metformin and sitagliptin

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 metformin and sitagliptin

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.

metformin and sitagliptin is available only with your doctor's prescription.

Before Using metformin and sitagliptin

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 metformin and sitagliptin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to metformin and sitagliptin 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 metformin and sitagliptin, 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 metformin and sitagliptin 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 metformin and sitagliptin 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 metformin and sitagliptin 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 metformin and sitagliptin. 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—metformin and sitagliptin 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 metformin and sitagliptin 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—metformin and sitagliptin should be stopped before you have one of these procedures.

• Vitamin B12 deficiency—metformin and sitagliptin may make this condition worse.

Proper Use of metformin and sitagliptin

Your doctor will tell you how much of metformin and sitagliptin 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.

metformin and sitagliptin 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 metformin and sitagliptin 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 metformin and sitagliptin. 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 metformin and sitagliptin, 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 metformin and sitagliptin

It is very important that your doctor check your progress at regular visits to make sure metformin and sitagliptin 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.

metformin and sitagliptin 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 metformin and sitagliptin 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 metformin and sitagliptin if you are going to have any medical or surgical procedures.

Pancreatitis may occur while you are using metformin and sitagliptin. Stop using metformin and sitagliptin 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.

metformin and sitagliptin 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 metformin and sitagliptin.

metformin and sitagliptin 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.

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More metformin and sitagliptin resources

• Metformin and sitagliptin Dosage
• Metformin and sitagliptin Use in Pregnancy & Breastfeeding
• Metformin and sitagliptin Drug Interactions
• Metformin and sitagliptin Support Group
• 21 Reviews for Metformin and sitagliptin - Add your own review/rating

Compare metformin and sitagliptin with other medications

• Diabetes, Type 2

Ketorolac Spray

Pronunciation: KEE-toe-ROLE-ak
Generic Name: Ketorolac
Brand Name: Sprix

Ketorolac Spray is only intended for short-term (up to 5 days) treatment of moderate to moderately severe pain. It should not be used to treat minor or long-term pain. Do not use more of Ketorolac Spray than prescribed. Do not use Ketorolac Spray to treat children.

Ketorolac Spray is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious, and sometimes fatal, heart and blood vessel problems (eg, a heart attack, a stroke). The risk may be greater if you already have heart problems or if you take Ketorolac Spray for a long time. Do not use Ketorolac Spray right before or after coronary artery bypass graft (CABG) surgery.

Ketorolac Spray may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Do not use Ketorolac Spray if:

• you are allergic to Ketorolac Spray, aspirin, or any other NSAIDs (eg, ibuprofen, celecoxib)


• you are taking another NSAID (eg, ibuprofen, celecoxib)


• you are in the last 3 months of pregnancy, are breast-feeding, or are in labor


• you have recently had or will be having CABG surgery


• you have a stomach ulcer or a history of ulcers or certain severe stomach or bowel problems (eg, bleeding, perforation)


• you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)


• you have bleeding in the brain (eg, a stroke, an aneurysm) or bleeding problems (eg, platelet disorder, hemophilia), or you are at risk of bleeding

Do not use Ketorolac Spray to prevent pain before any major surgery.

Ketorolac Spray is used for:

The short-term (up to 5 days) treatment of moderate to moderately severe pain.

Ketorolac Spray is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes these symptoms.

Do NOT use Ketorolac Spray if:

• you are allergic to any ingredient in Ketorolac Spray


• you have had an asthma attack, hives, or another severe allergic reaction (eg, severe rash, breathing difficulties, dizziness) to aspirin, or to an NSAID (eg, ibuprofen, naproxen, celecoxib)


• you have had a severe allergic reaction to ethylenediamine tetraacetic acid (EDTA)


• you are in the last 3 months of pregnancy, are breast-feeding, or are in labor


• you have recently had or will be having coronary artery bypass graft (CABG) surgery


• you have a stomach ulcer, or a history of ulcers or certain severe stomach problems (eg, bleeding, perforation)


• you have severe kidney problems or are at risk of kidney failure (eg, low blood volume, dehydrated)


• you have bleeding in the brain (eg, a stroke, an aneurysm), bleeding or clotting problems (eg, a platelet disorder, hemophilia), or you are at risk of bleeding


• you need to prevent pain before any major surgery


• you are taking pentoxifylline, probenecid, another formulation of Ketorolac Spray (eg, tablets, injection), or another NSAID (eg, ibuprofen, celecoxib)

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

Before using Ketorolac Spray:

Some medical conditions may interact with Ketorolac Spray. 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 kidney or liver problems, diabetes, stomach or bowel problems (eg, bleeding, perforation, ulcers, ulcerative colitis, Crohn disease), or frequent heartburn


• if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders (eg, anemia, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), blood vessel disease, or you are at risk of any of these diseases


• if you have poor health, dehydration or low fluid volume, low blood sodium levels, smoke, drink alcohol, or have a history of alcohol abuse


• if you take corticosteroids (eg, prednisone) or anticoagulants (eg, warfarin)


• if you weigh less than 110 lbs (50 kg)


• if you have recently taken other formulations of Ketorolac Spray (eg, tablets, injection)

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

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), pentoxifylline, rivaroxaban, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), thienopyridines (eg, clopidogrel), or other NSAIDs (eg, ibuprofen, celecoxib) because the risk of bleeding may be increased


• Probenecid because it may increase the risk of Ketorolac Spray's side effects


• Alprazolam, cyclosporine, lithium, methotrexate, quinolones (eg, ciprofloxacin), or thiothixene because the risk of their side effects may be increased by Ketorolac Spray


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, losartan), carbamazepine, diuretics (eg, furosemide, hydrochlorothiazide), or phenytoin because their effectiveness may be decreased by Ketorolac Spray

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

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

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


• Before you use each bottle for the first time, you must prime it. Remove the clear plastic cover and the blue plastic safety clip. Hold the bottle at arm's length away from you. Using your index and middle fingers on the top of the bottle and your thumb on the bottom of the bottle, press down evenly and release the pump 5 times. The bottle is now ready to use.


• To use this nose spray, gently blow your nose. Sit up straight or stand and tilt your head forward slightly. Place the tip of the spray container into the nose. Be sure to point the container away from the center of your nose. Breathe gently through the nostril and squeeze the spray container. If your dose requires 2 sprays, repeat the process for your other nostril. Replace the clear plastic cover after each use.


• Do NOT use Ketorolac Spray for more than 5 days. Ketorolac Spray is not for the treatment of mild to moderate or chronic pain (eg, headache).


• Avoid contact with the eyes. If you get Ketorolac Spray in your eyes, rinse it out with water. If eye irritation persists for more than 1 hour, contact your doctor.


• Each bottle contains 1 day's supply of Ketorolac Spray. Discard each bottle within 24 hours of opening it, even if it still contains some unused medicine.


• If you miss a dose of Ketorolac Spray and you are taking it regularly, take it as soon as possible. If it is almost time for the 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 Ketorolac Spray.

Important safety information:

• Ketorolac Spray may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ketorolac Spray with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Serious stomach ulcers or bleeding can occur with the use of Ketorolac Spray. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Ketorolac Spray with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose, use more often than prescribed, or use for longer than prescribed without checking with your doctor.


• Tell your doctor or dentist that you take Ketorolac Spray before you receive any medical or dental care, emergency care, or surgery.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Ketorolac Spray is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Ketorolac Spray unless your doctor tells you to.


• Check with your doctor or pharmacist before you take acetaminophen while you are taking Ketorolac Spray. The risk of liver problems may be increased.


• Lab tests, including kidney or liver function, blood electrolyte levels, complete blood cell counts, or blood pressure, may be performed while you use Ketorolac Spray. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Ketorolac Spray with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.


• Ketorolac Spray should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Ketorolac Spray may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketorolac Spray while you are pregnant. Ketorolac Spray is found in breast milk. Do not breast-feed while taking Ketorolac Spray.

Possible side effects of Ketorolac Spray:

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:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; increased tearing; mild nasal discomfort, irritation, or pain; mild stomach pain or upset; nausea; throat irritation; vomiting.

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, throat, or tongue, unusual hoarseness); bloody or black, tarry stools; bloody or cloudy urine; change in the amount of urine produced or trouble urinating; chest, jaw, or left arm pain; confusion; dark urine; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of appetite; mental or mood changes; mouth sores; numbness of an arm or leg; one-sided weakness; pale stools; persistent flu-like symptoms; red, swollen, blistered, or peeling skin with or without fever; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the arms, hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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.

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 decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea, vomiting, or stomach pain; slow or troubled breathing; tremor; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Ketorolac Spray:

Store unopened bottles of Ketorolac Spray in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store opened bottles of Ketorolac Spray at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store upright, away from heat, moisture, and light. Discard opened bottles of Ketorolac Spray within 24 hours of opening. Do not store in the bathroom. Keep Ketorolac Spray out of the reach of children and away from pets.

General information:

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


• Ketorolac Spray 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 Ketorolac Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ketorolac resources

• Ketorolac Use in Pregnancy & Breastfeeding
• Drug Images
• Ketorolac Drug Interactions
• Ketorolac Support Group
• 74 Reviews for Ketorolac - Add your own review/rating

Compare Ketorolac with other medications

• Pain
• Postoperative Pain

Salicylic Acid Foam and Urea Foam

Pronunciation: SAL-i-SIL-ik AS-id/ue-REE-a
Generic Name: Salicylic Acid Foam and Urea
Brand Name: Salvax Duo

Salicylic Acid Foam and Urea Foam is used for:

Treating dry, rough, scaly, or excess skin caused by certain conditions (eg, calluses, warts, psoriasis). It may also be used for certain other conditions as determined by your doctor.

Salicylic Acid Foam and Urea Foam is a kit that contains 2 keratolytic and debriding medicines. It works to loosen and shed hard, scaly skin and soften and moisturize the skin.

Do NOT use Salicylic Acid Foam and Urea Foam if:

• you are allergic to any ingredient in Salicylic Acid Foam and Urea Foam

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

Before using Salicylic Acid Foam and Urea Foam:

Some medical conditions may interact with Salicylic Acid Foam and Urea Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)


• if you have or have recently had a flu-like illness (eg, fever, chills, sore throat), chickenpox, or any other type of viral infection


• if you are a child or teenager who has recently had an influenza vaccine (eg, flu shot)


• if you have diabetes, poor blood circulation, a skin infection, or the affected area is broken or severely irritated


• if you are taking aspirin or other salicylate medicines (eg, methyl salicylate)

Some MEDICINES MAY INTERACT with Salicylic Acid Foam and Urea Foam. Tell your healthcare provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, heparin, warfarin), aspirin, methotrexate, or sulfonylureas (eg, tolbutamide) because the risk of their side effects may be increased by Salicylic Acid Foam and Urea Foam


• Lithium because its effectiveness may be decreased by Salicylic Acid Foam and Urea Foam

This may not be a complete list of all interactions that may occur. Ask your health care provider if Salicylic Acid Foam and Urea Foam 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 Salicylic Acid Foam and Urea Foam:

Use Salicylic Acid Foam and Urea Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands immediately before and after using Salicylic Acid Foam and Urea Foam unless your hands are part of the treated area.


• Shake well before each use and turn upside down to administer.


• Apply Salicylic Acid Foam and Urea Foam to the affected skin as directed by your doctor. Rub it in gently until the medicine is completely absorbed.


• If you miss a dose of Salicylic Acid Foam and Urea Foam, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Salicylic Acid Foam and Urea Foam.

Important safety information:

• Salicylic Acid Foam and Urea Foam is for external use only. Do not get it in your eyes, on your lips, or on the inside of your nose or mouth. If you get Salicylic Acid Foam and Urea Foam in any of these areas, rinse right away with cool water.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Check with your doctor before use if you have a condition that covers a large area of the body.


• Apply Salicylic Acid Foam and Urea Foam only to the affected area. Do not apply Salicylic Acid Foam and Urea Foam to normal healthy skin or to skin that is reddened, irritated, or infected. Do not use Salicylic Acid Foam and Urea Foam on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts growing hair.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Salicylic Acid Foam and Urea Foam has a salicylate in it. Before you start any new medicine, check the label to see if it has a salicylate in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Salicylic Acid Foam and Urea Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Salicylic Acid Foam and Urea Foam contains a salicylate, which has been linked to a serious illness called Reye syndrome. Do not give Salicylic Acid Foam and Urea Foam to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.


• Do not use Salicylic Acid Foam and Urea Foam for other skin conditions at a later time.


• Caution is advised when using Salicylic Acid Foam and Urea Foam in CHILDREN; they may be more sensitive to its effects.


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

Possible side effects of Salicylic Acid Foam and Urea Foam:

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:

Mild, temporary burning, itching, irritation, or stinging.

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); excessive burning, irritation, itching, peeling, redness, stinging, or tenderness of your skin.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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. Salicylic Acid Foam and Urea Foam may be harmful if swallowed.

Proper storage of Salicylic Acid Foam and Urea Foam:

Store Salicylic Acid Foam and Urea Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze. Do not expose to temperatures greater than 120 degrees F (49 degrees C). Do not store in the bathroom. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Salicylic Acid Foam and Urea Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Salicylic Acid Foam and Urea Foam, please talk with your doctor, pharmacist, or other health care provider.


• Salicylic Acid Foam and Urea Foam 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 Salicylic Acid Foam and Urea Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Salicylic Acid Foam and Urea resources

• Salicylic Acid Foam and Urea Use in Pregnancy & Breastfeeding
• Salicylic Acid Foam and Urea Drug Interactions
• Salicylic Acid Foam and Urea Support Group
• 0 Reviews for Salicylic Acid and Urea - Add your own review/rating

Compare Salicylic Acid Foam and Urea with other medications

• Foot Care

Boots Soothing Eye Drops

Boots Soothing Eye Drops

(Cetrimide, Hamamelis Water)

Soothing & antiseptic

10 ml e

Read all of this carton for full instructions.

Uses: A soothing and antiseptic sterile solution for the relief of minor eye irritation. It can be used to soothe eyes irritated by smoke and dust.

Before you use this medicine

Do not use:

• If you are allergic to any of the ingredients



• If you wear soft contact lenses

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Check the cap seal is not broken before first use. If it is, do not use the drops.

Tilt head back and hold down lower eye lid. Squeeze the bottle to put drops into the corner (lower sac) of the eye.

For use in the eyes only.

• Age: Adults and children


• How much: One or two drops


• How often: Morning and night, or when you need to

If anyone accidentally swallows some: Talk to a doctor

Possible side effects

Most people will not have problems, but some may get some of these:

• Red, swollen or itchy eyes (signs of allergic reaction) – if this happens stop using the drops

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton. Throw away any unused drops 28 days after first opening.

Active ingredients

These eye drops contain Cetrimide 0.01% w/v, Hamamelis Water 5% v/v.

Also contains: purified water, boric acid, borax.

PL 00014/5237

[P]

Text prepared 11/07

Manufactured for the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

by

Hamol Limited

Nottingham

NG90 2DB

If you need more advice ask your pharmacist.

BTC16394 vE 28/02/08

Boots Pharmacy Cold & Flu Day Liquid

1. Name Of The Medicinal Product

Boots Day Cold & Flu Relief Oral Solution

2. Qualitative And Quantitative Composition

Active ingredient	% w/v
Paracetamol Ph Eur Pseudoephedrine Hydrochloride BP Pholcodine Ph Eur	3.333 0.200 0.033

3. Pharmaceutical Form

Oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Combination product for the relief of the symptoms of colds and influenza. Decongestant for the relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract associated with the common cold. Cough suppressant for the relief of acute non-productive cough associated with upper respiratory tract infection. Analgesic for the relief of aches, pains and fever associated with colds and influenza.

For oral administration.

4.2 Posology And Method Of Administration

Take during the day.

Adults and children over 12 years: 30ml every four hours, up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night liquid is taken before bedtime.

Elderly: There is no specific requirement for dosage reduction in the elderly.

Children 6 to 12 years: 15ml every four hours, up to a maximum of 3 doses in 24 hours, if needed.

This medicine is contraindicated in children under 6 years of age (see section 4.3).

Children of 6-12 years of age: not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

Warning: Do not exceed the stated dose.

Keep all medicines out of the sight and reach of children.

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients.

Severe renal impairment.

Cardiovascular disease including hypertension and peripheral vascular disease.

Diabetes mellitus.

Phaeochromocytoma.

Hyperthyroidism.

Closed angle glaucoma.

Avoid in patients with prostatic enlargement or liver failure.

Pholcodine should not be given to subjects in, or at risk of developing respiratory failure.

Patients with chronic bronchitis, COPD, bronchiolitis or bronchiectasis due to sputum retention.

Concomitant use of other sympathomimetic decongestants.

Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment (see also section 4.5).

Beta-blockers – (see section 4.5).

Not to be used in children under the age of 6 years.

4.4 Special Warnings And Precautions For Use

Pholcodine

Should be used with caution by patients with liver or renal disease.

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

Do not take with any other cough and cold medicine.

Use of pholcodine with alcohol or other CNS depressants may increase the effects of the CNS and cause toxicity in relatively smaller doses.

Pseudoephedrine

If any of the following occur, this medicine should be stopped

Hallucinations

Restlessness

Sleep disturbances

Caution in moderate to severe renal impairment.

Paracetamol

Should be given with caution to patients with impaired renal or hepatic function. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Contains paracetamol.

Warning: Do not exceed the stated dose.

Do not use this product for longer than 5 days unless your doctor agrees.

If symptoms persist consult your doctor.

Do not take with any other paracetamol-containing products.

Label:

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet or combined Label/Leaflet:

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.

May be harmful to people on a low sodium diet. (Sodium)

Warning: this product contains 4.8% by volume of ethanol.

Each 30ml dose contains up to 1.16g of alcohol.

Harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. May modify or increase the effect of other medicines. (Alcohol)

This medicinal product contains 42.75g of sucrose.

When taken according to the dosage recommendations each 30ml dose supplies up to 5.34g of sucrose.

Unsuitable in hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency. (Sucrose)

This medicinal product contains 14.37g of glucose.

When taken according to the dosage recommendations each dose supplies up to 1.8g of glucose. (Glucose)

Harmful in high doses. Can cause headache, upset stomach and diarrhoea. (Glycerin)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Pholcodine

Not to be used in patients taking MAOIs or within 14 days of stopping treatment.

Interaction with neuromuscular blocking agents (anaphylaxis) has been reported.

The reduction in blood pressure caused by antihypertensives may accentuate the hypotensive effects of pholcodine. Diuretics may have the same effect.

Pholcodine may enhance the sedative effect of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers (phenothiazines and tricyclic antidepressants).

Pseudoephedrine

MAOIs and/or RIMAs: should not be given to patients treated with MAOIs or within 14 days of stopping treatment: increased risk of hypertensive crisis.

Moclobemide: risk of hypertensive crisis.

Antihypertensives: (including adrenergic neurone blockers, diuretics & beta-blockers): this medicine 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).

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The antigoagulant effect of warfarin and other coumarins may be enhanced by prolonged use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

In view of the possible association of foetal abnormalities with first trimester exposure to pseudoephedrine, the use of the product during pregnancy should be avoided.

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.

Although the safety of this product during lactation has not been established, data on the individual ingredients suggests that the product may be used during this period.

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

Amounts of pseudoephedrine secreted into breast milk are considered too small to be harmful.

There is no information available as to whether pholcodine is excreted in breast milk, but it is unlikely to be harmful to the infant.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Paracetamol

Immune system disorders: Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.

Blood and lymphatic system disorders: Very rarely there have been reports of blood dyscrasias including thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Pholcodine

The following side effects may be associated with the use of pholcodine:

Gastrointestinal disorders: Gastrointestinal disturbances (nausea and constipation), vomiting, diarrhoea, upset stomach, epigastric pain.

Immune system disorders: Hypersensitivity reactions and anaphylaxis.

Nervous system disorders: Occasional drowsiness, dizziness, excitation, confusion.

Respiratory, thorasic and mediastinal disorders: Sputum retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash.

Pseudoephedrine

Cardiovascular disorders: Tachycardia, palpitations, other cardiac dysrhythmias.

Ear and labyrinth disorders: Tinnitus.

Eye disorders: Blurred vision.

Gastrointestinal disorders: nausea and/or vomiting, anorexia.

General disorders and administration site conditions: Irritability.

Immune system disorders: Hypersensitivity reactions including cross-sensitivity that may occur with other sympathomimetics.

Nervous system disorders: Headache, tremor, anxiety, restlessness, excitability, insomnia, hallucinations (particularly in children) and paranoid delusions.

Psychiatric disorders: Sleep disturbance, nightmares.

Renal and urinary disorders: Difficulty in micturition including urinary retention.

Skin and subcutaneous tissue disorders: Skin reactions including rash, sweating.

Vascular disorders: Hypertension.

Harmful in high doses. Can cause headache, stomach upset and diarrhoea. (Glycerin)

4.9 Overdose

Immediate treatment is essential in the management of paracetamol overdosage.

Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested the equivalent of 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine, which may have a beneficial effect up to at least 48 hours after overdose, may be required. In addition symptomatic and general supportive therapy must be available, including the administration of a beta-blocker if supraventricular tachycardia supervenes and the administration of the specific narcotic antagonist naloxone.

Symptoms of paracetamol overdosage 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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Pholcodine

It is thought to be of low toxicity, but the effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms: These include nausea, drowsiness, restlessness, excitement, ataxia and respiratory depression.

Management: Treatment of overdose should be symptomatic and supportive. Gastric lavage may be of use. In cases of severe poisoning the specific narcotic antagonist nalaxone may be used.

Information for children:

Naloxone has been used successfully to reverse central or peripheral opioid effects in children (0.01mg/kg body weight). Other treatment option is activated charcoal (1g/kg body weight) if more than 4mg/kg has been ingested within 1 hour, provided the airway can be protected.

Other symptoms of overdosage may include headache, tachycardia, urinary retention, hallucinations, coma, hyperreflexia, tremor, hypertension and arrhythmias.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic actions. Pseudoephedrine is a sympathomimetic agent with both direct and indirect effects on adrenergic receptors. Pholcodine is a cough suppressant with little analgesic activity.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates, with about 10% as glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half life varies from about 1 to 4 hours.

Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to metabolism and is excreted largely unchanged in the urine. It has a half life of several hours but elimination is enhanced and half life shortened in acid urine.

Pholcodine is rapidly absorbed after oral administration and maximum plasma concentrations are attained at about 4-8 hours. The elimination half life ranges from 32 to 43 hours. The drug has a large volume of distribution and is only 23.5% protein bound.

Pholcodine is metabolised in the liver but undergoes little conjugation with glucuronide and sulphate.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acesulfame K

Citric Acid Monohydrate

Sodium Benzoate

Sodium Citrate

Levomenthol

Propylene Glycol

Alcohol 96%

Glycerol

Liquid Sugar

Liquid Glucose

Peach Flavour

Pear drop Flavour

Lime Flavour

Riboflavin-5-Phosphate Sodium (E101)

Purified water

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

Bottle of amber polyethylene terephthalate fitted with a child resistant closure of polypropylene with expanded polyethylene liner.

Pack size: 210ml, 240ml, 300ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

Nottingham NG2 3AA

Trading as BCM

Trading as Boots Pharmacy

8. Marketing Authorisation Number(S)

PL 00014/0565

9. Date Of First Authorisation/Renewal Of The Authorisation

17 September 1997

10. Date Of Revision Of The Text

December 2010

Triaminic Chest/Nasal Liquid

Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Triaminic Chest/Nasal and Mardrops-EX

Triaminic Chest/Nasal Liquid is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Triaminic Chest/Nasal Liquid is a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Triaminic Chest/Nasal Liquid if:

• you are allergic to any ingredient in Triaminic Chest/Nasal Liquid


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Triaminic Chest/Nasal Liquid:

Some medical conditions may interact with Triaminic Chest/Nasal Liquid. 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 fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid


• if you have chronic cough

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Triaminic Chest/Nasal Liquid's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Triaminic Chest/Nasal Liquid


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Triaminic Chest/Nasal Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Triaminic Chest/Nasal Liquid 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 Triaminic Chest/Nasal Liquid:

Use Triaminic Chest/Nasal Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Triaminic Chest/Nasal Liquid by mouth with or without food.


• Take Triaminic Chest/Nasal Liquid with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.


• If you miss a dose of Triaminic Chest/Nasal Liquid, 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 Triaminic Chest/Nasal Liquid.

Important safety information:

• Triaminic Chest/Nasal Liquid may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Triaminic Chest/Nasal Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Triaminic Chest/Nasal Liquid without checking with your doctor.


• Triaminic Chest/Nasal Liquid has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Triaminic Chest/Nasal Liquid may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Triaminic Chest/Nasal Liquid.


• Tell your doctor or dentist that you take Triaminic Chest/Nasal Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Triaminic Chest/Nasal Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Triaminic Chest/Nasal Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Triaminic Chest/Nasal Liquid, contact your doctor. You will need to discuss the benefits and risks of using Triaminic Chest/Nasal Liquid while pregnant. It is not known if Triaminic Chest/Nasal Liquid is found in breast milk. Do not breast-feed while taking Triaminic Chest/Nasal Liquid.

Possible side effects of Triaminic Chest/Nasal Liquid:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: Triaminic Chest/Nasal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Triaminic Chest/Nasal Liquid:

Store Triaminic Chest/Nasal Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Triaminic Chest/Nasal Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Triaminic Chest/Nasal Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Triaminic Chest/Nasal Liquid 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 Triaminic Chest/Nasal Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Triaminic Chest/Nasal resources

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

Compare Triaminic Chest/Nasal with other medications

• Cough and Nasal Congestion

Sodium Sulfacetamide

Dosage Form: lotion

Rx Only

DESCRIPTION:

Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sulfacetamide sodium is N-[(4-aminophenyl) sulfonyI]-acetamide, monosodium salt, monohydrate. The structural formula is:

Each gram of sulfacetamide sodium USP 10% and sulfur USP 5% contains 100 mg of Sodium Sulfacetamide USP and 50 mg of Sulfur USP in a cream containing: Benzyl Alcohol, Emulsifying Wax, Hamaelis virginiana (Witch Hazel) Distillate, Kaolin, Propanediol, Propylene Glycol, Purified Water, Quillaja (Quillaia) saponaria Extract, Silicon Dioxide, and Sodium Thiosulfate.

CLINICAL PHARMACOLOGY:

The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sulfacetamide sodium is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

INDICATIONS:

Sulfacetamide sodium and sulfur cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS:

Sulfacetamide sodium and sulfur cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfacetamide sodium and sulfur cleanser is not to be used by patients with kidney disease.

WARNINGS:

Although rare, sensitivity to sulfacetamide sodium may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.

PRECAUTIONS:

General - lf irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sulfacetamide sodium and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.

Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis and Impairment of Fertility - Longterm studies in animals have not been performed to evaluate carcinogenic potential.

Pregnancy: Category C - Animal reproduction studies have not been conducted with sulfacetamide sodium and sulfur lotion. It is also not known whether sulfacetamide sodium and sulfur cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium and sulfur cleanser should be given to a pregnant woman only if clearly needed.

Nursing Mothers - It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of sulfacetamide sodium and sulfur lotion. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when sulfacetamide sodium and sulfur cleanser is administered to a nursing woman.

Pediatric Use - Safety and effectiveness in children under the age of 12 have not been established.

ADVERSE REACTIONS:

Although rare, sulfacetamide sodium may cause local irritation.

DOSAGE AND ADMINISTRATION:

Use once daily or as directed by your physician. Wet skin. Apply in a film to entire face, avoiding contact with eyes or mucous membranes. Wait 10 minutes or until dry. Rinse thoroughly with water and pat dry.

HOW SUPPLIED:

Sulfacetamide sodium 10% and sulfur 5% cleanser is supplied in

6 oz (170 g) tube      NDC 67877-268-17

12 oz (340 g) bottle  NDC 67877-268-34


Store at 15°-25°C (59°-77°F).


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


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN


Rx Only


Manufactured for:

Ascend Laboratories, LLC

Montvale, NJ 07645


Manufactured by:

Crown Laboratories, Inc.

Johnson City, TN 37604

PRINTED IN USA                     P1815.01

ASCEND

Laboratories, LLC

NDC 67877-268-34

Sulfacetamide

Sodium

10%

& Sulfur

5%

Cleanser

Rx Only


NET WT 12oz

(340 g)

SULFACETAMIDE SODIUM, SULFUR  sulfacetamide sodium, sulfur  lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 67877-268 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (SULFACETAMIDE) SULFACETAMIDE SODIUM 100 mg  in 1 g SULFUR (SULFUR) SULFUR 50 mg  in 1 g

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 67877-268-17 170.1 g In 1 TUBE None 2 67877-268-34 340.2 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/08/2011

Labeler - Ascend Laboratories, LLC (141250469)

Establishment
Name	Address	ID/FEI	Operations
Crown Laboratories, Inc.		079035945	manufacture

Revised: 01/2012Ascend Laboratories, LLC

sibutramine

Generic Name: sibutramine (si BUE tra meen)

Brand Names: Meridia

What is sibutramine?

Sibutramine was withdrawn from the U.S. market in October 2010.

Sibutramine affects chemicals in the brain that affect weight maintenance.

Sibutramine is used together with diet and exercise to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

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

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

Sibutramine was withdrawn from the U.S. market in October 2010.

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body. You should not take sibutramine if you are allergic to it, or if you have severe or uncontrolled high blood pressure, an eating disorder (anorexia or bulimia), if you are taking stimulant diet pills, or if you have a history of coronary artery disease, stroke, or heart disease.

Before taking sibutramine, tell your doctor if you have glaucoma, high blood pressure, liver or kidney disease, depression, underactive thyroid, seizures, a bleeding disorder, a history of gallstones, or if you are older than 65 or younger than 16.

Tell your doctor about all prescription and over-the-counter medications you use, especially antidepressants, cold or allergy medication, narcotic pain medicine, or migraine headache medicines.

Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks along with a low calorie diet.

What should I discuss with my healthcare provider before taking sibutramine?

Do not use sibutramine if you have taken an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use sibutramine before the MAO inhibitor has cleared from your body. You should not take this medication if you are allergic to sibutramine, or if you have:

• 
  

  severe or uncontrolled hypertension (high blood pressure);

  
  


• 
  

  an eating disorder (anorexia or bulimia);

  
  


• 
  

  a history of coronary artery disease (atherosclerosis);

  
  


• 
  

  a history of heart disease (congestive heart failure, heart rhythm disorder);

  
  


• 
  

  a history of heart attack or stroke; or

  
  


• 
  

  if you are taking stimulant diet pills.

  
  

If you have any of these other conditions, you may need a sibutramine dose adjustment or special tests:

• 
  

  glaucoma;

  
  


• 
  

  high blood pressure;

  
  


• liver disease;


• kidney disease;


• 
  

  depression;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  epilepsy or seizure disorder;

  
  


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  a history of gallstones; or

  
  


• 
  

  if you are older than 65 or younger than 16.

  
  

FDA pregnancy category C. It is not known whether sibutramine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using sibutramine. It is not known whether sibutramine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 16 years old.

How should I take sibutramine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Sibutramine is usually taken once daily. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

Sibutramine can be taken with or without food.

You should lose at least 4 pounds during the first 4 weeks of taking sibutramine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks.

Your blood pressure and pulse will need to be checked often. Visit your doctor regularly.

Sibutramine should not be taken for longer than 2 years.

Store at room temperature away from moisture, heat, and light. Do not share sibutramine with another person. Keep the medication in a place where others cannot get to it.

See also: Sibutramine dosage (in more detail)

What happens if I miss a dose?

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 headache, dizziness, and fast heart rate.

What should I avoid while taking sibutramine?

Sibutramine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not take any other prescription or over-the-counter weight-loss products without your doctor's advice.

Avoid taking cough and cold or allergy medications while taking sibutramine.

Avoid drinking alcohol while taking sibutramine.

Sibutramine side effects

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

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  new or worsening shortness of breath;

  
  


• 
  

  agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;

  
  


• 
  

  very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out;

  
  


• 
  

  easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling; or

  
  


• 
  

  sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.

  
  

Less serious side effects may include:

• 
  

  dry mouth, upset stomach;

  
  


• 
  

  changes in appetite;

  
  


• 
  

  constipation, stomach pain;

  
  


• 
  

  headache, back pain, joint pain;

  
  


• 
  

  feeling nervous, dizzy, or depressed;

  
  


• 
  

  flu symptoms, runny or stuffy nose, sore throat, cough;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin;

  
  


• 
  

  trouble sleeping (insomnia); or

  
  


• 
  

  mild skin rash.

  
  

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.

Sibutramine Dosing Information

Usual Adult Dose for Obesity:

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Initial Dose: 10 mg orally once a day.

Usual Geriatric Dose for Obesity:

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Clinical studies of sibutramine did not include sufficient numbers of patients over 65 years of age. Sibutramine is contraindicated in this group of patients.

Usual Pediatric Dose for Obesity:

Sibutramine was voluntarily withdrawn from the US market by the manufacturer in October, 2010 due to clinical trial data indicating an increased risk of heart attack and stroke. The following dosage information applies to when the drug was available in the US.

Based on one study (n=60)

14 to 17 years:
Initial Dose: 10 mg orally once a day.

What other drugs will affect sibutramine?

Before using sibutramine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by sibutramine.

Ask your doctor before taking any decongestants, cough medicine, or other diet pills.

The following drugs can interact with sibutramine. Tell your doctor if you are using any of these:

• 
  

  lithium (Lithobid, Eskalith, and others);

  
  


• 
  

  tryptophan or L-tryptophan;

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  an antibiotic such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

  
  


• 
  

  an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and others;

  
  


• 
  

  ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine).

  
  


• 
  

  migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or

  
  


• 
  

  narcotic pain medication such as fentanyl (Actiq, Duragesic, Fentora, Onsolis), meperidine (Demerol), pentazocine (Talwin).

  
  

This list is not complete and other drugs may interact with sibutramine. 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 sibutramine resources

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

• sibutramine Advanced Consumer (Micromedex) - Includes Dosage Information


• Sibutramine MedFacts Consumer Leaflet (Wolters Kluwer)


• Meridia Prescribing Information (FDA)


• Meridia Consumer Overview


• Meridia Monograph (AHFS DI)

Compare sibutramine with other medications

• Obesity

Where can I get more information?

• Your pharmacist can provide more information about sibutramine.

See also: sibutramine side effects (in more detail)