measles, mumps, and rubella (MMR) vaccine

Generic Name: measles, mumps, and rubella (MMR) vaccine (MEE zels, MUMPS, and roo BEL a)

Brand Names: M-M-R II

What is measles, mumps, and rubella vaccine?

Measles, mumps, and rubella are serious diseases caused by viruses. They are spread from person to person through the air.

Measles virus can cause minor symptoms such as skin rash, cough, runny nose, eye irritation, or mild fever. It can also cause more serious symptoms such as ear infection, pneumonia, seizures, permanent brain damage, or death.

Mumps virus causes fever, headache, and swollen glands, but more serious symptoms include hearing loss, and painful swelling of the testicles or ovaries. Mumps can cause breathing problems or meningitis, and these infections can be fatal.

Rubella virus (also called German Measles) causes skin rash, mild fever, and joint pain. Becoming infected with rubella during pregnancy can result in a miscarriage or serious birth defects.

The measles, mumps, and rubella vaccine is used to help prevent these diseases in children and adults.

This vaccine works by exposing you to a small dose of the virus or protein from the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Measles, mumps, and rubella vaccine is for use in children between the ages of 12 months and 6 years old, and in adults who have never received the vaccine or had the diseases.

Like any vaccine, the measles, mumps, and rubella vaccine may not provide protection from disease in every person.

What is the most important information I should know about this vaccine?

The measles, mumps, and rubella (MMR) vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. At least 28 days (4 weeks) should pass between the first and second doses of this vaccine.

Adults born after 1956 should receive at least one MMR vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

Your booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Be sure to receive all recommended doses of this vaccine. You may not be fully protected against disease if you do not receive the full series.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you are allergic to:

• 
  

  eggs;

  
  


• 
  

  gelatin;

  
  


• 
  

  neomycin (Mycifradin, Neo-Fradin, Neo-Tab); or

  
  


• 
  

  if you have ever had a life-threatening allergic reaction to any vaccine containing measles, mumps, or rubella.

  
  

You should also not receive this vaccine if you have:

• 
  

  a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or blood cell disorders such as anemia;

  
  


• 
  

  severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation; or

  
  


• 
  

  if you are pregnant.

  
  

If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

• 
  

  thrombocytopenia purpura (easy bruising or bleeding);

  
  


• 
  

  active tuberculosis infection;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);

  
  


• 
  

  a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments;

  
  


• 
  

  if you have received an immune globulin or other blood product within the past year; or

  
  


• 
  

  if you have received a previous MMR vaccine within the past 28 days (4 weeks).

  
  

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a measles, mumps, and rubella vaccine if you are pregnant. Wait until after your child is born to receive the vaccine.

Avoid becoming pregnant for at least 3 months after receiving a measles, mumps, and rubella vaccine.

Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is this vaccine given?

This vaccine is given as an injection under the skin. You will receive this injection in a doctor's office or clinic setting.

The measles, mumps, and rubella vaccine is given in a series of shots. The first shot is usually given to a child who is 12 to 15 month old. The booster shots are then given between 4 and 6 years of age. At least 28 days (4 weeks) should pass between the first and second doses of this vaccine.

Adults born after 1956 should receive at least one MMR vaccination if they have never had the diseases or received an MMR vaccine during their lifetime.

Your booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

This vaccine can cause false results on a skin test for tuberculosis for up to 6 weeks. Tell any doctor who treats you if you have received a measles, mumps, and rubella vaccine within the past 4 to 6 weeks.

What happens if I miss a dose?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure to receive all recommended doses of this vaccine. You may not be fully protected if you do not receive the full series.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine?

Do not receive a "live" vaccine for at least 4 weeks after you have received the measles, mumps, and rubella vaccine. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

This vaccine side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

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.

Call your doctor at once if you have any of these serious side effects:

• 
  

  problems with hearing or vision;

  
  


• 
  

  extreme drowsiness, fainting;

  
  


• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  seizure (black-out or convulsions); or

  
  


• 
  

  high fever (within a few hours or a few days after the vaccine).

  
  

Less serious side effects include:

• 
  

  redness, pain, swelling, or a lump where the shot was given;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  low fever;

  
  


• 
  

  joint or muscle pain; or

  
  


• 
  

  nausea, vomiting, diarrhea.

  
  

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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Measles, mumps, and rubella (MMR) vaccine Dosing Information

Usual Adult Dose for Mumps Prophylaxis:

0.5 mL subcutaneously preferably into the outer aspect of the upper arm.

Usual Adult Dose for Rubella Prophylaxis:

0.5 mL subcutaneously preferably into the outer aspect of the upper arm.

Usual Adult Dose for Measles Prophylaxis:

0.5 mL subcutaneously preferably into the outer aspect of the upper arm.

Usual Pediatric Dose for Mumps Prophylaxis:

>= 12 months: 0.5 mL subcutaneously preferably into the outer aspect of the upper arm. The initial dose is generally given at 15 months of age and followed by a booster between the ages of 4 to 6 years.

MMR is indicated for use in patients >= 15 months. However, in relatively inaccessible populations for whom immunization programs are logistically difficult and in population groups in which natural measles infection may occur in a significant proportion of patients before 15 months of age, it may be desirable to administer measles vaccine at an earlier age.

= 12 months of age.

Usual Pediatric Dose for Rubella Prophylaxis:

>= 12 months: 0.5 mL subcutaneously preferably into the outer aspect of the upper arm. The initial dose is generally given at 15 months of age and followed by a booster between the ages of 4 to 6 years.

MMR is indicated for use in patients >= 15 months. However, in relatively inaccessible populations for whom immunization programs are logistically difficult and in population groups in which natural measles infection may occur in a significant proportion of patients before 15 months of age, it may be desirable to administer measles vaccine at an earlier age.

= 12 months of age.

Usual Pediatric Dose for Measles Prophylaxis:

>= 12 months: 0.5 mL subcutaneously preferably into the outer aspect of the upper arm. The initial dose is generally given at 15 months of age and followed by a booster between the ages of 4 to 6 years.

MMR is indicated for use in patients >= 15 months. However, in relatively inaccessible populations for whom immunization programs are logistically difficult and in population groups in which natural measles infection may occur in a significant proportion of patients before 15 months of age, it may be desirable to administer measles vaccine at an earlier age.

= 12 months of age.

What other drugs will affect measles, mumps, and rubella vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with measles, mumps, and rubella vaccine. 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 measles, mumps, and rubella (MMR) vaccine resources

• Measles, mumps, and rubella (MMR) vaccine Use in Pregnancy & Breastfeeding
• Measles, mumps, and rubella (MMR) vaccine Drug Interactions
• Measles, mumps, and rubella (MMR) vaccine Support Group
• 0 Reviews for Measles, mumps, and rubella (MMR) vaccine - Add your own review/rating

Compare measles, mumps, and rubella (MMR) vaccine with other medications

• Measles Prophylaxis
• Mumps Prophylaxis
• Rubella Prophylaxis

Where can I get more information?

• Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

Inapsine

Generic Name: droperidol (Injection route)

droe-PER-i-dol

Injection route(Solution)

Cases of QT prolongation and/or torsade de pointes, some fatal, have been reported in patients receiving droperidol at doses at or below recommended doses. All patients should undergo a 12-lead ECG prior to administration of droperidol to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. Do not administer droperidol if there is a prolonged QT interval. Droperidol is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome. Administer droperidol with extreme caution to patients who may be at risk for development of prolonged QT syndrome, are over 65 years old, abuse alcohol, or when used concomitantly with benzodiazepines, volatile anesthetics, and IV opiates. ECG monitoring should be performed prior to treatment and continued for 2 to 3 hours after completing treatment to monitor for arrhythmias .

Commonly used brand name(s)

In the U.S.

• Inapsine

Available Dosage Forms:

• Injectable


• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Dopamine Antagonist

Chemical Class: Butyrophenone

Uses For Inapsine

Droperidol is used to reduce the amount of nausea and vomiting you may have after surgery or other procedures.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, droperidol is used

• In certain patients with severe agitation and combativeness


• To produce sleepiness or drowsiness before surgery or certain procedures

For patients receiving this medicine for severe agitation and combativeness, the dose administered will depend on the degree of agitation and the size of the patient.

Before Using Inapsine

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

Droperidol has not been studied in children up to 2 years of age. There is no specific information comparing the use of droperidol in children with use in other age groups. However, based on experience with similar drugs, children may be more likely than older patients to experience side effects after receiving droperidol, such as muscle spasms in the tongue, face, neck, and back, and inability to move the eyes.

Geriatric

Older patients may be more likely than younger adult patients to experience dizziness and excessive sleepiness from droperidol. Older patients may also have problems with unusual heartbeats from droperidol

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 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.

• Acetophenazine


• Bepridil


• Bromperidol


• Cisapride


• Clozapine


• Dronedarone


• Levomethadyl


• Mesoridazine


• Molindone


• Perphenazine


• Pimozide


• Pipamperone


• Remoxipride


• Sparfloxacin


• Thioridazine


• Tiapride


• Triflupromazine


• Ziprasidone

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.

• Acecainide


• Acetazolamide


• Ajmaline


• Alfuzosin


• Amiloride


• Amiodarone


• Amisulpride


• Amitriptyline


• Amlodipine


• Amoxapine


• Apomorphine


• Aprindine


• Aranidipine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bretylium


• Brofaromine


• Bumetanide


• Canrenoate


• Castor Oil


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Chlorthalidone


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clopamide


• Clorgyline


• Clozapine


• Crizotinib


• Cyclothiazide


• Dasatinib


• Desipramine


• Dibenzepin


• Diltiazem


• Disopyramide


• Docusate


• Dofetilide


• Dolasetron


• Doxepin


• Ebastine


• Encainide


• Enflurane


• Erythromycin


• Ethacrynic Acid


• Etozolin


• Felodipine


• Fendiline


• Fenquizone


• Fexofenadine


• Flecainide


• Fluconazole


• Flunarizine


• Fluoxetine


• Fluspirilene


• Fluvoxamine


• Foscarnet


• Furazolidone


• Furosemide


• Gallopamil


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hydrochlorothiazide


• Hydroflumethiazide


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Indapamide


• Iproniazid


• Isocarboxazid


• Isoflurane


• Isradipine


• Lacidipine


• Lactulose


• Lapatinib


• Lazabemide


• Levofloxacin


• Lidoflazine


• Linezolid


• Lithium


• Lopinavir


• Lorcainide


• Lumefantrine


• Mannitol


• Mefloquine


• Methadone


• Metolazone


• Mianserin


• Mibefradil


• Moclobemide


• Morphine Sulfate Liposome


• Moxifloxacin


• Nefazodone


• Nialamide


• Nicardipine


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pargyline


• Paroxetine


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Phenelzine


• Piretanide


• Pirmenol


• Polythiazide


• Posaconazole


• Prajmaline


• Probucol


• Procainamide


• Procarbazine


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinethazone


• Quinidine


• Quinine


• Ranolazine


• Rasagiline


• Risperidone


• Ritanserin


• Salmeterol


• Saquinavir


• Selegiline


• Sematilide


• Sertindole


• Sertraline


• Sibutramine


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sorbitol


• Sotalol


• Spiramycin


• Spironolactone


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Ticrynafen


• Toloxatone


• Toremifene


• Torsemide


• Tranylcypromine


• Trazodone


• Triamterene


• Trichlormethiazide


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Urea


• Vandetanib


• Vasopressin


• Vemurafenib


• Voriconazole


• Xipamide


• Zimeldine


• Zolmitriptan


• Zotepine

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.

• Levodopa

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

• Age over 65 or


• Alcoholism or


• Congestive heart failure or


• Enlargement of the heart or


• Hypokalemia (too little potassium in the blood) or


• Hypomagnesemia (too little magnesium in the blood) or


• Irregular heartbeat


• Slow heartbeat—Droperidol may increase the risk of irregular heartbeats

• Epilepsy—The risk of seizures may be increased

• Heart disease or


• Mental depression or


• Parkinsonism—Droperidol may worsen these conditions

• Hypovolemia—The risk of dizziness may be increased

• Liver disease—The risk of side effects may be increased

• Pheochromocytoma—High blood pressure and rapid heart rate may occur

Proper Use of Inapsine

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.

• Your age;


• Your general physical condition;


• The reason you are receiving droperidol; and


• Other medicines you are taking or will receive before or after droperidol is given.

Precautions While Using Inapsine

For patients going home within a few hours after surgery:

• Droperidol and other medicines that may be given during surgery may cause some people to feel drowsy, tired, or weak for up to a few days afterwards. Therefore, for at least 24 hours (or longer if necessary) after receiving this medicine, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


• Unless otherwise directed by your medical doctor, do not drink alcoholic beverages or take other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness) for about 24 hours after you have received this medicine. To do so may add to the effects of droperidol. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; and muscle relaxants.

Inapsine 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

• Anxiety


• high blood pressure


• restlessness

Rare

• Fainting


• fever


• fixed upward position of the eyeballs


• irregular or slow heart rate


• spasm of the muscles of the tongue, face, neck, and back


• sudden death

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: Inapsine side effects (in more detail)

Symptoms of overdose

• Dizziness


• fixed upward position of the eyeballs


• restlessness


• slowed breathing


• spasm of the muscles of the tongue, face, neck, and back

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

• Drowsiness


• lightheadedness


• rapid heart rate

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.

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 Inapsine resources

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

• Inapsine Prescribing Information (FDA)


• Inapsine MedFacts Consumer Leaflet (Wolters Kluwer)


• Inapsine Concise Consumer Information (Cerner Multum)


• Inapsine Monograph (AHFS DI)


• Droperidol Prescribing Information (FDA)


• Droperidol Professional Patient Advice (Wolters Kluwer)

Compare Inapsine with other medications

• Nausea/Vomiting
• Nausea/Vomiting, Postoperative

Fluoderm Regular Cream

Generic Name: fluocinolone (Topical application route)

floo-oh-SIN-oh-lone a-SEET-oh-nide

Commonly used brand name(s)

In the U.S.

• Capex


• Derma-Smoothe/FS


• Synalar

In Canada

• Fluoderm Mild Cream


• Fluoderm Mild Ointment


• Fluoderm Regular Cream


• Fluoderm Regular Ointment


• Fluolar Mild


• Fluolar Regular


• Fluonide Mild-Cream


• Synalar Mild


• Synalar Regular


• Synamol

Available Dosage Forms:

• Cream


• Solution


• Shampoo


• Oil


• Ointment


• Lotion


• Gel/Jelly


• Kit

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Fluocinolone

Uses For Fluoderm Regular Cream

Fluocinolone topical is used to relieve redness, itching, swelling, or other discomfort caused by skin conditions. Fluocinolone scalp oil is used to treat psoriasis of the scalp, and fluocinolone shampoo for seborrheic dermatitis of the scalp. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Fluoderm Regular Cream

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinolone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For the body oil form, safety and efficacy in children 3 months of age and younger have not been established.

Geriatric

No information is available on the relationship of age to the effects of fluocinolone topical in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of fluocinolone

This section provides information on the proper use of a number of products that contain fluocinolone. It may not be specific to Fluoderm Regular Cream. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use cream, ointment, solution, and body oil:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin or scalp. Rub it in gently.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

To use shampoo:

• Wash your hands with soap and water before and after using this medicine.


• Wet hair and scalp thoroughly.


• Shake the container well, and apply about an ounce of the shampoo to the scalp area.


• Work the shampoo into a lather, and leave on the scalp for 5 minutes.


• Wash hair and scalp thoroughly with water.

To use scalp oil:

• Wash your hands with soap and water before and after using this medicine.


• Wet hair and scalp thoroughly.


• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.


• Cover the scalp with the supplied shower cap overnight for at least 4 hours.


• Wash hair with regular shampoo and clean well.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream, ointment, and solution):
    
    • Adults—Apply to the affected areas of the skin three to four times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For topical dosage form (body oil):
    
    • Adults—Apply to the affected areas of the skin three times a day for up to 2 weeks.
    
    
    • Children 3 months of age and older—Apply to the affected areas two times a day for up to 4 weeks.
    
    
  
  

• For seborrheic dermatitis:
  
  • For topical dosage form (shampoo):
    
    • Adults—Use on the scalp area once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

• For scalp psoriasis:
  
  • For topical dosage form (scalp oil):
    
    • Adults—Apply to the affected areas of the scalp and leave overnight.
    
    
    • Children 2 years of age and older—Apply to the affected areas 2 times a day for up to 4 weeks.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Fluoderm Regular Cream

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Fluoderm Regular Cream Side Effects

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

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

More common

• Body aches or pain


• congestion


• cough


• dryness or soreness of the throat


• fever


• headache


• hoarseness


• lightening of normal skin color


• lightening of treated areas of dark skin


• sore throat


• stuffy or runny nose


• tender, swollen glands in the neck


• trouble swallowing


• unusual tiredness or weakness


• voice changes

Less common

• Acne or pimples


• accumulation of pus


• blistering, crusting, irritation, itching, or reddening of the skin


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• burning and itching of the skin with pinhead-sized red blisters


• change in hearing


• cracked, dry, scaly skin


• diarrhea


• dry skin


• earache or pain in the ear


• ear drainage


• flushing or redness of the skin


• darkening of the skin


• itching, scaling, severe redness, soreness, or swelling of the skin


• itchy, raised, round, smooth, skin-colored bumps found on just one area of the body


• ooze thick white fluid


• raised, dark red, wart-like spots on skin, especially when used on the face


• redness or swelling in the ear


• skin irritation


• skin rash, encrusted, scaly and oozing


• spots on your skin resembling a blister or pimple


• swelling


• swollen, red, tender area of infection


• thickened patches of the skin


• vomiting

Incidence not known

• Redness and scaling around the mouth


• thinning, weakness, or wasting away of the 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

• Changes in skin color


• shiny skin

Incidence not known

• increased hair growth on the forehead, back, arms, and legs


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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.

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 Fluoderm Regular Cream resources

• Fluoderm Regular Cream Use in Pregnancy & Breastfeeding
• Fluoderm Regular Cream Drug Interactions
• Fluoderm Regular Cream Support Group
• 3 Reviews for Fluoderm Regular - Add your own review/rating

Compare Fluoderm Regular Cream with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Sclerosus

Neoral

Generic Name: cyclosporine (SYE kloe SPOR een)

Brand Names: Gengraf, Neoral, SandIMMUNE

What is Neoral (cyclosporine)?

Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Cyclosporine is used to prevent organ rejection after a kidney, liver, or heart transplant.

Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis.

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

What is the most important information I should know about Neoral (cyclosporine)?

You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), or any type of cancer.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Call your doctor at once if you have any signs of kidney failure, such as urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting, swelling, weight gain, or feeling short of breath. Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease. There are many other medicines that can cause serious medical problems if you take them together with cyclosporine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before taking Neoral (cyclosporine)?

You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have:

• 
  

  kidney disease;

  
  


• 
  

  untreated or uncontrolled high blood pressure; or

  
  


• 
  

  any type of cancer.

  
  

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

• 
  

  psoriasis that has been treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar; or

  
  


• 
  

  if you are also taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

  
  

FDA pregnancy category C. It is not known whether cyclosporine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cyclosporine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Neoral (cyclosporine)?

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

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

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. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice at room temperature to make the medicine taste better. Neoral "modified" (microemulsion) oral solution should be mixed with orange juice or apple juice that is at room temperature.

Cyclosporine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your blood pressure and kidney function may also need to be checked. Do not miss any scheduled appointments.

Your condition may need to be treated with a combination of different drugs. For best treatment results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person taking cyclosporine should remain under the care of a doctor.

Store cyclosporine at room temperature away from moisture and heat.

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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), and urinating less than usual or not at all.

What should I avoid while taking Neoral (cyclosporine)?

Avoid exposure to sunlight, sunlamps, or tanning beds. Cyclosporine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Avoid eating grapefruit or drinking grapefruit juice. Grapefruit may interact with cyclosporine and increase your blood levels of this medication.

Neoral (cyclosporine) 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. Call your doctor at once if you have any of these serious side effects:

• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  blurred vision, headache or pain behind your eyes, sometimes with vomiting;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  muscle pain or weakness, fast heart rate, feeling light-headed;

  
  


• 
  

  signs of infection such as fever, chills, sore throat, flu symptoms;

  
  


• 
  

  pale skin, easy bruising or bleeding, unusual weakness; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  tremors or shaking;

  
  


• 
  

  increased hair growth;

  
  


• 
  

  headache or body pain;

  
  


• 
  

  diarrhea, constipation, vomiting; or

  
  


• 
  

  numbness or tingly 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 Neoral (cyclosporine)?

Many drugs can interact with cyclosporine. Below is just a partial list. Tell your doctor about all other medications you are using, especially:

• 
  

  etoposide (VePesid, Etopophos);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  nefazodone;

  
  


• 
  

  repaglinide (Prandin);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

  a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar);

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  other medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

This list is not complete and there are many other medicines that can cause serious medical problems if you take them together with cyclosporine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Neoral resources

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

• Neoral Advanced Consumer (Micromedex) - Includes Dosage Information


• Neoral Prescribing Information (FDA)


• Neoral MedFacts Consumer Leaflet (Wolters Kluwer)


• Cyclosporine Prescribing Information (FDA)


• Cyclosporine Monograph (AHFS DI)


• Cyclosporine MedFacts Consumer Leaflet (Wolters Kluwer)


• Gengraf Prescribing Information (FDA)


• Sandimmune Prescribing Information (FDA)


• cyclosporine Ophthalmic Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Neoral with other medications

• Crohn's Disease
• Idiopathic Thrombocytopenic Purpura
• Inflammatory Bowel Disease
• Organ Transplant, Rejection Prophylaxis
• Organ Transplant, Rejection Reversal
• Psoriasis
• Rheumatoid Arthritis
• Ulcerative Colitis

Where can I get more information?

• Your pharmacist can provide more information about cyclosporine.

See also: Neoral side effects (in more detail)

Calciparine

1. Name Of The Medicinal Product

Calciparine, 25,000 IU Heparin activity per ml.

2. Qualitative And Quantitative Composition

Heparin Calcium 25,000 IU/ml

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for injection.

Sterile clear solution of 25,000 International Units of Heparin activity per ml as the calcium salt in water for injections.

4. Clinical Particulars

4.1 Therapeutic Indications

It is indicated for use as an anticoagulant for the prophylaxis and treatment of thromboembolic phenomena, especially myocardial infarction, acute arterial embolism or thrombosis, deep vein thrombosis, thrombophlebitis or pulmonary embolism.

4.2 Posology And Method Of Administration

For subcutaneous administration only using a 26-gauge needle. The best site is the subcutaneous tissue of the lateral abdominal wall. The needle should be inserted perpendicularly into a pinched-up fold of skin and held gently but firmly within the skinfold until injection has been completed. Do not rub the site of injection.

Calciparine is not intended for intramuscular use.

Adults

Prophylaxis:

A standard prophylactic dose regimen is 5,000 IU by subcutaneous injection 2 hours before operation, followed by 5,000 IU by subcutaneous injection every 8 to 12 hours for seven days. In patients still confined to bed at the end of this period, the same dosage should be continued until they are ambulant.

The standard prophylactic dose following myocardial infarction is 5,000 IU by subcutaneous injection twice daily for 10 days or until the patient is mobile.

In other medical conditions in which there is an associated increased risk of thromboembolic phenomena, the same dosage is recommended.

These standard prophylactic regimens do not require routine control in the absence of contra-indications or conditions listed under special warnings and precautions.

If a myocardial infarction is shown to be anterior and therefore has a risk of mural thrombosis of the left ventricle, a higher dose of 12,500 IU twice daily for at least 10 days is recommended. For this dosage regimen, regular monitoring should be considered.

Treatment:

For the treatment of existing thrombosis the standard dose is 0.1ml Calciparine (2,500 IU) per 10kg body weight 12 hourly. To enable dosage to be individually adjusted to maintain a coagulation time in a range of 1.5 to 3 times that of control it is recommended that the thrombin clotting time, whole blood clotting time or the activated partial thromboplastin time be measured on blood withdrawn 5 to 7 hours after the first injection and then at intervals until the patient is stabilised. During long term therapy the test should be repeated at least once each week.

Children

Dosage should be individually adjusted according to changes in whole blood clotting time and/or thrombin clotting time and/or APTT. The initial dose should be 0.1ml Calciparine (2,500 IU) by subcutaneous injection for each 10kg of body weight. The usual interval between doses is 12 hours, but this also may require individual adjustment.

Other special groups

For both prophylaxis and treatment, higher doses are likely to be required in patients of abnormally high body weight and in those suffering from cancer, diabetes mellitus or other diseases associated with marked hypercoagulability. Lower doses are usually indicated in the elderly and in those with low serum albumin or impaired renal or hepatic function. In such patients coagulation times should be checked frequently and dosage adjusted accordingly.

Use in pregnancy

Heparin does not cross the placental wall; no malformation or foetotoxicity have been reported in humans. Nonetheless, particular caution should be exercised due to uteroplacental haemorrhagic risks, particularly at the time of delivery. Calciparine should be discontinued if peridural anaesthesia is likely. Individual control is essential and the aim should be to maintain plasma heparin levels between 0.1 and 0.4 units/ml, as assessed by anti-XA assay, and a whole blood clotting time of 15 to 20 minutes.

The standard prophylactic dosage of 5,000 IU by subcutaneous injection every 8 hours is a suitable starting dose in the first 3 or 4 months of pregnancy but higher doses are needed as pregnancy progresses, 10,000 IU two or three times daily being usual in the last trimester. Dosage must be reduced during labour and standard prophylactic dosage is suitable post-partum.

Heparin is not excreted into breast milk.

4.3 Contraindications

• hypersensitivity to heparin.

• history of thrombocytopenia occurring with any kind of heparin

• active bleeding or increased risk of haemorrhage in relation to haemostasis disorders, except for disseminated intravascular coagulation not induced by heparin.

• organic lesion likely to bleed (including gastric and duodenal ulcer).

• threatened abortion

• sub-acute infectious endocarditis.

• post-operative period following surgery of the brain, spinal cord and eye.

• haemorrhagic cerebral vascular accident.

• in patients receiving Calciparine for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated.

• Calciparine should not be used in patients with advanced renal or hepatic dysfunction, in severe hypertension or patients in shock.

4.4 Special Warnings And Precautions For Use

4.4.1 Special warnings

Platelet count monitoring:

Platelet count must be performed before the treatment, and subsequently twice weekly; if a prolonged treatment is found to be necessary, this monitoring program must be respected, at least during the first month; after that time, monitoring can be carried out less frequently.

Some rare cases of thrombocytopenia, occasionally severe, have been reported; they may be associated (or not) with arterial or venous thrombosis, and the treatment should be discontinued; such diagnosis should be considered in the following cases:

• thrombocytopenia or,

• any significant decrease in platelet count (30 - 50% of the baseline value),

• worsening of the initial thrombosis while on therapy,

• thrombosis occuring on treatment,

• disseminated intravascular coagulation.

These effects are probably of immuno-allergic nature and in case of a first treatment they occur mainly between the 5th and the 21st day of therapy.

When a thrombocytopenia occurs with standard heparin, the substitution with a low molecular weight heparin may be considered if continuing the heparin treatment is necessary. In such cases, monitoring should be performed at least daily, and the treatment should be discontinued as soon as possible: initial thrombocytopenia continuing after substitution have been described.

In vitro platelet aggregation tests are only of limited value.

The concomitant use of salicylates, NSAIDs or antiplatelet agents represents a relative contra-indication for heparin administration (see 4.5, Interactions with Other Medicaments and Other Forms of Interactions).

4.4.2 Special precautions

Patients should be warned of an increased risk of bruising.

Administer with care in cases of:

• hepatic failure,

• renal failure,

• hypertension

• history of digestive ulcer or any other organic lesion likely to bleed,

• vascular diseases of the chorio-retina.

Special care should be taken in elderly patients and pregnant women.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients with a raised plasma potassium or at risk of increased plasma potassium levels such as patients with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis or taking drugs that may increase plasma potassium (e.g. ACE inhibitors, NSAIDs).

The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be monitored in patients at risk.

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of Calciparine may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision-making on the interval between the last administration of Calciparine at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anticoagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits (numbness and weakness in lower limbs) and bowel or bladder dysfunction. Nurses should be trained to detect such signs and symptoms. Patients should be instructed to inform immediately a nurse or clinician if they experience any of these.

If signs or symptoms of epidural or spinal haematomas are suspected, urgent diagnosis and treatment including spinal cord decompression should be initiated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of aspirin (or other salicylates), non-steroidal anti-inflammatory drugs, or the use of antiplatelet agents (see 4.4.1, Special warnings) is not recommended, as they may increase the risk of bleeding.

Where such combination cannot be avoided, careful clinical and biological monitoring should be undertaken.

Calciparine should be administered with care in patients receiving oral anticoagulant agents (additive anticoagulant effect), systemic corticosteroids (gluco-) and dextrans (parenteral administration).

During transfer from heparin to oral anticoagulant therapy, clinical monitoring should be particularly vigilant.

4.6 Pregnancy And Lactation

Pregnancy

Heparin does not cross the placental wall; no malformation or foetotoxicity have been reported in humans. Nonetheless, particular caution should be exercised due to uteroplacental haemorrhagic risks, particularly at the time of delivery. Calciparine should be discontinued if peridural anaesthesia is likely.

Lactation

Heparin is not excreted into breast milk.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Adverse reactions have been ranked under heading of system-organ class and frequency using the following convention: very commonly (>= 1/10); commonly (>= 1/100, <1/10); uncommonly (>= 1/1,000, <1/100); rarely (>= 1/10,000, <1/1,000); very rarely (<1/10,000).

Haematological and bleeding disorders:

• Very commonly: haemorrhagic manifestations at various sites, more frequent in patients with other risk factors (see Section 4.3 Contra-indications and Section 4.5 Interactions with Other Medicaments and Other Forms of Interaction).

• Commonly: thrombocytopenia, usually reversible, sometimes thrombogenic (see Section 4.4.1 Special warnings).

• Rarely: eosinophilia, reversible following treatment discontinuation.

• Very rarely: epidural or spinal haematoma in the context of peridural or spinal anaesthesia and of spinal puncture. These haematomas have caused various degrees of neurological impairment, including prolonged and permanent paralysis. (see Section 4.4.2 Special precautions).

Cutaneous and subcutaneous disorders:

• Very commonly: small hematomas at the injection site. In some cases, the emergence of firm nodules which do not indicate an encystment of the heparin may be noted. These nodules usually disappear after a few days and are not an indication to withdraw treatment. Pain and bruising may also occur.

• Uncommonly: localised or generalized hypersensitivity reactions, including angioedema, erythema, rash, urticaria, pruritus.

• Rarely: cutaneous necrosis usually occuring at the injection site. It is preceded by purpura or infiltrated or painful erythematous blotches, with or without systemic signs. In such cases, treatment should be immediately discontinued.

• Very rarely: Alopecia, calcinosis at injection site, especially in patients with severe renal failure

Hepato-biliary disorders:

• Commonly: raised transaminases, usually transient.

Metabolism and nutrition disorders:

• Rarely: osteoporosis after several months of treatment, at high doses.

• Very rarely: hypoaldosteronism with hyperkaliemia and / or metabolic acidosis particularly in patients at risk (diabetes, renal failure) (see Section 4.4 Special Warnings and Special Precautions for Use).

Reproductive disorders:

• Rarely: priapism

4.9 Overdose

Haemorrhage is the major clinical sign of overdosage. In case of bleeding, the platelet count and APTT should be determined. Minor bleeding rarely requires specific therapy, and reducing and/or delaying subsequent doses of Calciparine is usually sufficient.

The anticoagulant effect of heparin can be reversed immediately by intravenous administration of a 1% protamine sulphate solution. The dose of protamine sulphate required for neutralisation should be determined accurately by titrating the patient's plasma.

It is important to avoid overdosage of protamine sulphate because protamine itself has anticoagulant properties. A single dose of protamine sulphate should never exceed 50mg. Intravenous injection of protamine may cause a sudden fall in blood pressure, bradycardia, dyspnoea and transitory flushing, but these may be avoided or diminished by slow and careful administration.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antithrombotic agent.

ATC Code: B01 AB01

Heparin calcium is a preparation containing the calcium salt of sulphated polysaccharide acid present in mammalian tissues. It is an anticoagulant which inhibits the clotting of blood in vitro and in vivo.

No further data are presented here as the pharmacodynamic properties of heparin calcium are well known and it is the subject of a European Pharmacopoeial monograph.

5.2 Pharmacokinetic Properties

The slow and regular absorption kinetics of calciparine (or similar calcium heparins) given subcutaneously make it especially suitable for low dose prophylactic therapy. Calciparine has been used effectively in the routine prophylaxis of postoperative thromboembolism.

No further data are presented here as the properties of heparin calcium are well known. Heparin calcium is the subject of a European Pharmacopoeial monograph.

5.3 Preclinical Safety Data

There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for injection, hydrochloric acid and calcium hydroxide solution.

6.2 Incompatibilities

Other preparations should not be mixed with Calciparine.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Do not store above 25^oC. Do not freeze.

6.5 Nature And Contents Of Container

Unit dose disposable syringe 5,000 IU in 0.2ml

6.6 Special Precautions For Disposal And Other Handling

Refer to Section 4.2 Posology and Method of Administration.

7. Marketing Authorisation Holder

Sanofi–Synthelabo Ltd

One Onslow Street

Guildford

Surrey GU1 4YS

8. Marketing Authorisation Number(S)

11723/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

6^th November 1998/23^rd January 2003

10. Date Of Revision Of The Text

September 2004

Cotabflu

Pronunciation: KLOR-fen-IR-a-meen/KOE-deen/a-SEET-a-MIN-oh-fen
Generic Name: Chlorpheniramine/Codeine/Acetaminophen
Brand Name: Cotabflu

Cotabflu contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Cotabflu is used for:

Treating symptoms of upper respiratory allergies and other conditions, such as cough, runny nose, pain, and fever. Cotabflu may also be used for other conditions as determined by your doctor.

Cotabflu is a narcotic cough suppressant, analgesic, and antihistamine combination. The cough suppressant works in the brain to help decrease the cough reflex. The analgesic works in the brain to reduce pain and fever. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing.

Do NOT use Cotabflu if:

• you are allergic to any ingredient in Cotabflu


• you are breast-feeding


• you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, an enlarged prostate, narrow-angle glaucoma, or a peptic ulcer


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Cotabflu:

Some medical conditions may interact with Cotabflu. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had an allergic reaction to any other codeine- or morphine-related medicine (eg, oxycodone, dihydrocodeine, hydromorphone)


• if you have a history of glaucoma or increased pressure in the eye; heart problems (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); diabetes; high or low blood pressure; blood vessel problems (eg, in the brain, in the heart); adrenal gland problems (eg, Addison disease); prostate problems; stomach or bowel problems (eg, inflammatory bowel disease, ulcerative colitis, ulcers); seizures; stroke; liver problems (eg, hepatitis); kidney problems; thyroid problems; trouble sleeping; or recent stomach, bowel, or urinary surgery


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic cough, or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, increased pressure in the brain, an unusual growth in the brain (eg, tumor), a recent head or brain injury, or infection of the brain or nervous system


• if you have difficulty urinating; low blood volume; a certain bowel problem (pseudomembranous colitis); stomach pain; constipation; a blockage of your bladder, stomach, or bowels; or poor health


• if you are very overweight or are dehydrated


• if you drink alcohol, or if you have a history of alcohol or drug abuse or dependence or of suicidal thoughts or behaviors

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

• Anticoagulants (eg, warfarin) or isoniazid because the risk of bleeding or liver problems may be increased


• Anticholinergics (eg, scopolamine) because a serious bowel motility problem (paralytic ileus) may occur


• Cimetidine, furazolidone, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cotabflu's side effects


• Buprenorphine, naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Cotabflu's effectiveness


• Medicines that may harm the liver (eg, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

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

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

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


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

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

Important safety information:

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


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


• Do not drink alcohol while you are taking Cotabflu.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Cotabflu; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Cotabflu may cause or worsen constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Cotabflu, talk with your doctor or pharmacist.


• Cotabflu may cause dry mouth. To help relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute. Ask your doctor or pharmacist if you have any questions.


• Do NOT take more than the recommended dose, take more often than prescribed, or take for longer than prescribed without checking with your doctor.


• Cotabflu may harm your liver. Your risk may be greater if you drink alcohol while you are taking Cotabflu. Talk to your doctor before you take Cotabflu or other fever reducers if you drink alcohol.


• Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.


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


• Cotabflu has acetaminophen, an antihistamine (chlorpheniramine), and a narcotic cough suppressant (codeine) in it. Before you start any new medicine, check the label to see if it has any of these medicines, other antihistamines, or other narcotic pain relievers or cough suppressants in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• If your symptoms do not get better within 7 days, if they come back, or if you develop a high fever, rash, or persistent headache, check with your doctor.


• Cotabflu may interfere with skin allergy tests. If you are scheduled for a skin allergy test, talk to your doctor. You may need to stop taking Cotabflu for a few days before the tests.


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


• Use Cotabflu with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, confusion, dizziness, drowsiness, dry mouth, excitability, and trouble urinating.


• Caution is advised when using Cotabflu in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Cotabflu should not be used in CHILDREN younger than 6 years; 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 taking Cotabflu while you are pregnant. Cotabflu is found in breast milk. Do not breast-feed while taking Cotabflu.

When used for long periods of time or at high doses, Cotabflu may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Cotabflu stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Cotabflu. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Cotabflu, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.

Possible side effects of Cotabflu:

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

Constipation; dizziness; drowsiness; headache; light-headedness; mild dry mouth, throat, or nose; nausea; sweating; trouble sleeping; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); changes in thinking or behavior; confusion; difficulty urinating or inability to urinate; excitability; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; flushing or redness of the face; hallucinations; involuntary muscle movements; mental or mood changes (eg, anxiety, fear, irritability, nervousness); persistent trouble sleeping; seizures; severe dry mouth, nose, or throat; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath; slow or shallow breathing; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cotabflu side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; blurred vision; cold and clammy skin; coma; confusion; decreased coordination; decreased pupil size; decreased urination; fainting; hallucinations; increased sweating; limp muscles; loss of consciousness; ringing in the ears; seizures; severe dizziness, drowsiness, or light-headedness; severe nausea or vomiting; sleeplessness; slow, difficult, or shallow breathing; slow heartbeat; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual tiredness.

Proper storage of Cotabflu:

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

General information:

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


• Cotabflu 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 Cotabflu. 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 Cotabflu resources

• Cotabflu Side Effects (in more detail)
• Cotabflu Drug Interactions
• Cotabflu Support Group
• 1 Review for Cotabflu - Add your own review/rating

• Cotabflu Concise Consumer Information (Cerner Multum)

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