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Hycomine-S (Hydrocodone Compound)
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Pharmacology
See Hycodan product monograph for pharmacology of hydrocodone.
Pyrilamine maleate is a competitive H 1-receptor histamine-blocking drug, thereby counteracting the effects of histamine release associated with allergic manifestations of upper respiratory tract inflammatory disorders. H 1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the CNS.
Phenylephrine HCl effects its vasoconstrictor activity by releasing norepinephrine from sympathetic nerve endings, and from direct stimulation of a-adreno-receptors in blood vessels.
Ammonium chloride exerts an expectorant effect by virtue of a local action on the gastric mucosa.
See Hycodan product monograph for pharmacology of hydrocodone.
Pyrilamine maleate is a competitive H 1-receptor histamine-blocking drug, thereby counteracting the effects of histamine release associated with allergic manifestations of upper respiratory tract inflammatory disorders. H 1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the CNS.
Phenylephrine HCl effects its vasoconstrictor activity by releasing norepinephrine from sympathetic nerve endings, and from direct stimulation of a-adreno-receptors in blood vessels.
Ammonium chloride exerts an expectorant effect by virtue of a local action on the gastric mucosa.
Indications
See Hycodan Product Monograph For Pharmacology Of Hydrocodone.
Pyrilamine Maleate Is A Competitive H 1-receptor Histamine-blocking Drug, Thereby Counteracting The Effects Of Histamine Release Associated With Allergic Manifestations Of Upper Respiratory Tract Inflammatory Disorders. H 1-blocking Drugs Inhibit The Actions Of Histamine On Smooth Muscle, Capillary Permeability, And Can Both Stimulate And Depress The CNS.
Phenylephrine HCl Effects Its Vasoconstrictor Activity By Releasing Norepinephrine From Sympathetic Nerve Endings, And From Direct Stimulation Of A-adreno-receptors In Blood Vessels.
Ammonium Chloride Exerts An Expectorant Effect By Virtue Of A Local Action On The Gastric Mucosa.
See Hycodan Product Monograph For Pharmacology Of Hydrocodone.
Pyrilamine Maleate Is A Competitive H 1-receptor Histamine-blocking Drug, Thereby Counteracting The Effects Of Histamine Release Associated With Allergic Manifestations Of Upper Respiratory Tract Inflammatory Disorders. H 1-blocking Drugs Inhibit The Actions Of Histamine On Smooth Muscle, Capillary Permeability, And Can Both Stimulate And Depress The CNS.
Phenylephrine HCl Effects Its Vasoconstrictor Activity By Releasing Norepinephrine From Sympathetic Nerve Endings, And From Direct Stimulation Of A-adreno-receptors In Blood Vessels.
Ammonium Chloride Exerts An Expectorant Effect By Virtue Of A Local Action On The Gastric Mucosa.
Contraindications
Hypersensitivity to any of the components of the drug. Patients known to be hypersensitive to other opioids, antihistamines or sympathomimetic amines may exhibit crosssensitivity to hydrocodone, pyrilamine or phenylephrine. Should not be used in patients using monoamine oxidase inhibitors. Phenylephrine is contraindicated in patients with heart disease, hypertension, diabetes or hyperthyroidism. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure, and whenever ventilatory function is depressed.
Phenylephrine: Hypersensitive crises can occur with concurrent use of phenylephrine and MAO inhibitors, indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling.
Pyrilamine: Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients.
Hypersensitivity to any of the components of the drug. Patients known to be hypersensitive to other opioids, antihistamines or sympathomimetic amines may exhibit crosssensitivity to hydrocodone, pyrilamine or phenylephrine. Should not be used in patients using monoamine oxidase inhibitors. Phenylephrine is contraindicated in patients with heart disease, hypertension, diabetes or hyperthyroidism. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure, and whenever ventilatory function is depressed.
Phenylephrine: Hypersensitive crises can occur with concurrent use of phenylephrine and MAO inhibitors, indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by external cooling.
Pyrilamine: Antihistamines may produce drowsiness or excitation, particularly in children and elderly patients.
Safety Information / Warning
Information not available
Information not available
Precautions
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 complications, and that appropriate therapy for the primary disease is provided.
In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit-to-risk ratio should be carefully considered, especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child's age and weight is of great importance.
As hydrocodone may inhibit peristalsis, patients with chronic constipation should be given the drug only after weighing the potential therapeutic benefit against the hazards involved.
In patients with asthma or pulmonary emphysema, indiscriminate use may precipitate respiratory insufficiency resulting from increased viscosity of bronchial secretions and suppression of the cough reflex.
Special Risk Patients: Hycomine 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, narrow-angle glaucoma, and uncontrolled hypertension.
Carcinogenesis/Mutagenesis/Impairment of Fertility: Carcinogenicity, mutagenicity and reproduction studies have not been conducted.
Pregnancy: Animal reproduction studies have not been conducted. It is also not known whether Hycomine syrup or Hycomine-S pediatric syrup can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Since hydrocodone crosses the placental barrier, give the hydrocodone formulations to pregnant women only if clearly needed.
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 opioids use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine (0.7to 1.0mg/kgq6h), phenobarbital (2mg/kgq6h), and paregoric (2to 4drops/kg q4h), have been used to treat withdrawal symptoms in infants. The duration of therapy is 4to28days, with the dosages decreased as tolerated.
Lactation: It is not known whether hydrocodone 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 from Hycomine syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Drug Interactions : The CNS-depressant effect of Hycomine syrup and Hycomine-S pediatric syrup may be additive with that of other CNS depressants.
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 complications, and that appropriate therapy for the primary disease is provided.
In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit-to-risk ratio should be carefully considered, especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child's age and weight is of great importance.
As hydrocodone may inhibit peristalsis, patients with chronic constipation should be given the drug only after weighing the potential therapeutic benefit against the hazards involved.
In patients with asthma or pulmonary emphysema, indiscriminate use may precipitate respiratory insufficiency resulting from increased viscosity of bronchial secretions and suppression of the cough reflex.
Special Risk Patients: Hycomine 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, narrow-angle glaucoma, and uncontrolled hypertension.
Carcinogenesis/Mutagenesis/Impairment of Fertility: Carcinogenicity, mutagenicity and reproduction studies have not been conducted.
Pregnancy: Animal reproduction studies have not been conducted. It is also not known whether Hycomine syrup or Hycomine-S pediatric syrup can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Since hydrocodone crosses the placental barrier, give the hydrocodone formulations to pregnant women only if clearly needed.
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 opioids use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine (0.7to 1.0mg/kgq6h), phenobarbital (2mg/kgq6h), and paregoric (2to 4drops/kg q4h), have been used to treat withdrawal symptoms in infants. The duration of therapy is 4to28days, with the dosages decreased as tolerated.
Lactation: It is not known whether hydrocodone 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 from Hycomine syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Drug Interactions : The CNS-depressant effect of Hycomine syrup and Hycomine-S pediatric syrup may be additive with that of other CNS depressants.
Overdose
The signs and symptoms of overdosage of the individual components of Hycomine syrup or Hycomine-S pediatric syrup may be modified in varying degrees by the presence of other active ingredients.
Symptoms:
Serious overdosage with hydrocodone may be characterized by: respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.
Treatment: Primary attention should be given to re-establishing adequate respiratory exchange by providing a patent airway and instituting assisted or controlled ventilation. The narcotic antagonist naloxone HCl is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Administer an appropriate dose of naloxone, preferably by the i.v. route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. The instructions contained in the package insert should be carefully observed.
Oxygen, i.v. fluids, vasopressors, and other supportive measures should be employed as indicated.
Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may be of benefit.
The signs and symptoms of overdosage of the individual components of Hycomine syrup or Hycomine-S pediatric syrup may be modified in varying degrees by the presence of other active ingredients.
Symptoms:
Serious overdosage with hydrocodone may be characterized by: respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.
Treatment: Primary attention should be given to re-establishing adequate respiratory exchange by providing a patent airway and instituting assisted or controlled ventilation. The narcotic antagonist naloxone HCl is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including hydrocodone. Administer an appropriate dose of naloxone, preferably by the i.v. route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. The instructions contained in the package insert should be carefully observed.
Oxygen, i.v. fluids, vasopressors, and other supportive measures should be employed as indicated.
Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may be of benefit.
Recommended Dosage
Children over 12years: 10mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4hours, not to exceed a total of60mL in a 24-hour period. Maximum single dose 20mL.
Children 6to 12years: 5mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4hours: not to exceed a total of30mL in a 24-hour period. Maximum single dose 10mL.
Children 3to 6years: 2.5mL after meals and at bedtime with food or a glass of milk, at intervals of not less than 4hours, not to exceed a total of15mL in a 24-hour period. Maximum single dose 5mL.
Children less than 2 years: According to weight on the basis of 300µg (0.3mg) hydrocodone bitartrate/kg body weight/day, divided into 4equal doses taken after meals and at bedtime.
Children over 12years: 10mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4hours, not to exceed a total of60mL in a 24-hour period. Maximum single dose 20mL.
Children 6to 12years: 5mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4hours: not to exceed a total of30mL in a 24-hour period. Maximum single dose 10mL.
Children 3to 6years: 2.5mL after meals and at bedtime with food or a glass of milk, at intervals of not less than 4hours, not to exceed a total of15mL in a 24-hour period. Maximum single dose 5mL.
Children less than 2 years: According to weight on the basis of 300µg (0.3mg) hydrocodone bitartrate/kg body weight/day, divided into 4equal doses taken after meals and at bedtime.
Supplied / Packaging
Hycomine-S: Each 5mL of green, cherry-flavored pediatric syrup contains: hydrocodone bitartrate 2.5mg, pyrilamine maleate 6.25mg, phenylephrine HCl 5mg and ammonium chloride 30mg. Nonmedicinal ingredients: cherry flavor, hydrochloric acid, methylparaben, minoline green, propylparaben, purified water, sorbitol solution and sucrose. Alcohol-, lactose-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500mL.
Keep out of the reach of children. Store at 15 to 30°C. Dispense in a tight, light-resistant container.
Hycomine-S: Each 5mL of green, cherry-flavored pediatric syrup contains: hydrocodone bitartrate 2.5mg, pyrilamine maleate 6.25mg, phenylephrine HCl 5mg and ammonium chloride 30mg. Nonmedicinal ingredients: cherry flavor, hydrochloric acid, methylparaben, minoline green, propylparaben, purified water, sorbitol solution and sucrose. Alcohol-, lactose-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500mL.
Keep out of the reach of children. Store at 15 to 30°C. Dispense in a tight, light-resistant container.
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Brand Name
Hycomine-S
Hycomine-S
Generic Name
Hydrocodone Compound
Hydrocodone Compound
General Indications
Antitussive Antihistaminic Decongestant
Antitussive Antihistaminic Decongestant
