosage Forms:

Tablet
Tablet, Extended Release
Spray

Therapeutic Class: Nonbarbiturate Hypnotic

Uses For zolpidem

Zolpidem belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Zolpidem is used to treat insomnia (trouble in sleeping). Zolpidem helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

zolpidem is available only with your doctor’s prescription.

Before Using zolpidem

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 zolpidem, the following should be considered:

Sleep medicines may cause a special type of memory loss or “amnesia”. When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zolpidem only when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to zolpidem 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 zolpidem in the pediatric population. 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 zolpidem in the elderly. However, confusion and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects.

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 zolpidem 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.

Alprazolam
Buspirone
Butabarbital
Chlordiazepoxide
Chlorpromazine
Clonazepam
Clorazepate
Dexmedetomidine
Diazepam
Diphenhydramine
Doxylamine
Estazolam
Eszopiclone
Ethchlorvynol
Flumazenil
Flurazepam
Fospropofol
Halazepam
Hydromorphone
Hydroxyzine
Lorazepam
Meprobamate
Midazolam
Oxazepam
Oxycodone
Pentobarbital
Phenobarbital
Prazepam
Promethazine
Propofol
Quazepam
Ramelteon
Secobarbital
Tapentadol
Temazepam
Thioridazine
Triazolam
Zaleplon

Using zolpidem 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.

Bupropion
Desipramine
Ketoconazole
Rifampin
Sertraline
Venlafaxine

Interactions with Food/Tobacco/Alcohol

Using zolpidem 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 zolpidem, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of zolpidem

Take zolpidem only 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. If too much is taken, it may become habit-forming (causing mental or physical dependence).

zolpidem should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep. zolpidem works very quickly to put you to sleep.

You should swallow the extended-release tablets whole. Do not crush or chew them.

Do not take zolpidem when your schedule does not permit you to get a full night’s sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.

To use the oral spray:

Pull the child-resistant cap to separate it from the base.
Remove the clear protective cap from the pump.
Hold the container upright with the black spray opening pointed directly into your mouth.
Fully press down on the pump to make sure that a full dose (5 mg) of is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given.
Put the clear protective cap back over the pump after each use.

To use the sublingual tablets:

Do not open the blister pack that contains the tablet until you are ready to take it. Do not use the tablet if the seal of the blister pack is broken.
Remove the tablet from the blister pack by peeling back the top layer of paper, then push the tablet through the foil.
Place the tablet under your tongue. It should melt quickly. Do not crush, chew, or swallow the tablet. Do not eat or drink anything after using zolpidem.

Dosing

The dose of zolpidem 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 zolpidem. 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 the treatment of insomnia (trouble in sleeping):
- For oral dosage form (sublingual tablets):
  - Adults—10 milligrams (mg) placed under the tongue at bedtime.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults—10 milligrams (mg) once a day at bedtime.
  - Older adults—5 mg once a day at bedtime.
  - Children—Use and dose must be determined by the doctor.
- For oral dosage form (extended-release tablets):
  - Adults—12.5 milligrams (mg) once a day at bedtime.
  - Older adults—6.25 mg once a day at bedtime.
  - Children—Use and dose must be determined by the doctor.
- For oral dosage form (oral spray):
  - Adults—10 milligrams (mg) or 2 sprays into the mouth at bedtime.
  - Older adults—5 mg or 1 spray into the mouth at bedtime.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of zolpidem, 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.

Throw the child-resistant container of the oral spray when the 60 sprays have already been used.

Precautions While Using zolpidem

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

If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

zolpidem will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using zolpidem.

zolpidem may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, zolpidem may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking zolpidem are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

zolpidem may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.

If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping zolpidem suddenly may cause withdrawal side effects.

After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of zolpidem, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.

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

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.

zolpidem 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

Clumsiness or unsteadiness
confusion
mental depression

Rare

Dizziness, lightheadedness, or fainting
falling
fast heartbeat
hallucinations (seeing, hearing, or feeling things that are not there)
skin rash
swelling of the face
trouble with sleeping
unusual excitement, nervousness, or irritability
wheezing or difficulty with breathing

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

Symptoms of overdose

Clumsiness or unsteadiness (severe)
dizziness (severe)
double vision or other vision problems
drowsiness (severe)
nausea (severe)
slow heartbeat
troubled breathing
vomiting (severe)

More common

Sleepiness or unusual drowsiness

Less common

Abdominal or stomach pain
abnormal or decreased touch sensation
abnormal sensation of movement
appetite disorder
balance disorder
binge eating
bladder pain
bloody or cloudy urine
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in hearing
chest discomfort
chills
confusion about identity, place, and time
constipation
continuing ringing or buzzing or other unexplained noise in the ears
daytime drowsiness
diarrhea
difficult, burning, or painful urination
difficulty with moving
difficulty with swallowing
discouragement
double vision or other vision problems
drugged feelings
dryness of mouth
ear drainage
earache
eye redness
false or unusual sense of well-being
fear
feeling of unreality
feeling sad or empty
fever
flatulence
frequent bowel movements
frequent urge to urinate
general feeling of discomfort or illness
generalized slowing of mental and physical activity
headache
hearing loss
heartburn
hives or welts
itching ears
joint pain
lack of appetite
lack of feeling or emotion
lack or loss of self-control
lack or loss of strength
longer or heavier menstrual periods
loss of balance
loss of interest or pleasure
memory problems
mood swings
muscle aches, cramping, pain, or stiffness
nausea
nervousness
nightmares or unusual dreams
pain in the joints
redness of the skin
redness or soreness of the throat
sense of detachment from self or body
shortness of breath or troubled breathing
skin rash
skin wrinkling
sneezing
sore throat
stress symptoms
stuffy or runny nose
swollen joints
tiredness
trouble concentrating
trouble with sleeping
vision blurred
visual depth perception altered
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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zolmitriptan (Oral route)

30/06/10

zole-mi-TRIP-tan

Commonly used brand name(s):

In the U.S.

Zomig
Zomig-ZMT

Available Dosage Forms:

Tablet
Tablet, Disintegrating

Therapeutic Class: Antimigraine

Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1

Uses For zolmitriptan

Zolmitriptan is used to treat severe migraine headaches. Many people find that their headaches go away completely after they take zolmitriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Zolmitriptan often relieves symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.

Zolmitriptan is not an ordinary pain reliever. It should not be used to relieve any kind of pain other than migraine headaches.

Zolmitriptan may cause serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using zolmitriptan as well as the good that it can do.

Zolmitriptan is available only with your doctor’s prescription.

Before Using zolmitriptan

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 zolmitriptan, the following should be considered:

Allergies

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

Pediatric

There is no specific information comparing use of zolmitriptan in children or teenagers with use in other age groups.

Geriatric

There is no specific information comparing use of zolmitriptan in patients older than 65 years of age with use in younger adults.

Pregnancy

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

Breast Feeding

Interactions with Medicines

Using zolmitriptan 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.

Almotriptan
Cisapride
Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Frovatriptan
Isocarboxazid
Levomethadyl
Linezolid
Mesoridazine
Methylergonovine
Methysergide
Naratriptan
Phenelzine
Pimozide
Procarbazine
Rizatriptan
Sumatriptan
Terfenadine
Thioridazine
Tranylcypromine
Ziprasidone

Using zolmitriptan 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.

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprindine
Azimilide
Bretylium
Chloroquine
Citalopram
Clarithromycin
Clovoxamine
Desipramine
Desvenlafaxine
Dibenzepin
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Duloxetine
Erythromycin
Escitalopram
Femoxetine
Flecainide
Fluconazole
Fluoxetine
Fluvoxamine
Foscarnet
Gemifloxacin
Halofantrine
Haloperidol
Hydroquinidine
Ibutilide
Imipramine
Isradipine
Lidoflazine
Lorcainide
Mefloquine
Milnacipran
Nefazodone
Nortriptyline
Octreotide
Paroxetine
Pentamidine
Pirmenol
Prajmaline
Probucol
Procainamide
Prochlorperazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Reboxetine
Risperidone
Sematilide
Sertindole
Sertraline
Sibutramine
Sotalol
Spiramycin
St John’s Wort
Sultopride
Tapentadol
Tedisamil
Trifluoperazine
Trimipramine
Vasopressin
Venlafaxine
Zimeldine
Zotepine

Using zolmitriptan 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.

Cimetidine

Interactions with Food/Tobacco/Alcohol

Proper Use of zolmitriptan

Do not use zolmitriptan for a headache that is different from your usual migraines . Instead, check with your doctor.

To relieve your migraine as soon as possible, use zolmitriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using zolmitriptan.

Lying down in a quiet, dark room for a while after you use zolmitriptan may help relieve your migraine.

Ask your doctor ahead of time about other medicine you might take if zolmitriptan does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by zolmitriptan are sometimes caused by conditions that need other treatment.

If you feel much better after a dose of zolmitriptan, but your headache comes back or gets worse after a while, you may use more zolmitriptan. However, use zolmitriptan only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much zolmitriptan may increase the chance of side effects.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor’s directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of zolmitriptan or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

For patients using the oral disintegrating tablet form of zolmitriptan:

Make sure your hands are dry.
Remove tablet from package, and immediately place the tablet on top of your tongue.
The tablet will dissolve in seconds, and you may swallow it with your saliva. You do not need to drink water or other liquid to swallow the tablet.

Dosing

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

For oral dosage form (tablets):
- For migraine headaches:
  - Adults—2.5 mg or lower (tablet may be broken in half) as a single dose. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
  - Children—Use and dose must be determined by your doctor.
For oral dosage form (oral disintegrating tablets):
- For migraine headaches:
  - Adults—2.5 mg placed on top of your tongue. If the migraine comes back after being relieved, another dose may be taken two hours after the last dose. Do not take more than 10 mg in any twenty-four-hour period (one day).
  - Children—Use and dose must be determined by your doctor.

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 zolmitriptan

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine, or after taking zolmitriptan to relieve a migraine. As long as you are feeling drowsy or dizzy, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

zolmitriptan 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.

Stop taking zolmitriptan and get emergency help immediately if any of the following effects occur:

More common

Chest pain (severe)
heaviness, tightness, or pressure in chest and/or neck
sensation of burning, warmth, heat, numbness, tightness, or tingling

Less common or rare

Abdominal pain (severe)
changes in facial skin color
cough or hoarseness
diarrhea
fast or irregular heartbeat
fever or chills
loss of appetite
lower back or side pain
nausea
painful or difficult urination
puffiness or swelling of the eyelids or around the eyes, face, or lips
shortness of breath, troubled breathing, tightness in chest, and/or wheezing
skin rash, hives, and/or itching
weakness

Other side effects may occur that usually do not need medical attention. Some of the following effects, such as nausea, vomiting, drowsiness, dizziness, and general feeling of illness or tiredness, often occur during or after a migraine, even when zolmitriptan has not been used. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Dizziness
nausea
sleepiness
unusual tiredness or muscle weakness

Less common

Agitation
anxiety
depression
discomfort in jaw, mouth, or throat
difficulty in swallowing
dry mouth
fainting
heartburn
itching of the skin
large nonelevated blue or purplish patches in the skin
muscle aches
pounding heartbeat
sudden large increase in frequency and quantity of urine
sweating
swelling of face, fingers, feet and/or lower legs

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

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

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zoledronic acid (Intravenous route)

30/06/10

zoe-le-DRON-ik AS-id

Commonly used brand name(s):

In the U.S.

Reclast
Zometa

Available Dosage Forms:

Solution
Powder for Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For zoledronic acid

Zoledronic acid injection is used to treat Paget’s disease of the bone in men and women. It is also used in men with osteoporosis and in women with osteoporosis who have gone through menopause. zoledronic acid is used to reduce the risk of having more fractures in patients who have had a recent hip fracture.

zoledronic acid is to be administered only by or under the supervision of your doctor.

zoledronic acid is available only with your doctor’s prescription.

Bone loss, in men, from taking certain medicines for prostate cancer.
Bone loss, in breast cancer patients, from hormone therapy (prevention).

Before Using zoledronic acid

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 zoledronic acid, the following should be considered:

Allergies

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

Geriatric

Pregnancy

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

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of zoledronic acid

A nurse or other trained health professional will give you zoledronic acid. zoledronic acid is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes.

Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.

Drink extra fluids so you will pass more urine while you are using zoledronic acid. This will keep your kidneys working well and help prevent kidney problems.

Precautions While Using zoledronic acid

It is important that your doctor check your progress at regular visits after you have received zoledronic acid injection. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed. You will need a yearly dose of zoledronic acid if you are being treated for postmenopausal osteoporosis, so check with your doctor regularly.

Using zoledronic acid while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

zoledronic acid may cause low calcium in your blood. Check with your doctor immediately if you have numbness or tingling around the mouth, or if you have muscle spasms.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving zoledronic acid.

zoledronic acid Side Effects

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

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

More common

Agitation
black, tarry stools
blurred vision
chest pain
chills
coma
confusion
convulsions
cough
depression
difficult or labored breathing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fever
irregular heartbeat
irritability
lack or loss of strength
lethargy
lower back or side pain
mood or mental changes
muscle pain or cramps
muscle trembling or twitching
nausea or vomiting
numbness and tingling around the mouth, fingertips, or feet
painful or difficult urination
pale skin
rapid weight gain
seizures
shaking of the hands, arms, feet, legs, or face
shortness of breath
skin rash, cracks in the skin at the corners of the mouth, or soreness or redness around the fingernails and toenails
sore throat
sores, ulcers, or white spots on the lips or mouth
stupor
sudden sweating
swollen glands
tightness in the chest
trouble breathing with exercise
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Less common

Feeling of constant movement of self or surroundings
muscle cramps in the hands, arms, feet, legs, or face
muscle spasms
neck pain
pounding in the ears
rapid breathing
sensation of spinning
slow or fast heartbeat
sunken eyes
tingling of the hands or feet
tremor

Incidence not known

Blurred vision or other change in vision
decreased frequency or amount of urine
decreased vision
eye pain
eye tenderness
heavy jaw feeling
increased blood pressure
increased tearing
increased thirst
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loosening of a tooth
pain, swelling, or numbness in the mouth or jaw
redness of the eye
sensitivity of the eye to light
severe eye pain
swelling of the face, hands, fingers, lower legs, or ankles
tearing
troubled breathing
weight gain

More common

Abdominal or stomach pain
anxiety, nervousness, restlessness, or irritability
back pain
bad, unusual, or unpleasant (after) taste
bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloody or cloudy urine
bone pain
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
constipation
cracked lips
cracked, dry, or scaly skin
diarrhea
difficulty with swallowing
discouragement
dry mouth
ear congestion
fear or nervousness
feeling sad or empty
frequent urge to urinate
hair loss or thinning hair
headache
hyperventilation
joint pain or swollen joints
loss of appetite
loss of interest or pleasure
loss of voice
muscle stiffness or difficulty with moving
nasal congestion or runny nose
pain, swelling, or redness in the joints
partial loss of feeling
seeing, hearing, or feeling things that are not there
sleepiness or unusual drowsiness
sleeplessness, trouble sleeping, or unable to sleep
swelling or inflammation of the mouth
thirst
trouble with concentrating
unusually cold, shivering
vomiting
weight loss

Less common

Acid or sour stomach
belching
heartburn
indigestion
stomach discomfort, upset, or pain
unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
wrinkled skin

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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Znp

30/06/10

Generic Name: pyrithione (Topical route)

pir-i-THYE-one

Commonly used brand name(s):

In the U.S.

2 in 1 Dandruff
Beta Med
DermaZinc
DHS Zinc
Skincure
Zincon
Znp

Available Dosage Forms:

Shampoo
Spray
Cream
Bar
Lotion
Soap

Therapeutic Class: Dermatological Agent

Chemical Class: Pyrethrums

Uses For Znp

Pyrithione is used to help control the symptoms of dandruff and seborrheic dermatitis of the scalp.

This medicine is available without a prescription.

Before Using Znp

Allergies

Pediatric

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

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrithione 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 pyrithione

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

For best results, use this medicine at least 2 times a week or as directed by your doctor.

To use:

Before applying this shampoo, wet the hair and scalp with lukewarm water.
Apply enough shampoo to the scalp to work up a lather and rub in well, then rinse.
Apply the shampoo again and rinse thoroughly.

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

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 bar dosage form:
- For dandruff and seborrheic dermatitis:
  - Adults and children—Apply to the affected skin of body, face, or scalp once a day at least two times a week. Lather, massage into affected area, rinse, and repeat.

For cream dosage forms:
- For dandruff or seborrheic dermatitis:
  - Adults and children—Apply one to three times a day to affected skin on the body, face, or scalp or as directed by the doctor.
  - For Brylcreem Antidandruff—Adults: Apply to scalp once a day after shampooing and toweling hair dry. Massage into scalp for one minute.
  - Children—Use and dose must be determined by the doctor.

For lotion dosage form:
- For dandruff and seborrheic dermatitis:
  - For DermaZinc Scalp: Adults—Apply to scalp one to three times a day or as directed by the doctor.
  - For DermaZinc Spray: Adults—Apply one spray to affected skin of body, face, or scalp one to three times a day or as directed by the doctor. Medicine should cover a three-inch-square area. Treatment should continue for one week after symptoms lessen.
  - For DermaZinc Baby: Children—Apply to affected skin of face, body, or scalp one to four times a day or as directed by the doctor.

For lotion shampoo dosage forms:
- For dandruff and seborrheic dermatitis:
  - Adults and children up to 2 years of age—Use once a day as a shampoo on the scalp at least two times a week; however, may be used every day. Apply to wet hair and leave on the scalp for several minutes or massage into scalp vigorously before rinsing.
  - Children up to 2 years of age—Use and dose must be determined by the doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Znp

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

Znp 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

Irritation of skin

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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Zn Plus Protein

30/06/10

Generic Name: zinc supplement (Oral route, Parenteral route)

Commonly used brand name(s):

In the U.S.

Galzin
M2 Zinc 50
Orazinc 110
Orazinc 220
Zinc-220
Zinc Chelated
Zn Plus Protein

In Canada

Prostavan

Available Dosage Forms:

Tablet
Capsule
Tablet, Extended Release

Uses For Zn Plus Protein

Zinc supplements are used to prevent or treat zinc deficiency.

The body needs zinc for normal growth and health. For patients who are unable to get enough zinc in their regular diet or who have a need for more zinc, zinc supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection.

Zinc supplements may be used for other conditions as determined by your health care professional.

Lack of zinc may lead to poor night vision and wound-healing, a decrease in sense of taste and smell, a reduced ability to fight infections, and poor development of reproductive organs.

Acrodermatitis enteropathica (a lack of absorption of zinc from the intestine)
Alcoholism
Burns
Type 2 diabetes mellitus
Down’s syndrome
Eating disorders
Intestine diseases
Infections (continuing or chronic)
Kidney disease
Liver disease
Pancreas disease
Sickle cell disease
Skin disorders
Stomach removal
Stress (continuing)
Thalassemia
Trauma (prolonged)

In addition, premature infants may need additional zinc.

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

Claims that zinc is effective in preventing vision loss in the elderly have not been proven. Zinc has not been proven effective in the treatment of porphyria.

Injectable zinc is given by or under the supervision of a health care professional. Other forms of zinc are available without a prescription.

Once a medicine or dietary supplement 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, zinc supplements are used in certain patients with the following medical condition:

Wilson’s disease (a disease of too much copper in the body)

Importance of Diet

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

Zinc is found in various foods, including lean red meats, seafood (especially herring and oysters), peas, and beans. Zinc is also found in whole grains; however, large amounts of whole-grains have been found to decrease the amount of zinc that is absorbed. Additional zinc may be added to the diet through treated (galvanized) cookware. Foods stored in uncoated tin cans may cause less zinc to be available for absorption from food.

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

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

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

Normal daily recommended intakes in milligrams (mg) for zinc are generally defined as follows:

Persons	U.S. (mg)	Canada (mg)
Infants and children birth to 3 years of age	5–10	2–4
Children 4 to 6 years of age	10	5
Children 7 to 10 years of age	10	7–9
Adolescent and adult males	15	9–12
Adolescent and adult females	12	9
Pregnant females	15	15
Breast-feeding females	16–19	15

Before Using Zn Plus Protein

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

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

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. There is some evidence that the elderly may be at risk of becoming deficient in zinc due to poor food selection, decreased absorption of zinc by the body, or medicines that decrease absorption of zinc or increase loss of zinc from the body.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. There is evidence that low blood levels of zinc may lead to problems in pregnancy or defects in the baby. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Using dietary supplements in this class 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.

Amygdalin
Eltrombopag

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of zinc supplement

This section provides information on the proper use of a number of products that contain zinc supplement. It may not be specific to Zn Plus Protein. Please read with care.

Zinc supplements are most effective if they are taken at least 1 hour before or 2 hours after meals. However, if zinc supplements cause stomach upset, they may be taken with a meal. You should tell your health care professional if you are taking your zinc supplement with meals.

Dosing

The dose medicines in this class 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 these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage forms (capsules, lozenges, tablets, extended-release tablets):
- To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes (Note that the normal daily recommended intakes are expressed as an actual amount of zinc. The dosage form [e.g., zinc gluconate, zinc sulfate] has a different strength):
  - For the U.S
  - Adult and teenage males—15 milligrams (mg) per day.
  - Adult and teenage females—12 mg per day.
  - Pregnant females—15 mg per day.
  - Breast-feeding females—16 to 19 mg per day.
  - Children 4 to 10 years of age—10 mg per day.
  - Children birth to 3 years of age—5 to 10 mg per day.
  - For Canada
  - Adult and teenage males—9 to 12 mg per day.
  - Adult and teenage females—9 mg per day.
  - Pregnant females—15 mg per day.
  - Breast-feeding females—15 mg per day.
  - Children 7 to 10 years of age—7 to 9 mg per day.
  - Children 4 to 6 years of age—5 mg per day.
  - Children birth to 3 years of age—2 to 4 mg per day.
- To treat deficiency:
  - Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.

Missed Dose

If you miss taking zinc supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in zinc. However, if your health care professional has recommended that you take zinc, try to remember to take it as directed every day.

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 Zn Plus Protein

When zinc combines with certain foods it may not be absorbed into your body and it will do you no good. If you are taking zinc, the following foods should be avoided or taken 2 hours after you take zinc:

Bran
Fiber-containing foods
Phosphorus-containing foods such as milk or poultry
Whole-grain breads and cereals

Do not take zinc supplements and copper, iron, or phosphorus supplements at the same time. It is best to space doses of these products 2 hours apart, to get the full benefit from each dietary supplement.

Zn Plus Protein Side Effects

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

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

Rare – With large doses

Chills
continuing ulcers or sores in mouth or throat
fever
heartburn
indigestion
nausea
sore throat
unusual tiredness or weakness

Symptoms of overdose

Chest pain
dizziness
fainting
shortness of breath
vomiting
yellow eyes or skin

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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Zithromax Tri-Pak

30/06/10

Generic Name: azithromycin (Oral route)

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

Zithromax
Zithromax Tri-Pak
Zithromax Z-Pak
Zmax

Available Dosage Forms:

Powder for Suspension
Tablet
Capsule
Powder for Suspension, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For Zithromax Tri-Pak

Azithromycin is used to treat certain bacterial infections in many different parts of the body. This medicine may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Zithromax Tri-Pak

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of azithromycin in children and infants 6 months of age and older. Safety and efficacy have not been established in infants below 6 months of age.

Geriatric

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

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine
Methysergide
Pimozide

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.

Acecainide
Amiodarone
Azimilide
Bretylium
Disopyramide
Dofetilide
Ibutilide
Propafenone
Sematilide
Sotalol
Tedisamil

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.

Atorvastatin
Digoxin
Fentanyl
Lovastatin
Nelfinavir
Rifabutin
Simvastatin
Theophylline
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

This section provides information on the proper use of a number of products that contain azithromycin. It may not be specific to Zithromax Tri-Pak. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

You may take azithromycin tablets with or without food.

Measure the extended-release oral liquid with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water. It is best to take the extended-release oral liquid on an empty stomach or at least 1 hour before or 2 hours after a meal. If your child does not use all of the medicine in the bottle, throw it away after you give the dose.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

For oral dosage form (extended-release suspension):
- For treatment of infections:
  - Adults—2 grams (g) once a day as a single dose.
  - Children weighing 75 pounds (34 kg) or more— 2 g once a day as a single dose.
  - Children and infants 6 months of age and older weighing less than 75 pounds (34 kg)—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day as a single dose.
  - Infants below 6 months of age—Use and dose must be determined by your doctor.
For oral dosage forms (suspension or tablets):
- For treatment of infections:
  - Adults—500 to 2000 milligrams (mg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
  - Children and infants 6 months of age and older—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 10 to 30 milligrams (mg) per kilogram (kg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 12 mg/kg once a day for several days.
  - Infants below 6 months of age—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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate or freeze the extended-release oral liquid. Throw away any unused liquid after your dose.

You may store the oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.

Precautions While Using Zithromax Tri-Pak

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Azithromycin may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you or your child vomits within one hour of taking the extended-release oral liquid, call your doctor right away to see if more medicine is needed.

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.

Zithromax Tri-Pak 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

Diarrhea
loose stools

Less common

Blistering, crusting, irritation, itching, or reddening of the skin
cracked, dry, or scaly skin
fever
swelling

Rare

Abdominal or stomach pain
blistering, peeling, or loosening of the skin
bloody or cloudy urine
bloody, black, or tarry stools
body aches or pain
burning while urinating
chest pain
chills
congestion
cough increased
cough producing mucus
dark urine
difficult or labored breathing
difficult or painful urination
difficulty with breathing
dizziness
drowsiness
dryness or soreness of the throat
earache
fainting
fast, irregular, pounding, or racing heartbeat or pulse
general feeling of discomfort or illness
general feeling of tiredness or weakness
headache
indigestion
irregular or slow heart rate
itching
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
muscle aches and pains
nausea or vomiting
noisy breathing
passing of gas
rash
red irritated eyes
red skin lesions, often with a purple center
redness or swelling in the ear
runny nose
shivering
shortness of breath
sneezing
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
stomach pain, fullness, or discomfort
stuffy nose
sweating
swelling of the face, ankles, hands, feet, or lower legs
tender, swollen glands in the neck
tightness in the chest
trouble in swallowing
trouble sleeping
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal pain
voice changes
vomiting of blood
wheezing
yellow eyes or skin

Incidence not known

Abdominal or stomach cramps
abdominal tenderness
bleeding gums
bloating
blood in the urine or stools
blurred vision
change in hearing
clay-colored stools
coma
confusion
constipation
continuing ringing or buzzing or other unexplained noise in the ears
decreased urine output
depression
diarrhea, watery and severe, which may also be bloody
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
greatly decreased frequency of urination or amount of urine
hives
hostility
increased thirst
irritability
lethargy
loss of hearing
lower back or side pain
muscle twitching
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
seizures
stupor
unusual weight loss

Rare

Acid or sour stomach
aggressive, angry
bad, unusual, or unpleasant (after) taste
belching
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
changes in the color of the tongue
crying
depersonalization
dry mouth
dysphoria
euphoria
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
full feeling
heartburn
hyperventilation
increase in body movements
itching of the vagina or genital area
lack or loss of strength
mental depression
nervousness
pain during sexual intercourse
paranoia
quick to react or overreact emotionally
rapidly changing moods
rash with flat lesions or small raised lesions on the skin
redness of the skin
restlessness
sensation of spinning
shaking
shortness of breath
sleepiness or unusual drowsiness
sleeplessness
sore mouth or tongue
stomach upset
thick, white vaginal discharge with no odor or with a mild odor
unable to sleep
white patches in the mouth, tongue, or throat

Incidence not known

Difficulty in moving
fear or nervousness
increased sensitivity of skin to sunlight
muscle pain or stiffness
pain in joints
redness or other discoloration of the skin
severe sunburn
trouble sitting still

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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Zithromax Z-Pak

30/06/10

Generic Name: azithromycin (Oral route)

ay-zith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

Zithromax
Zithromax Tri-Pak
Zithromax Z-Pak
Zmax

Available Dosage Forms:

Powder for Suspension
Tablet
Capsule
Powder for Suspension, Extended Release

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For Zithromax Z-Pak

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

Before Using Zithromax Z-Pak

Allergies

Pediatric

Geriatric

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

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine
Methysergide
Pimozide

Acecainide
Amiodarone
Azimilide
Bretylium
Disopyramide
Dofetilide
Ibutilide
Propafenone
Sematilide
Sotalol
Tedisamil

Atorvastatin
Digoxin
Fentanyl
Lovastatin
Nelfinavir
Rifabutin
Simvastatin
Theophylline
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

This section provides information on the proper use of a number of products that contain azithromycin. It may not be specific to Zithromax Z-Pak. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

You may take azithromycin tablets with or without food.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

For oral dosage form (extended-release suspension):
- For treatment of infections:
  - Adults—2 grams (g) once a day as a single dose.
  - Children weighing 75 pounds (34 kg) or more— 2 g once a day as a single dose.
  - Children and infants 6 months of age and older weighing less than 75 pounds (34 kg)—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day as a single dose.
  - Infants below 6 months of age—Use and dose must be determined by your doctor.
For oral dosage forms (suspension or tablets):
- For treatment of infections:
  - Adults—500 to 2000 milligrams (mg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
  - Children and infants 6 months of age and older—Dose is based on body weight and must be determined by your doctor. However, the recommended dose is 10 to 30 milligrams (mg) per kilogram (kg) once a day as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 12 mg/kg once a day for several days.
  - Infants below 6 months of age—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 medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate or freeze the extended-release oral liquid. Throw away any unused liquid after your dose.

Precautions While Using Zithromax Z-Pak

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

If you or your child vomits within one hour of taking the extended-release oral liquid, call your doctor right away to see if more medicine is needed.

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.

Zithromax Z-Pak 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

Diarrhea
loose stools

Less common

Blistering, crusting, irritation, itching, or reddening of the skin
cracked, dry, or scaly skin
fever
swelling

Rare

Abdominal or stomach pain
blistering, peeling, or loosening of the skin
bloody or cloudy urine
bloody, black, or tarry stools
body aches or pain
burning while urinating
chest pain
chills
congestion
cough increased
cough producing mucus
dark urine
difficult or labored breathing
difficult or painful urination
difficulty with breathing
dizziness
drowsiness
dryness or soreness of the throat
earache
fainting
fast, irregular, pounding, or racing heartbeat or pulse
general feeling of discomfort or illness
general feeling of tiredness or weakness
headache
indigestion
irregular or slow heart rate
itching
joint or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
muscle aches and pains
nausea or vomiting
noisy breathing
passing of gas
rash
red irritated eyes
red skin lesions, often with a purple center
redness or swelling in the ear
runny nose
shivering
shortness of breath
sneezing
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
stomach pain, fullness, or discomfort
stuffy nose
sweating
swelling of the face, ankles, hands, feet, or lower legs
tender, swollen glands in the neck
tightness in the chest
trouble in swallowing
trouble sleeping
unpleasant breath odor
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal pain
voice changes
vomiting of blood
wheezing
yellow eyes or skin

Incidence not known

Abdominal or stomach cramps
abdominal tenderness
bleeding gums
bloating
blood in the urine or stools
blurred vision
change in hearing
clay-colored stools
coma
confusion
constipation
continuing ringing or buzzing or other unexplained noise in the ears
decreased urine output
depression
diarrhea, watery and severe, which may also be bloody
dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fainting
greatly decreased frequency of urination or amount of urine
hives
hostility
increased thirst
irritability
lethargy
loss of hearing
lower back or side pain
muscle twitching
pains in stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
seizures
stupor
unusual weight loss

Rare

Acid or sour stomach
aggressive, angry
bad, unusual, or unpleasant (after) taste
belching
burning feeling in the chest or stomach
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
change in taste
changes in the color of the tongue
crying
depersonalization
dry mouth
dysphoria
euphoria
excess air or gas in the stomach or intestines
feeling of constant movement of self or surroundings
full feeling
heartburn
hyperventilation
increase in body movements
itching of the vagina or genital area
lack or loss of strength
mental depression
nervousness
pain during sexual intercourse
paranoia
quick to react or overreact emotionally
rapidly changing moods
rash with flat lesions or small raised lesions on the skin
redness of the skin
restlessness
sensation of spinning
shaking
shortness of breath
sleepiness or unusual drowsiness
sleeplessness
sore mouth or tongue
stomach upset
thick, white vaginal discharge with no odor or with a mild odor
unable to sleep
white patches in the mouth, tongue, or throat

Incidence not known

Difficulty in moving
fear or nervousness
increased sensitivity of skin to sunlight
muscle pain or stiffness
pain in joints
redness or other discoloration of the skin
severe sunburn
trouble sitting still

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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Zithranol-RR

30/06/10

Generic Name: anthralin (Topical route)

AN-thra-lin

Commonly used brand name(s):

In the U.S.

Drithocreme
Dritho-Scalp
Psoriatec
Zithranol-RR

In Canada

Anthraforte 2%
Anthraforte 3%
Anthrascalp

Available Dosage Forms:

Paste
Ointment
Cream

Therapeutic Class: Antipsoriatic

Uses For Zithranol-RR

Anthralin is used to treat psoriasis. It may also be used to treat other skin conditions as determined by your doctor.

In the U.S., this medicine 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, anthralin is used in certain patients with the following medical condition:

Alopecia areata (patchy hair loss)

Before Using Zithranol-RR

Allergies

Pediatric

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

Geriatric

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of anthralin

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

Keep this medicine away from the eyes and mucous membranes, such as the mouth and the inside of the nose.

Do not apply this medicine to blistered, raw, or oozing areas of the skin or scalp.

Do not use this medicine on your face or sex organs or in the folds and creases of your skin. If you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Anthralin may be used in different ways. In some cases, it is applied at night and allowed to remain on the affected areas overnight, then washed off the next morning or before the next application. In other cases, it may be applied and allowed to remain on the affected areas for a short period of time (usually 10 to 30 minutes), then washed off. (This is called short contact treatment.) Make sure you understand exactly how you are to use this medicine. If you have any questions about this, check with your doctor.

Anthralin may cause irritation of normal skin. If it does, petrolatum may be applied to the skin or scalp around the affected areas for protection.

Apply a thin layer of anthralin to only the affected area of the skin or scalp and rub in gently and well.

Immediately after applying this medicine, wash your hands to remove any medicine that may be on them.

For patients using anthralin for short contact (usually 10 to 30 minutes) treatment:

After applying anthralin, allow the medicine to remain on the affected area for 10 to 30 minutes or as directed by your doctor. Then remove the medicine by bathing, if the anthralin was applied to the skin, or by shampooing, if it was applied to the scalp.

For patients using the cream form of anthralin for overnight treatment:

If anthralin cream is applied to the skin, any medicine remaining on the affected areas the next morning should be removed by bathing.
If anthralin cream is applied to the scalp, shampoo to remove the scales and any medicine remaining on the affected areas from the previous application. Dry the hair and, after parting, rub the cream into the affected areas. Check with your doctor to see when the cream should be removed.

For patients using the ointment form of anthralin for overnight treatment:

If anthralin ointment is applied to the skin at night, any ointment remaining on the affected areas the next morning should be removed with warm liquid petrolatum followed by bathing.
If anthralin ointment is applied to the scalp at night, shampoo the next morning to clean the scalp.

Dosing

For psoriasis:
- For cream dosage form:
  - Adults—Apply to the dry, affected area(s) of the skin once a day, preferably at night, or as directed by your doctor. Wash medicine off skin at the proper time.
  - Children—Use and dose must be determined by your doctor.
- For ointment dosage form:
  - Adults—Apply to the dry, affected area(s) of the skin once a day or as directed by your doctor. Wash medicine off skin at the proper time.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Zithranol-RR

Anthralin may stain the skin, hair, fingernails, clothing, bed linens, or bathtub or shower. The stain on the skin or hair will wear off in several weeks after you stop using this medicine. Some ways to prevent or lessen anthralin staining include:

Wear plastic gloves when you apply this medicine.
Avoid getting the medicine on your clothing or on bed linens. Ask your doctor if you can wear a plastic cap while sleeping if you apply your medicine to your scalp at bedtime.
Remove any medicine on the surface of the bathtub or shower stall by immediately rinsing it with hot water after bathing or showering. Afterwards wash the bathtub or shower stall with a household cleanser to remove any remaining deposits.

Zithranol-RR Side Effects

Anthralin has been shown to cause tumors in animals. However, there have been no reports of anthralin causing tumors in humans.

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:

More common

Redness or other skin irritation of treated or uninvolved skin not present before use of this medicine

Rare

Skin rash

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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Zirgan

30/06/10

Generic Name: ganciclovir (Ophthalmic route)

gan-SYE-kloe-vir

Oral routeCapsule

The clinical toxicity of ganciclovir includes granulocytopenia, anemia, and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis.

Ganciclovir is indicated only for prevention of CMV disease in patients with advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients.

Because ganciclovir is associated with a risk of more rapid rate of CMV retinitis progression, it should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions .

The clinical toxicity of ganciclovir includes granulocytopenia, anemia, and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis. Ganciclovir is indicated only for prevention of CMV disease in patients with advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients. Because ganciclovir is associated with a risk of more rapid rate of CMV retinitis progression, it should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions .

Intravenous routePowder for Solution

Ganciclovir sodium for injection is indicated for use only in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and for the prevention of CMV disease in transplant patients at risk for CMV disease .

The clinical toxicity of ganciclovir sodium for injection includes granulocytopenia, anemia, and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis. Ganciclovir sodium for injection is indicated for use only in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients and for the prevention of CMV disease in transplant patients at risk for CMV disease .

Commonly used brand name(s):

In the U.S.

Zirgan

Available Dosage Forms:

Gel/Jelly

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Uses For Zirgan

Ganciclovir ophthalmic (eye) gel is used to treat acute herpetic keratitis (dendritic ulcers). Herpetic keratitis is an eye infection (swelling of the front part of the eye) caused by herpes simplex virus.

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

Before Using Zirgan

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ganciclovir ophthalmic in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of Zirgan

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

First, wash your hands. Tilt your 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. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
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 dropper to any surface (including the eye). Always keep the container tightly closed.

Dosing

For ophthalmic dosage form (eye drops):
- For treatment of acute herpetic keratitis:
  - Adults and children 2 years of age and older—Put one drop in the affected eye five times a day, (every three hours) until the symptoms improve. Then, one drop three times a day for 7 days.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Zirgan

Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

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

Zirgan 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
red, sore eyes

Less common

Painful irritation of the clear front part of the eye
redness of the white part of eyes or inside of the eyelids

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

Recent Posts

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30/06/10

Uses For Zometa

Before Using Zometa

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of zoledronic acid

Precautions While Using Zometa

Zometa Side Effects

30/06/10

Uses For zolpidem

Before Using zolpidem

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of zolpidem

Dosing

Missed Dose

Storage

Precautions While Using zolpidem

zolpidem Side Effects

30/06/10

Uses For zolmitriptan

Before Using zolmitriptan

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of zolmitriptan

Dosing

Storage

Precautions While Using zolmitriptan

zolmitriptan Side Effects

30/06/10

Uses For zoledronic acid

Before Using zoledronic acid

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of zoledronic acid

Precautions While Using zoledronic acid

zoledronic acid Side Effects

30/06/10

Uses For Znp

Before Using Znp

Allergies

Pediatric

Geriatric

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of pyrithione

Dosing

Missed Dose

Storage

Precautions While Using Znp

Znp Side Effects

30/06/10

Uses For Zn Plus Protein