Exforge HCT

Generic Name: amlodipine, hydrochlorothiazide, and valsartan (am LOE di peen, HYE droe klor oh THYE a zide, val SAR tan)

Brand Names: Exforge HCT

What is amlodipine, hydrochlorothiazide, and valsartan?

Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Valsartan is an angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine, hydrochlorothiazide, and valsartan is used to treat high blood pressure (hypertension).

This medication is usually given after other blood pressure medications have been tried without successful treatment of symptoms.

Amlodipine, hydrochlorothiazide, and valsartan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about amlodipine, hydrochlorothiazide, and valsartan?

Your chest pain may become worse when you first start taking this medication or when your dose is increased. Call your doctor if your chest pain is severe or ongoing. You should not take this medication if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate.

Before taking amlodipine, hydrochlorothiazide, and valsartan, tell your doctor if you have kidney or liver disease, congestive heart failure, glaucoma, asthma or allergies, low or high blood levels of potassium, gout, lupus, diabetes, or a pencillin allergy.

Do not use this medication without telling your doctor if you are pregnant. Amlodipine, hydrochlorothiazide, and valsartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine, hydrochlorothiazide, and valsartan. Do not use potassium supplements or salt substitutes while you are taking amlodipine, hydrochlorothiazide, and valsartan, unless your doctor has told you to.

What should I discuss with my healthcare provider before taking amlodipine, hydrochlorothiazide, and valsartan?

You should not take this medication if you are allergic to amlodipine (Norvasc), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Vaseretic, Zestoretic and others), valsartan (Diovan), or sulfa drugs, or if you are unable to urinate.

To make sure you can safely take amlodipine, hydrochlorothiazide, and valsartan, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease;


• 
  

  congestive heart failure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  asthma or allergies;

  
  


• 
  

  low or high levels of magnesium or potassium in your blood;

  
  


• 
  

  gout;

  
  


• 
  

  lupus;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a penicillin allergy.

  
  

FDA pregnancy category D. Do not use this medication if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Amlodipine, hydrochlorothiazide, and valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking amlodipine, hydrochlorothiazide, and valsartan. Amlodipine, hydrochlorothiazide, and valsartan can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using amlodipine, hydrochlorothiazide, and valsartan.

How should I take amlodipine, hydrochlorothiazide, and valsartan?

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.

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

Take this medication with a full glass (8 ounces) of water. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance. Your chest pain may become worse when you first start taking this medication or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

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

It may take up to 2 weeks of using this medicine before your blood pressure improves. For best results, keep using the medication as directed.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using this medication.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

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 fast or slow heartbeat, confusion, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; feeling light-headed, and fainting.

What should I avoid while taking amlodipine, hydrochlorothiazide, and valsartan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine, hydrochlorothiazide, and valsartan. Do not use potassium supplements or salt substitutes while you are taking amlodipine, hydrochlorothiazide, and valsartan, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Amlodipine, hydrochlorothiazide, and valsartan side effects

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

• 
  

  eye pain, vision problems;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

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

  
  


• 
  

  slow, fast, or pounding heartbeats;

  
  


• 
  

  urinating less than usual, or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  numbness, tingling, or burning pain;

  
  


• 
  

  jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, fainting, or seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  dizziness;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  nausea, upset stomach;

  
  


• 
  

  muscle spasms, back pain; or

  
  


• 
  

  stuffy nose, sore throat.

  
  

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

What other drugs will affect amlodipine, hydrochlorothiazide, and valsartan?

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

• 
  

  any other blood pressure medications;

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  carbamazepine (Carbatrol, Equetro, Tegretol);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  cholestyramine (Prevalite, Questran) or colestipol (Colestid);

  
  


• 
  

  insulin or oral diabetes medication;

  
  


• 
  

  simvastatin (Zocor, Simcor, Vytorin);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);

  
  


• 
  

  any other diuretics (water pills);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;

  
  


• 
  

  a muscle relaxer such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), metaxalone (Skelaxin), or methocarbamol (Robaxin), orphenadrine (Norflex), or tizanidine (Zanaflex);

  
  


• 
  

  a narcotic medication such as hydrocodone (Lortab, Vicodin), meperidine (Demerol), methadone (Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin), and others.

  
  

This list is not complete and other drugs may interact with amlodipine, hydrochlorothiazide, and valsartan. 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 Exforge HCT resources

• Exforge HCT Side Effects (in more detail)
• Exforge HCT Use in Pregnancy & Breastfeeding
• Exforge HCT Drug Interactions
• Exforge HCT Support Group
• 1 Review for Exforge HCT - Add your own review/rating

• Exforge HCT Prescribing Information (FDA)


• Exforge HCT Advanced Consumer (Micromedex) - Includes Dosage Information


• Exforge HCT MedFacts Consumer Leaflet (Wolters Kluwer)


• Exforge HCT Consumer Overview

Compare Exforge HCT with other medications

• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about amlodipine, hydrochlorothiazide, and valsartan.

See also: Exforge HCT side effects (in more detail)

tacrolimus Oral, Intravenous

ta-KROE-li-mus

Oral route(Capsule)

Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .

Commonly used brand name(s)

In the U.S.

• Prograf

Available Dosage Forms:

• Capsule

Therapeutic Class: Immune Suppressant

Pharmacologic Class: Calcineurin Inhibitor

Uses For tacrolimus

Tacrolimus is used together with other medicines to prevent the body from rejecting a transplanted organ (e.g., kidney, liver, or heart). tacrolimus may be used with steroids, azathioprine (Imuran®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.

When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.

Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of tacrolimus as well as the risks of using it.

tacrolimus is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in the product labeling, tacrolimus is used in certain patients with the following medical conditions:

• Bone marrow transplant.


• Pancreas transplant.


• Rheumatoid arthritis.

Before Using tacrolimus

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 tacrolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tacrolimus 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 tacrolimus in children with liver transplants.

Appropriate studies have not been performed on the relationship of age to the effects of tacrolimus in children with kidney and heart transplants. 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 tacrolimus in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tacrolimus.

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 tacrolimus, 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 tacrolimus 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.

• Ziprasidone

Using tacrolimus 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.

• Aceclofenac


• Acemetacin


• Alclofenac


• Amikacin


• Amiloride


• Amiodarone


• Apazone


• Atazanavir


• Bacillus of Calmette and Guerin Vaccine, Live


• Basiliximab


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carbamazepine


• Carprofen


• Caspofungin


• Cisplatin


• Clometacin


• Clonixin


• Colchicine


• Crizotinib


• Cyclosporine


• Darunavir


• Dexketoprofen


• Dibekacin


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Efavirenz


• Etodolac


• Etofenamate


• Etravirine


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gentamicin


• Ibuprofen


• Indomethacin


• Indoprofen


• Infliximab


• Isoxicam


• Itraconazole


• Kanamycin


• Ketoprofen


• Ketorolac


• Lornoxicam


• Measles Virus Vaccine, Live


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mumps Virus Vaccine, Live


• Nabumetone


• Naproxen


• Nefazodone


• Nelfinavir


• Neomycin


• Netilmicin


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pazopanib


• Phenobarbital


• Phenylbutazone


• Phenytoin


• Pirazolac


• Piroxicam


• Pirprofen


• Poliovirus Vaccine, Live


• Posaconazole


• Propyphenazone


• Proquazone


• Rifabutin


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Sirolimus


• Smallpox Vaccine


• Spironolactone


• St John's Wort


• Streptomycin


• Sulindac


• Suprofen


• Telaprevir


• Tenidap


• Tenofovir


• Tenoxicam


• Tiaprofenic Acid


• Tobramycin


• Tolmetin


• Triamterene


• Typhoid Vaccine


• Varicella Virus Vaccine


• Vemurafenib


• Voriconazole


• Yellow Fever Vaccine


• Zomepirac

Using tacrolimus 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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Amprenavir


• Chloramphenicol


• Clarithromycin


• Clotrimazole


• Dalfopristin


• Danazol


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Diltiazem


• Erythromycin


• Fluconazole


• Fosphenytoin


• Ketoconazole


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Metoclopramide


• Metronidazole


• Mibefradil


• Nevirapine


• Nifedipine


• Quinupristin


• Rifapentine


• Ritonavir


• Saquinavir


• Schisandra sphenanthera


• Theophylline

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.

Using tacrolimus with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use tacrolimus, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Diabetes or


• Hyperkalemia (high potassium in the blood) or


• Hypertension (high blood pressure) or


• Myocardial hypertrophy (heart is larger than normal), history of or


• Paresthesias (numbness or tingling in the hands, arms, legs, or feet), history of or


• Seizures (convulsions), history of or


• Tremors—Use with caution. May make these conditions worse.

• Infection, active (eg, bacteria, fungus, or virus)—May decrease your body's ability to fight an infection.

• Kidney disease or


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

Proper Use of tacrolimus

Take tacrolimus exactly as directed by your doctor. Do not take more or less of it and do not take it more often than your doctor ordered. Using too much will increase the chance for side effects, while using too little may cause you to reject your transplanted organ.

tacrolimus comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

tacrolimus is always used together with other medicines. Make sure you understand when to take all of your medicines during the day. Your doctor will give you a daily plan for taking your medicines.

You may take tacrolimus with or without food. However, you should take it the same way each time.

You should not eat grapefruit or drink grapefruit juice while you are taking tacrolimus Grapefruit and grapefruit juice will increase the amount of medicine in the body.

Do not stop taking tacrolimus without first checking with your doctor. You might have to take medicine for the rest of your life to prevent your body from rejecting the transplant.

Dosing

The dose of tacrolimus 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 tacrolimus. 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 (capsules):
  
  • To prevent heart transplant rejection:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.075 milligram (mg) per kilogram (kg) of body weight per day, divided into two doses and taken every 12 hours. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To prevent kidney transplant rejection:
    
    • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.1 to 0.2 milligram (mg) per kilogram (kg) of body weight per day, divided into two doses and taken every 12 hours. Your doctor may adjust the dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To prevent liver transplant rejection:
    
    • Adults and teenagers 17 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.1 to 0.15 milligram (mg) per kilogram (kg) of body weight per day, divided into two doses and taken every 12 hours. Your doctor may adjust the dose as needed.
    
    
    • Teenagers and children younger than 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.15 to 0.2 mg per kg of body weight per day, divided into two doses and taken every 12 hours. Your doctor may adjust the dose as needed.
    
    
  
  

Missed Dose

DRUG: GENERAL, MISS, STANDARD

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 tacrolimus

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

tacrolimus may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats, and stay out of direct sunlight between the hours of 10 am and 3 pm. Avoid sunlamps and tanning beds.

tacrolimus may increase your risk of developing infections. Avoid being near people who are sick while you are using tacrolimus. Wash your hands often. Tell your doctor if you have any kind of infection before you start using tacrolimus. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

While you are being treated with tacrolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Tacrolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

tacrolimus may increase your risk for developing a rare and serious virus infection with the BK polyoma virus. This virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

tacrolimus may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes; loss of coordination; clumsiness; confusion; memory loss; difficulty speaking or understanding what others say; or weakness in the legs.

tacrolimus may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using tacrolimus: blurred vision, dizziness, headache, mental changes, seizures, high blood pressure, or a fast heartbeat.

Hyperkalemia (high potassium in the blood) may occur while you are using tacrolimus. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; an irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Tacrolimus may cause a condition called pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.

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.

tacrolimus 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

• Abdominal pain


• abnormal dreams


• agitation


• anxiety


• chills


• confusion


• convulsions (seizures)


• diarrhea


• dizziness


• fever and sore throat


• flu-like symptoms


• frequent urination


• headache


• infection


• itching


• loss of appetite


• loss of energy or weakness


• mental depression


• muscle trembling or twitching


• nausea


• nervousness


• pale skin


• seeing or hearing things that are not there


• shortness of breath


• skin rash


• swelling of the feet or lower legs


• tingling


• trembling and shaking of the hands


• trouble with sleeping


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

Less common

• Blurred vision


• chest pain


• increased sensitivity to pain


• muscle cramps


• numbness or pain in the legs


• ringing in the ears


• sweating

Rare

• Enlarged heart


• flushing of the face or neck


• general feeling of discomfort or illness


• weight loss


• wheezing

Incidence not known

• Black, tarry stools


• blistering, peeling, loosening of the skin


• bloating


• bloody urine


• blurred vision


• constipation


• cough


• drowsiness


• fainting


• fast, slow, or irregular heartbeat


• heartburn


• increased blood pressure


• increased thirst


• indigestion


• joint or muscle pain


• lightheadedness


• loss of appetite


• lower back or side pain


• nausea


• pinpoint red spots on skin


• pounding or rapid pulse


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• skin sores


• stomach pain


• troubled breathing


• ulcers or white spots in mouth or on lips


• weakness


• weight gain


• yellow eyes or skin

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

• Acid or sour stomach


• belching


• difficulty with moving


• lack or loss of strength


• muscle pain or stiffness


• unable to sleep

Less common

• Body aches or pain


• burning or stinging of the skin


• cracks in the skin


• crying


• delusions


• dementia


• depersonalization


• dysphoria


• euphoria


• excessive muscle tone


• feeling of constant movement of self or surroundings


• feeling that others are watching you or controlling your behavior


• feeling that others can hear your thoughts


• increased sensitivity of the skin to sunlight


• large, flat, blue or purplish patches in the skin


• loss of strength or energy


• muscle tension or tightness


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• paranoia


• quick to react or overreact emotionally


• rapidly changing moods


• redness or other discoloration of the skin


• restlessness


• scaly skin


• sensation of spinning


• severe mood or mental changes


• severe sunburn


• sleepiness or unusual drowsiness


• sore mouth or tongue


• sores on the skin


• swelling or inflammation of the mouth


• tender, swollen glands in the neck


• unusual behavior


• white patches in the mouth, tongue, or throat

Incidence not known

• Change in color vision


• decreased weight


• difficulty seeing at night


• feeling hot and cold


• hearing loss


• sudden sweating

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.

More tacrolimus Oral, Intravenous resources

• Tacrolimus Oral, Intravenous Use in Pregnancy & Breastfeeding
• Drug Images
• Tacrolimus Oral, Intravenous Drug Interactions
• Tacrolimus Oral, Intravenous Support Group
• 20 Reviews for Tacrolimus Oral, Intravenous - Add your own review/rating

Compare tacrolimus Oral, Intravenous with other medications

• Crohn's Disease
• Graft-versus-host disease
• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal

Alustra

Pronunciation: HYE-droe-kwin-one/VYE-ta-min A
Generic Name: Hydroquinone/Vitamin A
Brand Name: Alustra

Alustra is used for:

Bleaching freckles, age spots, and other skin discolorations that may occur due to pregnancy, skin trauma, use of birth control pills, or other hormone replacement therapy. It may also be used for other conditions as determined by your doctor.

Alustra is a combination depigmenting agent and vitamin A. It works by lightening the skin.

Do NOT use Alustra if:

• you are allergic to any ingredient in Alustra

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

Before using Alustra:

Some medical conditions may interact with Alustra. 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 asthma or damaged or irritated skin


• if you are unusually sensitive to sunlight or must be outside for prolonged periods of time

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

• Products that contain benzoyl peroxide or hydrogen peroxide because side effects, such as a dark staining of the skin, may occur


• Medicines that contain phenol, resorcinol, or salicylic acid because the risk of side effects may be increased


• Fluoroquinolones (eg, levofloxacin), phenothiazines (eg, chlorpromazine), sulfonamides (eg, glipizide, sulfamethoxazole), tetracyclines (eg, doxycycline), or thiazide diuretics (eg, hydrochlorothiazide) because the risk of sunburn may be increased

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

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

• Alustra comes with an additional patient leaflet. Read it carefully and reread it each time you get Alustra refilled.


• Alustra is for external use only.


• Before using Alustra for the first time, apply a small amount to an unbroken patch of skin and check in 24 hours for itching, blistering, or excessive redness or irritation. If these side effects develop, contact your doctor.


• Wash your hands before and after using Alustra, unless your hands are a part of the treated area.


• Remove all cosmetics with a mild soap before applying Alustra. Gently dry the area.


• Apply enough medicine to cover the affected area and gently rub it in until it is evenly distributed.


• If you miss a dose of Alustra, use it as soon as possible. If it is almost time for you 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 Alustra.

Important safety information:

• Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are using contains sulfites.


• Alustra may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Alustra. Use a sunscreen and wear protective clothing if you must be outside for a prolonged period.


• If your symptoms do not improve within 2 months or if they become worse, check with your doctor.


• Do not use products containing benzoyl peroxide or hydrogen peroxide with Alustra because your skin may become darkly stained. The stain can be removed by stopping use of the peroxide product and washing your skin with soap and water.


• Do not use other medicines or products on your skin, especially products that dry or irritate the skin, without first discussing it with your doctor.


• Avoid getting Alustra in your eyes, nose, or mouth. If you get Alustra in your eyes, rinse thoroughly with water.


• Do not exceed the recommended dose or use Alustra for longer than prescribed without checking with your doctor.


• Alustra may be harmful if swallowed. If you or someone you know may have taken Alustra by mouth, contact your local poison control center or emergency room immediately.


• Use Alustra with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while using Alustra, discuss with your doctor the benefits and risks of using Alustra during pregnancy. It is unknown if Alustra is excreted in breast milk. If you are or will be breast-feeding while you are using Alustra, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Alustra:

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 burning or redness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; blue-black darkening of the skin; cracking or excessive dryness, redness, stinging, or irritation.

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: Alustra 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; bone pain; change in texture of hair or nails; drowsiness; dry, scaly skin; headache; itching; nausea; vomiting.

Proper storage of Alustra:

Store Alustra 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 Alustra out of the reach of children and away from pets.

General information:

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


• Alustra 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 Alustra. 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 Alustra resources

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

• Alustra Concise Consumer Information (Cerner Multum)


• Epiquin Micro Prescribing Information (FDA)

Compare Alustra with other medications

• Dermatological Disorders

Penicillins

Penicillin is an antibiotic that disturbs the cell wall synthesis in bacteria. It was initially derived from the mold Penicillium rubrum. Since then, a number of naturally occurring penicillins have been derived e.g. penicillin G (benzylpenicillin) and penicillin V (phenoxymethylpenicillin).

Other antibiotics obtained from penicillins include amoxicillin, ampicillin, flucloxacillin. These are classed as semisynthetic penicillins.

Penicillins are bactericidal and mainly active against gram-positive bacteria.

The most important side effect of penicillins is hypersensitivity, such as rashes or anaphylaxis. Patients who are allergic to one penicillin will be allergic to all.

See also

• aminopenicillins
• antipseudomonal penicillins
• beta-lactamase inhibitors
• natural penicillins
• penicillinase resistant penicillins

Drug List:

Garamycin Injection

Generic Name: gentamicin (Injection route)

jen-ta-MYE-sin

Injection route(Solution)

Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside-induced ototoxicity is usually irreversible. Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided. Aminoglycosides can cause fetal harm when administered to a pregnant woman .

Commonly used brand name(s)

In the U.S.

• Garamycin

Available Dosage Forms:

• Solution


• Injectable

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For Garamycin

Gentamicin injection is used to treat serious bacterial infections in many different parts of the body.

Gentamicin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

Gentamicin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your kidneys and the part of your body that controls hearing. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefit of this medicine as well as the risks.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Garamycin

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gentamicin injection in children. However, this medicine should be used with caution in premature and newborn infants.

Geriatric

No information is available on the relationship of age to the effects of gentamicin injection in geriatric patients. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving gentamicin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 receiving 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 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.

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Lysine


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Succinylcholine


• Tacrolimus


• Tubocurarine


• Vancomycin


• Vecuronium

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.

• Indomethacin


• Methoxyflurane


• Polygeline

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Sulfite allergy, history of—This medicine contains sodium metabisulfite which may cause an allergic reaction in patients with these conditions.

• Hypocalcemia (low calcium in the blood) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood)—Should be corrected before receiving this medicine. If these conditions are not corrected, this medicine may increase risk for more serious side effects.

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

• Kidney disease, severe or


• Muscle problems or


• Myasthenia gravis (severe muscle weakness) or


• Nerve problems—Use with caution. May make these conditions worse.

Proper Use of Garamycin

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle or into a vein.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, you must receive this medicine on a regular schedule.

To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you or your child are receiving this medicine.

Precautions While Using Garamycin

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of a damage to your hearing or sense of balance.

Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem (e.g., Fanconi-like syndrome).

This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or convulsions.

Make sure your doctor knows that you are using this medicine before having a surgery or other procedures that require you to receive a numbing medicine (e.g., anesthetics, neuromuscular blocking agents). Using gentamicin injection together with numbing medicines may increase your risk of having difficulty in breathing, drowsiness, inability to breath without assistance, or unusual tiredness or weakness.

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.

Garamycin 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 or nurse immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach cramps or pain


• agitation


• back pain


• black, tarry stools


• blood in the urine


• blurred or double vision


• burning, numbness, tingling, or painful sensations


• change in frequency of urination or amount of urine


• chest pain


• chills


• coma


• confusion


• continuing ringing or buzzing or other unexplained noise in the ears


• cough


• difficult or troubled breathing


• difficulty with swallowing


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• dry mouth


• eye pain


• fast heartbeat


• fever with or without chills


• hallucinations


• headache


• hearing loss


• hives


• hoarseness


• increased thirst


• irregular heartbeats


• irregular, fast or slow, or shallow breathing


• irritability


• itching


• joint pain


• loss of appetite


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle pain or weakness


• muscle spasms (tetany) or twitching


• nausea or vomiting


• nervousness


• numbness and tingling around the mouth, fingertips, or feet


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


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


• right upper abdominal or stomach pain and fullness


• seizures


• sensation of spinning


• skin rash


• slow or fast heartbeat


• slow or irregular breathing


• sore throat


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


• stiff neck


• sweating


• swelling of the feet or lower legs


• swollen glands


• tightness in the chest


• trembling


• unusual bleeding or bruising


• unusual tiredness or weakness


• weight chest discomfort


• weight loss


• 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:

Incidence not known

• Blurred or loss of vision


• decreased appetite


• depression


• disturbed color perception


• hair loss or thinning of the hair


• halos around lights


• hives or welts


• increased salivation


• night blindness


• overbright appearance of lights


• pain at the injection site


• purple spots on the skin


• redness of the skin


• swelling or inflammation of the mouth


• tunnel vision


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Garamycin Injection 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 Garamycin Injection resources

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

Compare Garamycin Injection with other medications

• Bacteremia
• Bacterial Endocarditis Prevention
• Bacterial Infection
• Bone infection
• Brucellosis
• Burns, External
• Cystic Fibrosis
• Endocarditis
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Kidney Infections
• Meningitis
• Pelvic Inflammatory Disease
• Peritonitis
• Plague
• Pneumonia
• Rabbit Fever
• Skin Infection
• Surgical Prophylaxis

Anaprox-DS

Generic Name: naproxen (na PROX en)

Brand Names: Aleve, Aleve Caplet, Aleve Easy Open Arthritis, Aleve Gelcap, Anaprox, Anaprox-DS, Comfort Pac with Naproxen, EC-Naprosyn, Leader Naproxen Sodium, Midol Extended Relief, Naprelan 375, Naprelan 500, Naprelan 750, Naprosyn

What is Anaprox-DS (naproxen)?

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that cause inflammation and pain in the body.

Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.

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

What is the most important information I should know about Anaprox-DS (naproxen)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use naproxen. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking naproxen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result.

What should I discuss with my healthcare provider before taking Anaprox-DS (naproxen)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to naproxen, or if you have a history of allergic reaction to aspirin or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use naproxen:

• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  a history of stomach ulcers or bleeding;

  
  


• liver or kidney disease;


• 
  

  asthma;

  
  


• 
  

  polyps in your nose;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. Before using naproxen, tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen during pregnancy unless your doctor has told you to. Naproxen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take Anaprox-DS (naproxen)?

Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.

EC-Naprosyn is a slower-acting form of naproxen and this brand should be used only for treating arthritis or ankylosing spondylitis. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release or enteric-coated tablet. Swallow the pill whole. The extended-release pill is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you take naproxen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store naproxen at room temperature away from moisture and heat.

What happens if I miss a dose?

Since naproxen is sometimes taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, stomach pain, confusion, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Anaprox-DS (naproxen)?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen. Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen. Avoid prolonged exposure to sunlight. Naproxen can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Anaprox-DS (naproxen) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking naproxen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• 
  

  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  swelling or rapid weight gain;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

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

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  bruising, severe tingling, numbness, pain, muscle weakness; or

  
  


• 
  

  fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  upset stomach, mild heartburn or stomach pain, diarrhea, constipation;

  
  


• 
  

  bloating, gas;

  
  


• 
  

  dizziness, headache, nervousness;

  
  


• 
  

  skin itching or rash;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  ringing in your ears.

  
  

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

What other drugs will affect Anaprox-DS (naproxen)?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with naproxen may cause you to bruise or bleed easily.

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

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  diuretics (water pills) such as furosemide (Lasix);

  
  


• 
  

  steroids (prednisone and others);

  
  


• 
  

  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others; or

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

  
  

This list is not complete and there may be other drugs that can interact with naproxen. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Anaprox-DS resources

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

• Naproxen Professional Patient Advice (Wolters Kluwer)


• Naproxen Monograph (AHFS DI)


• Naproxen Prescribing Information (FDA)


• Aflaxen Advanced Consumer (Micromedex) - Includes Dosage Information


• Aleve MedFacts Consumer Leaflet (Wolters Kluwer)


• Aleve Consumer Overview


• Anaprox MedFacts Consumer Leaflet (Wolters Kluwer)


• EC-Naprosyn Enteric-Coated Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Naprosyn Consumer Overview


• Naprosyn Prescribing Information (FDA)

Compare Anaprox-DS with other medications

• Ankylosing Spondylitis
• Aseptic Necrosis
• Back Pain
• Bursitis
• Costochondritis
• Diffuse Idiopathic Skeletal Hyperostosis
• Dysautonomia
• Fever
• Frozen Shoulder
• Gout, Acute
• Headache
• Juvenile Rheumatoid Arthritis
• Muscle Pain
• Osteoarthritis
• Pain
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondylolisthesis
• Tendonitis

Where can I get more information?

• Your pharmacist can provide more information about naproxen.

See also: Anaprox-DS side effects (in more detail)

Calpol Sugar Free Infant Suspension Sachets

1. Name Of The Medicinal Product

CALPOL Sugar Free Infant Suspension Sachets

2. Qualitative And Quantitative Composition

Calpol Sugar Free Infant Suspension Sachets contains 120 mg Paracetamol in each 5 ml.

Excipients: maltitol liquid ((E965), contains 2.72 g of maltitol in each 5 ml) , sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral Suspension.

A pink strawberry flavoured suspension

4. Clinical Particulars

4.1 Therapeutic Indications

Calpol Sugar Free Infant Suspension Sachets is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

Age : 2 – 3 months	Dose
1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
• Do not give to babies less than 2 months of age. • Do not give more than 2 doses. • Leave at least 4 hours between doses. • If further doses are needed, talk to your doctor or pharmacist.

Children aged 3 months – 6 years:

Child's Age	How Much	How often (in 24 hours)
3 – 6 months	One 2.5 ml spoonful (small end)	4 times
6 – 24 months	One 5 ml spoonful (large end)	4 times
2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

It is important to massage the sachet for before use.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

Calpol Sugar Free Infant Suspension Sachets is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special Warnings And Precautions For Use

Calpol Sugar Free Infant Suspension Sachets should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Concomitant use of other paracetamol-containing products should be avoided.

Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.

Maltitol may have a mild laxative effect. Each 5 ml spoonful of this product contains 2.72 g of maltitol. Calorific value 2.3 kcal/g maltitol.

Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).

Carmoisine (E122) may cause allergic reactions.

The label contains the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give to babies less than 2 months of age.

For infants 2-3 months no more than 2 doses should be given.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Massage contents of sachet before opening.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Do not store above 25°C. Keep sachets in the outer carton.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

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

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

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

4.6 Pregnancy And Lactation

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 the doctor regarding its use.

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

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare.Very rarely hypersensitivity and anaphylatic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4.9 Overdose

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

Risk Factors:

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes

OR

b) Regularly consumes ethanol in excess of recommended amounts

OR

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

Symptoms

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, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

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

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.

ATC Code: NO2 BE01 – Other analgesics and antipyretics.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical Safety Data

Mutagenicity

There are no studies relating to the mutagenic potential of Calpol Sugar Free Infant Suspension Sachets.

In vivo mutagenicity tests of paracetamol in mammals are limited and show conflicting results. Therefore, there is insufficient information to determine whether paracetamol poses a mutagenic risk to man.

Paracetamol has been found to be non-mutagenic in bacterial mutagenicity assays, although a clear clastogenic effect has been observed in mammalian cells in vitro following exposure to paracetamol (3 and 10 mM for 2h).

Carcinogenicity

There are no studies to the carcinogenic potential of Calpol Sugar Free Infant Suspension Sachets.

There is inadequate evidence to determine the carcinogenic potential of paracetamol in humans. A positive association between the use of paracetamol and cancer of the ureter (but not of other sites in the urinary tract) was observed in a case-control study in which approximate lifetime consumption of paracetamol (whether acute or chronic) was estimated. However, other similar studies have failed to demonstrate a statistically significant association between paracetamol and cancer of the urinary tract, or paracetamol and renal cell carcinoma.

There is limited evidence for the carcinogenicity of paracetamol in experimental animals. Liver cell tumours can be detected in rats following chronic feeding of 500 mg/kg/day paracetamol.

Teratogenicity

There is no information relating to the teratogenic potential of Calpol Sugar Free Infant Suspension Sachets. In humans, paracetamol crosses the placenta and attains concentrations in the foetal circulation similar to those in the maternal circulation. Intermittent maternal ingestion of therapeutic doses of paracetamol are not associated with teratogenic effects in humans.

Paracetamol has been found to be foetotoxic to cultured rat embryo.

Fertility

There is no information relating to the effects of Calpol Sugar Free Infant Suspension Sachets on fertility. A significant decrease in testicular weight was observed when male Sprague-Dawley rats were given daily high doses of paracetamol (500 mg/kg/body weight/day) orally for 70 days.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol liquid

Sorbitol liquid (non crystallising) (E420)

Glycerol

Dispersible cellulose

Xanthan gum

Ethyl parahydroxybenzoate (E214)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Polysorbate 80

Strawberry flavour

Carmoisine (E122)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Do not store above 25°C. Keep sachets in the outer carton.

6.5 Nature And Contents Of Container

5 ml sachet composed of a laminate made of paper/PE/Aluminium/Surlyn. Pack sizes 12 or 20 sachets. A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0155

9. Date Of First Authorisation/Renewal Of The Authorisation

26/02/2007- 25/02/2009

10. Date Of Revision Of The Text

6^th June 2011

LEGAL STATUS

GSL for sachets