Description
Meperidine and promethazine combination injection is used to treat pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. It is also used with other medicines just before or during an operation to help the anesthetic (numbing medicine) work better.
Meperidine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts in the central nervous system (CNS) or brain to relieve pain.
Promethazine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult.
When meperidine 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.
This medicine is to be given only by or under the immediate supervision of your doctor.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of Mepergan® injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Mepergan® injection in the elderly. However, elderly patients are more likely to have age-related lung, kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving Mepergan® injection.
Breastfeeding
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.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Bromopride
- Calcium Oxybate
- Cisapride
- Dronedarone
- Isocarboxazid
- Levoketoconazole
- Linezolid
- Magnesium Oxybate
- Mesoridazine
- Methylene Blue
- Naltrexone
- Ozanimod
- Phenelzine
- Pimozide
- Piperaquine
- Potassium Citrate
- Potassium Oxybate
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- Saquinavir
- Selegiline
- Sodium Oxybate
- Sparfloxacin
- Terfenadine
- Thioridazine
- Toloxatone
- Tranylcypromine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
- Belladonna
- Belladonna Alkaloids
- Betel Nut
- Evening Primrose
- Isoniazid
- Midodrine
- Phenylalanine
Other Interactions
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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal problems or
- Alcohol abuse, history of or
- Brain tumor, history of or
- Breathing or other lung problems (eg, COPD, respiratory depression, sleep apnea) or
- Cor pulmonale (serious heart condition) or
- Drug dependence, especially with narcotics, or history of or
- Head injuries, history of—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problem (eg, respiratory depression) or
- Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.
- Diabetes or
- Heart rhythm problems or
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Pheochromocytoma or
- Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle or into a vein.
Precautions
It is very important that your doctor check your progress while you are using this medicine to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
Do not use too much of this medicine or use it more often than your doctor tells you to. This can be life-threatening. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that sometimes produces a pink frothy sputum, decreased awareness or responsiveness, extreme dizziness or weakness, increased sweating, irregular, fast, or slow, or shallow breathing, pale or blue lips, fingernails, or skin, sleepiness or unusual drowsiness, slow heartbeat, seizures, swelling in legs and ankles, or trouble breathing. Call your doctor right away if you notice these symptoms.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping pills, prescription pain medicine or narcotics, barbiturates or seizure medicines, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your medical doctor or dentist before taking any of the above while you are receiving this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea while using this medicine.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines. Check with your doctor first before you take any other medicines. Call your doctor right away if you have a fever, confusion, restlessness, loss of coordination, or diarrhea.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.
Do not change the dose or suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, restlessness, fever or chills, joint pain, nausea or vomiting, loss of appetite. runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
This medicine may cause some people to become dizzy, lightheaded, faint, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Getting up slowly from a lying or sitting position may also help.
This medicine may cause a serious allergic reaction called anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you 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.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Incidence not known
- Agitation
- anxiety
- blurred or loss of vision
- chest pain, discomfort, or tightness
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- cough
- darkening of the skin
- decrease blood pressure
- deepening of voice
- diarrhea
- difficulty in speaking
- difficulty swallowing
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- drooling
- dysphoria
- false or unusual sense of well-being
- fast, pounding, or irregular heartbeat or pulse
- fever
- halos around lights
- headache
- hives, itching, skin rash
- increase blood pressure
- increased hair growth
- increased hunger
- increased muscle mass
- increased sensitivity to pain
- loss of appetite
- loss of balance control
- mental depression
- muscle trembling, jerking, or stiffness
- nausea
- nervousness
- nightmares
- night blindness
- overactive reflexes
- overbright appearance of lights
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- redness to the face
- seeing, hearing, or feeling things that are not there
- seizures
- shakiness
- shakiness in the legs, arms, hands, and feet
- shivering
- shuffling walk
- slow or irregular heartbeat
- slurred speech
- stiffness of the limbs
- sweating
- talking or acting with excitement you cannot control
- trembling or shakiness of the hands or feet
- trouble breathing
- tunnel vision
- twisting movements of the body
- twitching
- uncontrolled movements, especially of the face, neck, and back
- uncoordinated muscle movements
- unusual tiredness or weakness
- vomiting
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Anxiety
- blurred vision
- change or loss of consciousness
- chest pain or discomfort
- chills
- cold, clammy skin
- cold sweats
- coma
- confusion
- constricted pupils
- cool, pale skin
- coughing that sometimes produces a pink frothy sputum
- difficult or trouble breathing
- headache
- increased hunger
- increased sweating
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness or fainting
- nausea
- nervousness
- nightmares
- pale or blue lips, fingernails, or skin
- seizures
- shakiness
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- slurred speech
- swelling in the legs and ankles
- trouble breathing
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:
Incidence not known
- Constipation
- decrease in frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- dry mouth
- increased sensitivity of the skin to sunlight
- pain at the injection site
- redness or other discoloration of the skin
- severe sunburn
- painful urination
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.
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