Before taking SECTRAL, tell your doctor if you have, or have ever had:

• Heart failure, heart block, slow heartbeat, or other heart problems
• Low blood pressure
• Blood vessel problems
• Circulation problems
• Breathing disorders, such as bronchitis, asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD)
• Allergies to medication
• Diabetes
• Stroke
• Overactive thyroid
• Liver or kidney disease
• Adrenal gland problems

If you have diabetes, this medicine may mask the symptoms of a low blood sugar episode. Monitor your blood sugar levels carefully while using SECTRAL.

Let your healthcare provider know you're taking SECTRAL before having any type of surgery, including a dental procedure.

Your doctor may recommend following a diet and exercise plan while taking SECTRAL. Follow these instructions carefully.

Use caution in hot weather or when exercising. These activities can increase your risk of experiencing dizziness, lightheadedness, or fainting.

Continue to take SECTRAL even if you feel well. You could experience serious heart problems, such as chest pain or a heart attack, if you stop using this medicine suddenly.

Your doctor will slowly lower your dose over several weeks if you need to stop treatment with SECTRAL.

Keep all appointments with your doctor's office and laboratory while using this medicine. Your doctor will want to check your blood pressure often.

Pregnancy and SECTRAL

SECTRAL should only be used during pregnancy when clearly needed.

Tell your doctor if you're pregnant or plan to become pregnant. You'll have to discuss the risks and benefits of taking this medicine during pregnancy.

SECTRAL passes into breast milk. Don't breastfeed a baby while using this drug.

Common Side Effects of SECTRAL

Tell your doctor if any of the following side effects become severe or don't go away:

• Diarrhea or constipation
• Mild dizziness or lightheadedness
• Frequent urination
• Gas
• Indigestion
• Nausea
• Headache
• Mild drowsiness or sleepiness
• Trouble sleeping
• Weakness

Serious Side Effects of SECTRAL

Tell your doctor right away if you experience any of the following serious side effects:

• Chest pain or tightness
• Shortness of breath
• Wheezing
• Swelling of the hands, ankles, or feet
• Slow heartbeat
• Yellowing of the skin or eyes
• Dark-colored urine
• Pale-colored stools
• Severe or persistent nausea or loss of appetite
• Difficulty breathing, especially while lying down
• Mental or mood changes
• Confusion
• Severe or persistent muscle or joint pain
• Severe headache
• Blurred vision
• Pounding in your chest or ears
• Signs of a severe allergic reaction, which may include rash, hives, itching or severe itching, difficulty breathing, chest tightness, or swelling of the face, mouth, lips, or tongue

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

• Drugs for allergies, asthma, colds, diabetes, or migraines
• Diet pills
• Other medicines for high blood pressure or heart problems, such as reserpine
• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen) and Indocin or Indo-Lemmon (indomethacin)

SECTRAL and Other Interactions

SECTRAL may cause dizziness or lightheadedness.

Don't drive, operate machinery, or perform other tasks that require alertness until you know how this medicine affects you.

SECTRAL and Alcohol

Alcohol may worsen certain side effects of SECTRAL.

Talk to your doctor before drinking alcoholic beverages while taking this drug.

Your dose will depend on your medical condition and response to treatment.

Try to take this medicine around the same time each day.

You can take SECTRAL with or without food.

Follow the instructions on your prescription label carefully. Don't take more or less SECTRAL than is recommended.

Don't stop taking SECTRAL without first talking with your doctor.

SECTRAL Overdose

Symptoms of an SECTRAL overdose may include:

• Fainting
• Lightheadedness
• Difficulty breathing, especially when lying down
• Shortness of breath
• Seizures
• Weakness
• Swelling of the ankles
• Slow heart rate
• Wheezing

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of SECTRAL

If you miss a dose of SECTRAL, take it as soon as you remember.

But if it's almost time for your next scheduled dose, skip the missed dose and continue with your regular medication schedule.

Don't double up on doses to make up for a missed one.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use RILUTEK if you are allergic to it.

To make sure RILUTEK is safe for you, tell your doctor if you have:

• liver disease.

RILUTEK can cause liver problems, especially in women, older adults, and people with a history of liver disease, or people using certain other medications harmful to the liver, such as: antibiotics or antifungal medication; antiviral or HIV/AIDS medicine; birth control pills or hormone replacement therapy; pain or arthritis medications; seizure medicine such as carbamazepine or phenytoin; or "statin" cholesterol-lowering medication.

FDA pregnancy category C. It is not known whether RILUTEK will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether RILUTEK passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using RILUTEK and call your doctor at once if you have:

• sudden chest pain or discomfort, wheezing, dry cough or hack, feeling short of breath;
• cough with mucus, stabbing chest pain;
• low white blood cells--fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• dizziness, spinning sensation;
• weakness, drowsiness;
• stomach pain, nausea, vomiting, loss of appetite;
• diarrhea; or
• numbness or tingling around your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid drinking alcohol. It may increase your risk of liver damage while taking RILUTEK.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid coffee, tea, cola, or other products that contain caffeine. Caffeine may cause too much RILUTEK to build up in your body.

Avoid smoking. Smoking cigarettes may make RILUTEK less effective.

RILUTEK can harm your liver. This effect is increased when you also use certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with RILUTEK.

Other drugs may interact with RILUTEK, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

RILUTEK is usually taken once every 12 hours. Take the medicine at the same times each day.

Take RILUTEK on an empty stomach, at least 1 hour before or 2 hours after a meal.

Before and during your treatment with RILUTEK, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line.

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

Serious Warnings and Precautions

• Some medications should not be taken during VFEND treatment (see listing under “Interactions with This Medication:”)
• VFEND may cause irregular heartbeat and rarely cardiac arrest and death
• VFEND may cause disturbances in vision
• VFEND may cause liver problems
• VFEND may cause severe skin reactions
• VFEND may cause harm to the fetus in pregnant women

Take special care with VFEND:

Before being treated with VFEND, tell your doctor if:

• you have any of the following conditions: history of heart disease, or an irregular heart beat.
• you have had any drug allergies including allergic reactions to other azoles.
• you are suffering from, or have ever suffered from liver disease.
• you are suffering from, or have ever suffered from kidney disease.
• you are already being treated with certain medication.
• you think you have galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, please check with your doctor before starting to take VFEND tablets since they contain lactose monohydrate.
• you think you have sucrose intolerance, fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption, please check with your doctor before starting to take VFEND powder for oral suspension since it contains sucrose.
• you are pregnant: VFEND must not be taken during pregnancy, unless indicated by your doctor. Effective contraception must be used in women of child-bearing potential. Contact your doctor immediately if you become pregnant while taking VFEND.
• you are breast-feeding: VFEND must not be taken during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.

While being treated with VFEND:

• tell your doctor immediately if you develop a severe skin rash or blisters.
• strong sunlight should be avoided while being treated with VFEND. Tell your doctor if you develop an increased sensitivity of skin to the sun.
• your doctor may wish to monitor the function of your liver and kidney by doing blood tests.

Like all medicines, VFEND can have side effects. If any side effects occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side effects are visual disturbances (blurring of vision, reduced vision, colour vision change and increased sensitivity to light), fever, rash, nausea, vomiting, diarrhea, headache, swelling of the extremities and stomach pains.

Other reported side effects include: changes in heart rate or rhythm, changes in blood pressure, blood cell changes, blood chemistry changes, dizziness, itchiness, weakness, back pain, chest pain, flu like symptoms, facial swelling, hallucinations and other nervous symptoms, tingling, cough, breathing difficulty, hair loss, pain and irritation of the eyes, joint pain.

The following side effects have also been reported with the use of VFEND: peripheral neuropathy (nerve damage) with symptoms such as a burning pain, tingling, numbness, sensitivity to touch and weakness, and hyponatremia (low levels of sodium in the blood) with symptoms such as nausea, vomiting, confusion, weakness, fatigue, cramps, decreased consciousness and seizures.

Check with your doctor immediately if chills, fever, flushing, sweating, muscle aches or pains, or other fIu-like symptoms occur, especially if they occur shortly before, or together with a skin rash. Also, contact your doctor in case of a fast heartbeat, chest tightness or faintness. Very rarely, these effects may be the first signs of a serious reaction to this medication.

Contact your doctor if you suffer persistent abdominal pain and tenderness or vomiting as this may be a sign of a serious condition (pancreatitis).

If you develop bone pain during treatment, contact your doctor.

Driving and using machines:

VFEND may cause changes to vision, including blurring and/or photophobia (sensitivity to light). The majority of visual symptoms appeared to spontaneously resolve within 60 minutes. While being treated with VFEND you must avoid potentially hazardous tasks, such as driving or operating machinery if you perceive any change in vision. You should not drive at night while taking VFEND.

Taking other medicines with VFEND:

It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription. Some medicines affect the way VFEND works and dosage adjustments or monitoring may be necessary, such as for the following:

• Cyclosporine (a medicine used in transplant patients)
• Tacrolimus (a medicine used in transplant patients)
• Tricyclic antidepressants
• Antiarrhythmics (drugs that stabilize heart function such as procainamide, amiodarone, quinidine, sotalol)
• Antipsychotic drugs
• HIV protease inhibitors
• Macrolide antibiotics
• Methadone
• Oral contraceptives
• Short-acting opiates (e.g. alfentanil, sufentanil)
• Long-acting opiates (e.g. oxycodone, fentanyl)
• Some oral anticoagulants (e.g. warfarin, coumarin)
• Fluconazole (used for fungal infections)
• Everolimus (used for treating advanced kidney cancer and in transplant patients)
• Benzodiazepines (e.g. midazolam, triazolam, alprazolam)
• Calcium channel blockers (heart medications)
• Sulfonylureas (e.g. glyburide, glipizide)

Tell your doctor if you are taking non-steroidal anti-inflammatories (NSAIDs) (used for treating pain and inflammation) including ibuprofen and diclofenac, as the NSAID dose may have to be adjusted.

The following list of medicines must not be taken during your course of VFEND treatment:

• Terfenadine* (a medicine for allergy)
• Astemizole* (a medicine for allergy)
• Cisapride* (a medicine for stomach problems)
• Pimozide (a medicine for treating mental illness)
• Quinidine (a medicine for irregular heart beat)
• Rifampicin (a medicine for treating tuberculosis)
• Carbamazepine (a medicine used to treat seizures)
• Long-acting barbiturates (medicines for severe insomnia and seizures) such as phenobarbital
• Sirolimus (used in transplant patients)
• Rifabutin (a medicine for fungal infections)
• Ergot Alkaloids: ergotamine and dihydroergotamine (a medicine for migraines)
• Ritonavir (doses of 400mg twice daily or higher) and efavirenz (doses of 400mg once daily or higher) (medicines for the treatment of HIV)
• St. John's wort (Hypericum perforatum)

Usual adult dose:

Your doctor will determine your dose depending on your weight and the type of infection (or suspected infection) you have.

Always take VFEND exactly as directed by your doctor. You should check with your doctor or pharmacist if you are unsure. Never change the dose yourself.

Your doctor will prescribe a higher dose of VFEND on your first day of treatment to more quickly obtain an effective blood level of the antibiotic in your body.

VFEND Injection:

During the first 24 hours, you will be administered 2 doses of 6 mg/kg (12 hours apart).

After the first 24 hours:

• If you have an Aspergillus infection, you will be administered 4 mg/kg, twice a day.
• If you have a Candida infection, you will be administered 3 mg/kg or 4 mg/kg, twice a day.

It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your medicine.

VFEND tablets must be taken at least one hour before or two hours after a meal. Swallow the tablet whole with some water.

VFEND oral suspension must be taken one hour before or following a meal. Shake the closed bottle for approximately 10 seconds before each use. The suspension should only be administered using the oral dispenser supplied with each pack.

VFEND oral suspension should not be mixed with any other medication or flavoring agent, and should not be further diluted with water or any other drinks.

If you have liver disease, your doctor may prescribe a lower dose of VFEND.

Your doctor may order periodic blood tests to monitor your liver function during VFEND treatment.

Continue taking VFEND until your doctor tells you to stop. Do not stop treatment early because your infection may not be cured. Patients with a weakened immune system or those with difficult infections may require long term treatment to prevent the infection from returning.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Take your box of VFEND tablets or bottle of VFEND oral suspension with you.

Missed dose:

If you miss taking a dose of VFEND, just take the next dose when it is due. Do not take a double dose to make up for the forgotten dose.

You should take this medication only to treat bacterial infections, and it's important to take it exactly as your doctor prescribes.

Using PERIOSTAT or other antibiotics incorrectly or using them to treat infections caused by other types of germs, such as viruses, contributes to the development of drug-resistant bacteria.

Every time you take an antibiotic, it kills the sensitive bacteria. Resistant germs, however, can grow and multiply, and then surviving bacteria can become resistant.

It's also important to understand that taking antibiotics, including PERIOSTAT, alters the normal balance of bacteria in your body.

In addition to killing harmful bacteria, the medication can also reduce the amount of good bacteria that help keep other germs in check.

As a result, some people taking PERIOSTAT develop yeast infections and antibiotic-related diarrhea.

Taking PERIOSTAT could make oral birth control pills less effective. If you are on oral contraceptives, you should use other forms of birth control while you take this antibiotic.

Before taking PERIOSTAT, let your doctor know if you're going to have any kind of surgery, including dental surgery.

Your doctor also needs to know if you've ever had liver or kidney disease.

Also tell your doctor if you have diabetes. Taking PERIOSTAT can interfere with tests for sugar in the urine.

Talk with your doctor before changing your diet or your diabetes treatment plan.

Pregnancy and PERIOSTAT

Pregnant women should not take PERIOSTAT because the drug can be harmful to an unborn baby.

Tetracyclines, including PERIOSTAT, also pass into breast milk, so women who are breastfeeding should not take this drug.

If you're a woman, let your doctor know if you are pregnant, plan to become pregnant, or are breastfeeding.

It's also important to note that unborn babies exposed to PERIOSTAT or children younger than 8 years old who take the drug may have permanently stained teeth.

Children younger than 8 should not take PERIOSTAT except as treatment for inhalational anthrax or if a doctor decides it's necessary.

PERIOSTAT for Dogs and Cats

PERIOSTAT is often used to treat bacterial infections in dogs, cats, and other animals.

PERIOSTAT may be prescribed to treat several bacterial infections, such as leptospirosis, urinary tract infections (UTI), toxoplasmosis, erlichiosis, or mycoplasma.

It's also used to treat tick-borne diseases, including Lyme disease and Rocky Mountain spotted fever.

Because PERIOSTAT can cause severe side effects in dogs and cats (such as nausea and diarrhea), it should be used only under the care and direction of a veterinarian.

Common Side Effects of PERIOSTAT

Common side effects of PERIOSTAT include:

• Diarrhea
• Itching of the rectum or vagina
• Sore mouth

Serious Side Effects of PERIOSTAT

Serious side effects of PERIOSTAT can also occur.

If you have any of these side effects, stop taking PERIOSTAT and call your doctor right away:

• Severe headache
• Blurry vision
• Rash or hives
• Trouble breathing or swallowing
• Sunburn
• Yellowing of the skin or eyes
• Dark-colored urine
• Light-colored bowel movements
• Loss of appetite
• Nausea or vomiting
• Stomach pain
• Extreme tiredness or weakness
• Confusion
• Less frequent urination

PERIOSTAT Drug Interactions

Certain drugs may affect the way PERIOSTAT works. This antibiotic could also interact with other medications.

It's very important to let your doctor know about everything you're taking, including street drugs as well as any over-the-counter (OTC) medications, herbs, or supplements.

Types of drugs that interact with PERIOSTAT include:

• Antacids
• Calcium supplements
• Iron supplements and laxatives that contain magnesium
• Penicillin
• Blood thinners, such as warfarin (Coumadin)
• Barbiturates and anti-seizure drugs, such as carbamazepine (Tegretol) and phenytoin (Dilantin)
• Oral birth control pills

Other PERIOSTAT Interactions

PERIOSTAT could upset your stomach.

Taking the drug with milk or food might help, but that may reduce the amount of medication your body can absorb from your stomach.

If you experience an upset stomach while taking PERIOSTAT, talk with your doctor about the best way to take this drug.

Taking PERIOSTAT could also make your skin more sensitive to sunlight. While you are on the medication, be sure to avoid sun exposure whenever possible.

If you do need to be outside, take precautions to protect your skin from the sun, such as:

• Wearing protective clothing,
• Wearing sunglasses
• Applying sunscreen

If you're taking PERIOSTAT to prevent malaria, it's important to understand that the drug does not fully protect you from this infection.

While you are on the drug, you must still take additional preventative measures, including:

• Applying effective insect repellent
• Using mosquito nets
• Wearing clothing that covers your whole body

PERIOSTAT and Alcohol

It's possible to drink alcohol while taking PERIOSTAT, but use of alcohol may increase your risk of side effects, including stomach upset.

Talk with your doctor about the risks of combining alcohol and PERIOSTAT.

For the prevention of malaria, you should start taking PERIOSTAT up to two days before traveling.

Continue taking the drug for four weeks after you leave an area where malaria is a risk.

Do not take PERIOSTAT to prevent malaria for more than four months.

The correct dosage for children older than 8 will depend on the child's weight.

Continue to take PERIOSTAT until your course of treatment is finished, even if you feel good.

Don't stop taking the medication unless directed by your doctor.

PERIOSTAT Overdose

Don't take more PERIOSTAT than your doctor prescribed.

Taking too much of the medication can increase your risk for developing side effects.

If you or someone else has symptoms of an overdose, call a poison control center.

If someone collapses or isn't breathing, call 911.

Missed Dose of PERIOSTAT

Be sure to take PERIOSTAT exactly as your doctor prescribed.

Skipping doses or not completing the full course of therapy could make the drug less effective.

It could also lead to the development of drug-resistant bacteria ("superbugs") that will not respond to antibiotics in the future.

If you forget to take a dose of PERIOSTAT, take the missed dose as soon as you remember it.

If it's almost time for your next regular dose, however, skip the missed one.

Don't take twice as much PERIOSTAT at one time to make up for a missed dose.