famotidine

fam-OH-ti-deen

Commonly used brand name(s)

In the U.S.

• Heartburn Relief


• Pepcid


• Pepcid AC

Available Dosage Forms:

• Tablet


• Powder for Suspension


• Tablet, Chewable


• Tablet, Disintegrating

Therapeutic Class: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Histamine H2 Antagonist

Uses For famotidine

Famotidine is used to treat stomach ulcers (gastric and duodenal), erosive esophagitis (heartburn or acid indigestion), and gastroesophageal reflux disease (GERD). GERD is a condition where the acid in the stomach washes back up into the esophagus. It is also used to treat certain conditions where there is too much acid in the stomach (e.g., Zollinger-Ellison syndrome, endocrine tumors).

Famotidine belongs to the group of medicines known as histamine H2-receptor antagonists or H2-blockers. It works by decreasing the amount of acid produced by the stomach.

famotidine is available with your doctor's prescription and also without a prescription. For the prescription form, there is more medicine in each tablet. Your doctor will have special instructions on the proper use and dose for your medical problem.

Before Using famotidine

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 famotidine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to famotidine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of famotidine in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 famotidine, 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 famotidine 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.

• Atazanavir


• Dasatinib


• Delavirdine


• Rilpivirine


• Tizanidine


• Tolazoline

Using famotidine 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.

• Cefditoren Pivoxil


• Cefpodoxime Proxetil


• Cyclosporine


• Itraconazole

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Kidney disease, moderate or severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of famotidine

Take famotidine exactly as directed by your doctor or as directed on the package. 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. To do so may increase the chance of side effects.

Keep using famotidine for the full time of treatment, even if you begin to feel better.

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

Dosing

The dose of famotidine 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 famotidine. 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 forms (suspension, tablets):
  
  • To treat stomach ulcers:
    
    • Adults—20 milligrams (mg) one or two times per day or 40 mg once a day at bedtime.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose at bedtime or divided in two doses. The total dose is usually not more than 40 mg per day.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    • Adults—20 milligrams (mg) two times per day.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
    
    
    • Infants 3 months to 1 year of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day.
    
    
    • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.5 milligram (mg) per kilogram (kg) of body weight per day, given as a single dose once a day.
    
    
  
  
  • To treat erosive esophagitis (heartburn):
    
    • Adults—10, 20, or 40 milligrams (mg) two times per day.
    
    
    • Teenagers and children above 1 year of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day, divided and given two times per day. The total dose is usually not more than 40 mg two times per day.
    
    
  
  
  • To treat too much stomach acid (Zollinger-Ellison syndrome):
    
    • Adults—20 milligrams (mg) every 6 hours. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of famotidine, 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.

Throw away any unused oral liquid after 30 days.

Precautions While Using famotidine

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

If your condition does not improve, or if it become worse, check with your doctor.

famotidine 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:

Rare

• Bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• bloody, black, or tarry stools


• chest pain


• chills


• cough or hoarseness


• diarrhea


• fever


• fever with or without chills


• general feeling of tiredness or weakness


• high fever


• itching


• joint or muscle pain


• lower back or side pain


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath


• sore throat


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


• swollen glands


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain


• anxiety


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


• clay-colored stools


• dark urine


• depression


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dry mouth


• fainting


• false sense of well-being


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


• headache


• hives


• hyperventilation


• irritability


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


• loss of appetite


• loss of bladder control


• loss of consciousness


• mood swings


• nausea


• nervousness


• noisy breathing


• personality changes


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


• rash


• restlessness


• seizures


• shaking


• skin rash


• swelling around the eyes


• tightness in the chest


• total body jerking


• trouble with sleeping


• troubled with breathing


• unpleasant breath odor


• vision changes


• vomiting of blood


• wheezing


• yellow eyes or skin

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

Less common

• Difficulty having a bowel movement (stool)

Rare

• Swelling of the breasts or breast soreness in both females and males

Incidence not known

• Abdominal or stomach discomfort


• blemishes on the skin


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


• continuing ringing or buzzing or other unexplained noise in the ears


• decreased interest in sexual intercourse


• difficulty with moving


• dry skin


• fear


• hair loss or thinning of the hair


• hearing loss


• hives or welts


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• mood or mental changes


• muscle cramps


• muscle stiffness


• pimples


• redness of the skin


• redness of the white part of the eyes


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


• sleeplessness


• unable to sleep


• 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: famotidine side effects (in more detail)

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More famotidine resources

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

• Famotidine Professional Patient Advice (Wolters Kluwer)


• Famotidine Monograph (AHFS DI)


• Famotidine MedFacts Consumer Leaflet (Wolters Kluwer)


• Pepcid Consumer Overview


• Pepcid Prescribing Information (FDA)


• Pepcid Injection Prescribing Information (FDA)

Compare famotidine with other medications

• Allergic Urticaria
• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Indigestion
• Pathological Hypersecretory Conditions
• Peptic Ulcer
• Stomach Ulcer
• Upper GI Hemorrhage
• Urticaria
• Zollinger-Ellison Syndrome

Guaifenesin AC Liquid

Generic Name: codeine and guaifenesin (KOE deen and gwye FEN a sin)

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, M-Clear WC, Mar-cof CG, Mytussin AC, Robafen AC, Robitussin-AC, Tussi-Organidin NR, Tussi-Organidin-S NR, Tussiden C, Tusso-C

What is Guaifenesin AC Liquid (codeine and guaifenesin)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.

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

The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.

Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What is the most important information I should know about Guaifenesin AC Liquid (codeine and guaifenesin)?

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. 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.

What should I discuss with my healthcare provider before taking Guaifenesin AC Liquid (codeine and guaifenesin)?

You should not take this medication if you are allergic to codeine or guaifenesin.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take codeine and guaifenesin:

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  asthma, COPD, emphysema, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a thyroid disorder;

  
  


• liver or kidney disease;


• 
  

  enlarged prostate; or

  
  


• 
  

  a history of depression, mental illness, or drug addiction;

  
  

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Older adults may be more likely to have side effects from this medication.

Liquid forms of this medication may contain sugar or artificial sweetener (phenylalanine). Talk to your doctor before using this form of codeine and guaifenesin if you have diabetes or phenylketonuria (PKU).

How should I take Guaifenesin AC Liquid (codeine and guaifenesin)?

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

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take codeine and guaifenesin with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

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.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

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

Do not stop using this medication suddenly after long-term use or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store codeine and guaifenesin at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. Keep track of how much of this medicine has been used from each new bottle. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of codeine can be fatal.

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).

What should I avoid while taking Guaifenesin AC Liquid (codeine and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Guaifenesin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Guaifenesin AC Liquid (codeine and guaifenesin) side effects

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

• 
  

  severe dizziness or drowsiness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, weak or shallow breathing.

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  constipation; or

  
  


• 
  

  skin rash or itching.

  
  

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 Guaifenesin AC Liquid (codeine and guaifenesin)?

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

Also tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  naloxone (Narcan); or

  
  


• 
  

  naltrexone (Vivitrol).

  
  

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

More Guaifenesin AC Liquid resources

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

• Brontex MedFacts Consumer Leaflet (Wolters Kluwer)


• ExeClear-C Prescribing Information (FDA)


• Guiatuss AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guaifenesin AC Liquid with other medications

• Cough

Where can I get more information?

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

See also: Guaifenesin AC side effects (in more detail)

Cyclobenzaprine

Pronunciation: SYE-kloe-BEN-za-preen
Generic Name: Cyclobenzaprine
Brand Name: Flexeril

Cyclobenzaprine is used for:

Treating muscle spasms caused by painful muscle conditions. It should be used along with rest and physical therapy. It may also be used for other conditions as determined by your doctor.

Cyclobenzaprine is a muscle relaxant. It works in parts of the brain and nervous system to help reduce muscle spasms.

Do NOT use Cyclobenzaprine if:

• you are allergic to any ingredient in Cyclobenzaprine


• you have an overactive thyroid, moderate to severe liver problems, or certain heart problems (eg, irregular heartbeat, congestive heart failure, heart block, conduction problems), or if you have recently had a heart attack


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

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

Before using Cyclobenzaprine:

Some medical conditions may interact with Cyclobenzaprine. 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 liver problems, heart problems, cerebral palsy, brain or spinal cord disease, or stroke


• if you have a history of glaucoma, increased pressure in the eye, or trouble urinating

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

• MAOIs (eg, phenelzine, rasagiline) because serious, sometimes fatal reactions, including high fever and severe seizures, may occur


• Tramadol because the risk of seizures may be increased


• Droperidol or fluoxetine because severe heart problems, including irregular heartbeat, may occur


• Anticholinergics (eg, methscopolamine, benztropine), barbiturates (eg, phenobarbital), cimetidine, fluconazole, fluvoxamine, mibefradil, naproxen, or phenothiazines (eg, chlorpromazine) because they may increase the risk of Cyclobenzaprine's side effects


• Carbamazepine because it may decrease Cyclobenzaprine's effectiveness or increase the risk of Cyclobenzaprine's side effects


• Guanethidine or guanfacine because their effectiveness may be decreased by Cyclobenzaprine


• Sympathomimetics (eg, albuterol, epinephrine, phenylephrine) because their effectiveness may be decreased or the risk of their side effects may be increased by Cyclobenzaprine

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

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

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


• Do not suddenly stop taking Cyclobenzaprine without checking with your doctor.


• If you miss a dose of Cyclobenzaprine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 Cyclobenzaprine.

Important safety information:

• Cyclobenzaprine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Cyclobenzaprine 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 are using Cyclobenzaprine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do NOT take more than the recommended dose or use for longer than 2 to 3 weeks without checking with your doctor.


• If your symptoms (eg, pain, tenderness, decreased range of motion) do not get better within 2 to 3 weeks or if they get worse, contact your doctor.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• If you experience dry mouth, use sugarless candy or gum, or melt bits of ice in your mouth. If dry mouth continues for more than 2 weeks, contact your dentist or doctor.


• Use Cyclobenzaprine with extreme caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, hallucinations, and fast or irregular heartbeat.


• Cyclobenzaprine should be used with extreme caution in CHILDREN younger than 15 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 Cyclobenzaprine while you are pregnant. It is not known if Cyclobenzaprine is found in breast milk. If you are or will be breast-feeding while you use Cyclobenzaprine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cyclobenzaprine:

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; dry mouth; fatigue; nausea; nervousness; stomach pain or upset.

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); chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness of an arm or a leg; one-sided weakness; seizures; sudden severe stomach pain; severe dizziness or vomiting; speech or vision problems; trouble urinating; yellowing of the skin or eyes.

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: Cyclobenzaprine 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 agitation; chest pain; coma; confusion; fast or irregular heartbeat; loss of coordination; hallucinations; seizures; severe drowsiness, dizziness, or headache; slurred speech; tremor; vomiting.

Proper storage of Cyclobenzaprine:

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

General information:

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


• Cyclobenzaprine 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 Cyclobenzaprine. 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 Cyclobenzaprine resources

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Sulpor 200mg / 5ml Oral Solution.

1. Name Of The Medicinal Product

Sulpiride 200mg/5ml Oral Solution.

Sulpor

2. Qualitative And Quantitative Composition

Sulpiride 200mg/5ml.

3. Pharmaceutical Form

A colourless to slightly yellow oral solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Acute and chronic schizophrenia.

4.2 Posology And Method Of Administration

For oral administration only.

Adults:

A starting dose of 400mg to 800mg daily, given in two divided doses (morning and early evening) is recommended.

Predominantly positive symptoms (formal thought disorder, hallucinations, delusions, incongruity of affect) respond to higher doses, and a starting dose of at least 400mg twice daily is recommended, increasing if necessary up to a suggested maximum of 1200mg twice daily. Increasing the dose beyond this level has not been shown to produce further improvement. Predominantly negative symptoms (flattening of affect, poverty of speech, anergia, apathy), as well as depression, respond to doses below 800mg daily; therefore, a starting dose of 400mg twice daily is recommended. Reducing this dose towards 200mg twice daily will normally increase the alerting effect of sulpiride.

Patients with mixed positive and negative symptoms, with neither predominating, will normally respond to dosage of 400-600mg twice daily.

Children:

Clinical experience in children under the age of 14 years of age is insufficient to permit specific recommendations.

Elderly:

The same dose ranges may be required in the elderly, but should be reduced if there is evidence of renal impairment.

4.3 Contraindications

Phaeochromocytoma. Acute porphyria. Hypersensitivity to any of the ingredients in this product. Severe renal, haematological or hepatic disease. Alcoholic intoxication and other disorders which depress CNS function.

Concomitant prolactin-dependant tumours e.g. pituitary gland prolactinomas and breast cancer

Association with levodopa (See 4.5 Interactions with other medicinal products and other forms of interaction)

4.4 Special Warnings And Precautions For Use

Increased motor agitation has been reported at high dosage in a small number of patients: in aggressive, agitated or excited phases of the disease process, low doses of sulpiride may aggravate symptoms. Care should be exercised where hypomania is present.

If extrapyramidal reactions occur, a reduction in dosage of sulpiride or initiation of anti-parkinsonian medication may be necessary.

As with all neuroleptic drugs, the presence of unexplained hyperthermia could indicate the neuroleptic malignant syndrome (NMS). In this event sulpiride and any associated neuroleptic treatment should be discontinued until the origin of the fever has been determined.

Although sulpiride only induces slight EEG modifications, caution is advised in prescribing it for patients with unstable epilepsy. Patients requiring sulpiride who are receiving anti-convulsant therapy should continue unchanged on the latter medication. Cases of convulsions, sometimes in patients with no previous history, have been reported.

Sulpiride has no significant anticholinergic or cardiovascular activity.

As with all drugs for which the kidney is the major elimination pathway, the usual precautions should be taken in cases of renal failure.

Patients should be warned against taking alcohol with sulpiride as reaction capacity may be impaired.

Abrupt cessation of treatment in some patients may produce a withdrawal response.

Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects. As with other neuroleptics, sulpiride should be used with particular caution (see section 4.2).

When neuroleptic treatment is absolutely necessary in a patient with Parkinson's disease, sulpiride can be used, although caution is in order.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Sulpiride and preventive measures undertaken.

Prolongation of the QT interval

Sulpiride may induce a prolongation of the QT interval. This effect, known to potentiate the risk of serious ventricular arrhythmias such as torsade de pointes is enhanced by the pre-existence of bradycardia or cardiovascular disease, hypokalaemia, congenital or acquired long QT interval, concomitant neuroleptic treatment, or a family history of QT prolongation (See section 4.5).

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk cannot be excluded for other antipsychotics or other patient populations. Sulpiride should be used with caution in patients with risk factors for stroke.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Sulpiride Oral Solution is not licensed for the treatment of dementia-related behavioural disturbances.

Excipient Warnings

The product contains liquid maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This product also contains parahydroxybenzoates (preservatives) which may cause allergic reactions (possibly delayed).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

While no drug interactions are known, unnecessary polypharmacy should be avoided. As with other psychotropic compounds, sulpiride may increase the effect of antihypertensives and CNS depressants or stimulants.

Sulpiride results in reciprocal antagonism of effects between levodopa and neuroleptics.

The bioavailability of sulpiride is reduced by concomitant administration with sucralfate and antacids and should not, therefore, be taken at the same time.

Also concurrent use with lithium may cause extrapyramidal symptoms to develop.

Sulpiride may reduce the effectiveness of ropinorole.

Combination with the following medications which could induce torsade de pointes:

- Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine; digitalics.

- Medications which induce hypokalaemia: Hypokalaemic diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, tetracosactides.

- Class Ia antiarrhythmic agents such as quinidine, disopyramide.

- Class III antiarrhythmic agents such as amiodarone, sotalol.

- Other medications such as pimozide, haloperidol; imipramine antidepressants; cisapride, thioridazine, IV erythromycin, pentamidine.

Use with concomitant QT prolonging drugs and with drugs causing electrolyte imbalance is not recommended. If the benefit is considered to outweigh the risk in the individual patient, co-administration should be undertaken with caution and ECG monitoring should be considered. (See section 4.4).

4.6 Pregnancy And Lactation

Despite the negative results of teratogenicity studies in animals and the lack of teratogenic effects during widespread clinical use in other countries, sulpiride should not be considered an exception to the general principle of avoiding drug treatment in pregnancy, particularly during the first 16 weeks, with potential benefits being weighed against possible hazards.

Sulpiride has been found in low concentrations in breast milk. It is, therefore, recommended that the use of sulpiride be avoided in patients who are breast feeding.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if they experience symptoms of slowing of reaction time, drowsiness or loss of concentration.

4.8 Undesirable Effects

Sulpiride is very well tolerated and usually only minor side-effects occur, if at all, at the recommended doses.

Neuroleptic malignant syndrome. As with other neuroleptics, rare cases of neuroleptic malignant syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated CPK levels, have been reported. In such an event, all antipsychotic drugs, including Sulpor, Sulpiride 200mg/5ml Oral Solution, should be discontinued (section 4.4 Special warnings and precautions for use).

Very rare cases of convulsions have been reported, in particular in epileptic patients (see section 4.4 Special warnings and precautions for use).

Extrapyramidal symptoms and related disorders:

-parkinsonism and related symptoms (tremor, hypertonia, hypokinesia, hypersalivation)

-acute dyskinesia and dystonia (spasm torticollis, oculogyric crisis, trismus)

-akinesia.

These symptoms are generally reversible upon administration of antiparkinsonian medication.

-tardive dyskinesia (characterised by rhythmic, involuntary movements primarily of the tongue and/or the face) have been reported, as with all neuroleptics, after a neuroleptic administration of more than 3 months. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

Sedation or drowsiness. Insomnia has been reported.

Hepatic reactions including jaundice and hepatitis have been reported.

As is usual with neuroleptics and psychotic drugs, sulpiride raises serum prolactin levels, which may be associated with galactorrhoea, oligomenorrhoea and amenorrhoea, and less frequently with gynaecomastia. Sexual function may also be increased or decreased.

Postural hypotension, body weight gain (potentially significant in very rare cases) and very rare cases of hypersensitivity reactions such as skin reactions have been reported.

A mild laxative effect or diarrhoea may be caused by the liquid maltitol in the formulation.

Very rare cases of QT prolongation and very rare cases of torsade de pointes have been reported.

Ventricular arrhythmias such as VF, VT (rare), sudden unexplained death, cardiac arrest are class effects of neuroleptics.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs – Frequency unknown

4.9 Overdose

The range of single toxic doses is 1 to 16g but no death has occurred even at the 16g dose.

The clinical manifestations of poisoning vary depending upon the size of the dose taken. After single doses of 1 to 3g restlessness and clouding of consciousness have been reported and (rarely) extrapyramidal symptoms.

Doses of 3 to 7g may produce a degree of agitation, confusion and extrapyramidal symptoms; more than 7g can cause, in addition, coma and low blood pressure.

The duration of intoxication is generally short, the symptoms disappearing within a few hours. Comas which have occurred after large doses have lasted up to four days. There are no specific complications from overdose. In particular no haematological or hepatic toxicity has been reported.

Overdose may be treated with alkaline osmotic diuresis and, if necessary, anti-parkinsonian drugs. Coma needs appropriate nursing. Emetic drugs are unlikely to be effective in sulpiride overdosage.

Sulpiride is partly removed by haemodialysis.

There is no specific antidote to sulpiride. Treatment is only symptomatic. Appropriate supportive measures should therefore be instituted, close supervision of vital functions and cardiac monitoring (risk of QT interval prolongation and subsequent ventricular arrhythmias) is recommended until the patient recovers.

If severe extrapyramidal symptoms occur anticholinergics should be administered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

One of the characteristics of sulpiride is its bimodal activity, as it has both antidepressant and neuroleptic properties. Schizophrenia characterised by a lack of social contact can benefit strikingly. Mood elevation is observed after a few days treatment, followed by disappearance of the florid schizophrenic symptoms. The sedation and lack of effect characteristically associated with classical neuroleptics of the phenothiazine or butyrophenone type are not features of sulpiride therapy.

Sulpiride is a member of the group of substituted benzamides, which are structurally distinct from the phenothiazines, butyrophenones and thioxanthenes. Current evidence suggests that the actions of sulpiride hint at an important distinction between different types of dopamine receptors or receptor mechanisms in the brain.

Behaviourally and biochemically, sulpiride shares with these classical neuroleptics a number of properties indicative of cerebral dopamine receptor antagonism. Essential and intriguing differences include lack of catalepsy at doses active in other behavioural tests, lack of effect in the dopamine sensitive adenylate cyclase systems, lack of effect upon noradrenaline or 5HT turnover, negligible anticholinesterase activity, no effect on muscarinic or GABA receptor binding, and a radical difference in the binding of tritiated sulpiride to striatal preparations in-vitro, compared to ³H-spiperone and ³H-haloperidol. These findings indicate a major differentiation between sulpiride and classical neuroleptics which lack such specificity.

5.2 Pharmacokinetic Properties

Peak sulpiride serum levels are reached 3-6 hours after an oral dose. The plasma half-life in man is approximately 8 hours. Approximately 40% sulpiride is bound to plasma proteins. 95% of the compound is excreted in the urine and faeces as unchanged sulpiride.

5.3 Preclinical Safety Data

In long-term animal studies with neuroleptic drugs, including sulpiride, an increased incidence of various endocrine tumours (some of which have occasionally been malignant) has been seen in some but not all strains of rats and mice studied. The significance of these findings to man is not known; there is no current evidence of any association between neuroleptic use and tumour risk in man. However, when prescribing neuroleptics to patients with existing mammary neoplasia or a history of this disease, possible risks should be weighed against benefits of therapy.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, citric acid monohydrate, liquid maltitol, lemon flavour, aniseed flavour and purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months – unopened

3 months - opened

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Bottle: 150ml amber (Type III) glass.

Closure: a) Aluminium, EPE wadded, roll-on pilfer-proof screw cap.

b) HDPE, EPE wadded, tamper evident screw cap.

c) HDPE, EPE wadded, tamper evident, child resistant closure.

6.6 Special Precautions For Disposal And Other Handling

The date of opening should be entered on the label next to the “use within 3 months of opening” statement.

Administrative Data

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.

8. Marketing Authorisation Number(S)

PL 00427/0129

9. Date Of First Authorisation/Renewal Of The Authorisation

08.08.01/07.04.09

10. Date Of Revision Of The Text

22/01/2010

Migranal

Generic Name: dihydroergotamine (Nasal route)

dye-hye-droe-er-GOT-a-meen

Nasal route(Solution)

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of dihydroergotamine with potent CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP3A4 inhibition elevates the serum levels of dihydroergotamine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated .

Commonly used brand name(s)

In the U.S.

• Migranal

Available Dosage Forms:

• Spray

Therapeutic Class: Antimigraine

Chemical Class: Ergot Alkaloid

Uses For Migranal

Dihydroergotamine belongs to the group of medicines called ergot alkaloids. It is a nasal solution used to help relieve migraine headaches. Nasal dihydroergotamine is not an ordinary pain reliever. It will not relieve any kind of pain other than throbbing headaches.

Nasal dihydroergotamine may cause blood vessels in the body to constrict (become narrower). This action can lead to serious effects that are caused by a decrease in the flow of blood (blood circulation) to many parts of the body. Be sure that you discuss with your doctor the risks of using this medicine as well as the good it can do.

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

Before Using Migranal

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

There is no specific information comparing use of nasal dihydroergotamine in children with use in other age groups.

Geriatric

There is no specific information comparing use of nasal dihydroergotamine in older adults with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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.

• Almotriptan


• Amprenavir


• Atazanavir


• Azithromycin


• Boceprevir


• Clarithromycin


• Cocaine


• Darunavir


• Delavirdine


• Dirithromycin


• Efavirenz


• Epinephrine


• Erythromycin


• Fosamprenavir


• Frovatriptan


• Indinavir


• Itraconazole


• Josamycin


• Ketoconazole


• Lidocaine


• Lopinavir


• Mepartricin


• Midodrine


• Miokamycin


• Naratriptan


• Nefazodone


• Nelfinavir


• Norepinephrine


• Phenylpropanolamine


• Posaconazole


• Propylhexedrine


• Pseudoephedrine


• Ritonavir


• Rizatriptan


• Rokitamycin


• Roxithromycin


• Saquinavir


• Saralasin


• Spiramycin


• Sumatriptan


• Telaprevir


• Tipranavir


• Troleandomycin


• Voriconazole


• Zolmitriptan

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.

• Crizotinib


• Dexfenfluramine


• Eletriptan


• Fluconazole


• Fluvoxamine


• Imatinib


• Ranolazine


• Sibutramine


• Telithromycin


• Vemurafenib

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.

• Nitroglycerin


• Propranolol

Interactions with Food/Tobacco/Alcohol

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

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

• Grapefruit Juice

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:

• Heart or blood vessel disease or


• Hypertension (high blood pressure) or


• Kidney disease or


• Liver disease or


• Infection—The chance of serious side effects caused by nasal dihydroergotmine may be increased. Heart or blood vessel disease and high blood pressure sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use nasal dihydroergotamine, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of Migranal

It is important to use this medicine properly. Make sure that you read the patient directions carefully before using this medicine.

Do not use nasal dihydroergotamine for a headache that is different from your usual migraine. Instead, check with your doctor.

To relieve your migraine as soon as possible, use nasal dihydroergotamine as soon as the headache begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using nasal dihydroergotamine.

Lying down in a quiet, dark room for a while after you use this medicine may help relieve your migraine.

If you feel much better after a dose of nasal dihydroergotamine, but your headache comes back or gets worse after a while, you may use more nasal dihydroergotamine. However, use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed.

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor's directions, even if your headaches continue to occur. Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches should occur less often, and they should be less severe, and easier to relieve. This can reduce the amount of nasal dihydroergotamine or other pain medicines that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

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 nasal dosage form (nasal solution):
  
  • For migraine headaches:
    
    • Adults—One spray (0.5 mg) in each nostril. After 15 minutes, another spray (0.5 mg) in each nostril should be used.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 Migranal

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Some people feel drowsy or dizzy during or after a migraine attack, or after taking nasal dihydroergotamine to relieve a migraine headache. As long as you are feeling drowsy or dizzy, do not drive, use machines or do anything else that could be dangerous if you are dizzy or are not alert.

Migranal 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:

Less common or rare

• Chest pain


• cough, fever, sneezing, or sore throat


• feeling of heaviness in chest


• irregular heartbeat


• itching of the skin


• numbness and tingling of face, fingers, or toes


• pain in arms, legs, or lower back


• pain in back, chest or left arm


• pale bluish-colored or cold hands or feet


• shortness of breath or troubled breathing


• weak or absent pulses in legs

Symptoms of overdose

• Confusion


• convulsions (seizures)


• delirium


• dizziness


• headaches


• nausea and/or vomiting


• numbness, tingling, and/or pain in the legs or arms


• shortness of breath


• stomach pain

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

• Burning or tingling sensation, dryness, soreness, or pain in the nose


• change in sense of taste


• diarrhea


• dizziness


• dry mouth


• fatigue


• headache


• increased sweating


• nausea and or vomiting


• muscle stiffness


• runny and or stuffy nose


• sudden sweatings and feelings of warmth


• sensation of burning, warmth, or heat


• sore throat


• sleepiness


• unexplained nose bleeds


• unusual tiredness or weakness

Less common

• Anxiety


• blurred vision


• cold clammy skin


• confusion


• congestion in chest


• cough


• decreased appetite


• depression


• difficulty swallowing


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


• ear pain


• eye pain


• fever


• heartburn


• increased watering of eyes


• increased watering of the mouth


• increased yawning


• muscle weakness


• nervousness


• pinpoint red spots on skin


• pounding heartbeat


• red or irritated eyes


• ringing or buzzing in ears


• skin rash


• stomach pain


• sudden fainting


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


• trembling or shaking of hands or feet


• trouble in sleeping


• unusual feeling of well being

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

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

See also: Migranal 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 Migranal resources

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

• Migranal Prescribing Information (FDA)


• Migranal Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Migranal Concise Consumer Information (Cerner Multum)


• D.H.E. 45 Prescribing Information (FDA)


• D.H.E. 45 injection Concise Consumer Information (Cerner Multum)


• D.H.E. 45 MedFacts Consumer Leaflet (Wolters Kluwer)


• Dihydroergotamine Mesylate Monograph (AHFS DI)

Compare Migranal with other medications

• Cluster Headaches
• Migraine

Lo/Ovral-28

Generic Name: ethinyl estradiol and norgestrel (ETH in il ess tra DYE ol and nor JESS trel)

Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28

What is Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

Ethinyl estradiol and norgestrel contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norgestrel is used as contraception to prevent pregnancy.

Ethinyl estradiol and norgestrel may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have a history of stroke or blood clot, circulation problems (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, unusual vaginal bleeding, liver disease or liver cancer, severe high blood pressure, severe migraine headaches, a heart valve disorder, or a history of jaundice caused by birth control pills.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use.

What should I discuss with my healthcare provider before taking Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). Do not use this medication if you have:

• 
  

  a history of a stroke or blood clot;

  
  


• 
  

  circulation problems (especially if caused by diabetes);

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe high blood pressure;

  
  


• 
  

  severe migraine headaches;

  
  


• 
  

  a heart valve disorder; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles; or

  
  


• 
  

  a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. You should not breast-feed while you are taking birth control pills.

How should I take Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period should begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. Get your prescription refilled before you run out of pills completely.

If you need medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

Do not smoke while taking birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Lo/Ovral-28 (ethinyl estradiol and norgestrel) side effects

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

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

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

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  a breast lump; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  nervousness, dizziness, tired feeling.

  
  

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 Lo/Ovral-28 (ethinyl estradiol and norgestrel)?

Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  modafinil (Provigil);

  
  


• 
  

  dexamethasone (Decadron, Hexadrol);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Tegretol), oxcarbazepine (Trileptal), topiramate (Topamax), and others;

  
  


• 
  

  a barbiturate such as phenobarbital (Solfoton) and others; or

  
  


• 
  

  HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), saquinavir (Invirase), fosamprenavir (Lexiva), ritonavir (Norvir), and others.

  
  

This list is not complete and other drugs may interact with birth control pills. 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 Lo/Ovral-28 resources

• Lo/Ovral-28 Side Effects (in more detail)
• Lo/Ovral-28 Use in Pregnancy & Breastfeeding
• Drug Images
• Lo/Ovral-28 Drug Interactions
• Lo/Ovral-28 Support Group
• 6 Reviews for Lo/Ovral-28 - Add your own review/rating

• Low-Ogestrel Prescribing Information (FDA)

Compare Lo/Ovral-28 with other medications

• Abnormal Uterine Bleeding
• Birth Control
• Emergency Contraception
• Endometriosis
• Gonadotropin Inhibition

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norgestrel.

See also: Lo/Ovral-28 side effects (in more detail)

Aggrastat

Pronunciation: tye-roe-FYE-ban
Generic Name: Tirofiban
Brand Name: Aggrastat

Aggrastat is used for:

Treating unstable angina or certain types of heart attacks in combination with heparin. It may also be used for other conditions as determined by your doctor.

Aggrastat is a platelet aggregation inhibitor. It works by blocking platelets from sticking together to form blood clots.

Do NOT use Aggrastat if:

• you are allergic to any ingredient in Aggrastat


• you have a history of stroke, major surgery, physical trauma, or bleeding conditions within the last 30 days


• you have an aneurysm, bleeding or clotting condition, malformation of the arteries or veins, or bleeding or tumors of the brain


• you have a tear of the aorta, severe high blood pressure, or inflammation around the heart


• you are taking another medicine of the same class (a platelet aggregation inhibitor)


• you have had clotting problems when using Aggrastat in the past

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

Before using Aggrastat:

Some medical conditions may interact with Aggrastat. 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 decreased blood platelets, high blood volume, kidney problems (eg, dialysis), or bleeding or blood vessel problems in the eye


• if you have recently had a spinal (epidural) procedure

Some MEDICINES MAY INTERACT with Aggrastat. However, no specific interactions with Aggrastat are known at this time.

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

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

• Aggrastat is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Aggrastat at home, carefully follow the injection procedures taught to you by your health care provider.


• If Aggrastat contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Aggrastat is only to be injected into the vein or artery.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Aggrastat, contact your doctor immediately.

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

Important safety information:

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


• Aggrastat may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Aggrastat.


• LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Aggrastat with caution in the ELDERLY because they may be more sensitive to its effects.


• Aggrastat is not recommended for use in CHILDREN younger than 18 years of age. 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 Aggrastat during pregnancy. It is unknown if Aggrastat is excreted in breast milk. Do not breast-feed while taking Aggrastat.

Possible side effects of Aggrastat:

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; headache; leg pain; nausea; pelvic pain; sweating.

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); bruising, pain, redness, or swelling at the injection site; changes in heart rhythm; chills; difficulty urinating; fainting; fever; numbness; tingling or weakness in the arms or legs; unusual bruising or bleeding (eg, bleeding gums, nosebleeds, bleeding in the eye, blood in the urine, black or tarry stools, coughing up blood, vomiting blood or material that looks like coffee ground).

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: Aggrastat 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 major and minor bleeding events.

Proper storage of Aggrastat:

Aggrastat is usually handled and stored by a health care provider. If you are using Aggrastat at home, store Aggrastat as directed by your pharmacist or health care provider. Keep Aggrastat out of the reach of children and away from pets.

General information:

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


• Aggrastat 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 Aggrastat. 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 Aggrastat resources

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

• Aggrastat Prescribing Information (FDA)


• Aggrastat Concise Consumer Information (Cerner Multum)


• Aggrastat Monograph (AHFS DI)

Compare Aggrastat with other medications

• Acute Coronary Syndrome