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Wednesday, 11 July 2012

Zanaflex Capsule

Generic Name: tizanidine (Oral route)

tye-ZAN-i-deen

Commonly used brand name(s)

In the U.S.

Comfort Pac w/Tizanidine

Zanaflex

Zanaflex Capsule

Available Dosage Forms:

Capsule

Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Uses For Zanaflex Capsule

Tizanidine is used to help relax certain muscles in your body. It relieves the spasms, cramping, and tightness of muscles caused by medical problems such as multiple sclerosis or certain injuries to the spine. Tizanidine does not cure these problems, but it may allow other treatment, such as physical therapy, to be more helpful in improving your condition.

Tizanidine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of the medicine's side effects.

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

Before Using Zanaflex Capsule

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tizanidine in children with use in other age groups.

Geriatric

Studies in older adults show that tizanidine stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your dose.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

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

Ciprofloxacin

Fluvoxamine

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.

Acyclovir

Amiodarone

Cimetidine

Desogestrel

Dienogest

Drospirenone

Estradiol Cypionate

Estradiol Valerate

Ethinyl Estradiol

Ethynodiol Diacetate

Etonogestrel

Famotidine

Levonorgestrel

Medroxyprogesterone Acetate

Mestranol

Mexiletine

Norelgestromin

Norethindrone

Norfloxacin

Norgestimate

Norgestrel

Ofloxacin

Propafenone

Rofecoxib

Ticlopidine

Vemurafenib

Verapamil

Zileuton

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.

Fosphenytoin

Lisinopril

Phenytoin

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.

Proper Use of tizanidine

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

When you take the different dosage forms (tablets, capsules, capsule contents sprinkled over applesauce) of tizanidine with food, it effects the amount of the medicine absorbed into your blood differently. Follow your doctor's instructions for when to take this medicine and whether or not you should take it with food.

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (capsules and tablets):
- For muscle relaxation:
  - Adults—The dose is 8 milligrams (mg) every six to eight hours as needed. No more than 36 mg should be taken within a twenty-four-hour period.
  - 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.

Precautions While Using Zanaflex Capsule

Your doctor should check your progress at regular visits, especially during the first few weeks of treatment with this medicine. During this time the amount of medicine you are taking may have to be changed often to meet your individual needs.

Do not suddenly stop taking this medicine. Unwanted effects may occur if the medicine is stopped suddenly. Check with your doctor for the best way to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using tizanidine.

This medicine may cause dizziness, drowsiness, lightheadedness, clumsiness or unsteadiness, or vision problems in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, and able to see well.

Tizanidine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Zanaflex Capsule Side Effects

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

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

More common

Chest pain or discomfort

fever

loss of appetite

lower back or side pain

nausea and/or vomiting

nervousness

pain or burning while urinating

painful or difficult urination

sores on the skin

tingling, burning, or prickling sensations

unusual tiredness

yellow eyes or skin

Less common

Black, tarry stools

bloody vomit

blurred vision

chills or sore throat

coldness

convulsions (seizures)

cough or hoarseness

dark urine

dry, puffy skin

eye pain

fainting

influenza (flu)-like symptoms

irregular heartbeat

kidney stones

persistent anorexia

pruritus

right upper quadrant tenderness

seeing things that are not there

shortness of breath

slow or irregular heartbeat

unusual tiredness or weakness

weight gain

Incidence not known

Continuing vomiting

general feeling of tiredness or weakness

headache

light-colored stools

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

Symptoms of overdose

Blurred vision

change in consciousness

chest pain or discomfort

confusion

decreased awareness or responsiveness

difficult or troubled breathing

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

irregular, fast or slow, or shallow breathing

lightheadedness, dizziness or fainting

loss of consciousness

pale or blue lips, fingernails, or skin

severe sleepiness

shortness of breath

sleepiness or unusual drowsiness

slow or irregular heartbeat

sweating

unusual tiredness or weakness

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

Anxiety

back pain

constipation

depression

diarrhea

difficulty in speaking

dizziness or lightheadedness, especially when getting up from a lying or sitting position

drowsiness

dry mouth

heartburn

increased sweating

increased muscle spasms or tone

muscle weakness

pain or burning in throat

runny nose

skin rash

sleepiness

stomach pain

uncontrolled movements of the body

Less common

Difficulty swallowing

dry skin

general feeling of discomfort or illness

increased need to urinate

joint or muscle pain or stiffness

loss of hair

migraine headache

mood changes

neck pain

passing urine more often

shivering

swelling of feet or lower legs

swollen area that feels warm and tender

trembling or shaking

trouble sleeping

unusual feeling of well-being

unusual tiredness or weakness

weight loss

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

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

See also: Zanaflex Capsule side effects (in more detail)

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

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zanaflex Capsule resources

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

Compare Zanaflex Capsule with other medications

Cluster Headaches
Muscle Spasm

Tuesday, 10 July 2012

Zofran Tablets

Pronunciation: on-DAN-se-tron
Generic Name: Ondansetron
Brand Name: Zofran

Zofran is used for:

Preventing nausea and vomiting associated with cancer chemotherapy, radiation treatment, or surgery. It may also be used for other conditions as determined by your doctor.

Zofran is a serotonin 5-HT₃ receptor blocker. It works by blocking a chemical thought to be a cause of nausea and vomiting in certain situations (eg, chemotherapy).

Do NOT use Zofran if:

you are allergic to any ingredient in Zofran

you are taking apomorphine

you have a certain type of irregular heartbeat (congenital long QT syndrome)

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

Before using Zofran:

Some medical conditions may interact with Zofran. 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 had an allergic reaction to another serotonin 5-HT₃ receptor blocker (eg, dolasetron, granisetron)

if you have liver problems, heart problems (eg, congestive heart failure, slow or irregular heartbeat, QT prolongation), or electrolyte problems (eg, low potassium or magnesium levels)

if you take medicines that may affect your heartbeat. Check with your doctor if you are unsure if any of your medicines may affect your heartbeat

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

Apomorphine because the risk of its side effects may be increased by Zofran

Antineoplastic agents (eg, cyclophosphamide) or tramadol because their effectiveness may be decreased by Zofran.

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

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

Take Zofran by mouth with or without food.

To prevent or reduce the possibility of nausea or vomiting, continue taking Zofran for the entire time recommended by your doctor even if you do not notice any nausea.

If you miss a dose of Zofran, 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 Zofran.

Important safety information:

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

Zofran should be used with extreme caution in CHILDREN younger than 4 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 Zofran while you are pregnant. It is not known if Zofran is found in breast milk. If you are or will be breast-feeding while you use Zofran, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Zofran:

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

Constipation; diarrhea; dizziness; drowsiness; headache; 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, throat, or tongue; wheezing; unusual hoarseness); chest or jaw pain, numbness of an arm or leg, or sudden severe headache or vomiting; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness; skin tingling or numbness; stomach pain; trouble urinating; uncontrolled muscle movements; vision changes or loss.

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: Zofran 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 fainting; severe dizziness; slowed/irregular heartbeat; sudden, temporary blindness.

Proper storage of Zofran:

Store Zofran between 36 and 86 degrees F (2 and 30 degrees C) in a tightly closed container. Protect from heat, moisture, and light. Do not store in the bathroom. Keep Zofran out of the reach of children and away from pets.

General information:

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

Zofran 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 Zofran. 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

More Zofran resources

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

Compare Zofran with other medications

Alcohol Dependence
Gastroenteritis
Nausea/Vomiting
Nausea/Vomiting, Chemotherapy Induced
Nausea/Vomiting, Postoperative
Nausea/Vomiting, Radiation Induced
Obsessive Compulsive Disorder
Postanesthetic Shivering
Pruritus

Thursday, 5 July 2012

Maxidone

Generic Name: hydrocodone and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, hye-droe-KOE-done bye-TAR-trate

Oral route(Solution;Tablet)

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product .

Commonly used brand name(s)

In the U.S.

Anexsia

Ceta Plus

Co-Gesic

Dolorex Forte

Hycet

Lorcet

Lortab

Maxidone

Norco

Stagesic

Vicodin

Zydone

Available Dosage Forms:

Tablet

Solution

Syrup

Elixir

Capsule

Liquid

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

Uses For Maxidone

Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Hydrocodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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

Before Using Maxidone

Allergies

Pediatric

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen oral solution in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

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

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

Interactions with Medicines

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.

Naltrexone

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Bromazepam

Brotizolam

Buprenorphine

Butabarbital

Butalbital

Butorphanol

Carisoprodol

Chloral Hydrate

Chlordiazepoxide

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Dantrolene

Dezocine

Diazepam

Estazolam

Ethchlorvynol

Fentanyl

Flunitrazepam

Flurazepam

Fospropofol

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methocarbamol

Methohexital

Midazolam

Morphine

Morphine Sulfate Liposome

Nalbuphine

Nitrazepam

Nordazepam

Opium

Oxazepam

Oxycodone

Oxymorphone

Pentazocine

Pentobarbital

Phenobarbital

Prazepam

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sodium Oxybate

Sufentanil

Tapentadol

Temazepam

Thiopental

Triazolam

Acenocoumarol

Carbamazepine

Escitalopram

Isoniazid

Phenytoin

Warfarin

Zidovudine

Interactions with Food/Tobacco/Alcohol

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

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Proper Use of hydrocodone and acetaminophen

This section provides information on the proper use of a number of products that contain hydrocodone and acetaminophen. It may not be specific to Maxidone. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

This medicine should come with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

For moderate to moderately severe pain:
- For oral dosage form (solution):
  - Adults and teenagers 14 years of age and older—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
  - Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
  - Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
  - Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.
  - Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults—One or two tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 5 to 12 tablets per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

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 Maxidone

It is very important that your doctor check the progress of you or your child while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

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

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause the neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or failure to gain weight.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Maxidone Side Effects

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

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

Incidence not known

Back, leg, or stomach pains

black, tarry stools

bleeding gums

blood in the urine or stools

blood in vomit

bluish lips or skin

chills

choking

cough or hoarseness

dark urine

decrease in the frequency of urination

decrease in urine volume

difficult or troubled breathing

difficulty in passing urine (dribbling)

difficulty with breathing

difficulty with swallowing

dizziness

fast heartbeat

fever

fever with or without chills

general body swelling

general feeling of tiredness or weakness

headache

hives

irregular, fast or slow, or shallow breathing

itching

light-colored stools

loss of appetite

lower back or side pain

nausea or vomiting

nosebleeds

not breathing

painful or difficult urination

pale or blue lips, fingernails, or skin

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

severe or continuing stomach pain

shortness of breath or troubled breathing

skin rash

sore throat

sore tongue

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

tightness in the chest

unable to speak

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

wheezing

yellow eyes and skin

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

Symptoms of overdose

Bloody or cloudy urine

change in consciousness

chest pain or discomfort

cold and clammy skin

decreased awareness or responsiveness

extreme drowsiness

general feeling of discomfort or illness

increased sweating

irregular heartbeat

lightheadedness, dizziness, or fainting

loss of consciousness

no blood pressure or pulse

no muscle tone or movement

not breathing

severe sleepiness

slow or irregular heartbeat

stopping of heart

sudden decrease in the amount of urine

unconsciousness

unpleasant breath odor

vomiting of blood

More common

Drowsiness

relaxed and calm

sleepiness

Incidence not known

Belching

changes in mood

difficulty having a bowel movement (stool)

fear or nervousness

feeling of indigestion

hearing loss

impaired hearing

pain in the chest below the breastbone

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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: Maxidone side effects (in more detail)

More Maxidone resources

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

Maxidone Prescribing Information (FDA)

Co-gesic Prescribing Information (FDA)

Dolacet MedFacts Consumer Leaflet (Wolters Kluwer)

Hycet Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Hycet Prescribing Information (FDA)

Liquicet Prescribing Information (FDA)

Lorcet Plus Prescribing Information (FDA)

Lortab Prescribing Information (FDA)

Lortab Consumer Overview

Lortab MedFacts Consumer Leaflet (Wolters Kluwer)

Norco Consumer Overview

Norco Prescribing Information (FDA)

Vicodin Consumer Overview

Vicodin Prescribing Information (FDA)

Vicodin ES Prescribing Information (FDA)

Vicodin HP Prescribing Information (FDA)

Xodol Prescribing Information (FDA)

Zolvit Prescribing Information (FDA)

Zydone Prescribing Information (FDA)

Compare Maxidone with other medications

Back Pain
Cough
Pain
Rheumatoid Arthritis

Monday, 2 July 2012

isosorbide mononitrate

eye-soe-SOR-bide mon-oh-NYE-trate

Commonly used brand name(s)

In the U.S.

Imdur

Imdur ER

Ismo

Monoket

Available Dosage Forms:

Tablet, Extended Release

Tablet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Uses For isosorbide mononitrate

Isosorbide mononitrate is used to prevent angina (chest pain) caused by coronary artery disease (heart disease). It does not work fast enough to relieve the pain of an angina attack that has already started.

Isosorbide mononitrate belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.

isosorbide mononitrate is available only with your doctor's prescription.

Before Using isosorbide mononitrate

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 isosorbide mononitrate, the following should be considered:

Allergies

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

Geriatric

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

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

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 isosorbide mononitrate, 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 isosorbide mononitrate 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.

Sildenafil

Tadalafil

Vardenafil

Interactions with Food/Tobacco/Alcohol

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

Proper Use of isosorbide mononitrate

Take isosorbide mononitrate exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The extended-release form releases medicine gradually to provide its effect for 8 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.

You should take isosorbide mononitrate first thing in the morning and follow the same schedule each day. isosorbide mononitrate works best if you have a "drug-free" period of time every day when you do not take it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.

Swallow the extended-release tablet whole with a half glass of water. Do not split, crush, or chew it.

Dosing

The dose of isosorbide mononitrate 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 isosorbide mononitrate. If your dose is different, do not change it unless your doctor tells you to do so.

For angina prevention:
- For oral dosage form (extended-release tablets):
  - Adults—At first, 30 or 60 milligrams (mg) once a day. Take the dose in the morning right after you wake up. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults—20 milligrams (mg) two times a day. Take the first dose in the morning right after you wake up, and the second dose 7 hours later.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of isosorbide mononitrate, 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 isosorbide mononitrate

If you will be taking isosorbide mononitrate for a long time, it is very important that your doctor check your progress at regular visits to make sure that isosorbide mononitrate is working properly. Blood tests may be needed to check for unwanted effects.

Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using isosorbide mononitrate. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

isosorbide mononitrate may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking isosorbide mononitrate, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.

Do not stop using isosorbide mononitrate without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

isosorbide mononitrate 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:

Less common

Abnormal heart sound

absence of or decrease in body movement

arm, back, or jaw pain

black, tarry stools

bladder pain

bleeding after defecation

bleeding gums

blood in the urine or stools

blurred vision

body aches or pain

burning while urinating

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain or discomfort

chest tightness or heaviness

chills

cold sweats

colds

confusion

convulsions

cough or hoarseness

decreased urine

diarrhea

difficult or labored breathing

difficult, burning, or painful urination

dilated neck veins

dizziness

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

dry mouth

ear congestion

extra heartbeats

fainting

fast, slow, irregular, pounding, or racing heartbeat or pulse

fever or chills

flu-like symptoms

frequent urge to urinate

frequent urination

general feeling of discomfort or illness

headache

headache, severe and throbbing

heart murmur

increased need to urinate

increased sweating

increased thirst

increased volume of pale, dilute urine

irregular breathing

itching, pain, redness, or swelling on the leg

joint pain, stiffness, or swelling

lightheadedness

loss of appetite

loss of voice

lower back, side, or stomach pain

mood changes

muscle aches and pains

muscle cramps

nasal congestion

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pain or discomfort in the arms, jaw, back, or neck

pain, tension, and weakness upon walking that subsides during periods of rest

partial or slight paralysis

passing urine more often

pinpoint red or purple spots on the skin

pounding in the ears

runny nose

shakiness in the legs, arms, hands, or feet

shivering

shortness of breath

sneezing

sore on the leg

sore throat

sudden decrease in the amount of urine

sweating

swelling

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

tightness in the chest

trembling or shaking of the hands or feet

trouble with sleeping

troubled breathing

uncomfortable swelling around the anus

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weakness

weight gain

wheezing

Rare

Bluish-colored lips, fingernails, or palms

dark urine

pale skin

rapid heart rate

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

Symptoms of overdose

Blurred or loss of vision

bulging soft spot on the head of an infant

change in consciousness

change in the ability to see colors, especially blue or yellow

cold, clammy skin

disturbed color perception

double vision

feeling of constant movement of self or surroundings

halos around lights

headache, severe and throbbing

loss of consciousness

night blindness

overbright appearance of lights

paralysis

sensation of spinning

tunnel vision

Less common

Acid or sour stomach

anxiety

back pain

belching

blemishes on the skin

bloated

breast pain

burning feeling in the chest or stomach

burning, dry, or itching eyes

change in color vision

changes in vision

cold sweats

congestion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

cough producing mucus

decreased interest in sexual intercourse

difficulty seeing at night

difficulty with moving

discharge, excessive tearing

double vision

drooping upper eyelids

dull ache or feeling of pressure or heaviness in the legs

earache

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

feeling of warmth

feeling unusually cold

frequent urge to defecate

frozen shoulder

full feeling

hearing loss

heartburn

hyperventilation

inability to have or keep an erection

increased appetite

increased sensitivity of the eyes to sunlight

increased sputum

indigestion

irritability

itching skin near damaged veins

lack or loss of strength

loss in sexual ability, desire, drive, or performance

muscle or bone pain

muscle stiffness or weakness

nightmares

noisy breathing

pain or tenderness around the eyes and cheekbones

passing gas

pimples

poor concentration

rash

redness of the face, neck, arms, and occasionally, upper chest

redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

redness, swelling, or soreness of the tongue

restlessness

seeing double

sensation of spinning

sleepiness or unusual drowsiness

sleeplessness

small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope

small lumps under the skin

sore mouth or tongue

stiff neck

stomach bloating, burning, cramping, or pain

stomach discomfort or upset

straining while passing stool

stuffy nose

sudden sweating

swollen feet and ankles

tender, swollen glands in the neck

tenderness in the stomach area

terrifying dreams causing sleep disturbances

tooth disorder

trouble with swallowing

unable to sleep

uncontrolled twisting movements of the neck

voice changes

weight loss

white patches in the mouth, tongue, or throat

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: isosorbide mononitrate side effects (in more detail)

More isosorbide mononitrate resources

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

Isosorbide Mononitrate Prescribing Information (FDA)

Isosorbide Mononitrate MedFacts Consumer Leaflet (Wolters Kluwer)

Isosorbide Mononitrate Professional Patient Advice (Wolters Kluwer)

Imdur Consumer Overview

Imdur Prescribing Information (FDA)

Imdur Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ismo Prescribing Information (FDA)

Monoket Prescribing Information (FDA)

Compare isosorbide mononitrate with other medications

Angina Pectoris Prophylaxis
Esophageal Spasm
Heart Failure

Sunday, 1 July 2012

Excedrin Sinus Headache Caplet

Generic Name: acetaminophen and phenylephrine (a SEET a MIN oh fen and FEN il EFF rin)

Brand Names: Alka-Seltzer Plus Cold and Sinus, Excedrin Sinus Headache Caplet, Mapap Sinus Congestion and Pain, Robitussin Nasal Relief, Sinus Congestion and Pain Daytime Cool Ice, Sinus Pain & Pressure, Sudafed PE Sinus Headache, Theraflu Daytime Severe Cold, Tylenol Sinus Congestion Daytime

What is Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine)?

Acetaminophen is a pain reliever and a fever reducer.

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

The combination of acetaminophen and phenylephrine is used to treat headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

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

What is the most important information I should know about Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use acetaminophen 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 before using any other pain, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What should I discuss with my healthcare provider before taking Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine)?

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine 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 this medicine if you have:

liver disease, cirrhosis, or a history of alcoholism;

diabetes;

glaucoma;

epilepsy or other seizure disorder;

enlarged prostate or urination problems; or

pheochromocytoma (an adrenal gland tumor).

It is not known whether acetaminophen and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

How should I take Excedrin Sinus Headache Caplet (acetaminophen 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. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. 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.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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:

chest pain, fast, slow, or uneven heart rate;

confusion, hallucinations;

tremor, seizure (convulsions);

urinating less than usual or not at all;

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

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

Less serious side effects may include:

dizziness, weakness;

mild headache;

mild nausea, diarrhea, upset stomach;

runny nose;

feeling nervous, restless, or anxious; or

sleep problems (insomnia).

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 Excedrin Sinus Headache Caplet (acetaminophen and phenylephrine)?

Ask a doctor or pharmacist if it is safe for you to take acetaminophen and phenylephrine if you are also using any of the following drugs:

leflunomide (Arava);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medicines to treat psychiatric disorders;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen 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 Excedrin Sinus Headache Caplet resources

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

Compare Excedrin Sinus Headache Caplet with other medications

Headache
Nasal Congestion
Sinus Symptoms

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and phenylephrine.

See also: Excedrin Sinus Headache Caplet side effects (in more detail)

Loteprednol Etabonate

Class: Corticosteroids
VA Class: OP300
Chemical Name: 17-(ethyl carbonate) chloromethyl 11β,17-dihydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate
Molecular Formula: C₂₄H₃₁ClO₇
CAS Number: 82034-46-6
Brands: Alrex, Lotemax, Zylet

Introduction

Synthetic nonfluorinated corticosteroid.¹ ² ³ ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹⁶ ¹⁷

Uses for Loteprednol Etabonate

Allergic Conjunctivitis

Symptomatic relief of seasonal allergic (hay fever, pollinosis) conjunctivitis.¹ ² ¹⁰ ¹² ¹⁷ ¹⁹

Inflammatory Ocular Disorders

Symptomatic relief of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (i.e., allergic conjunctivitis, acne rosacea keratitis, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis.¹ ⁸ ⁹ ¹⁰ ¹¹ ¹⁷ Use in conjunction with appropriate anti-infective therapy in some cases of conjunctival infection, when the benefits of reducing edema and inflammation outweigh the risks associated with use of topical corticosteroids.¹

Loteprednol etabonate 0.5% less effective than prednisolone acetate 1% in the management of anterior uveitis.¹ ²⁹

Postoperative Ocular Inflammation

Treatment of postoperative ocular inflammation following ocular surgery.¹ ²⁷ ²⁸

Bacterial Ophthalmic Infections

Used in fixed combination with tobramycin in certain bacterial ocular infections.³¹

Loteprednol Etabonate Dosage and Administration

General

For seasonal allergic rhinitis, do not use for >2 weeks.²⁶

For inflammatory ocular disorders, do not discontinue therapy prematurely.¹

When used in fixed combination with tobramycin, do not discontinue prematurely.³¹

Reevaluate patient if ocular signs and symptoms fail to improve after 2 days of therapy.¹ ² ²⁶ ³¹

Monitor intraocular pressure (IOP) in patients receiving therapy for ≥10 days.¹ ² ³¹

Administration

Ophthalmic Administration

Apply topically to the eyes as an ophthalmic suspension.¹ ² ⁸ ⁹ ¹⁰ ¹¹ ¹²

In fixed combination with tobramycin, apply topically to the eyes as an ophthalmic suspension.³¹

Shake suspension vigorously prior to use.¹ ² ³⁰ ³¹

Avoid contamination of the dropper tip.¹ ²

Dosage

Available as loteprednol etabonate; dosage expressed in terms of the salt.¹ ²

Adults

Seasonal Allergic Conjunctivitis

Ophthalmic

1 drop of a 0.2% suspension in the affected eye(s) 4 times daily.²

Inflammatory Ocular Disorders

Ophthalmic

1 or 2 drops of a 0.5% suspension in the affected eye(s) 4 times daily.¹ ⁸ ⁹ ¹⁰ ¹¹ During initial treatment (within the first week), may increase dosage up to 1 drop every hour.¹ When improvement occurs, decrease frequency of application.¹ ²⁶ ³⁰

Postoperative Ocular Inflammation

Ophthalmic

1 or 2 drops of a 0.5% suspension to the eye(s) undergoing surgery 4 times daily beginning 24 hours after surgery and continuing for 2 weeks after surgery.¹ ²⁷ ²⁸

Bacterial Ophthalmic Infections

Ophthalmic

Loteprednol etabonate and tobramycin ophthalmic suspension: 1 or 2 drops in the affected eye(s) every 4–6 hours.³¹ During the initial 24–48 hours, dosing may be increased to every 1–2 hours.³¹ When improvement occurs, decrease frequency of application.³¹

Cautions for Loteprednol Etabonate

Contraindications

Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial infection of the eye, and fungal diseases of ocular structures.¹ ² ³¹

Known hypersensitivity to loteprednol, other corticosteroids, or any ingredient in the formulations.¹ ² ³¹

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.¹ ² ³¹ Use with caution in the presence of glaucoma.¹ ² ³¹ Marked elevation in IOP (≥10 mm Hg) reported with loteprednol use; incidence lower than that reported with prednisolone acetate.¹ ² ³¹

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.¹ ² ³¹

Corticosteroid use after cataract surgery may delay healing and increase incidence of bleb formation.¹ ² ³¹

Immunosuppressive Effects

Risk of secondary ocular infection with prolonged use of corticosteroids.¹ ² ³¹

In acute purulent ocular conditions, corticosteroids may mask infection or exacerbate existing infection.¹ ² ³¹

Risk of prolongation or exacerbation of ocular viral infections (e.g., herpes simplex) with ophthalmic corticosteroids.¹ ² ³¹ Use with extreme caution in patients with history of herpes simplex.¹ ² ³¹

General Precautions

Use of Fixed Combination

Observe the usual precautions associated with tobramycin therapy when loteprednol is used in fixed combination with tobramycin.³¹

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 14 days should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).¹ ² ³¹

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.¹ ² ³¹ Consider fungus invasion in patients with persistent corneal ulceration who have or are receiving corticosteroid therapy; obtain fungal cultures when appropriate.¹ ² ³¹

Specific Populations

Pregnancy

Category C.¹ ² ³¹

Lactation

Not known whether distributed into human milk following topical application to the eye.¹ ² ³¹ Systemic corticosteroids distributed into human milk and may suppress growth, interfere with endogenous corticosteroid production, and cause other adverse effects.¹ ² ³¹ Use with caution.¹ ² ³¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ² ²⁶ ³¹

Common Adverse Effects

Abnormal/blurred vision, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, photophobia.¹ ²

Adverse systemic events include headache, rhinitis, and pharyngitis.¹ ²

Loteprednol Etabonate Pharmacokinetics

Absorption

Bioavailability

Limited systemic exposure following topical application to the eye; plasma concentrations usually are undetectable.¹

Onset

In clinical studies in patients with seasonal allergic conjunctivitis, improvement in ocular itching and bulbar conjunctival injection occurred within 2 hours following initiation of therapy.² ¹² ¹⁷ ¹⁹

In clinical studies in patients with contact lens-associated giant papillary conjunctivitis, improvement in papillae, conjunctival injection and itching, and lens intolerance was evident within 1 week of therapy.¹ ⁸ ⁹ ¹¹ ¹⁷

Duration

In patients with seasonal allergic conjunctivitis, improvement in ocular itching and bulbar conjunctival injection persisted through day 14 of therapy.²

In patients with contact lens-associated giant papillary conjunctivitis, improvement in papillae, conjunctival injection and itching, and lens intolerance persisted for up to 6 weeks while therapy was continued.¹ ⁸ ⁹ ¹¹ ¹⁷

Elimination

Metabolism

Undergoes extensive metabolism to inactive carboxylic acid metabolites.¹ ²

Stability

Storage

Ophthalmic

Suspension

Upright at 15–25°C.¹ ² ³¹ Do not freeze.¹ ² ³¹

ActionsActions

Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.¹ ² ³¹

Corticosteroids may induce phospholipase A2 inhibitory proteins; these proteins may inhibit release of arachidonic acid and, thus, control biosynthesis of potent mediators of inflammation (e.g., prostaglandins, leukotrienes).¹ ² ³¹

Advice to Patients

Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the suspension container.¹ ² ³¹

Consult a clinician if pain, redness, itching, or inflammation worsens.¹ ² ³¹

Importance of not wearing soft contact lenses during treatment with Lotemax or Zylet (benzalkonium chloride preservative may be absorbed by the lenses).¹ ³¹

Importance of removing soft contact lenses prior to administration of each dose of Alrex.² Delay reinsertion for 10 minutes after administration if eyes are not red; do not wear contact lenses if eye(s) are red.² Not indicated for contact lens-related irritation.²

Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.¹ ² ³¹

Importance of informing patients of other important precautionary information.¹ ² ³¹ (See Cautions.)

Preparations

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

Loteprednol Etabonate
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Suspension	0.2%	Alrex (with benzalkonium chloride and povidone)	Bausch & Lomb
		0.5%	Lotemax (with benzalkonium chloride and povidone)	Bausch & Lomb

Loteprednol Etabonate Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Suspension	0.5% with Tobramycin 0.3%	Zylet (with benzalkonium chloride and povidone)	Bausch & Lomb

Disclaimer

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

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

References

1. Bausch & Lomb Pharmaceuticals, Inc. Lotemax (loteprednol etabonate) ophthalmic suspension 0.5% prescribing information. Tampa, FL; 2005 May.

2. Bausch & Lomb Pharmaceuticals, Inc. Alrex (loteprednol etabonate) ophthalmic suspension 0.2% prescribing information. Tampa, FL; 1998 Mar.

3. Hochhaus G, Chen LS, Ratka A et al. Pharmacokinetic characterization and tissue distribution of the new glucocorticoid soft drug loteprednol etabonate in rats and dogs. J Pharm Sci. 1992; 81:1210-15. [PubMed 1491342]

4. Loftsson T, Bodor N. The pharmacokinetics and transdermal delivery of loteprednol etabonate and related soft steroids. Adv Drug Delivery Rev. 1994; 14:293-9.

5. Bodor N, Wu WM, Murakami T et al. Soft drugs 19. Pharmacokinetics, metabolism and excretion of a novel soft corticosteroid, loteprednol etabonate, in rats. Pharm Res. 1995; 12:875-9. [PubMed 7667193]

6. Druzgala P, Wu WM, Bodor N. Ocular absorption and distribution of loteprednol etabonate, a soft steroid, in rabbit eyes. Curr Eye Res. 1991; 10:933-7. [PubMed 1959381]

7. Anon. Corticosteroids. In: Zimmerman TJ, Kooner KS, Sharir M et al, eds. Textbook of ocular pharmacology. Philadelphia: Lippincott-Raven; 1997:620-6.

8. Asbell P, Howes J. A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. CLAO J. 1997; 23:31-6. [PubMed 9001768]

9. Friedlaender MH, Howes J for the Loteprednol etabonate Giant Papillary Conjunctivitis Study Group I. A double-masked, placebo-controlled evaluation of the efficacy and safety of loteprednol etabonate in the treatment of giant papillary conjunctivitis. Am J Ophthalmol. 1997; 123:455-64. [IDIS 383467] [PubMed 9124242]

10. Dell SJ, Shulman DG, Lowry GM et al, for the Loteprednol Allergic Conjunctivitis Study Group. Am J Ophthalmol. 1997; 123:791-7. (IDIS 387183)

11. Bartlett JD, Howes JF, Ghormley NR et al. Safety and efficacy of loteprednol etabonate for treatment of papillae in contact lens-associated giant papillary conjunctivitis. Curr Eye Res. 1993; 12:313-21. [PubMed 8319490]

12. Dell SJ, Lowry GM, Northcutt JA et al. A randomized, double-masked, placebo-controlled parallel study of a 0.2% loteprednol etabonate in patients with seasonal allergic conjunctivitis. J Allergy Clin Immunol. 1998; 102: 251-5. [IDIS 412946] [PubMed 9723669]

13. Novack GD, Howes J, Crockett RS et al. Changes in intraocular pressure during long-term use of loteprednol etabonate. J Glaucoma. 1998; 7: 266-9. [PubMed 9713785]

14. Bodor N, Bodor N, Wu WM. A comparison of intraocular pressure elevating activity of loteprednol etabonate and dexamethasone in rabbits. Curr Eye Res. 1992; 11:525-30. [PubMed 1505197]

15. Bartlett JD, Horwitz B, Laibovitz R et al. Intraocular pressure response to loteprednol etabonate in known steroid responders. J Ocul Pharmacol. 1993; 9:157-65. [PubMed 8345288]

16. Bodor N. Design of novel soft corticosteroids. Curr Probl Dermatol. 1993; 21:11-9. [PubMed 8299363]

17. Anon. Loteprednol etabonate. Drugs Future. 1997; 22:1086-90.

18. Howes JF, Baru H, Vered M et al. Loteprednol etabonate: comparison with other steroids in two models of intraocular inflammation. J Ocul Pharmacol. 1994; 10:289-93. [PubMed 8207332]

19. Schulman DG, Lothringer LL, Rubin JM et al. A randomized, double-masked, placebo controlled , parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis. Ophthalmology. 1999; 106:362-9. [IDIS 422861] [PubMed 9951491]

20. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]

21. Friedlaender MH. Current concepts in ocular allergy. Ann Allergy. 1991; 67:5-10,13. [IDIS 312766] [PubMed 1859041]

22. Trocme SD. Medical therapy for ocular allergy. Mayo Clin Proc. 1992; 67:557-65. [IDIS 296611] [PubMed 1359206]

23. 137. Reviewers’ comments (personal observation) Reviewers’ comments (personal observation) ketorolac tromethamine ophthalmic solution.

24. Tinkelman DG, Rupp G, Kaufman H et al. Double-masked, paired-comparison clinical study of ketorolac tromethamine 0.5% ophthalmic solution compared with placebo eyedrops in the treatment of seasonal allergic conjunctivitis. Surv Ophthalmol. 1993; 38(Suppl): 133-140. [PubMed 8236004]

25. Ballas Z, Blumenthal M, Tinkeman DG et al. Clinical evaluation of ketorolac tromethamine 0.5% ophthalmic solution for the treatment of seasonal allergic conjunctivitis. Surv Ophthalmol. 1993; 38(Suppl): 141-8.

26. Reviewers’ comments (personal observations).

27. The Loteprednol Etabonate Postoperative Inflammation Study Group 2. A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. Ophthalmology. 1998; 105:1780-6. [IDIS 413091] [PubMed 9754192]

28. Stewart R, Horwitz B, Howes J et al. Double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation. Loteprednol Etabonate Post-operative Inflammation Study Group 1. J Cataract Refract Surg. 1998; 24:1480-9. [PubMed 9818338]

29. Loteprednol Etabonate US Uveitis Study Group. Controlled evaluation of loteprednol etabonate and prednisolone acetate in the treatment of acute anterior uveitis. Am J Ophthalmol. 1999; 127:537-44. [IDIS 428957] [PubMed 10334346]

30. Bausch & Lomb, Tampa, FL: Personal communication.

31. Bausch & Lomb Pharmaceuticals, Inc. Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%) ophthalmic suspension prescribing information. Tampa, FL; 2004 Dec.

More Loteprednol Etabonate resources

Loteprednol Etabonate Side Effects (in more detail)
Loteprednol Etabonate Dosage
Loteprednol Etabonate Use in Pregnancy & Breastfeeding
Loteprednol Etabonate Drug Interactions
Loteprednol Etabonate Support Group
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Conjunctivitis
Cyclitis
Iritis
Keratitis
Postoperative Ocular Inflammation
Rosacea
Seasonal Allergic Conjunctivitis

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