No human overdosage data are available for Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution.
HydrocodoneOverdosage with hydrocodone is 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.
PseudoephedrineOverdosage with sympathomimetics, such as pseudoephedrine, may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusion and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsion, coma, and respiratory failure.
Treatment of overdosage consists of discontinuation of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.
Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution is contraindicated in:
Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:
Use of pseudoephedrine, a sympathomimetic amine, may result in the following:
The most common adverse reactions are central nervous system and cardiovascular reactions and include the following: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes, nervousness, sleeplessness, tremor or arrhythmia.
Other adverse reactions include:
Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation.
Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention.
Cardiovascular System: Fast, slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope.
Dermatological System: Skin rash, pruritus.
Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine)® Oral Solution (hydrocodone bitartrate and pseudoephedrine hydrochloride) is indicated for:
Relief of cough and nasal congestion associated with common cold.
Important Limitations Of UseNot indicated for pediatric patients under 18 years of age.
Systemic exposure (in terms of peak plasma concentrations and area under plasma concentration versus time curve) of hydrocodone bitartrate and pseudoephedrine hydrochloride after single-dose administration of 5 mg hydrocodone and 60 mg pseudoephedrine are equivalent to respective reference solutions of 5 mL hydrocodone bitartrate (5 mg/5 mL) and 5 mL pseudoephedrine hydrochloride (60 mg/5 mL).
Hydrocodone had a mean (SD) peak plasma concentration of 10.6 (2.63) ng/mL at 1.4 (0.55) hours. The mean plasma half-life of hydrocodone is approximately 4.9 hours. Pseudoephedrine had a mean (SD) peak plasma concentration of 212 (46.2) ng/mL at 1.8 (0.56) hours. The mean plasma half-life of pseudoephedrine is approximately 5.6 hours.
Included as part of the PRECAUTIONS section.
PRECAUTIONS Risks From Concomitant Use With Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids, including Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine), with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.
Advise both patients and caregivers about the risks of respiratory depression and sedation if Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) is used with benzodiazepines, alcohol, or other CNS depressants.
Respiratory DepressionHydrocodone bitartrate, one of the active ingredients of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administrating Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary.
Drug DependenceHydrocodone 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 of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution. Prescribe and administer Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) with the same degree of caution appropriate to the use of other opioid drugs.
Head Injury And Increased Intracranial PressureThe respiratory depression effects of opioids 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, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be avoided in these patients.
Activities Requiring Mental AlertnessHydrocodone bitartrate, one of the active ingredients in Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution. Concurrent use of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur.
Acute Abdominal ConditionsPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus.
Co-administration With AnticholinergicsThe concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution in patients taking anticholinergic medications.
Co-administration With MAOIs Or Tricyclic AntidepressantsPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy as an increase in blood pressure or hypertensive crisis, may occur. In addition, the use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate, one of the active ingredients in Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution, may increase the effect of either the antidepressant or hydrocodone.
Cardiovascular And Central Nervous System EffectsThe pseudoephedrine hydrochloride contained in Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution can produce cardiovascular and central nervous system effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or coronary artery disease.
DosingPatients should be advised to measure Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.
Coexisting ConditionsPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma.
Renal ImpairmentPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used with caution in patients with severe renal impairment.
Hepatic ImpairmentPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used with caution in patients with severe hepatic impairment.
Patient Counseling Information OverdosagePatients should be advised not to increase the dose or dosing frequency of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution because serious adverse events such as respiratory depression may occur with overdosage.
DosingPatients should be advised to measure Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is measured. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose.
Interactions With Benzodiazepines And Other Central Nervous System DepressantsInform patients and caregivers that potentially fatal additive effects may occur if Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol. Because of this risk, patients should avoid concomitant use of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with benzodiazepines or other CNS depressants, including alcohol.
Activities Requiring Mental AlertnessPatients should be advised to avoid engaging in hazardous tasks that require mental alertness and motor coordination such as operating machinery or driving a motor vehicle as Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution may produce marked drowsiness.
Drug DependencePatients should be cautioned that Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution contains hydrocodone bitartrate and can produce drug dependence.
MAOIsPatients should be informed that due to its pseudoephedrine component, they should not use Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with a MAOI or within 14 days of stopping the use of an MAOI.
Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of FertilityCarcinogenicity, mutagenicity, and reproductive studies have not been conducted with Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution; however, published information is available for the individual active ingredients or related active ingredients.
HydrocodoneCarcinogenicity studies were conducted with codeine, an opiate related to hydrocodone. In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 30 and 80 times, respectively, the MRHDD of hydrocodone on a mg/m² basis).
PseudoephedrineTwo-year feeding studies in rats and mice demonstrated no evidence of carcinogenic potential with ephedrine sulfate, a structurally related drug with pharmacological properties similar to pseudoephedrine, at dietary doses up to 10 and 27 mg/kg, respectively (approximately 0.3 and 0.5 times, respectively, the MRHDD of pseudoephedrine hydrochloride on a mg/m² basis).
Use In Specific Populations Pregnancy Teratogenic EffectsPregnancy Category C.
There are no adequate and well controlled studies of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution in pregnant women. Reproductive toxicity studies have not been conducted with Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution; however, studies are available with an individual active ingredient or related active ingredient. Hydrocodone was teratogenic in hamsters. Codeine, an opiate related to hydrocodone, increased resorptions and decreased fetal weight in rats. Because animal reproduction studies are not always predictive of human response, Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
HydrocodoneHydrocodone has been shown to be teratogenic in hamsters when given in a dose approximately 35 times the maximum recommended human daily dose (MRHDD) (on a mg/m² basis at a single subcutaneous dose of 102 mg/kg on gestation day 8). Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. In a study in which pregnant rats were dosed throughout organogenesis, a dose of codeine approximately 50 times the MRHDD of hydrocodone (on a mg/m² basis at an oral dose of 120 mg/kg/day of codeine) increased resorptions and decreased fetal weight; however, these effects occurred in the presence of maternal toxicity. In studies in which rabbits and mice were dosed throughout organogenesis, doses of codeine up to approximately 25 and 120 times, respectively, the MRHDD of hydrocodone (on a mg/m² basis at oral doses of 30 and 600 mg/kg/day, respectively), produced no adverse developmental effects.
Nonteratogenic EffectsBabies 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.
Labor And DeliveryAs with all opioids, administration of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.
Nursing MothersCaution should be exercised when Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) is administered to nursing mothers. Hydrocodone and pseudoephedrine are 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 Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution, 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.
Pediatric UseSafety and effectiveness of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution in pediatric patients under 18 years of age have not been established. The use of hydrocodone in children less than 6 years of age has been associated with fatal respiratory depression.
Geriatric UseClinical studies have not been conducted with Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution. Other reported clinical experience with the individual active ingredients of Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution has not identified differences in responses between the elderly and patients younger than 65 years of age. In general, dose selection for an elderly patient should be made with caution, 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. The pseudoephedrine contained in Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Renal ImpairmentPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be given with caution in patients with severe impairment of renal function. Pseudoephedrine is primarily excreted unchanged in the urine as unchanged drug with the remainder apparently being metabolized in the liver. Therefore, pseudoephedrine may accumulate in patients with renal impairment.
Hepatic ImpairmentPancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution should be given with caution in patients with severe impairment of hepatic function.
Administer Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution by the oral route only. Measure Pancof HC (Oral) (Hydrocodone bitartrate_Pseudoephedrine) Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose.
Adults 18 years Of Age And Older5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.
