Promethazine should not be used in children younger than 2 years because it may cause serious (possibly fatal) slow/shallow breathing. When using this medication in 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.Who should not take Phenadoz rectal?
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 narcotic 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.
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. In children, the 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 improve or if it worsens.
Remember that your doctor has prescribed this medication because he or she 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: 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 fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, 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, 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.
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 cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Promethazine may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
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 (see 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 breast-feeding.
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 affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
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 laboratory tests (including some pregnancy tests, glucose tolerance test, allergy skin testing), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. 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.
Do not share this medication with others.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
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.
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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