Hydrocodone and homatropine (Oral route)

Pronunciation:

hye-droe-KOE-done bye-TAR-trate, hoe-MAT-roe-peen meth-il-BROE-mide

Brand Names:

Hycodan
Hydromet
Tussigon

Dosage Forms:

Syrup
Solution
Tablet

Warnings:

Oral route(Tablet;Solution)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone bitartrate/homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate/homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate/homatropine methylbromide, prescribe hydrocodone bitartrate/homatropine methylbromide for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/homatropine methylbromide. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/homatropine methylbromide or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/homatropine methylbromide, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/homatropine methylbromide. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/homatropine methylbromide.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/homatropine methylbromide with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone bitartrate/homatropine methylbromide in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate/homatropine methylbromide. The co-ingestion of alcohol with hydrocodone bitartrate/homatropine methylbromide may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone bitartrate/homatropine methylbromide is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/homatropine methylbromide during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone bitartrate/homatropine methylbromide is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .

Oral route(Tablet)

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol .

Classifications:

Therapeutic—

Antimuscarinic/Antitussive Combination

Pharmacologic—

Homatropine

Chemical—

Hydrocodone

Uses of This Medicine:

Hydrocodone and homatropine combination is used to treat cough. Hydrocodone is an opioid antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough.

When hydrocodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using opioids to relieve their cough. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and homatropine combination oral liquid and tablets in the pediatric population. Safety and efficacy have not been established. This medicine should not be given to children younger than 6 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and homatropine combination in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and homatropine combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone
Potassium Chloride
Potassium Citrate
Safinamide
Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abametapir
Acepromazine
Aclidinium
Alfentanil
Almotriptan
Alprazolam
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Apalutamide
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asenapine
Atazanavir
Atropine
Avacopan
Baclofen
Belladonna
Belzutifan
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Berotralstat
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butalbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbidopa
Carbinoxamine
Carisoprodol
Carphenazine
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cilostazol
Cimetidine
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabrafenib
Dantrolene
Daridorexant
Darifenacin
Darunavir
Dasabuvir
Delavirdine
Delorazepam
Desipramine
Desmopressin
Desvenlafaxine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicloxacillin
Dicyclomine
Difenoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyrone
Dolasetron
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Duvelisib
Efavirenz
Elagolix
Eletriptan
Enflurane
Enzalutamide
Eplerenone
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etravirine
Fedratinib
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Flavoxate
Flibanserin
Fluconazole
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fosamprenavir
Fosaprepitant
Foscarbidopa
Foslevodopa
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gepirone
Glucagon
Glycopyrrolate
Glycopyrronium Tosylate
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Ipratropium
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lacosamide
Larotrectinib
Lasmiditan
Lemborexant
Lenacapavir
Lesinurad
Letermovir
LetibotulinumtoxinA-wlbg
Levocetirizine
Levodopa
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lonafarnib
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Magnesium Oxybate
Maribavir
Meclizine
Medazepam
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Methacholine
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylprednisolone
Metoclopramide
Metolazone
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Mitotane
Mobocertinib
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nafcillin
Nalbuphine
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicomorphine
Nilotinib
Nirmatrelvir
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Olanzapine
Oliceridine
Omaveloxolone
Ombitasvir
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Ozanimod
Palbociclib
Paliperidone
Palonosetron
Papaveretum
Paregoric
Paritaprevir
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenytoin
Pimozide
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Polythiazide
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Protriptyline
Quazepam
Quetiapine
Quinethazone
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Revefenacin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritlecitinib
Ritonavir
Rizatriptan
Ropeginterferon Alfa-2b-njft
Saquinavir
Schisandra sphenanthera
Scopolamine
Secobarbital
Secretin Human
Selegiline
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sofpironium
Solifenacin
Spironolactone
St John's Wort
Stramonium
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Tazemetostat
Telaprevir
Telithromycin
Telotristat Ethyl
Temazepam
Terodiline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Ticagrelor
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Tranylcypromine
Trazodone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Trofinetide
Troleandomycin
Tropicamide
Trospium
Tryptophan
Tucatinib
Umeclidinium
Venlafaxine
Verapamil
Vilazodone
Vonoprazan
Voriconazole
Vortioxetine
Voxelotor
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Desflurane
Mavacamten

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Acute pancreatitis (swelling of the pancreas) or
Addison's disease (adrenal gland problem) or
Alcohol use disorder, or history of or
Brain tumor, history of or
Drug use disorder or dependence, especially with opioids, or history of or
Enlarged prostate (eg, BPH, prostatic hypertrophy) or
Gallbladder disease or
Head injury, history of or
Increased pressure in the head or
Lung or breathing problems (eg, COPD) or
Narrow-angle glaucoma or
Problems with passing urine or
Thyroid disease or
Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Asthma, acute or severe or
Lung or breathing problems (eg, respiratory depression), severe or
Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

Hypotension (low blood pressure) or
Pancreatitis (swelling of the pancreas) or
Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease, severe or
Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of cough:
- For oral dosage form (solution):
  - Adults—5 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 30 mL in 24 hours.
  - Children—Use is not recommended.
- For oral dosage form (Hydromet solution):
  - Adults—5 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 30 mL in 24 hours.
  - Children 6 years of age and older—Use and dose must be determined by your doctor.
  - Children younger than 6 years of age—Use is not recommended.
- For oral dosage form (tablets):
  - Adults—1 tablet every 4 to 6 hours as needed. Do not take more than 6 tablets in 24 hours.
  - Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. 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.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check your 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.

Using this medicine could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

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 opioids, 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.

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.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and nalmefene to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Using opioids 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 gland problems. 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.

Do not change your dose or suddenly stop using this medicine 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 prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

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.

Side Effects of This Medicine:

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.

Check with your doctor immediately if any of the following side effects occur:

More common: Lightheadedness, dizziness, or fainting; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known: Agitation; bloating or swelling of the face, arms, hands, lower legs, or feet; blurred vision; change in the ability to see colors, especially blue or yellow; chest tightness; chills; confusion; constipation; constricted, pinpoint, or small pupils (black part of the eye); cough; cough producing mucus; dark urine; decrease in the frequency of urination; decrease in urine volume; diarrhea; difficulty, painful, or trouble breathing; difficulty in passing urine (dribbling); difficulty swallowing; discouragement; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; double vision; feeling sad or empty; fever; general feeling of tiredness or weakness; headache; hives, itching, skin rash; hoarseness; indigestion; irregular, fast or slow, or shallow breathing; irritability; lack of appetite; loss of consciousness; loss of interest or pleasure; lower back or side pain; muscle aches; nausea; nervousness; overactive reflexes; pain or cramping in the stomach; painful urination; pains in the stomach, side, or abdomen, possibly radiating to the back; pale or blue lips, fingernails, or skin; poor coordination; pounding in the ears; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; rapid weight gain; restlessness; seeing double; seeing, hearing, or feeling things that are not there; seizures; shakiness and unsteady walk; shivering; sore throat; sores, ulcers, or white spots on the lips or in the mouth; stuffy or runny nose; talking or acting with excitement you cannot control; tingling of the hands or feet; trembling or shaking; trouble concentrating; trouble sleeping; twitching; uncontrolled movements of the face; unsteadiness, trembling, or other problems with muscle control or coordination; unusual bleeding or bruising; unusual weight gain or loss; vomiting; yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Bloody or cloudy urine; change in consciousness; chest pain or discomfort; cold and clammy skin; coughing that sometimes produces a pink frothy sputum; decreased awareness or responsiveness; difficulty or trouble breathing; extreme drowsiness; general feeling of discomfort or illness; increased sweating; irregular, fast or slow, or shallow breathing; irregular heartbeat; lightheadedness, dizziness, or fainting; loss of consciousness; no blood pressure or pulse; no muscle tone or movement; not breathing; pale or blue lips, fingernails, or skin; severe sleepiness; slow or irregular heartbeat; stopping of heart; sudden decrease in the amount of urine; swelling in the legs and ankles; unpleasant breath odor

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. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Dry mouth

Incidence not known: Back pain; decreased appetite; difficulty in moving; drowsiness; false or unusual sense of well-being; fear or nervousness; feeling of warmth; increased sweating; joint pain; mood changes; muscle pain or stiffness; redness of the face, neck, arms and occasionally, upper chest; relaxed and calm; sleepiness; trouble getting pregnant

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 3/11/2025

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.