IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
HYDROCODONE/HOMATROPINE - ORAL
COMMON BRAND NAME(S): Hycodan, Tussigon
USES: This medication is used to relieve a dry cough usually caused by the common cold or other conditions as prescribed by your doctor. Relieving a cough helps you get more rest and sleep. This product contains 2 medications, hydrocodone and homatropine. Hydrocodone is a narcotic 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.g., asthma, emphysema), or for coughs with a lot of mucus or fluids (productive coughs), unless directed by your doctor. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, this product is not recommended to treat cold symptoms in children younger than 6 years. Some products (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Giving more than the recommended dose or using this medication along with other cough-and-cold products has resulted in serious (even fatal) side effects, including slowed/stopped breathing. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray). Do not use this product to make a child sleepy.
HOW TO USE: 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. Children 6-12 years of age should not take more than 3 tablets or 3 teaspoonfuls (15 milliliters) daily. If you are taking the syrup, measure the dose carefully using a special measuring device or spoon. Do not use a household spoon. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat.) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Though it is very unlikely to occur, this medication can also be habit-forming and may result in abnormal drug-seeking behavior (addiction). Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted. 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. Inform your doctor if your symptoms persist or worsen.
SIDE EFFECTS: 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.g., taking with food, lying down for 1-2 hours with as little head movement as possible). Lightheadedness, dizziness, drowsiness, vision changes, vomiting, and constipation may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: severe stomach/abdominal pain, slow/shallow/irregular breathing, difficulty waking up, mental/mood changes (e.g., agitation, confusion), difficult/painful urination. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to hydrocodone; or to homatropine; or to other narcotic medications (e.g., codeine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Addison's disease), abdominal problems (e.g., chronic constipation, gallbladder disease, ileus, pancreatitis), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, hypoxia, emphysema, intoxication with medications that can cause drowsiness or slow/shallow breathing), brain disorders (e.g., head injury, tumor, increased intracranial pressure), severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), certain eye problem (narrow-angle glaucoma), kidney disease, liver disease, personal/family history of regular drug/alcohol abuse, mental/mood disorders (e.g., psychosis), spinal problem (kyphoscoliosis), recent surgery, underactive thyroid (hypothyroidism), difficulty urinating (e.g., enlarged prostate, urethral stricture). This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Before having surgery, tell your doctor or dentist that you are using this medication. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to its effects, especially slow/shallow breathing, drowsiness, and difficulty urinating. Caution is advised when using this product in children, especially if they have breathing problems. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other anticholinergic drugs (e.g., belladonna alkaloids, benztropine), cimetidine, narcotic antagonists (e.g., naltrexone, naloxone), narcotic agonists/antagonists (e.g., butorphanol, nalbuphine), potassium tablets/capsules, pramlintide. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine, morphine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold/allergy products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow breathing, slow heartbeat, cold/clammy skin, loss of consciousness.
NOTES: Do not share this medication with others. It is against the law. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in a tightly closed container at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised September 2011. Copyright(c) 2011 First Databank, Inc.