Dimetapp Long Acting Cough Plus Cold

Generic Name: chlorpheniramine and dextromethorphan (klor feh NEER a meen and DEX troe meh THOR fan)

Brand Names: Coricidin HBP Cough & Cold, Dimetapp Long Acting Cough Plus Cold, Robitussin Cough & Cold Long-Acting, Scot-Tussin Sugar Free DM, Triaminic Cough & Runny Nose, Triaminic Cough & Runny Nose Softchews, Triaminic Night Time Cough & Runny Nose, Tricodene Sugar Free

What is Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

The combination of chlorpheniramine and dextromethorphan is used to treat sneezing, itching, watery eyes, runny nose, and cough caused by allergies, the common cold, or the flu.

Chlorpheniramine and dextromethorphan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

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. 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. Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine. 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 or cough suppressant. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

What should I discuss with my healthcare provider before taking Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

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

• 
  

  glaucoma;

  
  


• 
  

  kidney disease;

  
  


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  thyroid disease;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take chlorpheniramine and dextromethorphan.

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.

Artificially-sweetened liquid forms of this medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

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 for only 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.

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

The chewable tablet should be chewed before you swallow it.

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.

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.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

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

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. 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 Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

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 becoming overheated or dehydrated during exercise and in hot weather.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety).

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

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 or cough suppressant.

Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan) 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;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  restlessness or excitability (especially in children).

  
  

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 Dimetapp Long Acting Cough Plus Cold (chlorpheniramine and dextromethorphan)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  a diuretic (water pill), or blood pressure medication;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), others.

  
  

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

More Dimetapp Long Acting Cough Plus Cold resources

• Dimetapp Long Acting Cough Plus Cold Use in Pregnancy & Breastfeeding
• Dimetapp Long Acting Cough Plus Cold Drug Interactions
• 0 Reviews for Dimetapp Long Acting Cough Plus Cold - Add your own review/rating

Compare Dimetapp Long Acting Cough Plus Cold with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and dextromethorphan.

Orabase Gel-B

Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B

What is Orabase Gel-B (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

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

What is the most important information I should know about Orabase Gel-B (benzocaine topical)?

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

What should I discuss with my health care provider before using Orabase Gel-B (benzocaine topical)?

Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  asthma, bronchitis, emphysema, or other breathing disorder;

  
  


• 
  

  heart disease;

  
  


• 
  

  a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or

  
  


• 
  

  if you smoke.

  
  

FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Orabase Gel-B (benzocaine topical)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.

This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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 benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Orabase Gel-B (benzocaine topical)?

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.

Orabase Gel-B (benzocaine topical) side effects

Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• 
  

  headache, tired feeling, confusion;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  feeling light-headed or short of breath; and

  
  


• 
  

  pale, blue, or gray appearance of your skin, lips, or fingernails.

  
  

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 benzocaine topical and call your doctor at once if you have any of these other serious side effects:

• 
  

  headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);

  
  


• 
  

  severe burning, stinging, or sensitivity where the medicine is applied;

  
  


• 
  

  swelling, warmth, or redness; or

  
  


• 
  

  oozing, blistering, or any signs of infection.

  
  

Less serious side effects may include:

• 
  

  mild stinging, burning, or itching where the medicine is applied;

  
  


• 
  

  skin tenderness or redness; or

  
  


• 
  

  dry white flakes where the medicine was applied.

  
  

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 Orabase Gel-B (benzocaine topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. 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 Orabase Gel-B resources

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

• Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Anacaine Advanced Consumer (Micromedex) - Includes Dosage Information


• Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information


• Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Orabase Gel-B with other medications

• Oral and Dental Conditions

Where can I get more information?

• Your pharmacist can provide more information about benzocaine topical.

See also: Orabase-B side effects (in more detail)

Belimumab Intravenous

be-LIM-ue-mab

Commonly used brand name(s)

In the U.S.

• Benlysta

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Monoclonal Antibody

Uses For belimumab

Belimumab injection is used to treat systemic lupus erythematosus (SLE or lupus) in adults who are also receiving other therapy. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.

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

Before Using belimumab

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 belimumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to belimumab 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 belimumab injection in children. 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 belimumab injection in the elderly.

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

• Depression, history of or


• Mental illness, history of—Use with caution. May make these conditions worse.

• Infection or


• Weak immune system (eg, history of cancer or steroid use)—May decrease your body's ability to fight infection.

Proper Use of belimumab

A nurse or other trained health professional will give you belimumab. belimumab is given through a needle placed in one of your veins.

belimumab must be given slowly, so the needle will remain in place for at least one hour. You may also receive medicines to help prevent possible allergic reactions to the injection.

belimumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using belimumab

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

You should not receive belimumab if you are also using cyclophosphamide (Cytoxan®).

Tell your doctor if you are pregnant or if you plan to become pregnant. Women who could potentially get pregnant while receiving belimumab must use an effective form of birth control during therapy and for at least 4 months after the last dose. If you become pregnant while receiving belimumab, your doctor may want you to join a registry for pregnant patients.

belimumab may increase your risk of developing infections. Avoid being near people who are sick while you are receiving belimumab. Wash your hands often. Tell your doctor if you have any kind of infection before you receive the medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you have blurred vision; a cough that won't go away; fever, chills, or flu-like symptoms, such as a runny or stuffy nose; a headache; night sweats; or weight loss. These may be signs that you have an infection.

Belimumab may cause an infustion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have a headache; itching; dizziness, fainting, or lightheadedness; nausea; muscle or joint pain; or a rash.

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

belimumab 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. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

While you are being treated with belimumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Belimumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

belimumab 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

• Bladder pain


• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site of injection


• bloody or cloudy urine


• body aches or pain


• chest congestion


• chills


• cough


• cough-producing mucus


• diarrhea


• difficult, burning, or painful urination


• difficulty with breathing or swallowing


• dizziness


• ear congestion


• facial swelling


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hives


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nasal congestion


• nausea or vomiting


• pain or tenderness around the eyes and cheekbones


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose


• shivering


• shortness of breath or troubled breathing


• skin rash


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tightness in the chest


• trouble sleeping


• unusual tiredness or weakness


• wheezing

Less common

• Black, tarry stools


• fast heartbeat


• hoarseness


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


• swollen glands


• tender, swollen glands in the neck


• unusual bleeding or bruising


• 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

• Arm or leg pain


• sleeplessness


• unable to sleep

Less common

• Abdominal or stomach pain


• depression


• fear or nervousness


• headache, severe and throbbing


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: belimumab Intravenous side effects (in more detail)

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More belimumab Intravenous resources

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

Compare belimumab Intravenous with other medications

• Systemic Lupus Erythematosus

Donnatal Elixir

Generic Name: phenobarbital

Dosage Form: oral elixir
Donnatal Elixir

Donnatal Elixir Description

Each Donnatal(r) 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:

Phenobarbital, USP....................................... 6.2 mg

Hyoscyamine Sulfate, USP...................... 0.1037 mg

Atropine Sulfate, USP ...............................0.0194 mg

Scopolamine Hydrobromide, USP ...........0.0065 mg


INACTIVE INGREDIENTS:

Artificial Grape Flavor, FD and C Blue #1, FD and C Red #3, Ethyl Alcohol, Glycerin, Purified Water, Saccharin Sodium, Sorbitol, and Sucrose.

Donnatal Elixir - Clinical Pharmacology

This drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation.

Indications and Usage for Donnatal Elixir

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the following indications as “possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. May also be useful as adjunctive therapy in the treatment of duodenal ulcer. IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.

Contraindications

Glaucoma, obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus, intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis especially if complicated by toxic megacolon; myasthenia gravis; hiatal hernia associated with reflux esophagitis.

Donnatal® Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital is contraindicated in acute intermittent porphyria and in those patients in whom Phenobarbital produces restlessness and/or excitement.

Warnings

In the presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating).

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

Donnatal® Elixir may produce drowsiness or blurred vision. The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery, and not to perform hazardous work.

Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the anticoagulant may have to be decreased.

Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs.

Since barbiturates are metabolized in the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.

Precautions

GENERAL

Use with caution in patients with: autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, and hypertension.

Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer.

Do not rely on the use of the drug in the presence of complication of biliary tract disease. Theoretically, with overdosage, a curare-like action may occur.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals have not been performed to evaluate carcinogenic potential.

PREGNANCY

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Donnatal® Elixir. It is not known whether Donnatal®

Elixir can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Donnatal® Elixir should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Donnatal® Elixir is administered to a nursing woman.

Adverse Reactions

Adverse reactions may include xerostomia; urinary hesitancy and retention; blurred vision; tachycardia; palpitation; mydriasis; cycloplegia; increased ocular tension; loss of taste sense; headache; nervousness; drowsiness; weakness; dizziness; insomnia; nausea; vomiting; impotence; suppression of lactation; constipation; bloated feeling; musculoskeletal pain; severe allergic reaction or drug idiosyncrasies, including anaphylaxis, urticaria and other dermal manifestations; and decreased sweating. Elderly patients may react with symptoms of excitement, agitation, drowsiness, and other untoward manifestations to even small doses of the drug. Phenobarbital may produce excitement in some patients, rather than a sedative effect. In patients habituated to barbiturates, abrupt withdrawal may produce delirium or convulsions.

Overdosage

The signs and symptoms of overdose are headache, nausea, vomiting, blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of the mouth, difficulty in swallowing, and CNS stimulation. Treatment should consist of gastric lavage, emetics, and activated charcoal. If indicated, parenteral cholinergic agents such as physostigmine or bethanechol chloride, should be used.

Donnatal Elixir Dosage and Administration

The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.

Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.

Pediatric patients: may be dosed every 4 to 6 hours.

Starting dosage

Body weight q4h q6h

10 lb. (4.5 kg) 0.5 mL 0.75 mL

20 lb. (9.1 kg) 1.0 mL 1.5 mL

30 lb. (13.6 kg) 1.5 mL 2.0 mL

50 lb. (22.7 kg) ½ tsp ¾ tsp

75 lb. (34 kg) ¾ tsp 1 tsp

100 lb. (45.4 kg) 1 tsp 1½ tsp

STORAGE CONDITIONS

HOW SUPPLIED:

Donnatal® Elixir is a purple colored, grape flavored liquid.

4 fl oz (118 mL) bottles NDC 66213-423-04.

1 Pint (473 mL) bottles NDC 66213-423-16.

AVOID FREEZING

Store Donnatal® Elixir at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Use safety closures when dispensing this product unless otherwise directed by a physician or requested by purchaser.

Example bottle label

DONNATAL  phenobarbital elixir  elixir

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66213-423 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Phenobarbital (Phenobarbital) Phenobarbital 16.2 mg  in 5 mL Hyoscyamine sulfate (Hyoscyamine) Hyoscyamine sulfate 0.1037 mg  in 5 mL Scopolamine hydrobromide (Scopolamine) Scopolamine hydrobromide 0.0065 mg  in 5 mL Atropine sulfate (Atropine) Atropine sulfate 0.0194 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength Glycerin 2.007 g  in 5 mL alcohol .4158 g  in 5 mL water 2.1432 g  in 5 mL sucrose .2925 g  in 5 mL sorbitol .9068 g  in 5 mL saccharin sodium .02925 g  in 5 mL FD&C Blue No. 1   FD&C Red No. 3   GRAPE .041 g  in 5 mL

Product Characteristics Color purple Score      Shape Size Flavor GRAPE (Artificial grape) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66213-423-04 118 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2009

Labeler - PBM Pharmaceuticals Inc. (785470050)

Registrant - IriSys Inc (959205568)

Establishment
Name	Address	ID/FEI	Operations
IriSys Inc		959205568	manufacture

Revised: 07/2011PBM Pharmaceuticals Inc.

More Donnatal Elixir resources

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

Compare Donnatal Elixir with other medications

• Duodenal Ulcer
• Enterocolitis
• Irritable Bowel Syndrome

Dimetane Extentab

Generic Name: brompheniramine (brome feh NEER a meen)

Brand Names: BroveX, BroveX CT, Dimetane, Dimetane Extentab, Dimetapp Allergy, Dimetapp Allergy Liquigel, Lodrane 12 Hour

What is Dimetane Extentab (brompheniramine)?

Brompheniramine is an antihistamine. Brompheniramine blocks the effects of the naturally occurring chemical histamine in the body.

Brompheniramine is used to sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Brompheniramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Dimetane Extentab (brompheniramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Brompheniramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine. Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

What should I discuss with my healthcare provider before taking Dimetane Extentab (brompheniramine)?

Do not take brompheniramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking brompheniramine, talk to your doctor if you have

• 
  

  glaucoma or increased pressure in the eye;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  an enlarged prostate, bladder problems or difficulty urinating;

  
  


• 
  

  an overactive thyroid (hyperthyroidism);

  
  


• 
  

  hypertension or any type of heart problems; or

  
  


• 
  

  asthma.

  
  

You may not be able to take brompheniramine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Brompheniramine is in the FDA pregnancy category C. This means that it is not known whether brompheniramine will be harmful to an unborn baby. Do not take brompheniramine without first talking to your doctor if you are pregnant or could become pregnant during treatment. Brompheniramine passes into breast milk. Infants are especially sensitive to the effects of antihistamines, and serious side effects could occur in a nursing infant. Do not take brompheniramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from brompheniramine. You may require a lower dose of this medication.

How should I take Dimetane Extentab (brompheniramine)?

Take brompheniramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Brompheniramine can be taken with or without food.

Do not crush, chew, or break the extended- or timed-release forms of brompheniramine. Swallow them whole. They are specially formulated to release the medication slowly in the body.

To ensure that you get a correct dose, measure the liquid form of brompheniramine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is prescribed or is recommended on the package. The maximum amount of brompheniramine that you should take in 1 day is 24 mg. The regular-release tablets and the syrup are usually taken every 4 to 6 hours as needed (four to six times a day). The sustained-release tablets and capsules are usually taken every 8 to 12 hours as needed (two or three times a day). If your symptoms do not improve, or if they worsen, contact your healthcare provider. Store brompheniramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a brompheniramine overdose may include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Dimetane Extentab (brompheniramine)?

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.

Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking brompheniramine.

Dimetane Extentab (brompheniramine) side effects

Stop taking brompheniramine and seek emergency medical attention if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take brompheniramine and talk to your doctor if you experience

• 
  

  sleepiness, fatigue, or dizziness;

  
  


• 
  

  headache;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  difficulty urinating or an enlarged prostate.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Dimetane Extentab (brompheniramine)?

Do not take brompheniramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medications while taking brompheniramine without first talking to your pharmacist or doctor. Other medications may also contain brompheniramine or other similar drugs, and you may accidentally take too much of these medicines.

Brompheniramine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if brompheniramine is taken with any of these medications.

Drugs other than those listed here may also interact with brompheniramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Dimetane Extentab resources

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

• Brompheniramine 12-Hour Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Brompheniramine Professional Patient Advice (Wolters Kluwer)


• Brompheniramine Maleate, Dexbrompheniramine Maleate Monograph (AHFS DI)


• Brovex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Brovex CT Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


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


• VaZol Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Dimetane Extentab with other medications

• Allergic Reactions
• Cold Symptoms
• Hay Fever
• Urticaria

Where can I get more information?

• Your pharmacist has more information about brompheniramine written for health professionals that you may read.

See also: Dimetane Extentab side effects (in more detail)

Ozurdex

Dosage Form: intravitreal implant
FULL PRESCRIBING INFORMATION

Indications and Usage for Ozurdex

Retinal Vein Occlusion

Ozurdex® (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Posterior Segment Uveitis

Ozurdex® is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye.

Ozurdex Dosage and Administration

General Dosing Information

For ophthalmic intravitreal injection only.

Administration

The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide are recommended to be given prior to the injection.

Remove the foil pouch from the carton and examine for damage. Then, open the foil pouch over a sterile field and gently drop the applicator on a sterile tray. Carefully remove the cap from the applicator. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab. The long axis of the applicator should be held parallel to the limbus, and the sclera should be engaged at an oblique angle with the bevel of the needle up (away from the sclera) to create a shelved scleral path. The tip of the needle is advanced within the sclera for about 1 mm (parallel to the limbus), then re-directed toward the center of the eye and advanced until penetration of the sclera is completed and the vitreous cavity is entered. The needle should not be advanced past the point where the sleeve touches the conjunctiva.

Slowly depress the actuator button until an audible click is noted. Before withdrawing the applicator from the eye, make sure that the actuator button is fully depressed and has locked flush with the applicator surface. Remove the needle in the same direction as used to enter the vitreous.

Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Each applicator can only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new applicator must be used, and the sterile field, syringe, gloves, drapes, and eyelid speculum should be changed before Ozurdex® is administered to the other eye.

Dosage Forms and Strengths

Intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system.

Contraindications

Ocular or Periocular Infections

Ozurdex® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Advanced Glaucoma

Ozurdex® is contraindicated in patients with advanced glaucoma.

Hypersensitivity

Ozurdex® is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions

Intravitreal Injection-related Effects

Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments.

Patients should be monitored following the injection (see PATIENT COUNSELING INFORMATION, 17).

Potential Steroid-related Effects

Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex.

Adverse Reactions

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis):

Adverse Reactions Reported by Greater than 2% of Patients in the First Six Months

MedDRA Term	Ozurdex® N=497 (%)	Sham N=498 (%)
Intraocular pressure increased	125 (25%)	10 (2%)
Conjunctival hemorrhage	108 (22%)	79 (16%)
Eye pain	40 (8%)	26 (5%)
Conjunctival hyperemia	33 (7%)	27 (5%)
Ocular hypertension	23 (5%)	3 (1%)
Cataract	24 (5%)	10 (2%)
Vitreous detachment	12 (2%)	8 (2%)
Headache	19 (4%)	12 (2%)

Increased IOP with Ozurdex® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received Ozurdex® required surgical procedures for management of elevated IOP.

Following a second injection of Ozurdex® in cases where a second injection was indicated, the overall incidence of cataracts was higher after 1 year.

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects: Pregnancy Category C

Topical dexamethasone has been shown to be teratogenic in mice producing fetal resorptions and cleft palate. In the rabbit, dexamethasone produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. Pregnant rhesus monkeys treated with dexamethasone sodium phosphate intramuscularly at 1 mg/kg/day every other day for 28 days or at 10 mg/kg/day once or every other day at 3 or 5 days between gestation days 23 and 49 had fetuses with minor cranial abnormalities. A 1 mg/kg/dose in pregnant rhesus monkeys would be approximately 85 times higher than an Ozurdex® injection in humans (assuming 60 kg body weight).

There are no adequate and well-controlled studies in pregnant women. Ozurdex® (dexamethasone intravitreal implant) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Ozurdex® in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Ozurdex Description

Ozurdex® is an intravitreal implant containing 0.7 mg (700 μg) dexamethasone in the NOVADUR® solid polymer drug delivery system. Ozurdex® is preloaded into a single-use, specially designed DDS® applicator to facilitate injection of the rod-shaped implant directly into the vitreous. The NOVADUR® system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix without a preservative. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. Its structural formula is:

MW 392.47; molecular formula: C22H29FO5

Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.

The PLGA matrix slowly degrades to lactic acid and glycolic acid.

Ozurdex - Clinical Pharmacology

Mechanism of Action

Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

Pharmacokinetics

Plasma concentrations were obtained from 21 patients in two 6 month studies prior to dosing and on Days 7, 30, 60, and 90 following the intravitreal implant containing 0.35 mg or 0.7 mg dexamethasone. In both studies, the majority of plasma dexamethasone concentrations were below the lower limit of quantitation (LLOQ = 50 pg/mL). Plasma dexamethasone concentrations from 10 of 73 samples in the 0.7 mg dose group and from 2 of 42 samples in the 0.35 mg dose group were above the LLOQ, ranging from 52 pg/mL to 94 pg/mL. The highest plasma concentration value of 94 pg/mL was observed in one subject from the 0.7 mg group. Plasma dexamethasone concentration did not appear to be related to age, body weight, or sex of patients.

In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, iris-ciliary body, choroid, retina, vitreous humor, and sclera tissues for 18 hours, no metabolites were observed.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies in animals have been conducted to determine whether Ozurdex® (dexamethasone intravitreal implant) has the potential for carcinogenesis.

Although no adequate studies have been conducted to determine the mutagenic potential of Ozurdex®, dexamethasone has been shown to have no mutagenic effects in bacterial and mammalian cells in vitro or in the in vivo mouse micronucleus test.

Clinical Studies

Retinal Vein Occlusion

The efficacy of Ozurdex® for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) was assessed in two, multicenter, double-masked, randomized, parallel studies.

Following a single injection, Ozurdex® demonstrated the following clinical results for the percent of patients with ≥ 15 letters of improvement from baseline in best-corrected visual acuity (BCVA):

Number (Percent) of Patients with ≥ 15 Letters Improvement from Baseline in BCVA

*P-values were based on the Pearson's chi-square test.
	Study 1			Study 2
Study Day	DEX 700 N=201	Sham N=202	p-value*	DEX 700 N=226	Sham N=224	p-value*
Day 30	40 (20%)	15 (7%)	< 0.01	51 (23%)	17 (8%)	< 0.01
Day 60	58 (29%)	21 (10%)	< 0.01	67 (30%)	27 (12%)	< 0.01
Day 90	45 (22%)	25 (12%)	< 0.01	48 (21%)	31 (14%)	0.039
Day 180	39 (19%)	37 (18%)	0.780	53 (24%)	38 (17%)	0.087

In each individual study and in a pooled analysis, time to achieve ≥ 15 letters (3-line) improvement in BCVA cumulative response rate curves were significantly faster with Ozurdex® compared to sham (p < 0.01), with Ozurdex® treated patients achieving a 3-line improvement in BCVA earlier than sham-treated patients.

The onset of a ≥ 15 letter (3-line) improvement in BCVA with Ozurdex® occurs within the first two months after implantation in approximately 20-30% of subjects. The duration of effect persists approximately one to three months after onset of this effect.

Posterior Segment Uveitis

The efficacy of Ozurdex® was assessed in a single, multicenter, masked, randomized study of 153 patients with non-infectious uveitis affecting the posterior segment of the eye.

After a single injection, the percent of patients reaching a vitreous haze score of 0 (where a score of 0 represents no inflammation) was statistically significantly greater for patients receiving Ozurdex® versus sham at week 8 (primary time point) (47% vs. 12%). The percent of patients achieving a 3-line improvement from baseline BCVA was 43% for patients receiving Ozurdex® vs. 7% for sham at week 8.

How Supplied/Storage and Handling

Ozurdex® (dexamethasone intravitreal implant) 0.7 mg is supplied in a foil pouch with 1 single-use plastic applicator, NDC 0023-3348-07.

Storage: Store at 15°-30°C (59°-86°F).

Patient Counseling Information

In the days following intravitreal injection of Ozurdex®, patients are at risk for potential complications including in particular, but not limited to, the development of endophthalmitis or elevated intraocular pressure. If the eye becomes red, sensitive to light, painful, or develops a change in vision, the patients should seek immediate care from an ophthalmologist.

Patients may experience temporary visual blurring after receiving an intravitreal injection. They should not drive or use machines until this has resolved.

© 2011 Allergan, Inc.

Irvine, CA 92612, U.S.A.

® marks owned by Allergan, Inc.

U.S. Patents 6,726,918; 6,899,717; 7,033,605; and 7,767,223

Made in Ireland

72212US12C

Ozurdex®

(dexamethasone

intravitreal implant) 0.7 mg

© 2010 Allergan, Inc.

Irvine, CA 92612, U.S.A.

Rx Only

Rx Only

Needle Orientation

Open Other End

Ozurdex®

(dexamethasone

intravitreal implant) 0.7 mg

NDC 0023-3348-07

One Sterile, Single-Use

Applicator

For Intravitreal

Injection Only

ALLERGAN

Ozurdex®

(dexamethasone

intravitreal implant) 0.7 mg

Contents include:

One Sterile, Single-Use Applicator

NDC 0023-3348-07

For Intravitreal Injection Only

Rx only

ALLERGAN

Ozurdex  dexamethasone  implant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0023-3348 Route of Administration INTRAVITREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength dexamethasone (dexamethasone) dexamethasone 0.7 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0023-3348-07 1 POUCH In 1 CARTON contains a POUCH 1 1 SYRINGE In 1 POUCH This package is contained within the CARTON (0023-3348-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022315	09/01/2009

Labeler - Allergan, Inc. (144796497)

Establishment
Name	Address	ID/FEI	Operations
Allergan Pharmaceuticals Ireland		219682291	MANUFACTURE

Revised: 10/2011Allergan, Inc.

Diltiazem Immediate-Release Tablets

Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Cardizem

Diltiazem Immediate-Release Tablets are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Diltiazem Immediate-Release Tablets are a calcium channel blocker. It works by relaxing (dilating) blood vessels, lowering blood pressure, and decreasing the heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.

Do NOT use Diltiazem Immediate-Release Tablets if:

• you are allergic to any ingredient in Diltiazem Immediate-Release Tablets


• you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker


• you have very low blood pressure or you have fluid buildup in the lungs during or soon after a heart attack


• you are taking erythromycin

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

Before using Diltiazem Immediate-Release Tablets:

Some medical conditions may interact with Diltiazem Immediate-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 heart failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems


• if you have low blood pressure or kidney or liver disease


• if you take other medicines for high blood pressure or heart conditions

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

• Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, desipramine) because they may increase the risk of Diltiazem Immediate-Release Tablets's side effects, such as heart rhythm problems


• Moricizine or rifamycins (eg, rifampin) because they may decrease Diltiazem Immediate-Release Tablets's effectiveness


• Benzodiazepines (eg, midazolam), beta-blockers (eg, metoprolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, prednisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, atorvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin), macrolide immunomodulators (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Diltiazem Immediate-Release Tablets

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

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

• Take Diltiazem Immediate-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Taking Diltiazem Immediate-Release Tablets at the same time(s) each day will help you remember to take it.


• Continue to take Diltiazem Immediate-Release Tablets even if you feel well. Do not miss any doses.


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

Ask your health care provider any questions you may have about how to use Diltiazem Immediate-Release Tablets.

Important safety information:

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


• Diltiazem Immediate-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose or stop taking Diltiazem Immediate-Release Tablets without checking with your doctor.


• Diltiazem Immediate-Release Tablets may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Diltiazem Immediate-Release Tablets. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Be sure to have your blood pressure checked regularly while taking Diltiazem Immediate-Release Tablets.


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


• Lab tests, including electrocardiogram (ECG), heart rate, and blood pressure monitoring, may be performed while you use Diltiazem Immediate-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.


• Use Diltiazem Immediate-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.


• Diltiazem Immediate-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in 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 taking Diltiazem Immediate-Release Tablets while you are pregnant. Diltiazem Immediate-Release Tablets are found in breast milk. Do not breast-feed while taking Diltiazem Immediate-Release Tablets.

Possible side effects of Diltiazem Immediate-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:

Constipation; dizziness; facial flushing; headache; lightheadedness; tiredness; weakness.

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; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mood or mental changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.

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: Diltiazem 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; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.

Proper storage of Diltiazem Immediate-Release Tablets:

Store Diltiazem Immediate-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diltiazem Immediate-Release Tablets out of the reach of children and away from pets.

General information:

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


• Diltiazem Immediate-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 Diltiazem Immediate-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 Diltiazem resources

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

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