Hycodan (Hydrocodone Bitartrate and Homatropine Methylbromide)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Hycodan (Hydrocodone Bitartrate and Homatropine Methylbromide)

HYCODAN®
(hydrocodone bitartrate and homatropine methylbromide) Tablets And Oral Solution

DRUG DESCRIPTION

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

Each HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablet or teaspoonful (5 mL) contains:

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

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets also contain: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, starch and stearic acid.

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution also contains: caramel coloring, FD&C Red 40, liquid sugar, methylparaben, propylparaben, sorbitol solution and wild cherry imitation flavor. The hydrocodone component is 4,5α-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:

Hydrocodone Bitartrate Structural Formula Illustration

Homatropine Methylbromide Structural Formula Illustration

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).

What are the possible side effects of homatropine and hydrocodone (Hycodan, Hydromet, Tussigon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • painful urination;
  • urinating less than usual or not at all;
  • extreme drowsiness or weakness;
  • feeling like you might pass out;
  • weak or shallow breathing, or breathing that stops;
  • feeling anxious or fearful; or
  • unusual thoughts or...

Read All Potential Side Effects and See Pictures of Hycodan »

What are the precautions when taking hydrocodone bitartrate and homatropine methylbromide (Hycodan)?

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.,...

Read All Potential Precautions of Hycodan »

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.

DOSAGE AND ADMINISTRATION

It is important that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution is measured with an accurate measuring device (see PRECAUTIONS - Information for Patients). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose.

Adults and Adolescents 12 years of Age and Older

One (1) tablet or 5 mL (1 teaspoonful) of the oral solution every 4 to 6 hours as needed; do not exceed six (6) tablets or 30 mL (6 teaspoonfuls) in 24 hours.

Children 6 to 11 Years of Age

One-half (1/2) tablet or 2.5 mL (1/2 teaspoonful) of the oral solution every 4 to 6 hours as needed; do not exceed three (3) tablets or 15 mL (3 teaspoonfuls) in 24 hours.

HOW SUPPLIED

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is supplied as a white, biconvex tablet, one face bisected and debossed with “HYCODAN (hydrocodone bitartrate and homatropine methylbromide) ”, and the other face plain, available in:

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

Store tablets at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [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 (hydrocodone bitartrate and homatropine methylbromide) is also available as a clear red colored, wild cherry flavored oral solution in:

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

Store oral solution 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. August, 2008.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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 (hydrocodone bitartrate and homatropine methylbromide) may produce constipation.

Genitourinary System

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

Respiratory Depression

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSE). Use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children less than 6 years of age has been associated with fatal respiratory depression.

Overdose with HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children 6 years of age and older, in adolescents, and in adults has been associated with fatal respiratory depression.

Postmarketing events seen in children under 6 years of age include accidental overdose, bronchopneumonia, coma, cyanosis, death, death neonatal, dyspnea, pulmonary edema, respiratory arrest, and respiratory depression.

Postmarketing events seen in patients older than 6 years of age include accidental overdose, cardio-respiratory arrest, death due to drug toxicity, non-accidental overdose, and overdose.

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 (hydrocodone bitartrate and homatropine methylbromide) should be prescribed and administered with caution. However, psychic dependence is unlikely to develop when HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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.

Read the Hycodan (hydrocodone bitartrate and homatropine methylbromide) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Patients receiving opioids, antihistamines, antipsychotics, antianxiety agents or other CNS depressants (including alcohol) concomitantly with HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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 (hydrocodone bitartrate and homatropine methylbromide) 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

The use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression (see ADVERSE REACTIONS – Respiratory Depression). HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 (hydrocodone bitartrate and homatropine methylbromide) or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Pediatric Use

In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of opioid cough suppressants in a dose-dependent manner. Caution should be exercised when administering HYCODAN (hydrocodone bitartrate and homatropine methylbromide) to pediatric patients 6 years of age and older because of the potential for fatal respiratory depression. Overdose or concomitant administration of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) with other respiratory depressants may increase the risk of respiratory depression in pediatric patients. Benefit to risk ratio should be carefully considered especially in the pediatric population with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).

PRECAUTIONS

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 (hydrocodone bitartrate and homatropine methylbromide) 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 (hydrocodone bitartrate and homatropine methylbromide) . It is also not known whether HYCODAN (hydrocodone bitartrate and homatropine methylbromide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HYCODAN (hydrocodone bitartrate and homatropine methylbromide) 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 (hydrocodone bitartrate and homatropine methylbromide) 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 (hydrocodone bitartrate and homatropine methylbromide) , 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 (hydrocodone bitartrate and homatropine methylbromide) in pediatric patients under six have not been established. The use of HYCODAN (hydrocodone bitartrate and homatropine methylbromide) in children less than 6 years of age has been associated with cases of fatal respiratory depression (see ADVERSE REACTIONS - Respiratory Depression). HYCODAN (hydrocodone bitartrate and homatropine methylbromide) should be used with caution in pediatric patients 6 years of age and older (see WARNINGS - Pediatric Use).

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 (hydrocodone bitartrate and homatropine methylbromide) 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.

CONTRAINDICATIONS

HYCODAN (hydrocodone bitartrate and homatropine methylbromide) should not be administered to patients who are hypersensitive to hydrocodone or homatropine methylbromide.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Hydrocodone may produce marked drowsiness and 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 (hydrocodone bitartrate and homatropine methylbromide) should be cautioned accordingly.

Patients should be advised to measure HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Keep out of the reach of children.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Hydrocodone may produce marked drowsiness and 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 (hydrocodone bitartrate and homatropine methylbromide) should be cautioned accordingly.

Patients should be advised to measure HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Keep out of the reach of children.

Last reviewed on RxList: 3/19/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Hycodan Consumer

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

(HYE-droe-KOE-done/hoe-MAT-roe-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.

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.

Disclaimer

Hycodan Consumer (continued)

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.

Read the Hycodan (hydrocodone bitartrate and homatropine methylbromide) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Hycodan Consumer (continued)

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.

Hycodan Patient Information Including Side Effects

Brand Names: Hycodan, Hydromet, Tussigon

Generic Name: homatropine and hydrocodone (Pronunciation: HOM a TROE peen and HYE dro KOE done)

What is homatropine and hydrocodone (Hycodan)?

Hydrocodone is a narcotic cough medicine.

Homatropine is a drug that works against the narcotic to prevent an overdose of this medication.

The combination of homatropine and hydrocodone combination is used to treat cough.

Homatropine and hydrocodone may also be used for purposes not listed in this medication guide.

Hycodan

round, white, imprinted with HYCODAN

What are the possible side effects of homatropine and hydrocodone (Hycodan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • painful urination;
  • urinating less than usual or not at all;
  • extreme drowsiness or weakness;
  • feeling like you might pass out;
  • weak or shallow breathing, or breathing that stops;
  • feeling anxious or fearful; or
  • unusual thoughts or behavior.

Less serious side effects may include:

  • mild drowsiness, dizziness;
  • trouble concentrating;
  • nausea, vomiting, constipation; or
  • skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Hycodan (hydrocodone bitartrate and homatropine methylbromide) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about homatropine and hydrocodone (Hycodan)?

Before using homatropine and hydrocodone, tell your doctor if you have asthma or other breathing problems, liver or kidney disease, stomach problems, a underactive thyroid, Addison's disease, enlarged prostate or urination problems, glaucoma, or a history of drug addiction or alcoholism.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Drinking alcohol can increase certain side effects of homatropine and hydrocodone.

Before you take this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by homatropine and hydrocodone.

Homatropine and hydrocodone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Side Effects Centers

Hycodan Patient Information including How Should I Take

What should I discuss with my health care provider before taking homatropine and hydrocodone (Hycodan)?

You should not use this medication if you are allergic to homatropine or hydrocodone.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

  • asthma or other breathing problems;
  • a history of head injury or brain tumor;
  • liver disease;
  • kidney disease;
  • stomach problems;
  • underactive thyroid;
  • Addison's disease;
  • enlarged prostate or urination problems;
  • glaucoma; or
  • a history of drug addiction or alcoholism.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using homatropine and hydrocodone.

It is not known whether homatropine and hydrocodone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 6 years old. Homatropine and hydrocodone may cause serious breathing problems in a young child.

Older adults and people who are debilitated may be more likely to have side effects from this medication.

How should I take homatropine and hydrocodone (Hycodan)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water. Drink plenty of water to prevent constipation that may be caused by homatropine and hydrocodone.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using homatropine and hydrocodone.

Store at room temperature away from heat, moisture, and light.

Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers

Hycodan Patient Information including If I Miss a Dose

What happens if I miss a dose (Hycodan)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Hycodan)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness, limp muscles, cold or clammy skin, blue lips, slow heart rate, fainting, shallow breathing, or breathing that stops.

What should I avoid while taking homatropine and hydrocodone (Hycodan)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of homatropine and hydrocodone.

What other drugs will affect homatropine and hydrocodone (Hycodan)?

Before taking homatropine and hydrocodone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by homatropine and hydrocodone.

This list is not complete and other drugs may interact with homatropine and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about homatropine and hydrocodone.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com