Utrona-C

Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)

hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik

Commonly used brand name(s)

In the U.S.

• Phosphasal


• Urelle


• Uretron D/S


• Uribel


• Urimar-T


• UR N-C


• Ustell


• Uticap


• Utira-C


• Utrona-C

Available Dosage Forms:

• Tablet


• Capsule


• Tablet, Enteric Coated


• Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Hyoscyamine

Chemical Class: Salicylate, Non-Aspirin

Uses For Utrona-C

Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.

Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.

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

Before Using Utrona-C

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.

Geriatric

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

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.

• Amitriptyline


• Amoxapine


• Bupropion


• Cisapride


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Isocarboxazid


• Linezolid


• Maprotiline


• Mesoridazine


• Mirtazapine


• Nortriptyline


• Paroxetine


• Phenelzine


• Pimozide


• Potassium


• Protriptyline


• Selegiline


• Sertraline


• Sparfloxacin


• Thioridazine


• Tranylcypromine


• Trimipramine


• Venlafaxine


• Vilazodone

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.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Buspirone


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Trazodone


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Acetate


• Calcium Carbonate


• Calcium Citrate


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate

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:

• Congestive heart failure or


• Coronary heart disease or


• Glaucoma or


• Heart disease (e.g., mitral stenosis) or


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


• Myasthenia gravis (severe muscle weakness) or


• Stomach or intestinal (bowel) blockage or


• Stomach ulcers or


• Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

• Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this medicine also.

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Utrona-C. Please read with care.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

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 oral dosage form (tablets):
  
  • For treatment of symptoms of urinary tract infection or diagnostic procedure:
    
    • Adults—One tablet four times a day
    
    
    • Children 7 years of age and older—Use and dose must be determined by your doctor.
    
    
    • Children 6 years of age and younger—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

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 Utrona-C

It is very important that your doctor check the progress of you or your child 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.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

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.

Utrona-C 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:

Incidence not known

• Blurred vision


• dizziness


• rapid pulse

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

Incidence not known

• Blue-colored urine

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.

Antipsychotics

Antipsychotics act by blocking dopamine receptors in the brain and interfering with dopaminergic transmission. They are drugs, which are used to treat psychosis, including schizophrenia and mania.

Antipsychotics are classified as typical or atypical. Atypical antipsychotics are the recently developed drugs that are useful in patients that do not respond to treatment with other typical antipsychotics.

See also

• atypical antipsychotics
• phenothiazine antipsychotics
• thioxanthenes

Drug List:

Mevacor

Pronunciation: LOE-va-STAT-in
Generic Name: Lovastatin
Brand Name: Mevacor

Mevacor is used for:

Lowering high cholesterol in certain patients. It is used along with an appropriate diet. It is used in certain patients to reduce the risk of heart attack and chest pain caused by angina. It is also used to slow blood vessel blockage and to reduce the need for medical procedures to open blocked heart blood vessels. It may also be used for other conditions as determined by your doctor.

Mevacor is an HMG-CoA reductase inhibitor, also known as a "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Mevacor if:

• you are allergic to any ingredient in Mevacor


• you have liver problems or unexplained abnormal liver function tests


• you are pregnant or are breast-feeding


• you are taking a macrolide antibiotic (eg, clarithromycin, erythromycin), an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, mibefradil, nefazodone, or telithromycin

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

Before using Mevacor:

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

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


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


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


• if you have low blood pressure, a serious infection, kidney problems, diabetes, or a history of seizures


• if you are very ill, have certain muscle problems (eg, pain, weakness), or have metabolism, hormonal, or electrolyte problems


• if you drink alcohol or have a history of liver problems or alcohol abuse


• if you have a certain type of high cholesterol (homozygous familial hypercholesterolemia)


• if you have had an organ transplant or have recently had major surgery or a serious injury

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

• Amiodarone, certain azole antifungals (eg, itraconazole, ketoconazole), danazol, diltiazem, fibrates (eg, gemfibrozil, clofibrate), fluconazole, HIV protease inhibitors (eg, ritonavir ), imatinib, immunosuppressants (eg, cyclosporine), macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, nefazodone, niacin, non-nucleoside reverse transcriptase inhibitors (eg, delavirdine), streptogramins (eg, dalfopristin), telithromycin, vasopressin receptor antagonists (eg, conivaptan), verapamil, or voriconazole because they may increase the risk of muscle or kidney problems


• Bosentan, carbamazepine, rifampin, or St. John's wort because they may decrease Mevacor's effectiveness


• Anticoagulants (eg, warfarin), cimetidine, digoxin, hormonal birth control (eg, birth control pills), macrolide immunosuppressants (eg, tacrolimus), or spironolactone because the risk of their side effects may be increased by Mevacor

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

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

• Take Mevacor by mouth with food.


• Eating grapefruit or drinking grapefruit juice may increase the amount of Mevacor in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than one quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking Mevacor.


• Continue to take Mevacor even if you feel well. Do not miss any doses.


• If you miss a dose of Mevacor, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


• Drinking alcohol daily or in large amounts may increase the risk of liver problems with Mevacor. Check with your doctor before drinking alcohol while you are taking Mevacor.


• Follow the diet and exercise program given to you by your health care provider.


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


• Women who may become pregnant should use effective birth control while taking Mevacor. Check with your doctor if you have questions about using birth control.


• Do NOT take more than the recommended dose without checking with your doctor.


• Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort.


• Lab tests, including blood cholesterol levels, liver function tests, and creatine phosphokinase (CPK) blood levels, may be performed while you use Mevacor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Mevacor with caution in the ELDERLY; they may be more sensitive to its effects, especially serious muscle problems.


• Mevacor should be used with extreme caution in CHILDREN younger than 10 years old and in those who have not reached puberty; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Mevacor if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Mevacor is found in breast milk. Do not breast-feed while you are taking Mevacor.

Possible side effects of Mevacor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation.

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); chest pain; dark urine; muscle pain, tenderness, or weakness (with or without fever or fatigue); pale stools; red, swollen, blistered, or peeling skin; severe stomach pain; yellowing of the skin or eyes.

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

See also: Mevacor side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Mevacor:

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

General information:

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


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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mevacor resources

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

• Mevacor Prescribing Information (FDA)


• Mevacor Advanced Consumer (Micromedex) - Includes Dosage Information


• Lovastatin Prescribing Information (FDA)


• Lovastatin Professional Patient Advice (Wolters Kluwer)


• Lovastatin Monograph (AHFS DI)


• Altocor Consumer Overview


• Altoprev Prescribing Information (FDA)

Compare Mevacor with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

Somatropin (rDNA origin - Nonrefrigerated)

Pronunciation: soe-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Nonrefrigerated)
Brand Name: Saizen

Somatropin (rDNA origin - Nonrefrigerated) is used for:

Treating certain children or adults when the body does not produce enough growth hormone. It may also be used for other conditions as determined by your doctor.

Somatropin (rDNA origin - Nonrefrigerated) is a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Somatropin (rDNA origin - Nonrefrigerated) if:

• you are allergic to any ingredient in Somatropin (rDNA origin - Nonrefrigerated)


• you have or are currently being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing


• you have vision problems due to diabetes (diabetic retinopathy), premature epiphyseal closure (your bone growth is complete), or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)


• you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

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

Before using Somatropin (rDNA origin - Nonrefrigerated):

Some medical conditions may interact with Somatropin (rDNA origin - Nonrefrigerated). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have pituitary or adrenal gland problems, diabetes or a family history of diabetes, an underactive thyroid, curvature of the spine (scoliosis), kidney or liver problems, breathing problems, or Prader-Willi syndrome


• if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer


• if you are severely overweight or have had recent major surgery or trauma

Some MEDICINES MAY INTERACT with Somatropin (rDNA origin - Nonrefrigerated). However, no specific interactions with Somatropin (rDNA origin - Nonrefrigerated) are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Somatropin (rDNA origin - Nonrefrigerated) 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 Somatropin (rDNA origin - Nonrefrigerated):

Use Somatropin (rDNA origin - Nonrefrigerated) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Somatropin (rDNA origin - Nonrefrigerated) is sometimes used at home as an injection. Before you use Somatropin (rDNA origin - Nonrefrigerated), a health care provider will provide detailed instructions for its appropriate use. Ask any questions that you may have about Somatropin (rDNA origin - Nonrefrigerated) or giving injections.


• If you are using Somatropin (rDNA origin - Nonrefrigerated) at home, carefully follow the injection procedures taught to you by your health care provider. If the medicine contains particles, is discolored, or if the vial/container is cracked or damaged in any way, do not use it.


• Always change the location where you inject Somatropin (rDNA origin - Nonrefrigerated).


• Do not shake Somatropin (rDNA origin - Nonrefrigerated). Swirl the vial gently to mix it.


• If you miss a dose of Somatropin (rDNA origin - Nonrefrigerated), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Somatropin (rDNA origin - Nonrefrigerated).

Important safety information:

• Somatropin (rDNA origin - Nonrefrigerated) may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.


• Rare, sometimes fatal, lung and breathing problems may be caused by Somatropin (rDNA origin - Nonrefrigerated) in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Somatropin (rDNA origin - Nonrefrigerated), contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Somatropin (rDNA origin - Nonrefrigerated). Somatropin (rDNA origin - Nonrefrigerated) may need to be stopped.


• Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Somatropin (rDNA origin - Nonrefrigerated). The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.


• Rarely, children using Somatropin (rDNA origin - Nonrefrigerated) have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.


• Never reuse needles and syringes. Follow your health care provider's instructions for proper disposal of needles and syringes. Ask your health care provider or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full.


• Somatropin (rDNA origin - Nonrefrigerated) may contain benzyl alcohol. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol.


• Diabetes patients - Somatropin (rDNA origin - Nonrefrigerated) may affect your blood sugar levels. Check your blood sugar levels closely and ask your doctor before adjusting your diabetes medicine or changing your diet.


• Lab tests, including blood electrolytes, thyroid function, and eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Somatropin (rDNA origin - Nonrefrigerated) with caution in the ELDERLY because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss the benefits and risks of using Somatropin (rDNA origin - Nonrefrigerated) during pregnancy with your doctor. It is unknown if Somatropin (rDNA origin - Nonrefrigerated) is excreted in breast milk. If you plan to breast-feed while you are using Somatropin (rDNA origin - Nonrefrigerated), talk with your doctor about the risks to your baby.

Possible side effects of Somatropin (rDNA origin - Nonrefrigerated):

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild flu-like symptoms; mild swelling (eg, of the hands or feet); muscle or joint pain; nausea; nerve tingling; numbness; runny or stuffy nose; trouble sleeping.

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); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; constant feeling of need to empty the bowel; curvature of the spine; depression; ear infection; excessive thirst or hunger; fast heartbeat; fever; frequent urination; infection; nausea; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; severe, persistent, or unusual headaches; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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

See also: Somatropin (rDNA origin - Nonrefrigerated) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include: excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Somatropin (rDNA origin - Nonrefrigerated):

Store unmixed medicine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. After mixing, store Somatropin (rDNA origin - Nonrefrigerated) according to the product label. Contact your pharmacist if you have questions about the proper storage of Somatropin (rDNA origin - Nonrefrigerated). Keep Somatropin (rDNA origin - Nonrefrigerated), as well as needles and syringes, out of the reach of children and away from pets.

General information:

• If you have any questions about Somatropin (rDNA origin - Nonrefrigerated), please talk with your doctor, pharmacist, or other health care provider.


• Somatropin (rDNA origin - Nonrefrigerated) 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 Somatropin (rDNA origin - Nonrefrigerated). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Somatropin (rDNA origin - Nonrefrigerated) resources

• Somatropin (rDNA origin - Nonrefrigerated) Side Effects (in more detail)
• Somatropin (rDNA origin - Nonrefrigerated) Use in Pregnancy & Breastfeeding
• Somatropin (rDNA origin - Nonrefrigerated) Drug Interactions
• Somatropin (rDNA origin - Nonrefrigerated) Support Group
• 13 Reviews for Somatropin (rDNA origin - Nonrefrigerated) - Add your own review/rating

Compare Somatropin (rDNA origin - Nonrefrigerated) with other medications

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Tylenol Maximum Strength Flu Nighttime

Pronunciation: a-seet-a-MIN-oh-fen/dye-fen-HYE-dra-meen/sue-do-eh-FED-rin
Generic Name: Acetaminophen/Diphenhydramine/Pseudoephedrine
Brand Name: Examples include Benadryl Allergy/Cold and Tylenol Maximum Strength Flu Nighttime

Tylenol Maximum Strength Flu Nighttime is used for:

Relieving symptoms such as pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Tylenol Maximum Strength Flu Nighttime is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Tylenol Maximum Strength Flu Nighttime if:

• you are allergic to any ingredient in Tylenol Maximum Strength Flu Nighttime


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


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

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

Before using Tylenol Maximum Strength Flu Nighttime:

Some medical conditions may interact with Tylenol Maximum Strength Flu Nighttime. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, chronic bronchitis, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

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

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol Maximum Strength Flu Nighttime may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tylenol Maximum Strength Flu Nighttime


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tylenol Maximum Strength Flu Nighttime

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Maximum Strength Flu Nighttime 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 Tylenol Maximum Strength Flu Nighttime:

Use Tylenol Maximum Strength Flu Nighttime as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol Maximum Strength Flu Nighttime may be taken with or without food.


• If you miss a dose of Tylenol Maximum Strength Flu Nighttime, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Maximum Strength Flu Nighttime.

Important safety information:

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


• Do not take diet or appetite control medicines while you are taking Tylenol Maximum Strength Flu Nighttime without checking with you doctor.


• Tylenol Maximum Strength Flu Nighttime contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Tylenol Maximum Strength Flu Nighttime for longer than prescribed without checking with your doctor.


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


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


• Tylenol Maximum Strength Flu Nighttime may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol Maximum Strength Flu Nighttime or other pain relievers/fever reducers. Alcohol use combined with Tylenol Maximum Strength Flu Nighttime may increase your risk for liver damage.


• If you are scheduled for allergy skin testing, do not take Tylenol Maximum Strength Flu Nighttime for several days before the test because it may decrease your response to the skin tests.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol Maximum Strength Flu Nighttime.


• Use Tylenol Maximum Strength Flu Nighttime with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Tylenol Maximum Strength Flu Nighttime in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol Maximum Strength Flu Nighttime, discuss with your doctor the benefits and risks of using Tylenol Maximum Strength Flu Nighttime during pregnancy. It is unknown if Tylenol Maximum Strength Flu Nighttime is excreted in breast milk. Do not breast-feed while taking Tylenol Maximum Strength Flu Nighttime.

Possible side effects of Tylenol Maximum Strength Flu Nighttime:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

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

See also: Tylenol Maximum Strength Flu Nighttime side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Tylenol Maximum Strength Flu Nighttime:

Store Tylenol Maximum Strength Flu Nighttime at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Maximum Strength Flu Nighttime out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Maximum Strength Flu Nighttime, please talk with your doctor, pharmacist, or other health care provider.


• Tylenol Maximum Strength Flu Nighttime 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 Tylenol Maximum Strength Flu Nighttime. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tylenol Maximum Strength Flu Nighttime resources

• Tylenol Maximum Strength Flu Nighttime Side Effects (in more detail)
• Tylenol Maximum Strength Flu Nighttime Use in Pregnancy & Breastfeeding
• Tylenol Maximum Strength Flu Nighttime Drug Interactions
• 0 Reviews for Tylenol Maximum Strength Flu Nighttime - Add your own review/rating

Compare Tylenol Maximum Strength Flu Nighttime with other medications

• Rhinitis

Visine-A

Pronunciation: naf-AZ-oh-leen/fen-EAR-ay-meen
Generic Name: Naphazoline/Pheniramine
Brand Name: Examples include Naphcon-A and Visine-A

Visine-A is used for:

Temporarily relieving itchy, red eyes caused by allergies to things such as pollen, ragweed, grass, or animal hair and dander.

Visine-A is a decongestant and antihistamine combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery, itchy eyes. The decongestant constricts (narrows) the blood vessels, which reduces eye redness.

Do NOT use Visine-A if:

• you are allergic to any ingredient in Visine-A


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

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

Before using Visine-A:

Some medical conditions may interact with Visine-A. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have diabetes, an enlarged prostate, heart disease, high blood pressure, an overactive thyroid, narrow-angle glaucoma, or trouble urinating

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

• Furazolidone or MAO inhibitors (eg, phenelzine) because the risk of severe high blood pressure and fast heartbeat may be increased

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

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

• If Visine-A contains particles or is discolored, do not use it.


• Remove contact lenses before using Visine-A.


• To use Visine-A, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including your eye. Keep the container tightly closed.


• You may feel a brief tingling sensation in your eye and your pupils may become temporarily enlarged when using Visine-A.


• If you miss a dose of Visine-A and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Visine-A.

Important safety information:

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


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


• Overuse of topical products may worsen your condition.


• Visine-A is not recommended for use in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Visine-A:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Eye redness; tingling sensation.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in vision; eye pain; halos around lights; persistent redness or irritation.

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

See also: Visine-A side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Visine-A:

Store Visine-A at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Keep Visine-A out of the reach of children and away from pets.

General information:

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


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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Visine-A resources

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

Compare Visine-A with other medications

• Eye Redness/Itching

Effient

Generic Name: prasugrel (Oral route)

PRA-soo-grel

Oral route(Tablet)

Prasugrel can cause significant, sometimes fatal, bleeding in patients with active pathological bleeding or a propensity to bleed, a history of transient ischemic attack or stroke, a body weight of less than 60 kg, or concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytics, chronic use of NSAIDs). Prasugrel is not recommended in patients 75 years of age and older, except for high-risk situations (diabetes, history of prior myocardial infarction). Do not start prasugrel in patients likely to undergo urgent CABG and discontinue at least 7 days prior to any surgery. If possible, manage bleeding without discontinuing prasugrel, as discontinuation in the first few weeks after acute coronary syndrome may increase risk for subsequent cardiovascular events .

Commonly used brand name(s)

In the U.S.

• Effient

Available Dosage Forms:

• Tablet

Therapeutic Class: Platelet Aggregation Inhibitor

Pharmacologic Class: ADP-Induced Aggregation Inhibitor

Uses For Effient

Prasugrel is used to prevent strokes, heart attacks, or other serious problems with your heart or blood vessels. It is given to patients before they have a heart procedure called percutaneous coronary intervention (PCI).

A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Prasugrel reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping or sticking together. Prasugrel may also increase the chance for serious bleeding in some people.

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

Before Using Effient

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 prasugrel 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 prasugrel in the elderly. Because of prasugrel's toxicity, use in elderly patients 75 years of age and older is not recommended.

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 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


• Cilostazol


• Citalopram


• Dabigatran Etexilate


• Desirudin


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Nefazodone


• Paroxetine


• Rivaroxaban


• Sertraline


• Warfarin

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:

• Bleeding (eg, head, stomach, or bowel bleeding), active or


• Stroke, history of or


• Transient ischemic attack (TIA) or "mini-stroke", history of—Should not be used in patients with these conditions.

• Hypersensitivity reaction to clopidogrel (Plavix®) or ticlopidine (Ticlid®), history of or


• Liver disease, severe or


• Low body weight (less than 60 kilograms or 132 pounds) or


• Stomach or bowel bleeding, recurrent or


• Stomach ulcer or


• Surgery or other procedures (eg, heart bypass surgery, coronary angiography, PCI), recent or


• Trauma, recent—Use with caution. May increase risks for more serious side effects.

Proper Use of Effient

Take this medicine exactly as directed by your doctor. 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.

Do not stop taking this medicine without checking with your doctor first. To do so may increase your risk for clots.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

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 oral dosage form (tablets):
  
  • For prevention of heart attacks or strokes:
    
    • Adults weighing 60 kilograms (kg) and above—At first, 60 milligrams (mg) taken as a single loading dose, and then 10 mg once a day. You may take this medicine with aspirin (75 to 325 mg) once a day.
    
    
    • Adults weighing less than 60 kilograms (kg)—At first, 60 milligrams (mg) taken as a single loading dose, and then 5 mg once a day.
    
    
    • 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 Effient

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. Blood tests may be needed to check for unwanted effects.

Tell all of your medical doctors, dentists, and nurses that you are taking this medicine. Prasugrel may increase the risk of serious bleeding during an operation or some dental procedures. Treatment may have to be stopped about 7 days before the operation or dental procedure.

Check with your doctor right away if you have the following symptoms: change in mental status, dark or bloody urine, difficulty with speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, weakness, yellow eyes or skin. These may be symptoms of a serious condition called thrombotic thrombocytopenic purpura (TTP).

This medicine may cause serious allergic reactions, including angioedema. Angioedema can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have chest pain; a rash; itching; swelling of the face, lips, tongue, or throat; or trouble with swallowing or breathing while you are using the medicine.

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.

Effient 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

• Blurred vision


• dizziness


• headache


• nervousness


• pounding in the ears


• slow or fast heartbeat

Less common

• Black, tarry stools


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


• chest pain or discomfort


• chills


• cough


• difficult or labored breathing


• fainting


• fever


• irregular heartbeat


• lightheadedness, dizziness, or fainting


• painful or difficult urination


• rapid weight gain


• shortness of breath


• sore throat


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


• swollen glands


• tightness in the chest


• tingling of the hands or feet


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• wheezing

Incidence not known

• Change in mental status


• dark or bloody urine


• difficulty with speaking


• fever


• pale color of the skin


• pinpoint red spots on the skin


• seizures


• weakness


• yellow eyes or skin

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

Less common

• Back pain


• diarrhea


• nausea


• pain in the arms or legs


• rash

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: Effient 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 Effient resources

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

• Effient Prescribing Information (FDA)


• Effient Consumer Overview


• Effient Monograph (AHFS DI)


• Effient MedFacts Consumer Leaflet (Wolters Kluwer)


• Prasugrel Professional Patient Advice (Wolters Kluwer)

Compare Effient with other medications

• Acute Coronary Syndrome

Agents for hypertensive emergencies

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Agents for hypertensive emergencies are given parenterally as it is critical to reduce the blood pressure immediately because at that stage it could be life threatening. Hypertensive emergencies are hypertensive encephalopathy, eclampsia, acute left ventricular failure and acute heart failure.

Generally, agents used in hypertensive emergencies are vasodilators, which widen blood vessels and reduce blood pressure.

See also

Medical conditions associated with agents for hypertensive emergencies:

• Heart Failure
• Hypertensive Emergency
• Hypoglycemia
• Prevention of Radiographic Contrast Nephropathy

Drug List:

Corlopam

Hyperstat

Nitropress

Proglycem-Suspension

Aminosalicylates

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Aminosalicylates or aminosalicylic acid is used with other drugs to treat tuberculosis. Aminosalicylic acid is thought to inhibit folic acid synthesis and/or inhibit synthesis of a component of the cell wall. It is bacteriostatic against Mycobacterium tuberculosis. Aminosalicylates also prevent development of bacterial resistance to drugs such as streptomycin and isoniazid.

See also

Medical conditions associated with aminosalicylates:

• Tuberculosis, Active
• Tuberculosis, Resistant

Drug List:

Paser-Controlled-Release-Granules-Packet

Atenolol Tablets BP 50mg

1. Name Of The Medicinal Product

ATENOLOL TABLETS BP 50mg

2. Qualitative And Quantitative Composition

Each tablet contains 50mg Atenolol PhEur.

3. Pharmaceutical Form

Film-coated tablets

White, circular, biconvex film-coated tablets impressed “A” on one side and “H” on the other side of a score line on one face, plain on the reverse.

The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

1) For the management of hypertension, angina pectoris and cardiac dysrhythmias.

2) For early intervention in the acute phase of myocardial infarction.

4.2 Posology And Method Of Administration

Posology

Adults and children over 12 years:

Hypertension: Most patients respond to 100mg daily given as a single dose. Some patients, however, will respond to 50mg given as a single daily dose. The effect will be fully established after one to two weeks. A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents.

Angina: Most patients respond to 100mg once daily or 50mg twice daily. It is unlikely that a higher daily dose would be additionally beneficial.

Dysrhythmias: Initially controlled intravenously. A suitable oral maintenance dosage is 50-100mg daily, given as a single dose.

Myocardial Infarction: In suitable patients, initially controlled intravenously, followed by 50mg orally about 15 minutes after the intravenous dose provided no adverse effects occur. This should be followed by a further 50mg orally 12 hours later and then 12 hours later by 100mg orally to be given once daily.

If bradycardia and/or hypotension requiring treatment, or other adverse effects occur, atenolol should be discontinued.

The Elderly: Dosage requirements may be reduced, especially in patients with impaired renal function.

Children under 12 years: Atenolol is not recommended for use in children under 12 years of age.

Renal failure: Atenolol is excreted via the kidneys, therefore the dosage will need to be adjusted in severe renal conditions. No significant accumulation of atenolol occurs at a GFR greater than 35ml/min/1.73m² (normal range is 100-150ml/min/1.73m²). For patients with a creatinine clearance of 15-35ml/min/1.73m² the oral dose should be 50mg daily or 100mg once every two days, and for those with a creatinine clearance of less than 15ml/min/1.73m² the oral dose should be 50mg once every two days or 100mg once every four days.

Patients on haemodialysis should be given 50mg orally after each dialysis, when careful observations for a fall in blood pressure should be exercised.

Method of Administration

For oral administration.

4.3 Contraindications

Atenolol, as with other beta-blockers, should not be used in patients with any of the following:

• Second or third degree heart block

• Cardiogenic shock

• Uncontrolled heart failure

• Sick sinus syndrome (including sino-atrial block)

• Untreated phaeochromocytoma

• Metabolic acidosis

• Bradycardia (less than 45-50 beats per minute)

• Hypotension

• Hypersensitivity to atenolol or any of the excipients

• Severe peripheral circulatory disturbances.

4.4 Special Warnings And Precautions For Use

Heart Failure: care must be exercised in patients with heart failure because of the negative inotropic effects of atenolol. Such patients should be well controlled on digitalis before therapy commences. Close monitoring for progressive failure is essential. Similarly, care must be taken with patients with poor cardiac reserve.

Ischaemic Heart disease: especially in patients with ischaemic heart disease, treatment should not be discontinued suddenly. The dosage should be gradually reduced, i.e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris.

Untreated Congestive Heart disease: beta-blockers should not be used in such patients. The condition should be stabilised first.

First Degree Heart Block: due to its negative effect on conduction time, beta-blockers should only be given with caution to such patients.

Bradycardia: beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.

Prinzmetal's angina: beta-blockers may increase the number and duration of anginal attacks in patients with Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction. Non-selective beta-blockers should not be used for these patients, and beta-1 selective blockers only with the utmost care.

Peripheral Circulatory Disease: In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur.

Respiratory Disorders: atenolol is cardioselective but not totally cardiospecific. Therefore, if it is necessary to use atenolol in patients with a history of asthma, bronchospasm or reversible obstructive airways disease, it should be introduced carefully. If an increase in airways resistance occurs, this can usually be reversed by bronchodilators such as salbutamol or terbutaline.

Patient information leaflets and labels will carry the following warnings:

Patient Information Leaflet: Do not take this medicine if you have a history of wheezing or asthma. Consult your doctor or pharmacist first.

Labels: Do not take this medicine if you have a history of wheezing or asthma.

Liver or Kidney Insufficiency: patients with liver or kidney insufficiency may need a lower dosage, depending on the pharmacokinetic profile of the compound.

Phaeochromocytoma: atenolol should not be administered to patients with phaeochromocytoma without concurrent α-adrenoceptor blocking therapy.

Diabetics: the symptoms of hypoglycaemia may be masked by atenolol, in particular tachycardia. Diabetic patients should be warned that this 'warning sign' may not occur.

Insulin sensitivity may be reduced in patients treated with atenolol.

Thyrotoxicosis: atenolol as with other beta-blockers may mask the signs of thyrotoxicosis.

Allergies: beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions. Such patients may be unresponsive to the usual doses of adrenaline (epinephrine) used to treat allergic reactions.

Hypersensitivity: atenolol may cause a hypersensitivity reaction including angio-oedema and urticaria.

Psoriasis: patients with anamnestically known psoriasis should take beta-blockers only after careful consideration.

Elderly: these patients should be treated with caution, starting with a lower dosage but tolerance is usually good in the elderly.

Anaesthesia: in patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance beta-blockade be continued peri-operatively. The anaesthesist must be aware of beta-blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

• Alcohol – concomitant use with alcohol may lead to an enhanced hypotensive effect.

• Alpha blockers – some patients experience acute postural hypotension, tachycardia and palpitations when they start to take certain alpha blockers

• (e.g. prazosin, alfuzosin, and terazosin), this can be exacerbated if they are already taking a beta-blocker. It is recommended that they should start with a low dose of these alpha blockers, and the first dose should be taken just before they go to bed. Patients should be warned about the possibility of postural hypotension and how to manage it (lay down, raise legs and get up slowly). When adding a beta-blocker to an alpha blocker it may be advisable to decrease the dose of the alpha blocker and re-titrate as necessary.

• Anaesthetics – caution must be exercised when using anaesthetic agents with atenolol (see section 4.4). The anaesthetist should be informed and the choice of anaesthetic should be an agent with as little negative inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.

• Anti-arrhythmics - caution should be exercised when prescribing a beta-adrenoceptor blocking drug with Class I antiarrhythmic agents such as disopyramide, quinidine and amiodarone.

• Antidiabetics - concomitant use with insulin and oral antidiabetic drugs may intensify the blood sugar lowering effect. Beta-adrenergic blockade may prevent the appearance of signs of hypoglycaemia (tachycardia). (See section 4.4).

• Calcium channel blockers – concomitant administration of dihydropyridine derivatives (e.g. nifedipine), may increase the risk of hypotension, and in patients with latent cardiac insufficiency, treatment with beta-blocking agents may lead to cardiac failure. Beta-adrenoceptor blocking drugs should be used with caution in combination with verapamil and to a lesser extent diltiazem in patients with impaired ventricular function, and not at all in patients with conduction abnormalities due to the negative influence on contractility and auriculo-ventricular conduction. May result in severe hypotension, bradycardia and cardiac failure.

• Cardiac glycosides - digitalis glycosides in association with beta-blockers may increase auriculo-ventricular conduction time.

• Clonidine - care should be taken when transferring patients from clonidine to beta-adrenoceptor blocking agents; and if they are given concurrently, clonidine should not be discontinued until several days after the withdrawal of the beta-adrenoceptor.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. indometacin) may reduce the hypotensive effect of beta-blockers.

• Beta-sympathomimetic agents (e.g. isoprenaline, dobutamine) – combination with atenolol may reduce effects of both agents.

• Sympathomimetics that activate both beta- and alpha-adrenoceptors (e.g. noradrenaline (norepinephrine), adrenaline (epinephrine) – combination with atenolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication. Such interactions are considered to be more likely with non selective beta-blockers.

• Concomitant use with antihypertensive agents as well as other drugs with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension.

4.6 Pregnancy And Lactation

Atenolol has been used under close supervision for the treatment of pregnancy-associated hypertension in the third trimester. Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation. No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol crosses the placental barrier and appears in cord blood.

Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period.

There is significant accumulation of atenolol in breast milk. Breast feeding is therefore not recommended during administration of these compounds.

The possibility of foetal injury cannot be excluded and the use of atenolol in women who are, or may become pregnant, or who are breast feeding, requires that anticipated benefits be weighed against possible risks, particularly in the first and second trimester.

4.7 Effects On Ability To Drive And Use Machines

There are no studies on the effect of this medicine on the ability to drive. When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.

4.8 Undesirable Effects

The following undesirable effects have been observed during treatment with atenolol and other beta blockers with the following frequencies: Common (>1/100), uncommon (>1/1,000, <1/100), rare (>1/10000, < 1/1000) very rare (<1/10000), including isolated reports.

• Blood and Lymphatic System Disorders

Rare: Thrombocytopenia.

• Endocrine Disorders

Beta-blockers may mask the symptoms of thyrotoxicosis.

• Metabolic and Nutrition Disorders

Beta-blockers may mask the symptoms of hypoglycaemia.

• Psychiatric Disorders

Uncommon: Sleep disturbances.

Rare: Hallucinations, psychoses, confusion, mood changes and nightmares have been reported. Rarely cases of insomnia have been reported.

Unknown: Depression

• Nervous System Disorders

Rare: Dizziness, headaches, paraesthesia.

• Eye Disorders

Rare: Dry eyes, impaired vision.

• Cardiac Disorders

Common: Bradycardia,

Rare: A slowed AV-conduction or increase of an existing AV-block, postural hypotension which may be associated with syncope, heart failure deterioration

Unknown: cardiac arrest and circulatory collapse.

• Vascular Disorders

Common: Cold extremities.

Rare: increase of an existing intermittent claudication, Raynauds phenomenon

Unknown: Cyanotic extremities.

• Respiratory Disorders

Rare: Bronchospasm in patients with bronchial asthma or a history of asthmatic complaints.

• Gastrointestinal Disorders

Common: Nausea, diarrhoea, gastrointestinal disturbances.

Rare: Dry mouth.

Unknown: Vomiting.

• Hepatobiliary Disorders

Uncommon: Elevations of transaminase levels

Rare: cases of hepatic toxicity, including intrahepatic cholestasis have been reported.

• Skin and Subcutaneous Tissue Disorders

Rare: Skin rash, purpura, exacerbation of psoriasis, alopecia, psoriasiform skin reactions.

Unknown: Hypersensitivity reactions, including angio-oedema, urticaria.

• Musculoskeletal and Connective Tissue Disorders:

Common: Muscle fatigue.

• Reproductive system and breast disorders:

Rare: Impotence

• General Disorders and Administration Site Conditions:

Common: Fatigue.

• Investigations:

Very rare: an increase in Anti Nuclear Antibodies has been reported.

Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions. In all cases cessation of therapy should be gradual.

4.9 Overdose

The most important effects are on the heart. Bradycardia, hypotension, pulmonary oedema, syncope and cardiogenic shock may develop. First or second degree AV block may occur and rarely arrhythmias.

After ingestion of an overdose or in the case of hypersensitivity, the patient should be kept under close supervision and treated in an intensive care ward.

Activated charcoal and a laxative should be used to prevent absorption of any drug still present in the gastrointestinal tract, plasma or plasma substitutes can be used to treat hypotension or shock. The use of haemodialysis or haemoperfusion may be considered.

Excessive bradycardia can be treated with atropine 1-2mg intravenously and or a cardiac pacemaker. If necessary, this may be followed by a bolus dose of glucagon 10mg intravenously and if required, this may be repeated or followed by an intravenous infusion of glucagon 1-10mg/hour depending on response. If no response to glucagon occurs or if glucagon is unavailable, a beta-adrenoceptor stimulant such as dobutamine 2.5 to 10 micrograms/kg/minute by intravenous infusion may be given. Dobutamine, because of its positive inotropic effect could also be used to treat hypotension and acute cardiac insufficiency. It is likely that these doses would be inadequate to reverse the cardiac effects of beta-blocker blockade if a large overdose has been taken. The dose of dobutamine should therefore be increased if necessary to achieve the required response according to the clinical condition of the patient. Bronchospasm can usually be reversed by bronchodilators.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC CODE CO7A B03

Atenolol is a beta-adrenoceptor blocking agent which is cardioselective, its principal action being on beta-adrenergic receptors in the heart. It is without intrinsic sympathomimetic and membrane stabilising activities and as with other beta-blockers, has negative inotropic effects (and is therefore contraindicated in uncontrolled heart failure). Its mode of action in the treatment of hypertension is unclear.

It is probably the action of atenolol in reducing cardiac rate and contractility which makes it effective in eliminating or reducing the symptoms of patients with angina.

It is unlikely that any additional ancillary properties possessed by S (-) atenolol, in comparison with the racemic mixture, will give rise to different therapeutic effects.

Atenolol is effective and well-tolerated in most ethnic populations. However the response may be less in black patients.

Atenolol is effective for at least 24 hours after a single oral dose. The drug facilitates compliance by its acceptability to patients and simplicity of dosing. The narrow dose range and early patient response ensure that the effect of the drug in individual patients is quickly demonstrated. Atenolol is compatible with diuretics, other hypotensive agents and antianginals (but see section 4.5). Since it acts preferentially on beta-receptors in the heart, atenolol may, with care, be used successfully in the treatment of patients with respiratory disease, who cannot tolerate non-selective beta-blockers.

Human studies have shown that a negligible amount of atenolol crosses the blood brain barrier.

Early intervention in acute myocardial infarction reduces infarct size and may decrease morbidity and morality. Fewer patients with a threatened infarction progress to frank infarction; the incidence of ventricular arrhythmias is decreased and marked pain relief may result in reduced need of opiate analgesics. Early mortality is decreased. Atenolol is an additional treatment to standard coronary care.

5.2 Pharmacokinetic Properties

Absorption: following oral dosing of atenolol absorption is consistent but incomplete (approximately 40 – 50 %) with peak plasma concentrations occurring 2 – 4 hours after dosing.

Distribution: only small amounts are reported to cross the blood-brain barrier and plasma-protein binding is minimal (approximately 3%). The plasma half-life is about 6-7 hours but this may rise in severe renal impairment since the kidney is the major route of elimination.

(Women - it crosses the placenta and is distributed into breast milk where concentrations higher than those in maternal plasma have been achieved).

Metabolism: atenolol undergoes little or no hepatic metabolism and more than 90% of that absorbed reaches systemic circulation unaltered.

Elimination: mainly in the urine.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Also contains:

Tablet core:

Silica colloidal anhydrous

Magnesium stearate

Maize starch

Crospovidone

Sodium laurylsulphate

Hydrogenated vegetable oil

Calcium hydrogen phosphate dihydrate (E341)

Cellulose microcrystalline (E460)

Tablet coat:

Propylene glycol

Titanium dioxide (E171)

Hypromellose 5cP (E464)

Purified talc (E553)

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life

Three years from the date of manufacture.

Shelf-life after dilution/reconstitution

Not applicable.

Shelf-life after first opening

Not applicable.

6.4 Special Precautions For Storage

Blister packs

Do not store above 25ºC

Store in the original package

Keep container in the outer carton

Polypropylene containers, polyethylene containers and amber glass bottles

Do not store above 25°C

Store in the original container

Keep the container tightly closed

6.5 Nature And Contents Of Container

The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250 µm white rigid PVC. (ii) Surface printed 20 µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack sizes: 28s, 30s, 50s, 100s, 250s, 500s.

Product may also be supplied in bulk packs for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Actavis UK Limited

(Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 0142/0259

9. Date Of First Authorisation/Renewal Of The Authorisation

28.4.89

Renewed: 16.3.95

10. Date Of Revision Of The Text

06.09.2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)