This product is a compound preparation, its components are hydrocodone heavy tartrate, each containing 5mg; acetaminophen, each containing 500mg.
Molecular formula: C18 H21NO3C4 H6O6 H20, molecular weight: 494.50
The molecular formula is: C8 H19 NO2, molecular weight: 151.16
This product is a white tablet in the shape of a capsule.
Suitable for relieving moderate to moderate pain.
The dose should be adjusted according to the patient’s pain level and its response to the drug. However, it should be clear that the drug will be resistant to dihydrocodeinone and the incidence of adverse reactions is dose-related. Usually, the dosage of adults is 1 to 2 tablets every 4 to 6 hours, which can achieve an analgesic effect. The total dose for 24 hours should not exceed 5 tablets.
Common adverse reactions include dizziness, sedation, and nausea and vomiting. These reactions in ambulatory patients are more pronounced than in bedridden patients, and some adverse reactions can be alleviated when the patient is in a supine position. Other adverse reactions include:
Central nervous system: lethargy, mental paralysis, mental and physical impairment, anxiety, fear, irritability, mental dependence, and emotional changes.
Gastrointestinal system: Antiemetic phenothiazines can effectively inhibit nausea and vomiting reactions that may occur after using this product; some phenothiazine derivatives can counteract the analgesic effect of this product, so the dosage of anesthetic must be increased to ensure Its analgesic effect; while other phenothiazines can enhance the analgesic effect of anesthetics, reducing the amount of anesthetic to achieve analgesic effect. Long-term use of this product can cause constipation.
Genitourinary system: ureteral fistula, bladder sphincter spasm, and urinary retention have been reported.
Respiratory inhibition: Hydrocodone directly acts on the brainstem respiratory center, producing dose-related respiratory depression. Dihydrocodeinone also acts on the respiratory rhythm regulating center, causing irregular or periodic breathing. When significant respiratory depression occurs, the antagonist naloxone hydrochloride can be used and symptomatic supportive treatment if necessary.
Disabled for allergic to acetaminophen or hydrocodone.
This product is subject to the control of relevant anesthetic drugs. Repeated use of anesthetics can cause mental dependence, physical dependence and drug tolerance, so the prescription and administration of this product should be cautious.
However, short-term use of this product for analgesia does not lead to mental dependence. Physical dependence is a state of the body that must continue to be administered to prevent withdrawal symptoms. Some minor physical dependence may occur after anesthesia for several days, but only a few weeks of use of narcotic drugs may have clinically significant physical dependence.
Drug tolerance refers to a state in which the amount of anesthetic must be continuously increased to achieve the same analgesic effect. At first, it showed an analgesic time of anesthetic shortening, followed by an analgesic effect. The incidence of drug tolerance varies with individual patient differences.
Pregnant women and lactating women
Pregnancy use: Teratogenicity: Experiments have shown that 700 times the human dose of dihydrocodeinone has teratogenic effects on hamsters. There are no well-controlled and well-controlled studies on this product in pregnant women. Only when the expected benefit is greater than the expected risk to the fetus can it be used during pregnancy.
Non-teratogenicity: If a pregnant woman takes opioids regularly before giving birth, the baby she delivers may be physically dependent. The main withdrawal symptoms are: irritability and crying, tremors, hyperreflexia, increased respiratory rate, increased stool, sneezing, yawning, vomiting, and fever.
The severity of infant symptoms is not necessarily related to the length of time and dose of the mother taking opioids. At present, there is no uniform optimal treatment for infant withdrawal symptoms.
We recommend the following treatment regimen: chlorpromazine 0.7 to 1.0 mg/kg, once every 6 hours and compound camphor sputum 2 to 4 drops/kg, for every 4 Give it once an hour. The course of treatment is 4 to 28 days, and the amount is gradually reduced as the symptoms are alleviated.
Childbirth: Like all other anesthetics, maternal use is resistant within a short period of time before delivery, which can cause different degrees of respiratory depression in newborns. This is especially true when used in large doses.
Breast-feeding women: A small amount of acetaminophen can be secreted by milk, but the extent of the effect on the baby is unclear. It is not known whether dihydrocodeinone can be secreted by human milk. Many drugs can be secreted by the milk, and the mother of the lactating mother can have a potentially serious adverse effect on the baby. Sometimes the drug is important to the mother. Therefore, when deciding whether to stop the drug or stop breastfeeding, it is necessary to consider both aspects. factor.
The safety and effectiveness of this product for children is not yet clear.
Special attention should be paid to the use of any anesthetic (including resistance) in the elderly. Keep an eye on possible respiratory depression and common precautions.
This product produces superimposed central nervous system inhibition when used in combination with other anesthetic analgesics, antipsychotics, anxiolytics or other central nervous system inhibitors (including alcohol).
When the treatment requires a combination, the dose of one or all of the drugs should be reduced. When the hydrocodone preparation is combined with a monoamine oxidase inhibitor or a tricyclic antidepressant, both effects can be enhanced.
When hydrocodone is used in combination with an anticholinergic drug, it can cause paralytic ileus.
Drug/laboratory interactions: Acetaminophen results in a false positive reaction in the urine 5-indole acetic acid test.
Respiratory Inhibition: When used in large doses or for those who are allergic to this product, dose-related respiratory depression may result from the direct action of the drug on the brainstem respiratory center. Dihydrocodeinone can also act on the respiratory rhythm regulating center, causing irregular or periodic breathing.
Increased craniocerebral injury and intracranial pressure: When there is craniocerebral injury, other intracranial lesions or increased intracranial pressure, the respiratory depression and intracranial pressure increase of the anesthetic will be enhanced. In addition, the use of anesthetics can also mask the clinical course of patients with a craniocerebral injury.
Acute abdomen: The use of anesthesia can mask the clinical course of acute abdomen and delay diagnosis.
Patients with special risks: elderly patients with debilitating, severely impaired liver and kidney function, hypothyroidism, Addison’s disease, benign prostatic hyperplasia, and urethral stricture, all need to use any anesthetic analgesics (including resistance) pay attention. Keep an eye on possible respiratory depression and common precautions.
Patient Information: High-risk operations such as driving and machine operation require special mental and physical abilities. Like any anesthetic, it may damage the ability to operate in this area, so pay attention.
Alcohol and other central system inhibitors can be combined with resistance to produce a central inhibitory effect. Therefore, the joint use of the two should be avoided.
Dihydrocodeinone is addictive. Therefore, patients should take this product at the dose prescribed by the doctor’s prescription and should not exceed the prescribed frequency of use.
Laboratory examination: Patients with severe liver and kidney disease should regularly check liver and kidney function when taking this product.
Cough Reflex: Hydrocodone inhibits cough reflexes, so patients with postoperative or respiratory illness should be careful to use all anesthetics, including resistance.
Symptoms and signs: The most serious adverse reaction to acute acetaminophen overdose is potentially fatal liver necrosis. In addition, tubular necrosis, hypoglycemia coma, and thrombocytopenia can also occur.
A rare adult with acute overdose of acetaminophen has a liver necrosis below 10 grams or an acute overdose of 15 grams or less. Children are more tolerant of liver toxicity caused by an excess of acute acetaminophen than adults. The following treatments should be taken as soon as possible, whether adults or children have suspected or have taken in excess of acetaminophen.
If you take acetaminophen, which can cause a hepatotoxic dose, the early symptoms are nausea, vomiting, sweating, and general malaise. Usually, after 48 to 72 hours of overdose, clinical and laboratory tests show significant manifestations of hepatotoxicity.
Treatment: Immediate gastric lavage or introduction of ipecac syrup to promote vomiting, in order to promote gastric emptying. Do not believe the patient’s self-reported overdose. Once suspected, serum acetaminophen should be measured as soon as possible; however, the test should not be earlier than 4 hours after taking the drug. In addition, early liver function tests were performed at intervals of 24 hours.
Give the antidote N-acetylcysteine as soon as possible, and use it best within 16 hours, but it should not exceed 24 hours at the latest. After the patient recovers, there is no residue in the body, and the liver structure and function are not left behind.
Hydrocodone over dose
Symptoms and signs: Typical clinical manifestations of severe excess of hydrocodone are respiratory depression (reduced respiratory rate and/or tidal volume, Chen – breathing and cyanosis), extreme lethargy and even coma, bones Muscle relaxation and skin coldness, sometimes accompanied by bradycardia and hypotension. A severe overdose can cause apnea, circulatory failure, cardiac arrest, and even death.
Treatment: First and foremost, reestablish adequate gas exchange by establishing a patency of the airway and using assisted or controlled ventilation. Naloxone hydrochloride is a specific antidote to respiratory depression caused by excessive anesthetics such as dihydrocodeinone or allergic to anesthetics.
Therefore, it is best to administer an appropriate dose of naloxone hydrochloride intravenously, supplemented by respiratory resuscitation. Since the action time of hydrocodone is longer than that of naloxone, the patient should be closely observed during treatment and the antagonist naloxone hydrochloride should be administered repeatedly to maintain adequate breathing.
Naloxone hydrochloride should not be used if there is no significant respiratory and cardiovascular inhibition in the clinic. Oxygen inhalation, intravenous infusion, vasodilators, and other ancillary treatments may be given if necessary.
Gastric emptying effectively removes the unabsorbed residual drug.
Pharmacology and toxicology
Dihydrocodeinone is a semi-synthetic anesthetic, analgesic and antitussive drug with a variety of activities similar to codeine properties, most of which are associated with the central nervous system and smooth muscle. It is currently believed that the mechanism of action of dihydrocodeinone and other opioids may be related to central opioid receptors. In addition to analgesia, narcotic drugs can cause drowsiness, mood changes, and mental paralysis.
Acetaminophen has central and peripheral analgesic effects, but the specific mechanism of action is unknown. Its antipyretic effect is through the action of the hypothalamic body temperature regulation center. Acetaminophen inhibits prostaglandin synthetase, which has little effect on cardiovascular and respiratory systems at therapeutic doses but can cause circulatory failure and shallow breathing at toxic doses.
The pharmacokinetic behavior of a single component is described below:
Dihydrocodeinone: After oral administration of 10 mg of hydrocodone in five male healthy volunteers, the maximum serum drug concentration was reached at 1.3 ± 0.3 hours, with an average peak concentration of 23.6 ± 5.2 ng/ml and a half-life of 3.8 ± 0.3 hours. Dihydrocodeinone has complex metabolic pathways including reduction of O-desmethyl, N-dimethyl, and 6-keto to 6-alpha or 6-beta hydroxyl metabolites.
Acetaminophen: Acetaminophen is rapidly absorbed by the gastrointestinal tract and is distributed in most tissues. The plasma half-life is 1.25 to 3 hours, and the half-life can be increased when liver function is impaired or when taken in excess. Acetaminophen is mainly eliminated (combined) by liver metabolism and excreted by the kidneys. About 24% of the product was discharged in the urine 24 hours after oral administration. The form of excretion was mainly glucuronic acid conjugate, and a small part was other forms of conjugates and protoplasts.
Store at 15 to 30 °C in the dark. Keep out of reach of children.