ISTA Pharmaceuticals, Inc.

Address ISTA Pharmaceuticals, Inc., 15295 Alton Parkway Irvine, CA 92618 Contact Details Phone: (949) 788-6000 Website: http://www.istavision.com/ Careers: http://search6.smartsearchonline.com...

tigecycline

Generic Name: tigecycline (tye ge SYE kleen)

Brand Names: Tygacil

What is tigecycline?

Tigecycline is an antibiotic that fights bacteria in the body.

Tigecycline is used to treat many different bacterial infections of the skin or the digestive system, as well as pneumonia.

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

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

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Tigecycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using tigecycline.

You should not use this medication if you are allergic to tigecycline. Children should not use tigecycline. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Before using tigecycline, tell your doctor if you are allergic to a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap). Also tell your doctor if you have liver disease or if you are using a blood thinner such as warfarin (Coumadin, Jantoven).

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection, and how to properly mix and store the medication.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Avoid exposure to sunlight or tanning beds. Tigecycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What should I discuss with my healthcare provider before using tigecycline?

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

To make sure you can safely take tigecycline, tell your doctor if you have any of these other conditions:

• 
  

  liver disease;

  
  


• 
  

  if you are using a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  if you are allergic to a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn), or tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap).

  
  

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Tigecycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using tigecycline.

It is not known whether tigecycline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Children should not use tigecycline. Tigecycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

How should I use tigecycline?

Tigecycline is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Tigecycline must be given slowly, and the IV infusion can take up to 60 minutes to complete.

Tigecycline is a powder medicine that must be mixed with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Prepare your dose only when you are ready to give yourself an injection. After mixing, the liquid should appear as a yellow or orange color. Do not use the medication if it has changed to green or black, or if it has any particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Tigecycline will not treat a viral infection such as the common cold or flu.

Store unmixed powder at room temperature away from moisture and heat.

Mixed medicine must be used within 24 hours if you keep it at room temperature.

Tigecycline mixed in an IV bag with sodium chloride or dextrose solution may be stored in a refrigerator and used within 48 hours.

What happens if I miss a dose?

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

What happens if I overdose?

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

What should I avoid while using tigecycline?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using tigecycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Tigecycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Tigecycline side effects

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

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

  
  

Less serious side effects may include:

• 
  

  dizziness, sleep problems (insomnia);

  
  


• 
  

  headache; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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.

Tigecycline Dosing Information

Usual Adult Dose for Intraabdominal Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Skin or Soft Tissue Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Skin and Structure Infection:

100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 5 to 14 days, depending on the nature and severity of the infection

Usual Adult Dose for Pneumonia:

Community acquired: 100 mg IV initial dose, followed by 50 mg IV every 12 hours
Duration: 7 to 14 days, depending on the nature and severity of the infection

What other drugs will affect tigecycline?

Do not give any of the following drugs through the same IV line used to give your tigecycline injection:

• 
  

  amphotericin (Amphocin, Fungizone);

  
  


• 
  

  amphotericin B lipid complex (Abelcet);

  
  


• 
  

  diazepam (Valium); or

  
  


• 
  

  esomeprazole (Nexium I.V.).

  
  

This list is not complete and other drugs may interact with tigecycline. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More tigecycline resources

• Tigecycline Side Effects (in more detail)
• Tigecycline Dosage
• Tigecycline Use in Pregnancy & Breastfeeding
• Tigecycline Drug Interactions
• Tigecycline Support Group
• 0 Reviews for Tigecycline - Add your own review/rating

• tigecycline Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Tigecycline Professional Patient Advice (Wolters Kluwer)


• Tigecycline MedFacts Consumer Leaflet (Wolters Kluwer)


• Tigecycline Monograph (AHFS DI)


• Tygacil Prescribing Information (FDA)


• Tygacil Consumer Overview

Compare tigecycline with other medications

• Intraabdominal Infection
• Pneumonia
• Skin and Structure Infection
• Skin Infection

Where can I get more information?

• Your pharmacist can provide more information about tigecycline.

See also: tigecycline side effects (in more detail)

Mitrazol

Generic Name: miconazole topical (my CON a zole)

Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Mitrazol (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

Miconazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mitrazol (miconazole topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Mitrazol (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Mitrazol (miconazole topical)?

Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Mitrazol (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Mitrazol (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mitrazol (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Mitrazol resources

• Mitrazol Side Effects (in more detail)
• Mitrazol Use in Pregnancy & Breastfeeding
• Mitrazol Drug Interactions
• Mitrazol Support Group
• 0 Reviews for Mitrazol - Add your own review/rating

• Mitrazol Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Prescribing Information (FDA)


• Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mitrazol with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Mitrazol side effects (in more detail)

Dettol Antiseptic Wash

1. Name Of The Medicinal Product

Dettol Antiseptic Wash.

2. Qualitative And Quantitative Composition

Active Constituent	% w/v
Benzalkonium chloride	0.198

3. Pharmaceutical Form

Topical Spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the antiseptic cleansing of minor wounds such as cuts and skin grazes, insect bites and stings, small burns and scalds.

4.2 Posology And Method Of Administration

For adults and children: Spray onto the wound until it is visibly wet and clean, and any dirt and debris has been washed away. If necessary use a clean tissue or cotton wool to wipe up any excess liquid. Repeat as necessary.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

Label Warning: For external use only. Do not use around the eyes or ears, in the mouth or over large areas of the body. Do not inhale. In the case of accidental eye contact, the eye should be irrigated with copious amounts of cold water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Can be used.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Benzalkonium chloride is a quaternary ammonium compound which has been used for many years as a surfactant and antiseptic/disinfectant. It is known to be bactericidal in low concentrations to a wide range of Gram-positive and Gram-negative bacteria.

5.2 Pharmacokinetic Properties

Quaternary ammonium compounds such as benzalkonium chloride are only absorbed to a very small extent through human skin.

5.3 Preclinical Safety Data

The low level of benzalkonium chloride in the product, coupled with its low level of absorption from intact and broken skin, make it unlikely that any significant systemic toxic effects would arise from its use. There is evidence that it can have an irritant effect on mucous membranes.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The product contains the following excipients:

Propylene glycol

Sodium acid phosphate

Sodium phosphate

Mild pine perfume

Disodium edetate

Softened water

6.2 Incompatibilities

Benzalkonium chloride may be deactivated when used with soap or other surfactants.

6.3 Shelf Life

Two years at 30°C.

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

The liquid is contained in a natural HDPE container with a finger action spray pump for administration. The pump head is protected by a clear, polypropylene co-polymer overcap. The pack size is 100 ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser (UK) Limited

103-105 Bath Road

Slough, SL1 3UH

United Kingdom

8. Marketing Authorisation Number(S)

PL 19718/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

4 November 2002

10. Date Of Revision Of The Text

22/11/2010

Pioglitazone/Glimepiride

Pronunciation: PYE-oh-GLI-ta-zone/glye-MEP-ir-ide
Generic Name: Pioglitazone/Glimepiride
Brand Name: Duetact

Thiazolidinedione antidiabetics such as Pioglitazone/Glimepiride may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Pioglitazone/Glimepiride should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Pioglitazone/Glimepiride and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain. Your doctor may need to stop your medicine or change your dose.

Pioglitazone/Glimepiride is used for:

Treating type 2 diabetes in certain patients. It is used along with diet and exercise.

Pioglitazone/Glimepiride is a thiazolidinedione and sulfonylurea antidiabetic combination. It lowers blood sugar by making the cells of the body more sensitive to the action of insulin. It also causes the pancreas to release insulin, which helps to lower blood sugar.

Do NOT use Pioglitazone/Glimepiride if:

• you are allergic to any ingredient in Pioglitazone/Glimepiride


• you have bladder cancer, moderate to severe heart failure, liver problems or abnormal liver function tests, certain severe problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma), moderate to severe burns, or very high blood acid levels (acidosis)


• you have type 1 diabetes


• you are taking bosentan

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

Before using Pioglitazone/Glimepiride:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glipizide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have a history of kidney, thyroid, heart, or blood vessel problems; anemia, stroke; certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]); low blood sodium levels; or low levels of an enzyme called glucose 6-phosphate dehydrogenase (G6PD)


• if you have stomach or bowel problems (eg, stomach or bowel blockage, stomach paralysis), drink alcohol, or have had poor nutrition


• if you have very poor health, a high fever, a severe infection, severe diarrhea, high blood acid levels, or brain or nervous system problems, or have had a severe injury


• if you have a history of bladder cancer, bone fracture, low calcium intake, or weak bones (eg, osteoporosis)


• if you have swelling problems (edema) or eye or vision problems (eg, macular edema)


• if you will be having surgery

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

• Bosentan because liver problems may occur, and the effectiveness of both medicines may be decreased


• Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), azole antifungals (eg, miconazole, ketoconazole), chloramphenicol, clarithromycin, clofibrate, disopyramide, fenfluramine, fluoxetine, insulin, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), and sulfonamides (eg, sulfamethoxazole) because the risk of low blood sugar may be increased


• Calcium channel blockers (eg, diltiazem), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, promethazine), phenytoin, rifamycins (eg, rifampin), sympathomimetics (eg, albuterol, epinephrine), or thyroid supplements (eg, levothyroxine) because they may decrease Pioglitazone/Glimepiride's effectiveness, resulting in high blood sugar


• Gemfibrozil because blood sugar may be increased or decreased


• Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by Pioglitazone/Glimepiride

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

How to use Pioglitazone/Glimepiride:

Use Pioglitazone/Glimepiride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pioglitazone/Glimepiride comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pioglitazone/Glimepiride refilled.


• Take Pioglitazone/Glimepiride by mouth with breakfast or the first main meal of the day unless instructed otherwise by your doctor.


• Continue to take Pioglitazone/Glimepiride even if you feel well. Do not miss any doses.


• Taking Pioglitazone/Glimepiride at the same time each day will help you remember to take it.


• If you miss a dose of Pioglitazone/Glimepiride, skip the missed dose and go back to your regular dosing schedule, unless your doctor directs you otherwise. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pioglitazone/Glimepiride.

Important safety information:

• Pioglitazone/Glimepiride may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Pioglitazone/Glimepiride with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are taking Pioglitazone/Glimepiride; it may increase the risk of low blood sugar. Rarely, alcohol may interact with Pioglitazone/Glimepiride and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.


• Carry an ID card at all times that says you have diabetes.


• Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.


• Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Pioglitazone/Glimepiride exactly as prescribed, tell your doctor.


• It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.


• It may take 2 to 3 months to get the full effect from Pioglitazone/Glimepiride. Do NOT take more than the recommended dose without checking with your doctor.


• Pioglitazone/Glimepiride may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.


• Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.


• Pioglitazone/Glimepiride contains a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.


• Pioglitazone/Glimepiride may cause ovulation in women who have not reached menopause but do not ovulate. To avoid pregnancy, be sure to use effective birth control while using Pioglitazone/Glimepiride.


• Pioglitazone/Glimepiride may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pioglitazone/Glimepiride. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Pioglitazone/Glimepiride before you receive any medical or dental care, emergency care, or surgery.


• Pioglitazone/Glimepiride may be associated with an increased risk of bladder cancer. Tell your doctor right away if you notice symptoms that could be associated with bladder cancer (eg, a red color or blood in the urine, difficult or painful urination, an increased need to urinate). Discuss any questions or concerns with your doctor.


• An increased incidence of bone fracture has been reported in women who take Pioglitazone/Glimepiride. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain.


• Lab tests, including fasting blood sugar, hemoglobin A_1c, liver function, and eye exams, may be performed while you use Pioglitazone/Glimepiride. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Pioglitazone/Glimepiride with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of heart problems or low blood sugar.


• Pioglitazone/Glimepiride should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Pioglitazone/Glimepiride may cause harm to the fetus or newborn. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pioglitazone/Glimepiride while you are pregnant. It is not known if Pioglitazone/Glimepiride is found in breast milk. Do not breast-feed while taking Pioglitazone/Glimepiride.

When used for long periods of time Pioglitazone/Glimepiride may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of Pioglitazone/Glimepiride:

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

Cold-like symptoms; diarrhea; headache; leg or arm pain; nausea; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; fever, chills, or persistent sore throat; irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain); symptoms of liver problems (eg, dark urine, severe or persistent nausea, stomach pain, unexplained vomiting or loss of appetite, yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety, chills, dizziness or drowsiness, headache, increased hunger, increased sweating, tremors); unusual bone pain; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Pioglitazone/Glimepiride side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; fainting; fast heartbeat; lethargy; lightheadedness; seizures; severe dizziness or drowsiness; tremor; unusual sweating.

Proper storage of Pioglitazone/Glimepiride:

Store Pioglitazone/Glimepiride between 59 and 86 degrees F (15 and 30 degrees C). Do not store Pioglitazone/Glimepiride in the bathroom. Keep Pioglitazone/Glimepiride out of the reach of children and away from pets.

General information:

• If you have any questions about Pioglitazone/Glimepiride, please talk with your doctor, pharmacist, or other health care provider.


• Pioglitazone/Glimepiride is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pioglitazone/Glimepiride resources

• Pioglitazone/Glimepiride Side Effects (in more detail)
• Pioglitazone/Glimepiride Use in Pregnancy & Breastfeeding
• Pioglitazone/Glimepiride Drug Interactions
• Pioglitazone/Glimepiride Support Group
• 0 Reviews for Pioglitazone/Glimepiride - Add your own review/rating

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• Diabetes, Type 2

Kemadrin Tablets 5 mg

Kemadrin tablets 5 mg

procyclidine hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.



• If you have any further questions, ask your doctor or pharmacist.



• This medicine has been prescribed for you. Do not pass it to others. It may harm them, even if their symptoms are the same as yours.



• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1 What Kemadrin is and what it is used for



• 2 Before you take Kemadrin



• 3 How to take Kemadrin



• 4 Possible side effects



• 5 How to store Kemadrin



• 6 Further information

What Kemadrin is and what it is used for

Kemadrin contains a medicine called procyclidine. This belongs to a group of medicines called anticholinergics. They stop a substance called acetylcholine working in your body.

Kemadrin is used to:

• treat and relieve the signs of Parkinson's disease such as:
  
  
  • stiff muscles, paralysis and tremor
  
  
  
  • problems talking, writing and walking
  
  
  
  • producing too much saliva and dribbling
  
  
  
  • sweating and uncontrolled eye movements
  
  
  
  • depression
  
  



• stop side effects similar to the signs of Parkinson's disease or restlessness and unusual head and body movements caused by some medicines. Some people call these' extrapyramidal effects'.

Before you take Kemadrin

Do not take Kemadrin if:

• you are allergic (hypersensitive) to procyclidine or any of the other ingredients of Kemadrin (see Section 6: Further information)



• you have problems passing water (urinary retention)



• you suffer from a problem caused by too much pressure in your eye called 'closed angle glaucoma'



• you have stomach cramps and pains or constipation.

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Kemadrin.

Take special care with Kemadrin

Check with your doctor or pharmacist before taking your medicine if:

• you are elderly. Your dose may need to be carefully monitored to prevent any side effects



• you have an enlarged prostate gland



• you have a mental illness and are taking Kemadrin to control the side-effects of your medicines. Occasionally people who take this medicine may have a psychotic episode



• you have kidney or liver problems.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Kemadrin.

Kemadrin contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Kemadrin can affect the way some other medicines work. Also some other medicines can affect the way Kemadrin works.

In particular tell your doctor or pharmacist if you are taking any of the following:

• medicines used to treat mental health problems (including Alzheimer's disease and dementia)



• levodopa and amantadine, used in Parkinson's disease



• disopyramide, quinidine and nitrate tablets (including tablets that dissolve under the tongue), used to treat heart problems



• cisapride, domperidone and metoclopramide, used to treat sickness, indigestion and feeling sick (nausea)



• antihistamines, used to treat hayfever and allergies



• nefopam, used to treat pain



• ketoconazole, used to treat fungal infections.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Kemadrin.

Taking Kemadrin with food

You can take Kemadrin at any time of day, with or without food.

Some people find they feel less sick if they take it at meal times.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

You may have blurred vision, dizziness, confusion or disorientation while taking Kemadrin. If this happens do not drive or use any tools or machines.

How to take Kemadrin

Always take Kemadrin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

• Swallow the tablets with a drink of water.



• The tablet may be cut or broken in half along the line marked on one side of the tablet.

To treat Parkinson's disease:

• The usual starting dose is half a tablet three times a day.



• This can be increased by half or 1 tablet each day, every two or three days until an effect is seen. This is known as the 'maintenance dose'. The daily maintenance dose is usually three to six tablets.



• The maximum your doctor may decide to prescribe is 12 tablets.



• Although the dose is usually taken three times a day, your doctor may ask you to take a fourth dose before bedtime.

To treat uncontrolled body movements (extrapyramidal symptoms) caused by taking other medicines:

Kemadrin can be used to control side effects caused by other medicines.

• The usual starting dose is half a tablet three times a day.



• This can be increased by half a tablet each day until an effect is seen.



• The daily maintenance dose is usually two to six tablets.



• Your doctor may decide to stop your Kemadrin after 3 or 4 months to see if your side effects return.

Elderly

If you are elderly, your dose may need to be carefully monitored to prevent any side effects.

Children

Kemadrin tablets are not usually recommended for use in children.

If you take more Kemadrin than you should

If you take more Kemadrin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Kemadrin

Take a dose as soon as you remember it and then go on as before.

If you stop taking Kemadrin

Do not stop taking Kemadrin without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

If you are taking a medicine for mental illness (called a neuroleptic) at the same time as Kemadrin:

• you can develop uncontrolled movements of your face and tongue (tardive dyskinesia). The dose of either of your medicines may need to be adjusted.



• unusual body movements, particularly of your hands, arms and legs which may have previously been occuring with the medicine for your mental illness can be made worse by the addition of Kemadrin

If either of these happen, tell your doctor straight away.

Like all medicines, Kemadrin can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Common (affects less than 1 in 10 people)

• problems passing water (urinary retention)



• blurred vision



• dry mouth or constipation.

Uncommon (affects less than 1 in 100 people)

• feeling sick (nausea) or being sick (vomiting)



• inflamed gums (gingivitis)



• dizziness, nervousness, feeling confused, reduced concentration or memory, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable)



• skin rash.

Rare (affects less than 1 in 1000 people)

• 'psychotic' symptoms occurring together such as dizziness, confusion, reduced concentration or memory, disorientation, hearing unexpected noises or seeing unexpected sights (hallucinations), anxiety, agitation (feeling irritable).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Kemadrin

• Keep out of the reach and sight of children.



• Do not store above 25°C.



• Do not use Kemadrin after the expiry date which is stated on the foil and carton. The expiry date refers to the last day of that month.



• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Kemadrin contains.

• The active substance is procyclidine hydrochloride 5 mg.



• The other ingredients are lactose, sodium starch glycollate, povidone and magnesium stearate.

What Kemadrin looks like.

Each 5 mg tablets is white with a single score line and the marking 'WELLCOME S3A' on the same side. There are no markings on the other side. Kemadrin Tablets 5 mg come in bottles of 100 or 500 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

The Wellcome Foundation

trading as GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Manufacturer:

Glaxo Wellcome GmbH & Co. KG

Bad Oldesloe

Germany

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Kemadrin 5 mg tablets

Reference number 00003/5255R. This is a service provided by the Royal National Institute of Blind People.

Leaflet date: November 2007

Kemadrin is a registered trademark of the GlaxoSmithKline group of companies.

© 2007 GlaxoSmithKline group of companies

10000000042602

Diprivan 2%

For further copies of this leaflet, visit emc.medicines.org.uk or call AstraZeneca on 01582 836836.

Diprivan 20 mg/ml (2%)

Emulsion for Injection or Infusion

propofol

Read all of this leaflet carefully before you start having this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or nurse.


• If you think you have a side effect, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

• 1. What Diprivan is and what it is used for


• 2. Before you have Diprivan


• 3. How to have Diprivan


• 4. Possible side effects


• 5. How to store Diprivan


• 6. Further information

What Diprivan is and what it is used for

Diprivan contains a medicine called propofol. This belongs to a group of medicines called ‘general anaesthetics’.

Diprivan will be given to you as an injection by a doctor. It is used to:

• Help put you to sleep before an operation or other procedure.


• Keep you asleep during an operation or other procedure.


• Sedate you (make you feel sleepy) while you are in an Intensive Care Unit (ICU).

Before you have Diprivan

Do not have Diprivan if:

• You are allergic (hypersensitive) to propofol or any of the other ingredients of Diprivan (listed in Section 6: Further information).


• You are allergic to peanut or soya. This is because Diprivan contains soya oil.


• You are pregnant (see the section called ‘Pregnancy and breast-feeding’).

If any of the above apply to you, do not have Diprivan and tell your doctor, anaesthetist or nurse. If you are not sure, talk to one of these people before having Diprivan.

Children and young people

• When Diprivan is used before or during an operation, it should only be given to children aged 3 years and above.


• When it is used for sedation in an Intensive Care Unit, it should only be given to people aged 17 years and above.

Take special care with Diprivan

Before you have this medicine, tell your doctor, anaesthetist or nurse if:

• You have ever had a fit or convulsion.


• You have ever been told that you have very high levels of fat in your blood.


• You have ever been told that your body has problems using fat.


• Your body has lost lots of water (you are dehydrated).


• You have any other health problems, such as problems with your heart, breathing, kidneys or liver.


• You have been generally unwell for some time.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Diprivan.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines.

Pregnancy and breast-feeding

• Do not have Diprivan if you are pregnant.


• If you are trying to get pregnant or if you are breastfeeding, talk to your doctor or nurse before having this medicine.

Driving and using machines

After having Diprivan, you may still feel sleepy for some time. Do not drive or use any tools or machines until you are sure the effects have worn off.

• If you are able to go home shortly after having Diprivan, do not drive a car or use any tools or machines.


• Ask your doctor when you can start doing these activities again and when you can go back to work.

Important information about some of the ingredients of Diprivan

Diprivan contains sodium. If you are on a sodium controlled diet, you will need to take this into account.

Diprivan contains soya oil. If you are allergic to peanut or soya, do not use this medicine.

Diprivan contains disodium edetate. During prolonged use of Diprivan for intensive care, you may need to be given a zinc (a mineral) supplement.

How to have Diprivan

You will be given Diprivan by a doctor. It will be given to you as an injection into a vein. This is usually in the back of your hand or in your forearm.

• The doctor will give you the injection through a fine plastic tube called a ‘cannula’.


• The doctor can also use an electric pump to control how fast the injection is given. This may be done if you are having a long operation or if you are in an Intensive Care Unit.

The dose of Diprivan varies from one patient to another. The amount of Diprivan that you need depends on your age, size, physical fitness and the level of sleepiness or sleep that you need. The doctor will work out how much to give you.

You may need several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy way and to keep your blood pressure steady. The doctor will decide which medicines you need and when you need them.

Diprivan 2% Side Effects

Like all medicines, Diprivan may cause side effects although not everybody gets them.

Side effects that can happen during anaesthesia

The following side effects can happen during anaesthesia (while the injection is being given to you or when you are sleepy or asleep). Your doctor will be looking out for these. If they happen, your doctor will give you appropriate treatment.

Very common (affects more than 1 in 10 people)

• A feeling of pain at the site of the injection (while the injection is being given, before you fall asleep).

Common (affects less than 1 in 10 people)

• Low blood pressure.


• Changes in your breathing pattern.


• Slow heart beat.

Rare (affects less than 1 in 1,000 people)

• Twitching and shaking of your body, or a fit (may also happen when you wake up).


• Unusual colour of urine (may also happen when you wake up).

Very rare (affects less than 1 in 10,000 people)

• Allergic reactions.


• Stopping of your heart beat.


• Build up of fluid in the lungs which can make you very breathless (may also happen when you wake up).

Side effects that can happen after anaesthesia

The following side effects can happen after anaesthesia (when you are waking up or after you have woken up).

Common (affects less than 1 in 10 people)

• Feeling sick (nausea).


• Being sick (vomiting).


• Headache.

Uncommon (affects less than 1 in 100 people)

• Swelling and redness along a vein or blood clots.

Very rare (affects less than 1 in 10,000 people)

• Feeling sexually aroused.


• High temperature (fever).


• Redness or soreness where the injection was given.


• Being unconscious after the operation. (When this has happened, the patients have recovered without problems.)

Other possible side effects

The following side effects have been seen when Diprivan is used in intensive care at higher doses than recommended.

Very rare (affects less than 1 in 10,000 people)

• Breakdown of muscle cells (rhabdomyolysis).


• Heart failure.


• Inflamed pancreas (pancreatitis) which causes severe stomach pain.

The following side effects have been seen in children in intensive care when Diprivan has been stopped suddenly.

Common (affects less than 1 in 10 people)

• ‘Withdrawal symptoms’. These include unusual behaviour, sweating, shaking and feeling anxious.


• Flushing of the skin.

Do not be concerned by this list of possible side effects. You may not get any of them.

If you think you have a side effect or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How to store Diprivan

• The doctor and hospital pharmacist are responsible for storing, using and disposing of Diprivan correctly.


• Store Diprivan between 2°C and 25°C. Do not freeze.


• Do not use Diprivan after the expiry date which is stated on the carton.

Further information

What Diprivan 2% contains

The active substance is propofol. There is 20 mg of propofol in each millilitre.

The other ingredients are glycerol, purified egg phosphatide, sodium hydroxide, soya bean oil, water for injections, nitrogen and disodium edetate.

What Diprivan 2% looks like and contents of the pack

Diprivan 2% is a milky, white liquid. It comes in glass vials of 50 ml or pre-filled syringes of 50 ml.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations for Diprivan 2% are held by

AstraZeneca UK Ltd

600 Capability Green

Luton

LU1 3LU

UK

Diprivan 2% is manufactured by

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

UK

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name Diprivan 2%



Reference number 17901/0008 or 17901/0009

This is a service provided by the Royal National Institute of the Blind.

Leaflet prepared: August 2009

Diprivan is a trade mark of the AstraZeneca group of companies.

© AstraZeneca 2009

UK PAI 09 0057

P024960