PATIENT INFORMATION
HYCODAN
(hy-k∂-dan)
(hydrocodone bitartrate and homatropine methylbromide) Tablets and Oral
Solution
What is the most important information I should know about HYCODAN?
- Taking HYCODAN with benzodiazepines or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
- HYCODAN can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with HYCODAN.
- Women who breastfeed should talk to their healthcare provider before taking HYCODAN.
- Call your healthcare provider or get emergency medical help right away if anyone taking HYCODAN has any of the symptoms below:
- increased sleepiness
- shallow breathing
- Confusion
- limpness
- difficulty breathing
- your baby has difficulty breastfeeding
- Keep HYCODAN in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes HYCODAN, get emergency medical help right away.
- HYCODAN can cause serious side effects including death.
- Take HYCODAN exactly as prescribed by your healthcare provider. If you take the wrong dose of HYCODAN, you could overdose and die.
- HYCODAN is not for children under 6 years of age.
What is HYCODAN?
- HYCODAN is a prescription medicine used to treat a cough in adults and children 6 years and older. HYCODAN contains hydrocodone and is a narcotic cough suppressant.
- HYCODAN is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence. Keep HYCODAN in a safe place to prevent misuse and abuse. Selling or giving away HYCODAN may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
- HYCODAN is not for children under 6 years of age.
Who should not take HYCODAN?
- Do not take HYCODAN if you are allergic to hydrocodone or homatropine methylbromide. See the end of this Medication Guide for a complete list of ingredients.
Before you take HYCODAN, tell your healthcare provider about all of your medical conditions, including if you:
- have a drug dependence
- plan to have surgery
- have lung or breathing problems
- drink alcohol
- have had a head injury
- have kidney or liver problems
- have pain in your stomach-area (abdomen)
- have diabetes
- have a history of severe or persistent cough
- have thyroid problems, such as hypothyroidism
- have prostate problems
- have Addison’s disease
- have problems with your urinary tract (urethral stricture)
- have glaucoma (increased pressure in eyes)
- are pregnant or plan to become pregnant. It is not known if HYCODAN can harm your unborn baby. You and your healthcare provider should decide if you should take HYCODAN while you are pregnant.
- are breastfeeding or plan to breastfeed. It is not known if HYCODAN passes into your breast milk. You and your healthcare provider should decide if you will take HYCODAN or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking HYCODAN with certain other medicines can cause side effects or affect how well HYCODAN or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:
- take pain medicines such as narcotics
- take cold or allergy medicines that contain antihistamines or cough suppressants
- take medicines for mental illness (anti-psychotics, anti-anxiety)
- drink alcohol
- take medicines for depression, including monoamine oxidase inhibitors (MAOIs) and tricyclics Ask your healthcare provider if you are not sure if you take one of these medicines.
How should I take HYCODAN?
- Take HYCODAN exactly as your healthcare provider tells you to take it.
- Your healthcare provider will tell you how much HYCODAN to take and when to take it. Do not change your dose without talking to your healthcare provider.
- Ask your pharmacist to give you a measuring device to help you measure the correct amount of HYCODAN. Do not use a household teaspoon to measure your medicine. You may accidently take too much. If you take too much HYCODAN, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking HYCODAN?
- HYCODAN can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with HYCODAN.
- Avoid drinking alcohol during treatment with HYCODAN. Drinking alcohol can increase your chances of having serious side effects.
What are the possible side effects of HYCODAN?
HYCODAN may cause serious side effects, including:
- See “What is the most important information I should know about HYCODAN?
- Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you are sleeping more than usual, have shallow slow breathing, or confusion.
- Physical dependence or abuse. Take HYCODAN exactly as your healthcare provider tells you to take it. Stopping HYCODAN suddenly could cause withdrawal symptoms.
- Bowel problems including constipation or stomach pain.
- Increased intracranial pressure
The most common side effects of HYCODAN include:
- sleepiness
- confusion
- nausea and vomiting
- difficulty urinating
- trouble breathing
These are not all the possible side effects of HYCODAN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store HYCODAN?
- Store HYCODAN tablets and oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep HYCODAN tablets in a tightly closed, child-resistant container and out of the light.
- Keep HYCODAN tablets and oral solution, and all medicines out of the reach of children.
General information about the safe and effective use of HYCODAN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HYCODAN for a condition for which it was not prescribed. Do not give HYCODAN to other people, even if they have the same symptoms that you have.
You can ask your pharmacist or healthcare provider for information about HYCODAN that is written for health professionals.
What are the ingredients in HYCODAN?
Active ingredient: hydrocodone bitartrate and homatropine methylbromide.
Inactive ingredients in HYCODAN tablets: calcium phosphate dibasic, colloidal silicon dioxide, lactose, magnesium stearate, starch and stearic acid.
Inactive ingredients in HYCODAN oral solution: caramel coloring, FDA&C Red 40, liquid sugar, methylparaben, propylparaben, sorbitol solution and wild cherry imitation flavor.