Dilantin Suspension

Pronunciation: FEN-i-toin
Generic Name: Phenytoin
Brand Name: Dilantin

Dilantin Suspension is used for:

Treating tonic-clonic (grand mal) and partial seizures. It is also used to prevent and treat seizures that may occur during or after brain or nervous system surgery. It may also be used for other conditions as determined by your doctor.

Dilantin Suspension is an anticonvulsant. It works in the brain to block the spread of seizure activity.

Do NOT use Dilantin Suspension if:

• you are allergic to any ingredient in Dilantin Suspension or to another hydantoin (eg, fosphenytoin)


• you are taking cabazitaxel, crizotinib, dronedarone, etravirine, lurasidone, nifedipine, nisoldipine, praziquantel, ranolazine, rilpivirine, rivaroxaban, roflumilast, ticagrelor, or vandetanib

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

Before using Dilantin Suspension:

Some medical conditions may interact with Dilantin Suspension. 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 the blood disease porphyria, liver disease, diabetes, a weakened immune system, bone problems (eg, weak bones, osteoporosis), or a history of lymph gland problems


• if you or a family member has had anticonvulsant hypersensitivity syndrome (AHS)


• if you are in very poor health or you receive nutrition through an enteral tube (eg, G-tube)


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


• if you have been tested and know whether or not you have a gene type called HLA-B*1502


• if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or attempts

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

• Many other prescription and nonprescription medicines (eg, used for allergic reactions, asthma or other breathing problems, blood thinning, diabetes, infections, inflammation, aches and pains, attention deficit hyperactivity disorder, alcoholism, cancer, high blood pressure, indigestion, irregular heartbeat or other heart problems, hepatitis C, high blood iron levels, high cholesterol, HIV, birth control, hormone replacement, immune system suppression, mental or mood problems, pain, sleep, seizures, stomach or bowel problems), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Dilantin Suspension. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Dilantin Suspension

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

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

• Dilantin Suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Dilantin Suspension refilled.


• Take Dilantin Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Shake well before each use. Be sure the medicine is completely mixed before you take a dose.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you take a calcium product (eg, certain antacids), colesevelam, or molindone, ask your doctor or pharmacist how to take it with Dilantin Suspension.


• Do not suddenly stop taking Dilantin Suspension. You may have an increased risk of seizures if you stop taking it. If you need to stop Dilantin Suspension, your doctor will gradually lower your dose.


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


• Taking Dilantin Suspension at the same time each day will help you remember to take it.


• If you miss a dose of Dilantin Suspension, 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 Dilantin Suspension.

Important safety information:

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


• Check with your doctor before you drink alcohol while you are taking Dilantin Suspension. Alcohol may increase or decrease the amount of medicine in your blood.


• Do not change brands or doseforms (eg, tablets, capsules, injection) of Dilantin Suspension without talking with your doctor.


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


• Patients who take Dilantin Suspension may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Dilantin Suspension closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.


• Proper dental care is important while you are taking Dilantin Suspension. Brush and floss your teeth and visit the dentist regularly.


• Dilantin Suspension 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.


• There have been reports of lymph node problems, including cancer, in patients who take Dilantin Suspension. It is not known if Dilantin Suspension may be the cause. Contact your doctor right away if you develop swollen lymph nodes.


• Rarely, a serious and sometimes fatal effect (AHS) has occurred in patients who take Dilantin Suspension. The risk may be higher in black patients and in patients with a weakened immune system. It may also be higher if a patient or family member has had AHS in the past. If this effect occurs, it usually happens within 2 to 4 weeks of starting treatment. However, it has also occurred in patients who have been taking Dilantin Suspension for 3 months or more. Contact your doctor right away if you develop swollen lymph nodes, fever, rash, or symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes).


• Long-term treatment with Dilantin Suspension may cause low blood vitamin D levels. This may increase the risk of low blood calcium or phosphate levels. It may also increase the risk of bone softening, weak bones, or other bone problems (eg, fractures). Discuss any questions or concerns with your doctor.


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


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Dilantin Suspension. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Patients who have a certain gene type called HLA-B*1502 may have an increased risk of serious skin reactions from Dilantin Suspension. This gene type is found most commonly in Asian patients. Tell your doctor if you have been tested and know whether or not you have the HLA-B*1502 gene type. Discuss any questions or concerns with your doctor.


• Dilantin Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Dilantin Suspension.


• Lab tests, including blood phenytoin levels or liver function, may be performed while you use Dilantin Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Women who take Dilantin Suspension may experience an increase in seizure activity if they become pregnant. Discuss any questions or concerns with your doctor. If you think you may be pregnant, contact your doctor.


• Dilantin Suspension may cause harm to the fetus. If you may become pregnant, discuss other possible treatment options with your doctor. If a decision is made to take Dilantin Suspension, use effective birth control while you are taking it. Talk with your doctor if you are planning to become pregnant, or if you have questions or concerns about this information.


• PREGNANCY and BREAST-FEEDING: Dilantin Suspension may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. You will need to discuss the benefits and risks of taking Dilantin Suspension while you are pregnant. You and your doctor will need to decide if you will continue to take Dilantin Suspension while you are pregnant. Dilantin Suspension is found in breast milk. Do not breast-feed while taking Dilantin Suspension.

Possible side effects of Dilantin Suspension:

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; drowsiness; headache; mild nervousness; nausea; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, eyes, face, lips, or tongue); bone pain; burning, numbness, or tingling; butterfly-shaped rash on the face; clumsiness or unsteadiness; confusion; delirium; new or worsening mental or mood changes (eg, agitation, anxiety, behavior changes, depression, irritability, panic attacks, restlessness, suicidal thoughts or attempts); new or worsening seizures; red, swollen, blistered, or peeling skin; severe muscle pain; severe or persistent trouble sleeping; signs of infection (eg, chills, fever, sore throat); slurred speech; sores in the mouth or around the eyes; swollen lymph nodes; swollen or tender gums; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble walking; unusual bruising or bleeding; unusual eye movements; unusual muscle movements; unusual tiredness or weakness.

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: Dilantin 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; decreased coordination; fainting; loss of consciousness; severe dizziness or drowsiness; severe or persistent nausea or vomiting; slow or difficult breathing; sluggishness; speech problems (eg, slurred speech); tremor; unusual eye movements.

Proper storage of Dilantin Suspension:

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

General information:

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

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


• Dilantin Suspension 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 Dilantin Suspension. 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 Dilantin resources

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

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Dilt-XR

Generic Name: diltiazem (Oral route)

dil-TYE-a-zem

Commonly used brand name(s)

In the U.S.

• Cardizem


• Cardizem CD


• Cardizem LA


• Cartia XT


• Dilacor XR


• Dilt-CD


• Diltia XT


• Dilt-XR


• Diltzac


• Matzim LA


• Taztia XT


• Tiazac

Available Dosage Forms:

• Capsule, Extended Release


• Tablet, Extended Release


• Tablet


• Capsule, Extended Release, 24 HR


• Capsule, Extended Release, 12 HR

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Calcium Channel Blocker

Chemical Class: Benzothiazepine

Uses For Dilt-XR

Diltiazem is used alone or together with other medicines to treat severe chest pain (angina) or high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Diltiazem is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. As a result, diltiazem relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload .

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

Before Using Dilt-XR

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diltiazem in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of diltiazem in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require an adjustment in the dose for patients receiving diltiazem .

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

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Alprenolol


• Amiodarone


• Aprepitant


• Atazanavir


• Atenolol


• Atorvastatin


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Clonidine


• Clozapine


• Colchicine


• Crizotinib


• Dantrolene


• Dilevalol


• Dronedarone


• Droperidol


• Erythromycin


• Esmolol


• Everolimus


• Fentanyl


• Labetalol


• Levobunolol


• Lurasidone


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Ranolazine


• Simvastatin


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Tolvaptan

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

• Alfentanil


• Alfuzosin


• Amlodipine


• Aspirin


• Buspirone


• Carbamazepine


• Celecoxib


• Cilostazol


• Cimetidine


• Clopidogrel


• Colestipol


• Cyclosporine


• Dalfopristin


• Digitoxin


• Digoxin


• Dutasteride


• Efavirenz


• Enflurane


• Fosaprepitant


• Fosphenytoin


• Guggul


• Indinavir


• Lithium


• Lovastatin


• Methylprednisolone


• Midazolam


• Moricizine


• Nevirapine


• Nifedipine


• Phenytoin


• Quinupristin


• Rifampin


• Rifapentine


• Ritonavir


• Sirolimus


• St John's Wort


• Tacrolimus


• Triazolam

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Bowel blockage, severe or


• Congestive heart failure—Use with caution. May make this condition worse .

• Heart attack or


• Heart block (type of abnormal heart rhythm, can use if have a pacemaker that works properly) or


• Hypotension (low blood pressure), severe or


• Lung problem (e.g., pulmonary congestion) or


• Sick sinus syndrome (type of abnormal heart rhythm, can use if have a pacemaker that works properly)—Should not be used in patients with these conditions .

• Kidney disease or


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

Proper Use of diltiazem

This section provides information on the proper use of a number of products that contain diltiazem. It may not be specific to Dilt-XR. Please read with care.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet .

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well .

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease .

Swallow the extended-release tablet or extended-release capsule whole. Do not open, crush, or chew it. It is best to take the extended-release capsule on an empty stomach .

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 chest pain:
  
  • For oral dosage form (tablets):
    
    • Adults—At first, 30 milligrams (mg) four times a day before meals and at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 mg once a day either in the evening or in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 120 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

• For high blood pressure:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 180 to 240 milligrams (mg) once a day either in the morning or at bedtime. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For oral dosage form (extended-release capsules):
    
    • Adults—At first, 180 to 240 mg once a day in the morning. Your doctor may increase your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Dilt-XR

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; itching; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness .

Dilt-XR Side Effects

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

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

More common

• Body aches or pain


• congestion


• cough


• dryness or soreness of throat


• fever


• hoarseness


• runny nose


• tender or swollen glands in neck


• trouble in swallowing


• voice changes

Less common

• Chest pain or discomfort


• chills


• diarrhea


• difficult or labored breathing


• feeling faint, dizzy, or lightheaded


• feeling of warmth or heat


• flushing or redness of skin, especially on face and neck


• general feeling of discomfort or illness


• headache


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• shivering


• shortness of breath


• slow or irregular heartbeat


• sore throat


• sweating


• swelling of hands, ankles, feet, or lower legs


• tightness in chest


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Blistering, peeling, or loosening of skin


• itching


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• no heart beat


• red irritated eyes


• red skin lesions, often with a purple center


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

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

• Sneezing


• stuffy nose

Less common

• Acid or sour stomach


• belching


• constipation


• continuing ringing or buzzing or other unexplained noise in ears


• degenerative disease of the joint


• difficulty in moving


• hearing loss


• heartburn


• indigestion


• lack or loss of strength


• muscle aching or cramping


• muscle pains or stiffness


• pain or tenderness around eyes and cheekbones


• rash


• sleeplessness


• stomach discomfort, upset, or pain


• swollen joints


• unable to sleep

Incidence not known

• Hair loss or thinning of hair

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: Dilt-XR side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Dilt-XR resources

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

• Dilt-XR Prescribing Information (FDA)


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


• Diltiazem Prescribing Information (FDA)


• Cardizem Consumer Overview


• Cardizem MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem Prescribing Information (FDA)


• Cardizem CD Prescribing Information (FDA)


• Cardizem CD 24-Hour Sustained-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem LA Prescribing Information (FDA)


• Cardizem LA 24-Hour Extended-Release Beads Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cartia XT Prescribing Information (FDA)


• DILT-CD Prescribing Information (FDA)


• Dilacor XR Prescribing Information (FDA)


• Diltia XT Prescribing Information (FDA)


• Diltiazem Hydrochloride Monograph (AHFS DI)


• Matzim LA Prescribing Information (FDA)


• Taztia XT Prescribing Information (FDA)


• Taztia XT 24-Hour Extended-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Tiazac Prescribing Information (FDA)


• Tiazac Consumer Overview

Compare Dilt-XR with other medications

• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome
• Supraventricular Tachycardia

Dimetapp Decongestant Drops

Pronunciation: FEN-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Examples include Dimetapp Decongestant and Little Colds Decongestant

Dimetapp Decongestant Drops are used for:

Relieving congestion due to colds, flu, and allergies. It may also be used for other conditions as determined by your doctor.

Dimetapp Decongestant Drops are a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Dimetapp Decongestant Drops if:

• you are allergic to any ingredient in Dimetapp Decongestant Drops


• you are taking furazolidone or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days


• you have high blood pressure or an abnormally fast heartbeat

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

Before using Dimetapp Decongestant Drops:

Some medical conditions may interact with Dimetapp Decongestant Drops. 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 disease, diabetes, phenylketonuria (PKU), an adrenal gland tumor, or thyroid disease

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

• Rauwolfia derivatives (eg, reserpine) or tricyclic antidepressants (eg, amitriptyline) because they may decrease Dimetapp Decongestant Drops's effectiveness


• Cocaine, furazolidone, MAOIs (eg, phenelzine), methyldopa, oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dimetapp Decongestant Drops's side effects


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), or droxidopa because the risk of their side effects may be increased by Dimetapp Decongestant Drops


• Guanethidine because its effectiveness may be decreased by Dimetapp Decongestant Drops

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

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

• Take Dimetapp Decongestant Drops by mouth with food, water, or milk to reduce stomach irritation.


• Use the dropper that comes with Dimetapp Decongestant Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Dimetapp Decongestant Drops and are taking it regularly, 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 Dimetapp Decongestant Drops.

Important safety information:

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


• If your symptoms do not get better within 7 days or if you develop a high fever, check with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Dimetapp Decongestant Drops.


• Do not take diet or appetite control medicines while you are taking Dimetapp Decongestant Drops.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• Diabetes patients - Dimetapp Decongestant Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Use Dimetapp Decongestant Drops with caution in the ELDERLY; they may be more sensitive to its effects.


• Dimetapp Decongestant Drops should be used with extreme caution in CHILDREN younger than 2 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 Dimetapp Decongestant Drops while you are pregnant. It is not known if Dimetapp Decongestant Drops are found in breast milk. If you are or will be breast-feeding while you use Dimetapp Decongestant Drops, check with your doctor. Discuss any possible risks to your baby.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Dimetapp Decongestant Drops. This is known as DEPENDENCE or addiction. If you stop taking Dimetapp Decongestant Drops suddenly, you may have WITHDRAWAL symptoms. These may include depression.

Possible side effects of Dimetapp Decongestant Drops:

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:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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).

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: Dimetapp Decongestant 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; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Dimetapp Decongestant Drops:

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

General information:

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


• Dimetapp Decongestant Drops 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 Dimetapp Decongestant Drops. 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 Dimetapp Decongestant resources

• Dimetapp Decongestant Side Effects (in more detail)
• Dimetapp Decongestant Use in Pregnancy & Breastfeeding
• Dimetapp Decongestant Drug Interactions
• 0 Reviews · Be the first to review/rate this drug

Dimenhydrinate

Dimenhydrinate Injection USP

Rx only

Dimenhydrinate Description

Dimenhydrinate, an anti-nauseant/antiemetic, is the 8-chlorotheophylline salt of diphenhydramine.  It contains not less than 53% and not more than 55.5% of diphenhydramine, and not less than 44% and not more than 47% of 8-chlorotheophylline, calculated on the dried basis.  Chemically, it is 8-chlorotheophylline compound with 2(diphenylmethoxy)-N,N-dimethylethylamine (1:1), and the structural formula is:

 C17H21NO•C7H7ClN4O2                                M.W. 469.96

Dimenhydrinate Injection, USP contains a sterile solution of Dimenhydrinate 50 mg/mL; Propylene Glycol 50%; Benzyl Alcohol 5% as preservative; and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.

Dimenhydrinate - Clinical Pharmacology

While the precise mode of action of Dimenhydrinate is not known, it has a depressant action on hyperstimulated labyrinthine function.

Indications and Usage for Dimenhydrinate

Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.

Contraindications

Neonates and patients with a history of hypersensitivity to Dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Dimenhydrinate.

Note: This product contains Benzyl Alcohol.  Benzyl Alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.

Warnings

Caution should be used when Dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since Dimenhydrinate is capable of masking ototoxic symptoms, and an irreversible state may be reached.

This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.  The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Therefore, patients should be warned accordingly.

Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias).

The preparation should not be injected intra-arterially.

Pediatric Patients

For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death.

As in adults, antihistamines may diminish mental alertness in pediatric patients.  In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS).

Precautions

General

Drowsiness may be experienced by some patients, especially with high dosage.  This effect frequently is not undesirable in conditions for which the drug is used.

Information for Patients

Because of the potential for drowsiness, patients taking Dimenhydrinate should be cautioned against operating automobiles or dangerous machinery (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity screening tests performed with Dimenhydrinate, diphenhydramine, and 8-chlorotheophylline produced positive results in the bacterial systems and negative results in the mammalian systems.  There are no human data that indicate Dimenhydrinate is a carcinogen or mutagen or that it impairs fertility.

Pregnancy

Pregnancy Category B.

Reproduction studies have been performed in rats at doses up to 20 times the human dose, and in rabbits at doses up to 25 times the human dose (on a mg/kg basis), and have revealed no evidence of impaired fertility or harm to the fetus due to Dimenhydrinate. There are no adequate and well-controlled studies in pregnant women.  However, clinical studies in pregnant women have not indicated that Dimenhydrinate increases the risk of abnormalities when administered in any trimester of pregnancy.  It would appear that the possibility of fetal harm is remote when the drug is used during pregnancy.  Nevertheless, because the studies in humans cannot rule out the possibility of harm, Dimenhydrinate should be used during pregnancy only if clearly needed.

Labor and Delivery

The safety of Dimenhydrinate given during labor and delivery has not been established. Reports have indicated Dimenhydrinate may have an oxytocic effect.  Caution is advised when this effect is unwanted or in situations where it may prove detrimental.

Nursing Mothers

Small amounts of Dimenhydrinate are excreted in breast milk.  Because of the potential for adverse reactions in nursing infants from Dimenhydrinate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Adverse Reactions

The most frequent adverse reaction to Dimenhydrinate is drowsiness.  Dizziness may also occur.  Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.

Overdosage

Drowsiness is the usual clinical side effect.  Convulsions, coma, and respiratory depression may occur with massive overdosage.  No specific antidote is known.  If respiratory depression occurs, mechanically assisted respiration should be initiated and oxygen should be administered.  Convulsions should be treated with appropriate doses of diazepam.  Phenobarbital (5 to 6 mg/kg) may be given to control convulsions in pediatric patients.

The oral LD50 in mice and rats is 203 mg/kg and 1320 mg/kg, respectively.  The intraperitoneal LD50 in mice is 149 mg/kg.

Dimenhydrinate Dosage and Administration

Dimenhydrinate in the injectable form is indicated when the oral form is impractical.

Adults

Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a similar dose every 4 hours.  Its administration may be attended by some degree of drowsiness in some patients, and 100 mg every 4 hours may be given in conditions in which drowsiness is not objectionable or is even desirable.

For intramuscular administration, each milliliter (50 mg) of solution is injected as needed, but for intravenous administration, each milliliter (50 mg) of solution must be diluted in 10 mL of 0.9% Sodium Chloride Injection, USP and injected over a period of 2 minutes.

Pediatric

For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m2 of body surface area is administered four times daily.  The maximum dose should not exceed 300 mg daily (see CONTRAINDICATIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Dimenhydrinate Supplied

Dimenhydrinate Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:

Product No.	NDC No.	Strength	Vial Size
361601	63323-366-01	50 mg/mL	1 mL in 2 mL vial, in packages of 25.
361610	63323-366-10	50 mg/mL	10 mL in a 10 mL vial, packaged individually.

Protect from light.

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Vial stoppers do not contain natural rubber latex.

45981B

Revised: April 2008

PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Label        

NDC 63323-366-01

361601

Dimenhydrinate INJECTION, USP

50 mg/mL

For IM Use

For IV Use: See package insert.

Rx only

1 mL Multiple Dose Vial

 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Tray Label

NDC 63323-366-01

361601

Dimenhydrinate INJECTION, USP

50 mg/mL

For IM Use

*For IV Use

Rx only

1 mL Multiple Dose Vial

 

 

Dimenhydrinate  Dimenhydrinate  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 63323-366 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimenhydrinate (Dimenhydrinate) Dimenhydrinate 50 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL 0.05 mL  in 1 mL PROPYLENE GLYCOL 0.5 mL  in 1 mL SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 63323-366-01 25 VIAL In 1 TRAY contains a VIAL 1 1 mL In 1 VIAL This package is contained within the TRAY (63323-366-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040519	11/29/2004

Labeler - APP Pharmaceuticals, LLC (608775388)

Establishment
Name	Address	ID/FEI	Operations
APP Pharmaceuticals, LLC		840771732	MANUFACTURE

Revised: 08/2011APP Pharmaceuticals, LLC

Dimenhydrinate Chewable Tablets

Pronunciation: dye-men-HYE-dri-nate
Generic Name: Dimenhydrinate
Brand Name: Dramamine

Dimenhydrinate Chewable Tablets are used for:

Preventing and treating nausea, vomiting, and dizziness caused by motion sickness. It may also be used for other conditions as determined by your doctor.

Dimenhydrinate Chewable Tablets are an antihistamine and anticholinergic. It works in the brain to decrease nausea, vomiting, and dizziness.

Do NOT use Dimenhydrinate Chewable Tablets if:

• you are allergic to any ingredient in Dimenhydrinate Chewable Tablets or other similar medicines


• you are taking sodium oxybate (GHB)


• you are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 14 days


• you are breast-feeding

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

Before using Dimenhydrinate Chewable Tablets:

Some medical conditions may interact with Dimenhydrinate Chewable 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 or planning to become pregnant


• 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 asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung disease, shortness of breath, or sleep apnea


• if you have a blockage of the stomach, intestine, or urinary tract; difficulty urinating; diabetes; ulcers; enlargement of the prostate; glaucoma; heart disease; irregular heartbeat; high blood pressure; porphyria; or thyroid disease


• if you have phenylketonuria

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

• Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur


• MAO inhibitors (eg, phenelzine) because serious side effects, such as high blood pressure or seizure, may occur


• Antibiotics that may cause hearing problems (eg, gentamicin, vancomycin) because Dimenhydrinate Chewable Tablets may mask symptoms of hearing problems

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

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

• Dimenhydrinate Chewable Tablets may be taken with or without food.


• Chew thoroughly before swallowing.


• Use Dimenhydrinate Chewable Tablets exactly as directed on the package, unless instructed differently by your doctor. If you are taking Dimenhydrinate Chewable Tablets without a prescription, follow any warnings and precautions on the label.


• Take the first dose at least 30 minutes before activity or travel.


• If you miss a dose of Dimenhydrinate Chewable Tablets and you are taking it regularly, 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 Dimenhydrinate Chewable Tablets.

Important safety information:

• Dimenhydrinate Chewable Tablets may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Dimenhydrinate Chewable Tablets. Using Dimenhydrinate Chewable Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Dimenhydrinate Chewable Tablets. Dimenhydrinate Chewable Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Dimenhydrinate Chewable Tablets may cause dizziness. Alcohol, hot weather, exercise, and fever can increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness.


• Do not exceed the recommended dose or use Dimenhydrinate Chewable Tablets more frequently or for longer than prescribed without first checking with your doctor.


• Phenylketonuria patients - Dimenhydrinate Chewable Tablets contains phenylalanine.


• Do not become overheated in hot weather or during exercise or other activities since heatstroke may occur.


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


• Do not use Dimenhydrinate Chewable Tablets with any medicine that contains diphenhydramine. Before you begin taking any new prescription or nonprescription medicine, including one used on the skin, read the ingredients to see if it also contains diphenhydramine or another similar medicine (eg, antihistamine). If it does, or if you are uncertain if it does, contact your doctor or pharmacist.


• Use Dimenhydrinate Chewable Tablets with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.


• Safe use and instructions for use in CHILDREN differs according to the brand used. Talk to your doctor or pharmacist if you have any questions about the brand you are using.


• Use of Dimenhydrinate Chewable Tablets are not recommended in CHILDREN younger than 2 years of age without first talking with the child's doctor. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Dimenhydrinate Chewable Tablets during pregnancy. Dimenhydrinate Chewable Tablets are excreted in breast milk. Do not breast-feed while taking Dimenhydrinate Chewable Tablets.

Possible side effects of Dimenhydrinate Chewable 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, throat, and nose; thickening of mucus in nose or throat.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; convulsions; decreased alertness; difficulty urinating; excessive excitability; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; pounding in the chest; seizures; tremor; unusual bruising or bleeding; wheezing; 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: Dimenhydrinate 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 coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; severe drowsiness; tremor; weakness.

Proper storage of Dimenhydrinate Chewable Tablets:

Store Dimenhydrinate Chewable Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), or according to directions on the package label. Store in the original package or container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dimenhydrinate Chewable Tablets out of the reach of children and away from pets.

General information:

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


• Dimenhydrinate Chewable 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 Dimenhydrinate Chewable 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 Dimenhydrinate resources

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

Compare Dimenhydrinate with other medications

• Motion Sickness
• Nausea/Vomiting

Dilaudid Tablets

Pronunciation: HYE-droe-MOR-fone
Generic Name: Hydromorphone
Brand Name: Dilaudid

Dilaudid is used for:

Treating pain in certain patients.

Dilaudid is an opioid (narcotic) analgesic. It works by binding to certain receptors in the brain and nervous system to reduce pain.

Do NOT use Dilaudid if:

• you are allergic to any ingredient in Dilaudid or any other codeine- or morphine-related medicine (eg, morphine, codeine, oxycodone)


• you have difficult or slowed breathing, chronic obstructive pulmonary disease (COPD), or right-sided heart problems (cor pulmonale), or you are having a severe asthma attack


• you are in labor


• you have severe diarrhea or other bowel problems caused by antibiotics or poisoning


• you have a brain injury or growths in the brain along with increased pressure in the brain


• you are taking sodium oxybate (GHB)

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

Before using Dilaudid:

Some medical conditions may interact with Dilaudid. 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 lung or breathing problems (eg, asthma, emphysema, bronchitis), seizures (eg, epilepsy), adrenal gland problems, an enlarged prostate, heart problems, low blood pressure, dehydration, low blood volume, an underactive thyroid, or urinary blockage


• if you have severe drowsiness, a recent head injury, spinal problems, growths in the brain, or increased pressure in the brain


• if you have liver or kidney problems, gallbladder problems, or stomach or bowel problems (eg, inflammation), or if you have had recent stomach or bowel surgery


• if you drink alcohol regularly, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts


• if you have a personal or family history of mental or mood problems, alcohol abuse, or other substance abuse or dependence


• if you are in poor health or shock, or will be having surgery

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

• Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased


• Barbiturate anesthetics (eg, thiopental), cimetidine, or sodium oxybate (GHB) because the risk of severe drowsiness, coma, or slowed or difficult breathing may be increased


• Agonist/antagonist analgesics (eg, pentazocine) or naltrexone because they may decrease Dilaudid's effectiveness and withdrawal may occur

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

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

• Dilaudid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Dilaudid must only be taken by mouth.


• If you are taking Dilaudid for persistent pain, take it on a regular schedule to help control the pain more effectively.


• Do not change your dose or suddenly stop taking Dilaudid without checking with your doctor.


• If Dilaudid is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Dilaudid properly.


• If you miss a dose of Dilaudid 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 Dilaudid.

Important safety information:

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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you take Dilaudid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Dilaudid 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.


• Dilaudid may be habit-forming. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Misuse or abuse of Dilaudid may cause severe side effects, including severe breathing problems, seizures, coma, and possibly death.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if this product has sulfites in it.


• Constipation is a common side effect of Dilaudid. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use Dilaudid.


• If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.


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


• Use Dilaudid with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness and breathing problems.


• Dilaudid should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Dilaudid may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dilaudid while you are pregnant. Dilaudid is found in breast milk. Do not breast-feed while taking Dilaudid.

When used for long periods of time or at high doses, Dilaudid 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 Dilaudid stops working well. Do not take more than prescribed.

Some people who use Dilaudid 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. Dependence is unlikely to be an issue in terminally ill patients where comfort is more important. If you are taking Dilaudid regularly, do not suddenly stop taking it without checking with your doctor. WITHDRAWAL symptoms have occurred when Dilaudid is suddenly stopped and may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping Dilaudid.

Possible side effects of Dilaudid:

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, drowsiness; dry mouth; flushing; lightheadedness; nausea; sweating; 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); fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizure; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; shallow, slowed, or difficult breathing; tremor; trouble urinating; 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: Dilaudid 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 bluish skin; chest pain; cold and clammy skin; coma; difficult or slow breathing; excessive sweating; limp muscles; nausea and vomiting; numbness of an arm or leg; pinpoint pupils; seizures; severe drowsiness or dizziness; slow or irregular heartbeat.

Proper storage of Dilaudid:

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

General information:

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


• Dilaudid 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 Dilaudid. 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 Dilaudid resources

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

Compare Dilaudid with other medications

• Cough
• Pain

Dimaphen Elixir

Generic Name: brompheniramine and phenylephrine (BROM fen IR a meen and FEN il EFF rin)

Brand Names: Alacol, Alenaze-D, Alenaze-D NR, B-Vex D, BPM PE, Brom Tann PE, Bromfed, Bromfed-PD Capsules, BroveX ADT, BroveX PEB, Brovex-D, Children's Cold & Allergy, Dimaphen Elixir, Dimetapp Cold & Allergy, Entre-B, J-Tan D, J-Tan D SR, Phenyl 15/12mg, Phenyl 7.5/6mg, RespaHist II, Rhinabid, Rhinabid PD, Seradex-LA, Tanabid SR, V-Hist, VazoBid, VaZol-D, Vazotab, Zotex-PE

What is Dimaphen Elixir (brompheniramine and phenylephrine)?

Brompheniramine 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 brompheniramine and phenylephrine is used to treat nasal congestion, sneezing, itching, watery eyes, and runny nose caused by allergies, hay fever, and the common cold.

Brompheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Dimaphen Elixir (brompheniramine and phenylephrine)?

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. You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist about taking brompheniramine and phenylephrine if you have heart disease or high blood pressure, diabetes, a thyroid disorder, glaucoma, kidney disease, an enlarged prostate, or problems with urination.

What should I discuss with my healthcare provider before taking Dimaphen Elixir (brompheniramine and phenylephrine)?

You should not use this medication if you are allergic to brompheniramine or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use brompheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and phenylephrine if you have:

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  heart disease or high blood pressure;

  
  


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  diabetes;

  
  


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  a thyroid disorder;

  
  


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  glaucoma;

  
  


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  kidney disease;

  
  


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  an enlarged prostate; or

  
  


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  problems with urination.

  
  

FDA pregnancy category C. It is not known whether brompheniramine and phenylephrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Brompheniramine and phenylephrine 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 Dimaphen Elixir (brompheniramine and phenylephrine)?

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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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. Take the medicine with a full glass of water. Do not crush, chew, break, or open an extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before you swallow it.

Measure liquid 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.

Shake the oral suspension (liquid) well just before you measure a dose. Do not take brompheniramine and phenylephrine for longer than 7 days in a row. 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 at room temperature away from moisture and heat.

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 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 Dimaphen Elixir (brompheniramine and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Drinking alcohol can increase certain side effects of brompheniramine and phenylephrine. Ask a doctor or pharmacist before using any other cold, cough, allergy, or pain medicine. Antihistamines and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Dimaphen Elixir (brompheniramine and phenylephrine) 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 a serious side effect such as:

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  fast, pounding, or uneven heartbeat;

  
  


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  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


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

  
  


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  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


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  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:

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  drowsiness or dizziness;

  
  


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  blurred vision;

  
  


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  dry mouth, nose, or throat;

  
  


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  mild stomach pain, constipation;

  
  


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  problems with memory or concentration;

  
  


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  feeling restless or excited (especially in children);

  
  


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  sleep problems (insomnia); or

  
  


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  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 Dimaphen Elixir (brompheniramine and phenylephrine)?

Before using brompheniramine and phenylephrine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine and phenylephrine.

Tell your doctor about all other medications you are using, especially:

• 
  

  medicines to treat high blood pressure;

  
  


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  a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


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  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and other drugs may interact with brompheniramine and phenylephrine. 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 Dimaphen Elixir resources

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

• Alenaze-D Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfed MedFacts Consumer Leaflet (Wolters Kluwer)


• BroveX-D Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Entre-B Prescribing Information (FDA)


• J-Tan D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rhinabid Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Dimaphen Elixir with other medications

• Hay Fever
• Nasal Congestion
• Rhinitis

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine and phenylephrine.

See also: Dimaphen side effects (in more detail)