How much hydromet is safe to take




















Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www. It is very important that your doctor check your or your child's progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your cough does not improve or if it gets worse within 5 days, call your doctor. This medicine will add to the effects of alcohol and other CNS depressants medicines that can make you drowsy or less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Check with your doctor before taking any of these medicines while you are using this medicine. If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Symptoms of an overdose include: extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin. In case of an overdose, call your doctor right away. This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

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. 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.

There are no available data with hydrocodone bitartrate and homatropine methylbromide oral solution 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 see Data. Reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution; however, studies are available with individual active ingredients or related active ingredients see Data.

In animal reproduction studies, hydrocodone administered by the subcutaneous route to pregnant hamsters during the period of organogenesis produced a teratogenic effect at a dose approximately 45 times the maximum recommended human dose MRHD see Data. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U. 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 and abnormal sleep pattern, high pitched cry, tremor, 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 the newborn.

Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions 5. 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 reversal of opioid-induced respiratory depression in the neonate.

Opioids, including hydrocodone bitartrate and homatropine methylbromide, can prolong labor through actions which 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. A limited number of pregnancies have been reported in published observational studies and postmarketing reports describing hydrocodone use during pregnancy. However, these data cannot definitely establish or exclude any drug-associated risk during pregnancy.

Methodological limitations of these observational studies include small sample size and lack of details regarding dose, duration and timing of exposure. Reproductive toxicity studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide; however, studies are available with individual active ingredients or related active ingredients. H y d r ocodone. Reproductive toxicology studies were also conducted with codeine, an opiate related to hydrocodone. 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 with hydrocodone bitartrate and homatropine methylbromide oral solution.

There are no data on the presence of hydrocodone bitartrate and homatropine methylbromide in human milk, the effects of hydrocodone bitartrate and homatropine methylbromide on the breastfed infant, or the effects of hydrocodone bitartrate and homatropine methylbromide on 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 the early post-partum period with relative infant doses of hydrocodone ranging between 1.

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 see Clinical Considerations. Infants exposed to hydrocodone bitartrate and homatropine methylbromide 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. Chronic use of opioids, such as hydrocodone, a component of hydrocodone bitartrate and homatropine methylbromide oral solution, may cause reduced fertility in females and males of reproductive potential.

It is not known whether these effects on fertility are reversible [see Adverse Reactions 6 , Clinical Pharmacology Hydrocodone bitartrate and homatropine methylbromide oral solution is not indicated for use in patients younger than 18 years of age because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks for use of hydrocodone in these patients [see Indications 1 , Warnings and Precautions 5.

Life-threatening respiratory depression and death have occurred in children who received hydrocodone [see Warnings and Precautions 5. Clinical studies have not been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution in geriatric populations. Use caution when considering the use of hydrocodone bitartrate and homatropine methylbromide oral solution in patients 65 years of age or older.

Elderly patients may have increased sensitivity to hydrocodone; greater frequency of decreased hepatic, renal, or cardiac function; or concomitant disease or other drug therapy [see Warnings and Precautions 5.

Respiratory depression is the chief risk for elderly patients treated with opioids, including hydrocodone bitartrate and homatropine methylbromide oral solution. Respiratory depression has occurred after large initial doses of opioids were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration [see Warnings and Precautions 5.

Hydrocodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, monitor these patients closely for respiratory depression, sedation, and hypotension. The pharmacokinetics of hydrocodone bitartrate and homatropine methylbromide oral solution has not been characterized in patients with renal impairment.

Patients with renal impairment may have higher plasma concentrations than those with normal function [see Clinical Pharmacology Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur. Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders. This is not a complete list of side effects and others may occur.

Call your doctor for medical advice about side effects. Avoid driving or operating machinery until you know how this medicine will affect you.

Dizziness or severe drowsiness can cause falls or other accidents. Use Homatropine And Hydrocodone Hydromet exactly as directed on the label, or as prescribed by your doctor.

Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label and read all medication guides.

Never use this medicine in larger amounts, or for longer than prescribed. Cold or cough medicine is only for short-term use until your symptoms clear up. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medicine in a place where others cannot get to it.

Selling or giving away this medicine is against the law. Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device not a kitchen spoon. Rinse after each use. Call your doctor if your symptoms do not improve after 5 days, or if you have a fever, rash, or headaches.



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