metaproterenol

met-a-proe-TER-e-nol

Commonly used brand name(s)

In the U.S.

• Alupent

In Canada

• Alti-Orciprenaline

Available Dosage Forms:

• Syrup


• Tablet

Therapeutic Class: Bronchodilator

Pharmacologic Class: Beta-2 Adrenergic Agonist

Uses For metaproterenol

Metaproterenol is used to treat asthma and bronchospasm in patients with bronchitis, emphysema, and other lung diseases.

Metaproterenol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

metaproterenol is available only with your doctor's prescription.

Before Using metaproterenol

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 metaproterenol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to metaproterenol 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 metaproterenol oral solution and tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of metaproterenol in geriatric patients.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking metaproterenol, 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 metaproterenol 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


• Arotinolol


• Atenolol


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bupranolol


• Carteolol


• Carvedilol


• Celiprolol


• Dilevalol


• Esmolol


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Nipradilol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Sotalol


• Talinolol


• Tertatolol


• Timolol

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

• Diabetes or


• Heart or blood vessel disease or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


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

• Heart rhythm problems (e.g., arrhythmia) or


• Tachycardia (fast or rapid heartbeat)—Should not be used in patients with these conditions.

Proper Use of metaproterenol

Use metaproterenol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using metaproterenol or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

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

Dosing

The dose of metaproterenol 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 metaproterenol. 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 asthma and bronchospasm:
  
  • For oral dosage form (solution):
    
    • Adults—Two teaspoonfuls (10 milliliters [mL]) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children older than 9 years of age or weighing more than 60 pounds (lbs)—Two teaspoonfuls (10 mL) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children 6 to 9 years of age or weighing less than 60 lbs—One teaspoonful (5 mL) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children younger than 6 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults—20 milligrams (mg) three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children older than 9 years of age or weighing more than 60 pounds (lbs)—20 mg three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children 6 to 9 years of age or weighing less than 60 lbs—10 mg three or four times a day. Your doctor may adjust your dose as needed.
    
    
    • Children younger than 6 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of metaproterenol, 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 metaproterenol

It is very important that your doctor check your progress or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Check with your doctor at once if you or your child continue to have breathing problems after using a dose of metaproterenol or if your condition gets worse.

Do not change your dose or stop using metaproterenol without asking your doctor first.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

metaproterenol 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

• Fast, pounding, or irregular heartbeat or pulse

Less common

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


• trembling or shaking of the hands or feet


• worsening of asthma

Rare

• Blurred vision


• chest pain


• chills


• cough


• diarrhea


• dizziness


• fainting


• fever


• general feeling of discomfort or illness


• headache


• increased sweating


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• nervousness


• pounding in the ears


• puffiness of the face and fingers


• runny nose


• shivering


• slow or fast heartbeat


• sore throat


• sweating


• swelling


• trouble sleeping


• unusual tiredness or weakness


• vomiting

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

Symptoms of overdose

• Arm, back, or jaw pain


• chest discomfort


• chest tightness or heaviness


• confusion


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


• dry mouth


• general feeling of discomfort or illness


• shortness of breath


• sleeplessness


• unable to sleep

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

Less common

• Abdominal or stomach pain

Rare

• Bad, unusual, or unpleasant (after) taste


• change in appetite


• drowsiness


• dry mouth or throat


• itching skin


• pain


• raised red swellings on the skin, lips, tongue, or in the throat


• tightening of the muscles


• weakness

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: metaproterenol side effects (in more detail)

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More metaproterenol resources

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

• metaproterenol Concise Consumer Information (Cerner Multum)


• Metaproterenol MedFacts Consumer Leaflet (Wolters Kluwer)


• Alupent Monograph (AHFS DI)


• Alupent Prescribing Information (FDA)


• Metaproterenol Prescribing Information (FDA)

Compare metaproterenol with other medications

• Asthma, acute
• Asthma, Maintenance
• COPD, Acute
• COPD, Maintenance

anticholinergics and antispasmodics Oral, Parenteral, Rectal, Transdermal

Class Name: anticholinergics and antispasmodics (Oral route, Parenteral route, Rectal route, Transdermal route)

Commonly used brand name(s)

In the U.S.

• Akineton


• Artane


• Bentyl


• Cantil


• Cogentin


• Colidrops Pediatric


• Cystospaz


• Detrol


• Ditropan


• Ed-Spaz


• Enablex


• HyoMax


• HyoMax-DT


• HyoMax-FT


• HyoMax-SR


• Hyosyne


• IB-Stat


• Kemadrin


• Levsinex


• Neosol


• Norflex


• Nulev


• Oscimin


• Oscimin-SR


• Oxytrol


• Pamine


• Pro-Banthine


• Pro-Hyo


• Robinul


• Sanctura


• Scopodex


• Spacol T/S


• Spasdel


• Symax


• Symax Duotab


• Symmetrel


• Toviaz


• Transderm Scop


• Urispas


• Vesicare

In Canada

• Buscopan


• Levsin


• Pms-Procyclidine


• Pms-Trihexyphenidyl


• Transderm-V

Available Dosage Forms:

• Tablet


• Capsule


• Suppository


• Solution


• Capsule, Extended Release


• Elixir


• Capsule, Liquid Filled


• Syrup


• Tablet, Extended Release


• Gel/Jelly


• Patch, Extended Release


• Spray


• Liquid


• Tablet, Disintegrating


• Tablet, Chewable

Uses For This Medicine

The anticholinergics and antispasmodics are a group of medicines that include the natural belladonna alkaloids (atropine, belladonna, hyoscyamine, and scopolamine) and related products.

The anticholinergics and antispasmodics are used to relieve cramps or spasms of the stomach, intestines, and bladder. Some are used together with antacids or other medicines in the treatment of peptic ulcers. Others are used to prevent nausea, vomiting, and motion sickness.

Anticholinergics and antispasmodics are also used in certain surgical and emergency procedures. In surgery, some are given by injection before anesthesia to help relax you and to decrease secretions, such as saliva. During anesthesia and surgery, atropine, glycopyrrolate, hyoscyamine, and scopolamine are used to help keep the heartbeat normal. Scopolamine is also used to prevent nausea and vomiting after anesthesia and surgery. Atropine is also given by injection to help relax the stomach and intestines for certain types of procedures.

Anticholinergics are used to treat poisoning caused by medicines such as neostigmine and physostigmine, certain types of mushrooms, and “nerve” gases or organic phosphorous pesticides (eg, demeton [Systox®], diazinon, malathion, parathion, and ronnel [Trolene®]). Anticholinergics can be used for painful menstruation, runny nose, and to prevent urination during sleep.

The anticholinergics and antispasmodics are available only with your doctor's prescription.

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

• Asthma therapy


• Diarrhea


• Excessive watering of the mouth

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

Unusual excitement, nervousness, restlessness, or irritability, and unusual warmth, dryness, and flushing of the skin are more likely to occur in children. Children are usually more sensitive to the effects of anticholinergics. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be more likely to cause severe side effects. Shortness of breath or difficulty with breathing has occurred in children taking dicyclomine.

Geriatric

Confusion or memory loss; constipation; difficult urination; drowsiness; dryness of the mouth, nose, throat, or skin; and unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in the elderly. The elderly are usually more sensitive than younger adults to the effects of anticholinergics. Also, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

If you are pregnant or if you may become pregnant, make sure your doctor knows if your medicine contains any of the following:

• Atropine—Atropine has not been shown to cause birth defects or other problems in animals. However, when injected into women during pregnancy, atropine increased the heartbeat of the fetus.


• Belladonna—Belladonna has not been studied in pregnant women or animals.


• Clidinium—Clidinium has not been studied in pregnant women. However, clidinium has not been shown to cause birth defects or other problems in animals.


• Dicyclomine—Dicyclomine has been associated with a few cases of human birth defects, but dicyclomine has not been confirmed as the cause.


• Glycopyrrolate—Glycopyrrolate has not been studied in pregnant women. However, glycopyrrolate did not cause birth defects in animal studies, but did decrease the chance of becoming pregnant and the newborn's chance of surviving after weaning.


• Hyoscyamine—Hyoscyamine has not been studied in pregnant women or animals. However, when injected into women during pregnancy, hyoscyamine increased the heartbeat of the fetus.


• Mepenzolate—Mepenzolate has not been studied in pregnant women. However, studies in animals have not shown that mepenzolate causes birth defects or other problems.


• Propantheline—Propantheline has not been studied in pregnant women or animals.


• Scopolamine—Scopolamine has not been studied in pregnant women or animals.

Breast Feeding

Although these medicines may pass into the breast milk, they have not been reported to cause problems in nursing babies. However, the flow of breast milk may be reduced in some patients. The use of dicyclomine is contraindicated and should not be used in nursing mothers because it has been reported to cause breathing problems in infants.

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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Ambenonium


• Cisapride


• Dronedarone


• Mesoridazine


• Metoclopramide


• Pimozide


• Posaconazole


• Potassium


• Sparfloxacin


• Thioridazine

Using medicines in this class 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.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Digoxin


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Sorafenib


• Sotalol


• Sunitinib


• Telavancin


• Terfenadine


• Tetrabenazine


• Thioridazine


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (severe) or


• Heart failure or


• Hyperthyroidism (an overactive thyroid) or


• Tachycardia (increased heart rate)—These medicines may increase the heart rate and make these conditions worse.

• Brain damage (in children)—This condition may increase the unwanted nervous system effects of these medicines.

• Colitis (severe) or


• Dryness of the mouth (severe and continuing) or


• Enlarged prostate or


• Fever or


• Glaucoma or


• Heart disease or


• Hernia (hiatal) or


• High blood pressure (hypertension) or


• Intestinal blockage or severe constipation or


• Lung disease (chronic) or


• Myasthenia gravis or


• Urinary tract blockage or difficult urination—These medicines may make these conditions worse.

• Down's syndrome—These medicines may cause an increase in pupil size and heart rate for patients with this condition.

• Liver disease—This condition may cause higher blood levels of the medicines which could increase the side effects.

• Spastic paralysis (in children)—This condition may increase the effects of the medicines.

Proper Use of This Medicine

To use any of these medicines by mouth:

• Take the medicine 30 minutes to 1 hour before meals unless otherwise directed by your doctor.


• Do not take the medicine within 2 or 3 hours of taking an antacid or a medicine for diarrhea. Taking the medicine too close together with antacids or antidiarrhea medicines may prevent the medicine from working properly.

To use the injectable form of dicyclomine:

• The injectable form should only be given intramuscularly (into a muscle). Do not give it intravenously (into a vein).


• The injectable form should only be used for 1 or 2 days. Your doctor may give you an oral medicine that works the same way.

To use the rectal suppository form of scopolamine:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• To insert the suppository: First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

To use the transdermal patch form of scopolamine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Wash and dry your hands thoroughly before and after handling the patch.


• Apply the patch to the hairless area of skin behind the ear. Do not place it over any cuts or irritations.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Dosing

The dose medicines in this class 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 these medicines. 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 anisotropine


• For oral dosage forms (tablets):
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—50 milligrams (mg) three times per day. Your doctor may adjust the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For atropine


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers, intestine problems, or urinary problems:
    
    • Older adults, adults, and teenagers—300 to 1200 micrograms (mcg) every 4 to 6 hours.
    
    
    • Children—Dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) of body weight every 4 to 6 hours. However, the dose will not be more than 400 mcg every 4 to 6 hours.
    
    
  
  


• For injectable dosage form:
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—400 to 600 micrograms (mcg) injected into a muscle, vein, or under the skin every 4 to 6 hours.
    
    
    • Children—The dose is based on body weight. The usual dose is 10 mcg per kilogram (kg) of body weight injected under the skin every 4 to 6 hours. However, the dose will not be more than 400 mcg every 4 to 6 hours.
    
    
  
  
  • To treat heart problems:
    
    • Older adults, adults, and teenagers—400 to 1000 micrograms (mcg) injected into a vein every 1 to 2 hours as needed. The total dose will not be more than 2 milligrams (mg).
    
    
    • Children—The dose is based on body weight. The usual dose is 10 to 30 mcg per kilogram (kg) of body weight injected into a vein.
    
    
  
  

• For belladonna


• For oral dosage form (oral solution):
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—180 to 300 micrograms (mcg) three or four times a day. The dose should be taken 30 to 60 minutes before meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—The dose is based on body weight. The usual dose is 9 mcg per kilogram (kg) (4 mcg per pound) of body weight three or four times a day.
    
    
  
  

• For clidinium


• For oral dosage form (capsules):
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—2.5 to 5 milligrams (mg) three or four times a day. The dose should be taken before meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For dicyclomine


• For oral dosage forms (capsules, syrup, tablets):
  
  • To treat intestine problems:
    
    • Older adults, adults, and teenagers—20 milligrams (mg) four times per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 160 mg per day.
    
    
    • Children and infants—Use is not recommended.
    
    
    • Infants younger than 6 months of age—Avoid use; use is contraindicated.
    
    
  
  


• For injectable dosage form (intramuscular only):
  
  • To treat intestine problems:
    
    • Older adults, adults, and teenagers—10 to 20 milligrams (mg) injected into a muscle four times per day.
    
    
    • Children and infants—Use is not recommended.
    
    
    • Infants younger than 6 months of age—Avoid use; use is contraindicated.
    
    
  
  

• For glycopyrrolate


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—To start, 1 to 2 milligrams (mg) two or three times a day. Some people may also take 2 mg at bedtime. Your doctor may change the dose if needed. However, your dose will not be more than 8 mg a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injectable dosage form:
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—100 to 200 micrograms (mcg) injected into a muscle or vein. The dose may be repeated every four hours up to four times a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For homatropine


• For oral dosage form:
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—5 to 10 milligrams (mg) three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For hyoscyamine


• For oral dosage forms (capsules, elixir, oral solution, tablets):
  
  • To treat duodenal or stomach ulcers, intestine problems, or urinary problems:
    
    • Older adults, adults, and teenagers—125 to 500 micrograms (mcg) four to six times a day. Some people may take 375 mcg two times a day. The tablets should be taken 30 to 60 minutes before meals. Your doctor may change the dose if needed.
    
    
    • Children—Dose is based on body weight. The usual dose is 12.5 to 187 mcg every four hours if needed.
    
    
  
  


• For injectable dosage form:
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—250 to 500 mcg injected into a muscle, vein, or under the skin every four to six hours.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For mepenzolate


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—25 to 50 milligrams (mg) four times a day, with meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For methantheline


• For oral dosage form (tablets):
  
  • To treat intestine or stomach ulcers, intestine problems, or urinary problems:
    
    • Older adults, adults, and teenagers—50 to 100 milligrams (mg) every six hours. Your doctor may change the dose if needed.
    
    
    • Children 1 year of age and older—12.5 to 50 mg four times a day. Your doctor may change the dose if needed.
    
    
    • Children 1 month to 1 year of age—12.5 mg four times a day. Your doctor may change the dose if needed.
    
    
    • Children up to 1 month of age—12.5 mg two times a day. Your doctor may change the dose if needed.
    
    
  
  

• For methscopolamine


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—2.5 to 5 milligrams (mg) four times a day, one-half hour before meals and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose is based on body weight. The usual dose is 200 micrograms (mcg) per kilogram (kg) (90.9 mcg per pound) of body weight four times a day. The dose should be taken before meals and at bedtime.
    
    
  
  

• For pirenzepine


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers or intestine problems:
    
    • Older adults, adults, and teenagers—50 milligrams (mg) two times a day, in the morning and at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For propantheline


• For oral dosage form (tablets):
  
  • To treat duodenal or stomach ulcers:
    
    • Older adults, adults, and teenagers—7.5 to 15 milligrams (mg) three times a day, one-half hour before meals, and 30 mg at bedtime. Your doctor may change the dose if needed.
    
    
    • Children—Dose is based on body weight. The usual dose is 375 micrograms (mcg) per kilogram (kg) (170 mcg per pound) of body weight four times a day. Your doctor may change the dose if needed.
    
    
  
  

• For scopolamine


• For oral dosage form (tablets):
  
  • To treat urinary problems or intestine problems or painful menstruation:
    
    • Older adults, adults, and teenagers—10 to 20 milligrams (mg) three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For injectable dosage form:
  
  • To treat urinary problems or intestine problems:
    
    • Older adults, adults, and teenagers—10 to 20 mg three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For rectal dosage form (suppository):
  
  • To treat urinary problems or intestine problems or painful menstruation:
    
    • Older adults, adults, and teenagers—Insert one 10 mg suppository rectally three or four times a day. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For transdermal dosage form (patch):
  
  • To treat motion sickness:
    
    • Older adults, adults, and teenagers—Apply one patch behind the ear at least 4 hours before the antinausea effect is needed.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • To treat nausea and vomiting after surgery
    
    • Older adults, adults, and teenagers—Apply one patch behind the ear the evening before surgery to prevent nausea and vomiting after surgery.
    
    
    • Children—Use is not recommended.
    
    
  
  

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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the liquid form of this medicine tightly closed and keep it from freezing. Do not refrigerate the syrup form of this medicine.

Precautions While Using This Medicine

If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of any of the belladonna alkaloids or taking scopolamine with alcohol or other central nervous system (CNS) depressants may lead to unconsciousness and possibly death. Some signs of overdose are clumsiness or unsteadiness; dizziness; severe drowsiness; fever; hallucinations (seeing, hearing, or feeling things that are not there); confusion; shortness of breath or troubled breathing; slurred speech; unusual excitement, nervousness, restlessness, or irritability; fast heartbeat; and unusual warmth, dryness, and flushing of skin.

These medicines 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 taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Check with your doctor before you stop using this medicine. Your doctor may want you to reduce gradually the amount you are using before stopping completely. Stopping this medicine may cause withdrawal side effects such as vomiting, sweating, and dizziness.

Anticholinergics and antispasmodics may cause some people to have blurred vision. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well. These medicines may also cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

These medicines, especially in high doses, may cause some people to become dizzy or drowsy. 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 or are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help lessen this problem.

These medicines 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.

For patients taking scopolamine:

• This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Side Effects of This Medicine

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

• Confusion (especially in the elderly)


• dizziness, lightheadedness that continues, or fainting


• eye pain


• skin rash or hives

Incidence not known

• Cough


• difficulty with swallowing


• fast irregular, pounding, or racing heartbeat or pulse


• fever


• hives or welts


• hoarseness


• irritation


• itching skin


• joint pain, stiffness, or swelling


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


• redness of the skin


• shortness of breath


• skin rash


• tightness in the chest


• trouble with breathing


• wheezing

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

More common

• Constipation


• decreased sweating


• dryness of the mouth, nose, throat, or skin

Less common or rare

• Bloated feeling


• blurred vision


• difficult urination


• difficulty with swallowing


• drowsiness


• false sense of well-being


• headache


• increased sensitivity of eyes to light


• loss of memory


• nausea or vomiting


• redness or other signs of irritation at the place of injection


• trouble with sleeping


• unusual tiredness or weakness

Incidence not known

• Decreased interest in sexual intercourse


• inability to have or keep an erection


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


• loss of taste

For patients using scopolamine:

After you stop using scopolamine, your body may need time to adjust. The length of time this takes depends on the amount of scopolamine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

• Anxiety


• irritability


• nightmares


• pupil of one eye is larger (patch only)


• sensitivity of eyes to light (patch only)


• trouble in sleeping

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 Healthcare (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 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 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 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 HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

amlodipine and benazepril

am-LOE-di-peen BES-i-late, ben-AZ-e-pril hye-droe-KLOR-ide

Oral route(Capsule)

When pregnancy is detected, discontinue amlodipine besylate/benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus .

Commonly used brand name(s)

In the U.S.

• Lotrel

Available Dosage Forms:

• Capsule

Therapeutic Class: ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For amlodipine and benazepril

Amlodipine and benazepril is a combination of medicines that is used 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.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, benazepril relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

amlodipine and benazepril is available only with your doctor's prescription.

Before Using amlodipine and benazepril

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 amlodipine and benazepril, the following should be considered:

Allergies

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

Pregnancy

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

Breast Feeding

Amlodipine

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.

Benazepril

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 amlodipine and benazepril, 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 amlodipine and benazepril 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.

• Alteplase, Recombinant


• Amiloride


• Amiodarone


• Atazanavir


• Azathioprine


• Azilsartan Medoxomil


• Candesartan Cilexetil


• Canrenoate


• Conivaptan


• Dantrolene


• Droperidol


• Eplerenone


• Eprosartan


• Losartan


• Olmesartan Medoxomil


• Potassium


• Simvastatin


• Spironolactone


• Telaprevir


• Telmisartan


• Triamterene


• Valsartan

Using amlodipine and benazepril with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Aceclofenac


• Acemetacin


• Alclofenac


• Aliskiren


• Alprenolol


• Apazone


• Atenolol


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benoxaprofen


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Bufexamac


• Bumetanide


• Bupivacaine


• Buthiazide


• Capsaicin


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorthalidone


• Clometacin


• Clonixin


• Clopamide


• Clopidogrel


• Cyclopenthiazide


• Cyclothiazide


• Dalfopristin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Diltiazem


• Dipyrone


• Droxicam


• Esmolol


• Ethacrynic Acid


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Fluconazole


• Flufenamic Acid


• Flurbiprofen


• Furosemide


• Gold Sodium Thiomalate


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibuprofen


• Imatinib


• Indapamide


• Indinavir


• Indomethacin


• Indoprofen


• Isoxicam


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lithium


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nesiritide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Penbutolol


• Phenylbutazone


• Pindolol


• Pirazolac


• Piretanide


• Piroxicam


• Pirprofen


• Polythiazide


• Propranolol


• Propyphenazone


• Proquazone


• Quinethazone


• Quinupristin


• Rifapentine


• Ritonavir


• Sotalol


• St John's Wort


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Torsemide


• Trichlormethiazide


• Xipamide


• Zomepirac

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

• Angina (chest pain) or


• Heart attack, acute or


• Heart or blood vessel disease (e.g., coronary artery disease) or


• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Angioedema (swelling of the face, lips, tongue, or throat), history of—Should not be used in patients with these conditions.

• Bee-sting allergy treatments or


• Dialysis—Increased risk of serious allergic reaction occurring.

• Dehydration or


• Heart failure or other heart problems (e.g., aortic stenosis) or


• Hyponatremia (low sodium in the blood) or


• Hypovolemia (low blood volume)—Use with caution. The blood pressure-lowering effects of amlodipine and benazepril may be increased.

• Diabetes—Increased risk of potassium levels in the body becoming too high.

• Kidney disease or


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

• Kidney disease, severe or


• Scleroderma (an autoimmune disease) or


• Systemic lupus erythematosus (SLE), history of—Increased risk of blood problems caused by ACE inhibitors.

Proper Use of amlodipine and benazepril

In addition to the use of amlodipine and benazepril, 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 amlodipine and benazepril 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.

Dosing

The dose of amlodipine and benazepril 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 amlodipine and benazepril. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (capsules):
  
  • For high blood pressure:
    
    • Adults—At first, one capsule containing 2.5 milligrams (mg) of amlodipine and 10 mg of benazepril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of benazepril per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of amlodipine and benazepril, 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 amlodipine and benazepril

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

Using amlodipine and benazepril while you are pregnant can harm your unborn baby. If you think you have become pregnant while using amlodipine and benazepril, tell your doctor right away.

amlodipine and benazepril may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, lips, tongue, or throat while you are using amlodipine and benazepril.

Check with your doctor right away if you have a strong stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.

Check with your doctor if you become sick while taking amlodipine and benazepril, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Liver problems may occur while you are using amlodipine and benazepril. Stop using amlodipine and benazepril and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

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

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with amlodipine and benazepril is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking amlodipine and benazepril.

Black patients may be less sensitive to the blood pressure-lowering effects of amlodipine and benazepril. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

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.

amlodipine and benazepril Side Effects

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

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

Less common

• Dizziness, lightheadedness, or fainting


• swelling of the ankles, feet, or lower legs

Signs and symptoms of too much potassium in the body

• Confusion


• irregular heartbeat


• nervousness


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


• shortness of breath


• weakness or heaviness of the legs

Rare

• Bleeding gums


• blisters in the mouth spreading to the trunk, scalp, or other areas


• chills


• fever


• nausea or vomiting


• nosebleeds


• pale skin


• sore throat


• sores in the mouth, or on the arms, feet, hands, legs, or lips (sudden)


• stomach pain or bloating with fever, nausea, or vomiting


• swelling of the face, mouth, hands, or feet


• trouble with swallowing or breathing (sudden) or hoarseness


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

Incidence not known

• Chest pain


• difficulty with swallowing


• heartburn


• pain or burning in the throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth

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

Less common

• Awareness of heartbeat


• cough (dry, continuing)


• feeling of warmth


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


• sleepiness

Incidence not known

• Acid or sour stomach


• belching


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


• body aches or pain


• congestion


• cracked, dry, or scaly skin


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• fear


• frequent urination


• inability to have or keep an erection


• increased volume of pale, dilute urine


• indigestion


• lack or loss of strength


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


• muscle or bone pain


• runny nose


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


• sleeplessness


• small lump under the skin


• stomach discomfort or upset


• sudden sweating


• swelling


• tender, swollen glands in the neck


• trembling or shaking of the hands or feet


• trouble with sleeping


• trouble with swallowing


• unable to sleep


• voice changes

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: amlodipine and benazepril 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 amlodipine and benazepril resources

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

Compare amlodipine and benazepril with other medications

• High Blood Pressure

Exemestane 25mg Film-coated Tablets (Actavis UK Ltd)

1. Name Of The Medicinal Product

Exemestane 25mg Film-coated Tablets

2. Qualitative And Quantitative Composition

Each film-coated tablet contains 25 mg exemestane.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

Exemestane 25 mg film-coated tablets are white, round, lenticular, with uniform appearance and intact edges.

4. Clinical Particulars

4.1 Therapeutic Indications

Adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy.

Treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status.

4.2 Posology And Method Of Administration

Adult and elderly patients

The recommended dose of Exemestane 25mg Film-coated Tablets is one 25 mg tablet to be taken once daily, after a meal.

In patients with early breast cancer, treatment with Exemestane 25mg Film-coated Tablets should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane 25mg Film-coated Tablets), or earlier if tumour relapse occurs.

In patients with advanced breast cancer, treatment with Exemestane 25mg Film-coated Tablets should continue until tumour progression is evident.

No dose adjustments are required for patients with hepatic or renal insufficiency (see section 5.2).

Children

Exemestane 25mg Film-coated Tablets is not recommended for use in children.

4.3 Contraindications

Known hypersensitivity to the active substance or to any of the excipients.

Pre-menopausal women and pregnant or lactating women.

4.4 Special Warnings And Precautions For Use

Exemestane should not be administered to women with pre-menopausal endocrine status. Therefore, whenever clinically appropriate, the post-menopausal status should be ascertained by assessment of LH, FSH and oestradiol levels.

Exemestane should be used with caution in patients with hepatic or renal impairment.

Exemestane is a potent oestrogen lowering agent, and a reduction in bone mineral density and an increased fracture rate has been observed following administration (see section 5.1). During adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally assessed by bone densitometry at the commencement of treatment. Although adequate data to show the effects of therapy in the treatment of the bone mineral density loss caused by exemestane are not available, treatment for osteoporosis should be initiated in at risk patients. Patients treated with Exemestane 25mg Film-coated Tablets should be carefully monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In vitro evidence showed that the drug is metabolised through cytochrome P450 (CYP) 3A4 and aldoketoreductases (see section 5.2) and does not inhibit any of the major CYP isoenzymes. In a clinical pharmacokinetic study, the specific inhibition of CYP 3A4 by ketoconazole showed no significant effects on the pharmacokinetics of exemestane.

In an interaction study with rifampicin, a potent CYP450 inducer, at a dose of 600 mg daily and a single dose of exemestane 25 mg, the AUC of exemestane was reduced by 54% and C_max by 41%. Since the clinical relevance of this interaction has not been evaluated, the co-administration of drugs, such as rifampicin, anticonvulsants (e.g. phenytoin and carbamazepine) and herbal preparations containing Hypericum perforatum (St John's Wort) known to induce CYP3A4 may reduce the efficacy of exemestane.

Exemestane should be used cautiously with drugs that are metabolised via CYP3A4 and have a narrow therapeutic window. There is no clinical experience of the concomitant use of exemestane with other anticancer drugs.

Exemestane should not be coadministered with oestrogen-containing medicines as these would negate its pharmacological action.

4.6 Pregnancy And Lactation

Pregnancy

No clinical data on exposed pregnancies are available with exemestane. Studies on animals have shown reproductive toxicity (see section 5.3). Exemestane 25mg Film-coated Tablets is therefore contraindicated in pregnant women.

Lactation

It is not known whether exemestane is excreted into human milk. Exemestane 25mg Film-coated Tablets should not be administered to lactating woman.

Women of perimenopausal status or child-bearing potential

The physician needs to discuss the necessity of adequate contraception with women who have the potential to become pregnant including women who are perimenopausal or who have recently become postmenopausal, until their postmenopausal status is fully established (see section 4.3 and section 4.4).

4.7 Effects On Ability To Drive And Use Machines

Drowsiness, somnolence, asthenia and dizziness have been reported with the use of the drug. Patients should be advised that, if these events occur, their physical and/or mental abilities required for operating machinery or driving a car may be impaired.

4.8 Undesirable Effects

Exemestane was generally well tolerated across all clinical studies conducted with exemestane at a standard dose of 25 mg/day, and undesirable effects were usually mild to moderate.

The withdrawal rate due to adverse events was 7.4% in patients with early breast cancer receiving adjuvant treatment with exemestane following initial adjuvant tamoxifen therapy. The most commonly reported adverse reactions were hot flushes (22%), arthralgia (18%) and fatigue (16%).

The withdrawal rate due to adverse events was 2.8% in the overall patient population with advanced breast cancer. The most commonly reported adverse reactions were hot flushes (14%) and nausea (12%).

Most adverse reactions can be attributed to the normal pharmacological consequences of oestrogen deprivation (e.g. hot flushes).

The reported adverse reactions are listed below by system organ class and by frequency.

Frequencies are defined as:

Very common (

Common (

Uncommon (

Rare (

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Metabolism and nutrition disorders:
Common	Anorexia
Psychiatric disorders:
Very common	Insomnia
Common	Depression
Nervous system disorders:
Very common	Headache
Common	Dizziness, carpal tunnel syndrome
Uncommon	Somnolence
Vascular disorders:
Very common	Hot flushes
Gastrointestinal disorders:
Very common	Nausea
Common	Abdominal pain, vomiting, constipation, dyspepsia, diarrhoea
Skin and subcutaneous tissue disorders:
Very common	Increased sweating
Common	Rash, alopecia
Musculoskeletal and bone disorders:
Very common	Joint and musculoskeletal pain (Includes: arthralgia, and less frequently pain in limb, osteoarthritis, back pain, arthritis, myalgia and joint stiffness)
Common	Osteoporosis, fracture
General disorders and administration site conditions:
Very common	Fatigue
Common	Pain, peripheral oedema
Uncommon	Asthenia
Blood and lymphatic system disorders

In patients with advanced breast cancer thrombocytopenia and leucopenia have been rarely reported. An occasional decrease in lymphocytes has been observed in approximately 20% of patients receiving exemestane, particularly in patients with pre-existing lymphopenia; however, mean lymphocyte values in these patients did not change significantly over time and no corresponding increase in viral infections was observed. These effects have not been observed in patients treated in early breast cancer studies.

Hepatobiliary disorders

Elevation of liver function test parameters including enzymes, bilirubin and alkaline phosphatase have been observed.

The table below presents the frequency of pre-specified adverse events and illnesses in the early breast cancer study (IES), irrespective of causality, reported in patients receiving trial therapy and up to 30 days after cessation of trial therapy.

Adverse events and illnesses	Exemestane (N = 2249)	Tamoxifen (N = 2279)
Hot flushes	491 (21.8%)	457 (20.1%)
Fatigue	367 (16.3%)	344 (15.1%)
Headache	305 (13.6%)	255 (11.2%)
Insomnia	290 (12.9%)	204 (9.0%)
Sweating increased	270 (12.0%)	242 (10.6%)
Gynaecological	235 (10.5%)	340 (14.9%)
Dizziness	224 (10.0%)	200 (8.8%)
Nausea	200 (8.9%)	208 (9.1%)
Osteoporosis	116 (5.2%)	66 (2.9%)
Vaginal haemorrhage	90 (4.0%)	121 (5.3%)
Other primary cancer	84 (3.6%)	125 (5.3%)
Vomiting	50 (2.2%)	54 (2.4%)
Visual disturbance	45 (2.0%)	53 (2.3%)
Thromboembolism	16 (0.7%)	42 (1.8%)
Osteoporotic fracture	14 (0.6%)	12 (0.5%)
Myocardial infarction	13 (0.6%)	4 (0.2%)

In the IES study, the frequency of ischemic cardiac events in the exemestane and tamoxifen treatment arms was 4.5% versus 4.2%, respectively. No significant difference was noted for any individual cardiovascular event including hypertension (9.9% versus 8.4%), myocardial infarction (0.6% versus 0.2%) and cardiac failure (1.1% versus 0.7%).

In the IES study, exemestane was associated with a greater incidence of hypercholesterolemia compared with tamoxifen (3.7% vs. 2.1%).

In a separate double blinded, randomized study of postmenopausal women with early breast cancer at low risk treated with exemestane (N=73) or placebo (N=73) for 24 months , exemestane was associated with an average 7-9% mean reduction in plasma HDL-cholesterol, versus a 1% increase on placebo. There was also a 5-6% reduction in apolipoprotein A1 in the exemestane group versus 0-2% for placebo. The effect on the other lipid parameters analysed (total cholesterol, LDL cholesterol, triglycerides, apolipoprotein-B and lipoprotein-a) was very similar in the two treatment groups . The clinical significance of these results is unclear.

In the IES study, gastric ulcer was observed at a higher frequency in the exemestane arm compared to tamoxifen (0.7% versus <0.1%). The majority of patients on exemestane with gastric ulcer received concomitant treatment with non-steroidal anti-inflammatory agents and/or had a prior history.

Adverse reactions from post-marketing experience

Hepatobiliary disorders: Hepatitis, cholestatic hepatitis.

Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

4.9 Overdose

Clinical trials have been conducted with exemestane given up to 800 mg in a single dose to healthy female volunteers and up to 600 mg daily to postmenopausal women with advanced breast cancer; these dosages were well tolerated. The single dose of exemestane that could result in life-threatening symptoms is not known. In rats and dogs, lethality was observed after single oral doses equivalent respectively to 2000 and 4000 times the recommended human dose on a mg/m² basis. There is no specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Hormone antagonists and related agents; enzyme inhibitors. ATC code: L02BG06

Exemestane is an irreversible, steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione. In post-menopausal women, oestrogens are produced primarily from the conversion of androgens into oestrogens through the aromatase enzyme in peripheral tissues. Oestrogen deprivation through aromatase inhibition is an effective and selective treatment for hormone dependent breast cancer in postmenopausal women. In postmenopausal women, exemestane p.o. significantly lowered serum oestrogen concentrations starting from a 5 mg dose, reaching maximal suppression (>90%) with a dose of 10-25 mg. In postmenopausal breast cancer patients treated with the 25 mg daily dose, whole body aromatization was reduced by 98%.

Exemestane does not possess any progestogenic or oestrogenic activity. A slight androgenic activity, probably due to the 17-hydro derivative, has been observed mainly at high doses. In multiple daily doses trials, exemestane had no detectable effects on adrenal biosynthesis of cortisol or aldosterone, measured before or after ACTH challenge, thus demonstrating its selectivity with regard to the other enzymes involved in the steroidogenic pathway.

Glucocorticoid or mineralocorticoid replacements are therefore not needed. A non dose-dependent slight increase in serum LH and FSH levels has been observed even at low doses: this effect is, however, expected for the pharmacological class and is probably the result of feedback at the pituitary level due to the reduction in oestrogen levels that stimulate the pituitary secretion of gonadotropins also in postmenopausal women.

Adjuvant Treatment of Early Breast Cancer

In a multicentre, randomised, double-blind study, conducted in 4724 postmenopausal patients with oestrogen-receptor-positive or unknown primary breast cancer, patients who had remained disease-free after receiving adjuvant tamoxifen therapy for 2 to 3 years were randomised to receive 3 to 2 years of exemestane (25 mg/day) or tamoxifen (20 or 30 mg/day) to complete a total of 5 years of hormonal therapy.

After a median duration of therapy of about 30 months and a median follow-up of about 52 months, results showed that sequential treatment with exemestane after 2 to 3 years of adjuvant tamoxifen therapy was associated with a clinically and statistically significant improvement in disease-free survival (DFS) compared with continuation of tamoxifen therapy. Analysis showed that in the observed study period exemestane reduced the risk of breast cancer recurrence by 24% compared with tamoxifen (hazard ratio 0.76; p=0.00015). The beneficial effect of exemestane over tamoxifen with respect to DFS was apparent regardless of nodal status or prior chemotherapy.

Exemestane also significantly reduced the risk of contralateral breast cancer (hazard ratio 0.57, p=0.04158).

In the whole study population, a trend for improved overall survival was observed for exemestane (222 deaths) compared to tamoxifen (262 deaths) with a hazard ratio 0.85 (log-rank test: p = 0.07362), representing a 15% reduction in the risk of death in favor of exemestane. A statistically significant 23% reduction in the risk of dying (hazard ratio for overall survival 0.77; Wald chi square test: p = 0.0069) was observed for exemestane compared to tamoxifen when adjusting for the pre-specified prognostic factors (i.e., ER status, nodal status, prior chemotherapy, use of HRT and use of bisphosphonates).

Main efficacy results in all patients (intention to treat population) and oestrogen receptor positive patients are summarised in the table below:

Endpoint Population	Exemestane Events /N (%)	Tamoxifen Events /N (%)	Hazard Ratio (95% CI)	p-value*
Disease-free survival a
All patients	354 /2352 (15.1%)	453 /2372 (19.1%)	0.76 (0.67-0.88)	0.00015
ER+ patients	289 /2023 (14.3%)	370 /2021 (18.3%)	0.75 (0.65-0.88)	0.00030
Contralateral breast cancer
All patients	20 /2352 (0.9%)	35 /2372 (1.5%)	0.57 (0.33-0.99)	0.04158
ER+ patients	18 /2023 (0.9%)	33 /2021 (1.6%)	0.54 (0.30-0.95)	0.03048
Breast cancer free survival b
All patients	289 /2352 (12.3%)	373 /2372 (15.7%)	0.76 (0.65-0.89)	0.00041
ER+ patients	232 /2023 (11.5%)	305 /2021 (15.1%)	0.73 (0.62-0.87)	0.00038
Distant recurrence free survival c
All patients	248 /2352 (10.5%)	297 /2372 (12.5%)	0.83 (0.70-0.98)	0.02621
ER+ patients	194 /2023 (9.6%)	242 /2021 (12.0%)	0.78 (0.65-0.95)	0.01123
Overall survival d
All patients	222 /2352 (9.4%)	262 /2372 (11.0%)	0.85 (0.71-1.02)	0.07362
ER+ patients	178 /2023 (8.8%)	211 /2021 (10.4%)	0.84 (0.68-1.02)	0.07569

* Log-rank test; ER+ patients = oestrogen receptor positive patients;

^a Disease-free survival is defined as the first occurrence of local or distant recurrence, contralateral breast cancer, or death from any cause;

^b Breast cancer free survival is defined as the first occurrence of local or distant recurrence, contralateral breast cancer or breast cancer death;

^c Distant recurrence free survival is defined as the first occurrence of distant recurrence or breast cancer death;

^d Overall survival is defined as occurrence of death from any cause.

In the additional analysis for the subset of patients with oestrogen receptor positive or unknown status, the unadjusted overall survival hazard ratio was 0.83 (log-rank test: p = 0.04250), representing a clinically and statistically significant 17% reduction in the risk of dying.

Results from a bone substudy demonstrated that women treated with exemestane following 2 to 3 years of tamoxifen treatment experienced moderate reduction in bone mineral density. In the overall study, the treatment emergent fracture incidence evaluated during the 30 months treatment period was higher in patients treated with exemestane compared with tamoxifen (4.5% and 3.3% correspondingly, p = 0.038).

Results from an endometrial substudy indicate that after 2 years of treatment there was a median 33% reduction of endometrial thickness in the exemestane -treated patients compared with no notable variation in the tamoxifen-treated patients. Endometrial thickening, reported at the start of study treatment, was reversed to normal (< 5 mm) for 54% of patients treated with exemestane.

Treatment of Advanced Breast Cancer

In a randomised peer reviewed controlled clinical trial, exemestane at the daily dose of 25 mg has demonstrated statistically significant prolongation of survival, Time to Progression (TTP), Time to Treatment Failure (TTF) as compared to a standard hormonal treatment with megestrol acetate in postmenopausal patients with advanced breast cancer that had progressed following, or during, treatment with tamoxifen either as adjuvant therapy or as first-line treatment for advanced disease.

5.2 Pharmacokinetic Properties

Absorption

After oral administration, exemestane is absorbed rapidly. The fraction of the dose absorbed from the gastrointestinal tract is high. The absolute bioavailability in humans is unknown, although it is anticipated to be limited by an extensive first pass effect. A similar effect resulted in an absolute bioavailability in rats and dogs of 5%. After a single dose of 25 mg, maximum plasma levels of 18 ng/ml are reached after 2 hours. Concomitant intake with food increases the bioavailability by 40%.

Distribution

The volume of distribution of exemestane, not corrected for the oral bioavailability, is ca 20,000 l. The kinetics is linear and the terminal elimination half-life is 24 h. Binding to plasma proteins is 90% and is concentration independent. Exemestane and its metabolites do not bind to red blood cells.

Exemestane does not accumulate in an unexpected way after repeated dosing.

Metabolism and excretion

Exemestane is metabolised by oxidation of the methylene moiety on the 6 position by CYP 3A4 isoenzyme and/or reduction of the 17-keto group by aldoketoreductase followed by conjugation. The clearance of exemestane is ca 500 l/h, not corrected for the oral bioavailability.

The metabolites are inactive or the inhibition of aromatase is less than the parent compound.

The amount excreted unchanged in urine is 1% of the dose. In urine and faeces equal amounts (40%) of ¹⁴C-labeled exemestane were eliminated within a week.

Special populations

Age

No significant correlation between the systemic exposure of exemestane and the age of subjects has been observed.

Renal insufficiency

In patients with severe renal impairment (CL_cr < 30 ml/min) the systemic exposure to exemestane was 2 times higher compared with healthy volunteers.

Given the safety profile of exemestane, no dose adjustment is considered to be necessary.

Hepatic insufficiency

In patients with moderate or severe hepatic impairment the exposure of exemestane is 2-3 fold higher compared with healthy volunteers. Given the safety profile of exemestane, no dose adjustment is considered to be necessary.

5.3 Preclinical Safety Data

Toxicological studies

Findings in the repeat dose toxicology studies in rat and dog were generally attributable to the pharmacological activity of exemestane, such as effects on reproductive and accessory organs. Other toxicological effects (on liver, kidney or central nervous system) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Mutagenicity

Exemestane was not genotoxic in bacteria (Ames test), in V79 Chinese hamster cells, in rat hepatocytes or in the mouse micronucleus assay. Although exemestane was clastogenic in lymphocytes in vitro, it was not clastogenic in two in vivo studies.

Reproductive toxicology

Exemestane was embryotoxic in rats and rabbits at systemic exposure levels similar to those obtained in humans at 25 mg/day. There was no evidence of teratogenicity.

Carcinogenicity

In a two-year carcinogenicity study in female rats, no treatment-related tumors were observed. In male rats the study was terminated on week 92, because of early death by chronic nephropathy. In a two-year carcinogenicity study in mice, an increase in the incidence of hepatic neoplasms in both genders was observed at the intermediate and high doses (150 and 450 mg/kg/day). This finding is considered to be related to the induction of hepatic microsomal enzymes, an effect observed in mice but not in clinical studies. An increase in the incidence of renal tubular adenomas was also noted in male mice at the high dose (450 mg/kg/day). This change is considered to be species- and gender-specific and occurred at a dose which represents 63-fold greater exposure than occurs at the human therapeutic dose. None of these observed effects is considered to be clinically relevant to the treatment of patients with exemestane.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Povidone K30

Maize starch (bleached)

Starch, pregelatinized (partially)

Sodium starch glycolate, type A

Cellulose microcrystalline type 101

Talc

Silica, colloidal anhydrous

Magnesium stearate

Polysorbate 80

Film-coating:

Polyvinyl alcohol-partly hydrolyzed

Titanium dioxide (E171)

Macrogol 3350

Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

No special storage conditions

6.5 Nature And Contents Of Container

Al/PVC blister.

Pack sizes:

10, 30, 40, 60, 84, 90 and 100 film-coated tablets

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Rekjavíkurvegur 76-78,

220 Hafnarfjörður

Iceland

8. Marketing Authorisation Number(S)

PL 30306/0272

9. Date Of First Authorisation/Renewal Of The Authorisation

06/10/2010

10. Date Of Revision Of The Text

22/07/11

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)