Influenza a virus vaccine, h1n1, inactivated Intramuscular

in-floo-EN-za AY VYE-rus VAX-een, H1N1, in-AK-ti-vay-ted

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

Uses For influenza a virus vaccine, h1n1, inactivated

Influenza virus vaccine, H1N1 is used to prevent infection caused by the influenza A (H1N1) 2009 virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease. It is also known as a "flu shot".

Influenza is a virus infection of the throat, bronchial tubes, and lungs. Influenza infection causes fever, chills, cough, headache, muscle aches, and pains in your back, arms, and legs. In addition, adults and children weakened by other diseases or medical conditions, and persons 50 years of age and over, even if they are healthy, may get a much more serious illness that may have to be treated in a hospital. Each year thousands of people die as a result of an influenza infection.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using influenza a virus vaccine, h1n1, inactivated

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to influenza a virus vaccine, h1n1, inactivated 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 influenza virus vaccine, H1N1 in the pediatric population. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of influenza virus vaccine, H1N1 in children 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 influenza virus vaccine, H1N1 in children below 6 months of age. 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 influenza virus vaccine, H1N1 in the elderly.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to eggs, egg products, or chicken products, history of—Should not be used in patients with these conditions.

• Guillain-Barré syndrome, history of—May cause the symptoms of this condition to return.

• Immune system problems (e.g., cancer, HIV)—This vaccine may not work as well if you have weak immune system.

Proper Use of influenza a virus vaccine, h1n1, inactivated

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

Some children who have not received the vaccine before should receive 2 doses at least 1 month apart.

Precautions While Using influenza a virus vaccine, h1n1, inactivated

It is very important that your child return to your doctor’s office at the right time for the second dose. Be sure to notify your doctor of any side effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Avoid contact with people who are sick or at increased risk of getting the infection after you receive this vaccine. Talk to your doctor about this if you have concerns.

Influenza virus vaccine, H1N1 may not protect all persons given the vaccine. Also, this vaccine will not treat flu symptoms if you already have the virus.

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

influenza a virus vaccine, h1n1, inactivated Side Effects

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

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

More common

• Difficulty with moving


• fever


• general feeling of discomfort or illness


• joint pain


• muscle aching or cramping


• muscle pains or stiffness


• swollen joints


• unusual tiredness or weakness

Incidence not known

• Back pain, sudden and severe


• black, tarry stools


• bleeding gums


• blindness


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blue-yellow color blindness


• blurred vision


• body aches or pain


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning, tingling, numbness or pain in the hands, arms, feet, or legs


• chest pain


• chills


• congestion


• convulsions


• cough


• decreased vision


• diarrhea


• difficult or labored breathing


• difficulty with swallowing


• dizziness


• dryness or soreness of the throat


• eye pain


• fainting


• fast heartbeat


• feeling faint, dizzy, or lightheadedness


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• headache


• hives


• hoarseness


• itching


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


• muscle weakness, sudden and progressing


• pain in the arms or legs


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• redness of the face, neck, arms, and occasionally, upper chest


• redness, soreness, or itching skin


• runny nose


• sensation of pins and needles


• shortness of breath


• skin rash


• sneezing


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• sores, welting, or blisters


• stabbing pain


• stuffy nose


• sweating


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tender, swollen glands in the neck


• tightness in the chest


• trouble with swallowing


• unusual bleeding or bruising


• voice changes


• weakness of the muscles in your face


• wheezing

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

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site

Incidence not known

• Lack or loss of strength

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

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

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

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

Janumet

Generic Name: sitagliptin and metformin (Oral route)

met-FOR-min hye-droe-KLOR-ide, sit-a-GLIP-tin FOS-fate

Oral route(Tablet)

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk of lactic acidosis increases with conditions such as sepsis, dehydration, excessive alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. Discontinue therapy and hospitalize the patient immediately for suspected lactic acidosis .

Commonly used brand name(s)

In the U.S.

• Janumet

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Sitagliptin

Chemical Class: Metformin

Uses For Janumet

Metformin and sitagliptin combination is used to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing glucose when there is too much sugar in the blood.

Metformin and sitagliptin combination does not help patients who have insulin-dependent or type 1 diabetes, because they cannot produce insulin from their pancreas. Their blood glucose is best controlled by insulin injections.

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

Before Using Janumet

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 metformin and sitagliptin combination in the pediatric population. Safety and efficacy have not been established in children below 18 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of metformin and sitagliptin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving metformin and sitagliptin combination.

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.

• Acetrizoic Acid


• Diatrizoate


• Ethiodized Oil


• Iobenzamic Acid


• Iobitridol


• Iocarmic Acid


• Iocetamic Acid


• Iodamide


• Iodipamide


• Iodixanol


• Iodohippuric Acid


• Iodopyracet


• Iodoxamic Acid


• Ioglicic Acid


• Ioglycamic Acid


• Iohexol


• Iomeprol


• Iopamidol


• Iopanoic Acid


• Iopentol


• Iophendylate


• Iopromide


• Iopronic Acid


• Ioseric Acid


• Iosimide


• Iotasul


• Iothalamate


• Iotrolan


• Iotroxic Acid


• Ioversol


• Ioxaglate


• Ioxitalamic Acid


• Ipodate


• Metrizamide


• Metrizoic Acid


• Tyropanoate Sodium

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.

• Acetazolamide


• Alatrofloxacin


• Balofloxacin


• Cimetidine


• Ciprofloxacin


• Clinafloxacin


• Dichlorphenamide


• Dofetilide


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Topiramate


• Tosufloxacin


• Trovafloxacin Mesylate


• Zonisamide

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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Cephalexin


• Clorgyline


• Dilevalol


• Enalaprilat


• Enalapril Maleate


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Rifampin


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine


• Trospium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acid in the blood (diabetic ketoacidosis or metabolic acidosis) or


• Kidney disease or


• Type 1 diabetes—This medicine should not be used in patients with these conditions.

• Alcohol intoxication or excessive use or


• Underactive adrenal glands or


• Underactive pituitary gland or


• Undernourished condition or


• Weakened physical condition or


• Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking sitagliptin and metformin combination.

• Congestive heart failure, acute or


• Dehydration, severe or


• Heart or blood vessel problems or


• Liver disease or


• Sepsis (severe infection) or


• Shock—These conditions can cause serious problems. If they happen, stop taking this medicine as soon as possible.

• Fever or


• Infection of any type or


• Surgery (major) or


• Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you with insulin.

• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertriglyceridemia (high triglycerides and fats in the blood)


• Obesity or


• Pancreas problems, history of—Use with caution. May increase risk for pancreatitis (swelling of the pancreas).

• Radiologic procedures (e.g., X-rays, CT scans, and MRIs) that require dyes to be injected in your vein—This medicine should be stopped before you have one of these procedures.

• Vitamin B12 deficiency—This medicine may make this condition worse.

Proper Use of Janumet

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

Metformin and sitagliptin combination should be taken with meals to help reduce any stomach upset.

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

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.

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 type 2 diabetes:
    
    • For patients taking metformin alone:
      
      • Adults—At first, 50 milligrams (mg) of sitagliptin, plus the dose of metformin already being taken, two times per day. Your doctor may gradually increase your dose until your blood sugar is controlled. If you are taking 850 mg of metformin two times per day, you may start with 50 mg of sitagliptin and 1000 mg of metformin two times per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients taking sitagliptin alone:
      
      • Adults—At first, 50 milligrams (mg) of sitagliptin and 500 mg of metformin two times per day. Your doctor may gradually increase your dose until your blood sugar is controlled. However, the dose is usually not more than 50 mg of sitagliptin and 1000 mg of metformin two times per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients using metformin and sitagliptin together as separate tablets:
      
      • Adults—The dose is the same as the dose you are already taking. Your doctor may gradually increase your dose until your blood sugar is controlled.
      
      
      • Children—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 Janumet

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Under certain conditions, too much metformin and sitagliptin can cause lactic acidosis. Symptoms of lactic acidosis are severe and quick to appear. They usually occur when other health problems not related to the medicine are present and are very severe, such as a heart attack or kidney failure. Symptoms of lactic acidosis include abdominal or stomach discomfort; decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; and unusual sleepiness, tiredness, or weakness.

If symptoms of lactic acidosis occur, you should check your blood sugar and get immediate emergency medical help.

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take this medicine with another type of diabetes medicine (e.g., insulin, glimepiride, or pioglitazone). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; fast heartbeat; headaches that continue; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your family should also know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your diabetes medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); ketones in the urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness (passed out); or unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes and a list of all your medicines.

It is important to tell the doctor in charge that you are taking this medicine if you are going to have any medical or surgical procedures.

Pancreatitis may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have a sudden and severe stomach pain, chills, constipation, nausea, vomiting, loss of appetite, fever, or lightheadedness.

This medicine may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; blistering, peeling, or loosening of the skin; fever or chills; trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Janumet 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

• Anxiety


• blurred vision


• chills


• cold sweats


• confusion


• cool, pale skin


• depression


• dizziness


• fast heartbeat


• headache


• increased hunger


• loss of consciousness


• mental cloudiness


• nausea


• nervousness


• nightmares


• not thinking clearly


• seizures


• shakiness


• slurred speech


• unusual tiredness or weakness

Rare

• Abdominal or stomach discomfort


• decreased appetite


• diarrhea


• fast, shallow breathing


• general feeling of discomfort


• muscle pain or cramping


• shortness of breath


• sleepiness

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

More common

• Bloated


• excess air or gas in the stomach or intestines


• fever


• full feeling


• indigestion


• lack or loss of strength


• muscle aches


• passing gas


• sore throat


• stuffy or runny nose


• vomiting

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

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

See also: Janumet 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 Janumet resources

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

• Janumet Prescribing Information (FDA)


• Janumet MedFacts Consumer Leaflet (Wolters Kluwer)


• Janumet Consumer Overview

Compare Janumet with other medications

• Diabetes, Type 2

Glycopyrrolate

glye-koe-PIR-oh-late

Commonly used brand name(s)

In the U.S.

• Cuvposa


• Robinul


• Robinul Forte

Available Dosage Forms:

• Tablet


• Solution

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Antimuscarinic

Uses For glycopyrrolate

Glycopyrrolate is used to treat peptic ulcers in adults. It is also used to treat chronic, severe drooling caused by certain neurologic disorders (e.g., cerebral palsy) in children 3 to 16 years of age. glycopyrrolate is an anticholinergic.

Glycopyrrolate may also be used for other conditions as determined by your doctor.

glycopyrrolate is available only with your doctor's prescription.

Before Using glycopyrrolate

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 glycopyrrolate, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glycopyrrolate in children 3 to 16 years of age. However, safety and efficacy have not been established in children younger than 3 years of age.

Geriatric

No information is available on whether the risk of glycopyrrolate-induced adverse effects are increased in the elderly; however, it should be used with caution because elderly patients are more likely to have age related liver disease, kidney disease, heart disease, or prostate problems. This may require a dosage adjustment or careful monitoring in elderly patients receiving glycopyrrolate.

Pregnancy

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

Breast Feeding

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 glycopyrrolate, 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 glycopyrrolate 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.

• Potassium

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.

Other Medical Problems

The presence of other medical problems may affect the use of glycopyrrolate. Make sure you tell your doctor if you have any other medical problems, especially:

• Colostomy (bowel surgical procedure) or


• Congestive heart failure or


• Heart disease or


• Heart rhythm problems or


• Hiatal hernia with gastroesophageal reflux disease (GERD) or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Ileostomy (bowel surgical procedure) or


• Liver disease or


• Nerve problems (e.g., neuropathy) or


• Prostatic hypertrophy (enlarged prostate) or


• Ulcerative colitis—Use with caution. May make these conditions worse.

• Glaucoma or


• Myasthenia gravis (severe muscle weakness) or


• Obstructive uropathy (urinary blockage due to enlarged prostate or other condition) or


• Paralytic ileus (bowel blockage) or


• Stomach or intestinal problems (e.g., ulcerative colitis, toxic megacolon, bowel obstruction), severe or


• Trouble urinating—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of glycopyrrolate

Your doctor will tell you how much of glycopyrrolate to use and how often. The dose may need to be changed several times in order to find out what works best for you or your child. Do not use more medicine or use it more often than your doctor tells you to.

glycopyrrolate comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

You should take glycopyrrolate at least one hour before or two hours after meals.

Dosing

The dose of glycopyrrolate 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 glycopyrrolate. 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 (solution):
  
  • For severe drooling:
    
    • Children 3 to 16 years of age—Dose is based on body weight and must be determined by your child's doctor. The dose is 0.02 milligram (mg) per kilogram (kg) of body weight three times a day. Your child's doctor may increase your child's dose as needed. However, the dose is usually not more than 1.5 to 3 mg per dose.
    
    
    • Children younger than 3 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  


• For oral dosage form (tablet):
  
  • For peptic ulcers:
    
    • Adults and children 12 years of age and older—The initial dose is 1 mg three times daily. Your doctor will adjust the dose as needed. However, the dose is usually not more than 8 mg per day.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of glycopyrrolate, 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 glycopyrrolate

It is very important that your doctor or your child's doctor check your progress at regular visits. This will allow your doctor to make sure that glycopyrrolate is working properly and to check for unwanted effects.

You should not take potassium chloride tablets or other potassium supplements (in tablet or capsule forms) while is using glycopyrrolate. Using these medicines together may cause delayed movement of the potassium supplement through the esophagus and stomach.

glycopyrrolate may cause constipation or diarrhea. Constipation or diarrhea can be an early symptom of a serious bowel problem. Stop using glycopyrrolate and check with your doctor if you or your child has constipation, diarrhea, abdominal or stomach distention (swelling), pain, nausea, or vomiting.

Stop using glycopyrrolate and check with your doctor right away if your child is unable to urinate, has dry diapers or undergarments, or has the following symptoms while using glycopyrrolate: crying, irritability, decrease in the frequency of urine, or difficult or painful urination.

If you or your child develops a skin rash, hives, or any allergic reaction to glycopyrrolate, stop taking the medicine and check with your doctor as soon as possible.

glycopyrrolate may make you or your child sweat less, causing your body temperature to increase. Use extra care to avoid becoming overheated during exercise or hot weather while you are taking glycopyrrolate, since overheating may result in heat stroke.

glycopyrrolate may make you or your child drowsy or cause blurred vision. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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

glycopyrrolate Side Effects

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

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

More common

• Body aches or pain


• chills


• constipation


• cough


• decrease in the frequency of urination


• decrease in urine volume


• difficulty in passing urine (dribbling)


• difficulty with breathing


• ear congestion


• feeling of warmth


• fever


• headache


• loss of voice


• nasal congestion


• painful urination


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Less common

• Abdominal or stomach discomfort or pain


• abdominal or stomach distension


• chest pain


• confusion


• convulsions


• dizziness


• dry heaves


• dry mouth


• fainting


• increase in heart rate


• lightheadedness


• pain or tenderness around the eyes and cheekbones


• rapid breathing


• shortness of breath or troubled breathing


• stuffy nose


• sunken eyes


• thirst


• tightness in the chest


• vomiting


• wheezing


• wrinkled skin

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

• low blood pressure


• muscle weakness


• trouble breathing

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

• Altered mood


• anxiety


• attack, assault, or force


• bloated


• change in taste


• chapped lips


• crying


• dry skin


• dry tongue


• excess air or gas in the stomach or intestines


• full feeling


• hyperventilation


• irregular heartbeats


• irritability


• loss of taste


• moaning


• nervousness


• pain


• paleness of the skin


• passing gas


• rash


• restlessness


• shaking


• trouble with sleeping


• uncontrolled eye movements

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: glycopyrrolate 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 glycopyrrolate resources

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

• Glycopyrrolate MedFacts Consumer Leaflet (Wolters Kluwer)


• Glycopyrrolate Monograph (AHFS DI)


• Glycopyrrolate Professional Patient Advice (Wolters Kluwer)


• Cuvposa Prescribing Information (FDA)


• Cuvposa Consumer Overview


• Cuvposa Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Robinul Prescribing Information (FDA)


• Robinul Forte MedFacts Consumer Leaflet (Wolters Kluwer)

Compare glycopyrrolate with other medications

• Anesthesia
• Excessive Salivation
• Peptic Ulcer

Boots Diclofenac Potassium 12.5mg Tablets

1. Name Of The Medicinal Product

Diclofenac potassium 12.5mg Tablets

Double Action Pain Relief 12.5mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 12.5mg Diclofenac potassium.

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Film coated Tablet

White round, unscored biconvex film coated tablet, 5mm diameter, with 'I' marked on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Short term relief of headache, dental pain, period pain, rheumatic pain, muscular pain, backache and the symptoms of colds and flu including fever.

4.2 Posology And Method Of Administration

Adults and children aged 14 years and over:

Initially two tablets, followed by one or two tablets every 4 to 6 hours as needed. No more than 6 tablets (75 mg) should be taken in any 24 hour period.

Double Action Pain Relief 12.5mg Tablets should not be used for longer than 3 days. If symptoms persist or worsen consult your doctor.

To be taken preferably with or after food, swallowed whole with a drink of water.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms (see section 4.4).

Children and Adolescents:

Double Action Pain Relief 12.5mg Tablets are not to be used in children and adolescents under 14 years of age.

4.3 Contraindications

Known hypersensitivity to diclofenac or to any of the excipients.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes) of proven ulceration or bleeding.

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

Severe heart failure, hepatic failure or renal failure (see section 4.4).

Use with concomitant NSAIDs including cyclooxygenase-2-selective inhibitors should be avoided (see section 4.5).

Concomitant use of anticoagulants and antiplatelets (see section 4.5).

Pregnancy or breastfeeding (see section 4.6).

This product contains soya. If you are allergic to peanut or soya, do not use this medicinal product.

4.4 Special Warnings And Precautions For Use

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2. and GI and Cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Cardiovascular and cerebrovascular effects

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) up to 3 days for relief of pain.

Gastrointestinal

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

Although diclofenac is usually well tolerated, there have been reported incidences of gastro-intestinal bleeding. Therefore, patients with a history of gastro-intestinal disease should not take diclofenac without being closely monitored by their doctor (see section 4.3).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving diclofenac, the treatment should be withdrawn.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3) and in the elderly.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).

Respiratory disorders:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Renal:

Renal impairment, as the use of NSAIDs may result in further deterioration of renal function (see sections 4.3 and 4.8).

Patients with impaired renal or cardiac function, particularly the elderly, and patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function should only consider use of diclofenac with great caution and always only under their doctor's supervision, who will need to monitor renal function.

Hepatic:

As with other NSAIDs, values of one or more liver enzymes may increase. In the case of diclofenac being prescribed for a prolonged period, close medical surveillance is needed and regular monitoring of hepatic function is indicated as a precautionary measure (see sections 4.3 and 4.8).

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Haematological effects:

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Anaphylactic (anaphylactoid) reactions:

As with other non-steroidal anti-inflammatory drugs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases without earlier exposure to diclofenac.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease there may be increase risk of aseptic meningitis (see section 4.8).

Dermatological effects:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs including diclofenac (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Double Action Pain Relief 12.5mg Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Impaired female fertility:

There is limited evidence that drugs which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

In common with other NSAIDs, diclofenac potassium may mask the signs and symptoms of infection due to its pharmacodynamic properties.

The label will state:

Read the enclosed leaflet before taking this medicine.

Do not take if you:

• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

• are allergic to diclofenac or any other ingredient of the product, aspirin, ibuprofen or other related painkillers

• are taking other NSAID painkillers, or aspirin

• are taking medicines that thin the blood

• are pregnant or breastfeeding.

Speak to a pharmacist or your doctor before taking this product if you:

• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, liver, heart, kidney or bowel problems

• are allergic to peanut or soya

• are on a controlled potassium diet

• are a smoker

If symptoms persist or worsen, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Diclofenac should be avoided in combination with:

Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4).

Other NSAIDs: including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.3).

Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.3).

Diclofenac should be used with caution in combination with:

Antihypertensive and diuretics: NSAIDs may diminish the effect of these drugs. Diclofenac and other non-steroidal anti-inflammatory drugs may increase the risk of renal impairment associated with the use of ACE-inhibitors. Diuretics can increase the risk on nephrotoxity of NSAIDs.

Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, which should therefore be monitored frequently under medical supervision (see section 4.4 Special warnings and special precautions for use).

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Selective serotonin reuptake inhibitors (SSRIs) and anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increased plasma glycoside levels.

Lithium: There is evidence for potential increases in plasma levels of lithium, due to decreased elimination of lithium.

Methotrexate: There is a potential for an increase in plasma methotrexate, due to decreased elimination of methotrexate.

Ciclosporin: Increased risk of nephrotoxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthoroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

Antidiabetics: Clinical studies have shown that diclofenac potassium can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic agents during treatment with diclofenac. Monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

4.6 Pregnancy And Lactation

Pregnancy

The use of diclofenac in pregnant women has not been studied. Therefore, Double Action Pain Relief 12.5mg Tablets should not be used during pregnancy except on the advice of a doctor.

Lactation

Like other NSAIDs, diclofenac passes into the breast milk in small amounts. Therefore, Double Action Pain Relief 12.5mg Tablets should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Fertility

As with other NSAIDs, the use of diclofenac may impair female fertility and is not recommended in women attempting to conceive (see section 4.4).

4.7 Effects On Ability To Drive And Use Machines

Usually there is no effect at the recommended low-dose and short duration of treatment. However patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous system disturbances while taking diclofenac should refrain from driving or using machines.

4.8 Undesirable Effects

Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (

Available data do not suggest an increased risk with use of low dose diclofenac (up to 75 mg/day) for up to 3 days treatment for the relief of pain or fever.

Gastro-intestinal: the most commonly-observed adverse events are gastrointestinal in nature.

Common - Nausea, vomiting, diarrhoea, flatulence, dyspepsia, abdominal pain.

Rare – Gastritis, melaena, haematemesis. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (See section 4.4).

Very rare - Constipation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (See section 4.4) have been reported following administration, pancreatitis.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs.

These may consist of (a) non-specific allergic reactions and anaphylaxis – rare (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, - rare or (c) assorted skin disorders, including rashes of various types (common); urticaria (rare); purpura, angiodema pruritus, and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiforme – very rare.

Cardiovascular: Rare – Oedema.

Very rare - Hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events ( for example myocardial infarction or stroke) (see section 4.4).

Renal: Very rare- Nephrotoxicity in various forms, interstitial nephritis, nephrotic syndrome and renal failure.

Hepatic: Rare - Abnormal liver function, hepatitis and jaundice.

Neurological and special senses: Common - Headache, dizziness, vertigo. Very rare - Visual disturbances, optic neuritis, paraesthesia, depression, confusion, hallucinations, tinnitus, malaise, fatigue and drowsiness.

Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).

Haematological: Very rare - Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia.

Dermatological: Very rare - Photosensitivity, bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis.

Other organ systems: Very rare – Impotence.

4.9 Overdose

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions.

In serious poisoning metabolic acidosis may occur and the prothrombin time / INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur.

Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintainance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents with 1 hour of ingestion of a potentially toxic amount if frequent of prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: NSAID, ATC code: {M01 AB 05}

Diclofenac potassium tablets contain the potassium salt of diclofenac, a non-steroidal compound with pronounced and clinically demonstrable analgesic, anti-inflammatory and anti-pyretic properties.

Diclofenac is a potent inhibitor of prostaglandin bio-synthesis and modulator of arachidonic acid release and uptake.

Diclofenac potassium tablets have a rapid onset of action and are, therefore, suitable for the treatment of acute episodes of pain and inflammation.

In migraine attacks Diclofenac potassium has been shown to be effective in relieving the headache and in improving the accompanying symptom of nausea.

Diclofenac in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.

5.2 Pharmacokinetic Properties

Absorption

Diclofenac is rapidly and completely absorbed from sugar-coated tablets. Food intake does not affect absorption.

Peak plasma concentration after one 12.5 mg tablet was 0.944 μmol/l after 54 minutes. The plasma concentrations show a linear relationship to the size of the dose.

Diclofenac undergoes first-pass metabolism and is extensively metabolised.

Distribution

Diclofenac is highly bound to plasma proteins (99.7%), chiefly albumin (99.4%)

Elimination

The total systemic clearance of diclofenac in plasma is 263 ± 56 ml/min (mean ± SD).

The terminal half-life in plasma is 1-2 hours.

Repeated oral administration of Diclofenac Potassium for 8 days in daily doses of 50 mg t i d does not lead to accumulation of diclofenac in the plasma.

Approx. 60% of the dose administered is excreted in the urine in the form of metabolites, and less than 1% as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Biotransformation

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

Characteristics in patients

The age of the patient has no influence on the absorption, metabolism, or excretion of diclofenac.

In patients suffering from renal impairment, no accumulation of the unchanged active substance can be inferred from the single-dose kinetics when applying the usual dosage schedule. At a creatinine clearance of <10 ml/min the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.

In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis) the kinetics and metabolism are the same as for patients without liver disease.

5.3 Preclinical Safety Data

Relevant information on the safety of Diclofenac potassium is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Silica colloidal anhydrous

Sodium starch glycollate

Povidone

Starch maize

Calcium hydrogen phosphate anhydrous

Magnesium stearate

Film coating:

Polyvinyl alcohol partially hydrolysed

Titanium dioxide E171

Talc

Lecithin soya E322

Xanthan gum E415

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Blister pack. Pack size: 18 tablets

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0243

9. Date Of First Authorisation/Renewal Of The Authorisation

3^rd March 2009

10. Date Of Revision Of The Text

24^th June 2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

Immuzim

Dosage Form: FOR ANIMAL USE ONLY
Immuzim

Echinacea Sp.

Active Ingredients:

Echinacea [Echinacea angustifolia] 7.5mg per ml

Echinacea [Echinacea pallida] 7.5mg per ml

Inactive Ingredients:

Acetic acid glacial and Propionic acid [organic preservatives[Salt,Water

FOR USE ON ANIMALS ONLY

Immuzim contains NO animal parts or residues

Imported to the USA by :

Emerald Valley Natural Health Inc, Exeter, NH 03833


Batch No: 94414

Use by Date: 03/12/11


Immuzim is manufactured in the UK by

SCA Nutec [Provimi Ltd]

Nutec Mill, Eastern Avenue

Lichfield, Staffordshire, WS13 7SE, UK


Exported by :

Equiglobal Ltd

Manningtree, Essex, CO11 1UT, UK


20 Litres/5.283 gallons [US]

Immuzim  echinacea angustifolia root and echinacea pallida root  extract

Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 52338-398 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA ROOT (ECHINACEA ANGUSTIFOLIA ROOT) ECHINACEA ANGUSTIFOLIA ROOT 7.5   in 1 mL ECHINACEA PALLIDA ROOT (ECHINACEA PALLIDA ROOT) ECHINACEA PALLIDA ROOT 7.5   in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 52338-398-20 20000 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2010

Labeler - SCA NuTec (233072193)

Establishment
Name	Address	ID/FEI	Operations
SCA NuTec		233072193	manufacture

Revised: 04/2010SCA NuTec

Insulin aspart, recombinant Subcutaneous

IN-su-lin AS-part, ree-KOM-bi-nant

Commonly used brand name(s)

In the U.S.

• Novolog


• Novolog FlexPen

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

Uses For insulin aspart, recombinant

Insulin aspart is a fast-acting type of human insulin. Insulin is used by people with diabetes to help keep blood sugar levels under control. If you have diabetes, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health. Since insulin aspart acts faster than regular human insulin, you normally should use insulin aspart with a longer-acting insulin.

insulin aspart, recombinant is available only with your doctor's prescription.

Before Using insulin aspart, recombinant

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 insulin aspart, recombinant, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin aspart in children. However, safety and efficacy of insulin aspart mix 50/50 and 70/30 in the pediatric population have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of insulin aspart have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of insulin aspart in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment of dosage in patients receiving insulin aspart.

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 insulin aspart, recombinant, 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 insulin aspart, recombinant 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.

• Alatrofloxacin


• Balofloxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gatifloxacin


• Gemifloxacin


• Grepafloxacin


• Levofloxacin


• Lomefloxacin


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Prulifloxacin


• Rufloxacin


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

Using insulin aspart, recombinant 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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bitter Melon


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clorgyline


• Dilevalol


• Esmolol


• Fenugreek


• Glucomannan


• Guar Gum


• Iproniazid


• Isocarboxazid


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Moclobemide


• Nadolol


• Nebivolol


• Nialamide


• Oxprenolol


• Pargyline


• Penbutolol


• Phenelzine


• Pindolol


• Procarbazine


• Propranolol


• Psyllium


• Selegiline


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Toloxatone


• Tranylcypromine

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.

Other Medical Problems

The presence of other medical problems may affect the use of insulin aspart, recombinant. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.

• Infection or any illness or


• Stress (e.g., physical or emotional)—These conditions increase blood sugar and may increase the amount of insulin aspart you need.

• Kidney disease or


• Liver disease—Effects of insulin aspart may be increased or decreased; your doctor may need to change your insulin dose.

Proper Use of insulin aspart, recombinant

Each package of insulin aspart contains a patient information sheet. Read this sheet carefully before beginning treatment and each time you refill for any new information, and make sure you understand:

• How to prepare the medicine.


• How to inject the medicine.


• How to use disposable insulin delivery device.


• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (e.g., abdomen, thigh, or upper arm). If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, insulin aspart should be taken within 5-10 minutes before the meal or immediately before the meal.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

When used in an insulin pump: Carefully read and follow the external insulin pump instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. If you do not understand how you are to use the insulin pump, contact your health care professional.

You should never mix insulin aspart with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.

insulin aspart, recombinant can also be given as an intravenous (IV) infusion only by a healthcare professional in a clinic or hospital.

Dosing

The dose of insulin aspart, recombinant 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 insulin aspart, recombinant. 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 injection dosage form:
  
  • For diabetes mellitus:
    
    • Adults—The dose is based on your blood sugar and must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

After a cartridge has been inserted into a pen, store the cartridge and pen at room temperature, not in the refrigerator.

Precautions While Using insulin aspart, recombinant

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks you take insulin aspart, recombinant. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.


• Other medicines—Do not take other medicines during the time you are taking insulin aspart unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.


• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.


• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.

Insulin aspart may cause a serious allergic reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.

Too much insulin aspart can cause hypoglycemia (low blood sugar). Symptoms of low blood sugar include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; depression; difficulty in thinking; dizziness or lightheadedness; drowsiness; excessive hunger; fast heartbeat; headache; irritability or abnormal behavior; nervousness; nightmares; restless sleep; shakiness; slurred speech; and tingling in the hands, feet, lips, or tongue.

Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

insulin aspart, recombinant Side Effects

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

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

More common

• Anxious feeling


• behavior change similar to being drunk


• blurred vision


• cold sweats


• confusion


• convulsions (seizures)


• depression


• difficulty in thinking


• dizziness or lightheadedness


• drowsiness


• excessive hunger


• fast heartbeat


• headache


• irritability or abnormal behavior


• low blood sugar


• nervousness


• nightmares


• restless sleep


• shakiness


• slurred speech


• tingling in the hands, feet, lips, or tongue


• unconsciousness

Less common or rare

• Depression of the skin at the place of injection


• dryness of the mouth


• fast or weak pulse


• feeling of pressure, itching, redness, soreness, stinging, swelling, or tingling at the place of injection


• increased thirst


• irregular heartbeat


• loss of appetite


• mood or mental changes


• muscle cramps or pain


• nausea or vomiting


• shortness of breath


• skin rash or itching over the whole body


• sweating


• thickening of the skin at the place of injection


• unusual tiredness or weakness


• wheezing

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

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

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