Antitussive – Antihistaminic – Decongestant
Action And Clinical Pharmacology: See Hycodan for pharmacology of hydrocodone.
Pyrilamine maleate is a competitive H1-receptor histamine-blocking drug, thereby counteracting the effects of histamine release associated with allergic manifestations of upper respiratory tract inflammatory disorders. H1-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 And Clinical Uses: To control cough, and to provide symptomatic relief of congestion in the upper respiratory tract due to the common cold, nasopharyngitis, tracheitis, and bronchitis, which do not respond to products of lesser potency.
Contra-Indications: Hypersensitivity to any of the components. Patients known to be hypersensitive to other opioids, antihistamines or sympathomimetic amines may exhibit cross- sensitivity to hydrocodone, pyrilamine or phenylephrine. Do not use in patients using monoamine oxidase inhibitors. Hydrocodone is contraindicated in the presence of an intracranial lesion associated with increased intracranial pressure, and whenever ventilatory function is depressed.
Phenylephrine is contraindicated in patients with heart disease, hypertension, diabetes or hyperthyroidism.
Manufacturers’ Warnings In Clinical States: See Hycodan.
Hypersensitive crises can occur with concurrent use of phenylephrine and MAO inhibitors, indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, discontinue these drugs immediately and institute therapy to lower blood pressure. Manage fever by external cooling.
Pyrilamine may produce drowsiness or excitation, particularly in children and elderly patients.
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 these preparations 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.
Use with caution in sedated or debilitated patients, in patients who have undergone thoracotomies or laparotomies, since suppression of the cough reflex may lead to retention of secretions postoperatively in these patients.
Use with caution in glaucoma, prostatic hypertrophy, urinary retention, and in the aged.
The CNS-depressant effect of hydrocodone may be additive with that of other CNS depressants (see Warnings).
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.
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 (0.7 to 1.0 mg/kg q6h), phenobarbital (2 mg/kg q6h), and paregoric (2 to 4 drops/kg q4h), have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, 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. Only Hycomine-S pediatric syrup is recommended for pediatric use.
Drug Interactions: The CNS-depressant effect of Hycomine syrup and Hycomine-S pediatric syrup may be additive with that of other CNS depressants (see Warnings).
Adverse Reactions: See Hycodan.
Symptoms And Treatment Of Overdose: Symptoms: 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.
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: Give primary attention to re-establishing adequate respiratory exchange by providing a patent airway and instituting assisted or controlled ventilation. The narcotic antagonist naloxone 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 hydrochloride may exceed that of the antagonist, keep the patient under continued surveillance and repeat doses of the antagonist as needed to maintain adequate respiration. Observe carefully the manufacturer’s package insert instructions.
Employ oxygen, i.v. fluids, vasopressors, and other supportive measures as indicated.
Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may be of benefit.
Dosage And Administration: Hycomine: Adults, 5 mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4 hours not to exceed 30 mL in a 24-hour period. Maximum single dose 15 mL.
Hycomine-S: Children over 12 years: 10 mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4 hours, not to exceed a total of 60 mL in a 24-hour period. Maximum single dose 20 mL.
Children 6 to 12 years: 5 mL after meals and at bedtime with food or a glass of milk at intervals of not less than 4 hours: not to exceed a total of 30 mL in a 24-hour period. Maximum single dose 10 mL.
Children 3 to 6 years: 2.5 mL after meals and at bedtime with food or a glass of milk, at intervals of not less than 4 hours, not to exceed a total of 15 mL in a 24-hour period. Maximum single dose 5 mL.
Children less than 2 years: According to weight on the basis of 300 g (0.3 mg) hydrocodone bitartrate/kg body weight/day, divided into 4 equal doses taken after meals and at bedtime.
Availability And Storage: Hycomine: Each 5 mL of orange, cherry-flavored syrup contains: hydrocodone bitartrate 5 mg, pyrilamine maleate 12.5 mg, phenylephrine HCl 10 mg and ammonium chloride 60 mg. Nonmedicinal ingredients: casiline orange, cherry flavor, hydrochloric acid, methylparaben, propylparaben, purified water, sorbitol solution and sucrose. Alcohol-, lactose-, sodium-, sulfite- and tartrazine-free. Bottles of 100 and 500 mL.
Hycomine-S: Each 5 mL of green, cherry-flavored pediatric syrup contains: hydrocodone bitartrate 2.5 mg, pyrilamine maleate 6.25 mg, phenylephrine HCl 5 mg and ammonium chloride 30 mg. 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 500 mL.
Store at room temperature (15 to 30°C) in a tightly closed container. Protect from light. (Shown in Product Recognition Section)
HYCOMINE® HYCOMINEÂ®-S DuPont Pharma Hydrocodone Compound Antitussive – Antihistaminic – Decongestant