Promethazine should not be used in children younger than 2 years since it might cause slow/shallow breathing (respiratory depression), which in some cases could be fatal. This problem has occurred even with normal doses in this age group.
Use this drug with caution in children older than 2 years. The lowest effective dosage should be used, and other drugs that affect breathing should be avoided. Seek immediate medical attention in the unlikely event that slow/shallow breathing occurs.
This medication can cause severe tissue damage, possibly requiring surgery. Tell your doctor/nurse immediately if you experience burning, pain, redness, swelling, or numbness at or near the injection site. If this occurs, the injection should be stopped and the injection site checked.
It is preferred that this medication be given by injection into a muscle. There may be an increased risk of side effects if this medication is given by injection into a vein. This medication must not be given by injection under the skin.Who should not take K-Phen-50 injection?
Promethazine injection is used to treat nausea and vomiting related to certain conditions (e.g., after surgery, motion sickness). It is also used with other medication to treat life-threatening allergic symptoms (anaphylaxis) and reactions to blood products. The injectable form may be used to treat milder allergic reactions when you cannot take another medication by mouth. It may also be used before/after surgery, other procedures, or labor and delivery to help you feel calmer, to prevent nausea/vomiting, and to help certain narcotic pain relievers (e.g., meperidine) work better.
Promethazine is an antihistamine (phenothiazine type). It works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its other effects (e.g., anti-nausea, calming, pain relief) may work by affecting other natural substances (e.g., acetylcholine) and by acting directly on certain parts of the brain.
This medication should not be used in children younger than 2 years.
See also Warning section.
It is best to inject this medication deep into a muscle. It may also be injected slowly into a large vein (not in the hand or wrist) by a health care professional. Do not inject this medication under the skin or into an artery. If you have any questions about the proper use of this medication, ask your doctor or pharmacist.
Your dosage and how often you receive the medication will be determined by your weight, age, condition, and response to therapy. Injections may be repeated if needed, usually every 4 hours.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.
Inform your doctor if your condition does not improve or if it worsens.
Some people, especially children, may experience excitability rather than drowsiness.
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.
This medication can cause severe tissue damage, possibly requiring surgery. Tell your doctor/nurse immediately if you experience burning, pain, redness, swelling, or numbness at or near the injection site.
Tell your doctor right away if you have any side effects, including: lack of coordination, severe dizziness, fainting, confusion, slow heartbeat, involuntary muscle movements, muscle spasms (e.g., rolling eyes, twisting neck/back), restlessness, decreased/painful urination, signs of serious infection (e.g., persistent sore throat, fever), unusual bleeding/ bruising, severe stomach/abdominal pain, yellowing of eyes/skin.
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.
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 (e.g., prochlorperazine); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites including metabisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be given to a patient who is in a coma.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), blood/immune system problems (e.g., bone marrow depression), a certain eye problem (narrow-angle glaucoma), heart disease (e.g., angina, irregular heartbeat), high or low blood pressure, liver disease, certain nervous system problem (neuroleptic malignant syndrome), Reye's syndrome, seizure, stomach/bowel problems (e.g., blockage, ulcer disease), sun sensitivity when using other medications, urination problems (e.g., due to enlarged prostate, blockage).
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. Children should be supervised during bicycle riding and other possibly hazardous activities to avoid injury. Avoid alcoholic beverages.
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.
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.
Caution is advised when using this drug in children because they may be more sensitive to its effects, especially slowed breathing (see Warning section). Special caution should be taken in children who a severe loss of body water (dehydration), those who have a family history of sudden infant death syndrome (SIDS), and those who are hard to wake up from sleep.
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, blood sugar tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately. 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: slow/shallow breathing, deep sleep, seizures, muscle spasms, flushing, widened pupils.
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 at room temperature away from light and moisture. Do not store in the bathroom. 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 August 2014. Copyright(c) 2014 First Databank, Inc.
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