Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1368
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Hydrocodone Bitartrate and Homatropine Methylbromide (Syrup)
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| dailymed-instance:dosage |
Adults and children 12 years of age and over: 5 mL (teaspoonful) of the syrup every four to six hours as needed; do not exceed 6 teaspoonfuls in 24 hours. Children 6 to 12 years of age: 2.5 mL (��teaspoonful) of the syrup every four to six hours as needed; do not exceed 3 teaspoonfuls in 24 hours.
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| dailymed-instance:descripti... |
This product contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting narcotic antitussive. Homatropine Methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage. Each 5 mL (teaspoonful) contains:Hydrocodone Bitartrate, USP . . . . . . . . . 5 mgHomatropine Methylbromide, USP . . . . 1.5 mgAlcohol . . . . . . . . . . . . . . . . . . less than 0.1%(contributed by flavorings) Also contains: Caramel, NF; Cherry Flavor; D&C Red No. 33; Glycerin, USP; Liquid Sugar; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF and Sorbitol Solution, USP. Citric Acid, USP or Sodium Citrate, USP may be added for pH adjustment. The hydrocodone component is 4,5��-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, and has the following structural formula: Homatropine Methylbromide is 8-Azoniabicyclo[3.2.1]octane,3-[(hydroxyphenylacetyl)-oxy]-8,8-dimethyl-, bromide,endo-; a white crystal or fine white crystalline powder, and has the following structural formula:
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| dailymed-instance:clinicalP... |
Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence. Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6��5.2 ng/mL. Maximum serum levels were achieved at 1.3��0.3 hours and the half-life was determined to be 3.8��0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-��- and 6-��-hydroxymetabolites.
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| dailymed-instance:contraind... |
This product should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.
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| dailymed-instance:supply |
This product is a red-colored, cherry-flavored syrup in 16 fl oz (473 mL) and gallon (3785 mL) bottles.<br/>RECOMMENDED STORAGE: Store at controlled room temperature, 15�����30��C (59�����86��F) [see USP]. AVOID FREEZING Dispense in a tight, light-resistant container as defined in the USP.
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| dailymed-instance:precautio... |
General: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complication, and that appropriate therapy for the primary disease is provided.<br/>Special Risk Patients: This product should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.<br/>Information For Patients: Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this product should be cautioned accordingly.<br/>Drug Interactions: Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents or other Central Nervous System (CNS) depressants (including alcohol) concomitantly with this product may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.<br/>Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery, will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.<br/>Labor and Delivery: As with all narcotics, administration of this product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.<br/>Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.<br/>Pediatric Use: Safety and effectiveness in children under six years of age have not been established.
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| dailymed-instance:genericMe... |
Hydrocodone Bitartrate and Homatropine Methylbromide
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| dailymed-instance:fullName |
Hydrocodone Bitartrate and Homatropine Methylbromide (Syrup)
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| dailymed-instance:adverseRe... |
CNS: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.<br/>Gastrointestinal System: Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration may produce constipation.<br/>Genitourinary System: Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.<br/>Respiratory Depression: This product may produce dose-related respiratory depression by acting directly on brain stem respiratory centers .<br/>Dermatological: Skin rash, pruritus.
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| dailymed-instance:warning |
May be habit forming. Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs .<br/>Respiratory Depression: This product produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.<br/>Head Injury and Increased Intracranial Pressure: The respiratory depression properties of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.<br/>Acute Abdominal Conditions: The administration of this product or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.<br/>Pediatric Use: In young children, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in children with respiratory embarrassment (e.g., croup).
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| dailymed-instance:indicatio... |
This product is indicated for the symptomatic relief of cough.
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| dailymed-instance:name |
Hydrocodone Bitartrate and Homatropine Methylbromide
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