Hycodan

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 4,5?-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 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 homatropine and hydrocodone and call your doctor at once if you have any of these serious side effects:

  • 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...

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


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.

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.

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. Consult your doctor before breast-feeding.


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)?
  • What are the possible side effects of homatropine and hydrocodone (Hycodan)?
  • What is the most important information I should know about homatropine and hydrocodone (Hycodan)?
  • What should I discuss with my health care provider before taking homatropine and hydrocodone (Hycodan)?
  • How should I take homatropine and hydrocodone (Hycodan)?
  • What happens if I miss a dose (Hycodan)?
  • What happens if I overdose (Hycodan)?
  • What should I avoid while taking homatropine and hydrocodone (Hycodan)?
  • What other drugs will affect homatropine and hydrocodone (Hycodan)?
  • Where can I get more information?

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 homatropine and hydrocodone combination is used to treat cough.

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

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 homatropine and hydrocodone and call your doctor at once if you have any of these serious side effects:

  • 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.

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 a asthma or other breathing problems, 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.

Do not take more of this medication than prescribed. Adults should not take more than 1 tablet every 4 to 6 hours or 1 teaspoon of the liquid medicine every 4 to 6 hours. Children should not take more than one half-tablet every 4 to 6 hours or one half-teaspoon of the liquid medicine every 4 to 6 hours.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Homatropine and hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Avoid drinking alcohol, which can increase some of the side effects of homatropine and hydrocodone.

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

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

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