HYCODAN contains hydrocodone (dihydrocodeinone) bitartrate, a semisynthetic centrally-acting opioid antitussive. Homatropine methylbromide is included in a subtherapeutic amount to discourage deliberate overdosage.

Each HYCODAN tablet or teaspoonful (5 mL) contains:

Hydrocodone Bitartrate, USP............5 mg
Homatropine Methylbromide, USP............1.5 mg

HYCODAN tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, starch and stearic acid.

HYCODAN syrup also contains: caramel coloring, FD&C Red 40, liquid sugar, methylparaben, propylparaben, sorbitol solution and wild cherry imitation flavor. The hydrocodone component is 4,5 α -epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5), a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine, has a molecular weight of (494.50), and may be represented by the following structural formula:

C₁₈H₂₁NO₃·C₄H₆0₆ · 2 1/2 H₂O
HYDROCODONE BITARTRATE

C₁₇H₂₄BrNO₃
HOMATROPINE METHYLBROMIDE

Homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-; a white crystal or fine white crystalline powder, with a molecular weight of (370.29).

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough.

Adults

One (1) tablet or one (1) teaspoonful (5 mL) of the syrup every 4 to 6 hours as needed; do not exceed six (6) tablets or six (6) teaspoonfuls in 24 hours.

Children 6 to 12 Years of Age

One-half (1/2) tablet or one-half (1/2) teaspoonful (2.5 mL) of the syrup every 4 to 6 hours as needed; do not exceed three (3) tablets or three (3) teaspoonfuls in 24 hours.

HYCODAN is supplied as a white, biconvex tablet, one face bisected and debossed with "HYCODAN", and the other face plain, available in:

Bottles of 100..........NDC 63481-042-70
Bottles of 500..........NDC 63481-042-85

Store tablets at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required).

HYCODAN is also available as a clear red colored, wild cherry flavored syrup in:

Bottles of one pint..........NDC 63481-234-16

Store syrup at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

Oral prescription where permitted by state law.

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. May, 2003. FDA Rev date: 01/16/02

Central Nervous System

Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes.

Gastrointestinal System

Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of HYCODAN may produce constipation.

Genitourinary System

Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates.

Respiratory Depression

HYCODAN may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE).

Dermatological

Skin rash, pruritus.

Drug Abuse And Dependence

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is a Schedule III opioid. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, HYCODAN should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when HYCODAN is used for a short time for the treatment of cough. Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

Patients receiving opioids, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with HYCODAN may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of HYCODAN and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (see Drug Abuse And Dependence).

Respiratory Depression

HYCODAN produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated.

Head Injury and Increased Intracranial Pressure

The respiratory depression properties of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of HYCODAN or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In young pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup).

General

Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of cough is identified, that modification of cough does not increase the risk of clinical or physiological complications, and that appropriate therapy for the primary disease is provided.

Special Risk Patients

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal functions, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture, asthma, and narrow-angle glaucoma.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of HYCODAN in animals to evaluate the carcinogenic and mutagenic potential and the effect on fertility have not been conducted.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with HYCODAN. It is also not known whether HYCODAN can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HYCODAN should be given to a pregnant woman only if clearly needed.

Nonteratogenic Effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.

Labor and Delivery

As with all opioids, administration of HYCODAN to the mother shortly before delivery may result in some degree of respiratory depression in the newborn, especially if higher doses are used.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from HYCODAN, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of HYCODAN in pediatric patients under six have not been established.

Signs and Symptoms

Serious overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur. The ingestion of very large amounts of HYCODAN may, in addition, result in acute homatropine intoxication.

Treatment

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

HYCODAN should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

Hydrocodone is a semisynthetic opioid antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and physiological dependence.

Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-β-hydroxymetabolites.

Hydrocodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using HYCODAN should be cautioned accordingly.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

HYDROCODONE/HOMATROPINE - ORAL

(hye-droe-KOE-done/ho-MAT-tro-peen)

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.

Do not use this medication in children younger than 6 years unless specifically directed by the doctor. To decrease the risk for serious side effects, carefully follow all of the doctor's dosage directions. Do not give other cough and cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask your doctor or pharmacist about other ways to relieve cough and cold symptoms (e.g., saline nose drops/spray, using a humidifier or infant nasal suction bulb).

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 dependence, especially if it is used regularly for a long time or if it is used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat. Report any such reactions to your doctor immediately. When stopping long-term, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call 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.

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., pseudomembranous colitis), 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. Use caution while engaging in activities requiring alertness or clear vision such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

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.

This medication should be used only when clearly needed during pregnancy. Using this drug for long periods or in high doses near the expected delivery date is not recommended because it may harm the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. 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 (e.g., furazolidone, isocarboxazid, linezolid, 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 August 2008 Copyright(c) 2008 First DataBank, Inc.