Web PLR Articles Directory Scotland: September 2012

Sunday, 30 September 2012

Triaminic Flu Cough & Fever

Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)

Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Children's Tylenol Flu, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M

What is Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan will not treat a cough that is caused by smoking.

Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about this medication?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking this medication?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

liver disease, cirrhosis, or a history of alcoholism;

a blockage in your digestive tract (stomach or intestines);

diabetes;

kidney disease;

epilepsy or other seizure disorder;

cough with mucus, or cough caused by emphysema or chronic bronchitis;

enlarged prostate or urination problems;

pheochromocytoma (an adrenal gland tumor); or

if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

The chewable tablet must be chewed thoroughly before you swallow it.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking this medication?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medication 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 this medication and call your doctor at once if you have a serious side effect such as:

fast or pounding heartbeats, severe restless feeling or nervousness;

mood changes, confusion, hallucinations, unusual thoughts or behavior;

tremor, seizure (convulsions);

easy bruising or bleeding, unusual weakness;

urinating less than usual or not at all;

feeling short of breath;

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

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, drowsiness;

dry mouth, nose, or throat;

constipation or diarrhea;

blurred vision; or

feeling nervous or restless.

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.

What other drugs will affect Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medicines you use, especially:

leflunomide (Arava);

topiramate (Topamax);

zonisamide (Zonegran);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

bladder or urinary medications;

blood pressure medication;

a bronchodilator;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. 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 Triaminic Flu, Cough & Fever resources

Triaminic Flu, Cough & Fever Side Effects (in more detail)
Triaminic Flu, Cough & Fever Use in Pregnancy & Breastfeeding
Triaminic Flu, Cough & Fever Drug Interactions
Triaminic Flu, Cough & Fever Support Group
1 Review for Triaminic Flu, Cough & Fever - Add your own review/rating

Compare Triaminic Flu, Cough & Fever with other medications

Cold Symptoms
Influenza

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine.

See also: Triaminic Flu, Cough & Fever side effects (in more detail)

Friday, 28 September 2012

Saxagliptin

Pronunciation: SAX-a-GLIP-tin
Generic Name: Saxagliptin
Brand Name: Onglyza

Saxagliptin is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It works by increasing the amount of insulin released by your body, and by decreasing the amount of sugar made by your body.

Do NOT use Saxagliptin if:

you are allergic to any ingredient in Saxagliptin

you have type 1 diabetes

you have high blood or urine ketone levels associated with diabetes (diabetic ketoacidosis)

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

Before using Saxagliptin:

Some medical conditions may interact with Saxagliptin. 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 a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, sitagliptin)

if you have kidney problems or are on dialysis

if you have an unusual or prolonged infection or a history of diabetic ketoacidosis

if you have a history of pancreatitis, gallstones, high blood triglyceride levels, or alcohol abuse

if you are using insulin

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

Thiazolidinediones (eg, pioglitazone) because the risk of peripheral edema (swelling of the hands and feet) may be increased

Clarithromycin, itraconazole, ketoconazole, nefazodone, protease inhibitors (eg, atazanavir, boceprevir, ritonavir), or telithromycin because they may increase the risk of Saxagliptin's side effects

Sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased by Saxagliptin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Saxagliptin 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 Saxagliptin:

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

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

Take Saxagliptin by mouth with or without food.

Continue to take Saxagliptin even if you feel well. Do not miss any doses.

If you miss a dose of Saxagliptin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Saxagliptin.

Important safety information:

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

Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Saxagliptin.

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

Do NOT take more than the recommended dose without checking with 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.

The risk of low blood sugar may be increased when Saxagliptin is used along with certain other medicines for diabetes (eg, sulfonylureas). 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.

Lab tests, including fasting blood glucose, hemoglobin A_1c, and kidney function, may be performed while you use Saxagliptin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Saxagliptin with caution in the ELDERLY; they may be more sensitive to its effects.

Saxagliptin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Saxagliptin while you are pregnant. It is not known if Saxagliptin is found in breast milk. If you are or will be breast-feeding while you use Saxagliptin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Saxagliptin:

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:

Headache; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, sore throat).

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); flaking, peeling, or swelling of the skin; frequent or painful urination; swelling of the hands, ankles, legs, or feet; symptoms of pancreatitis (eg, severe stomach or back pain with or without nausea or vomiting).

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: Saxagliptin 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.

Proper storage of Saxagliptin:

Store Saxagliptin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Saxagliptin out of the reach of children and away from pets.

General information:

If you have any questions about Saxagliptin, please talk with your doctor, pharmacist, or other health care provider.

Saxagliptin 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 Saxagliptin. 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

More Saxagliptin resources

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

Saxagliptin Professional Patient Advice (Wolters Kluwer)

saxagliptin Advanced Consumer (Micromedex) - Includes Dosage Information

Onglyza Prescribing Information (FDA)

Onglyza Consumer Overview

Compare Saxagliptin with other medications

Diabetes, Type 2

Wednesday, 26 September 2012

Insulin Aspart Cartridges

Pronunciation: IN-su-lin AS-part
Generic Name: Insulin Aspart
Brand Name: Novolog

Insulin Aspart Cartridges are used for:

Treating diabetes mellitus. Insulin Aspart Cartridges are usually used with a longer-acting insulin or insulin pump therapy.

Insulin Aspart Cartridges are a fast-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Aspart Cartridges if:

you are allergic to any ingredient in Insulin Aspart Cartridges

you are having an episode of low blood sugar

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

Before using Insulin Aspart Cartridges:

Some medical conditions may interact with Insulin Aspart Cartridges. 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 drink alcoholic beverages or smoke

if you have kidney or liver problems; nerve problems; adrenal, pituitary, or thyroid problems; or diabetic ketoacidosis

if you use 3 or more insulin injections per day

if you are fasting, are on a low-salt (sodium) diet, have blood electrolyte problems (eg, high blood sodium levels, low blood potassium levels), or you exercise

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

Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, pramlintide, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased

Atypical antipsychotics (eg, risperidone), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Aspart Cartridges's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Insulin Aspart Cartridges 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 Insulin Aspart Cartridges:

Use Insulin Aspart Cartridges as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Insulin Aspart Cartridges. Talk to your pharmacist if you have questions about this information.

Use Insulin Aspart Cartridges within 5 to 10 minutes before a meal unless directed otherwise by your doctor.

If you will be using Insulin Aspart Cartridges at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Aspart Cartridges. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

You may use Insulin Aspart Cartridges in an insulin pump if you are directed to do so by your doctor. If you are using an insulin pump, do NOT dilute Insulin Aspart Cartridges or mix it together with any other type of insulin.

Insulin Aspart Cartridges should be clear and colorless. Do not use Insulin Aspart Cartridges if it contains particles; is cloudy, thickened, or discolored; or if the vial or container is cracked or damaged.

If you are mixing Insulin Aspart Cartridges with NPH insulin, draw Insulin Aspart Cartridges into the syringe first. Inject the dose immediately after mixing, as directed by your doctor. Do not mix Insulin Aspart Cartridges with any other type of insulin.

Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.

Injection sites within an injection area (abdomen, buttock, thigh, upper arm) must be rotated from one injection to the next. Do not inject medicine into skin that is red, swollen, or itchy.

Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.

Insulin Aspart Cartridges begins lowering blood sugar within 10 to 20 minutes after an injection. The peak effect occurs within 1 to 3 hours after a dose. The effect lasts for up to 3 to 5 hours.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you should ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Insulin Aspart Cartridges.

Important safety information:

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

Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.

Do NOT use more than the recommended dose, use Insulin Aspart Cartridges more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.

Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.

Stress or illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.

Tell your doctor or dentist that you take Insulin Aspart Cartridges before you receive any medical or dental care, emergency care, or surgery.

If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.

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

An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. 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.

Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If not treated, loss of consciousness, coma, or death may occur. If these symptoms occur, tell your doctor right away.

Check with your doctor if you notice a depression in the skin or skin thickening at the injection site. You may need to change your injection technique.

Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Aspart Cartridges. Tell your doctor if you have had a recent change in diet or physical activity.

Lab tests, including fasting blood glucose levels and hemoglobin A_1c levels, may be performed while you use Insulin Aspart Cartridges. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Insulin Aspart Cartridges with caution in the ELDERLY; if low blood sugar occurs, it may be more difficult to recognize in these patients.

Insulin Aspart Cartridges should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Insulin Aspart Cartridges while you are pregnant. It is not known if Insulin Aspart Cartridges are found in breast milk. If you are or will be breast-feeding while you use Insulin Aspart Cartridges, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Insulin Aspart Cartridges:

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:

Redness, swelling, itching, or mild pain at the injection site; 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; wheezing); burning, numbness, or tingling of the arms, hands, legs, or feet; changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mental or mood changes; muscle pain, weakness, or cramping; seizures; slurred speech; swelling; tremor; trouble concentrating; unusual hunger; unusual sweating; weakness.

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 chills; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Proper storage of Insulin Aspart Cartridges:

VIALS: Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Insulin Aspart Cartridges has been frozen or overheated, throw it away. Do not draw up medicine into a syringe and store for later use. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

CARTRIDGE SYSTEMS and PREFILLED SYRINGES: Store new (unopened) cartridge systems or prefilled syringes in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Aspart Cartridges. Store used (open) cartridge systems or prefilled syringes at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges or prefilled syringes in the refrigerator. Store away from heat and light. If Insulin Aspart Cartridges has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems or prefilled syringes after 28 days, even if they still contain medicine.

Avoid temperatures above 98.6 degrees F (37 degrees C). Do not leave Insulin Aspart Cartridges in a car on a warm or sunny day. Do not use Insulin Aspart Cartridges after the expiration date stamped on the label. Keep Insulin Aspart Cartridges, as well as syringes and needles, out of the reach of children and away from pets. If you are using Insulin Aspart Cartridges in an insulin pump, or if Insulin Aspart Cartridges has been mixed with other medicines or diluted, you may need to store it differently. Ask your doctor, pharmacist, or other health care provider how to store Insulin Aspart Cartridges.

General information:

If you have any questions about Insulin Aspart Cartridges, please talk with your doctor, pharmacist, or other health care provider.

Insulin Aspart Cartridges are 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 Insulin Aspart Cartridges. 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

More Insulin Aspart resources

Insulin Aspart Use in Pregnancy & Breastfeeding
Insulin Aspart Drug Interactions
Insulin Aspart Support Group
4 Reviews for Insulin Aspart - Add your own review/rating

Compare Insulin Aspart with other medications

Diabetes, Type 1
Diabetes, Type 2

Monday, 24 September 2012

Inspra

Generic Name: eplerenone (Oral route)

e-PLER-en-one

Commonly used brand name(s)

In the U.S.

Inspra

Available Dosage Forms:

Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Aldosterone Receptor Antagonist

Uses For Inspra

Eplerenone belongs to the general class of medicines called antihypertensives. It is used alone or together with other medicines to treat high blood pressure (hypertension). This medicine is also used to treat congestive heart failure (CHF) after a heart attack.

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

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

Before Using Inspra

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eplerenone in children with hypertension below 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of eplerenone in children with heart failure. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Amiloride

Clarithromycin

Itraconazole

Ketoconazole

Nefazodone

Nelfinavir

Potassium

Ritonavir

Spironolactone

Triamterene

Troleandomycin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alacepril

Arsenic Trioxide

Benazepril

Captopril

Cilazapril

Delapril

Enalaprilat

Enalapril Maleate

Erythromycin

Fluconazole

Fosinopril

Imidapril

Lisinopril

Moexipril

Pentopril

Perindopril

Quinapril

Ramipril

Saquinavir

Spirapril

Temocapril

Trandolapril

Verapamil

Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Licorice

Interactions with Food/Tobacco/Alcohol

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

Proper Use of Inspra

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

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

For oral dosage form (tablets):
- For congestive heart failure after a heart attack:
  - Adults—At first, 25 milligrams (mg) once a day, then your dose may be increased to 50 mg once a day. Your doctor may adjust your dose as needed and tolerated.
  - Children—Use and dose must be determined by your doctor.
- For high blood pressure:
  - Adults, teenagers, and children above 4 years of age—At first, 50 milligrams (mg) once a day. Your doctor may increase your dose to 50 mg two times a day.
  - Children up to 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Inspra

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take the following medicines if you are using eplerenone:

Amiloride (e.g., Midamor®) or

Clarithromycin (e.g., Biaxin®) or

Itraconazole (e.g., Sporanox®) or

Ketoconazole (e.g., Nizoral®) or

Nefazodone (e.g., Serzone®) or

Nelfinavir (e.g., Viracept®) or

Ritonavir (e.g., Norvir®) or

Spironolactone (e.g., Aldactone®) or

Triamterene (e.g., Dyrenium®) or

Troleandomycin (e.g., Tao®).

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium.

This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Inspra Side Effects

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

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

Less common

Excess of cholesterol in the blood

excess of triglycerides in the blood

Incidence not known

Abdominal or stomach pain

arm, back, or jaw pain

chest pain or discomfort

chest tightness or heaviness

confusion

difficulty with breathing

dizziness

fast or irregular heartbeat

headache

irregular heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

nausea

nervousness

numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

rash

shortness of breath

sweating

vomiting

weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abnormal vaginal bleeding

breast pain

chills

cloudy urine

cough

diarrhea

fever

general feeling of discomfort or illness

joint pain

loss of appetite

muscle aches and pains

swelling of the breasts or breast soreness in both females and males

unusual tiredness or weakness

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

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

See also: Inspra side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Inspra resources

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

Inspra Prescribing Information (FDA)

Inspra MedFacts Consumer Leaflet (Wolters Kluwer)

Inspra Concise Consumer Information (Cerner Multum)

Inspra Monograph (AHFS DI)

Eplerenone Prescribing Information (FDA)

Eplerenone Professional Patient Advice (Wolters Kluwer)

Compare Inspra with other medications

Heart Failure
High Blood Pressure

Sunday, 23 September 2012

Urokinase 100,000 I.U.

1. Name Of The Medicinal Product

Urokinase medac 100,000 I.U.

Powder for solution for injection or infusion

2. Qualitative And Quantitative Composition

Each vial contains 100,000 I.U. of human urokinase extracted from human urine.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for injection or infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Intravascular lysis of blood clots in the following conditions:

• extensive acute proximal deep vein thrombosis

• acute massive pulmonary embolism

• acute occlusive peripheral arterial disease with limb threatening ischemia

• thrombosed arteriovenous haemodialysis shunts

• thrombosed central venous catheters

4.2 Posology And Method Of Administration

Urokinase medac should only be used by physicians experienced in the management of thrombotic diseases in hospitals where adequate diagnostic and monitoring techniques are available.

Depending on the indication, the route of administration of Urokinase medac is by systemic intravenous infusion, by local intra-arterial catheter-directed infusion during arteriography, or by local instillation.

It must not be given by subcutaneous or intramuscular injection.

For instructions regarding reconstitution and further dilution, see section 6.6.

Adults

The dosage may be adjusted individually depending on the clinical condition. The following dose regimens should be used as a guideline.

Deep vein thrombosis

Urokinase medac should be administered by intravenous infusion into a peripheral vein using an initial dose of 4,400 I.U./kg bodyweight infused over 10 – 20 min, followed by a maintenance dose of 100,000 I.U. per hour for 2 – 3 days.

Pulmonary embolism

Occlusive peripheral arterial disease

Urokinase medac should be administered by local intra-arterial catheter-directed graded infusion using an initial dose of 4,000 I.U./min (i.e. 240,000 I.U. per hour) for 2 – 4 hours or until restoration of antegrade flow, followed by a dose of 1,000 – 2,000 I.U./min until complete lysis or a maximum of 48 hours.

Thrombosed arteriovenous haemodialysis shunts

Urokinase medac should be administered by local forced periodic infusion (pulse spray) into both branches of the shunt at a concentration of 5,000 to 25,000 I.U./ml up to a total dose of 250,000 I.U. If necessary, the application can be repeated every 30 – 45 minutes up to a maximum of 2 hours.

Thrombosed central venous catheters

Urokinase medac should be dissolved in physiological saline at a concentration of 5,000 I.U./ml. A volume sufficient to completely fill the lumen of the occluded catheter should be instilled and either locked for a duration of 20 to 60 minutes or pushed with aliquots of saline before the lysate is aspirated. The procedure may be repeated if necessary.

Special populations

• Elderly patients: Available data are limited in patients over 65 years and it is not known whether they respond differently from younger subjects. Urokinase medac should be used with caution in elderly patients (see section 4.4).

• Patients with renal or hepatic impairment: A dose reduction may be required in patients with impaired renal and/or hepatic function. In these cases, the fibrinogen level should not fall below 100 mg/dl.

Paediatric patients

There is very limited experience with urokinase in children with thromboembolic occlusive vascular disease and urokinase should not be used in this indication.

Urokinase medac may be used in children of all ages for the treatment of thrombosed central venous catheters using the same lock procedure as in adults.

Therapeutic monitoring

Before starting thrombolytic therapy, haemostasis tests should be performed including haematocrit, platelet count, thrombin time (TT) and activated partial thromboplastin time (aPTT).

If heparin has been given, it should be discontinued and the aPTT should be less than twice the normal control value before urokinase therapy is initiated.

For systemic administration, a 3 to 5 fold prolongation of the TT measured 4 hours after initiation of therapy is generally considered sufficient. However, results of coagulation tests and fibrinolytic activity do not reliably predict either efficacy or risk of bleeding.

Follow-up treatment

In order to prevent recurrent thrombosis subsequent administration of anticoagulants should be instituted provided the aPTT is less than twice the normal control value.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients

• Active clinically relevant bleeding

• Aneurysm and arteriovenous malformation

• Intracranial neoplasm or other neoplasm with risk of haemorrhage

• Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia

• Severe uncontrolled arterial hypertension (systolic > 200 mmHg, diastolic > 100 mmHg; grade III or IV hypertensive retinopathy)

• Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis

• Recent cerebrovascular accident (e.g. within 2 months)

• Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)

• Recent major surgery until primary wound healing, recent organ biopsy, lumbar puncture, translumbal aortography (e.g. within 10 days)

4.4 Special Warnings And Precautions For Use

In the following conditions, the risk of bleeding may be increased and should be weighed against the anticipated benefits:

• Recent severe gastrointestinal bleeding

• Recent surgery other than thoracic or neurosurgery, recent obstetrical delivery, puncture of non-compressible vessels

• Moderate coagulation defects including those due to severe hepatic or renal diseases

• Cavernous pulmonary diseases

• Genitourinary tract diseases with existing or potential sources of bleeding (e.g. implanted bladder catheter)

• High likelihood of a left heart thrombus (e.g. mitral stenosis with atrial fibrillation) with possible risk of cerebral embolism

• Known septic thrombotic disease

• Severe cerebrovascular disease

• Elderly patients (especially those over 75 years)

Concomitant administration of urokinase with other thrombolytic agents, anticoagulants, or agents inhibiting platelet function may further increase the risk of serious bleeding (see section 4.5).

When bleeding occurs in patients receiving urokinase, it may be difficult to control. Although urokinase is intended to produce sufficient amounts of plasmin to lyse intravascular deposits of fibrin, other fibrin deposits including those which provide haemostasis (at sites of needle puncture, catheter insertion, cut, etc.) are also subject to lysis, and bleeding from such sites may result. Oozing of blood from sites of percutaneous trauma occurs frequently.

The possibility of bruising or haematoma formation, especially after intramuscular injections, is high during urokinase therapy. Intramuscular injections and unnecessary handling of the patient should be avoided. Venipunctures and invasive venous procedures should be performed as infrequently as possible and with care to minimize bleeding. If bleeding from an invasive site is not serious, urokinase therapy may be continued while closely observing the patient; local measures such as application of pressure should be initiated immediately.

Arterial invasive procedures must be avoided before and during urokinase treatment to minimise bleeding. If an arterial puncture is absolutely essential, it should be performed by a physician experienced in the procedure, using a radial or brachial rather than a femoral artery. Direct pressure should be applied at the puncture site for at least 30 minutes, a pressure dressing applied, and the site checked frequently for evidence of bleeding.

If severe bleeding occurs following systemic treatment with urokinase, infusion should be stopped immediately and measures to manage the bleeding implemented. Plasma volume expanders other than dextrans may be used to replace blood volume deficits; if blood loss has been extensive, administration of packed red blood cells is preferred to whole blood. If very rapid reversal of the fibrinolytic state is required, administration of an antifibrinolytic agent such as epsilon-aminocaproic acid may be considered (see section 4.9).

Urokinase medac is a highly purified enzyme produced from human urine. It also contains human serum albumin. Products manufactured from human source materials have the potential to transmit infectious agents. Procedures to control such risks strongly reduce but cannot completely eliminate the risk of transmitting infectious agents.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anticoagulants

Oral anticoagulants or heparin may increase the risk of haemorrhage and should not be used concomitantly with urokinase.

Active substances affecting platelet function

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function (e.g., acetylsalicylic acid, other non-steroidal anti-inflammatory agents, dipyridamole, dextrans) should be avoided.

Contrast agents

Contrast agents may delay fibrinolysis.

4.6 Pregnancy And Lactation

There are no adequate data from the use of urokinase in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/fetal development, parturition or postnatal development. The potential risk for humans is unknown. However, low-molecular urokinase fragments and active plasmin cross the placenta.

Urokinase should not be used during pregnancy or in the immediate post-partum period unless clearly necessary.

It is unknown whether urokinase is excreted into human breast milk. Breast feeding should be avoided during treatment with urokinase.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

Haemorrhage

The most frequent and severe adverse effect of urokinase therapy is haemorrhage. The haemostatic status of the patient may be more profoundly altered with urokinase therapy than with heparin or coumarin-derivative anticoagulant therapy.

Severe spontaneous bleeding, including fatalities resulting from cerebral haemorrhage, has occurred during urokinase therapy. Less severe spontaneous bleeding has occurred approximately twice as frequently as that occurring during heparin therapy. Patients with pre-existing haemostatic defects have the greatest risk of spontaneous bleeding.

Moderate decreases in haematocrit not accompanied by clinically detectable bleeding have been reported in approximately 20 % of patients receiving urokinase.

Hypersensitivity reactions

In contrast to streptokinase, urokinase is reportedly non-antigenic. However, mild allergic reactions including bronchospasm and rash have been reported rarely. In addition, very rare cases of fatal anaphylaxis have been reported.

Infusion reactions

Fever and chills, including shaking chills (rigors), have been reported occasionally in patients receiving urokinase. Symptomatic treatment is usually sufficient to alleviate discomfort caused by urokinase-induced fever; however, acetylsalicylic acid should not be used.

Other infusion reactions reported with urokinase therapy include dyspnoea, cyanosis, hypoxemia, acidosis, back pain, and nausea and/or vomiting; these reactions generally occurred within one hour of beginning urokinase infusion.

The following frequency convention was used as a basis for the evaluation of undesirable effects:

Very common
Common:
Uncommon:
Rare:
Very rare	< 1/10,000

Immune system disorders

Rare	Hypersensitivity reactions including dyspnoea, hypotension, flushing, urticaria, rash
Very rare	Anaphylactic reactions

Vascular disorders

Very common	Haemorrhage from puncture sites, wounds
Haematoma
Epistaxis, gingival bleeding
Haematuria (microscopic)
Common	Intracranial haemorrhage
Gastrointestinal haemorrhage, retroperitoneal haemorrhage
Urogenital haemorrhage
Muscle haemorrhage
Embolism, including cholesterol embolism
Uncommon	Intrahepatic haemorrhage

General disorders and administration site conditions

Common

Fever, chills

Investigations

Very common

Decrease in haematocrit without clinically detectable haemorrhage

Transient increase in transaminases

4.9 Overdose

Haemorrhage that occurs during treatment with urokinase may be controlled with local pressure and treatment continued. If severe bleeding occurs, treatment with urokinase must be stopped and inhibitors such as aprotinin, epsilon-aminocaproic acid, p-aminoethylbenzoic acid or tranexamic acid can be given. In serious cases, human fibrinogen, factor XII, packed red cells or whole blood should be given as appropriate. For correction of volume deficiency, dextrans should be avoided.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: B01A D04, antithrombotic agent.

Urokinase medac is a highly purified form of naturally occurring human urokinase extracted from urine. Urokinase exists in two distinct molecular entities, a high molecular weight (approximately 54,000 daltons) and a low molecular weight (approximately 33,000 daltons). Urokinase medac contains more than 85 % of the HMW form.

Urokinase is a thrombolytic agent which converts plasminogen into plasmin (fibrinolysin) a proteolytic enzyme that degrades fibrin as well as fibrinogen and other plasma proteins. The activity of urokinase leads to a dose-dependent decrease in plasminogen and fibrinogen levels and to increased presence of fibrin and fibrogen degradation products, which have an anticoagulant effect and potentiate the effect of heparin. These effects persist for 12 – 24 hours after the end of urokinase infusion.

5.2 Pharmacokinetic Properties

Urokinase is eliminated rapidly from the circulation by the liver with a half-life of 10 to 20 minutes. The inactive degradation products are excreted via the bile and primarily via the kidneys.

Elimination is delayed in patients with liver disease and impaired kidney function.

5.3 Preclinical Safety Data

There is no preclinical safety data of additional value to the prescribing physician.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, human albumin.

6.2 Incompatibilities

No information is available regarding loss of activity in PVC containers or plastic bags/syringes.

6.3 Shelf Life

32 months

Use reconstituted material immediately.

After reconstitution and dilution, chemical and physical stability has been demonstrated for 72 hours at room temperature. From a microbiological point of view, the product should be used immediately after reconstitution and dilution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.

6.4 Special Precautions For Storage

Do not store above 25 °C.

Keep the vial in the outer container to protect from light.

6.5 Nature And Contents Of Container

All presentations are contained in borosilicate clear type 1 glass vials closed with chlorobutyl rubber stoppers and sealed with an aluminium flip-off cap.

6.6 Special Precautions For Disposal And Other Handling

The powder for solution for infusion should be dissolved in water for injection and further diluted with 0.9 % sodium chloride solution or glucose 5 % or glucose 10 % solution.

The powder is to be reconstituted as follows:

For a 100,000 I.U. vial use 2 ml of water for injection.

After reconstitution the solution must be clear and colourless.

7. Marketing Authorisation Holder

medac

Gesellschaft für klinische

Spezialpräparate mbH

Fehlandtstr. 3

20354 Hamburg

Germay

Phone: +49 (0)4103 8006-0

Fax: +49 (0)4103 8006-100

8. Marketing Authorisation Number(S)

PL 11587/0067

9. Date Of First Authorisation/Renewal Of The Authorisation

17/03/2010

10. Date Of Revision Of The Text

22/09/2010

Sudafed PE Non-Drying Sinus

Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX

What is Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.

Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

heart disease or high blood pressure;

diabetes;

circulation problems;

glaucoma;

overactive thyroid; or

enlarged prostate or problems with urination.

It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.

What should I avoid while taking Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine) side effects

fast, pounding, or uneven heartbeat;

severe dizziness, anxiety, restless feeling, or nervousness;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

vomiting, upset stomach;

warmth, tingling, or redness under your skin;

feeling excited or restless (especially in children);

sleep problems (insomnia);

skin rash or itching;

headache; or

dizziness.

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.

What other drugs will affect Sudafed PE Non-Drying Sinus (guaifenesin and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:

medicines to treat high blood pressure;

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with guaifenesin and phenylephrine. 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 Sudafed PE Non-Drying Sinus resources

Sudafed PE Non-Drying Sinus Side Effects (in more detail)
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Sudafed PE Non-Drying Sinus Drug Interactions
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Cough and Nasal Congestion
Sinus Symptoms

Where can I get more information?

Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Sudafed PE Non-Drying Sinus side effects (in more detail)

Benylin Four Flu Liquid

1. Name Of The Medicinal Product

Benylin Four Flu liquid

2. Qualitative And Quantitative Composition

Each 20 ml contains:

Diphenhydramine hydrochloride 25 mg

Paracetamol 1000 mg

Pseudoephedrine hydrochloride 45 mg

Also contains:

Ethanol

Ponceau 4R (E 124)

Sodium

Fructose

E306 Natural tocopherols extract (from soya oil)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral solution

A clear orange to brown oral solution

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing, fever, headache, muscular aches and pains.

4.2 Posology And Method Of Administration

For oral use

Adults, the elderly and children aged 12 years and over:

One 20 ml dose up to four times daily, as required. Do not take more frequently than every four hours.

Children under 12 years:

Benylin Four Flu Liquid is not recommended for use in children under the age of 12 years (see section 4.4).

Do not exceed the stated dose.

4.3 Contraindications

Known hypersensitivity to diphenhydramine, paracetamol, pseudoephedrine or to any of the excipients.

Concomitant use of other sympathomimetic agents including those given by other routes, beta-blockers (see section 4.5) and monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOI treatment (see section 4.5).

Cardiovascular disease including hypertension

Diabetes mellitus

Phaeochromocytoma

Hyperthyroidism

Closed angle glaucoma

Severe renal impairment

4.4 Special Warnings And Precautions For Use

As both diphenhydramine and pseudoephedrine have been associated with central nervous system adverse events (see section 4.8), there is a possibility that the risk of experiencing such adverse events may be increased by use of the combination.

If any of the following occur, Benylin Four Flu Liquid should be stopped

• Hallucinations

• Restlessness

• Sleep disturbances

Use with caution in prostatic hypertrophy, urinary retention, susceptibility to angle-closure glaucoma, moderate renal impairment, hepatic disease or occlusive vascular disease.

The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Benylin Four Flu Liquid is not recommended for use in children under the age of 12 years (see section 4.2).

The product labelling will contain the following advice:-

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Do not take with any other paracetamol-containing products.

If symptoms persist, consult your doctor or pharmacist.

Keep out of the reach and sight of children.

Ask a doctor before use if you suffer from a chronic or persistent cough, if you have asthma, are suffering from an acute asthma attack or where cough is accompanied by excessive secretions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

CNS depressants: may enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

Antimuscarinic drugs: may have an additive muscarinic action with other drugs, such as atropine and some antidepressants.

• MAOIs (see section 4.3) and/or RIMAs: Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome (diphenhydramine) or hypertensive crisis (pseudoephedrine).

• Moclobemide: risk of hypertensive crisis.

• Antihypertensives (including adrenergic neurone blockers & beta-blockers - see section 4.3): Benylin Four Flu Liquid may block the hypotensive effects.

• Cardiac glycosides: increased risk of dysrhythmias

• Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

• Appetite suppressants and amphetamine-like psychostimulants: risk of hypertension

• Oxytocin – risk of hypertension

• Enhances effects of anticholinergic drugs (such as TCAs)

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone, and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The use of drugs which induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptive steroids, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

The active ingredients in Benylin Four Flu have not been conclusively associated with adverse effects on the developing foetus; but as with all drugs, care should be exercised in use of the product, particularly during the first trimester.

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

All of the actives are excreted into breast milk, although few adverse effects have been reported as a result of ingestion, cautious use of Benylin Four Flu is advised during lactation.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Benylin Four Flu may cause drowsiness. If patients are affected they should not drive or use machinery.

4.8 Undesirable Effects

System Organ Class	Adverse Event
Blood and the lymphatic system disorders	Blood disorders; blood dyscrasias such as thrombocytopenia and agranulocytosis have been reported following paracetamol use, but were not necessarily causally related to the drug
Immune system disorders	Hypersensitivity reactions, including skin rash and cross-sensitivity with other sympathomimetics
Psychiatric disorders	Confusion; depression; sleep disturbances; irritability; anxiety; restlessness; excitability; insomnia; hallucinations and paranoid delusions
Nervous system disorders	Drowsiness (usually diminishes within a few days); paradoxical stimulation; headache; psychomotor impairment; extrapyramidal effects; dizziness; tremor; convulsions
Eye disorders	Blurred vision
Cardiac disorders	Palpitations; tachycardia; arrhythmia; other cardiac dysrhythmias
Vascular disorders	Hypotension; hypertension
Respiratory, thoracic and mediastinal disorders	Thickened respiratory tract secretions
Gastrointestinal disorders	Gastrointestinal disturbances; dry mouth; nausea and/or vomiting
Hepato-biliary disorders	Liver dysfunction
Skin and subcutaneous tissue disorders	Rash
Renal and urinary disorders	Urinary retention

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

A. Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

B. Regularly consumes ethanol in excess of recommended amounts.

C. Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, coma and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the local centres and/or experts that provide advice on poisons and overdoses or a liver unit.

Diphenhydramine

Symptoms of overdose may include drowsiness, hyperpyrexia and anticholinergic effects. With higher doses, and particularly in children, symptoms of CNS excitation include insomnia, nervousness, tremors and epileptiform convulsions. With massive overdose, coma or cardiovascular collapse may follow.

Treatment of overdose should be symptomatic and supportive. Measures to promote gastric emptying (such as induced emesis or gastric lavage), and in cases of acute poisoning activated charcoal, may be useful.

Pseudoephedrine

As with other sympathomimetic agents, symptoms of overdose include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition.

Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC code: N02BE51. Diphenhydramine has a potent antihistaminic action although the actions most beneficial in influenza are its antitussive and to a lesser extent anticholinergic properties, which may alleviate mucus hypersecretion. Paracetamol has central analgesic and antipyretic actions and pseudoephedrine is an indirectly acting sympathomimetic which has vasoconstrictor, bronchodilator and decongestant effects.

5.2 Pharmacokinetic Properties

Diphenhydramine is well absorbed after oral administration with peak plasma levels at 2.5 hours and is subject to extensive first pass metabolism. The drug is 75% bound to plasma proteins, but binding decreases with chronic liver disease. Metabolism is by 2 successive N-demethylations followed by oxidation to a carboxylic acid. The terminal half life lies between 3.4 and 9.3 hours.

Paracetamol is rapidly and completely absorbed with peak plasma levels seen within 30 to 60 minutes. Less than 50% is protein bound and the drug is uniformly distributed throughout the body fluids. Paracetamol is eliminated by metabolism to inactive conjugates followed by urinary excretion. The half life is 2.75- 3.25 hours.

Pseudoephedrine is rapidly absorbed, with peak serum levels after approximately 2.6 hours and onset of effect within about 30 minutes. It is well distributed throughout body fluids and tissues. Approximately 50% of the drug is excreted unchanged, the remainder undergoes metabolism to inactive metabolites. About 6% is converted to the active metabolite norpseudoephedrine.

5.3 Preclinical Safety Data

The active ingredients of Benylin Four Flu liquid are well known constituents of medicinal products and their safety profile is well documented. The results of preclinical studies do not therefore add anything of relevance for therapeutic purposes.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyethylene glycol, glycerol, propylene glycol, saccharin sodium, citric acid monohydrate, sodium benzoate, eucalyptol, menthol, carmellose sodium, sodium citrate, ethanol 10% v/v, colourings: Quinoline Yellow E 104, Ponceau 4R (E 124), Patent Blue V (E 131), flavourings: honey, lemon and cream. Water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

30 ml and 200 ml round amber glass bottles with aluminium screw cap.

30 ml and 200 ml round amber glass bottles with a plastic child resistant, tamper evident closure fitted with a polyester faced wad or polyethylene/expanded polyethylene laminated wad.

A polypropylene measuring cup is supplied with each 200 ml bottle.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Keep bottle tightly closed.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0057

9. Date Of First Authorisation/Renewal Of The Authorisation

01/06/2008

10. Date Of Revision Of The Text

01/06/2008

Sunday, 30 September 2012

What is Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

What is the most important information I should know about this medication?

What should I discuss with my healthcare provider before taking this medication?

How should I take Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking this medication?

This medication side effects

What other drugs will affect Triaminic Flu, Cough & Fever (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?

More Triaminic Flu, Cough & Fever resources

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Where can I get more information?

Friday, 28 September 2012

Saxagliptin is used for:

Do NOT use Saxagliptin if:

Before using Saxagliptin:

How to use Saxagliptin:

Important safety information:

Possible side effects of Saxagliptin:

If OVERDOSE is suspected:

General information:

More Saxagliptin resources

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Wednesday, 26 September 2012

Insulin Aspart Cartridges are used for:

Do NOT use Insulin Aspart Cartridges if:

Before using Insulin Aspart Cartridges:

How to use Insulin Aspart Cartridges:

Important safety information:

Possible side effects of Insulin Aspart Cartridges:

If OVERDOSE is suspected:

General information:

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Monday, 24 September 2012

Commonly used brand name(s)

Uses For Inspra

Before Using Inspra

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of Inspra

Dosing

Missed Dose

Storage

Precautions While Using Inspra

Inspra Side Effects

More Inspra resources

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Sunday, 23 September 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling