hydrocodone and acetaminophen

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

Oral route(Solution;Tablet)

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

Commonly used brand name(s)

In the U.S.

• Anexsia


• Ceta Plus


• Co-Gesic


• Dolorex Forte


• Hycet


• Lorcet


• Lortab


• Maxidone


• Norco


• Stagesic


• Vicodin


• Zydone

Available Dosage Forms:

• Tablet


• Solution


• Syrup


• Elixir


• Capsule


• Liquid

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Hydrocodone

Uses For hydrocodone and acetaminophen

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

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

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

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

hydrocodone and acetaminophen is available only with your doctor's prescription.

Before Using hydrocodone and acetaminophen

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 hydrocodone and acetaminophen, the following should be considered:

Allergies

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

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

Geriatric

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

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking hydrocodone and acetaminophen, 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 hydrocodone and acetaminophen with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using hydrocodone and acetaminophen 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.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Flurazepam


• Fospropofol


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Phenobarbital


• Prazepam


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiopental


• Triazolam

Using hydrocodone and acetaminophen 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.

• Acenocoumarol


• Carbamazepine


• Escitalopram


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

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

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

• Ethanol

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

• Cabbage

Other Medical Problems

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

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, history of or


• Breathing or lung problems (e.g., asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale, emphysema, hypoxia) or


• CNS depression or


• Drug dependence, especially narcotic abuse or dependence, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Hypothyroidism (an underactive thyroid) or


• Problems with passing urine—Use with caution. May increase risk for more serious side effects.

• Brain tumor or


• Head injuries or


• Increased pressure in the head—Some of the side effects of hydrocodone can cause serious problems in people who have these medical problems.

• Kidney disease or


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

• Lung disease or


• Respiratory depression (hypoventilation or slow breathing)—Use with caution. May make these conditions worse.

• Stomach or digestion problems—hydrocodone and acetaminophen may mask the diagnosis of these conditions.

Proper Use of hydrocodone and acetaminophen

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

hydrocodone and acetaminophen should come with a patient information leaflet. Read the information carefully. Ask your doctor if you have any questions.

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

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

Dosing

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

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using hydrocodone and acetaminophen

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

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

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

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

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

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

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

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

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

hydrocodone and acetaminophen Side Effects

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

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

Incidence not known

• Back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blood in the urine or stools


• blood in vomit


• bluish lips or skin


• chills


• choking


• cough or hoarseness


• dark urine


• decrease in the frequency of urination


• decrease in urine volume


• difficult or troubled breathing


• difficulty in passing urine (dribbling)


• difficulty with breathing


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• hives


• irregular, fast or slow, or shallow breathing


• itching


• light-colored stools


• loss of appetite


• lower back or side pain


• nausea or vomiting


• nosebleeds


• not breathing


• painful or difficult urination


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


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


• severe or continuing stomach pain


• shortness of breath or troubled breathing


• skin rash


• sore throat


• sore tongue


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


• tightness in the chest


• unable to speak


• unusual bleeding or bruising


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• wheezing


• yellow eyes and skin

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

Symptoms of overdose

• Bloody or cloudy urine


• change in consciousness


• chest pain or discomfort


• cold and clammy skin


• decreased awareness or responsiveness


• extreme drowsiness


• general feeling of discomfort or illness


• increased sweating


• irregular heartbeat


• lightheadedness, dizziness, or fainting


• loss of consciousness


• no blood pressure or pulse


• no muscle tone or movement


• not breathing


• severe sleepiness


• slow or irregular heartbeat


• stopping of heart


• sudden decrease in the amount of urine


• unconsciousness


• unpleasant breath odor


• vomiting of blood

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


• relaxed and calm


• sleepiness

Incidence not known

• Belching


• changes in mood


• difficulty having a bowel movement (stool)


• fear or nervousness


• feeling of indigestion


• hearing loss


• impaired hearing


• pain in the chest below the breastbone


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

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

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

See also: hydrocodone and acetaminophen side effects (in more detail)

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

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

More hydrocodone and acetaminophen resources

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

Compare hydrocodone and acetaminophen with other medications

• Back Pain
• Cough
• Pain
• Rheumatoid Arthritis

Pediatex 12 DM

Generic Name: carbinoxamine, dextromethorphan, and pseudoephedrine (kar bi NOX a meen/dex troe meh THOR fan/soo doe eh FEH drin)

Brand Names: Andehist DM NR, Carb PSE 12 DM, Carbaxef-DM, Carbodex DM, Carbofed DM Drops, Cordron-12 DM, Cordron-DM NR, Mintex DM, Pediatex 12 DM, Pediatex-DM, PSE Allergy DM, PSE Carb DM Drops, PSE Carbinoxamine DM, Pseudo Carb DM

What is Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

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

The combination of carbinoxamine, dextromethorphan, and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Carbinoxamine, dextromethorphan, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine, dextromethorphan, and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, dextromethorphan, and pseudoephedrine before the MAO inhibitor has cleared from your body. Carbinoxamine, dextromethorphan, and pseudoephedrine 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. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

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

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, dextromethorphan, or pseudoephedrine, or if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  thyroid disease;

  
  


• 
  

  a stomach ulcer or a stomach obstruction,

  
  


• 
  

  emphysema or chronic bronchitis; or

  
  


• 
  

  an enlarged prostate or urination problems.

  
  

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

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine, dextromethorphan, and pseudoephedrine 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.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

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. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing intructions for children. Death can occur from the misuse of cough and cold medicines in very young children.

Measure the 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 where you can get one.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include extreme drowsiness, confusion, feeling restless or nervous, blurred vision, dry mouth, nausea, vomiting, restlessness, hallucinations, fainting, and seizure (convulsions).

What should I avoid while taking Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Tell your doctor if you regularly use other medicines that make you sleepy (such as narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by carbinoxamine or dextromethorphan.

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

Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine) 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:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  wheezing, tightness in your chest;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

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

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  lack of coordination;

  
  


• 
  

  upset stomach;

  
  


• 
  

  stuffy nose, chest congestion;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  dry mouth or nose; or

  
  


• 
  

  blurred vision.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Pediatex 12 DM (carbinoxamine, dextromethorphan, and pseudoephedrine)?

Before taking carbinoxamine, dextromethorphan, and pseudoephedrine, tell your doctor if you are using any of the following drugs:

• 
  

  a diuretic (water pill), or blood pressure medicine;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

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

  
  

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

More Pediatex 12 DM resources

• Pediatex 12 DM Side Effects (in more detail)
• Pediatex 12 DM Use in Pregnancy & Breastfeeding
• Pediatex 12 DM Drug Interactions
• Pediatex 12 DM Support Group
• 0 Reviews for Pediatex2 DM - Add your own review/rating

• Pediatex 12 DM Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Andehist DM NR Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Cordron-DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Pediatex 12 DM with other medications

• Cough
• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about carbinoxamine, dextromethorphan, and pseudoephedrine.

See also: Pediatex2 DM side effects (in more detail)

Z-COF 12 Suspension

Pronunciation: DEX-troe-meth-OR-fan/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Z-COF 12

Z-COF 12 Suspension is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Z-COF 12 Suspension is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use Z-COF 12 Suspension if:

• you are allergic to any ingredient in Z-COF 12 Suspension


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• 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 Z-COF 12 Suspension:

Some medical conditions may interact with Z-COF 12 Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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


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


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


• if you have a history of glaucoma, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, an overactive thyroid, seizures, or stroke


• if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

Some MEDICINES MAY INTERACT with Z-COF 12 Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk Z-COF 12 Suspension's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Z-COF 12 Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Z-COF 12 Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Z-COF 12 Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Z-COF 12 Suspension:

Use Z-COF 12 Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Z-COF 12 Suspension by mouth with or without food.


• Shake well before each use.


• Take Z-COF 12 Suspension with a full glass of water (8 oz/240 mL).


• Drink plenty of water while taking Z-COF 12 Suspension.


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


• If you miss a dose of Z-COF 12 Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Z-COF 12 Suspension.

Important safety information:

• Z-COF 12 Suspension may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Z-COF 12 Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Z-COF 12 Suspension without checking with your doctor.


• Z-COF 12 Suspension has pseudoephedrine and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Z-COF 12 Suspension for longer than prescribed without checking with your doctor.


• If your symptoms do not improve within 7 days or if they become worse, check with your doctor.


• Do not use Z-COF 12 Suspension for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Z-COF 12 Suspension may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Z-COF 12 Suspension.


• Tell your doctor or dentist that you take Z-COF 12 Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Z-COF 12 Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Z-COF 12 Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Z-COF 12 Suspension, contact your doctor. You will need to discuss the benefits and risks of using Z-COF 12 Suspension while you are pregnant. It is not known if Z-COF 12 Suspension is found in breast milk. Do not breast-feed while taking Z-COF 12 Suspension.

Possible side effects of Z-COF 12 Suspension:

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

Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; seizures; severe or persistent dizziness, lightheadedness, or headache; tremor.

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: Z-COF2 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Z-COF 12 Suspension:

Store Z-COF 12 Suspension 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 Z-COF 12 Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Z-COF 12 Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Z-COF 12 Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Z-COF 12 Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Z-COF 12 resources

• Z-COF 12 Side Effects (in more detail)
• Z-COF 12 Use in Pregnancy & Breastfeeding
• Z-COF 12 Drug Interactions
• Z-COF 12 Support Group
• 0 Reviews for Z-COF2 - Add your own review/rating

Compare Z-COF 12 with other medications

• Cough and Nasal Congestion

Carbocaine HCl

Generic Name: mepivacaine (me PIV a kane)

Brand Names: Carbocaine, Carbocaine HCl, Polocaine, Polocaine-MPF

What is Carbocaine HCl (mepivacaine)?

Mepivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain.

Mepivacaine is used as a local (in only one area) anesthetic for an epidural or spinal block. It is also used as an anesthetic for dental procedures.

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

What is the most important information I should know about Carbocaine HCl (mepivacaine)?

You should not receive mepivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving this medication, tell your doctor if you have liver disease, kidney disease, high or low blood pressure, asthma or a sulfite allergy, a history of heart disease or stroke, heart block or coronary artery disease, a heart rhythm disorder, or a thyroid disorder.

This medication can cause numbness for an extended period of time. Avoid eating, chewing gum, or drinking hot liquids until the feeling in your mouth has returned completely. Chewing while your mouth is numb could result in a bite injury to your tongue, lips, or inside of your cheek.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from mepivacaine.

What should I discuss with my health care provider before receiving Carbocaine HCl (mepivacaine)?

You should not receive mepivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving mepivacaine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;


• kidney disease;


• 
  

  low or high blood pressure;

  
  


• 
  

  asthma or a sulfite allergy;

  
  


• 
  

  a history of heart disease or stroke;

  
  


• 
  

  heart block or coronary artery disease;

  
  


• 
  

  a heart rhythm disorder; or

  
  


• 
  

  a thyroid disorder.

  
  

If you have any of these conditions, you may need a dose adjustment or special precautions to safely receive mepivacaine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive mepivacaine, tell your doctor if you are pregnant. It is not known whether mepivacaine passes into breast or if it could harm a nursing baby. Before you receive mepivacaine, tell your doctor if you are breast-feeding a baby.

How is mepivacaine given?

Mepivacaine is given as an injection placed into an area of your lower back near your spine. You will receive this injection in a hospital or surgical setting.

When used for a dental procedure, mepivacaine is given as an injection that is usually placed into the gum area inside your mouth. You will receive this injection in a dentist's office or oral surgical setting.

Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from mepivacaine. Your breathing, blood pressure, oxygen levels, and other vital signs may be watched closely while you are receiving mepivacaine.

What happens if I miss a dose?

Since mepivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include extreme drowsiness, fainting, seizure (convulsions), shallow breathing, or slow heart rate.

What should I avoid after receiving Carbocaine HCl (mepivacaine)?

This medication can cause numbness for an extended period of time. Avoid eating, chewing gum, or drinking hot liquids until the feeling in your mouth has returned completely. Chewing while your mouth is numb could result in a bite injury to your tongue, lips, or inside of your cheek.

Carbocaine HCl (mepivacaine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling or puffiness of your face, lips, tongue, or throat. Tell your caregivers at once if you have a serious side effect such as:

• 
  

  weak or shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  sweating, anxiety, confusion;

  
  


• 
  

  blurred vision, ringing in your ears;

  
  


• 
  

  numbness or tingling around your mouth;

  
  


• 
  

  slow heart rate, weak pulse;

  
  


• 
  

  metallic taste in your mouth;

  
  


• 
  

  tremors, muscle twitching; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting;

  
  


• 
  

  nervousness;

  
  


• 
  

  dizziness; or

  
  


• 
  

  drowsiness.

  
  

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 Carbocaine HCl (mepivacaine)?

Before receiving mepivacaine, tell your doctor if you are using any of the following drugs:

• 
  

  cold medicine, diet pills, stimulants, or medication to treat ADHD;

  
  


• 
  

  medicine to treat a psychiatric disorder (Haldol, Inapsine, Thorazine, Prolixin, Serentil, Mellaril, and others);

  
  


• 
  

  medication to treat nausea and vomiting, such as Compazine or Motillium;

  
  


• 
  

  ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

  
  

This list is not complete and there may be other drugs that can interact with mepivacaine. 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.

More Carbocaine HCl resources

• Carbocaine HCl Use in Pregnancy & Breastfeeding
• Carbocaine HCl Drug Interactions
• Carbocaine HCl Support Group
• 0 Reviews for Carbocaine HCl - Add your own review/rating

• Mepivacaine Prescribing Information (FDA)


• Carbocaine Prescribing Information (FDA)


• Carbocaine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carbocaine HCl with other medications

• Local Anesthesia

Where can I get more information?

• Your doctor or pharmacist can provide more information about mepivacaine.

Calpol Six Plus Fast Melts (Packsize 12)

1. Name Of The Medicinal Product

Calpol Six Plus Fastmelts (250 mg Orodispersible Tablets)

2. Qualitative And Quantitative Composition

Paracetamol 250 mg

For excipients, see 6.1.

3. Pharmaceutical Form

Orodispersible tablet

Round, white, bi-convex tablets with central concave depression.

4. Clinical Particulars

4.1 Therapeutic Indications

Calpol Six Plus Fastmelts is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

Oral:

Tablets should be placed in the mouth where they melt on the tongue. The tablet will rapidly disperse to a pleasant tasting paste that can be easily ingested. Alternatively the tablet can be dispersed in a teaspoonful of water or milk.

Adults and children

Child's Age	How Much	How often (in 24 hours)
Under 6 years	Not recommended	N/A
6 - 9 years	1 tablet	4 times
9 - 12 years	2 tablets	4 times
12 – 16 years	2 to 3 tablets	4 times
Adults and children over 16 years	2 to 4 tablets	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

Use in the Elderly

Normal adult dosage is appropriate. However, a reduction in dosing may be necessary in frail, elderly subjects (see Section 5.2).

4.3 Contraindications

Calpol Six Plus Fastmelts are contraindicated in patients with known hypersensitivity to paracetamol or any other ingredient and in subjects with phenylketonuria.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe hepatic or severe renal impairment.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Calpol Six Plus Fastmelts contain aspartame which is a source of phenylalanine equivalent to 0.04 mg/250 mg tablet. The phenylalanine in the tablets may be harmful to people with phenylketonuria.

Calpol Six Plus Fastmelts contain mannitol which may have a mild laxative effect.

The label should contain the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage (leaflet).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

Adverse effects of paracetamol are rare. Very rarelyhypersensitivity and anaphylactic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below)

Risk Factors:

If the patient

a) Is on long term treatment with carbamazepine, phenobarbitol, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes

OR

b) Regularly consumes ethanol in excess of recommended amounts

OR

c) Is likely to be glutathione deplete e.g, eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentrations should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patient who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose.

Paracetamol is distributed rapidly throughout all tissues. Protein binding is low.

The plasma half-life is in the range of 1 to 4 hours after therapeutic doses.

Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdose there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted reaction with hepatic proteins is increased leading to necrosis.

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mannitol (E421)

Crospovidone

Aspartame

Strawberry flavouring E. 9620941

Magnesium stearate

Polymethacrylate (Eudragit E 100)

Polyacrylate dispersion 30%

Colloidal Anhydrous Silica

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Strip containing 12 tablets.

The blister consists of a blister complex (Polyamide/PVC/Aluminium) and either:

an aluminium sealing sheet

or

a paper/aluminium child resistant sealing sheet.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0121

9. Date Of First Authorisation/Renewal Of The Authorisation

13^th July 2005/ 11 March 2009

10. Date Of Revision Of The Text

6^th June 2011

Kelnor

Generic Name: ethinyl estradiol and ethynodiol diacetate (ETH in ill ESS tra DYE ol and ETH in o DYE ol dye AS e tate)

Brand Names: Kelnor, Zovia 1/35, Zovia 1/50

What is Kelnor (ethinyl estradiol and ethynodiol diacetate)?

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

Ethinyl estradiol and ethynodiol diacetate are used as contraception to prevent pregnancy.

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

What is the most important information I should know about Kelnor (ethinyl estradiol and ethynodiol diacetate)?

Do not use this medication if you are pregnant or if you have recently had a baby or if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

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

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Kelnor (ethinyl estradiol and ethynodiol diacetate)?

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

• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

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

  
  


• 
  

  abnormal vaginal bleeding;

  
  


• 
  

  liver disease or liver cancer; or

  
  


• 
  

  a history of jaundice caused by birth control pills.

  
  

Before using this medication, tell your doctor if you have any of the following conditions.

• 
  

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

  
  


• 
  

  high cholesterol or if you are overweight;

  
  


• 
  

  kidney disease;

  
  


• 
  

  a history of depression;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  a history of irregular menstrual cycles;

  
  


• 
  

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

  
  


• 
  

  uterine fibroid tumors;

  
  


• 
  

  varicose veins; or

  
  


• 
  

  tuberculosis.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Kelnor (ethinyl estradiol and ethynodiol diacetate)?

Take this medication exactly as it was prescribed for you. Do not take larger amounts, or take it for longer than recommended by your doctor. You will take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

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

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

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

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

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

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

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant.

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

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

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

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

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

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Kelnor (ethinyl estradiol and ethynodiol diacetate)?

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

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

Kelnor (ethinyl estradiol and ethynodiol diacetate) side effects

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

• 
  

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

  
  


• 
  

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

  
  


• 
  

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

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

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

  
  


• 
  

  swelling in your hands, ankles, or feet;

  
  


• 
  

  a breast lump; or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  mild nausea, vomiting, bloating, stomach cramps;

  
  


• 
  

  breast pain, tenderness, or swelling;

  
  


• 
  

  freckles or darkening of facial skin;

  
  


• 
  

  increased hair growth, loss of scalp hair;

  
  


• 
  

  changes in weight or appetite;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  vaginal itching or discharge;

  
  


• 
  

  changes in your menstrual periods, decreased sex drive; or

  
  


• 
  

  headache, nervousness, dizziness, tired feeling.

  
  

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 Kelnor (ethinyl estradiol and ethynodiol diacetate)?

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

• 
  

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

  
  


• 
  

  phenylbutazone (Azolid, Butazolidin);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic;

  
  


• 
  

  seizure medications;

  
  


• 
  

  a barbiturate sedative; or

  
  


• 
  

  HIV or AIDS medications.

  
  

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

More Kelnor resources

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

• Kelnor Prescribing Information (FDA)

Compare Kelnor with other medications

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

Where can I get more information?

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

See also: Kelnor side effects (in more detail)

Jekovit

Jekovit may be available in the countries listed below.

Ingredient matches for Jekovit

Ergocalciferol

Ergocalciferol is reported as an ingredient of Jekovit in the following countries:

• Finland

International Drug Name Search

Clolar

Pronunciation: kloe-FAR-a-been
Generic Name: Clofarabine
Brand Name: Clolar

Clolar is used for:

Treating certain types of leukemia in children and adolescents who have had at least 2 previous treatment regimens of medicine.

Clolar is a form of antimetabolite chemotherapy. It works by blocking cancer cell growth, which results in death of the cancer cell.

Do NOT use Clolar if:

• you are allergic to any ingredient in Clolar


• you are taking medicines that may affect the kidney, such as aminoglycoside antibiotics (eg, gentamicin), amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), tacrolimus, and vancomycin. Ask your doctor if you are unsure whether any of your medicines might affect your kidneys


• you are taking medicines that may affect the liver, such as acetaminophen, certain medicines for HIV infection, isoniazid, ketoconazole, and methotrexate. Ask your doctor if you are unsure whether any of your medicines might affect your liver

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

Before using Clolar:

Some medical conditions may interact with Clolar. 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 high or low blood pressure, kidney problems, liver problems, or heart problems


• if you have an infection, certain blood problems (eg, low white blood cell levels, low platelet levels), or bone marrow problems


• if you have previously had a hematopoietic stem cell transplant (HSCT)

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

• Medicines that may affect your heart function or blood pressure because the side effects of Clolar such as low blood pressure or heart effects may be increased. Ask your doctor if you are unsure whether any of your medicines might affect your heart function or blood pressure


• Medicines that affect your kidneys or liver because the risk of Clolar's side effects may be increased

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

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

• Clolar is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Clolar at home, a health care provider will teach you how to use it. Be sure you understand how to use Clolar. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Clolar if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Do not administer any other medicines through the same intravenous line as Clolar.


• If Clolar accidentally spills on your skin, wash it off immediately with soap and water.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


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

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

Important safety information:

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


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.


• Notify your doctor immediately if you experience symptoms of dehydration such as dry mouth; decreased urination; unusual thirst; weakness; unusual drowsiness or lethargy; muscle pain, cramps, or weakness; severe dizziness or fainting; or rapid heartbeat.


• Clolar may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Clolar may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


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


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


• Women who may become pregnant must use an effective form of birth control while they take Clolar. If you have questions about effective birth control, talk with your doctor.


• Men who use Clolar should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you use Clolar.


• Lab tests, including blood counts, blood pressure, lung function, liver function, kidney function, and blood uric acid levels, may be performed while you use Clolar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Safety and effectiveness of Clolar have not been established in ADULTS.


• PREGNANCY AND BREAST-FEEDING: Clolar has been shown to cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clolar while you are pregnant. Do not breast-feed while taking Clolar.

Possible side effects of Clolar:

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:

Back pain; constipation; cough; decreased weight; diarrhea; dizziness; drowsiness; dry or irritated skin; flushing; gum bleeding; headache; itching; joint or muscle pain or weakness; loss of appetite; minor pain, swelling, or redness at the injection site; nausea; stomach pain; swelling or soreness of the mouth; tiredness or weakness; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering or severe swelling or pain at the injection site; blood in the urine; cloudy or dark urine; decreased urination; fainting; fast breathing; fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes; nosebleed; persistent cough; pneumonia; red, swollen, blistered, or peeling skin; severe dizziness or lightheadedness; severe or persistent tiredness or weakness; severe or persistent vomiting or diarrhea; shaking; shortness of breath; small red spots under the skin; swelling of arms or legs; tingling, pain, redness, or swelling of the palms of the hands or soles of the feet; unusual bleeding or easy bruising; unusual tiredness or weakness; unusually pale skin; white patches in the mouth; yellowing of the skin or eyes.

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

See also: Clolar 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 rash; vomiting.

Proper storage of Clolar:

Store undiluted vials of Clolar at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. After diluting, Clolar may be stored at room temperature and must be used within 24 hours. Keep Clolar out of the reach of children and away from pets.

General information:

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


• Clolar 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 Clolar. 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 Clolar resources

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

• Clolar Prescribing Information (FDA)


• Clolar Consumer Overview


• Clolar Monograph (AHFS DI)


• Clolar Advanced Consumer (Micromedex) - Includes Dosage Information


• Clofarabine Professional Patient Advice (Wolters Kluwer)

Compare Clolar with other medications

• Acute Lymphoblastic Leukemia