If you are in an emergency situation, this toll-free, hour hotline can help you get through this difficult time: call TALK , or visit the Suicide Prevention Lifeline.
We also have step by step guides on what to do to help yourself, a friend or a family member. Miss America Camille Schrier wants to help educate others about the importance of using medications safely. Prescription opioids are effective drugs if used safely. If misused, a person can become addicted to them. It's important to be smart about your health. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether this medication passes into breast milk or if it could harm an unborn baby. Do not use dextromethorphan and promethazine without telling your doctor if you are breast-feeding a baby. Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.
Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon.
If you do not have a dose-measuring device, ask your pharmacist for one. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days.
Store dextromethorphan and promethazine at room temperature, away from heat, light, and moisture. Since cough and cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose. Symptoms of a dextromethorphan and promethazine overdose may include feeling restless or nervous, severe drowsiness, dizziness, dry mouth, large pupils, flushing, nausea, vomiting, shallow breathing, and fainting.
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Avoid drinking alcohol. It can increase some of the side effects of dextromethorphan and promethazine. Avoid taking diet pills, caffeine pills, or other stimulants such as ADHD medications without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.
Avoid using other drugs that make you sleepy such as cold medicine, sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety. Dextromethorphan is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of this medicine.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using dextromethorphan and promethazine and call your doctor at once if you have any of these serious side effects:. Children should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central nervous system depressants, including narcotic analgesics, sedatives, hypnotics, and tranquilizers, may have an additive effect and should be avoided or their dosage reduced.
Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of monoamine oxidase MAO inhibitors and products containing dextromethorphan. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half.
Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.
Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Concomitant use of other agents with anticholinergic properties should be undertaken with caution.
Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.
Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine or of dextromethorphan. There are no animal or human data concerning the carcinogenicity, mutagenicity, or impairment of fertility with these drugs. Promethazine was nonmutagenic in the Salmonella test system of Ames. Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.
These doses are from approximately 2. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women.
Promethazine and dextromethorphan should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Limited data suggest that use of promethazine HCl during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn.
The effect on later growth and development of the newborn is unknown. See also " Nonteratogenic Effects ". Caution should be exercised when promethazine and dextromethorphan is administered to a nursing woman. Clinical studies of promethazine hydrochloride and dextromethorphan hydrobromide syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride and dextromethorphan hydrobromide syrup and observed closely. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.
DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage , we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
View Package Photos. Drug Label Info. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. Respiratory Depression Promethazine may lead to potentially fatal respiratory depression.
Lower Seizure Threshold Promethazine may lower seizure threshold. Bone Marrow Depression Promethazine should be used with caution in patients with bone marrow depression.
Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome NMS has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice. General: Dextromethorphan should be used with caution in sedated patients, in the debilitated, and in patients confined to the supine position.
Cardiovascular — Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic — Dermatitis, photosensitivity, urticaria. Hematologic — Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal — Dry mouth, nausea, vomiting, jaundice. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death.
Treatment: The treatment of overdosage with promethazine and dextromethorphan is essentially symptomatic and supportive. Limited experience with dialysis indicates that it is not helpful.
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