Promethegan 50 mg rectal suppository

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Medication name

Generic name:
Promethazine suppository - rectal

Pronunciation
(proe-METH-a-zeen)

Brand name(s)
Phenergan , Promethegan

Warning

Promethazine should not be used by children younger than 2 years because it may cause serious (possibly fatal) slow/shallow breathing. When this medication is used by children 2 years and older, the lowest effective dosage should be used, and other drugs that affect breathing should be avoided. Get medical help right away if slow/shallow breathing occurs.

In children, drugs for nausea should only be used in cases of prolonged vomiting of a known cause. Avoid use of promethazine in children with liver disease (including possible Reye's syndrome).

Uses

See also Warning section.

Promethazine is used to prevent and treat nausea and vomiting related to certain conditions (such as motion sickness, or before/after surgery). It is also used to treat allergy symptoms such as rash, itching, and runny nose. It may be used to help you feel sleepy/relaxed before and after surgery or to help certain opioid pain relievers (such as meperidine) work better. The suppository form is used when medications cannot be taken by mouth.

Promethazine is an antihistamine and works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (such as anti-nausea, calming, pain relief) may work by affecting other natural substances (such as acetylcholine) and by acting directly on certain parts of the brain.

How to use

Unwrap and insert one suppository rectally as directed by your doctor, usually 2 to 4 times daily. Remain lying down for a few minutes after using this medication, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for rectal use only.

For motion sickness, the first dose of promethazine should be used 30 to 60 minutes before beginning travel. For allergies, this medication may be used once daily at bedtime to avoid being drowsy during the day. When used before surgery, promethazine may be used the night before or just before the procedure and may be continued afterwards as directed.

The dosage is based on your age, medical condition, and response to treatment. Children's dosage may also be based on weight. Do not increase your dose or use this medication more often than directed.

Tell your doctor if your condition does not get better or if it gets worse.

Side effects

Drowsiness, dizziness, constipation, blurred vision, or dry mouth may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • nausea/vomiting that doesn't stop
  • fainting
  • slow heartbeat
  • mental/mood changes (such as hallucinations, nervousness, irritability, restlessness, confusion)
  • unusual/uncontrolled movements (such as fixed upward stare, neck twisting, tongue movements)
  • shaking (tremor)
  • difficulty urinating
  • easy bleeding/bruising
  • signs of infection (such as sore throat that doesn't go away, fever)
  • severe stomach/abdominal pain
  • yellowing eyes/skin

Get medical help right away if you have any very serious side effects, including:

  • slow/shallow breathing
  • seizures

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

  • fever
  • muscle stiffness/pain/tenderness/weakness
  • severe tiredness
  • severe confusion
  • sweating
  • fast/irregular heartbeat
  • dark urine
  • signs of kidney problems (such as change in the amount of urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before using promethazine, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (such as prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • breathing problems (such as asthma, chronic obstructive pulmonary disease-COPD, sleep apnea)
  • blood/immune system problems (such as bone marrow depression)
  • high pressure in the eye (glaucoma)
  • heart disease (such as irregular heartbeat)
  • high blood pressure
  • liver disease
  • certain brain disorders (such as neuroleptic malignant syndrome, Reye's syndrome, seizures)
  • stomach/intestine problems (such as blockage, ulcer)
  • overactive thyroid (hyperthyroidism)
  • difficulty urinating (for example, due to enlarged prostate)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Children may be more sensitive to the side effects of this drug, especially slowed breathing and uncontrolled movements (see also Warning section). This drug can often cause excitement in young children instead of drowsiness. Special care should be taken when using this medication in children who have lost a lot of fluid (dehydration), those who have a family history of sudden infant death syndrome (SIDS), and those who are hard to wake up from sleep.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if promethazine passes into breast milk. It may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

  • antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)
  • metoclopramide

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as some pregnancy tests, glucose tolerance test, allergy skin testing), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness/dizziness, fainting, slow/shallow breathing, seizures, muscle stiffness/twitching, widened pupils. In children, mental/mood changes (such as restlessness, irritability, hallucinations) may occur before drowsiness.

Notes

Do not share this medication with others.

Missed dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.