eprosartan and hydrochlorothiazide

ep-roe-SAR-tan MES-i-late, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

• Teveten HCT

Available Dosage Forms:

• Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Eprosartan

Chemical Class: Thiazide

Uses For eprosartan and hydrochlorothiazide

Eprosartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Eprosartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, eprosartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

eprosartan and hydrochlorothiazide is available only with your doctor's prescription.

Before Using eprosartan and hydrochlorothiazide

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 eprosartan and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eprosartan and hydrochlorothiazide 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 eprosartan and hydrochlorothiazide combination in the pediatric population. 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 eprosartan and hydrochlorothiazide combination in the elderly.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	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.
2nd Trimester	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.
3rd Trimester	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

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 eprosartan and hydrochlorothiazide, 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 eprosartan and hydrochlorothiazide 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.

• Dofetilide

Using eprosartan and hydrochlorothiazide 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.

• Acetyldigoxin


• Arsenic Trioxide


• Benazepril


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Enalapril


• Enalaprilat


• Flecainide


• Ketanserin


• Levomethadyl


• Lisinopril


• Lithium


• Metildigoxin


• Moexipril


• Ouabain


• Perindopril


• Proscillaridin


• Quinapril


• Ramipril


• Sotalol


• Trandolapril

Using eprosartan and hydrochlorothiazide 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.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bepridil


• Bromfenac


• Captopril


• Carbamazepine


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cyclophosphamide


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

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

• Anuria (not able to form urine) or


• Sulfonamide (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®) allergy—Should not be used in patients with these conditions.

• Allergies or


• Asthma, history of—May increase likelihood of having an allergic reaction.

• Diabetes or


• Gout or


• Kidney problems or


• Liver problems or


• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

• Electrolyte imbalances (e.g., high calcium or low potassium, magnesium, or sodium in the body) or


• Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. The blood pressure-lowering effects of eprosartan and hydrochlorothiazide may be increased.

Proper Use of eprosartan and hydrochlorothiazide

eprosartan and hydrochlorothiazide should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

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

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

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

You may take eprosartan and hydrochlorothiazide with or without food.

Dosing

The dose of eprosartan and hydrochlorothiazide 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 eprosartan and hydrochlorothiazide. 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 high blood pressure:
    
    • Adults—One tablet once a day. Your doctor may increase your dose as needed or administer twice daily. Usually the dose is not more than 800 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of eprosartan and hydrochlorothiazide, 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 eprosartan and hydrochlorothiazide

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

Using eprosartan and hydrochlorothiazide while you are pregnant (especially in your second or third trimester) 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 eprosartan and hydrochlorothiazide, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. These symptoms are more likely to occur when you begin taking eprosartan and hydrochlorothiazide, or when the dose is increased.

Check with your doctor right away if you become sick while taking eprosartan and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of potassium, magnesium, or sodium in the body).

Stop using eprosartan and hydrochlorothiazide and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

eprosartan and hydrochlorothiazide may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using eprosartan and hydrochlorothiazide. eprosartan and hydrochlorothiazide may affect the results of certain medical tests.

Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Drinking alcohol or taking narcotic pain relievers or sleeping pills with eprosartan and hydrochlorothiazide may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

eprosartan and hydrochlorothiazide 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:

Rare

• Abdominal or stomach pain


• ankle, knee, or great toe joint pain


• arm, back, or jaw pain


• bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• coma


• confusion


• convulsions


• cramps in the legs


• decreased urine output


• difficult with breathing


• difficult, burning, or painful urination


• dizziness


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


• dry mouth


• fainting


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth


• fever


• flushed or dry skin


• frequent urge to urinate


• frequent urination


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• increased volume of pale, dilute urine


• irregular heartbeat


• itching of the skin


• joint stiffness or swelling


• loss of appetite


• loss of bladder control


• loss of consciousness


• lower back or side pain


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• numbness and tingling of the face, fingers, or toes


• pain in the arms legs, or lower back, especially pain in the calves and/or heels upon exertion


• pale skin


• pale, bluish-colored, or cold hands or feet


• pinpoint red or purple spots on the skin


• rapid weight gain


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


• shortness of breath


• sudden decrease in the amount of urine


• sudden sweating


• sugar in the urine


• sweating


• swelling of the face, ankles, or hands


• swelling of the legs and feet


• swelling or puffiness of the face


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• weakness or heaviness of the legs

Incidence not known

• Back, leg, or stomach pains


• black, tarry stools


• bleeding gums blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• chills


• constipation


• cough or hoarseness


• coughing up blood


• darkened urine


• decrease in urine output or decrease in urine-concentrating ability


• decreased frequency or amount of urine


• diarrhea


• difficulty with swallowing


• drowsiness


• fever with or without chills


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• greatly decreased frequency of urination or amount of urine


• hives


• indigestion


• irritability


• joint or muscle pain


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


• mood changes


• nosebleeds


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


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


• red skin lesions, often with a purple center


• red, irritated eyes


• skin rash


• sore throat


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


• swollen or painful glands


• thickening of bronchial secretions


• troubled breathing


• unusual weight loss


• vision changes


• weak pulse


• weight gain


• wheezing


• 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:

Rare

• Acid or sour stomach


• belching


• body aches or pain


• bone pain


• burning feeling in the chest or stomach


• burning or stinging of the skin


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


• burning, dry, or itching eyes


• change in hearing


• cold or flu-like symptoms


• congestion


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


• cough producing mucus


• degenerative disease of the joint


• depression


• difficulty with moving


• discharge, excessive tearing


• ear congestion


• ear drainage


• earache


• excess air or gas in the stomach or intestines


• fear or nervousness


• feeling of constant movement of self or surroundings


• feeling unusually cold


• full feeling


• headache, severe and throbbing


• hearing loss


• heartburn


• increased sweating


• irritation in the mouth


• itching ears


• lack or loss of strength


• loose teeth


• loss of voice


• multiple swollen and inflamed skin lesions


• muscle pain or stiffness


• nasal congestion


• pain or burning in the throat


• pain, inflammation, or swelling in the calves, shoulders, or hands


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


• passing gas


• persistent breath odor or bad taste in your mouth


• rash with flat lesions or small raised lesions on the skin


• redness and swelling of the gums


• redness or swelling of the ears


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• runny or stuffy nose


• sensation of spinning


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• shivering


• skin rash, encrusted, scaly, and oozing


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• stomach discomfort or upset


• tender, swollen glands in the neck


• tenderness in the stomach area


• toothache


• trembling or shaking of the hands or feet


• trouble sleeping


• unable to sleep


• unsteadiness, trembling, or other problems with muscle control or coordination


• voice changes


• weight loss

Incidence not known

• Decreased interest in sexual intercourse


• hair loss or thinning of the hair


• hives or welts


• inability to have or keep an erection


• increased sensitivity of the skin to sunlight


• loss in sexual ability, desire, drive, or performance


• muscle spasm


• redness of the skin


• redness or other discoloration of the skin


• severe sunburn


• tenderness of the salivary glands

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: eprosartan and hydrochlorothiazide side effects (in more detail)

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More eprosartan and hydrochlorothiazide resources

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

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• High Blood Pressure

Isoproterenol

Pronunciation: eye-so-pro-TER-e-nole
Generic Name: Isoproterenol
Brand Name: Isuprel

Isoproterenol is used for:

Treating certain heart problems (eg, heart attack, congestive heart failure), blood vessel problems (eg, shock), and certain types of irregular heartbeat (eg, heart block). It is also used during anesthesia to treat airway constriction. It may also be used for other conditions as determined by your doctor.

Isoproterenol is a sympathomimetic. It works by relaxing blood vessels and helping the heart pump blood more efficiently. It helps to relax the airway during anesthesia to help you breathe more easily.

Do NOT use Isoproterenol if:

• you are allergic to any ingredient in Isoproterenol


• you have a certain type of irregular heartbeat (eg, tachyarrhythmia, certain ventricular arrhythmias), an adrenal gland tumor (pheochromocytoma), or chest pain due to angina


• you have a fast heartbeat or heart block caused by digoxin toxicity


• you are taking droxidopa or epinephrine

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

Before using Isoproterenol:

Some medical conditions may interact with Isoproterenol. 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 (especially sulfites)


• if you are sensitive to sympathomimetic amines (eg, phenylephrine)


• if you have asthma, diabetes, heart problems or heart blood vessel problems (eg, coronary artery disease), an overactive thyroid, or high blood pressure

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

• Catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone) because side effects of Isoproterenol may be increased


• Droxidopa, epinephrine, or inhaled anesthetics (eg, halothane) because the risk of severe side effects such as irregular heartbeat and heart attack may be increased

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

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

• Isoproterenol is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Isoproterenol at home, carefully follow the injection procedures taught to you by your health care provider.


• If Isoproterenol contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Isoproterenol, 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 Isoproterenol.

Important safety information:

• Isoproterenol may cause blurred vision or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Isoproterenol. Using Isoproterenol alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• 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 taking contains sulfites.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Isoproterenol.


• LAB TESTS, including blood pressure, blood gases, urine flow, heart rate, and heart function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Isoproterenol with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


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

Possible side effects of Isoproterenol:

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; flushing; headache; mild tremors; nausea; nervousness; paleness; sweating; weakness.

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); blurred vision; chest pain; fast or irregular heartbeat; severe headache or dizziness; wheezing.

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: Isoproterenol 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 irregular heartbeat.

Proper storage of Isoproterenol:

Isoproterenol is usually handled and stored by a health care provider. If you are using Isoproterenol at home, store Isoproterenol as directed by your pharmacist or health care provider. Keep Isoproterenol out of the reach of children and away from pets.

General information:

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


• Isoproterenol 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 Isoproterenol. 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 Isoproterenol resources

• Isoproterenol Side Effects (in more detail)
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• Isoproterenol Drug Interactions
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• 2 Reviews for Isoproterenol - Add your own review/rating

• Isoproterenol Professional Patient Advice (Wolters Kluwer)


• Isoproterenol Hydrochloride Monograph (AHFS DI)


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• Adams-Stokes Syndrome
• Asthma, acute
• AV Heart Block
• Bronchospasm During Anesthesia
• Cardiac Arrhythmia
• COPD, Acute
• Shock

cefotetan Injection

sef-oh-TEE-tan

Commonly used brand name(s)

In the U.S.

• Cefotan

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: 2nd Generation Cephalosporin

Uses For cefotetan

Cefotetan injection is used to treat bacterial infections in many different parts of the body. cefotetan is also given before certain types of surgery to prevent infections.

Cefotetan injection belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, cefotetan will not work for colds, flu, or other virus infections.

cefotetan is available only with your doctor's prescription.

Before Using cefotetan

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 cefotetan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cefotetan 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 cefotetan injection in the pediatric population. 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 cefotetan injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving cefotetan injection.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Using cefotetan 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 cefotetan, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

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

• Colitis (inflammation in gut), history of or


• Diarrhea, severe, history of or


• Hemolytic anemia or


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

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

Proper Use of cefotetan

A nurse or other trained health professional will give you cefotetan. cefotetan is given as a shot into one of your muscles, or through a needle placed in one of your veins.

Precautions While Using cefotetan

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

Hemolytic anemia may occur while you are using cefotetan. Stop using cefotetan and check with your doctor right away if you have back, leg, or stomach pains; bleeding gums; chills; dark urine; difficulty with breathing; fever; general body swelling; headache; loss of appetite; nausea or vomiting; nosebleeds; pale skin; sore throat; unusual tiredness or weakness; or yellowing of the eyes or skin.

Cefotetan injection may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Do not drink alcohol while you are receiving cefotetan injection and for 3 days (72 hours) after your last dose. Drinking alcohol during this period may cause flushing; headache; sweating; and fast, pounding, or irregular heartbeat.

Before you have any medical tests, tell the medical doctor in charge that you are receiving cefotetan. The results of some tests may be affected by cefotetan.

cefotetan 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:

Less common

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• bloating


• chest pain


• chills


• cough


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• fever


• general body swelling


• headache


• increased thirst


• loss of appetite


• nausea or vomiting


• nosebleeds


• pain


• painful or difficult urination


• pale skin


• shortness of breath


• sore throat


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


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• yellowing of the eyes or skin

Rare

• Blood in the urine


• bluish color


• change in frequency of urination or amount of urine


• changes in skin color


• drowsiness


• increased thirst


• swelling of the feet or lower legs


• tenderness


• weakness

Incidence not known

• Blistering, peeling, or loosening of the skin


• cough or hoarseness


• coughing up blood


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever with or without chills


• general feeling of tiredness or weakness


• high fever


• increased menstrual flow or vaginal bleeding


• itching


• itching of the vagina or genital area


• joint or muscle pain


• lower back or side pain


• nosebleeds


• pain during sexual intercourse


• paralysis


• pinpoint red spots on the skin


• prolonged bleeding from cuts


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


• rash


• red or black, tarry stools


• red or dark brown urine


• red skin lesions, often with a purple center


• red, irritated eyes


• seizures


• skin rash


• sudden decrease in the amount of urine


• swollen or painful glands


• thick, white vaginal discharge with no odor or with a mild odor


• tightness in the chest


• unpleasant breath odor


• vomiting of blood


• wheezing

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

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

See also: cefotetan 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 cefotetan Injection resources

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Cognex

Generic Name: Tacrine Hydrochloride
Class: Parasympathomimetic (Cholinergic) Agents
VA Class: AU300
Chemical Name: 9-Acridinamine, 1,2,3,4-tetrahydro-,monohydrochloride
CAS Number: 1684-40-8

Introduction

Centrally active, reversible anticholinesterase agent.^{2 3 4 5 6 12}

Uses for Cognex

Alzheimer’s Disease

Palliative treatment of mild to moderate dementia of the Alzheimer’s type (Alzheimer’s disease, presenile or senile dementia).^{1 3 5 12 13 14 15 16 17 18 24 46 47 53}

Cognex Dosage and Administration

General

• 
  

  Carefully adjust dose according to individual response and tolerance (e.g., serum ALT concentrations).¹

  
  


• 
  

  Observe for adverse effects following initiation of therapy or an increase in dosage.^{1 46 47 48}

  
  


• 
  

  Monitoring of ALT concentrations needed; adjustment in the treatment regimen may be needed in patients with ALT elevations.¹

  
  

Liver Function Monitoring

• 
  

  Monitor serum ALT concentrations every other week from at least week 4 to week 16 and every 3 months thereafter.¹

  
  


• 
  

  If serum ALT concentrations are >2 times to ≤3 times the ULN, monitor weekly until serum concentrations return to within normal limits.¹

  
  


• 
  

  If serum ALT concentrations are >3 times to ≤5 times the ULN, reduce dosage and monitor weekly until serum concentrations return to within normal limits.¹

  
  


• 
  

  If serum ALT concentrations are >5 times the ULN, discontinue therapy, at least temporarily, and monitor until serum concentrations return to normal.¹

  
  


• 
  

  During rechallenge, monitor ALT concentrations every week for 16 weeks, every month for 2 months, then every 3 months thereafter.¹

  
  

Administration

Administration

Administer orally^{1 12 13 14 15 16 17 25 27 28} between (i.e., ≥1 hour before) meals whenever possible.^{1 53} (See Food under Pharmacokinetics.) If mild GI upset occurs, administer with meals.^{1 53}

Therapy should be initiated using a low dosage for the first 4 weeks.¹ Increase dosage based on response and tolerance.¹

Do not attempt dosage escalation during initial 4-week period due to possible delayed-onset liver function abnormalities.¹ Decrease rate of dosage escalation if patient does not tolerate the recommended titration schedule; acceleration of recommended schedule is not advisable.¹

Administer highest tolerated dosage; cognitive improvement is more likely to occur at higher dosages.⁴⁶ Discontinue therapy if there is no improvement in clinical status after 3–6 months.⁴⁶

Dosage adjustment or temporary discontinuance may be necessary in patients with serum ALT elevations.¹

If tacrine therapy is interrupted for >4 weeks and reinitiation of the drug is not contraindicated, resume therapy using the lowest dosage and titrate upward.¹

Rechallenge

When therapy is withheld due to elevated serum ALT concentrations, rechallenge with the drug when ALT concentrations have returned to within normal limits.¹

Rechallenge in patients with elevations <10 times the ULN not associated with serious hepatic injury.¹

Carefully weigh risks against the possible benefits in patients with elevations >10 times the ULN.¹

Elevations in ALT concentrations (≥3 times the ULN) reported in patients who are rechallenged; time to onset of such elevations may be more rapid than with initial therapy.¹

Dosage

Available as tacrine hydrochloride; dosage expressed in terms of tacrine.¹

Adjust dosage or discontinue therapy in patients with serum ALT elevations as required.^{1 53}

Adults

Alzheimer’s Disease

Initiation and Titration

Oral

Initially, 10 mg 4 times daily for at least 4 weeks.^{1 46 47 53}

If well tolerated and increased serum ALT concentrations have not occurred, increase dosage to 20 mg 4 times daily;¹ if tolerated, increase dosage in 40-mg daily increments (divided into 4 doses daily) at 4-week intervals¹ up to a maximum of 160 mg daily (40 mg 4 times daily).^{1 46 47}

Dosage Adjustment for ALT Elevations

Oral

If serum ALT concentrations are ≤3 times the ULN, continue usual dosages.¹

If serum ALT concentrations are >3 times to ≤5 times the ULN, reduce dosage by 40 mg daily.¹ Resume usual dosages when ALT concentrations have returned to within normal limits.¹

If serum ALT concentrations are >5 times the ULN, withhold tacrine.¹ Consider rechallenge when ALT concentrations have returned to within normal limits.¹

Rechallenge

Oral

Initially, 10 mg 4 times daily for at least 6 weeks.¹ If tolerated with no unacceptable changes in serum ALT concentrations, resume recommended dosage titration schedule.¹

Prescribing Limits

Adults

Alzheimer’s Disease

Oral

Maximum 160 mg daily (40 mg 4 times daily).^{1 46 47}

Special Populations

Hepatic Impairment

Reduced clearance is likely; dosage adjustments should be considered.^{1 b} (See Hepatic Impairment under Cautions.)

Cautions for Cognex

Contraindications

• 
  

  Known hypersensitivity to tacrine or acridine derivatives.¹

  
  


• 
  

  Jaundice, serum total bilirubin concentration >3 mg/dL, and/or clinical signs and/or symptoms of hypersensitivity (e.g., rash, fever) associated with elevations of ALT attributed to tacrine.¹

  
  

Warnings/Precautions

Warnings

Permanently discontinue therapy in patients with clinical evidence of jaundice confirmed by elevations in serum total bilirubin concentration >3 mg/dL and/or clinical signs and/or symptoms of hypersensitivity (e.g., rash, fever) associated with elevations of ALT; do not rechallenge with the drug.¹

Anesthesia

Potential for exaggerated succinylcholine-type muscle relaxation during anesthesia.¹

Cardiovascular Effects

Possible bradycardia or other vagotonic effects on the heart.^a Use with caution in patients with conduction abnormalities, bradyarrhythmias, or sick sinus syndrome.^a

GI Effects

Possible diarrhea, nausea, and vomiting at recommended dosages.¹

Potential for increased gastric acid secretion.¹

Carefully monitor patients, especially those at increased risk for developing ulcers (e.g., those with history of peptic ulcer disease, those receiving concomitant NSAIA therapy), for symptoms of active or occult GI disease.¹

Hepatic Effects

Increased serum ALT concentrations reported in >50% of patients receiving tacrine.^{1 37} Risk of increased ALT higher in women than men.^{1 37} Serum ALT concentrations return to normal following discontinuance or dosage reduction.^{1 37} Clinically evident hepatic injury occurs rarely.^{1 31} (See Hepatic Impairment under Cautions.)

Frequent monitoring of ALT needed.¹ (See Liver Function Monitoring under Dosage and Administration.)

GU Effects

Potential urinary obstruction secondary to cholinergic activity.¹

Nervous System Effects

Possible increased risk of seizures secondary to cholinergic activity or possibly as a manifestation of Alzheimer’s disease.¹

Abrupt discontinuance or rapid dosage reduction (e.g., by ≥80 mg daily) may result in sudden worsening of the degree of cognitive impairment.¹

Respiratory Effects

Use with caution in patients with a history of asthma.¹

General Precautions

Hematologic Effects

Possible decreased ANC; however, serious hematologic abnormalities attributable to tacrine not reported.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether tacrine is distributed into milk.¹

Pediatric Use

Safety and efficacy not established.^{1 31}

Hepatic Impairment

Possible reduced clearance.¹

Use with caution in patients with current evidence or history of liver function abnormalities (i.e., clinically important elevations in serum ALT, AST, bilirubin, and/or γ-glutamyltransferase [γ-glutamyltranspeptidase, GT, GGTP]).^{1 31 32 48} Discontinue therapy, at least temporarily, if ALT concentrations are >5 times the ULN.¹

Renal Impairment

Possible fluid and electrolyte disturbances resulting from adverse GI effects.³² Use with caution.³²

Common Adverse Effects

Elevated aminotransferases (ALT, AST), nausea, vomiting, diarrhea, anorexia, dyspepsia, myalgia, ataxia.¹

Interactions for Cognex

Metabolized primarily by CYP1A2.¹ Dosage adjustments may be necessary with concomitant administration of drugs that affect or are metabolized by this system.^{1 53}

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with drugs metabolized by CYP1A2.^{1 53}

Smoking

Pharmacokinetic interaction (decreased tacrine concentrations).¹

Specific Drugs

Drug	Interaction	Comments
Antacids (magnesium- or aluminum-containing)	Change in tacrine bioavailability unlikely1
Anticholinergic agents	Possible interference with activity of anticholinergic agents1
Cholinergic agonists	Synergistic effect1
Cholinesterase inhibitors	Synergistic effect1
Cimetidine	Increased tacrine concentrations and AUC1
Diazepam	Pharmacokinetic interaction unlikely1
Digoxin	Pharmacokinetic interaction unlikely1
Fluvoxamine	Increased tacrine concentrations and AUCa
Neuromuscular blocking agents (e.g., succinylcholine)	Exaggerated muscle relaxation1
Theophylline	Increased theophylline elimination half-life and theophylline concentrations1	Monitor plasma theophylline concentrations and adjust theophylline dosage as required1
Warfarin	Effect on anticoagulant activity unlikely1

Cognex Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed following oral administration; undergoes dose-dependent, first-pass metabolism.¹ Absolute bioavailability is approximately 17%.¹

Peak plasma concentrations are attained in 1–2 hours.¹ Plasma concentrations are approximately 50% higher in women than men.¹

Food

Food reduces bioavailability by approximately 30–40%.¹

Distribution

Extent

Not evaluated.¹

Not known whether tacrine is distributed into milk.¹

Plasma Protein Binding

About 55%.¹

Elimination

Metabolism

Extensively metabolized, principally via CYP1A2 to multiple metabolites.¹

Elimination Route

Not known whether tacrine undergoes biliary excretion or enterohepatic circulation.¹

Half-life

2–4 hours.¹

Special Populations

Pharmacokinetics not evaluated in patients with hepatic impairment to date; however, clearance may be reduced.¹ Clearance not altered in patients with renal impairment.¹

Stability

Storage

Oral

Capsules

15–30°C. Protect from moisture.¹

ActionsActions

• 
  

  Precise mechanism(s) of action in patients with dementia of the Alzheimer’s type not fully elucidated.¹ Binds reversibly with and inactivates cholinesterases (e.g., acetylcholinesterase), thus inhibiting hydrolysis of acetylcholine^{1 4 5 6 7 13} and resulting in increased acetylcholine concentrations at cholinergic synapses.^{1 4 5 6 7}

  
  

Advice to Patients

• 
  

  Risk of adverse effects (e.g., nausea, vomiting, loose stools, diarrhea).¹ Importance of caregivers monitoring for adverse effects and informing clinicians if they occur.¹

  
  


• 
  

  Importance of clinicians informing caregivers that potential beneficial effects of therapy depend on administration of the drug at regular intervals.¹

  
  


• 
  

  Need for periodic laboratory monitoring (i.e., liver function tests).¹

  
  


• 
  

  Importance of clinicians informing caregivers that abrupt discontinuation or large decrease in total daily dose may cause a sudden worsening of the degree of cognitive impairment.¹

  
  


• 
  

  Importance of informing clinicians of any new events or any increase in severity of existing adverse clinical events.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Tacrine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	10 mg (of tacrine)	Cognex	First Horizon
		20 mg (of tacrine)	Cognex	First Horizon
		30 mg (of tacrine)	Cognex	First Horizon
		40 mg (of tacrine)	Cognex	First Horizon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cognex 10MG Capsules (SHIONOGI PHARMA): 120/$315.99 or 360/$893.99

Cognex 20MG Capsules (SHIONOGI PHARMA): 120/$315.99 or 360/$879.92

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Parke-Davis. Cognex (tacrine hydrochloride) capsules prescribing information. Morris Plains, NJ; 1997 Oct.

2. Parke-Davis. Cognex treatment IND investigator’s brochure. Morris Plains, NJ; 1992.

3. Cooper JK. Drug treatment of Alzheimer’s disease. Arch Intern Med. 1991; 151:245-9. [IDIS 277908] [PubMed 1992951]

4. Kumar V, Becker RE. Clinical pharmacology of tetrahydroaminoacridine: a possible therapeutic agent for Alzheimer’s disease. Int J Clin Pharmacol Ther Toxicol. 1989; 27:478-85. [PubMed 2684868]

5. Volger BW. Alternatives in the treatment of memory loss in patients with Alzheimer’s disease. Clin Pharm. 1991; 10:447-56. [IDIS 281504] [PubMed 2065522]

6. Freeman SE, Dawson RM. Tacrine: a pharmacological review. Prog Neurobiol. 1991; 36:257-77. [PubMed 1714613]

7. Drukarch B, Kits KS, Van der Meer EG et al. 9-Amino-1,2,3,4-tetrahydroacridine (THA), an alleged drug for the treatment of Alzheimer’s disease, inhibits acetylcholinesterase activity and slow outward K⁺current. Eur J Pharmacol. 1987; 141:153-7. [PubMed 2444444]

8. Rogawski MA. Tetrahydroaminoacridine blocks voltage-dependent ion channels in hippocampal neurons. Eur J Pharmacol. 1987; 142:169-72. [PubMed 2446884]

9. Freeman SE, Law WM, Szilagyi M. Blockade of a cardiac K⁺ channel by tacrine: interactions with muscarinic and adenosine receptors. Eur J Pharmacol. 1988; 154:59-65. [PubMed 3181293]

10. Mozar HN, Bal DG, Howard JT. Perspectives on the etiology of Alzheimer’s disease. JAMA. 1987; 257:1503-7. [PubMed 2950247]

11. Parke-Davis, Morris Plains, NJ: Personal communication.

12. Parke-Davis. Cognex treatment IND protocol 970-58. Morris Plains, NJ; 1992.

13. Farlow M, Gracon SI, Hershey LA et al. A controlled trial of tacrine in Alzheimer’s disease. JAMA. 1992; 268:2523-9. [IDIS 304558] [PubMed 1404819]

14. Davis KL, Thal LJ, Gamzu ER et al. A double-blind, placebo-controlled multicenter study of tacrine for Alzheimer’s disease. New Engl J Med. 1992; 327:1253-9. [IDIS 303816] [PubMed 1406817]

15. Peripheral and Central Nervous System Drugs Advisory Committee Meeting, July 7, 1989. Rockville, MD: Dept. of Health and Human Services, Public Health Service, Food and Drug Administration; 1989:227.

16. Eagger SA, Levy R, Sahakian BJ. Tacrine in Alzheimer’s disease. Lancet. 1991; 337:989-92. [IDIS 280218] [PubMed 1673209]

17. Anon. Tacrine for Alzheimer’s disease. Med Lett Drugs Ther. 1993; 35:87-8. [PubMed 8361451]

18. Small GW. Tacrine for treating Alzheimer’s disease. JAMA. 1992; 268:2564-5. [IDIS 304559] [PubMed 1404825]

19. Dom R. Tacrine in Alzheimer’s disease. JAMA. 1993; 269:2848-9. [IDIS 315101] [PubMed 8497088]

20. Cutler NR, Sramek JJ. Tacrine in Alzheimer’s disease. New Engl J Med. 1993; 328:808. [IDIS 310606] [PubMed 8437603]

21. Growdon JH. Treatment for Alzheimer’s disease? New Engl J Med. 1992; 327:1306-8. Editorial.

22. Pirozzolo FJ, Baskin DS, Swihart AA et al. Oral tetrahydroaminoacridine in the treatment of senile dementia, Alzheimer’s type. New Engl J Med. 1987; 316:1603. [IDIS 230804] [PubMed 3587295]

23. Lachs M. Tacrine in Alzheimer’s disease. New Engl J Med. 1993; 328:810. [IDIS 310609] [PubMed 8437607]

24. Food and Drug Administration Division of Neuropharmacological Drug Products. Tacrine as a treatment for Alzheimer’s dementia: an interim report from the FDA. N Engl J Med. 1991; 324:349-52. [IDIS 277140] [PubMed 1986300]

25. Summers WK, Majovski LV, Marsh GM et al. Oral tetrahydroaminoacridine in long-term treatment of senile dementia, Alzheimer type. N Engl J Med. 1986; 315:1241-5. [IDIS 222579] [PubMed 2430180]

26. Relman AS. Tacrine as a treatment for Alzheimer’s dementia: editor’s note. N Engl J Med. 1991; 324:349. [IDIS 277140] [PubMed 1986300]

27. Gauthier S, Bouchard R, Lamontagne A et al. Tetrahydroaminoacridine–lecithin combination treatment in patients with intermediate-stage Alzheimer’s disease: results of a Canadian double-blind, cross-over, multicenter study. N Engl J Med. 1990; 322:1272-6. [IDIS 265329] [PubMed 2183056]

28. Chatellier G, Lacombez L, and Groupe Francais d’Etude de la Tetrahydroaminoacridine. Tacrine (tetrahydroaminoacridine; THA) and lecithin in senile dementia of the Alzheimer type: a multicentre trial. Br Med J. 1990; 300:495-9.

29. Ulus IH, Wurtman RJ. Prevention by choline of the depletion of membrane phosphatidylcholine by a cholinesterase inhibitor. N Engl J Med. 1988; 318:191. [PubMed 3336410]

30. Gauthier S. Tetrahydroaminoacridine and lecithin for Alzheimer’s disease. N Engl J Med. 1990; 323:920. [IDIS 272229] [PubMed 1697647]

31. Parke-Davis, Morris Plains, NJ: Personal communication.

32. Reviewers’ comments (personal observations).

33. Osterrieder W. 9-amino-1,2,3,4-tetrahydroacridine (THA) is a potent blocker of cardiac potassium channels. Br J Pharmacol. 1987; 92:521-5. [PubMed 2447986]

34. Schauf CL, Settin A. Tetrahydroaminoacridine blocks potassium channels and inhibits sodium inactivation in Myxicola. Soc Neurosci Abstract. 1987; 13:566.

35. Drukarch B, Kits KS, Vander Meer EG et al. 9-Amino-1,2,3,4-tetrahydroacridine (THA), an alleged drug for the treatment of Alzheimer’s disease, inhibits acetylcholinesterase activity and slows outward K⁺current. Eur J Pharmacol. 1987; 141:153-7. [PubMed 2444444]

36. Knapp MJ, Knopman DS, Soloman PR et al. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer’s disease. JAMA. 1994; 217:985-91.

37. Watkins PB, Zimmerman HJ, Knapp MJ et al. Hepatotoxic effects of tacrine administration in patients with Alzheimer’s disease. JAMA. 1994; 217:992-8.

38. Winker MA. Tacrine for Alzheimer’s disease: which patient, what dose? JAMA. 1994; 271:1023-4. Editorial.

39. Byrne EJ, Arie T. Tetrahydroaminoacridine and Alzheimer’s disease: for the few, but we don’t know which few. BMJ. 1994; 308:868-9. [IDIS 327976] [PubMed 8173360]

40. Maltby N, Broe GA, Creasey H et al. Efficacy of tacrine in mild to moderate Alzheimer’s disease: double blind trial. BMJ. 1994; 308:879-83. [IDIS 327979] [PubMed 8173365]

41. Pendlebury WW, Soloman PR. Tacrine is safe and effective. BMJ. 1994; 308:1506.

42. Levy R. Patient heterogeneity explains varied response. BMJ. 1994; 308:1506. [PubMed 8019288]

43. Roberts C, Ford J, Mäkelä P et al. Serum tacrine concentrations too low. BMJ. 1994; 308:1506.

44. Wilcock GK. Negative conclusions not justified. BMJ. 1994; 308:1507. [PubMed 8019291]

45. Broe GA, Creasey H, Maltby N et al. Author’s reply. BMJ. 1994; 308:1507.

46. American Psychiatric Association. Practice guidelines for the treatment of patients with Alzheimer’s disease and other dementias of late life. Am J Psychiatry. 1997; 154(Suppl):1-39.

47. Small GW, Rabins PV, Barry PP et al. Diagnosis and treatment of Alzheimer disease and related disorders: consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatrics Society. JAMA. 1997; 278:1363-71. [IDIS 393115] [PubMed 9343469]

48. Watkins PB, Zimmerman HJ, Knapp MJ et al. Hepatotoxic effects of tacrine administration in patients with Alzheimer’s disease. JAMA. 1994; 271:992-8. [IDIS 327345] [PubMed 8139084]

49. Mos RC. Donepezil: a viewpoint. Drugs Aging. 1997; 10:240.

50. Whitehouse PJ. Donepezil: a viewpoint. Drugs Aging. 1997; 10:240-1.

51. Solomon PR, Knapp MJ, Gracon SI et al. Long-term tacrine treatment in patients with Alzheimer’s disease. Lancet. 1996; 348:275-6. [IDIS 370167] [PubMed 8684234]

52. Knopman D, Schneider L, Davis K et al. Long-term tacrine (Cognex) treatment: effects on nursing home placement and mortality. Neurology. 1996; 47:166-77. [IDIS 370441] [PubMed 8710072]

53. Samuels SC, Davis KL. A risk-benefit assessment of tacrine in the treatment of Alzheimer’s disease. Drug Saf. 1997; 16:66-77. [PubMed 9010644]

54. Doody Rs, Stevens JC, Beck C et al. Practice parameter: management of dementia (an evidence-based review). Report of the quality standards subcommittee of the American Academy of Neurology. Neurology. 2001; 56:1154-66. [IDIS 463599] [PubMed 11342679]

a. First Horizon. Cognex (tacrine hydrochloride) capsules prescribing information. Roswell, GA; 2002 Jan.

b. AHFS drug information 2006. McEvoy GK, ed. Tacrine. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1251-4

More Cognex resources

• Cognex Side Effects (in more detail)
• Cognex Dosage
• Cognex Use in Pregnancy & Breastfeeding
• Drug Images
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Boots NicAssist 2 mg Lozenge

BootsNicAssist 2 mg Lozenge

(Nicotine)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to help you stop smoking. However, you still need to use it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice


• You must contact a pharmacist or doctor for advice if you need to use the lozenges for longer than 9 months

What this medicine is for

This medicine contains nicotine which belongs to a group of medicines called nicotine replacement therapy (NRT). It acts to substitute the nicotine that you normally get from cigarettes and can help you to stop smoking.

It can be used to relieve the symptoms of nicotine withdrawal and reduce the cravings for nicotine that you get when you try to stop smoking. When you suck the lozenge, nicotine is released slowly and taken into the body through the lining of the mouth.

To help you quit smoking you should also try to use a behavioural support programme or counselling to increase your chances of success.

The benefits of stopping smoking far outweigh any potential risk from using nicotine from NRT. It is the toxins in cigarette smoke such as tar, lead, cyanide and ammonia that cause known smoking related diseases, not the nicotine.

Before you use this medicine

This medicine can be used by adults of 18 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use:

• 
  If you are allergic to any of the ingredients in this medicine (see “What is in this medicine”)


• 
  If you are a non-smoker


• 
  If you have phenylketonuria (this medicine contains aspartame (E951), a source of phenylalanine equivalent to 5 mg per lozenge, which may be harmful to you)


• 
  If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains maltitol, a source of fructose)

Talk to your pharmacist or doctor:

• If you have heart problems including a previous heart attack, heart failure, problems with your heart rate or rhythm, angina, have had a stroke, or high blood pressure not controlled by medication – try to give up smoking first without using NRT. However, if you still need help to stop smoking you can use this medicine but your doctor may want to monitor you more closely


• If you have high blood pressure


• If you have problems with your circulation


• If you have a tumour near your kidney (your doctor may have told you that you have a condition called phaeochromocytoma)


• If you have an ulcer in your stomach, or problems such as pain or swelling of the stomach or oesophagus (the passage between your mouth and your stomach)


• If your liver or kidneys do not work properly


• If you have an overactive thyroid gland


• If you have diabetes – monitor your blood sugar levels more often when you start using this medicine. You may find that you need to adjust the amount of insulin that you use, or the amount of tablets that you take (ask your doctor or diabetes nurse about this)


• If you are on a low salt (sodium) diet (each lozenge contains 9.8 mg sodium, which may be harmful to you)


• If you are pregnant or breastfeeding (see “Other important information”)

Other important information

Driving and using machines: Using this medicine is not known to affect your ability to drive or use machines. However you should bear in mind that giving up smoking can change your behaviour.

Using this medicine with food and drink: Coffee, acidic and soft drinks may decrease the absorption of nicotine. Do not drink them for 15 minutes before sucking a lozenge.

Information about some of the ingredients in this medicine: Maltitol (E965) may have a mild laxative effect. Each lozenge contains 0.9 g maltitol. This provides 2 kcal per lozenge. This may need to be taken into account if you have diabetes.

If you are pregnant: You should try to stop smoking without using NRT.

However, if you still need help to stop smoking, you can use this product as the risk to your baby is far less than if you continue to smoke. You should talk to your pharmacist or doctor for more advice.

If you are breastfeeding: You should try to stop smoking without using NRT.

However, if you still need help to stop smoking, you can use this medicine. You should talk to your pharmacist or doctor for more advice.

Do not use the lozenges in the 2 hours before you feed your baby. Then breastfeed your baby just before you use the lozenge, to make sure that your baby gets the smallest amount of nicotine possible.

The amount of nicotine that your baby may receive when you are using the lozenges or other NRT products is much smaller and less harmful than the second-hand smoke they would inhale if you smoked. Tobacco smoke causes breathing and other health problems in babies and children. If your husband, partner or other household members smoke too, try to get them to give up with you.

Nicotine products and children: Nicotine can be very dangerous to children. The amount of nicotine tolerated by adults and adolescents can make children very ill, and can sometimes be fatal. Do not leave your lozenges where children may get hold of them.

If you take other medicines

Before you use this medicine, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Theophylline (for breathing problems)


• Tacrine (for Alzheimer’s disease)


• Olanzapine or clozapine (used to treat schizophrenia)


• Insulin (for diabetes)

When you stop smoking your metabolism slows down. This can mean that some medicines may stay in your body longer than usual.

If you take any medicine on a regular basis, tell your doctor that you intend to stop smoking and follow his or her advice about these medicines. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine

Check the foil is not broken before use. If it is, do not use that lozenge.

Read all of the following information carefully before starting to use the lozenges. Ask your pharmacist or doctor if you need any advice.

• To improve your chances of successfully giving up smoking you should stop smoking completely when you start to use the lozenges and when you are using the lozenges


• Use the “How to suck the lozenge” instructions to make sure that you suck the lozenge correctly to release the nicotine

The lozenges are available in two strengths. Use the information and table below to decide which strength of lozenge to use.

• The 2 mg lozenges should be used for strong or very strong nicotine dependent smokers


• You should also use the 2 mg lozenges if you have previously failed to give up smoking using the 1 mg lozenges or if you are worried your cravings for nicotine may make you smoke again

Suck the lozenge. Do not chew or swallow it.

If you have a low to moderate dependency and smoke less than 20 cigarettes per day, use the 1 mg lozenge.

If you have a moderate to strong dependency and smoke from 20 to 30 cigarettes per day, use the 1 mg or 2 mg lozenge.

If you have a strong to very strong dependency and smoke over 30 cigarettes per day, use the 2 mg lozenge.

If you use the 2 mg lozenge and find that you get side effects, try using the 1 mg lozenge instead.

How to suck the lozenge

• 1. Suck a lozenge until the taste becomes strong.


• 2. Rest the lozenge between your gums and cheek.


• 3. Suck again when the taste has faded.


• 4. Repeat this routine until the lozenge dissolves completely (about 30 minutes).

How many to use:

Adults over 18 years: Suck one lozenge every one to two hours when you feel the urge to smoke.

Most people use between 8 to 12 lozenges per day. However, if you still have an urge to smoke you can use more lozenges.

Don’t use more than fifteen 2 mg lozenges per day.

Normally you should use the lozenges for at least 3 months, but this may vary from person to person. After 3 months, you should gradually reduce the number of lozenges used each day.

When you are using only one or two lozenges per day you should stop completely.

In general you should not use the Boots NicAssist 2 mg Lozenges for more than 6 months.

However, some people may need to use them for longer to stop then smoking again.

If you need to use the lozenges for longer than 9 months, ask your pharmacist or doctor for advice.

Counseling may improve your chances of giving up smoking.

Children and adolescents under 18 years: Do not use the lozenges, unless your doctor tells you to.

If you use too many: Sucking too many lozenges can result in the same symptoms as smoking too much. The general symptoms of too much nicotine include weakness, sweating, increased production of saliva, throat burn, feeling sick, being sick, diarrhoea, pain in the abdomen, disturbance of hearing and vision, headache, fast, slow or irregular heart beat, shortness of breath and circulatory problems.

If this happens talk to your doctor or pharmacist for advice.

If a child uses or swallows any lozenges: Talk to a doctor straight away. Take the child to the nearest casualty department. Take the medicine and this leaflet with you. Even small quantities of nicotine are dangerous in children and may result in severe symptoms or death.

Possible side effects

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

If you get any of these serious side effects, stop using the lozenges and do not smoke. See a doctor at once:

• Fast, slow or irregular heart beat


• Difficulty breathing, swelling of the lips, face, throat or tongue (signs of severe allergic reaction)

These serious effects are rare, affecting only 1 to 10 people out of 10,000.

These other effects are less serious. If they bother you talk to a pharmacist or doctor:

In the first few days you may feel dizzy, get headaches or have difficulty sleeping. These may be withdrawal symptoms from stopping smoking and may be caused because you are not getting enough nicotine.

Common side effects (affecting 1 to 10 people out of 100)

• Dizziness and headache


• Dryness of the mouth, hiccups, stomach trouble such as feeling sick, flatulence, heartburn, increased saliva production and irritation of the mouth and throat - this may happen because you are sucking the lozenge too fast, try to suck more slowly

Uncommon side effects (affecting 1 to 10 people out of 1000)

• Palpitations

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

When you stop smoking you may also develop mouth ulcers. The reason why this happens is unknown.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or edge of the blister strip. If you have out of date medicine or you no longer need the lozenges take them to your nearest pharmacy for safe disposal.

What is in this medicine

Each compressed lozenge contains nicotine 2 mg (as nicotine bitartrate dihydrate 6.144 mg), which is the active ingredient.

As well as the active ingredient, the lozenge also contains maltitol (E965), sodium carbonate anhydrous, sodium hydrogen carbonate, polyacrylate, xanthan gum, colloidal anhydrous silica, levomenthol, peppermint oil, aspartame (E951), magnesium stearate.

The pack contains 36, 72, 96, 144 or 204 white, round, mint flavoured lozenges. Not all pack sizes may be marketed.

Who makes this medicine

Manufactured for

The Boots Company PLC

Nottingham

NG2 3AA

by

Novartis Consumer Health GmbH

Zielstattstrasse

40 81379 Munich

Germany

Marketing Authorisation held by

Novartis Consumer Health

Horsham West

Sussex

RH12 5AB

Leaflet prepared January 2010

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Other formats

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

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots NicAssist 2 mg Lozenge

Reference number: 00030/0203

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