Anturol

Generic Name: oxybutynin (Transdermal route)

ox-i-BUE-ti-nin

Commonly used brand name(s)

In the U.S.

• Anturol


• Gelnique


• Oxytrol

Available Dosage Forms:

• Gel/Jelly


• Patch, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Antimuscarinic

Uses For Anturol

Oxybutynin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.

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

Before Using Anturol

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of oxybutynin 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 oxybutynin in the elderly.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

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

• Potassium

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.

• Donepezil


• Galantamine


• Ketoconazole


• Rivastigmine

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:

• Esophagitis (inflammation of the esophagus) or


• Intestinal or stomach problems (e.g., blockage, constipation, intestinal atony, ulcerative colitis, or gastroesophageal reflux disease [GERD]) or


• Myasthenia gravis (severe muscle weakness) or


• Narrow-angle glaucoma, controlled or


• Urinary problems (e.g., blockage)—Use with caution. May make these conditions worse.

• Narrow-angle glaucoma, uncontrolled or


• Stomach problems (e.g., gastric retention) or


• Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.

Proper Use of oxybutynin

This section provides information on the proper use of a number of products that contain oxybutynin. It may not be specific to Anturol. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, breasts, or genital area. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use the gel:

• Wash your hands with soap and water before and after using this medicine.


• Before applying this medicine, wash the application site (e.g., stomach, upper arms, shoulders, or thighs) with mild soap and water. Rinse well and pat dry.


• Tear and squeeze the entire contents of the packet into the palm of your hand or directly on the application site. Gently rub it until the gel dries.


• Do not apply this medicine on the same application site you applied the last one.


• Do not bathe, swim, shower, or exercise for 1 hour after applying oxybutynin.


• Cover the application site with a dry cloth after the medicine has dried to avoid direct contact or transfer of oxybutynin to another person.

To use the skin patch:

• Use this medicine exactly as directed by your doctor. It will work only if applied correctly.


• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.


• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.


• Apply the patch to a clean, dry, and intact skin area on your stomach, hips, or buttocks. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.


• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.


• When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one.

The gel form contains alcohol which is flammable. Do not use this medicine near heat, an open flame, or while smoking.

Dosing

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

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

• For bladder problems:
  
  • For transdermal dosage form (gel):
    
    • Adults—
      
      • Anturol™: 84 milligrams (mg) or 3 pumps of gel applied on dry, intact skin once a day.
      
      
      • Gelnique®: Apply the gel on dry, intact skin once a day.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For transdermal dosage form (skin patch):
    
    • Adults—Apply one patch two times per week, which is one patch every 3 to 4 days.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

If you miss a dose of this medicine, apply 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.

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.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Precautions While Using Anturol

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop using this medicine and seek medical attention right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

If you develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are using this medicine, since overheating may result in heat stroke.

This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.

This medicine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Avoid drinking alcohol while you are using this medicine.

Do not use cosmetics or other skin care products on the treated skin areas. However, you may use this medicine with a sunscreen.

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.

Anturol 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

• Bladder pain


• blistering, crusting, irritation, itching, or reddening of the skin


• bloody or cloudy urine


• burning, skin rash, swelling, or soreness at the application site


• cracked, dry, or scaly skin


• difficult, burning, or painful urination


• frequent urge to urinate


• lower back or side pain


• redness, pain, itching, or irritation at the application site


• unusually warm skin

Less common

• Abdominal or stomach pain


• diarrhea


• loss of appetite


• nausea


• weakness

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

Symptoms of overdose

• Chest pain or discomfort


• confusion


• decrease in the frequency of urination


• decrease in urine volume


• decreased urination


• difficulty in passing urine (dribbling)


• dizziness


• dry mouth


• fainting


• fast, slow, or irregular heartbeat


• feeling of warmth


• fever


• increase in heart rate


• lightheadedness


• pounding or rapid pulse


• rapid breathing


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


• sunken eyes


• thirst


• unusual feeling of excitement


• unusual tiredness or weakness


• vomiting


• wrinkled 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

• Body aches or pain


• chills


• cough


• difficulty with breathing


• ear congestion


• headache


• loss of voice


• nasal congestion


• runny nose


• sneezing


• sore throat

Less common

• Back pain


• bloated


• changes in vision


• constipation


• excess air or gas in the stomach or intestines


• full feeling


• muscle aches


• passing gas


• sleepiness or unusual drowsiness


• stuffy or runny nose

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 Anturol resources

• Anturol Use in Pregnancy & Breastfeeding
• Anturol Drug Interactions
• Anturol Support Group
• 0 Reviews for Anturol - Add your own review/rating

• Anturol Consumer Overview


• Oxybutynin Prescribing Information (FDA)


• Ditropan MedFacts Consumer Leaflet (Wolters Kluwer)


• Ditropan Prescribing Information (FDA)


• Ditropan Consumer Overview


• Ditropan XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ditropan XL Prescribing Information (FDA)


• Gelnique Prescribing Information (FDA)


• Gelnique Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Gelnique Consumer Overview


• Oxybutynin Chloride Monograph (AHFS DI)


• Oxytrol Prescribing Information (FDA)


• Oxytrol Consumer Overview


• Oxytrol System MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Anturol with other medications

• Overactive Bladder

Tronolane Cream

Pronunciation: pra-MOX-een/zink OX-ide
Generic Name: Pramoxine/Zinc Oxide
Brand Name: Tronolane

Tronolane Cream is used for:

Treating pain, soreness, burning, and itching of the anal area due to hemorrhoids. It may also be used for other conditions as determined by your doctor.

Tronolane Cream is a topical anesthetic. It works by blocking pain signals from the nerve endings in the skin. This helps relieve discomfort.

Do NOT use Tronolane Cream if:

• you are allergic to any ingredient in Tronolane Cream

Contact your doctor or health care provider right away if this applies to you.

Before using Tronolane Cream:

Some medical conditions may interact with Tronolane Cream. 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

Some MEDICINES MAY INTERACT with Tronolane Cream. Because little, if any, of Tronolane Cream is absorbed into your body, the risk of it interacting with another medicine is low.

Ask your health care provider if Tronolane Cream 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 Tronolane Cream:

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

• Tronolane Cream is for external use around the rectal area only.


• Wash your hands before and after using Tronolane Cream.


• Wash the affected area with mild soap and warm water, and rinse before you apply Tronolane Cream. Gently pat dry with toilet paper.


• Remove the cap from the tube. Use the pointed end of the cap to break the seal on the tube. Attach the applicator to the tube. Gently squeeze the tube to apply the cream to the rectal area.


• Do NOT insert the applicator or the tube into the rectum. Do not put Tronolane Cream into the rectum using your fingers or any other device or applicator.


• Clean the applicator after each use.


• Do not apply Tronolane Cream to large areas of the body.


• If you miss a dose of Tronolane Cream, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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

Important safety information:

• Tronolane Cream is for use around the rectal area only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool tap water.


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


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


• Talk with your doctor before you use any other medicines on your anal area.


• Tronolane Cream may cause harm if swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Do not use Tronolane Cream in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Tronolane Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Tronolane Cream. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding from the rectum; new or worsening irritation, pain, redness, swelling, or other symptoms.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Tronolane Cream may be harmful if swallowed.

Proper storage of Tronolane Cream:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate. Store away from heat and light. Keep Tronolane Cream out of the reach of children and away from pets.

General information:

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


• Tronolane Cream 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 Tronolane Cream. 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.

Cartia XT

Generic Name: diltiazem (Oral route)

dil-TYE-a-zem

Commonly used brand name(s)

In the U.S.

• Cardizem


• Cardizem CD


• Cardizem LA


• Cartia XT


• Dilacor XR


• Dilt-CD


• Diltia XT


• Dilt-XR


• Diltzac


• Matzim LA


• Taztia XT


• Tiazac

Available Dosage Forms:

• Capsule, Extended Release


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release, 24 HR


• Capsule, Extended Release, 12 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Uses For Cartia XT

Diltiazem is used alone or together with other medicines to treat severe chest pain (angina) or 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 .

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

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

Before Using Cartia XT

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diltiazem in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diltiazem in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving diltiazem .

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

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 taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Cisapride

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.

• Acebutolol


• Alprenolol


• Amiodarone


• Aprepitant


• Atazanavir


• Atenolol


• Atorvastatin


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clonidine


• Clozapine


• Colchicine


• Crizotinib


• Dantrolene


• Dilevalol


• Dronedarone


• Droperidol


• Erythromycin


• Esmolol


• Everolimus


• Fentanyl


• Labetalol


• Levobunolol


• Lurasidone


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Ranolazine


• Simvastatin


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Tolvaptan

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.

• Alfentanil


• Alfuzosin


• Amlodipine


• Aspirin


• Buspirone


• Carbamazepine


• Celecoxib


• Cilostazol


• Cimetidine


• Clopidogrel


• Colestipol


• Cyclosporine


• Dalfopristin


• Digitoxin


• Digoxin


• Dutasteride


• Efavirenz


• Enflurane


• Fosaprepitant


• Fosphenytoin


• Guggul


• Indinavir


• Lithium


• Lovastatin


• Methylprednisolone


• Midazolam


• Moricizine


• Nevirapine


• Nifedipine


• Phenytoin


• Quinupristin


• Rifampin


• Rifapentine


• Ritonavir


• Sirolimus


• St John's Wort


• Tacrolimus


• Triazolam

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Bowel blockage, severe or


• Congestive heart failure—Use with caution. May make this condition worse .

• Heart attack or


• Heart block (type of abnormal heart rhythm, can use if have a pacemaker that works properly) or


• Hypotension (low blood pressure), severe or


• Lung problem (e.g., pulmonary congestion) or


• Sick sinus syndrome (type of abnormal heart rhythm, can use if have a pacemaker that works properly)—Should not be used in patients with these conditions .

• Kidney disease or


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

Proper Use of diltiazem

This section provides information on the proper use of a number of products that contain diltiazem. It may not be specific to Cartia XT. Please read with care.

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

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

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

Swallow the extended-release tablet or extended-release capsule whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach .

Dosing

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

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

• For chest pain:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 mg once a day either in the evening or in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 120 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

• For high blood pressure:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 to 240 milligrams (mg) once a day either in the morning or at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 180 to 240 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Cartia XT

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

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem .

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness .

Cartia XT Side Effects

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

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

More common

• Body aches or pain


• congestion


• cough


• dryness or soreness of throat


• fever


• hoarseness


• runny nose


• tender or swollen glands in neck


• trouble in swallowing


• voice changes

Less common

• Chest pain or discomfort


• chills


• diarrhea


• difficult or labored breathing


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


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


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• shivering


• shortness of breath


• slow or irregular heartbeat


• sore throat


• sweating


• swelling of hands, ankles, feet, or lower legs


• tightness in chest


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Blistering, peeling, or loosening of skin


• itching


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


• no heart beat


• red irritated eyes


• red skin lesions, often with a purple center


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

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

• Sneezing


• stuffy nose

Less common

• Acid or sour stomach


• belching


• constipation


• continuing ringing or buzzing or other unexplained noise in ears


• degenerative disease of the joint


• difficulty in moving


• hearing loss


• heartburn


• indigestion


• lack or loss of strength


• muscle aching or cramping


• muscle pains or stiffness


• pain or tenderness around eyes and cheekbones


• rash


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep

Incidence not known

• Hair loss or thinning of hair

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: Cartia XT 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 Cartia XT resources

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

• Cartia XT 24-Hour Sustained-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Cartia XT Prescribing Information (FDA)


• Diltiazem Prescribing Information (FDA)


• Cardizem Consumer Overview


• Cardizem MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem Prescribing Information (FDA)


• Cardizem CD Prescribing Information (FDA)


• Cardizem LA 24-Hour Extended-Release Beads Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem LA Prescribing Information (FDA)


• DILT-CD Prescribing Information (FDA)


• Dilacor XR 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilacor XR Prescribing Information (FDA)


• Dilt-XR Prescribing Information (FDA)


• Diltia XT Prescribing Information (FDA)


• Diltiazem Hydrochloride Monograph (AHFS DI)


• Matzim LA Prescribing Information (FDA)


• Taztia XT Prescribing Information (FDA)


• Taztia XT 24-Hour Extended-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Tiazac Prescribing Information (FDA)


• Tiazac Consumer Overview

Compare Cartia XT with other medications

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Etrivex 500 micrograms / g Shampoo

Etrivex

500 micrograms/g shampoo

clobetasol propionate

SHAMPOO

Etrivex 500 micrograms/g shampoo

Clobetasol propionate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You might need to read it again.


• If you have further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What is Etrivex 500 micrograms/g shampoo and what it is used for


• 2. Before you use Etrivex 500 micrograms/g shampoo


• 3. How to use Etrivex 500 micrograms/g shampoo


• 4. Possible side effects


• 5. How to store Etrivex 500 micrograms/g shampoo


• 6. Further information

What is Etrivex 500 micrograms/g Shampoo and what it is used for

Etrivex shampoo contains the active substance called clobetasol propionate; it belongs to a group of medicines called topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups depending on their strength; clobetasol propionate is a very strong corticosteroid. “Topical’ means that it should only be applied to the surface of the skin. Topical steroids reduce the redness, itchiness and inflammation associated with skin conditions.

Scalp psoriasis is caused by the skin cells of your scalp being produced too quickly. Etrivex shampoo is used to treat scalp psoriasis of moderate intensity in adults.

Before you use Etrivex 500 micrograms/g shampoo

Do not use Etrivex 500 micrograms/g shampoo

• if you have been told that you are allergic (hypersensitive) to Clobetasol propionate or any of the other ingredients in Etrivex shampoo. Please check by reading the list of ingredients below. If you answer yes, you must inform your doctor before starting treatment.


• If you have bacterial, viral, fungal or parasitic skin infections such as cold sores, varicella (chicken pox), herpes zoster (shingles), impetigo (type of rash on the face), ringworm, athletes foot, thrush, skin tuberculosis or skin disease caused by syphilis.


• If you have ulcerous wounds (weeping wounds) on your scalp


• In children under two years old


• Do not apply Etrivex shampoo in the eyes (risk of glaucoma which is high pressure in the eye)

Take special care with Etrivex 500 micrograms/g shampoo

• If this product has been prescribed for a child or adolescent below 18 years of age, you must check with your doctor every week before continuing to use this product.


• When using Etrivex shampoo, it must only be used on the scalp, do not use it as a regular shampoo or on other areas of the body and do not use Etrivex shampoo as a shower gel, body wash or bath foam.


• When treating the scalp with Etrivex shampoo you must not cover the area being treated, for example: a shower cap must not be used as it may make the active substance pass through the skin and affect the other parts of the body.


• When using Etrivex shampoo, avoid contact with the face, eyelids, axillae (armpits), erosive skin (chapped skin) surface and genital regions. Rinse off immediately with water if any product runs from the scalp.


• If you get Etrivex shampoo in your eye(s), wash the affected eye thoroughly with water. If any irritation persists, please seek advice from your doctor.


• If you do not notice an improvement of your scalp psoriasis, please see your doctor.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription.

Pregnancy and Breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine. Do not use Etrivex shampoo if you are pregnant or breastfeeding unless your doctor clearly tells you to.

Driving and using machines:

Etrivex shampoo has no or very little influence on the ability to drive and use machines.

How to use Etrivex 500 micrograms/g Shampoo

Always use Etrivex Shampoo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual daily dose per application is an amount equivalent to around a half tablespoon (around 7.5 ml) sufficient to cover the entire scalp.

Unless your doctor has instructed otherwise, wash your hands and apply Etrivex Shampoo directly to your dry scalp once daily taking care to well cover and massage the affected areas. Avoid using large amounts of Etrivex Shampoo, only use enough to cover your scalp when dry. Wash your hands carefully after application. Leave the product to work for 15 minutes without covering, and then add water, rinse and dry your hair as usual. Your regular shampoo can be used if more shampoo is required to wash your hair. Do not add more of Etrivex shampoo to your hair.

Your doctor will tell you how long you need to use Etrivex shampoo for to control your scalp psoriasis. Treatment should not normally continue for more than 4 weeks. However, if your scalp psoriasis is significantly improved before the end of treatment, please see your doctor. On the contrary, if no improvement is seen by the end of the treatment, please tell your doctor. This treatment needs careful supervision; you should let your doctor review your progress at regular intervals. Do not use Etrivex shampoo for longer than your doctor tells you.

Nonetheless, your doctor may ask you to use Etrivex shampoo again in the future following a period of no use.

If this product has been prescribed for children or adolescents between the ages of 2 and 18 years, the instructions given by your doctor must be followed. You must check with the doctor every week before continuing treatment.

If you have used Etrivex shampoo for much longer than you should, please see your doctor. This product is for use on the scalp only. Do not swallow it. If you accidentally do so, small amounts are not harmful. If you are not sure, seek immediate medical advice.

If you forget to use Etrivex shampoo, do not use a double dose on the next application to make up for a forgotten dose. Go back to your regular schedule. If you miss several doses, tell your doctor.

If you stop using Etrivex shampoo, please see your doctor. It may be that worsening of the disease occurs when treatment with Etrivex shampoo is stopped, especially if it has been used for a long time. Tell your doctor if you observe such a worsening of your skin conditions.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Etrivex shampoo can have side effects, although not everybody gets them.

• The following are common side effects affecting less than 1 in 10 people: skin discomfort, acne and eye burning or stinging.


• The following are uncommon side effects affecting fewer than 1 in a 100 people : irritation, itching, urticaria, visible small vessels or thinning skin around the treated areas.

These are generally of a mild to moderate nature.

• If you have a burning sensation or redness to the areas that have been treated, do not use Etrivex shampoo until these symptoms have disappeared.


• Stop using the medicine and tell your doctor as soon as possible if you find your condition gets worse during treatment (this is more likely to happen if you have been using Etrivex shampoo longer than prescribed) or if you experience swelling of the eyelids, face or lips as you may be allergic to the product or have a skin infection.


• 
  Using large amounts or keeping the product on the scalp for more than 15 minutes may:
  
  • cause the skin to become thinner so that it can damage more easily
  
  
  • allow the active substance to pass through the skin ; this can affect other parts of the body, especially in children, and during pregnancy
  
  


• 
  Repeated courses of topical steroids over a long time may sometimes cause acne, pustular eruptions (big pimples) and changes in hair growth and skin colour. Striae (stretch marks), purpura (bruising), surface veins, erythema (skin redness) and contact dermatitis (local allergic reactions) may become noticeable


• If you have rosacea (severe flushing of skin on and around the nose) the application of Etrivex shampoo on the face may cause your rosacea to worsen.


• Application of Etrivex shampoo on the face may induce perioral dermatitis (spotty red rash around the mouth).


• Application of Etrivex Shampoo to the skin may cause thinning of skin and therefore it should never be used on the face or on other areas of the skin than the scalp.


• If you have any unusual discomfort that you do not understand, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

How to store Etrivex 500 micrograms/g Shampoo

Keep out of the reach and sight of children.

Do not use Etrivex Shampoo after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of that month.

Store in the original plastic bottle.

Discard the bottle 4 weeks after first opening.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help to protect the environment.

Further information

What Etrivex Shampoo contains:

The active substance is clobetasol propionate

Each gram (millilitre) of Etrivex Shampoo contains 500 micrograms of the active ingredient Clobetasol propionate.

The other ingredients are: ethanol, coco alkyl dimethyl betaine, sodium laureth sulfate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.

What Etrivex Shampoo looks like and contents of the pack:

Etrivex Shampoo is a thick, semi transparent liquid shampoo with an alcoholic smell that is colourless to pale yellow in appearance.

Etrivex shampoo is available on prescription from your doctor in white high density polyethylene (HDPE) plastic bottles of 60 ml or 125 ml fitted with polypropylene snap closure. The HDPE bottle of 30 ml is fitted with polypropylene screw closure. Bottles contains 30 ml, 60 ml or 125 ml of shampoo (not all pack sizes may be marked).

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Galderma (UK) Ltd.

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PL 10590/0052

PA 590/23/1

Manufacturer:

Laboratoires Galderma

Z.I.- Montdésir

74540, Alby-sur-Chéran

France

This medicinal product is authorised in the Member States under the following names:

United Kingdom, Italy, Ireland and Portugal: Etrivex 500 micrograms/g shampoo

France, Germany, Belgium, Poland, Spain, Hungary, The Netherlands, Sweden, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500 micrograms/g shampoo

This leaflet was last approved in November 2007.

P23932-2

Acepril Tablets 12.5 mg, 25 mg and 50 mg

1. Name Of The Medicinal Product

Acepril Tablets 12.5mg, 25mg and 50mg

2. Qualitative And Quantitative Composition

Each tablet contains captopril 12.5 mg, 25mg or 50mg.

For excipients, see 6.1

3. Pharmaceutical Form

Tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension: Acepril is indicated for the treatment of hypertension.

Heart Failure: Acepril is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and, when appropriate, digitalis and beta-blockers.

Myocardial Infarction:

  - short-term (4 weeks) treatment: Acepril is indicated in any clinically stable patient within the first 24 hours of an infarction.

  - long-term prevention of symptomatic heart failure: Acepril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction (ejection fraction

Type I Diabetic Nephropathy: Acepril is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes.

(See Section 5.1).

4.2 Posology And Method Of Administration

Dose should be individualised according to patient's profile (see 4.4) and blood pressure response. The recommended maximum daily dose is 150 mg.

Acepril may be taken before, during and after meals.

Hypertension: the recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril may be used alone or with other antihypertensive agents, especially thiazide diuretics. A once-daily dosing regimen may be appropriate when concomitant antihypertensive medication such as thiazide diuretics is added.

In patients with a strongly active renin-angiotensin-aldosterone system (hypovolaemia, renovascular hypertension, cardiac decompensation) it is preferable to commence with a single dose of 6.25 mg or 12.5 mg. The inauguration of this treatment should preferably take place under close medical supervision. These doses will then be administered at a rate of two per day. The dosage can be gradually increased to 50 mg per day in one or two doses and if necessary to 100 mg per day in one or two doses.

Heart failure: treatment with captopril for heart failure should be initiated under close medical supervision. The usual starting dose is 6.25 mg - 12.5 mg BID or TID. Titration to the maintenance dose (75 - 150 mg per day) should be carried out based on patient's response, clinical status and tolerability, up to a maximum of 150 mg per day in divided doses. The dose should be increased incrementally, with intervals of at least 2 weeks to evaluate patient's response.

Myocardial infarction:

  - short-term treatment: Acepril treatment should begin in hospital as soon as possible following the appearance of the signs and/or symptoms in patients with stable haemodynamics. A 6.25 mg test dose should be administered, with a 12.5 mg dose being administered 2 hours afterwards and a 25 mg dose 12 hours later. From the following day, captopril should be administered in a 100 mg/day dose, in two daily administrations, for 4 weeks, if warranted by the absence of adverse haemodynamic reactions. At the end of the 4 weeks of treatment, the patient's state should be reassessed before a decision is taken concerning treatment for the post-myocardial infarction stage.

  - chronic treatment: if captopril treatment has not begun during the first 24 hours of the acute myocardial infarction stage, it is suggested that treatment be instigated between the 3rd and 16th day post-infarction once the necessary treatment conditions have been attained (stable haemodynamics and management of any residual ischaemia). Treatment should be started in hospital under strict surveillance (particularly of blood pressure) until the 75 mg dose is reached. The initial dose must be low (see 4.4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. Treatment should be initiated with a dose of 6.25 mg followed by 12.5 mg 3 times daily for 2 days and then 25 mg 3 times daily if warranted by the absence of adverse haemodynamic reactions. The recommended dose for effective cardioprotection during long-term treatment is 75 to 150 mg daily in two or three doses. In cases of symptomatic hypotension, as in heart failure, the dosage of diuretics and/or other concomitant vasodilators may be reduced in order to attain the steady state dose of captopril. Where necessary, the dose of captopril should be adjusted in accordance with the patient's clinical reactions. Captopril may be used in combination with other treatments for myocardial infarction such as thrombolytic agents, beta-blockers and acetylsalicylic acid.

Type I Diabetic nephropathy: in patients with type I diabetic nephropathy, the recommended daily dose of captopril is 75-100 mg in divided doses. If additional lowering of blood pressure is desired, additional antihypertensive medications may be added.

Renal impairment: since captopril is excreted primarily via the kidneys, dosage should be reduced or the dosage interval should be increased in patients with impaired renal function. When concomitant diuretic therapy is required, a loop diuretic (e.g. furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment.

In patients with impaired renal function, the following daily dose may be recommended to avoid accumulation of captopril.

Creatinine clearance (ml/min/1.73 m²)	Daily starting dose (mg)	Daily maximum dose (mg)
>40	25-50	150
21-40	25	100
10-20	12.5	75
<10	6.25	37.5

Elderly patients: as with other antihypertensive agents, consideration should be given to initiating therapy with a lower starting dose (6.25 mg BID) in elderly patients who may have reduced renal function and other organ dysfunctions (see above and section 4.4).

Dosage should be titrated against the blood pressure response and kept as low as possible to achieve adequate control.

Children and adolescents: the efficacy and safety of captopril have not been fully established. The use of captopril in children and adolescents should be initiated under close medical supervision. The initial dose of captopril is about 0.3 mg/kg body weight. For patients requiring special precautions (children with renal dysfunction, premature infants, new-borns and infants, because their renal function is not the same with older children and adults) the starting dose should be only 0.15 mg captopril/kg weight. Generally, captopril is administered to children 3 times a day, but dose and interval of dose should be adapted individually according to patient's response.

4.3 Contraindications

1. History of hypersensitivity to captopril, to any of the excipients or any other ACE inhibitor.

2. History of angioedema associated with previous ACE inhibitor therapy.

3. Hereditary / idiopathic angioneurotic oedema.

4. Second and third trimester of pregnancy (see 4.6)

5. Lactation (see 4.6).

4.4 Special Warnings And Precautions For Use

Hypotension: rarely hypotension is observed in uncomplicated hypertensive patients. Symptomatic hypotension is more likely to occur in hypertensive patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, vomiting or haemodialysis. Volume and/or sodium depletion should be corrected before the administration of an ACE inhibitor and a lower starting dose should be considered.

Patients with heart failure are at higher risk of hypotension and a lower starting dose is recommended when initiating therapy with an ACE inhibitor. Caution should be used whenever the dose of captopril or diuretic is increased in patients with heart failure.

As with any antihypertensive agent, excessive blood pressure lowering in patients with ischaemic cardiovascular or cerebrovascular disease may increase the risk of myocardial infarction or stroke. If hypotension develops, the patient should be placed in a supine position. Volume repletion with intravenous normal saline may be required.

Renovascular hypertension: there is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors. Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision with low doses, careful titration and monitoring of renal function.

Renal impairment: in cases of renal impairment (creatinine clearance

Angioedema: angioedema of the extremities, face, lips, mucous membranes, tongue, glottis or larynx may occur in patients treated with ACE inhibitors particularly during the first weeks of treatment. However, in rare cases, severe angioedema may develop after long-term treatment with an ACE inhibitor. Treatment should be discontinued promptly. Angioedema involving the tongue, glottis or larynx may be fatal. Emergency therapy should be instituted. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged until complete resolution of symptoms has occurred.

Cough: cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.

Hepatic failure: rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.

Hyperkalaemia: elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including captopril. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.

Lithium: the combination of lithium and captopril is not recommended (see 4.5)

Aortic and mitral valve stenosis/Obstructive hypertropic cardiomyopathy: ACE inhibitors should be used with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction.

Neutropenia/Agranulocytosis: neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors, including captopril. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Captopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is pre-existing impaired renal function. some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy.

If captopril is used in such patients, it is advised that white blood cell count and differential counts should be performed prior to therapy, every 2 weeks during the first 3 months of captopril therapy, and periodically thereafter. During treatment all patients should be instructed to report any sign of infection (e.g. sore throat, fever) when a differential white blood cell count should be performed. Captopril and other concomitant medication (see 4.5) should be withdrawn if neutropenia (neutrophils less than 1000/mm³) is detected or suspected.

In most patients neutrophil counts rapidly return to normal upon discontinuing captopril.

Proteinuria: proteinuria may occur particularly in patients with existing renal function impairment or on relatively high doses of ACE inhibitors.

Total urinary proteins greater than 1 g per day were seen in about 0.7% of patients receiving captopril. The majority of patients had evidence of prior renal disease or had received relatively high doses of captopril (in excess of 150 mg/day), or both. Nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months whether or not captopril was continued. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria.

Patients with prior renal disease should have urinary protein estimations (dip-stick on first morning urine) prior to treatment, and periodically thereafter.

Anaphylactoid reactions during desensitisation: sustained life-threatening anaphylactoid reactions have been rarely reported for patients undergoing desensitising treatment with hymenoptera venom while receiving another ACE inhibitor. In the same patients, these reactions were avoided when the ACE inhibitor was temporarily withheld, but they reappeared upon inadvertent rechallenge. Therefore, caution should be used in patients treated with ACE inhibitors undergoing such desensitisation procedures.

Anaphylactoid reactions during high-flux dialysis / lipoprotein apheresis membrane exposure: anaphylactoid reactions have been reported in patients haemodialysed with high-flux dialysis membranes or undergoing low-density lipoprotein apheresis with dextran sulphate absorption. In these patients, consideration should be given to using a different type of dialysis; membrane or a different class of medication.

Surgery/Anaesthesia: hypotension may occur in patients undergoing major surgery or during treatment with anaesthetic agents that are known to lower blood pressure. If hypotension occurs, it may be corrected by volume expansion.

Diabetic patients: the glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor.

Lactose: Acepril contains lactose, therefore it should not be used in cases of congenital galactosaemia, glucose and galactose malabsorption or lactase deficiency syndromes (rare metabolic diseases).

Ethnic differences: as with other angiotensin converting enzyme inhibitors, captopril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potassium sparing diuretics or potassium supplements: ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium (see 4.4).

Diuretics (thiazide or loop diuretics): prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with captopril (see 4.4). The hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake or by initiating therapy with a low dose of captopril. However, no clinically significant drug interactions have been found in specific studies with hydrochlorothiazide or furosemide.

Other antihypertensive agents: captopril has been safely co-administered with other commonly used anti-hypertensive agents (e.g. beta-blockers and long-acting calcium channel blockers). Concomitant use of these agents may increase the hypotensive effects of captopril. Treatment with nitroglycerine and other nitrates, or other vasodilators, should be used with caution.

Treatments of acute myocardial infarction: captopril may be used concomitantly with acetylsalicylic acid (at cardiologic doses), thrombolytics, beta-blockers and/or nitrates in patients with myocardial infarction.

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors. Use of captopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see 4.4)

Tricyclic antidepressants / Antipsychotics: ACE inhibitors may enhance the hypotensive effects of certain triclyclic antidepressants and antipsychotics (see 4.4). Postural hypotension may occur.

Allopurinol, procainamide, cytostatic or immunosuppressive agents: concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at higher than currently recommended doses.

Non-steroidal anti-inflammatory medicinal products: it has been described that non-steroidal anti-inflammatory medicinal products (NSAIDs) and ACE inhibitors exert an additive effect on the increase in serum potassium whereas renal function may decrease. These effects are, in principle, reversible. Rarely, acute renal failure may occur, particularly in patients with compromised renal function such as the elderly or dehydrated. Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor.

Sympathomimetics: may reduce the antihypertensive effects of ACE inhibitors; patients should be carefully monitored.

Antidiabetics: pharmacological studies have shown that ACE inhibitors, including captopril, can potentiate the blood glucose-reducing effects of insulin and oral antidiabetics such as sulphonylurea in diabetics. Should this very rare interaction occur, it may be necessary to reduce the dose of the antidiabetic during simultaneous treatment with ACE inhibitors.

Clinical Chemistry

Captopril may cause a false-positive urine test for acetone.

4.6 Pregnancy And Lactation

Pregnancy: Acepril is not recommended during the first trimester of pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible. Controlled studies with ACE inhibitors have not been done in humans, but limited number of cases of first trimester exposures have not shown malformations.

Acepril is contraindicated during the second and third trimesters of pregnancy. Prolonged captopril exposure during the second and third trimesters is known to induce toxicity in foetuses (decreased renal function, oligohydramnios, skull ossification retardation) and in neonates (neonatal renal failure, hypotension, hyperkalaemia) (see also 5.3).

Lactation: Acepril is contraindicated in the lactation period.

4.7 Effects On Ability To Drive And Use Machines

As with other antihypertensives, the ability to drive and use machines may be reduced, namely at the start of the treatment, or when posology is modified, and also when used in combination with alcohol, but these effects depend on the individual's susceptibility.

4.8 Undesirable Effects

Undesirable effects reported for captopril and/or ACE inhibitor therapy include:

Blood and lymphatic disorders:

very rare: neutropenia/agranulocytosis (see 4.4), pancytopenia particularly in patients with renal dysfunction (see 4.4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA-titres.

Metabolism and nutrition disorders:

rare: anorexia

very rare: hyperkalaemia, hypoglycaemia (see 4.4)

Psychiatric disorders:

common: sleep disorders

very rare: confusion, depression.

Nervous system disorders:

common: taste impairment, dizziness

rare: drowsiness, headache and paraesthesia

very rare: cerebrovascular incidents, including stroke, and syncope.

Eye disorders:

very rare: blurred vision

Cardiac disorders:

uncommon: tachycardia or tachyarrhythmia, angina pectoris, palpitations.

very rare: cardiac arrest, cardiogenic shock

Vascular disorders:

uncommon: hypotension (see 4.4), Raynaud syndrome, flush, pallor

Respiratory, thoracic and mediastinal disorders:

common: dry, irritating (non-productive) cough (see 4.4) and dyspnoea

very rare: bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia

Gastrointestinal disorders:

common: nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth.

rare: stomatitis/aphthous ulcerations

very rare: glossitis, peptic ulcer, pancreatitis.

Hepato-biliary disorders:

very rare: impaired hepatic function and cholestasis (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders:

common: pruritus with or without a rash, rash, and alopecia.

uncommon: angioedema (see 4.4)

very rare: urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis.

Musculoskeletal, connective tissue and bone disorders:

very rare: myalgia, arthralgia.

Renal and urinary disorders:

rare: renal function disorders including renal failure, polyuria, oliguria, increased urine frequency.

very rare: nephrotic syndrome.

Reproductive system and breast disorders:

very rare: impotence, gynaecomastia.

General disorders:

uncommon: chest pain, fatigue, malaise

very rare: fever

Investigations:

very rare: proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decreases in haemoglobin, haematocrit, leucocytes, thrombocytes, positive ANA-titre, elevated ESR.

4.9 Overdose

Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure.

Measures to prevent absorption (e.g. gastric lavage, administration of adsorbents and sodium sulphate within 30 minutes after intake) and hasten elimination should be applied if ingestion is recent. If hypotension occurs, the patient should be placed in the shock position and salt and volume supplementations should be given rapidly. Treatment with angiotensin-II should be considered. Bradycardia or extensive vagal reactions should be treated by administering atropine. The use of a pacemaker may be considered.

Captopril may be removed from circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ACE inhibitors, plain, ATC code: C09AA01.

Captopril is a highly specific, competitive inhibitor of angiotensin-I converting enzyme (ACE inhibitors).

The beneficial effects of ACE inhibitors appear to result primarily from the suppression of the plasma renin-angiotensin-aldosterone system. Renin is an endogenous enzyme synthesised by the kidneys and released into the circulation where it converts angiotensinogen to angiotensin-I, a relatively inactive decapeptide. Angiotensin-I is then converted by angiotensin converting enzyme, a peptidyldipeptidase, to angiotensin-II. Angiotensin-II is a potent vasoconstrictor responsible for arterial vasoconstriction and increased blood pressure, as well as for stimulation of the adrenal gland to secrete aldosterone. Inhibition of ACE results in decreased plasma angiotensin-II, which leads to decreased vasopressor activity and to reduced aldosterone secretion. Although the latter decrease is small, small increases in serum potassium concentrations may occur, along with sodium and fluid loss. The cessation of the negative feedback of angiotensin-II on the renin secretion results in an increase of the plasma renin activity.

Another function of the converting enzyme is to degrade the potent vasodepressive kinin peptide bradykinin to inactive metabolites. Therefore, inhibition of ACE results in an increased activity of circulating and local kallikrein-kinin-system which contributes to peripheral vasodilation by activating the prostaglandin system; it is possible that this mechanism is involved in the hypotensive effect of ACE inhibitors and is responsible for certain adverse reactions.

Reductions of blood pressure are usually maximal 60 to 90 minutes after oral administration of an individual dose of captopril. The duration of effect is dose related. The reduction in blood pressure may be progressive, so to achieve maximal therapeutic effects, several weeks of therapy may be required. The blood pressure lowering effects of captopril and thiazide-type diuretics are additive.

In patients with hypertension, captopril causes a reduction in supine and erect blood pressure, without inducing any compensatory increase in heart rate, nor water and sodium retention.

In haemodynamic investigations, captopril caused a marked reduction in peripheral arterial resistance. In general there were no clinically relevant changes in renal plasma flow or glomerular filtration rate. In most patients, the antihypertensive effect began about 15 to 30 minutes after oral administration of captopril; the peak effect was achieved after 60 to 90 minutes. The maximum reduction in blood pressure of a defined captopril dose was generally visible after three to four weeks.

In the recommended daily dose, the antihypertensive effect persists even during long-term treatment. Temporary withdrawal of captopril does not cause any rapid, excessive increase in blood pressure (rebound). The treatment of hypertension with captopril leads also to a decrease in left ventricular hypertrophy.

Haemodynamic investigations in patients with heart failure, showed that captopril caused a reduction in peripheral systemic resistance and a rise in venous capacity. This resulted in a reduction in pre-load and after-load of the heart (reduction in ventricular filling pressure). In addition, rises in cardiac output, work index and exercise capacity have been observed during treatment with captopril. In a large, placebo-controlled study in patients with left ventricular dysfunction (LVEF

A retrospective analysis showed that captopril reduced recurrent infarcts and cardiac revascularisation procedures (neither were target criteria of the study).

Another large, placebo-controlled study in patients with myocardial infarction showed that captopril (given within 24 hours of the event and for a duration of one month) significantly reduced overall mortality after 5 weeks compared to placebo. The favourable effect of captopril on total mortality was still detectable even after one year. No indication of a negative effect in relation to early mortality on the first day of treatment was found.

Captopril cardioprotection effects are observed regardless of the patient's age or gender, location of the infarction and concomitant treatments with proven efficacy during the post-infarction period (thrombolytic agents, beta-blockers and acetylsalicylic acid).

Type I diabetic nephropathy

In a placebo-controlled, multicentre double blind clinical trial in insulin-dependent (Type I) diabetes with proteinuria, with or without hypertension (simultaneous administration of other antihypertensives to control blood pressure was allowed), captopril significantly reduced (by 51%) the time to doubling of the baseline creatinine concentration compared to placebo; the incidence of terminal renal failure (dialysis, transplantation) or death was also significantly less common under captopril than under placebo (51%). In patients with diabetes and microalbuminuria, treatment with captopril reduced albumin excretion within two years.

The effects of treatment with captopril on the preservation of renal function are in addition to any benefit that may have been derived from the reduction in blood pressure.

5.2 Pharmacokinetic Properties

Captopril is an orally active agent that does not require biotransformation for activity. The average minimal absorption is approximately 75%. Peak plasma concentrations are reached within 60-90 minutes. The presence of food in the gastrointestinal tract reduces absorption by about 30-40%. Approximately 25-30% of the circulating drug is bound to plasma proteins.

The apparent elimination half-life of unchanged captopril in blood is about 2 hours. Greater than 95% of the absorbed dose is eliminated in the urine within 24 hours; 40-50% is unchanged drug and the remainder are inactive disulphide metabolites (captopril disulphide and captopril cysteine disulphide). Impaired renal function could result in drug accumulation. Therefore, in patients with impaired renal function the dose should be reduced and/or dosage interval prolonged (see 4.2).

Studies in animals indicate that captopril does not cross the blood-brain barrier to any significant extent.

5.3 Preclinical Safety Data

Animal studies performed during organogenesis with captopril have not shown any teratogenic effect but captopril has produced foetal toxicity in several species, including foetal mortality during late pregnancy, growth retardation and postnatal mortality in the rat. Preclinical data reveal no other specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology, genotoxicity and carcinogenicity.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, corn starch, microcrystalline cellulose, stearic acid.

6.2 Incompatibilities

None.

6.3 Shelf Life

48 Months.

6.4 Special Precautions For Storage

Store below 30°C.

Protect from moisture.

6.5 Nature And Contents Of Container

The 12.5mg tablets are available in blister packs of 56 tablets. The 25mg & 50mg tablets are available in blister packs of 56 and 84 tablets.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

E.R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

12.5mg: 0034/0298

25mg: 0034/0299

50mg: 0034/0300

9. Date Of First Authorisation/Renewal Of The Authorisation

3rd December 1995

10. Date Of Revision Of The Text

June 2005