BEFORE you use DIFICID talk to your doctor or pharmacist:

• If you have severe kidney problems or severe liver problems
• If you have inflammatory bowel disease
• If you have any allergies to this drug or its ingredients or components of the container
• If you have a known allergy to other antibiotics
• If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine. You should not take DIFICID if you are pregnant, unless your doctor tells you otherwise.
• If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine. It is not known whether fidaxomicin passes into breast milk.
• DIFICID should not be used in children or adolescents less than 18 years of age, as there is no information on the use in that population.

DIFICID may cause the following side effects:

• nausea, constipation, vomiting
• decreased appetite
• dizziness, headache
• dry mouth, altered taste (dysgeusia)
• bloated feeling, wind (flatulence)

DIFICID can cause abnormal blood test results (i.e., increased or abnormal liver enzymes). Your doctor will decide when to perform blood tests and will interpret the results.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Usual adult dose:

The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.

Swallow the tablets whole with a glass of water. You can take DIFICID before, during or after meals.

Full course of medication should be completed as prescribed.

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.

Missed dose:

Take the tablet as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with NITROLINGUAL PUMP SPRAY:

• Medications used to treat hypertension (high blood pressure) such as:

  • Diuretics (“water pills”)

  • Calcium Channel Blockers [medications used to treat conditions such as high blood pressure, angina (chest pain), and other heart conditions (e.g. diltiazem, nifedipine, verapamil)]

• Tricyclic antidepressants (e.g.: imipramine, amitriptyline, desipramine, nortriptyline)

• Antipsychotics (medications used to treat schizophrenia or bipolar depression)

• Medications used to relieve muscle spasms including tizanidine (e.g. Zanaflex)

• Alcoholic beverages (when combined with NITROLINGUAL PUMP SPRAY it may cause your blood pressure to drop too low)

• Topical aesthetics prilocaine/lidocaine (e.g. EMLA)

• Medication used to treat pulmonary hypertension such as riociguat (e.g. Adempas)

Before taking CYTOTEC, you should tell your doctor if you have:

•Inflammatory bowel disease (IBD)

•Irritable bowel syndrome (IBS)

•Any other intestinal problems

•Heart disease

You should also alert your physician if you suspect you are dehydrated before taking this medicine.

This drug must be taken regularly for you to benefit. Don't stop taking CYTOTEC without first talking to your doctor.

Call your doctor if you experience severe nausea, stomach pain, or diarrhea lasting several days while on CYTOTEC.

Common Side Effects of CYTOTEC

You should tell your doctor if any of the following side effects are severe or don't go away:

•Upset stomach or stomach pain

•Constipation, diarrhea, or vomiting

•Gas or indigestion

•Headache

Serious Side Effects of CYTOTEC

You should call your doctor immediately if you experience any of the side effects listed in the Warnings section or any of the following serious side effects:

•Bloody vomit

•Bloody or black, tarry stools

•Any signs of infection

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking, especially:

•Antacids

•Aspirin

•Arthritis medications

•Vitamins

CYTOTEC comes as a tablet to take by mouth. It's typically taken four times a day, after meals and at bedtime with food.

You should follow the instructions on your prescription label carefully when taking this medicine. Don't take more or less of the drug than your doctor prescribes.

Do not use NITRO-DUR if:

• are allergic to nitroglycerin, nitrates, or to any nonmedicinal ingredient in the formulation.

• are taking medication for erectile dysfunction such as VIAGRA (sildenafil citrate), CIALIS (tadalafil), LEVITRA or STAXYN (vardenafil).

• are taking medications used to treat high blood pressure in your lungs such as ADEMPAS (riociguat), REVATIO (sildenafil citrate) or ADCIRCA (tadalafil).

• have had a recent heart attack, or other serious heart problems, stroke, or head injury.

• experience lightheadedness, dizziness or fainting when going from lying or sitting to standing up (postural hypotension).

• have severe anemia (low iron levels in your blood or low red blood cell count).

• have narrowing of the heart valves.

• have an eye disease called closed angle glaucoma or any other condition that increases the pressure in your eyes.

These are not all the possible side effects you may feel when taking NITRO-DUR. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Headache

• Flushing of the face

• Nausea, vomiting

• Rash, redness, itching and/or burning in the area where the patch was applied

NITRO-DUR may also lower the blood pressure and cause dizziness, lightheadedness, or a fainting feeling, especially when you get up quickly from lying or sitting. Getting up slowly may help. If you feel dizzy, sit or lie down. You may be more likely to experience headaches, dizziness, or lightheadedness if you drink alcohol, stand for a long time, or if the weather is hot. While using NITRO-DUR, be careful about the amount of alcohol you drink. Also use extra care when exercising, standing for a long time, driving, or during hot weather.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

The following may interact with NITRO-DUR:

• Do not take any drugs used to treat erectile dysfunction such as VIAGRA (sildenafil citrate), CIALIS (tadalafil), LEVITRA or STAXYN (vardenafil) if you are using NITRO-DUR.

• Do not use NITRO-DUR if you are taking drugs used to treat high blood pressure in your lungs such as ADEMPAS (riociguat), REVATIO (sildenafil citrate) or ADCIRCA (tadalafil).

• Drugs used to treat high blood pressure.

• Diuretics (“water pills”).

• Drugs used to treat depression called “tricyclic antidepressants”.

• Tranquillizers.

• Other drugs that may have the same effect as NITRO-DUR.

• Alcohol.

• Drugs used to treat migraine headaches (such as dihydroergotamine).

• Nonsteroidal anti-inflammatory drugs (NSAIDs), used to reduce pain and swelling (such as ibuprofen, naproxen, and celecoxib).

• Acetylsalicylic acid (Aspirin).

BEFORE you use NITROSTAT talk to your doctor or pharmacist if you:

• have hypotension (low blood pressure).
• are pregnant, think you may be pregnant, or are planning to become pregnant.
• are breast-feeding.

Like all medications, NITROSTAT can cause some side effects. For most patients, these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor or pharmacist as soon as you can, if you do not feel well while taking NITROSTAT.

NITROSTAT may cause the following side effects: low blood pressure upon rising from a seated position, sweating, paleness, other skin reactions that may be severe.

NITROSTAT may cause a false test result of decreased serum cholesterol.

NITROSTAT may cause dizziness, vertigo, or fainting. Avoid driving or operating machinery until you are sure that NITROSTAT does not affect your ability to perform these activities.

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health food store without a prescription.

Before using NITROSTAT, tell your doctor if you are taking:

• medicines that are used to treat angina, heart failure, or an irregular heartbeat.
• medicines that reduce blood pressure.
• diuretics (water pills).
• medicines to treat depression or psychiatric illness.
• ergotamine or similar drugs for migraine headaches.
• aspirin.
• blood thinner medicine heparin.
• medicines for erectile dysfunction.

Usual adult dose:

Dissolve one tablet underneath the tongue (sublingual use) or in the mouth at the first sign of chest pain.

• You should sit down when taking NITROSTAT tablets and be careful when you stand up. This eliminates the possibility of falling due to light headedness or dizziness.
• The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.
• If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, seek emergency medical help.
• NITROSTAT may be used 5 to 10 minutes prior to activities that might cause chest pain.
• You may feel a burning or tingling sensation in your mouth when you take NITROSTAT.
• Always take the tablets exactly as your doctor tells you to. Do not change the dose or stop taking NITROSTAT without talking to your doctor.
• Do not chew, crush, or swallow NITROSTAT tablets.
• Do not consume alcohol while taking NITROSTAT as this can lower your blood pressure.

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.

Use Humalog exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Humalog is injected under the skin, or into a vein through an IV. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

After using Humalog, eat a meal within 15 minutes. If you did not use an injection before the meal, use the medicine right after you eat.

If you use this medicine with an insulin pump, do not mix or dilute Humalog with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 3 days. Change the medicine in the reservoir every 7 days.

Concentrated Humalog (200 units/ml) must not be given with an insulin pump, or mixed with other insulins. Do not inject concentrated Humalog into a vein.

If you use an injection pen, use only the injection pen that comes with Humalog. A dose counter on the injection pen shows your dose in units. Do not convert your dose. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe or infusion pump.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Humalog is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin lispro:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 28 days.

Storing opened (in use) Humalog:

• Store the vial in a refrigerator or at room temperature and use within 28 days.

• Store the cartridge or injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

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

Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with HUMALOG use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of HUMALOG

The glucose lowering effect of HUMALOG may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of HUMALOG

The glucose lowering effect of HUMALOG may be increased or decreased with co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Blunt Signs And Symptoms Of Hypoglycemia

The signs and symptoms of hypoglycemia [see WARNINGS AND PRECAUTIONS] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMALOG.

Humalog is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use Humalog if you are having an episode of hypoglycemia (low blood sugar).

Humalog is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Before taking this medicine

You should not use Humalog if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog should not be given to a child younger than 3 years old. Humalog should not be used to treat type 2 diabetes in a child of any age.

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

• liver or kidney disease; or

• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Use Humalog exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Humalog is injected under the skin, or into a vein through an IV. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

After using Humalog, eat a meal within 15 minutes. If you did not use an injection before the meal, use the medicine right after you eat.

If you use this medicine with an insulin pump, do not mix or dilute Humalog with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 3 days. Change the medicine in the reservoir every 7 days.

Concentrated Humalog (200 units/ml) must not be given with an insulin pump, or mixed with other insulins. Do not inject concentrated Humalog into a vein.

If you use an injection pen, use only the injection pen that comes with Humalog. A dose counter on the injection pen shows your dose in units. Do not convert your dose. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe or infusion pump.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Humalog is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin lispro:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 28 days.

Storing opened (in use) Humalog:

• Store the vial in a refrigerator or at room temperature and use within 28 days.

• Store the cartridge or injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

Get emergency medical help if you have signs of insulin allergy to Humalog: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

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

Humalog is a fast-acting insulin that begins to work very quickly. If you use this medication with meal, use it within 15 minutes before or just after you eat.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

You should not use Humalog if you are having an episode of hypoglycemia (low blood sugar).

Humalog is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Before taking this medicine

You should not use Humalog if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog should not be given to a child younger than 3 years old. Humalog should not be used to treat type 2 diabetes in a child of any age.

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

• liver or kidney disease; or

• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with HUMALOG use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of HUMALOG

The glucose lowering effect of HUMALOG may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of HUMALOG

The glucose lowering effect of HUMALOG may be increased or decreased with co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when HUMALOG is co-administered with these drugs.

Drugs That May Blunt Signs And Symptoms Of Hypoglycemia

The signs and symptoms of hypoglycemia [see WARNINGS AND PRECAUTIONS] may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMALOG.