MEDICATION GUIDE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
(HIGH-droe-KOE-dohn by-TAR-trate and hoe-MAT-troe-peen METH-ill-BROE-mide)
tablets and oral solution, for oral administration, C II

What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?

Hydrocodone bitartrate and homatropine methylbromide is not for children under 18 years of age.
Hydrocodone bitartrate and homatropine methylbromide can cause serious side effects, including:

• Addiction, abuse and misuse. Taking hydrocodone bitartrate and homatropine methylbromide or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take hydrocodone bitartrate and homatropine methylbromide exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.

o  Do not share your hydrocodone bitartrate and homatropine methylbromide with other people.

      o Keep hydrocodone bitartrate and homatropine methylbromide in a safe place away from children.

• Life-threatening breathing problems (respiratory depression). Hydrocodone bitartrate and homatropine methylbromide can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking hydrocodone bitartrate and homatropine methylbromide, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly, or have certain other health problems. Children are at higher risk for respiratory depression. Breathing problems can happen even if you take hydrocodone bitartrate and homatropine methylbromide exactly as prescribed by your healthcare provider.

      o increased sleepiness        o shallow breathing
      o confusion                        o limpness
      o difficulty breathing

Keep hydrocodone bitartrate and homatropine methylbromide in a safe place away from children. Accidental use of even 1 dose of    hydrocodone bitartrate and homatropine methylbromide, especially by a child, is a medical emergency and can cause breathing problems    (respiratory depression) which can lead to death. If a child accidentally takes hydrocodone bitartrate and homatropine methylbromide, get    emergency medical help right away.

• Overdose and death due to medicine dosing errors. Overdose and death can happen if you measure the wrong dose of hydrocodone bitartrate and homatropine methylbromide. Always use an accurate milliliter (mL) measuring device to measure the correct amount of hydrocodone bitartrate and homatropine methylbromide. Do not use a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking hydrocodone bitartrate and homatropine methylbromide, including:

      o certain antibiotics

      o certain medicines to treat a fungal infection

      o certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C

      o rifampin

      o carbamazepine

      o phenytoin

   Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider or pharmacist if you are not sure if your    medicine is listed above.

• Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in people who take hydrocodone bitartrate and homatropine methylbromide with benzodiazepines or other central nervous system depressants, including alcohol.

      o Do not take benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with hydrocodone bitartrate and          homatropine methylbromide.

      o Do not drink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with hydrocodone bitartrate          and homatropine methylbromide.

• Opioid withdrawal in a newborn. Use of hydrocodone bitartrate and homatropine methylbromide during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take hydrocodone bitartrate and homatropine methylbromide if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.

What is hydrocodone bitartrate and homatropine methylbromide?

• Hydrocodone bitartrate and homatropine methylbromide is a prescription medicine used in adults to treat a cough. Hydrocodone bitartrate and homatropine methylbromide contains hydrocodone, an opioid (narcotic) cough suppressant.
• Hydrocodone bitartrate and homatropine methylbromide is a federal controlled substance (C-II) because it contains hydrocodone that can be abused or lead to dependence. Keep hydrocodone bitartrate and homatropine methylbromide in a safe place to prevent misuse and abuse. Selling or giving away hydrocodone bitartrate and homatropine methylbromide 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.

Who should not take hydrocodone bitartrate and homatropine methylbromide?
Hydrocodone bitartrate and homatropine methylbromide is not for children under 18 years of age. See “What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?”
Do not take hydrocodone bitartrate and homatropine methylbromide if you:

• have severe breathing problems (respiratory depression) or breathing problems caused by asthma. See “What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?”
• have a blockage (obstruction) in your bowel such as a paralytic ileus.
• are allergic to hydrocodone, homatropine, or any of the ingredients in hydrocodone bitartrate and homatropine methylbromide. See the end of this Medication Guide for a complete list of ingredients.

Ask your healthcare provider if you have any questions about this information.

Before you take hydrocodone bitartrate and homatropine methylbromide, tell your healthcare provider about all of your medical conditions, including if you:
• have a drug addiction                                                • have bile duct or pancreas problems
• have lung or breathing problems                                 • have glaucoma (increased pressure in eyes)
• have a fever and are coughing up mucus                     • have prostate problems
• have had a recent head injury                                     • have problems with your urinary tract or difficulty urinating
• have had a brain tumor or other brain problems            • have kidney or liver problems
• have or have had seizures                                           • have adrenal gland problems
• have pain in your stomach-area (abdomen)                  • have low blood pressure
• have constipation or other bowel problems                   • plan to have surgery

• are pregnant or plan to become pregnant. Hydrocodone bitartrate and homatropine methylbromide can harm your unborn baby. See “What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?”

• are breastfeeding or plan to breastfeed. Hydrocodone passes into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression), and death. You and your healthcare provider should decide if you will take hydrocodone bitartrate and homatropine methylbromide or breastfeed. You should not do both. See “What should I avoid while taking hydrocodone bitartrate and homatropine methylbromide?”

• plan to have children. Hydrocodone bitartrate and homatropine methylbromide may affect the ability to have a child in females and males (fertility problems). It is not known if these fertility problems will be reversible, even after you stop taking hydrocodone bitartrate and homatropine methylbromide. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking hydrocodone bitartrate and homatropine methylbromide with certain other medicines can cause side effects or affect how well hydrocodone bitartrate and homatropine methylbromide or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

• take pain medicines such as opioids (narcotics).
• take cold or allergy medicines that contain antihistamines or cough suppressants.
• drink alcohol.
• take muscle relaxants.
• take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
• take medicines to lower your blood pressure.
• take water pills (diuretics).
• take medicines called “anticholinergics” used to treat certain health problems including asthma, chronic obstructive pulmonary disease (COPD), or stomach problems.

Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take hydrocodone bitartrate and homatropine methylbromide?

• See “What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?”
• Take hydrocodone bitartrate and homatropine methylbromide exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
• Take hydrocodone bitartrate and homatropine methylbromide by mouth only.
• Take hydrocodone bitartrate and homatropine methylbromide using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to help you measure the correct amount of hydrocodone bitartrate and homatropine methylbromide. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
• Do not overfill the measuring device.
• Rinse the measuring device with water after each use.
• If you take too much hydrocodone bitartrate and homatropine methylbromide, call your healthcare provider or go to the nearest hospital emergency room right away.
• Tell your healthcare provider if your cough does not get better within 5 days of treatment with hydrocodone bitartrate and homatropine methylbromide.

What should I avoid while taking hydrocodone bitartrate and homatropine methylbromide?

• Avoid driving a car or operating machinery during treatment with hydrocodone bitartrate and homatropine methylbromide. Hydrocodone bitartrate and homatropine methylbromide can cause you to be drowsy, slow your thinking and motor skills, and affect your vision.
• Do not drink alcohol during treatment with hydrocodone bitartrate and homatropine methylbromide. Drinking alcohol can increase your chances of having serious side effects.

Avoid the use of hydrocodone bitartrate and homatropine methylbromide if you:

• are pregnant. Use of hydrocodone bitartrate and homatropine methylbromide during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
• are breastfeeding. Use of hydrocodone bitartrate and homatropine methylbromide while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.
• take a medicine called a monoamine oxidase inhibitor (MAOI). Avoid taking an MAOI within 14 days after you stop taking hydrocodone bitartrate and homatropine methylbromide. Avoid starting hydrocodone bitartrate and homatropine methylbromide if you stopped taking an MAOI in the last 14 days.

What are the possible side effects of hydrocodone bitartrate and homatropine methylbromide?Hydrocodone bitartrate and homatropine methylbromide can cause serious side effects, including:

• See “What is the most important information I should know about hydrocodone bitartrate and homatropine methylbromide?”
• Bowel problems including severe constipation or stomach pain. See “Who should not take hydrocodone bitartrate and homatropine methylbromide?”
• Increased pressure in your head (intracranial). Avoid the use of hydrocodone bitartrate and homatropine methylbromide if you have a head injury or have been told that you have changes in the tissue of your brain (brain lesions) or increased pressure in your head.
• Increased risk of seizures in people with seizure disorders. If you have a seizure disorder, hydrocodone bitartrate and homatropine methylbromide may increase how often you have a seizure.
• Low blood pressure. A sudden drop in blood pressure can happen in some people during treatment with hydrocodone bitartrate and homatropine methylbromide and this may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). Your risk of having this problem may be increased if you take hydrocodone bitartrate and homatropine methylbromide with certain other medicines that lower blood pressure. If you have any of these symptoms while taking hydrocodone bitartrate and homatropine methylbromide, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
• Adrenal gland problems. Hydrocodone bitartrate and homatropine methylbromide can cause serious and life-threatening adrenal gland problems. Your healthcare provider may do blood tests to check for adrenal gland problems. Call your healthcare provider right away if you have any of these symptoms:

    o nausea    

    o vomiting    

    o not wanting to eat (anorexia)    

    o fatigue    

    o weakness    

    o dizziness    

    o low blood pressure 

The most common side effects of hydrocodone bitartrate and homatropine methylbromide include:

• sleepiness                                                         • headache

• confusion                                                          • dry mouth
• coordination problems                                        • nausea
• decrease in mental and physical performance       • vomiting
• lack of energy                                                    • constipation
• lightheadedness
• dizziness 

These are not all the possible side effects of hydrocodone bitartrate and homatropine methylbromide.
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 hydrocodone bitartrate and homatropine methylbromide?

• Store hydrocodone bitartrate and homatropine methylbromide at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30° C (59° to 86° F).
• Store hydrocodone bitartrate and homatropine methylbromide in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
• Keep hydrocodone bitartrate and homatropine methylbromide and all medicines out of the reach of children.

How should I dispose of hydrocodone bitartrate and homatropine methylbromide?Remove unused hydrocodone bitartrate and homatropine methylbromide from the container and mix it with an undesirable, non-toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash. You can also follow your state or local guidelines on how to safely throw away hydrocodone bitartrate and homatropine methylbromide.  General information about the safe and effective use of hydrocodone bitartrate and homatropine methylbromide.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use hydrocodone bitartrate and homatropine methylbromide for a condition for which it was not prescribed. Do not give hydrocodone bitartrate and homatropine methylbromide to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about hydrocodone bitartrate and homatropine methylbromide that is written for health professionals.  What are the ingredients in hydrocodone bitartrate and homatropine methylbromide?
Active ingredients: hydrocodone bitartrate and homatropine methylbromide
Inactive ingredients in hydrocodone bitartrate and homatropine methylbromide tablets: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch.
Inactive ingredients in hydrocodone bitartrate and homatropine methylbromide oral solution: cherry flavor, FD&C Red #40, glycerin, hydrochloric acid, maltitol syrup, purified water, sodium benzoate, sorbitol, and sucralose. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.Manufactured by: KVK-TECH, INC., Newtown, PA 18940

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 07/2018