paliperidone Intramuscular

pal-ee-PER-i-done

Intramuscular route(Suspension, Extended Release)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Paliperidone palmitate is not approved for use in patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

• Invega Sustenna

Available Dosage Forms:

• Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For paliperidone

Paliperidone injection is used to treat the symptoms of schizophrenia. paliperidone should not be used to treat behavioral problems in elderly patients who have dementia.

paliperidone is available only with your doctor's prescription.

Before Using paliperidone

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 paliperidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to paliperidone 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 paliperidone injection 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 paliperidone injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving paliperidone injection.

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

• Cisapride


• Dronedarone


• Mesoridazine


• Metoclopramide


• Pimozide


• Sparfloxacin


• Thioridazine

Using paliperidone 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.

• Acecainide


• Ajmaline


• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Azimilide


• Azithromycin


• Bretylium


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Hydromorphone


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Pazopanib


• Perflutren Lipid Microsphere


• Pirmenol


• Posaconazole


• Prajmaline


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Sematilide


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

Using paliperidone 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.

• Paroxetine

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

• Alzheimer's disease or dementia or


• Dehydration or


• Heart attack, recent or history of or


• Heart failure or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., arrhythmia, QT prolongation), or a history of or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood) or


• Parkinson's disease or


• Stroke, history of or


• Trouble with swallowing—May cause side effects to become worse.

• Blood or bone marrow problems (e.g., leukopenia, neutropenia) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Hyperprolactinemia (high prolactin in the blood) or


• Neuroleptic malignant syndrome (NMS), history of or


• Priapism (painful or prolonged erection of the penis) or


• Seizures, history of or


• Stomach or bowel problems (e.g., slow or blocked bowels)—Use with caution. May make these conditions worse.

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

Proper Use of paliperidone

A nurse or other trained health professional will give you paliperidone. paliperidone is given as a shot into one of your muscles.

Precautions While Using paliperidone

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

Stop using paliperidone and check with your doctor right away if you have any of the following symptoms while using paliperidone: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

paliperidone may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using paliperidone: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

paliperidone can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

For diabetic patients: paliperidone may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Paliperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

paliperidone may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to paliperidone before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.

Paliperidone injection may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

paliperidone 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 allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines, including narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using paliperidone.

paliperidone might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.

paliperidone may increase your weight. Your doctor may need to check your weight on a regular basis while you are using paliperidone. Talk to your doctor about ways to prevent weight gain.

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.

paliperidone Side Effects

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

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

More common

• Anxiety


• bladder pain


• bloody or cloudy urine


• body aches or pain


• chills


• cough


• difficult, burning, or painful urination


• difficulty with breathing


• difficulty with swallowing


• dry mouth


• ear congestion


• fever


• frequent urge to urinate


• headache


• hyperventilation


• inability to sit still


• irregular heartbeats


• irritability


• loss of balance control


• loss of voice


• lower back or side pain


• mask-like face


• nasal congestion


• need to keep moving


• nervousness


• restlessness


• runny nose


• shaking


• shortness of breath


• shuffling walk


• slowed movements


• slurred speech


• sneezing


• sore throat


• stiffness of the arms and legs


• tic-like (jerky) movements of the head, face, mouth, and neck


• trembling and shaking of the fingers and hands


• trouble with sleeping


• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs


• unusual tiredness or weakness

Less common

• Blurred vision


• difficulty with speaking


• dizziness


• drooling


• headache


• inability to move the eyes


• increase in body movements


• increased blinking or spasms of the eyelid


• loss of balance control


• muscle trembling, jerking, or stiffness


• pounding in the ears


• restlessness


• slow or fast heartbeat


• sticking out of the tongue


• stiffness of the limbs


• tremor


• trouble with breathing, speaking, or swallowing


• twisting movements of the body


• uncontrolled movements, especially of the face, neck, and back


• uncontrolled twisting movements of the neck, trunk, arms, or legs


• unusual facial expressions

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

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


• sleeplessness


• unable to sleep

Less common

• Back pain


• constipation


• diarrhea


• difficulty with moving


• dry mouth


• increased weight


• joint pain


• lack or loss of strength


• muscle aching or cramping


• muscle pains or stiffness


• nausea


• nightmares


• pain in the arms or legs


• stuffy or runny nose


• swollen joints


• tearing of the skin


• toothache


• upper abdominal or stomach pain


• vomiting

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: paliperidone Intramuscular side effects (in more detail)

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

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More paliperidone Intramuscular resources

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

Compare paliperidone Intramuscular with other medications

• Bipolar Disorder
• Depression
• Schizoaffective Disorder
• Schizophrenia

Hex-Wash

Generic Name: chlorhexidine gluconate liquid

Dosage Form: FOR ANIMAL USE ONLY
Hex-Wash

USE DIRECTIONS:

Do not use in concentrated form.  Must

be diluted prior to use.

DILUTIONS:

Pre-mix one (1) ounce Hex-Wash with five (5)

gallons of water.  Use a separate towel for each

cow and discard towel after applications, then rinse

with warm water and examine each quarter with

strip cup.



PROTECT FROM FREEZING

IF FROZEN: SHAKE VIGOROUSLY

AFTER THAWING

WARNING:  CONTAINS CHLORHEXIDINE

GLUCONATE.

Not for human use.

Avoid contamination of food.  Avoid contact

with eyes.  Not for internal use.

OBSERVE LABEL DIRECTIONS

KEEP OUT OF REACH OF CHILDREN!

FIRST AID:

INTERNAL:  If swallowed, do not induce vomiting.

Drink large quantities of water.  See physician immediately.

EYES:  Flush eyes with clear water for 15 minutes.If irritated, obtain medical guidance.



GET MEDICAL ATTENTION IMMEDIATELY.

Hex-Wash

CHLORHEXIDINE GLUCONATE UDDER WASH

Active Ingredient..........0.50% Chlorhexidine Gluconate



Lot#:______________________

Exp. Date:___________________

Next Content:________________

Manufactured For:

Tetradyne LLC

PO Box 17003

Reno, NV 89511

Hex-Wash  Hex-Wash  liquid

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 66399-738 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 0.5 L  in 100 L

Inactive Ingredients Ingredient Name Strength GLYCERIN

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66399-738-01 3.78 L In 1 JUG None 2 66399-738-02 18.9 L In 1 PAIL None 3 66399-738-03 56.7 L In 1 DRUM None 4 66399-738-04 113.4 L In 1 DRUM None 5 66399-738-05 207.9 L In 1 DRUM None 6 66399-738-06 945 L In 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None 7 66399-738-07 1039.5 L In 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/10/2001

Labeler - Tetradyne LLC (130969293)

Revised: 11/2010Tetradyne LLC

Amrix

Generic Name: cyclobenzaprine (sye kloe BEN za preen)

Brand Names: Amrix, Comfort Pac with Cyclobenzaprine, Fexmid, Flexeril

What is Amrix (cyclobenzaprine)?

Cyclobenzaprine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Cyclobenzaprine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

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

What is the most important information I should know about Amrix (cyclobenzaprine)?

Do not take cyclobenzaprine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take cyclobenzaprine before the MAO inhibitor has cleared from your body.

You should not take cyclobenzaprine if you have recently had a heart attack, or if you have a heart rhythm disorder, congestive heart failure, heart block, or an overactive thyroid.

Cyclobenzaprine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of cyclobenzaprine.

What should I discuss with my doctor before taking Amrix (cyclobenzaprine)?

Do not take cyclobenzaprine if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take cyclobenzaprine before the MAO inhibitor has cleared from your body. Do not use cyclobenzaprine if you have recently had a heart attack, or if you have:

• 
  

  a heart rhythm disorder;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  heart block; or

  
  


• 
  

  an overactive thyroid.

  
  

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

• 
  

  problems with urination;

  
  


• 
  

  enlarged prostate;

  
  


• 
  

  glaucoma; or

  
  


• 
  

  liver disease.

  
  

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

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether cyclobenzaprine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

How should I take Amrix (cyclobenzaprine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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

Cyclobenzaprine is only part of a complete program of treatment that may also include rest, physical therapy, or other pain relief measures. Follow your doctor's instructions.

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

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the 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 cyclobenzaprine can be fatal.

Overdose symptoms may include drowsiness, fast heartbeat, tremors or shaking, slurred speech, confusion, nausea, vomiting, hallucinations (seeing things), chest pain, or seizure (convulsions).

What should I avoid while taking Amrix (cyclobenzaprine)?

Cyclobenzaprine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of cyclobenzaprine. Cold or allergy medicine, narcotic pain medicine, sleeping pills, and medicine for seizures, depression or anxiety can add to sleepiness caused by cyclobenzaprine. Tell your doctor if you regularly use any of these medicines, or any other muscle relaxer.

Amrix (cyclobenzaprine) 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 cyclobenzaprine and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, weakness, lack of coordination;

  
  


• 
  

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

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  unusual thoughts or behavior, hallucinations (seeing things); or

  
  


• 
  

  easy bruising or bleeding, unusual weakness.

  
  

Less serious side effects may include:

• 
  

  dry mouth or throat;

  
  


• 
  

  blurred vision;

  
  


• 
  

  drowsiness, dizziness, tired feeling;

  
  


• 
  

  loss of appetite, stomach pain, nausea;

  
  


• 
  

  diarrhea, constipation, gas; or

  
  


• 
  

  muscle weakness.

  
  

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

What other drugs will affect Amrix (cyclobenzaprine)?

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

• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  guanethidine (Ismelin);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  tramadol (Ultram);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

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

More Amrix resources

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

• Amrix Advanced Consumer (Micromedex) - Includes Dosage Information


• Amrix Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Amrix Prescribing Information (FDA)


• Cyclobenzaprine Prescribing Information (FDA)


• Cyclobenzaprine Monograph (AHFS DI)


• Cyclobenzaprine MedFacts Consumer Leaflet (Wolters Kluwer)


• Fexmid Prescribing Information (FDA)


• Flexeril Prescribing Information (FDA)


• Flexeril Consumer Overview

Compare Amrix with other medications

• Fibromyalgia
• Migraine
• Muscle Spasm
• Sciatica
• Temporomandibular Joint Disorder

Where can I get more information?

• Your pharmacist can provide more information about cyclobenzaprine.

See also: Amrix side effects (in more detail)

Triaminic Cough & Sore Throat Softchews

Generic Name: acetaminophen and dextromethorphan (a SEET a MIN oh fen and DEX troe me THOR fan)

Brand Names: Children's Triacting, Triaminic Cough & Sore Throat, Triaminic Cough & Sore Throat Softchews, Tylenol Cough and Sore Throat Daytime

What is Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Acetaminophen is a pain reliever and fever reducer.

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

The combination of acetaminophen and dextromethorphan is used to treat cough and pain or fever caused by the common cold or flu.

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

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

What is the most important information I should know about Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

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 take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. 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. Do not use a cough or cold 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 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.

What should I discuss with my healthcare provider before taking Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Do not take this medication if you are allergic to acetaminophen or dextromethorphan. 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 a cough or cold 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 or a history of alcoholism.

It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant. It is not known whether acetaminophen and dextromethorphan will harm an unborn baby. Do not use cold or cough medicine without medical advice if you are pregnant.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

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

Drink extra fluids while you are taking this medication. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and dextromethorphan. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since cough or cold medicine is taken 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. 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.

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 dizziness, drowsiness, feeling restless or nervous, diarrhea, loss of appetite, seizure (convulsions), or coma.

What should I avoid while taking Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

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

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

Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan) 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:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

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

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  upset stomach.

  
  


• 
  

  mild loss of appetite; or

  
  

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 Triaminic Cough & Sore Throat Softchews (acetaminophen and dextromethorphan)?

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

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid;

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  ranolazine (Ranexa);

  
  


• 
  

  ritonavir (Norvir, Kaletra);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  gout medication such as probenecid (Benemid);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), bupropion (Wellbutrin, Zyban, Aplenzin), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

  
  

This list is not complete and other drugs may interact with acetaminophen and dextromethorphan. 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 Triaminic Cough & Sore Throat Softchews resources

• Triaminic Cough & Sore Throat Softchews Use in Pregnancy & Breastfeeding
• Triaminic Cough & Sore Throat Softchews Drug Interactions
• 0 Reviews for Triaminic Cough & Sore Throat Softchews - Add your own review/rating

Compare Triaminic Cough & Sore Throat Softchews with other medications

• Cold Symptoms
• Cough
• Pain

Where can I get more information?

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

Cipralex 5, 10, 15, and 20 mg Film-Coated Tablets

Cipralex 5 mg film-coated tablets

Cipralex 10 mg film-coated tablets

Cipralex 15 mg film-coated tablets

Cipralex 20 mg film-coated tablets

Escitalopram

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Cipralex is and what it is used for


• 2. Before you take Cipralex


• 3. How to take Cipralex


• 4. Possible side effects


• 5. How to store Cipralex


• 6. Further information

What Cipralex Is And What It Is Used For

Cipralex contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Before You Take Cipralex

Do not take Cipralex

• if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Cipralex (see section 6 “Further information”).


• If you take other medicines which belongs to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic).

Take special care with Cipralex

Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:

• if you have epilepsy. Treatment with Cipralex should be stopped if seizures occur or if there is an increase in the seizure frequency (see also section 4 “Possible side effects").


• if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.


• if you have diabetes. Treatment with Cipralex may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.


• If you have a decreased level of sodium in the blood.


• if you have a tendency to easily develop bleedings or bruises.


• if you are receiving electroconvulsive treatment.


• If you have coronary heart disease.

Please note

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty to in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself.


• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Use in children and adolescents under 18 years of age

Cipralex should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Cipralex for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Cipralex for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or worsen when patients under 18 are taking Cipralex. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of Cipralex in this age group have not yet been demonstrated.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Tell your doctor if you are taking any of the following medicines:

• ”Non-selective monoamine oxidase inhibitors (MAOIs)”, containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking Cipralex. After stopping Cipralex you must allow 7 days before taking any of these medicines.


• “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).


• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson’s disease). These increase the risk of side effects.


• The antibiotic linezolid.


• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.


• Imipramine and desipramine (both used to treat depression).


• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.


• Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Cipralex.


• St. John's Wort (Hypericum perforatum) - a herbal remedy used for depression.


• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anticoagulants).


• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulants). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Cipralex in order to verify that your dose of anticoagulant is still adequate.


• Mefloquin (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures.


• Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures, and antidepressants.


• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases) clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Cipralex may need to be adjusted.

Taking Cipralex with food and drink

Cipralex can be taken with or without food (see section 3 “How to take Cipralex”).

As with many medicines, combining Cipralex with alcohol is not advisable, although Cipralex is not expected to interact with alcohol.

Pregnancy and breast-feeding

Inform your doctor if you are pregnant or planning to become pregnant. Do not take Cipralex if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

If you take Cipralex during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If used during pregnancy Cipralex should never be stopped abruptly.

Do not take Cipralex if you are breast-feeding unless you and your doctor have discussed the risks and benefits involved.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You are advised not to drive a car or operate machinery until you know how Cipralex affects you.

How To Take Cipralex

Always take Cipralex exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

Depression

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The starting dose of Cipralex is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine.

Generalised anxiety disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The normally recommended dose of Cipralex is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (above 65 years of age)

The normally recommended starting dose of Cipralex is 5 mg taken as one daily dose.

Children and adolescents (below 18 years of age)

Cipralex should not normally be given to children and adolescents. For further information please see section 2 “Before you take Cipralex”.

You can take Cipralex with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

If necessary, you can divide the tablets by firstly placing the tablet on a flat surface with the score facing upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers as shown in the drawing.

Duration of treatment

It may take a couple of weeks before you start to feel better. Continue to take Cipralex even if it takes some time before you feel any improvement in your condition.

Do not change the dose of your medicine without talking to your doctor first.

Continue to take Cipralex for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.

If you take more Cipralex than you should

If you take more than the prescribed dose of Cipralex, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the Cipralex box/container with you when you go to the doctor or hospital.

If you forget to take Cipralex

Do not take a double dose to make up for forgotten doses. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Cipralex

Do not stop taking Cipralex until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Cipralex is gradually reduced over a number of weeks.

When you stop taking Cipralex, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Cipralex is stopped. The risk is higher, when Cipralex has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Cipralex, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Cipralex can cause side effects, although not everybody gets them.

The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

See your doctor if you get any of the following side effects during treatment:

Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):

• Unusual bleeds, including gastrointestinal bleeds

Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):

• If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction), contact your doctor or go to a hospital straight away.


• If you have a high fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome. If you feel like this contact your doctor.

If you experience the following adverse events you should contact your doctor or go to the hospital straight away:

• Difficulties urinating


• Seizures (fits), see also section Take special care with Cipralex


• Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis

In addition to above the following side effects have been reported:

Very common (more than 1 out of 10 persons):

• Feeling sick (nausea)

Common (more than 1 out of 100 persons and less than 1 out of 10 persons):

• Blocked or runny nose (sinusitis)


• Decreased or increased appetite


• Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning, tremors, prickling of the skin


• Diarrhoea, constipation, vomiting, dry mouth


• Increased sweating


• Pain in muscle and joints (arthralgia and myalgia)


• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)


• Fatigue, fever


• Increased weight

Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):

• Nettle rash (urticaria), rash, itching (pruritus)


• Grinding one’s teeth, agitation, nervousness, panic attack, confusion state


• Disturbed sleep, taste disturbance, fainting (syncope)


• Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)


• Loss of hair


• Vaginal bleeding


• Decreased weight


• Fast heart beat


• Swelling of the arms or legs


• Nosebleeds

Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):

• Aggression, depersonalisation, hallucination


• Slow heart beat

Some patients have reported (frequency not known):

• Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special care with Cipralex”


• Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)


• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)


• Abnormal liver function test (increased amounts of liver enzymes in the blood)


• Movement disorders (involuntary movements of the muscles)


• Painful erections (priapism)


• Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of blood platelets (thrombycytopenia)


• Sudden swelling of skin or mucosa (angioedemas)


• Increase in the amount of urine excreted (inappropriate ADH secretion)


• Flow of milk in women that are not nursing


• Mania

In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Cipralex). These are:

• Motor restlessness (akathisia)


• Anorexia

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Cipralex

Keep out of the reach and sight of children.

Do not use Cipralex after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Cipralex contains

The active substance is escitalopram. Each Cipralex tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).

The other ingredients are:

Core: microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium and magnesium stearate.

Coating: hypromellose, macrogol 400 and titanium dioxide (E 171).

What Cipralex looks like and contents of the pack

Cipralex is presented as 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. The tablets are described below.

5 mg: Round, white biconvex film-coated tablets marked with “EK” on one side.

10 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “L” on each side of the score on one side of the tablet.

15 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “M” on each side of the score on one side of the tablet.

20 mg: Oval, white film-coated tablets. The tablets are scored and marked with “E” and “N” on each side of the score on one side of the tablet.

Cipralex is available in the following pack sizes:

Blister (transparent) in cardboard box

5, 10, 15 and 20 mg : 14, 28, 56 and 98 tablets

Blisters (white) in cardboard box

5, 10, 15 and 20 mg: 14, 20, 28, 50, 100 and 200 tablets

Polypropylene container

15 and 20 mg: 100 tablets

5 and 10 mg: 100 and 200 tablets

Unit dose:

5, 10, 15 and 20 mg: 49x1, 56x1, 98x1, 100x1 and 500x1 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

H Lundbeck A/S

Ottiliavej 9

DK-2500 Copenhagen

Denmark

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Cipralex

Belgium: Sipralexa

Bulgaria: Cipralex

Cyprus: Cipralex

Czech Republic: Cipralex

Denmark: Cipralex

Estonia: Cipralex

Finland: Cipralex

France: Seroplex

Germany: Cipralex

Greece: Cipralex

Hungary: Cipralex

Iceland: Cipralex

Ireland: Lexapro

Italy: Cipralex

Latvia: Cipralex

Lithuania: Cipralex

Luxembourg: Sipralexa

Malta: Cipralex

The Netherlands: Cipralex

Norway: Cipralex

Poland: Cipralex

Portugal: Cipralex

Romania: Cipralex

Slovakia: Cipralex

Slovenia: Cipralex

Spain: Cipralex

Sweden: Cipralex

United Kingdom: Cipralex

This leaflet was approved: 09/04/2008

progesterone

Generic Name: progesterone (proe JESS te rone)

Brand Names: First Progesterone MC10, First Progesterone MC5, Progest, Prometrium

What is progesterone?

Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. Progesterone is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

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

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

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Do not use this medication if you have any of the following conditions: a history of breast cancer, abnormal vaginal bleeding, liver disease, if you are pregnant, or if you have had a stroke, heart attack, or blood clot within the past year.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

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

Progesterone should not be used to prevent heart disease or dementia, because this medication may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before using progesterone?

Some forms of this medication may contain peanut oil. Do not use progesterone without telling your doctor if you have a peanut allergy. Do not use progesterone if you have:

• 
  

  a history of breast cancer;

  
  


• 
  

  abnormal vaginal bleeding that a doctor has not checked;

  
  


• 
  

  liver disease;

  
  


• 
  

  if you are pregnant; or

  
  


• 
  

  if you have had a stroke, heart attack, or blood clot within the past year.

  
  

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

• 
  

  heart disease, circulation problems;

  
  


• 
  

  risk factors for coronary artery disease (such as smoking, being overweight, and having high blood pressure or high cholesterol);

  
  


• 
  

  migraines,

  
  


• 
  

  asthma;

  
  


• 
  

  kidney disease;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of depression; or

  
  


• 
  

  diabetes.

  
  

Do not use progesterone without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Progesterone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use progesterone?

Use this medication exactly as it was prescribed for you. Do not use larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Progesterone is sometimes given for only a short period of time, such as 6 to 12 days at a time during each menstrual cycle. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

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

Take the pill form of progesterone with a full glass of water.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone injection is given as a shot into a muscle. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

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

Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any scheduled appointments.

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

What happens if I miss a dose?

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

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

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

What should I avoid while using progesterone?

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

Progesterone 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:

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

  
  


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  sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;

  
  


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  fast or pounding heartbeats;

  
  


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

  
  


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  unusual or unexpected vaginal bleeding;

  
  


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  migraine headache;

  
  


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

  
  


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  swelling in your hands, ankles, or feet;

  
  


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  fever, chills, body aches, flu symptoms;

  
  


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  a breast lump; or

  
  


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

  
  

Less serious side effects may include:

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  mild nausea, diarrhea, bloating, stomach cramps;

  
  


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  dizziness, spinning sensation;

  
  


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  hot flashes;

  
  


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  mild headache;

  
  


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  joint pain;

  
  


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  breast pain or tenderness;

  
  


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  cough;

  
  


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  acne or increased hair growth;

  
  


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  changes in weight; or

  
  


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  vaginal itching, dryness, or discharge.

  
  

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.

Progesterone Dosing Information

Usual Adult Dose for Amenorrhea:

5 to 10 mg IM for six to eight consecutive days.

400 mg orally for 10 days. Give dose in the evening.

Secondary Amenorrhea:
90 mg intravaginally, 4% gel, every other day for a total of six doses. If no response observed, the administration of the 8% gel every other day for a total of six doses may be used.

Usual Adult Dose for Uterine Bleeding:

5 to 10 mg IM daily for 6 doses.

Usual Adult Dose for Endometrial Hyperplasia -- Prophylaxis:

200 mg orally for 12 consecutive days, per 28 day cycle. Give dose in the evening.

Usual Adult Dose for Progesterone Insufficiency:

Assisted Reproductive Technology (ART) - Gel:
90 mg of the 8% gel, once daily intravaginally, in women who require supplementation.
90 mg of the 8% gel, twice daily intravaginally, in women with partial or complete ovarian failure who require replacement.
If pregnancy occurs, therapy with the intravaginal gel may be continued until placental autonomy is achieved, up to 10 to 12 weeks.

Assisted Reproductive Technology (ART) - Vaginal Insert
100 mg administered vaginally two or three times daily starting at oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose in this age group has not been determined.

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: rub 1/4 to 1/2 teaspoon into the palms of the hands, soles of the feet, or other soft areas of skin once or twice daily.

Usual Adult Dose for Premature Labor:

Study (n=459) - National Institute of Child Health and Human Development (NICHD) - Prevention of Recurrent Preterm Delivery in Women at High Risk: 17-alpha-hydroxyprogesterone caproate (17P) 250 mg IM once weekly starting on the 21st week of gestation through time of delivery or week 36 of gestation.

Study (n=142) - Reduce Incidence of Spontaneous Preterm Birth in Women at Increased Risk: 100 mg vaginal suppository daily, between 24 and 34 weeks of gestation.

Usual Adult Dose for Seizures:

(Study=25) - Catamenial epilepsy [complex partial or secondary generalized motor seizures]:
200 mg lozenge three times daily administered in relation to pattern of seizure exacerbation during luteal phase of menstrual cycle. For patients with perimenstrual exacerbation, dose was provided on day 23 through day 25 of menstrual cycle. For patients with seizure exacerbation during entire luteal phase, dose was provided on day 15 through day 25 of each menstrual cycle. The desired progesterone serum level was between 5 and 25 ng/mL 4 hours after taking the lozenge. All patients continued taking their best antiseizure medication.

Usual Adult Dose for Perimenopausal Symptoms:

Progesterone deficiency associated with menopause and perimenopause:
progesterone 1.7% topical cream: Rub 1/4 to 1/2 teaspoonful into the palms of the hands, soles of feet, or other soft area once or twice daily.

What other drugs will affect progesterone?

There may be other drugs that can interact with progesterone. 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 progesterone resources

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

• progesterone Advanced Consumer (Micromedex) - Includes Dosage Information


• Progesterone Natural MedFacts for Professionals (Wolters Kluwer)


• Progesterone Prescribing Information (FDA)


• Progesterone Professional Patient Advice (Wolters Kluwer)


• Progesterone Monograph (AHFS DI)


• Progesterone MedFacts Consumer Leaflet (Wolters Kluwer)


• Crinone Prescribing Information (FDA)


• Crinone Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Crinone Advanced Consumer (Micromedex) - Includes Dosage Information


• Endometrin Prescribing Information (FDA)


• Endometrin Insert MedFacts Consumer Leaflet (Wolters Kluwer)


• Endometrin Consumer Overview


• Prochieve Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Prochieve Prescribing Information (FDA)


• Progestins Monograph (AHFS DI)


• Prometrium Prescribing Information (FDA)

Compare progesterone with other medications

• Amenorrhea
• Endometrial Hyperplasia, Prophylaxis
• Perimenopausal Symptoms
• Premature Labor
• Progesterone Insufficiency
• Seizures
• Uterine Bleeding

Where can I get more information?

• Your pharmacist can provide more information about progesterone.

See also: progesterone side effects (in more detail)

Ultrasound contrast media

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