Relieving a cough helps you get more rest and sleep. This product contains 2 medications, hydrocodone and homatropine. Hydrocodone is an opioid cough suppressant antitussive that works on certain centers in the brain to stop the urge to cough. Homatropine belongs to a class of drugs known as anticholinergics. This medication is generally used for short-term treatment.
It should not be used for persistent coughs from smoking or long-term breathing problems e. Opioid cough suppressants should not be used by children younger than 18 years. Children are at higher risk for serious even fatal side effects, especially breathing problems.
Talk with the doctor about the risks and benefits of this medication. Cough-and-cold products do not cure colds. Cough due to a common cold often does not need to be treated with medicine. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with or without food, usually every 4 or 6 hours as needed or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy.
Follow your doctor's directions closely. The manufacturer recommends that adults should not take more than 6 tablets or 6 teaspoons 30 milliliters daily. Do not use a household spoon because you may not get the correct dose. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. If you suddenly stop using this medication, you may have withdrawal symptoms such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches.
To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used this medication for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal. Though it helps many people, this medication has a risk for abuse and may sometimes cause addiction. Take this medication exactly as prescribed to lower the risk of addiction.
Ask your doctor or pharmacist for more details. When taken for a long time, this medication may not work as well and may require different dosing. Tell your doctor if this medication stops working well.
Nausea commonly occurs with the use of hydrocodone and usually goes away after the first few doses. Consult your doctor or pharmacist about ways to decrease nausea e. Lightheadedness, dizziness, drowsiness, vomiting, and constipation may also occur.
If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To prevent constipation, eat dietary fiber, drink enough water, and exercise. To find out if your medication is available as a Teva generic, contact your local pharmacy. If the pharmacy doesn't regularly stock a certain medication from Teva, ask if it can be ordered for you at no additional cost.
The product catalog provides you with a full listing of Teva's brand and generic product lines. The catalog displays all strengths and sizes along with the description, imprint code, NDC and photo for each product. Call your doctor for instructions. This medicine may make you dizzy or drowsy.
Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness. Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby.
Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine. This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor.
Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping. Using too much of this medicine may cause infertility unable to have children.
Talk with your doctor before using this medicine if you plan to have children. Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests. Do not take other medicines unless they have been discussed with your doctor.
This includes prescription or nonprescription over-the-counter [OTC] medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.
Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Prescribe hydrocodone bitartrate and homatropine methylbromide oral solution for the shortest duration that is consistent with individual patient treatment goals [see Warnings and Precautions 5.
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy [see Warnings and Precautions 5. Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Warnings and Precautions 5. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with hydrocodone bitartrate and homatropine methylbromide oral solution, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [see Warnings and Precautions 5.
Do not abruptly discontinue hydrocodone bitartrate and homatropine methylbromide oral solution in a physically-dependent patient [see Drug Abuse and Dependence 9. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for:. Hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with:. Hydrocodone bitartrate and homatropine methylbromide oral solution contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and homatropine methylbromide oral solution exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence 9 ], which can lead to overdose and death [see Overdosage 10 ].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and homatropine methylbromide oral solution.
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 e.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing hydrocodone bitartrate and homatropine methylbromide oral solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information 17 ].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, including hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution.
Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls 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 hydrocodone bitartrate and homatropine methylbromide oral solution, close observation, supportive measures, and use of opioid antagonists e. Carbon dioxide CO 2 retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and homatropine methylbromide oral solution, the risk is greatest during the initiation of therapy, when hydrocodone bitartrate and homatropine methylbromide oral solution is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions 5.
To reduce the risk of respiratory depression, proper dosing of hydrocodone bitartrate and homatropine methylbromide oral solution is essential [see Dosage and Administration 2.
Monitor patients closely, especially within the first 24 to 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 the 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 of hydrocodone bitartrate and homatropine methylbromide oral solution, especially by children, can result in respiratory depression and death.
Children are particularly sensitive to the respiratory depressant effects of hydrocodone [see Warnings and Precautions 5. Because of the risk of life-threatening respiratory depression and death, hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated in children less than 6 years of age [see Contraindications 4 ].
Use of hydrocodone bitartrate and homatropine methylbromide oral solution in children also exposes them to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence 9 ] , which can lead to overdose and death [see Warnings and Precautions 5. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, hydrocodone bitartrate and homatropine methylbromide oral solution is not indicated for use in patients younger than 18 years of age [see Indications 1 , Use in Specific Populations 8.
The dosage of hydrocodone bitartrate and homatropine methylbromide oral solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Dosage and Administration 2. The use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [ s ee Contraindications 4 ].
Hydrocodone bitartrate and homatropine methylbromide oral solution-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of hydrocodone bitartrate and homatropine methylbromide oral solution [ see Warnings and Precautions 5.
Elderly, Cachectic, or Debilitated Patients : 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 [ see Warnings and Precautions 5. Because of the risk of respiratory depression, avoid the use of opioid antitussives, including hydrocodone bitartrate and homatropine methylbromide oral solution in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients.
If hydrocodone bitartrate and homatropine methylbromide oral solution is prescribed, monitor such patients closely, particularly when initiating hydrocodone bitartrate and homatropine methylbromide oral solution and when hydrocodone bitartrate and homatropine methylbromide oral solution is given concomitantly with other drugs that depress respiration [ see Warnings and Precautions 5.
To reduce the risk of overdose and respiratory depression, ensure that the dose of hydrocodone bitartrate and homatropine methylbromide oral solution is communicated clearly and dispensed accurately [see Dosage and Administration 2.
Advise patients to always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate and homatropine methylbromide oral solution. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [see Overdosage 10 ].
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. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of hydrocodone bitartrate and homatropine methylbromide oral solution.
Avoid concurrent use of hydrocodone bitartrate and homatropine methylbromide oral solution with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur [see Warnings and Precautions 5.
Concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with a CYP3A4 inhibitor, such as macrolide antibiotics e. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in hydrocodone bitartrate and homatropine methylbromide oral solution-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions.
Concomitant use of hydrocodone bitartrate and homatropine methylbromide 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 physical dependence to hydrocodone. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients who are taking a CYP3A4 inhibitor or inducer.
If concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution with a CYP3A4 inhibitor or inducer is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [ see Drug Interactions 7.
Concomitant use of opioids, including hydrocodone bitartrate and homatropine methylbromide oral solution, 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 [see Drug Interactions 7.
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 hydrocodone bitartrate and homatropine methylbromide oral solution is used with benzodiazepines, alcohol, or other CNS depressants [see Patient Counseling Information 17 ]. Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on hydrocodone bitartrate and homatropine methylbromide oral solution therapy. The co-ingestion of alcohol with hydrocodone bitartrate and homatropine methylbromide oral solution may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Drug Interactions 7.
Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications 4 ]. The use of hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of anticholinergics with hydrocodone bitartrate and homatropine methylbromide oral solution may produce paralytic ileus [see Drug Interactions 7.
The hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution 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 hydrocodone bitartrate and homatropine methylbromide oral solution may cause spasm of the sphincter of Oddi, resulting in an increase in biliary tract pressure.
Opioids may cause increases in serum amylase [see Warnings and Precautions 5. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. In patients who may be susceptible to the intracranial effects of CO 2 retention e.
Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. The hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution 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 hydrocodone bitartrate and homatropine methylbromide oral solution therapy.
Hydrocodone bitartrate and homatropine methylbromide oral solution 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 e.
Monitor these patients for signs of hypotension after initiating hydrocodone bitartrate and homatropine methylbromide oral solution. In patients with circulatory shock, hydrocodone bitartrate and homatropine methylbromide oral solution may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients with circulatory shock.
Hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate and homatropine methylbromide oral solution 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 [see Use in Specific Populations 8.
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 insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of 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 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. Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of hydrocodone bitartrate and homatropine methylbromide oral solution.
The following serious adverse reactions are described, or described in greater detail, in other sections:. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most common adverse reactions to hydrocodone bitartrate and homatropine methylbromide oral solution include: Sedation somnolence, mental clouding, lethargy , impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Anaphylaxis : Anaphylaxis has been reported with hydrocodone, one of the ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution.
Body as a whole : Coma, death, fatigue, falling injuries, lethargy. Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.
Central Nervous System : Facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor. Cases of androgen deficiency have occurred with chronic use of opioids. Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, dry mouth, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm spasm of the sphincter of Oddi.
Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Laboratory : Increases in serum amylase. Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression. Respiratory : Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection. No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution.
Concomitant use of alcohol with hydrocodone bitartrate and homatropine methylbromide oral solution can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone.
Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on hydrocodone bitartrate and homatropine methylbromide oral solution therapy [see Warnings and Precautions 5. The concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution and CYP3A4 inhibitors, such as macrolide antibiotics e.
These effects could be more pronounced with concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and homatropine methylbromide is achieved [see Warnings and Precautions 5. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see Clinical Pharmacology If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals.
The concomitant use of hydrocodone bitartrate and homatropine methylbromide oral solution and CYP3A4 inducers such as rifampin, carbamazepine, or phenytoin, can decrease the plasma concentration of hydrocodone [see Clinical Pharmacology After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see Clinical Pharmacology Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients who are taking CYP3A4 inducers.
If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients who are taking benzodiazepines or other CNS depressants [see Warnings and Precautions 5.
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation.
Discontinue hydrocodone bitartrate and homatropine methylbromide oral solution if serotonin syndrome is suspected. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients who are taking monoamine oxidase inhibitors MAOIs or have taken MAOIs within 14 days.
The use of MAOIs or tricyclic antidepressants with hydrocodone, one of the active ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution, may increase the effect of either the antidepressant or hydrocodone.
MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity e. Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Avoid the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients taking muscle relaxants.
If concomitant use is necessary, monitor patients for signs of respiratory depression that may be greater than otherwise expected. Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Monitor patients for signs of urinary retention or reduced gastric motility when hydrocodone bitartrate and homatropine methylbromide oral solution is used concomitantly with anticholinergic drugs.
Hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions 5.
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