The dosage is based on your medical condition and response to treatment. If you are using a liquid form, use a medication-measuring device or spoon to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose.
If your liquid form is a suspension, shake the bottle well before each dose. If you are using sustained-release tablets or capsules, swallow the medication whole. Do not crush, chew, or break the tablets or capsules. Doing so can destroy the long action of the drug and may increase side effects. Do not increase your dose or use this product more often or for longer than directed. Your condition will not improve any faster, and your risk of side effects will increase.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time more than a few weeks or in high doses. In such cases, withdrawal symptoms such as anxiety , restlessness, sweating , shaking chills, nausea , vomiting , and diarrhea may occur if you suddenly stop using this medication.
Animal reproduction studies have not been conducted with the drug combination — Promethazine and Codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Promethazine hydrochloride and codeine phosphate syrup should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy.
Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
Labor and Delivery Narcotic analgesics cross the placental barrier. The closer to the delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression.
Limited data suggests that use of promethazine hydrochloride 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.
See also Nonteratogenic Effects. Nursing Mothers Codeine and its active metabolite, morphine, are present in human milk. There are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk. Women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants.
In women with normal codeine metabolism normal CYP2D6 activity , the amount of codeine secreted into human milk is low and dose-dependent. There is no information on the effects of the codeine on milk production. Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with promethazine hydrochloride and codeine phosphate syrup.
Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. It is not known whether promethazine is excreted in human milk.
Risk factors include conditions associated with hypoventilation, such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression see WARNINGS - Ultra-Rapid Metabolism of Codeine and Respiratory Depression.
Geriatric Use Clinical studies of promethazine hydrochloride and codeine phosphate 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 codeine phosphate syrup and observed closely. CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions.
Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension common to narcotic analgesics. Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Oliguria, urinary retention, antidiuretic effect has been reported common to narcotic analgesics.
Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Flushing of the face, sweating and pruritus due to opiate-induced histamine release ; weakness.
Promethazine Central Nervous System: Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness, confusion, disorientation and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria.
Hallucinations have also been reported. Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis.
Dry mouth, nausea, vomiting, jaundice. Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride. Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur.
Respiratory depression, nightmares, delirium and agitated behavior have also been reported in some of these patients. Abuse Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low.
Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine.
However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence Psychological dependence, physical dependence, and tolerance are known to occur with codeine.
The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis.
Elderly patients are also comparatively intolerant to opiates. Promethazine Signs and symptoms of overdosage with promethazine range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness and sudden death.
Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis and extensor-plantar reflexes Babinski reflex. Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical reaction has been reported in children receiving single doses of 75 mg to mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms - dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms, may occur.
Treatment Treatment of overdosage with Promethazine and Codeine is essentially symptomatic and supportive. Srinivasan, Wielbo and Tebbett speculate that codeineglucuronide is responsible for a large percentage of the analgesia of codeine, and, thus, these patients should experience some analgesia. Some medications are CYP2D6 inhibitors and reduce or even completely block the conversion of codeine to morphine.
The most well-known of these are two of the selective serotonin reuptake inhibitors , paroxetine Paxil and fluoxetine Prozac as well as the antihistamine diphenhydramine Benadryl , and the antidepressant bupropion Wellbutrin, also known as Zyban.
Other drugs, such as rifampicin and dexamethasone , induce CYP isozymes and thus increase the conversion rate. CYP2D6 converts codeine into morphine, which then undergoes glucuronidation.
Life-threatening intoxication, including respiratory depression requiring intubation, can develop over a matter of days in patients who have multiple functional alleles of CYP2D6, resulting in ultra-rapid metabolism of opioids such as codeine into morphine.
Evidence supporting the hypothesis that ultrarapid metabolizers may get greater analgesia from codeine due to increased morphine formation is limited to case reports.
Guidelines released by the Clinical Pharmacogenomics Implementation Consortium CPIC advise against administering codeine to ultrarapid metabolizers, where this genetic information is available. The CPIC also suggests that codeine use be avoided in poor metabolizers, due to its lack of efficacy in this group. Codeine and its metabolites are excreted almost entirely by the kidney, mainly as conjugates with glucuronic acid.
Chemistry[ edit ] Relation to other opioids[ edit ] Codeine has been used in the past as the starting material and prototype of a large class of mainly mild to moderately strong opioids; such as hydrocodone in Germany , oxycodone in Germany , dihydrocodeine in Germany , and its derivatives such as nicocodeine in Austria.
In general, the various classes of morphine derivatives such as ketones, semisynthetics like dihydromorphine , halogeno-morphides, esters, ethers, and others have codeine, dihydrocodeine, and isocodeine analogues. As an analgesic, codeine compares weakly to other opiates. Related to codeine in other ways are codoxime , thebacon , codeine-N-oxide genocodeine , related to the nitrogen morphine derivatives as is codeine methobromide, and heterocodeine , which is a drug six times stronger than morphine and 72 times stronger than codeine due to a small re-arrangement of the molecule, viz.
Drugs bearing resemblance to codeine in effects due to close structural relationship are variations on the methyl groups at the 3 position including ethylmorphine a. While having no narcotic effects of its own, the important opioid precursor thebaine differs from codeine only slightly in structure.
Pseudocodeine and some other similar alkaloids not currently used in medicine are found in trace amounts in opium as well. History[ edit ] Codeine, or 3-methylmorphine, is an alkaloid found in the opium poppy , Papaver somniferum var. Opium poppy has been cultivated and utilized throughout human history for a variety of medicinal analgesic, anti-tussive and anti-diarrheal and hypnotic properties linked to the diversity of its active components, which include morphine, codeine and papaverine.
Until the beginning of the 19th century, raw opium was used in diverse preparations known as laudanum see Thomas de Quincey 's Confessions of an English Opium-Eater , and paregoric elixirs , a number of which were popular in England since the beginning of the 18th century; the original preparation seems to have been elaborated in Leiden , the Netherlands around by a chemist named Lemort; in the London Pharmacopoeia mentions an Elixir Asthmaticum, replaced by the term Elixir Paregoricum "pain soother" in The progressive isolation of opium's several active components opened the path to improved selectivity and safety of the opiates-based pharmacopeia.
Codeine is the most widely used opiate in the world, [43] [44] and is one of the most commonly used drugs overall according to numerous reports by organizations including the World Health Organization and its League of Nations predecessor agency.
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