bevacizumab Intravenous

be-va-SIZ-yoo-mab

Intravenous route(Solution)

Gastrointestinal perforation, some cases fatal, has occurred in up to 2.4% of bevacizumab-treated patients. Discontinue bevacizumab if gastrointestinal perforation or wound dehiscence occurs. Discontinue at least 28 days prior to elective surgery. Do not initiate bevacizumab for at least 28 days after surgery and until the surgical wound is fully healed. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding, have occurred up to 5-fold more frequently in bevacizumab-treated patients. Do not administer bevacizumab to patients with serious hemorrhage or recent hemoptysis .

Commonly used brand name(s)

In the U.S.

• Avastin

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For bevacizumab

Bevacizumab injection is given with other medicines to treat patients with metastatic (a cancer that has spread) carcinoma of the colon or rectum. bevacizumab is also used to treat a certain type of metastatic lung cancer called non-squamous, non-small cell lung cancer, and a certain type of brain tumor called glioblastoma.

Bevacizumab is a substance that helps the body fight cancer. It prevents the growth of certain types of blood vessels to cancer cells. This helps to decrease the growth of cancer cells by starving the cells of nutrients that are needed to grow.

Bevacizumab is also used in combination with other medicines (e.g., interferon alfa) to treat patients with cancer of the kidney that has spread to other areas of the body.

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

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, bevacizumab is used in certain patients with the following medical conditions:

• Glioblastoma multiforme, recurrent, following prior treatment with temozolomide (used for a certain type of brain cancer that is getting worse or not responding to treatment).


• Metastatic colorectal cancer, first-line therapy, in combination with capecitabine and oxaliplatin (used together with other medicines for cancer of the colon or rectum that has spread to other areas of the body).

Before Using bevacizumab

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 bevacizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bevacizumab 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 bevacizumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bevacizumab injection in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel problems, which may require caution in patients receiving bevacizumab injection.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 bevacizumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or


• Bleeding problems or


• Blood clots or


• Esophagus problems or


• Heart attack, history of or


• Heart failure or


• Hypertension (high blood pressure) or


• Kidney problems or


• Liver problems or


• Protein in the urine or


• Stomach or intestinal problems or


• Stroke, history of or


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

• Hemoptysis (coughing up blood), recent history of—Should not be used in patients with this condition.

Proper Use of bevacizumab

You will receive bevacizumab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you bevacizumab. bevacizumab is given through a needle placed in one of your veins.

Bevacizumab is often given together with other cancer medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.

Precautions While Using bevacizumab

It is very important that your doctor check your progress at regular visits to make sure that bevacizumab is working properly and to check for unwanted effects. Your doctor will need to check your urine and blood pressure at regular visits while you are receiving bevacizumab. Be sure to keep all appointments. You may be taught how to check your blood pressure at home.

Using bevacizumab while you are pregnant can harm your unborn baby. Use two forms of birth control to keep from getting pregnant. Keep using two forms of birth control for at least 6 months after your treatment ends. If you think you have become pregnant while using the medicine, tell your doctor right away.

bevacizumab may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using bevacizumab. You may need to stop using bevacizumab several weeks before and after having surgery.

bevacizumab may increase your chance of having bleeding problems. Stop using bevacizumab and tell your doctor right away if you start to notice any signs of bleeding.

bevacizumab may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using bevacizumab and tell your doctor right away if you develop chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using bevacizumab.

Tell your doctor right away if you are having severe stomach pain accompanied by other symptoms such as constipation, fever, nausea, and vomiting. These could be symptoms of a serious medical condition.

bevacizumab may also increase your risk of having a serious condition called tracheoesophageal fistula (an abnormal opening in one or more places between the esophagus and the trachea). Tell your doctor right away if you start having trouble swallowing, coughing, or choking while eating, trouble breathing, or chest pain or discomfort while you are using bevacizumab.

Bevacizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you start to cough up blood or if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Bevacizumab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

If you plan to have children, talk with your doctor before using bevacizumab. Some women using bevacizumab have become infertile (unable to have children).

bevacizumab Side Effects

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

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

More common

• Black, tarry stools


• bleeding gums


• body aches or pain


• burning, tingling, numbness, or pain in the hands, arms, feet, or legs


• chest pain or discomfort


• chills


• cloudy urine


• convulsions


• cough


• cracks in the skin


• decreased urine output


• difficult or labored breathing


• dilated neck veins


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


• ear congestion


• extreme fatigue


• fever


• high blood pressure


• irregular breathing


• irregular heartbeat


• lack or loss of strength


• lightheadedness


• loss of appetite


• loss of heat from the body


• loss of voice


• mood changes


• nasal congestion


• nervousness


• pain


• pain, redness, or swelling in the arm or leg


• painful or difficult urination


• pinpoint red spots on the skin


• pounding in the ears


• rapid breathing


• redness


• runny nose


• sensation of pins and needles


• shortness of breath


• slow or fast heartbeat


• sore throat


• sores on the skin


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


• stabbing pain


• sunken eyes


• sweating


• swelling of the face, fingers, feet, or lower legs


• swelling or inflammation of the mouth


• swollen glands


• thirst


• tightness in the chest


• trouble with breathing


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• watery or bloody diarrhea


• weight gain


• wheezing


• wrinkled skin


• yellow skin

Less common

• Abdominal or stomach pain


• bone pain


• difficulty having a bowel movement (stool)


• difficulty with swallowing


• fainting


• severe constipation


• severe vomiting


• stomach tenderness

Rare

• Back pain


• blisters


• blurred vision


• coma


• confusion


• dizziness


• drowsiness


• headache


• increased thirst


• muscle pain or cramps


• open sores


• pale skin

Incidence not known

• Bloody mucus or unexplained nosebleeds


• hoarseness


• sudden weakness in the arms or legs


• sudden, severe chest pain


• voice changes

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

More common

• Acid or sour stomach


• belching


• bloody nose


• change in taste or bad unusual or unpleasant (after) taste


• change in walking and balance


• clumsiness or unsteadiness


• diarrhea


• dry mouth


• excess flow of tears


• hair loss


• heartburn


• indigestion


• low blood pressure


• stomach discomfort, upset, or pain


• thinning of the hair


• weight loss

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: bevacizumab Intravenous side effects (in more detail)

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More bevacizumab Intravenous resources

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

Compare bevacizumab Intravenous with other medications

• Breast Cancer
• Breast Cancer, Metastatic
• Colorectal Cancer
• Glioblastoma Multiforme
• Macular Degeneration
• Malignant Glioma
• Neurofibromatosis
• Non-Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma
• Solid Tumors

Budeprion XL

Generic Name: bupropion (Oral route)

bue-PROE-pee-on

Oral route(Tablet;Tablet, Extended Release;Tablet, Extended Release, 12 HR;Tablet, Extended Release, 24 HR)

Wellbutrin(R) formulations and Forfivo XL: Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients. Zyban(R): Serious neuropsychiatric events, including depression, suicidal ideation, suicide attempt, and completed suicide, have been reported in patients with and without preexisting psychiatric disease who were taking bupropion for smoking cessation; some experienced worsening of their psychiatric illnesses. All patients should be observed for changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. The patient should stop taking bupropion and contact a healthcare provider immediately if any neuropsychiatric behavior that is not typical for the patient is observed, or if the patient develops suicidal ideation or suicidal behavior. This risk should be weighed against the benefits of its use .

Oral route(Tablet, Extended Release)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .

Commonly used brand name(s)

In the U.S.

• Aplenzin


• Budeprion SR


• Budeprion XL


• Buproban


• Wellbutrin


• Wellbutrin SR


• Wellbutrin XL


• Zyban

Available Dosage Forms:

• Tablet, Extended Release, 24 HR


• Tablet, Extended Release, 12 HR


• Tablet


• Tablet, Extended Release

Therapeutic Class: Antidepressant

Chemical Class: Aminoketone

Uses For Budeprion XL

Bupropion is used to treat mental depression. It is also used as part of a support program to help people stop smoking. This medicine may also be used to prevent depression in patients with seasonal affective disorder, which is sometimes called winter depression.

Bupropion is sold under different brand names for different uses. If you are already taking medicine for mental depression or to help you stop smoking, discuss this with your doctor before taking bupropion. It is very important that you receive only one prescription for bupropion at a time.

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

Before Using Budeprion XL

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 bupropion in the pediatric population. Studies with other medicines used for depression have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking these medicines. Because of this toxicity, use in children is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bupropion in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving bupropion.

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 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.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Methylene Blue


• Metoclopramide


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

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.

• Betamethasone


• Budesonide


• Carbimazole


• Clobetasone


• Corticotropin


• Cortisone


• Cosyntropin


• Danazol


• Deflazacort


• Desonide


• Dexamethasone


• Fludrocortisone


• Flunisolide


• Fluticasone


• Hydrocortisone


• Linezolid


• Methenolone


• Methylprednisolone


• Methyltestosterone


• Nandrolone


• Oxandrolone


• Oxymetholone


• Paramethasone


• Prednisolone


• Prednisone


• Rimexolone


• Stanozolol


• Testosterone


• Theophylline

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.

• Amantadine


• Citalopram


• Desipramine


• Efavirenz


• Flecainide


• Fluoxetine


• Haloperidol


• Levodopa


• Lopinavir


• Metoprolol


• Nortriptyline


• Paroxetine


• Propafenone


• Risperidone


• Ritonavir


• Sertraline


• St John's Wort


• Thioridazine


• Tipranavir


• Zolpidem

Interactions with Food/Tobacco/Alcohol

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

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

• Ethanol

Other Medical Problems

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

• Alcohol use, if stopped suddenly, or


• Eating disorders (e.g., anorexia nervosa, bulimia nervosa), history of or


• Sedative (sleeping medicine) use, if stopped suddenly (e.g., alprazolam [Xanax®], diazepam [Valium®], triazolam [Restoril®]), or


• Seizures or epilepsy, history of—Should not be used in patients with these conditions.

• Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk of or


• Depression, history of or


• Hypertension (high blood pressure) or


• Psychosis (mental disease that affects emotions and behaviors) or


• Schizophrenia (mental illness)—Use with caution. May make these conditions worse.

• Brain or spine tumor or


• Diabetes or


• Drug or alcohol abuse (e.g., opiates, cocaine, stimulants) or


• Head injury, history of or


• Liver disease (including cirrhosis), severe—The risk of seizures may be increased when bupropion is taken by patients with these conditions.

• Heart attack, recent or


• Heart disease, unstable—The effects of bupropion in patients with these conditions are not known.

• Kidney disease or


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

• Mania or hypomania, history of—Use of bupropion may activate these conditions.

Proper Use of bupropion

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

Use bupropion only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so, may increase the chance of side effects.

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

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Swallow the sustained-release tablets whole. Do not break, crush, divide, or chew it.

You may take this medicine with or without food. But, if you have nausea, take this medicine with food.

To lessen stomach upset, this medicine may be taken with food, unless your doctor has told you to take it on an empty stomach.

If you are taking Zyban® tablets to help you stop smoking, you may continue to smoke for about 1 week after you start using this medicine. Then, you should set a target date to quit smoking during your second week of Zyban® treatment. Talk to your doctor if you are having trouble to stop smoking after you have used this medicine for at least 7 weeks.

Do not smoke if you are using a nicotine patch or any other medicine containing nicotine together with Zyban® tablets. To do so, may increase risk for more serious side effects.

This medicine must be taken for several weeks, usually 4 weeks, before you start to feel better. You will probably need to keep taking bupropion for several months to help prevent the return of your depression. Your doctor will check your progress at regular visits, especially during the first few weeks that you take this medicine.

If you have trouble with sleeping (insomnia), do not take this medicine too close to bedtime.

For patients taking the extended-release tablet form of this medicine:

• Take doses at least 24 hours apart to decrease the chance of seizures.


• Swallow the tablets whole. Do not crush, break, or chew them.


• While taking this medicine, part of the tablet may pass into your stools. This is normal and is nothing to worry about.


• If you use this medicine to prevent depression in seasonal affective disorder, take it during the autumn season before your symptoms start. Continue using this medicine through the winter season and until early spring.

To help you remember to use your medicine, take it at the same time each day.

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 (extended-release tablets):
  
  • For depression:
    
    • Adults—
      
      • Aplenzin™: At first, 174 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 522 mg per day.
      
      
      • Forfivo XL®: 450 mg once a day.
      
      
      • Wellbutrin XL®: At first, 150 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 450 mg once a day.
      
      
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For seasonal affective disorder:
    
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 300 mg once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (tablets):
  
  • For depression:
    
    • Adults—At first, 100 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg three times a day. Take doses at least 4 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For oral dosage form (sustained-release tablets):
  
  • For depression:
    
    • Adults—At first, 150 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose usually is not more than 200 mg two times a day. Take doses at least 8 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To help you stop smoking:
    
    • Adults—At first, 150 milligrams (mg) once a day for the first 3 days. Then, your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day. Take doses at least 8 hours apart to decrease the chance of seizures.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you are taking the extended-release tablets and you miss a dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Budeprion XL

Your doctor will check your progress at regular visits, especially during the first few months that you take this medicine. The amount of bupropion you take may have to be adjusted to meet the needs of your condition and to help avoid unwanted effects.

Do not take bupropion with or within 14 days of taking a drug with monoamine oxidase inhibitor (MAOI) activity (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking bupropion. If you do, you might have convulsions (seizures).

Your blood pressure might get too high while you are using this medicine. This may cause headaches, blurred vision, and other symptoms. You might need to measure your blood pressure at home. If you think your blood pressure is getting too high, call your doctor right away.

Bupropion may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you take this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Drinking alcoholic beverages should be limited or avoided, if possible, while taking bupropion. This will help prevent seizures.

This medicine may cause some people to have a false sense of well-being, or to become drowsy, dizzy, or less alert than they are normally. 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 not alert and clearheaded.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.

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

This medicine may cause changes in your appetite or weight. Your doctor may need to check your weight regularly during treatment with this medicine.

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

Budeprion XL 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

• Anxiety


• dry mouth


• hyperventilation


• irregular heartbeats


• irritability


• nervousness


• restlessness


• shaking


• shortness of breath


• trouble with sleeping

Less common

• Buzzing or ringing in the ears


• headache (severe)


• skin rash, hives, or itching

Rare

• Confusion


• fainting


• false beliefs that cannot be changed by facts


• having extreme distrust of people


• seeing, hearing, or feeling things that are not there


• seizures (convulsions)


• trouble with concentrating

Incidence not known

• Actions that are out of control


• anger


• assaulting others


• attacking others


• being aggressive


• being impulsive


• chest pain or discomfort


• fast or pounding heartbeat


• force


• inability to sit still


• need to keep moving


• sweating


• talking, feeling, or acting with excitement

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

Symptoms of overdose

• Blue lips, fingernails, or skin


• blurred vision


• change in consciousness


• dark-colored urine


• decreased awareness or responsiveness


• difficult or troubled breathing


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


• fever


• irregular, fast or slow, or shallow breathing


• loss of consciousness


• muscle cramps, pain, or spasms


• muscle stiffness or tightness


• nausea


• severe sleepiness


• unusual tiredness or weakness


• vomiting

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

• Abdominal or stomach pain


• constipation


• decrease in appetite


• dizziness


• increased sweating


• trembling


• weight loss (unusual)

Less common

• Blurred vision


• change in sense of taste


• drowsiness


• frequent need to urinate


• sore throat


• unusual feeling of well-being

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: Budeprion XL 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 Budeprion XL resources

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

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• Wellbutrin SR Prescribing Information (FDA)


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• Depression
• Seasonal Affective Disorder

Balanced Salt Solution

Dosage Form: irrigating solution
Balanced Salt Solution

Sterile Irrigating Solution

Balanced Salt Solution Description

Balanced Salt Solution Sterile Irrigating Solution is a sterile Balanced Salt Solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection.

The pH is approximately 7.0.

The osmolality is approximately 300 mOsm/Kg.

Balanced Salt Solution - Clinical Pharmacology

Balanced Salt Solution Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

Indications and Usage for Balanced Salt Solution

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

Warnings

• NOT FOR INJECTION OR INTRAVENOUS INFUSION.


• Do not use unless product is clear, seal is intact and container is undamaged.


• Do not use if product is discolored or contains a precipitate.


• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.


• The use of additives with this solution may cause corneal decompensation.


• This solution contains no preservative, unused contents should be discarded.

Precautions

Open under aseptic conditions only.

Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which Balanced Salt Solution Sterile Irrigating Solution was used as an irrigating solution.

Adverse Reactions

Irrigation or any other trauma may result in corneal swelling or bullous keratopathy.

Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Balanced Salt Solution Dosage and Administration

The irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the aluminum tab. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

How is Balanced Salt Solution Supplied

Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and aluminum closure with a tear tab.

NDC	REF	Size
Balanced Salt Solution Sterile Irrigating Solution
0264-2514-10	S2514-10	500 mL

STORAGE

Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from freezing.

 

Rx Only

Issued: November 2009

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA


Y36-002-712

PRINCIPAL DISPLAY PANEL - 500 mL Label

Balanced Salt Solution

Sterile Irrigating Solution

NDC 0264-2514-10

REF S2514-10

500 mL

NOT FOR I.V. USE

SINGLE USE ONLY

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA

BALANCED SALT  sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-2514 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (SODIUM CATION) Sodium Chloride 6.4 mg  in 1 mL Potassium Chloride (POTASSIUM CATION) Potassium Chloride 0.75 mg  in 1 mL Calcium Chloride (CALCIUM CATION) Calcium Chloride 0.48 mg  in 1 mL Magnesium Chloride (MAGNESIUM CATION) Magnesium Chloride 0.3 mg  in 1 mL Sodium Acetate (SODIUM CATION) Sodium Acetate 3.9 mg  in 1 mL Sodium Citrate (SODIUM CATION) Sodium Citrate 1.7 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium Hydroxide   Hydrochloric Acid   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0264-2514-10 12 BOTTLE In 1 CASE contains a BOTTLE, GLASS 1 500 mL In 1 BOTTLE, GLASS This package is contained within the CASE (0264-2514-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091387	02/03/2010

Labeler - B. Braun Medical Inc. (002397347)

Establishment
Name	Address	ID/FEI	Operations
B Braun Medical Inc		037425308	MANUFACTURE

Revised: 01/2011B. Braun Medical Inc.

More Balanced Salt Solution resources

• Balanced Salt Solution Side Effects (in more detail)
• Balanced Salt Solution Support Group
• 0 Reviews · Be the first to review/rate this drug

Betaxolol Hydrochloride

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: 2-Propanol, 1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl) amino)-, hydrochloride
Molecular Formula: C₁₈H₂₉NO₃•ClH
CAS Number: 63659-19-8
Brands: Kerlone

Introduction

A β₁-selective adrenergic blocking agent.^{1 2 3 4 5 6 7 8 9 10 24 25}

Uses for Betaxolol Hydrochloride

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 28}

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.³⁷

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.³⁷

Betaxolol Hydrochloride Dosage and Administration

General

• 
  

  Individualize dosage according to patient response and tolerance.^{1 28 30}

  
  


• 
  

  If long-term therapy is discontinued, reduce dosage gradually over a period of about 2 weeks.¹ (See Abrupt Withdrawal of Therapy under Cautions.)

  
  

Administration

Oral Administration

Administer orally;¹ absorption does not appear to be affected by food or alcohol.¹

Dosage

Available as betaxolol hydrochloride; dosage expressed in terms of the salt.¹ Commercially available tablets containing 10 or 20 mg of betaxolol hydrochloride contain 8.94 or 17.88 mg of betaxolol, respectively.¹

Adults

Hypertension

Oral

Initially, 5–10 mg once daily.^{1 28 30 37} Increase dosage gradually up to 20 mg daily.^{1 2 3 16 30 37}

Prescribing Limits

Adults

Hypertension

Oral

Maximum 40 mg daily.^{1 28}

Special Populations

Hepatic Impairment

Dosage reductions are not routinely necessary.¹ Use with caution; monitor patients carefully.¹

Renal Impairment

Initially, 5 mg once daily in those with severe impairment or undergoing dialysis.¹ Increase dosage in increments of 5 mg daily, no more frequently than at 2-week intervals, up to a maximum of 20 mg daily.¹

Geriatric Patients

Initially, 5 mg daily.¹

Bronchospastic Disease

Use the lowest possible dosage (5–10 mg once daily).¹

If dosage must be increased, consider divided administration of the daily dose to avoid the higher peak plasma concentrations associated with once-daily dosing.¹

Cautions for Betaxolol Hydrochloride

Contraindications

• 
  

  Known hypersensitivity to betaxolol.¹

  
  


• 
  

  Patients with sinus bradycardia, heart block greater than first degree, cardiogenic shock, or overt cardiac failure.¹

  
  

Warnings/Precautions

Warnings

Cardiac Failure

Possible precipitation of CHF.¹

Avoid use in patients with decompensated CHF; may use cautiously in patients with inadequate myocardial function and, if necessary, in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).¹

Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.¹

Abrupt WIthdrawal of Therapy

Abrupt discontinuance of therapy is not recommended as it may exacerbate angina symptoms or precipitate MI in patients with CAD.¹

Gradually decrease dosage over a period of about 2 weeks and monitor patients carefully; advise patients to temporarily limit their physical activity during withdrawal of therapy.¹

If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly and initiate appropriate measures for the management of unstable angina pectoris.¹

Bronchospastic Disease

Possible bronchoconstriction.¹

Generally should not be used in patients with bronchospastic disease, but may be used with caution in such patients who do not respond to or cannot tolerate alternative treatment.¹

Administer the lowest effective dosage (5–10 mg once daily); a bronchodilator (e.g., a β₂-adrenergic agonist) should be available.¹

Major Surgery

Possible risks associated with general anesthesia (e.g., severe hypotension, difficulty maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.¹ Use with caution in patients undergoing major surgery involving general anesthesia.¹ Use particular care if anesthetics that depress the myocardium (e.g., cyclopropane, ether, trichloroethylene) are used.¹

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., may mask tachycardia but not sweating or dizziness).¹

Use with caution in patients with diabetes mellitus receiving hypoglycemic drugs.¹

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.¹ Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.¹

Sensitivity Reactions

Anaphylactic Reactions

Possible increased reactivity to repeated, accidental, diagnostic, or therapeutic challenges with a variety of allergens while taking β-blocking agents.¹ Such patients may be unresponsive to usual doses of epinephrine.¹

General Precautions

Intraocular Pressure

Possible reduction in intraocular pressure.¹ May interfere with glaucoma screening test; withdrawal of therapy may cause return to increased intraocular pressure.¹ (See Interactions.)

Specific Populations

Pregnancy

Category C.¹

Lactation

Distributed into milk.¹ Use with caution.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Possible increased incidence of bradycardia in patients >65 years of age compared with younger adults.¹ Bradycardia (possibly dose related) may respond to dosage reduction.¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Although elimination half-life may be increased, clearance may remain unchanged, resulting in little change in the AUC.¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Clearance may be decreased.¹ Dosage adjustment may be needed based on degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Bradycardia, edema, headache, dizziness, fatigue, lethargy, insomnia, nervousness, bizarre dreams, impotence, dyspnea, pharyngitis, rhinitis, upper respiratory infection, dyspepsia, nausea, diarrhea, chest pain, arthralgia, rash.¹

Interactions for Betaxolol Hydrochloride

Specific Drugs

Drug	Interaction	Comments
β-Adrenergic blocking agents (opthalmic solution)	Possible additive effects on intraocular pressure or systemic β blockade1
Calcium-channel blocking agents	Potential hypotension, AV conduction disturbances, and left ventricular failure1	Avoid concomitant use in patients with impaired cardiac function1
Chlorthalidone	Pharmacokinetic interaction unlikely1
Cimetidine	Pharmacokinetic interaction unlikely1
Clonidine	β-Adrenergic blockade may exacerbate rebound hypertension following discontinuance of clonidinea	Discontinue β-blockers several days before initiating gradual withdrawal of clonidine1 If replacing clonidine, delay initiation of the β-blocker for several days after stopping clonidinea
Hydrochlorothiazide	Pharmacokinetic interaction unlikely1
Nifedipine	Pharmacokinetic interaction unlikely1
Reserpine	Additive effects1	Monitor for signs of hypotension and bradycardia (e.g., vertigo, syncope, postural hypotension)1
Warfarin	No potentiation of anticoagulant effect1

Betaxolol Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration usually attained within 1.5–6 hours.¹

Absolute bioavailability is 89%.¹

Onset

Reductions in BP and heart rate observed within 24 hours after 5- to 40-mg doses (given once daily); these effects usually are maximal within 1 or 2 weeks.¹

Food

Food or alcohol does not appear to affect absorption.¹

Distribution

Extent

Distributed into milk.¹

Plasma Protein Binding

Approximately 50%.¹

Elimination

Metabolism

Metabolized in the liver.¹

Elimination Route

Excreted in the urine as metabolites and unchanged drug.¹

Half-life

14–22 hours.¹

Special Populations

Clearance varies with the degree of renal impairment.¹

In patients with hepatic impairment, half-life was increased by 33%, but clearance was unchanged.¹

In geriatric patients, elimination may be reduced.¹

Stability

Storage

Oral

Tablets

15–25°C.¹

ActionsActions

• 
  

  Inhibits response to adrenergic stimuli by competitively blocking β₁-adrenergic receptors within the myocardium.¹ Blocks β₂-adrenergic receptors within the bronchial and vascular smooth muscle only at high doses.¹

  
  


• 
  

  Decreases resting and exercise-stimulated heart rate, cardiac output, cardiac work, and reflex orthostatic tachycardia and inhibits isoproterenol-induced tachycardia.¹

  
  


• 
  

  One of the most potent^{2 6 11 14 15 17 19 20 25} and selective^{2 11 14 15 17 20 25} β₁-adrenergic blocking agents currently available.

  
  


• 
  

  No intrinsic sympathomimetic activity^{1 11 13 15 22} and little or no membrane-stabilizing effect on the heart.^{1 2 8 9 11 16 17 18 22 24 25}

  
  


• 
  

  Reduces BP by decreasing cardiac output, decreasing sympathetic outflow from the CNS, and/or suppressing renin release.¹

  
  

Advice to Patients

• 
  

  Importance of taking betaxolol exactly as prescribed.¹

  
  


• 
  

  Importance of not interrupting or discontinuing therapy without consulting clinician; patients should temporarily limit their physical activity when discontinuing therapy.¹

  
  


• 
  

  Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.¹

  
  


• 
  

  In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).¹

  
  


• 
  

  Importance of patients informing anesthesiologist or dentist that they are receiving betaxolol therapy prior to undergoing major surgery.¹

  
  


• 
  

  Importance of informing patients with diabetes that the drug may mask signs and symptoms of hypoglycemia, including increased heart rate.¹

  
  


• 
  

  Importance of avoiding some activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.¹

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Betaxolol Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	10 mg*	Betaxolol Hydrochloride Tablets	Amide
			Kerlone	Sanofi-Synthelabo
		20 mg*	Betaxolol Hydrochloride Tablets	Amide
			Kerlone	Sanofi-Synthelabo

Comparative Pricing

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

Betaxolol HCl 10MG Tablets (ACTAVIS TOTOWA): 30/$44.99 or 90/$113.97

Kerlone 10MG Tablets (SANOFI-AVENTIS U.S.): 30/$50.99 or 90/$134.97

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Sanofi-Synthelabo. Kerlone (betaxolol hydrochloride) tablets prescribing information. New York, NY; 2003 Mar.

2. Alcon Laboratories. Betoptic product monograph. In: Barnhart ER, publisher. Physicians’ desk reference for ophthalmology. 19th ed. Oradell, NJ: Medical Economics Company Inc; 1991:211-2.

3. Weiner N. Drugs that inhibit adrenergic nerves and block adrenergic receptors. In: Gilman AG, Goodman LS, Rall TW et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 7th ed. New York: Macmillan Publishing Company; 1985:181-214.

4. Windholz M, ed. The Merck index. 10th ed. Rahway, NJ: Merck & Co, Inc; 1983:169.

5. Reynolds JEF, ed. Martindale: the extra pharmacopoeia. 28th ed. London: The Pharmaceutical Press; 1982:1684.

6. Manoury P. Betaxolol: chemistry and biological profile in relation to its physicochemical properties. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:13-9.

7. Reiss GR, Brubaker RF. The mechanism of betaxolol, a new ocular hypotensive agent. Ophthalmology. 1983; 90:1369-72. [PubMed 6664677]

8. Berrospi R, Leibowitz HM. Betaxolol: a new beta-adrenergic blocking agent for treatment of glaucoma. Arch Ophthalmol. 1982; 100:943-6. [IDIS 151861] [PubMed 6124227]

9. Caldwell DR, Salisbury CR, Guzek JP. Effects of topical betaxolol in ocular hypertensive patients. Arch Ophthalmol. 1984; 102:539-40. [IDIS 183932] [PubMed 6704008]

10. Smith JP, Weeks RH, Newland EF et al. Betaxolol and acetazolamide: combined ocular hypotensive effect. Arch Ophthalmol. 1984; 102:1794-5. [IDIS 192616] [PubMed 6391442]

11. Cavero I, Lefeevre-Borg F, Manoury P et al. In vitro and in vivo pharmacological evaluation of betaxolol, a new, potent, and selective beta₁-adrenoceptor antagonist. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:31-42.

12. Levy NS, Boone L. Effect of 0.25% betaxolol v placebo. Glaucoma. 1983; 5:230-2.

13. Vareilles P, Silverstone D, Plazonnet B et al. Comparison of the effects of timolol and other adrenergic agents on intraocular pressure in the rabbit. Invest Ophthalmol Vis Sci. 1977; 16:987-96. [PubMed 21145]

14. Shanks RG. Comparison of betaxolol with other beta-blocking drugs in healthy volunteers. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:133-41.

15. Cadigan PJ, London D, Pentecost BL. Effects of betaxolol, given in single doses by mouth, on pulse rate and blood pressure in normal subjects. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:101-7.

16. Berry DP Jr, Van Buskirk EM, Shields MB. Betaxolol and timolol: a comparison of efficacy and side effects. Arch Ophthalmol. 1984; 102:42-5. [IDIS 180348] [PubMed 6367723]

17. Boudot JP, Cavero I, Feenard S et al. Preliminary studies on SL 75212, a new potent cardioselective beta-adrenoceptor antagonist. Br J Pharmacol. 1979; 66:445P. [PubMed 43176]

18. Cadigan PJ, London DR, Pentecost BL et al. Cardiovascular effects of single oral doses of the new beta-adrenoceptor blocking agent betaxolol (SL 75212) in healthy volunteers. Br J Clin Pharmacol. 1980; 9:569-75. [IDIS 115944] [PubMed 6104498]

19. Morselli PL, Thiercelin JF, Padovani P et al. Comparative pharmacokinetics of several beta-blockers in renal and hepatic insufficiency. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:233-41.

20. Warrington SJ, Taylor EA, Kilborn JR. Comparison of pharmacodynamic effects of betaxolol with atenolol, practolol, and propranolol given intravenously. In: Morselli PL, ed. LERS monograph series. Vol 1. New York: Raven Press; 1983:109-22.

21. Machin PJ, Hurst DN, Bradshaw RN et al. β1-Selective adrenoceptor antagonists. 2: 4-ether-linked phenoxypropanolamines. J Med Chem. 1983; 26:1570-6. [IDIS 177952] [PubMed 6138435]

22. Beresford R, Heel RC. Betaxolol: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in hypertension. Drugs. 1986; 31:6-28. [IDIS 210401] [PubMed 2866947]

23. Durand A, Pauloin D, Bernard F et al. In vitro metabolism of betaxolol and metoprolol: influence of the structure. Proceedings of World Conference on Clinical Pharmacology and Therapeutics. Washington, DC; 1983 July 31-August 5. Abstract No. N568.

24. Alcon Laboratories. Betoptic S (betaxolol hydrochloride) suspension prescribing information. Fort Worth, TX; 1991 Aug.

25. Alcon Laboratories. Betoptic S (betaxolol hydrochloride) product monograph. Fort Worth, TX; 1990 Feb.

26. The USP Drug Nomenclature Committee. Nomenclature policies and recommendations: I. Review and current proposals and decisions. Pharmacopeial Forum. 1991; 17:1509-11.

27. The United States Pharmacopeia, 23rd rev, and The national formulary, 18th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1995:198.

28. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

29. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1993; 35:55-60. [PubMed 8099706]

30. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

31. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

32. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

33. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

34. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

35. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

36. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

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38. Douglas JG, Bakris GL, Epstein M et al. Management of high blood pressure in African Americans: Consensus statement of the Hypertension in African Americans Working Group of the International Society on Hypertension in Blacks. Arch Intern Med. 2003; 163:525-41.

39. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

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41. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

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Broncho-Grippex Expectorant

Generic Name: guaifenesin (Oral route)

gwye-FEN-e-sin

Commonly used brand name(s)

In the U.S.

• Allfen


• Altarussin


• Amibid LA


• Antitussin


• Bidex 400


• Diabetic Siltussin DAS-Na


• Diabetic Tussin EX


• Drituss G


• Guaifenex G


• Guaifenex LA


• Mucinex


• Robitussin

In Canada

• Benylin-E


• Benylin E Extra Strength Chest Congestion


• Broncho-Grippex Expectorant


• Robitussin Extra Strength

Available Dosage Forms:

• Tablet, Extended Release


• Solution


• Capsule, Extended Release


• Packet


• Liquid


• Tablet


• Capsule


• Elixir


• Syrup

Therapeutic Class: Expectorant

Uses For Broncho-Grippex Expectorant

Guaifenesin is used to help clear mucus or phlegm (pronounced flem) from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Broncho-Grippex Expectorant

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

Although there is no specific information comparing use of guaifenesin in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, check with your doctor before using this medicine in children who have a chronic cough, such as occurs with asthma, or who have an unusually large amount of mucus or phlegm with the cough. Children with these conditions may need a different kind of medicine. Also, guaifenesin should not be given to children and infants younger than 2 years of age unless you are directed to do so by your doctor.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of guaifenesin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of guaifenesin

This section provides information on the proper use of a number of products that contain guaifenesin. It may not be specific to Broncho-Grippex Expectorant. Please read with care.

Drinking plenty of water while taking guaifenesin may help loosen mucus or phlegm in the lungs.

For patients taking the extended-release capsule form of this medicine:

• Swallow the capsule whole, or open the capsule and sprinkle the contents on soft food such as applesauce, jelly, or pudding and swallow without crushing or chewing.

For patients taking the extended-release tablet form of this medicine:

• If the tablet has a groove in it, you may carefully break it into two pieces along the groove. Then swallow the pieces whole, without crushing or chewing them.


• If the tablet does not have a groove, it must be swallowed whole. Do not break, crush, or chew it before swallowing.

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 regular (short-acting) oral dosage forms (capsules, oral solution, syrup, or tablets):
  
  • For cough:
    
    • Adults—200 to 400 milligrams (mg) every four hours.
    
    
    • Children 6 to 12 years of age—100 to 200 mg every four hours.
    
    
    • Children 4 to 6 years of age—50 to 100 mg every four hours.
    
    
    • Children and infants up to 4 years of age—Use is not recommended .
    
    
  
  


• For long-acting oral dosage forms (extended-release capsules or tablets):
  
  • For cough:
    
    • Adults—600 to 1200 mg every twelve hours.
    
    
    • Children 6 to 12 years of age—600 mg every twelve hours.
    
    
    • Children 4 to 6 years of age—300 mg every twelve hours.
    
    
    • Children and infants up to 4 years of age—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.

Precautions While Using Broncho-Grippex Expectorant

If your cough has not improved after 7 days or if you have a fever, skin rash, continuing headache, or sore throat with the cough, check with your doctor. These signs may mean that you have other medical problems.

Broncho-Grippex Expectorant 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.

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 or rare

• Diarrhea


• dizziness


• headache


• hives


• nausea or vomiting


• skin rash


• stomach pain

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: Broncho-Grippex Expectorant 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.

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