IMPORTANT SAFETY INFORMATION

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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:

  • Abdominal problems (gallbladder disease, pancreatitis)
  • Adrenal gland problems (Addidison’s disease, pheochromocytoma)
  • Large blood loss (recent blood donation, stomach/intestinal bleeding)
  • Brain disorders (seizures, head injury, tumor, increased pressure in head)
  • Heart problems (irregular heartbeat, low blood pressure)
  • Kidney disease
  • Liver disease
  • Breathing problems (COPD, asthma, emphysema)
  • 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

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:

  • You should be aware that Demerol Tablets contains 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 down the toilet.

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:

  • Asthma, COPD, sleep apnea or other breathing disorders
  • Liver or kidney disease
  • Underactive thyroid
  • Curvature of the spine
  • A history of head injury or brain tumor
  • Epilepsy or other seizure disorder
  • Low blood pressure
  • Gallbladder disease
  • Sickle cell anemia
  • Pheochromocytoma (tumor of the adrenal gland), Addison’s disease or other adrenal gland disorders
  • Enlarged prostate, urination problems
  • Mental illness
  • A history or drug or alcohol addiction
  • If you recently drank large amounts of alcohol
  • If you are pregnant or planning to become pregnant

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 . 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:

  • Acyclovir
  • Cimetidine
  • CNS Depressants
  • Phenytoin
  • Ritonavir

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:

  • Weak or shallow breathing, slow/irregular heartbeat
  • Severe drowsiness, feeling like you might pass out
  • Seizure (convulsions)
  • Cold, clammy skin
  • Muscle movements you cannot control
  • Confusion, mood changes
  • Severe weakness or dizziness
  • Agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting
  • Severe stomach pain
  • Trouble urinating
  • Change in amount of urine

Less serious side effects may include:

  • Constipation
  • Loss of appetite
  • Headache, dizziness, mild weakness
  • Dry mouth
  • Sweating
  • Itching
  • Urinating less than usual
  • Loss of interest in sex

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.