Hydrocodone-Homatropine

Hydrocodone-Homatropine is a combination medication used to treat cough. Hydrocodone-Homatropine may be used alone or with other medications.

• Hydrocodone-Homatropine is available under the following different brand names: Tussigon 

Common side effects of Hydrocodone-Homatropine include:

• Nausea,
• Lightheadedness,
• Dizziness,
• Drowsiness,
• Vomiting, and
• Constipation

Serious side effects of Hydrocodone-Homatropine include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Interrupted breathing during sleep,
• Stomach pain,
• Mental or mood changes,
• Agitation,
• Confusion,
• Hallucinations,
• Difficult or painful urination,
• Eye pain,
• Swelling or redness of the eye,
• Vision changes,
• Seeing halos around lights,
• Blurred vision,
• Slow, shallow or irregular breathing,
• Severe drowsiness,
• Difficulty waking up,
• Seizure,
• Fainting, and
• Severe dizziness

Rare side effects of Hydrocodone-Homatropine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet: Schedule II

• 5 mg/1.5 mg (Tussigon)
• Generic available

Oral solution: Schedule II

• (5 mg/1.5 mg)/5 mL (Hydromet)
• Generic available

Cough

Adult dosage

• 5 mg/1.5 mg (1 tablet) orally every 4-6 hours
• Not to exceed 30 mg/9 mg (6 tablets) in 24 hours

Pediatric dosage

• Adolescents above 18 years: 5 mg/1.5 mg (1 tablet) orally every 4-6 hours, up to 30 mg/9 mg (6 tablets) in 24 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Hydrocodone-Homatropine has severe interactions with the following drug:
  • alvimopan
• Hydrocodone-Homatropine has serious interactions with at least 124 other drugs.
• Hydrocodone-Homatropine has moderate interactions with at least 222 other drugs.
• Hydrocodone-Homatropine has minor interactions with the following drugs:
  • dimenhydrinate
  • donepezil
  • galantamine
  • levodopa
  • ziconotide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Children below 6 years
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to hydrocodone, homatropine, or any inactive primary glaucoma or a predisposition to glaucoma 

Effects of drug abuse

• Overdose 
• Death

Short-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodone-Homatropine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Hydrocodone-Homatropine?”

Cautions

• The hydrocodone in the medication may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures; monitor patients with a history of seizure disorders for worsened seizure control during therapy
• Severe hypotension
  • Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (. g, phenothiazines or general anesthetics)
  • Monitor these patients for signs of hypotension after initiating therapy; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid the use of medication in patients with circulatory shock
• Neonatal Opioid Withdrawal Syndrome
  • This medication is not recommended for use in pregnant women; prolonged use during pregnancy can result in withdrawal in the neonate; neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
  • Observe newborns for signs of neonatal opioid withdrawal syndrome and manage; accordingly, advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available
• Adrenal insufficiency
  • Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use; presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure
  • If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible; if adrenal insufficiencies once diagnosed, treat with physiologic replacement doses of corticosteroids
  • The Wean patient off the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers
  • Other opioids may be tried as some cases reported the use of a different opioid without recurrence of adrenal insufficiency; the information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency
• Addiction, Abuse, and Misuse
  • Medication contains hydrocodone, a Schedule II controlled substance; as an opioid, medication exposes users to risks of addiction, abuse, and misuse
  • Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed with the medication; addiction can occur at recommended dosages and if the drug is misused or abused
  • Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (. g, major depression); opioids are sought by drug abusers, and people with addiction disorders are subject to criminal diversion
  • Consider risks when prescribing or dispensing medication; strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on proper disposal of unused drug
  • Contact the local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product
• Life-threatening respiratory depression
  • Serious, life-threatening, or fatal respiratory depression is reported with the use of opioids, including hydrocodone, one of the active ingredients in the drug combination; hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls the respiratory rhythm and may produce irregular and periodic breathing
  • Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death; management of respiratory depression includes discontinuation of therapy, close observation, supportive measures, and use of opioid antagonists (. g, naloxone), depending on the patient’s clinical status
  • Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate sedating effects of opioids; while serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, the risk is greatest during initiation of therapy, when drug combination is used
  • concomitantly with other drugs that may cause respiratory depression in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (. g, elderly, cachectic, or debilitated patients)
  • To reduce the risk of respiratory depression, proper dosing is essential; monitor patients closely, especially within the first 24-72 hours of initiating therapy or when used in patients at higher risk; overdose of hydrocodone in adults has been associated with fatal respiratory depression, and use of hydrocodone in children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended
  • Accidental ingestion of even one dose, especially by children, can result in respiratory depression and death
• Pediatric population
  • Children are particularly sensitive to the respiratory depressant effects of hydrocodone; because of the risk of life-threatening respiratory depression and death, the drug is contraindicated in children below 6 years
  • Use in children also exposes them to risks of addiction, abuse, and misuse, which can lead to overdose and death; because the benefits of symptomatic treatment of cough associated with allergies or common cold do not outweigh the risks of use of hydrocodone in pediatric patients, this medication is not indicated for use in patients below 18 years
• Use in other at-risk population
  • Dosage should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathologies, such as foreign body or lower respiratory tract disease
  • Use in patients with acute or severe bronchial asthma in an unmonitored setting or absence of resuscitative equipment is contraindicated
  • Opioid analgesics and antitussives, including hydrocodone, one of the active ingredients, should not be used in patients with acute febrile illness associated with productive cough or in patients with a chronic respiratory disease where interference with the ability to clear the tracheobronchial tree of secretions would have a deleterious effect on patient’s respiratory function
  • Treated patients with significant chronic obstructive pulmonary disease or corpulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of the decreased respiratory drive including apnea, even at recommended dosages
  • Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients
  • Because of the risk of respiratory depression, avoid the use of opioid antitussives in patients with compromised respiratory function, patients at risk of respiratory failure, and elderly, cachectic, or debilitated patients; monitor such patients closely, particularly when initiating therapy and when the medication is given concomitantly with other drugs that depress respiration
• Accidental overdose and death due to medication errors
  • Dosing errors can result in accidental overdose and death; to reduce the risk of overdose and respiratory depression, ensure that the dose is communicated clearly and dispensed accurately
  • Advise patients to always use an accurate milliliter measuring device when measuring and administering oral solution; inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions
  • For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose
• Mental alertness
  • Hydrocodone, one of the active ingredients in the medication, 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 taking the medication
  • Avoid concurrent use of the medication with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur
• Cytochrome P450 3A4 Inhibitors and Inducers
  • Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (. g, erythromycin), azole-antifungal agents (.g, ketoconazole), and protease inhibitors (g, ritonavir), may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of the medication is achieved
  • Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, may increase hydrocodone plasma concentrations and prolong opioid adverse reactions
  • Concomitant use of the medication with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed a physical dependence on hydrocodone
  • Avoid use in patients who are taking a CYP3A4 inhibitor or inducer; if concomitant use of the medication with a CYP3A4 inhibitor or inducer is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal
• Concomitant Use with Benzodiazepines or Other CNS Depressants
  • Concomitant use of opioids with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
  • Because of these risks, avoid the use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol
  • Advise both patients and caregivers about the risks of respiratory depression and sedation if the drug is used with benzodiazepines, alcohol, or other CNS depressants
  • Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on therapy; the co-ingestion of alcohol may result in increased plasma levels and a potentially fatal overdose of hydrocodone
• Patients with Gastrointestinal Conditions
  • Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; the use of hydrocodone in the medication may obscure the diagnosis or clinical course of patients with acute abdominal conditions
  • Concurrent use of anticholinergics may produce paralytic ileus; the hydrocodone in the drug combination may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders
  • Use with caution in patients with underlying intestinal motility disorders; the hydrocodone in the medication may cause spasm of the sphincter of Oddi, increasing biliary tract pressure
  • Opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms
  • Patients with a head injury, impaired consciousness, increased intracranial pressure, or brain tumors
  • Avoid use in patients with a head injury, intracranial lesions, or a pre-existing increase in intracranial pressure; in patients who may be susceptible to intracranial effects of CO2 retention
  •  (. g, those with evidence of increased intracranial pressure or brain tumors), the medication may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure
  • Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries

Pregnancy and Lactation

• Not recommended for use in pregnant women, including during or immediately before labor; prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome
• There are no available data with use in pregnant women to inform a drug-associated risk for adverse developmental outcomes; published studies with hydrocodone have reported inconsistent findings and have important methodological limitations
• Reproductive toxicity studies have not been conducted; however, studies are available with individual active ingredients or related active ingredients
• Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth
• Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high-pitched crying, tremors, vomiting, diarrhea, and failure to gain weight
• The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by newborn
• Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage them accordingly
• Labor or delivery
  • Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates
  • An opioid antagonist, such as naloxone, must be available for the reversal of opioid-induced respiratory depression in the neonate; opioids can prolong labor through actions that temporarily reduce the strength, duration, and frequency of uterine contractions
  • However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor; monitor neonates exposed to opioids during labor for signs of excess sedation and respiratory depression
• Infertility
  • Chronic use of opioids, such as hydrocodone may cause reduced fertility in females and males of reproductive potential; it is not known whether these effects on fertility are reversible
• Lactation
  • Because of the potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, advise patients that breastfeeding is not recommended during treatment
  • There are no data on the presence of the drugs in human milk, their effects on the breastfed infant, or milk production; however, data are available with hydrocodone and homatropine
  • Hydrocodone is present in breast milk; published cases report variable concentrations of hydrocodone and hydromorphone (an active metabolite) in breast milk with administration of immediate-release hydrocodone to nursing mothers in early post-partum period with relative infant doses of hydrocodone ranging between 1.4 and 3.7%
  • There are case reports of excessive sedation and respiratory depression in breastfed infants exposed to hydrocodone; no information is available on the effects of hydrocodone on milk production.
  • No information is available on the levels of homatropine in breast milk or on milk production; the published literature suggests that homatropine may decrease milk production based on its anticholinergic effects
  • Infants exposed to the drugs through breast milk should be monitored for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid is stopped, or when breastfeeding is stopped