HOW SHOULD THIS MEDICINE BE USED?

Demerol® (meperidine hydrochloride, USP) Tablets should be taken EXACTLY as prescribed by your doctor. Follow all directions on your prescription label. Never take Demerol Tablets in larger amounts or for longer than prescribed. Tell your doctor if the medicine seems to have stopped working for relieving your pain.

Take Demerol Tablets with a full glass of water. You may need to take it with food or milk if it gives you an upset stomach.

Demerol Tablets are a Schedule II Controlled Substance.  They can be abused in a manner similar to morphine or other opioids. Demerol Tablets are the type of drug that is sought out by people with drug and addiction disorders. Demerol Tablets can have additive effects when used in combination with alcohol, other opioids, or illicit drugs.

Demerol Tablets can be abused by crushing, chewing, snorting or injecting.  These practices can lead to overdose or death.

Demerol Tablets may be habit-forming.  Do not share this medicine with anyone and keep it in a safe place where others cannot get to it.  Take Demerol Tablets exactly as prescribed by your doctor. MISUSE OF DEMEROL TABLETS CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.  SELLING OR GIVING AWAY DEMEROL TABLETS IS AGAINST THE LAW.

Do not keep leftover Demerol Tablets.  Ask your pharmacist where to locate a drug take-back disposal program.  If there is no drug take-back program available to you, flush any unused tablets down the toilet.  Disposal of dangerous drugs by flushing is recommended in order to avoid accidental overdose.  This advice applies to a very small number of medicines.  The FDA has determined that this method of disposal is the most appropriate means to dispose of Demerol Tablets and presents the least risk to human safety.

Do not stop using Demerol Tablets abruptly after long-term use, or you could have unpleasant withdrawal symptoms.

WHO SHOULD NOT TAKE DEMEROL® (MEPERIDINE HYDROCHLORIDE, USP) TABLETS?

You should not take Demerol® (meperidine hydrochloride, USP) Tablets if you are allergic to meperidine, or any of the other ingredients in Demerol Tablets, or if you have severe asthma or breathing problems.

Other ingredients in Demerol Tablets are calcium sulfate, dibasic calcium phosphate, starch, stearic acid and talc.

Demerol Tablets can slow or stop your breathing, especially when you start the medicine or when your dose changes.  Do not take Demerol Tablets in larger amounts than prescribed or for longer than prescribed.

You should not take Demerol Tablets if  you have used an MAOI (monoamine oxidase inhibitor) in the last 14 days.   A DANGEROUS DRUG REACTION COULD OCCUR, LEADING TO SERIOUS SIDE EFFECTS.  Common MAOI’s are Furoxone (furazolidone), Nardil (phenelzine), Marplan (isocarboxazid), Eldepryl, Emsam, and Zelapar (selegiline), or Parnate (tranylcypromine).

Demerol Tablets should not be used to treat chronic pain.  Demerol Tablets are usually only prescribed for a short period of time.  Prolonged use can cause serious side effects. Caution is advised if this medicine is used for conditions which require long-term or high dosage treatments (for example, sickle cell anemia, cancer, burns). Consult your doctor for details.

Do not drink alcohol or take other opioid or illicit drugs when taking Demerol Tablets. Serious side effects, including death, can occur when Demerol Tablets are  combined with alcohol, other opioids, or illicit drugs.

To make sure that you can safely take Demerol Tablets, tell your doctor if you have any of the following conditions:

  • Brain disorders (seizures, head injury, tumor, increased pressure in head)
  • Breathing problems (COPD, asthma, emphysema)
  • Heart problems (irregular heartbeat, low blood pressure)
  • Abdominal problems (gallbladder disease, pancreatitis)
  • Adrenal gland problems (Addison’s disease, pheochromocytoma)
  • Large blood loss (recent blood donation, stomach/intestinal bleeding)
  • Kidney disease
  • Liver disease
  • Mental/mood disorder (depression, psychosis)
  • Personal or family history of drug or alcohol abuse
  • Sickle cell anemia
  • Stomach/intestinal disorders
  • A curvature of the spine known as kyphoscoliosis
  • Underactive thyroid
  • Trouble urinating (due to enlarged prostate or narrowing of urethra)
  • You recently drank large amounts of alcohol

Demerol Tablets can lower your blood pressure to dangerous levels.  Your doctor may monitor your blood pressure while you are taking the medicine.

Demerol Tablets may make you dizzy or drowsy.  Do not drive, use machinery, or do any activity that requires mental alertness while taking Demerol Tablets.  To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Tell your doctor if you are pregnant or planning to become pregnant.    Demerol Tablets can harm your unborn child or, if used during delivery, can cause your baby to stop breathing.  This medicine will be used during pregnancy only if clearly needed.

Demerol Tablets can pass into breast milk and may harm a nursing baby.  If you are taking Demerol Tablets while nursing, you and your doctor will need to make a decision whether to stop nursing or stop taking the medicine.

Children and older adults may be more sensitive to Demerol Tablets.

Demerol Tablets have the potential to produce tolerance and drug dependence. Physical dependence will result in withdrawal symptoms after abrupt discontinuation.

Your doctor will prescribe Demerol Tablets with caution if you:

  • Are taking other drugs that effect the central nervous system such as: sedatives, hypnotics, anesthetics, tranquilizers, alcohol, or other opioid medicines
  • Have a convulsion disorder
  • Have an abnormal heart rhythm
  • Have an acute stomach condition
  • Have any kind of alcohol or drug dependency
  • Have sickle cell anemia
  • Have adrenal gland problems
  • Have breathing disorder, fast heart rate, or loss of consciousness or coma
  • Have a type of scoliosis associated with slow breathing
  • Have swelling of the skin
  • Have an underactive thyroid
  • Have a liver, lung, or kidney disorder
  • Have an enlarged prostate or trouble urinating
  • Have an impaired contact with reality caused by substance abuse

DEMEROL TABLETS CONTAIN A MORPHINE-LIKE SUBSTANCE AND CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION

DEMEROL TABLETS MAY BE HABIT-FORMING AND ATTEMPTS TO SUDDENLY STOP TAKING THE DRUG CAN CAUSE SERIOUS WITHDRAWAL SYMPTOMS. DEMEROL TABLETS SHOULD BE USED ONLY BY THE PERSON FOR WHOM IT WAS PRESCRIBED. KEEP THE MEDICINE IN A SECURE PLACE WHERE OTHERS CANNOT GET TO IT.

DO NOT DRINK ALCOHOL WHILE YOU ARE TAKING DEMEROL TABLETS. DANGEROUS SIDE EFFECTS OR DEATH CAN OCCUR.  CHECK YOUR FOOD AND MEDICINE LEVELS TO BE SURE THOSE PRODUCTS DO NOT CONTAIN ALCOHOL.

NEVER TAKE DEMEROL TABLETS IN LARGER AMOUNTS OR FOR LONGER THAN RECOMMENDED BY YOUR DOCTOR OR YOU COULD HAVE SERIOUS LIFE-THREATENING SIDE EFFECTS. TELL YOUR DOCTOR IF THE MEDICINE STOPS WORKING IN RELIEVING YOUR PAIN.

INFORMATION YOU SHOULD BE AWARE OF WHEN TAKING DEMEROL TABLETS:

  • Demerol Tablets contain a morphine-like substance.
  • You should report pain and any side effects during therapy.
  • Do not adjust the dose of Demerol Tablets without consulting your doctor.
  • Demerol Tablets may impair mental and/or physical ability to drive, operate machinery, etc).
  • Do not combine Demerol Tablets with alcohol or any other sleep aids or tranquilizers.
  • Talk to your doctor if you are pregnant or planning to become pregnant while taking Demerol Tablets.
  • Demerol Tablets can be abused.  Protect it from theft and never share this drug with anyone.
  • If you have been taking Demerol Tablets for more than a few weeks and it is time to stop the drug, talk to your doctor about tapering your dose rather than an abrupt withdrawal.
  • Keep your medicine in a secure place and out of reach of children.  When Demerol Tablets are no longer needed, the unused tablets should be destroyed by flushing them down the toilet.

TAKING OTHER MEDICINES:

Drug interactions may change how your medicines work or increase your risk for serious side effects. Do not start, stop or change the dosage of any medications without your doctor’s approval.

Do not take Demerol Tablets with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing.

Some products that may interact with Demerol Tablets include:

  • Acyclovir
  • Cimetidine
  • CNS Depressants
  • Phenytoin
  • Ritonavir

Taking MAO Inhibitors with Demerol Tablets may cause a serious and possibly fatal drug interaction.

THIS LIST IS NOT COMPLETE AND OTHER DRUGS MAY INTERACT WITH DEMEROL TABLETS.  TELL YOUR DOCTORS ABOUT ALL MEDICINES YOU USE.  THIS INCLUDES PRESCRIPTION, OVER-THE-COUNTER, VITAMIN AND HERBAL PRODUCTS.  DO NOT START A NEW MEDICATION WITHOUT TELLING YOUR DOCTOR.

IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Demerol® (meperidine hydrochloride, USP) Tablets

WHAT ARE  DEMEROL TABLETS USED FOR?

Demerol® (meperidine hydrochloride, USP) Tablets are an opioid pain medication.  Demerol is used to treat moderate-to-severe pain.

Demerol Tablets are a narcotic pain reliever similar to morphine.

WHEN SHOULD I NOT TAKE THE DRUG?

You should not take Demerol Tablets if you are allergic to it.

You should not use Demerol Tablets if you have used an MAOI (monoamine oxidase inhibitor) in the last 14 days.  Common MAOI’s are Furoxone (furazolidone), Nardil (phenelzine), Marplan (isocarboxazid), Eldepryl , Emsam and Zelapar (selegiline),  or Parnate (tranylcypromine).  A DANGEROUS DRUG INTERACTION COULD OCCUR, LEADING TO SERIOUS SIDE EFFECTS.

You should also not take Demerol Tablets if you have severe asthma or breathing problems.

WHAT WARNINGS SHOULD I KNOW ABOUT DEMEROL TABLETS?

DEMEROL TABLETS SHOULD NOT BE USED TO TREAT CHRONIC PAIN.  IT SHOULD ONLY BE USED TO TREAT TO TREAT ACUTE PAIN. PROLONGED USE CAN CAUSE SEIZURES.

DEMEROL TABLETS ARE  A SCHEDULE II CONTROLLED SUBSTANCE.  IT CAN BE ABUSED IN A MANNER SIMILAR TO MORPHINE OR OTHER OPIOIDS. DEMEROL TABLETS ARE THE TYPE OF DRUG THAT IS SOUGHT BY DRUG ABUSERS AND PEOPLE WITH ADDICTION DISORDERS.

DEMEROL TABLETS CAN BE ABUSED BY CRUSHING, CHEWING, SNORTING, OR INJECTING.  THESE PRACTICES CAN LEAD TO OVERDOSE OR DEATH.

Interactions with Alcohol and Drugs of Abuse

Using Demerol Tablets with alcohol, other opioids, or illicit drugs can decrease your breathing and heart rate and cause you to lose consciousness, possibly leading to death.

Head Injury and Increased Intercranial Pressure

If you have a head injury, Demerol Tablets can increase the pressure in your head. Your doctor will only prescribe it if it is essential.

Respiratory Conditions

If you have any respiratory conditions such as acute asthma, COPD, or other respiratory conditions, Demerol Tablets can close off your airway.

Hypotensive Effect

Demerol Tablets can lower blood pressure to dangerous levels.  You doctor should monitor your blood pressure closely if you are taking Demerol Tablets.

Usage in Pregnancy, Labor and Delivery

You should not use Demerol Tablets if you are pregnant.  It could harm your unborn child. It should not be used during labor and delivery, as it can cause your baby to stop breathing.

Nursing Mothers

Demerol Tablets pass into the milk of nursing mothers.  Because this can seriously harm nursing infants, a decision will need to be made whether to stop nursing or stop taking the drug.

DEMEROL TABLETS USE SHOULD BE RESERVED FOR PATIENTS WHERE THE BENEFITS OF TAKING THE DRUG OUTWEIGH THE POTENTIAL HARM.

Other Precautions:

Demerol Tablets should be used with caution if you have any of the following conditions:

CHILDREN AND OLDER ADULTS MAY BE MORE SENSITIVE TO DEMEROL TABLETS.  SAFETY AND EFFECTIVENESS IN CHILDREN AND ELDERLY PATIENTS HAVE NOT BEEN ESTABLISHED

INFORMATION YOU SHOULD BE AWARE OF WHEN TAKING DEMEROL TABLETS:

DEMEROL TABLETS ARE USUALLY ONLY USED FOR VERY SHORT PERIODS OF TIME.  REPEATED OR HIGH DOSES MAY CAUSED DRUG LEVELS TO BUILD UP IN YOUR BODY AND CAUSE SERIOUS SIDE EFFECTS INCLUDING SEIZURES.

Demerol Tablets may make you dizzy or drowsy.  Do not drive, use machinery, or do any activity that requires mental alertness while taking Demerol Tablets.

Demerol Tablets have  the potential to produce tolerance and drug dependence.  Physical dependence will result in withdrawal symptoms after abrupt discontinuation.

DEMEROL TABLETS CONTAIN A MORPHINE-LIKE SUBSTANCE. DEMEROL TABLETS CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.

DEMEROL TABLETS MAY BE HABIT-FORMING AND SHOULD BE USED ONLY BY THE PERSON FOR WHOM IT WAS PRESCRIBED.  KEEP THE MEDICINE IN A SECURE PLACE WHERE OTHERS CANNOT GET TO IT.

DO NOT DRINK ALCOHOL WHILE YOU ARE TAKING DEMEROL TABLETS. DANGEROUS SIDE EFFECTS OR DEATH CAN OCCUR.  CHECK YOUR FOOD AND MEDICINE LEVELS TO BE SURE THOSE PRODUCTS DO NOT CONTAIN ALCOHOL.

NEVER TAKE DEMEROL TABLETS IN LARGER AMOUNTS OR FOR LONGER THAN RECOMMENDED BY YOUR DOCTOR OR YOU COULD HAVE SERIOUS LIFE-THREATENING SIDE EFFECTS. TELL YOUR DOCTOR IF THE MEDICINE STOPS WORKING IN RELIEVING YOUR PAIN.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER?

To make sure that you can safely take Demerol Tablets, tell your doctor if you have any of the following conditions:

Your doctor will prescribe Demerol Tablets with caution if you:

DEMEROL TABLETS CONTAIN A MORPHINE-LIKE SUBSTANCE . DEMEROL TABLETS CAN BE ABUSED AND ARE SUBJECT TO CRIMINAL DIVERSION.

DEMEROL TABLETS MAY BE HABIT-FORMING AND SHOULD BE USED ONLY BY THE PERSON IT WAS PRESCRIBED FOR.  KEEP THE MEDICINE IN A SECURE PLACE WHERE OTHERS CANNOT GET TO IT.

DO NOT DRINK ALCOHOL WHILE YOU ARE TAKING DEMEROL TABLETS. DANGEROUS SIDE EFFECTS OR DEATH CAN OCCUR.  CHECK YOUR FOOD AND MEDICINE LEVELS TO BE SURE THOSE PRODUCTS DO NOT CONTAIN ALCOHOL.

NEVER TAKE DEMEROL TABLETS IN LARGER AMOUNTS OR FOR LONGER THAN RECOMMENDED BY YOUR DOCTOR OR YOU COULD HAVE SERIOUS LIFE-THREATENING SIDE EFFECTS. TELL YOUR DOCTOR IF THE MEDICINE STOPS WORKING AS WELL IN RELIEVING YOUR PAIN.

WHAT OTHER MEDICATIONS MIGHT INTERACT WITH DEMEROL TABLETS?

Drug interactions may change how your medicines work or increase your risk for serious side effects. Do not start, stop or change the dosage of any medications without your doctor’s approval.

Do not take Demerol Tablets with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing.

Some products that may interact with Demerol Tablets include:

Taking MAO Inhibitors with Demerol Tablets may cause a serious and possibly fatal drug interaction.

WHAT ARE THE SIDE EFFECTS OF DEMEROL TABLETS?

Get immediate emergency medical help if you have any of these signs of an allergic reaction: hives, difficulty breathing, severe dizziness, and swelling of your face, lips, tongue or throat.

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

Less serious side effects may include:

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 Validus Pharmaceuticals LLC at 1-866-982-5348 (1-886-9VALIDUS).

WHAT IF I OVERDOSE?

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

Overdose symptoms may include extreme drowsiness, muscle weakness, confusion, cold and clammy skin, pinpoint pupils, shallow breathing, slow heart rate, fainting or coma.

Overdose treatments include ventilating of the airway, administering  drugs that reverse the effect of Demerol Tablets, providing oxygen, and other supportive measures, such as stomach pumping.