C-Tanna 12D

Generic Name: carbetapentane, phenylephrine, and pyrilamine (kar BET a PEN tane, FEN il EFF rin, and pir IL a meen)

Brand Names: C-Tanna 12D, Tannate 12D S, Tannihist-12D, Tussi-12D, Tussi-12D S

What is C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

Carbetapentane is a cough suppressant.

Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of carbetapentane, phenylephrine, and pyrilamine is used to treat runny or stuffy nose, sinus congestion, and cough caused by allergies, the common cold, or flu.

Carbetapentane, phenylephrine, and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Tell your doctor about all your medical conditions before you take this carbetapentane, phenylephrine, and pyrilamine.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Avoid drinking alcohol while you are taking this medication.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

What should I discuss with my healthcare provider before taking C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

You should not use this medication if you are allergic to carbetapentane, phenylephrine, or pyrilamine, or to other decongestants or antihistamines. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease, high blood pressure, or a heart rhythm disorder;

  
  


• 
  

  asthma, emphysema, or chronic obstructive pulmonary disease (COPD);

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  glaucoma;

  
  


• 
  

  kidney disease;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease;

  
  


• 
  

  a stomach ulcer or obstruction;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may not be able to take carbetapentane, phenylephrine, and pyrilamine, or you may need a dose adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Store the medicine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

Avoid drinking alcohol while you are taking this medicine. Do not use any other over-the-counter cough, cold, allergy, pain, or sleeping medication without first asking your doctor or pharmacist. Decongestants, antihistamines, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains a decongestant, antihistamine, or cough suppressant.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid using other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbetapentane, phenylephrine, and pyrilamine.

C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, blurred vision;

  
  


• 
  

  dry mouth, nose, or eyes;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  feeling excited or restless; or

  
  


• 
  

  sleep problems (insomnia).

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect C-Tanna 12D (carbetapentane, phenylephrine, and pyrilamine)?

The following drugs can interact with carbetapentane, phenylephrine, and pyrilamine. Tell your doctor if you are using any of these:

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quinaglute, Quinidex);

  
  


• 
  

  ranolazine (Ranexa)

  
  


• 
  

  ritonavir (Norvir);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

  
  

This list is not complete and there may be other drugs that can interact with carbetapentane, phenylephrine, and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More C-Tanna 12D resources

• C-Tanna 12D Side Effects (in more detail)
• C-Tanna 12D Use in Pregnancy & Breastfeeding
• C-Tanna 12D Drug Interactions
• C-Tanna 12D Support Group
• 0 Reviews for C-Tanna2D - Add your own review/rating

• Carbetapentane/Phenylephrine/Pyrilamine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare C-Tanna 12D with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane, phenylephrine, and pyrilamine.

See also: C-Tanna2D side effects (in more detail)

cortisone

Generic Name: cortisone (KOR ti sone)

Brand Names: Cortone Acetate

What is cortisone?

Cortisone is a steroid that prevents the release of substances in the body that cause inflammation.

Cortisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

Cortisone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about cortisone?

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Before taking cortisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your dosage needs may change if you have surgery, are ill, are under stress, or have a fever or infection. Do not change your medication dose or schedule without your doctor's advice. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using cortisone. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Wear a medical alert tag or carry an ID card stating that you take cortisone. Any medical care provider who treats you should know that you take steroid medication.

What should I discuss with my healthcare provider before taking cortisone?

You should not use this medication if you are allergic to cortisone, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

To make sure you can safely take cortisone, tell your doctor if you have any of these other conditions:

• 
  

  liver disease (such as cirrhosis);

  
  


• 
  

  kidney disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  diabetes;

  
  


• 
  

  a history of malaria;

  
  


• 
  

  tuberculosis;

  
  


• 
  

  osteoporosis;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  glaucoma or cataracts;

  
  


• 
  

  herpes infection of the eyes;

  
  


• 
  

  stomach ulcers, ulcerative colitis, or diverticulitis;

  
  


• 
  

  depression or mental illness;

  
  


• 
  

  congestive heart failure; or

  
  


• 
  

  high blood pressure.

  
  

It is not known whether cortisone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Cortisone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using cortisone.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I take cortisone?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your dosage needs may change if you have surgery, are ill, are under stress, or have a fever or infection. Do not change your medication dose or schedule without your doctor's advice. Tell your doctor about any illness or infection you have had within the past several weeks.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using cortisone. Do not stop using cortisone suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Wear a medical alert tag or carry an ID card stating that you take cortisone. Any medical care provider who treats you should know that you take steroid medication. Store at room temperature away from moisture, heat, and light.

See also: Cortisone dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of cortisone is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while taking cortisone?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid.

Do not receive a "live" vaccine while using cortisone. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Avoid drinking alcohol while you are taking cortisone.

Cortisone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  problems with your vision;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath;

  
  


• 
  

  severe depression, unusual thoughts or behavior, seizure (convulsions);

  
  


• 
  

  bloody or tarry stools, coughing up blood;

  
  


• 
  

  pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  sleep problems (insomnia), mood changes;

  
  


• 
  

  acne, dry skin, thinning skin, bruising or discoloration;

  
  


• 
  

  slow wound healing;

  
  


• 
  

  increased sweating;

  
  


• 
  

  headache, dizziness, spinning sensation;

  
  


• 
  

  nausea, stomach pain, bloating; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cortisone Dosing Information

Usual Adult Dose for Adrenal Insufficiency:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Shock:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Hemolytic Anemia:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Erythroblastopenia:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Loeffler's Syndrome:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Sarcoidosis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Berylliosis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Lymphoma:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Nephrotic Syndrome:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Uveitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Iritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Keratitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Conjunctivitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Iridocyclitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Chorioretinitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Choroiditis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Systemic Lupus Erythematosus:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Dermatomyositis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Ankylosing Spondylitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Bursitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Osteoarthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Rheumatoid Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Gouty Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Psoriatic Arthritis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Adult Dose for Epicondylitis:

25 mg to 300 mg per day, oral or IM, in 1 to 2 divided doses.

Usual Pediatric Dose for Adrenal Insufficiency:

0.5 mg to 0.75 mg/kg/day orally given in equally divided doses every 8 hours. Alternatively, 0.25 mg to 0.35 mg/kg IM once daily

What other drugs will affect cortisone?

Many drugs can interact with cortisone. Below is just a partial list. Tell your doctor if you are using:

• 
  

  aspirin (taken on a daily basis or at high doses);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane); or

  
  


• 
  

  seizure medications such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there are many other drugs that can interact with cortisone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More cortisone resources

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

• Cortisone MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortisone Acetate Monograph (AHFS DI)

Compare cortisone with other medications

• Adrenal Insufficiency
• Ankylosing Spondylitis
• Berylliosis
• Bursitis
• Chorioditis
• Chorioretinitis
• Conjunctivitis
• Dermatomyositis
• Epicondylitis, Tennis Elbow
• Erythroblastopenia
• Gouty Arthritis
• Hemolytic Anemia
• Idiopathic Thrombocytopenic Purpura
• Iridocyclitis
• Iritis
• Keratitis
• Loeffler's Syndrome
• Lymphoma
• Nephrotic Syndrome
• Osteoarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Sarcoidosis
• Shock
• Systemic Lupus Erythematosus
• Uveitis

Where can I get more information?

• Your pharmacist can provide more information about cortisone.

See also: cortisone side effects (in more detail)

COPD

Generic Name: dyphylline and guaifenesin (DYE fil in and gwye FEN e sin)

Brand Names: COPD, Difil G, Difil-G Forte, Dilex-G, Dilex-G 200, Dy-G, Dyflex-G, Dyphyllin-GG, Dyphylline GG, Dyphylline GG ES, Jay-Phyl, Lufyllin-GG, Panfil G

What is COPD (dyphylline and guaifenesin)?

Dyphylline is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of dyphylline and guaifenesin is used to treat cough and breathing problems caused by bronchial asthma, chronic bronchitis, or emphysema. This medication is not a cure for asthma, bronchitis, or emphysema.

Dyphylline and guaifenesin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dyphylline and COPD (dyphylline and guaifenesin)?

You should not use this medicine if you are allergic to dyphylline or guaifenesin. This medication will not treat an asthma attack.

Before taking this medication, tell your doctor if you have heart disease or a history of heart attack, high blood pressure, overactive thyroid, or a stomach ulcer.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

What should I discuss with my healthcare provider before taking COPD (dyphylline and guaifenesin)?

You should not use this medicine if you are allergic to dyphylline or guaifenesin. This medication will not treat an asthma attack.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or a history of heart attack;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  a stomach ulcer.

  
  

FDA pregnancy category C. It is not known whether dyphylline and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Dyphylline and guaifenesin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take COPD (dyphylline and guaifenesin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take dyphylline and guaifenesin with food if it upsets your stomach.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using dyphylline and guaifenesin.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, thirst, sweating, fast or slow heart rate, ringing in your ears, feeling anxious or irritable, and seizure (convulsions).

What should I avoid while taking COPD (dyphylline and guaifenesin)?

Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

COPD (dyphylline and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  rapid breathing;

  
  


• 
  

  muscle twitching;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  extreme thirst with headache, nausea, vomiting, and weakness.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  mild nausea, vomiting, or stomach pain;

  
  


• 
  

  feeling restless, agitated, or irritable;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  warmth, redness, or tingly feeling under your skin.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect dyphylline and guaifenesin ?

Tell your doctor about all other medicines you use, especially:

• 
  

  probenecid (Benemid);

  
  


• 
  

  aminophylline (Phyllocontin, Truphylline); or

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl).

  
  

This list is not complete and other drugs may interact with dyphylline and guaifenesin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More COPD resources

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

• COPD MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilex-G Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare COPD with other medications

• Asthma
• Bronchitis

Where can I get more information?

• Your pharmacist can provide more information about dyphylline and guaifenesin.

See also: COPD side effects (in more detail)

Concerta Extended-Release Tablets

Pronunciation: METH-il-FEN-i-date
Generic Name: Methylphenidate
Brand Name: Concerta

Use Concerta Extended-Release Tablets with caution if you have a history of emotional problems or alcohol or substance abuse. Abuse of Concerta Extended-Release Tablets may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Concerta Extended-Release Tablets. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.

Concerta Extended-Release Tablets are used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.

Concerta Extended-Release Tablets are a central nervous system stimulant. Exactly how it works is not known.

Do NOT use Concerta Extended-Release Tablets if:

• you are allergic to any ingredient in Concerta Extended-Release Tablets


• you have severe anxiety, agitation, or tension


• you have glaucoma


• you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome


• you have serious heart problems (eg, heart defect, irregular heartbeat)


• you are not able to swallow the tablet whole


• you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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

Before using Concerta Extended-Release Tablets:

Some medical conditions may interact with Concerta Extended-Release Tablets. 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 a history of high blood pressure, heart problems (eg, heart failure, fast or irregular heartbeat), or a recent heart attack, or if a family member has a history of irregular heartbeat or sudden death


• if you have a history of seizures or abnormal electroencephalograms (EEGs)


• if you have a history of overactive thyroid, chronic fatigue, cystic fibrosis, narrowing of the esophagus, or stomach or bowel problems (eg, blockage, inflammation, narrowing)


• if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

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

• MAOIs (eg, phenelzine) because severe high blood pressure may occur


• Clonidine because serious side effects may occur


• Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Concerta Extended-Release Tablets


• Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Concerta Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Concerta Extended-Release Tablets 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 Concerta Extended-Release Tablets:

Use Concerta Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Concerta Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Concerta Extended-Release Tablets refilled.


• Take Concerta Extended-Release Tablets by mouth in the morning with or without food.


• Swallow Concerta Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.


• Take Concerta Extended-Release Tablets with a full glass of liquid (eg, water, milk, juice) (8 oz/240 mL).


• If you miss a dose of Concerta Extended-Release Tablets, 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 Concerta Extended-Release Tablets.

Important safety information:

• Concerta Extended-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Concerta Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


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


• If your symptoms do not get better within 1 month or if they get worse, check with your doctor.


• Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition.


• Tell your doctor or dentist that you take Concerta Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.


• You may notice the tablet shell in your stool. This is normal and not a cause for concern.


• Concerta Extended-Release Tablets may be visible on abdominal x-rays. If you will be having an abdominal x-ray, be sure your doctor and lab personnel know you are taking Concerta Extended-Release Tablets.


• Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Concerta Extended-Release Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Concerta Extended-Release Tablets may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Concerta Extended-Release Tablets.


• Caution is advised when using Concerta Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.


• Concerta Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


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

When used for long periods of time or at high doses, Concerta Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Concerta Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Concerta Extended-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Concerta Extended-Release Tablets. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Concerta Extended-Release Tablets, your doctor will lower your dose over time.

Possible side effects of Concerta Extended-Release Tablets:

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

Dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping; weight loss.

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; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain or discomfort; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, abnormal thoughts, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unresponsiveness, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

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: Concerta 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 confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.

Proper storage of Concerta Extended-Release Tablets:

Store Concerta Extended-Release Tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Concerta Extended-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Concerta Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Concerta Extended-Release Tablets are 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 Concerta Extended-Release Tablets. 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 Concerta resources

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

Compare Concerta with other medications

• ADHD
• Narcolepsy

Control Rx

Generic Name: sodium fluoride (Oral route, Dental route, Oromucosal route)

SOE-dee-um FLOOR-ide

Commonly used brand name(s)

In the U.S.

• APF Gel


• Aquafresh


• CaviRinse


• Control Rx


• Denta 5000 Plus


• Dentagel


• Dentall 1100 Plus


• EtheDent


• Fluorabon


• Fluor-A-Day


• Fluoridex Daily Defense


• Fluoridex Daily Defense Enhanced Whitening

In Canada

• Fluorosol


• Koala Pals Fluoride Tooth Gel - Berrylicious Flavor


• Pdf


• Pedi-Dent

Available Dosage Forms:

• Gel/Jelly


• Tablet, Chewable


• Paste


• Solution


• Liquid


• Tablet, Enteric Coated


• Tablet


• Lozenge/Troche


• Cream

Therapeutic Class: Cariostatic

Uses For Control Rx

Fluoride has been found to be helpful in reducing the number of cavities in the teeth. It is usually present naturally in drinking water. However, some areas of the country do not have a high enough level in the water to prevent cavities. To make up for this, extra fluoride may be added to the diet. Some children may require both dietary fluoride and topical fluoride treatments by the dentist. Use of a fluoride toothpaste or rinse may be helpful as well.

Taking extra oral fluoride does not replace good dental habits. These include eating a good diet, brushing and flossing the teeth often, and having regular dental checkups.

Fluoride may also be used for other conditions as determined by your doctor.

This medicine is available only with a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

People get needed fluoride from fish, including the bones, tea, and drinking water that has fluoride added to it. Food that is cooked in water containing fluoride or in Teflon-coated pans also provides fluoride. However, foods cooked in aluminum pans provide less fluoride.

The daily amount of fluoride needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

There is no RDA or RNI for fluoride. Daily recommended intakes for fluoride are generally defined as follows:

• Infants and children—


• Birth to 3 years of age: 0.1 to 1.5 milligrams (mg).


• 4 to 6 years of age: 1 to 2.5 mg.


• 7 to 10 years of age: 1.5 to 2.5 mg.

• Adolescents and adults—


• 1.5 to 4 mg.

Remember:

• The total amount of fluoride you get every day includes what you get from the foods and beverages that you eat and what you may take as a supplement.


• This total amount should not be greater than the above recommendations, unless ordered by your health care professional. Taking too much fluoride can cause serious problems to the teeth and bones.

Before Using Control Rx

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

Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Using this medicine with any of the following may cause an increased risk of certain side effects 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.

• Dairy Food

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:

• Brown, white, or black discoloration of teeth or


• Joint pain or


• Kidney problems (severe) or


• Stomach ulcer—Sodium fluoride may make these conditions worse.

Proper Use of sodium fluoride

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

Take this medicine only as directed by your health care professional. Do not take more of it and do not take it more often than ordered. Taking too much fluoride over a period of time may cause unwanted effects.

For individuals taking the chewable tablet form of this medicine:

• Tablets should be chewed or crushed before they are swallowed.


• This medicine works best if it is taken at bedtime, after the teeth have been thoroughly brushed. Do not eat or drink for at least 15 minutes after taking sodium fluoride.

For individuals taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even though it comes in a dropper bottle. The amount to be taken is to be measured with the specially marked dropper.


• Always store this medicine in the original plastic container. Fluoride will affect glass and should not be stored in glass containers.


• This medicine may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food. However, if this medicine is mixed with foods or beverages that contain calcium, the amount of sodium fluoride that is absorbed may be reduced.

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 (lozenges, solution, tablets, or chewable tablets):
  
  • To prevent cavities in the teeth (not enough fluoride in the water):
    
    • Children—Dose is based on the amount of fluoride in drinking water in your area. Dose is also based on the child's age and must be determined by your health care professional.
    
    
  
  

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 Control Rx

The level of fluoride present in the water is different in different parts of the U.S. If you move to another area, check with a health care professional in the new area as soon as possible to see if this medicine is still needed or if the dose needs to be changed. Also, check with your health care professional if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtration (e.g., tap water to filtered tap water).

Do not take calcium supplements or aluminum hydroxide–containing products and sodium fluoride at the same time. It is best to space doses of these two products 2 hours apart, to get the full benefit from each medicine.

Inform your health care professional as soon as possible if you notice white, brown, or black spots on the teeth. These are signs of too much fluoride in children when it is given during periods of tooth development.

Control Rx 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 as soon as possible if any of the following side effects occur:

Sodium fluoride in drinking water or taken as a supplement does not usually cause any side effects. However, taking an overdose of fluoride may cause serious problems.

• Sores in the mouth and on the lips (rare)

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

• Black, tarry stools


• bloody vomit


• diarrhea


• drowsiness


• faintness


• increased watering of the mouth


• nausea or vomiting


• shallow breathing


• stomach cramps or pain


• tremors


• unusual excitement


• watery eyes


• weakness

Check with your doctor as soon as possible if any of the following side effects occur:

• Pain and aching of bones


• stiffness


• white, brown, or black discoloration of the teeth—occurs only during periods of tooth development in children

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.

Copaxone

Generic Name: Glatiramer Acetate
Class: Biologic Response Modifiers
Chemical Name: l-Glutamic acid polymer with l-alanine, l-lysine, and l-tyrosine, acetate
Molecular Formula: (C₅H₉NO₄ • C₃H_7-5H₉NO₄ • C₃H₇NO₂ • C₆H₁₄N₂O₂ • C₉H₁₁NO₃)_x • x(C₂H₄O₂)
CAS Number: 147245-92-9

Introduction

Immunomodulatory agent; synthetic polypeptide mixture consisting of 4 naturally occurring amino acids.^{1 2 3 4 5 6 7 8}

Uses for Copaxone

Multiple Sclerosis (MS)

Treatment to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis (RRMS).^{1 6 7 8 9 16 18}

The Medical Advisory Board of the National Multiple Sclerosis Society recommends therapy with an immunomodulator (e.g., glatiramer acetate, interferon-β) should be considered as soon as possible following a definite diagnosis of MS with a relapsing course and for selected patients with an initial attack who are at high risk for MS.^{14 15 18}

May be useful in patients who do not respond adequately to or who do not tolerate interferon-β.¹⁵

Copaxone Dosage and Administration

Administration

Administer only by sub-Q injection; do not administer IV.¹

Administer initial self-administered dose under the supervision of qualified clinicians.¹

Sub-Q Administration

Commercially available prefilled syringes intended for single use only; discard unused portion.¹

Warm prefilled syringes to room temperature by removing from refrigerator about 20 minutes prior to use.^{1 18}

Inject sub-Q into the arm, abdomen, hip, or thigh.^{1 6 18}

To minimize risk of serious injection site reactions (e.g., lipoatrophy, necrosis), rotate injection sites daily; follow a planned rotation of sites within an area so that any one area is not injected more than once every week.^{1 6 18} (See Acute Injection Reactions under Cautions.)

Dosage

Available as glatiramer acetate; dosage expressed in terms of the salt.^a

Adults

Multiple Sclerosis

Sub-Q

20 mg once daily.^{1 6}

Therapy should be continued indefinitely except when there is a clear lack of benefit, intolerable adverse effects, or availability of better treatments.¹⁴

Special Populations

No special population dosage recommendations at this time.^{1 6}

Cautions for Copaxone

Contraindications

• 
  

  Known hypersensitivity to glatiramer, mannitol, or any other ingredient in the formulation.

  
  

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Anaphylaxis accompanied by anti-glatiramer IgE antibodies reported rarely.^{10 18}

General Precautions

Effects on Immune Response

Possible modification of immune response and interference with useful immune function.¹

Possible interference with the recognition of foreign antigens, which may undermine the body’s tumor surveillance ability and defenses against infection.¹

Possibility of adverse effects resulting from continued alteration of cellular immunity associated with chronic administration of the drug.¹

Antibody Formation

Development of IgG antibodies to glatiramer reported in most patients;^{1 10} however, data to date indicate that antibodies do not neutralize therapeutic effects.^{3 18 20}

Animal studies suggest that immune complexes are deposited in renal glomeruli.¹

Acute Injection Reactions

Acute injection reactions reported in approximately 10% of patients, generally within minutes after sub-Q injection.^a Symptoms are transient and generally self-limited and include flushing,^{1 2 6 7 8} chest pain^{1 2 6} or tightness,^{6 7 8} palpitations,^{1 2 5 6 7 8} anxiety,^{1 2 5 6 7 8} dyspnea,^{1 2 5 6 7 8} constriction of the throat,¹ and urticaria.¹

Reactions generally occur several months after initiation of therapy and generally are isolated events.⁷

Not currently known whether reactions have an immunologic or nonimmunologic mechanism.^{1 6}

Chest Pain

Transient chest pain reported, generally >1 month after initiation of therapy.¹ Episodes generally last only a few minutes, often are unassociated with other symptoms, and do not appear to produce clinically important sequelae.¹

Injection Site Reactions

Injection site reactions, including lipoatrophy and, rarely, skin necrosis reported; injection site rotation and proper administration techniques may prevent these effects.^a

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether glatiramer is distributed into milk.¹ Use with caution in nursing women.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

Common Adverse Effects

Injection site reactions,^{1 2 5} vasodilation,¹ chest pain,¹ asthenia,¹ infection,¹ pain,¹ nausea,¹ arthralgia,¹ anxiety,¹ hypertonia.¹

Interactions for Copaxone

Interactions with other drugs not fully evaluated to date.¹

No clinically important interactions reported in clinical trials between glatiramer and drugs commonly used in multiple sclerosis, including concurrent corticosteroid therapy for up to 28 days.¹ Not formally evaluated in combination with interferon-β.^{1 6}

Copaxone Pharmacokinetics

Distribution

Following sub-Q injection, some portion of the dose may enter the lymphatic circulation and some may enter systemic circulation.¹ Does not appear to cross the blood-brain barrier.⁶

Elimination

Metabolism

Hydrolyzed locally at injection site to small oligopeptides and free amino acids.^{1 6}

Stability

Storage

Parenteral

Injection

2–8°C; protect from light.^a May be stored at room temperature (15–30°C) for up to one week.¹

ActionsActions

• 
  

  Mechanism of action not fully elucidated;¹ appears to modify immune processes responsible for the pathogenesis of MS.^{1 6 8 15}

  
  


• 
  

  Induces and activates drug-specific suppressor T-cells that migrate into the CNS and down-regulate immune response (e.g., inflammation) to myelin antigens in the periphery.^{1 6 8 15}

  
  

Advice to Patients

• 
  

  Importance of reading and understanding manufacturer’s patient information before beginning therapy.¹

  
  


• 
  

  Importance of clinicians instructing patient and/or caregivers in proper injection techniques and about avoiding reuse of syringes and needles and proper disposal of such equipment in a puncture-resistant container after use.¹

  
  


• 
  

  Importance of clinicians advising patient about adverse effects, including instructions to contact clinician immediately and withhold further administration of the drug if hives, skin rash with irritation, dizziness, sweating, chest pain, breathing difficulty, or severe pain at the injection site occurs.¹

  
  


• 
  

  Importance of not changing dosage or discontinuing therapy without consulting clinician.¹

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  

Preparations

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

Glatiramer Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	20 mg/1 mL	Copaxone (available as 1-mL prefilled syringe)	TEVA Neuroscience

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 June 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. TEVA Neuroscience. Copaxone (glatiramer acetate injection) prescribing information. Kansas City, MO; 2004 Feb.

2. Johnson KP, Brooks BR, Cohen JA et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology. 1995; 45:1268-76. [IDIS 350103] [PubMed 7617181]

3. Johnson KP, Brooks BR, Cohen JA et al. Extended use of glatiramer acetate (Copaxone) is well tolerated and maintains its clinical effect on multiple sclerosis relapse rate and degree of disability. Neurology. 1998; 50:701-8. [IDIS 403141] [PubMed 9521260]

4. Bornstein MB, Miller A, Slagle S et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987; 317:408-14. [IDIS 232708] [PubMed 3302705]

5. Comi G, Filippi M, Wolinsky JS et al. European/Canadian multicenter, double-blind, randomized, placebo-controlled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. Ann Neurol. 2001; 49:290-7. [IDIS 461166] [PubMed 11261502]

6. Simpson D, Noble S, Perry C. Glatiramer acetate: a review of its use in relapsing-remitting multiple sclerosis. CNS Drugs. 2002; 16:825-50. [PubMed 12421116]

7. Calabresi PA. Considerations in the treatment of relapsing-remitting multiple sclerosis. Neurology. 2002; 58(Suppl 4):S10-S22.

8. Miller AE. Glatiramer acetate in the treatment of multiple sclerosis. Neurol Clin. 2005; 23:215-31. [PubMed 15661095]

9. Goodin DS, Frohman EM, Garmany GP Jr et al. Disease modifying therapies in multiple sclerosis: report of the therapeutics and technology assessment subcommittee of the American Academy of Neurology and the MS council for clinical practice guidelines. Neurology. 2002; 58: 169-178. [IDIS 475332] [PubMed 11805241]

10. Rauschka H, Farina C, Sator P et al. Severe anaphylactic reaction to glatiramer acetate with specific IgE. Neurology. 2005; 64:1481. [IDIS 534043] [PubMed 15851756]

11. Ge Y, Grossman RI, Udupa JK et al. Glatiramer acetate (Copaxone) treatment in relapsing-remitting MS. Neurology. 2000; 54:813-7. [IDIS 443731] [PubMed 10690968]

12. Johnson KP, Ford CC, LIsak RP et al. Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data. Acta Neurol Scand. 2005; 111:42-7. [PubMed 15595937]

13. Rizvi SA, Agius MA. Current approved options for treating patients with multiple sclerosis. Neurology. 2004; 63(Suppl 6):S8-S14. [IDIS 528071] [PubMed 15623672]

14. Disease management consensus statement from the Medical Advisory Board of the National Multiple Sclerosis Society. Available at: http://www.nationalmssociety.org/pdf/forpros/Exp_Consensus.pdf. Accessed September 6, 2005.

15. Mezzapesa DM, Rovaris M, Filippi M. Glatiramer acetate in multiple sclerosis. Expert Rev Neurotherapeutics. 2005; 5:451-8.

16. Boneschi FM, Rovaris M, Johnson KP et al. Effects of glatiramer acetate on relapse rate and accumulated disability in multiple sclerosis: meta-analysis of three double-blind, randomized, placebo-controlled clinical trials. Multiple Sclerosis. 2003; 9:349-55. [PubMed 12926839]

17. Johnson KP, Brooks BR, Ford CC et al. Glatiramer acetate (Copaxone): comparison of continuous versus delayed therapy in a six-year organized multiple sclerosis trial. Multiple Sclerosis. 2003; 9:585-91. [PubMed 14664471]

18. Teva Neuroscience, Overland Park, KS. Personal communication.

19. Johnson KP, Panitch HS, Ford CC et al. Long-term slowing of disability progression in patients receiving continuous glatiramer acetate compared with those withdrawing from therapy: 10 year results from an ongoing trial. Neurology. 2004; 62(7 Suppl 5):A180.

20. Teitelbaum D, Brenner T, Abramsky O et al. Antibodies to glatiramer acetate do not interfere with its biological functions and therapeutic efficacy. Mult Scler. 2003; 9:592-9. [PubMed 14664472]

a. TEVA Neuroscience. Copaxone (glatiramer acetate injection) prescribing information. Kansas City, MO; 2006 May.

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Constulose Solution

Pronunciation: LAK-tyoo-lose
Generic Name: Lactulose
Brand Name: Constulose

Constulose Solution is used for:

Treating constipation. It may also be used for other conditions as determined by your doctor.

Constulose Solution is a colonic acidifier. It works by drawing water into the colon, which softens the stool and helps to produce a bowel movement.

Do NOT use Constulose Solution if:

• you are allergic to any ingredient in Constulose Solution


• you are on a low galactose diet

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

Before using Constulose Solution:

Some medical conditions may interact with Constulose Solution. 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 appendix disease, rectal bleeding, a blockage of the intestinal tract, or a disease called galactosemia

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

• Antacids because they may decrease Constulose Solution's effectiveness

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

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

• Constulose Solution may be mixed with fruit juice, water, or milk. Drink 1 or more 8-ounce glasses of liquid with each dose.


• A bowel movement should occur 24 to 48 hours after taking Constulose Solution.


• If you miss a dose of Constulose Solution and you are taking it regularly, take 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 take 2 doses at once.

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

Important safety information:

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


• Diabetes patients - Constulose Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• LAB TESTS, including blood electrolyte levels, may be performed while you use Constulose Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Constulose Solution with caution in the ELDERLY; they may be more sensitive to its effects.


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

Possible side effects of Constulose Solution:

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:

Belching; gas; nausea; stomach cramps; vomiting.

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); diarrhea.

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: Constulose 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 diarrhea; stomach cramps.

Proper storage of Constulose Solution:

Store Constulose Solution at room temperature between 68 and 77 degrees F (20 and 25 degrees C). A normal darkening of the solution may occur under normal storage conditions. This will not affect the product. Exposure to temperatures above 86 degrees F (30 degrees C) will cause extreme darkening of the solution. Do not use the medicine if this occurs. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Constulose Solution out of the reach of children and away from pets.

General information:

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


• Constulose Solution 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 Constulose Solution. 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.

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• Constulose Side Effects (in more detail)
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