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Endacof-Plus (Generic Hydrocodone Combination Products)

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Combination products with hydrocodone may lead to addiction. Follow the directions on your hydrocodone combo product precisely. Do not take it in larger amounts, more frequently, or otherwise differently than prescribed by your doctor. Discuss your pain management options, treatment duration, and goals with your healthcare professional while taking hydrocodone combo medicines. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you now have or has had any of these conditions, there is a higher chance that you will misuse a hydrocodone combo medication. If you suspect an opioid addiction, consult your doctor right away and ask for advice. You can also contact the SAMHSA National Helpline by calling 1-800-662-HELP, which is operated by the U.S. Substance Abuse and Mental Health Services Administration.

The initial 24 to 72 hours of treatment with hydrocodone, as well as any time your dose is increased, can be particularly dangerous for your breathing. Throughout your therapy, your doctor will keep a close eye on you. If you have asthma or slow breathing, let your doctor know. Most likely, your doctor will advise against using a hydrocodone combo product. A head injury, a brain tumour, or any condition that raises the pressure inside of your skull should also be disclosed to your doctor. Lung ailments including chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, should also be mentioned. The likelihood that you will experience breathing issues may be increased if you are an older adult, weak, or undernourished as a result of a sickness. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: sluggish breathing, protracted breath gaps, or shortness of breath.

Children who used a hydrocodone combo medicine reported serious and potentially fatal breathing issues, including slow or difficult breathing and fatalities. Children under the age of 18 should never take hydrocodone to manage pain or a cough. See your kid’s doctor about other therapies if your child is currently receiving a prescription for a cough and cold remedy that contains hydrocodone.

A hydrocodone combination product’s risk of serious or life-threatening respiratory issues, sedation, or coma may rise when certain drugs are also taken.
If you are taking, intend to take, or intend to discontinue taking any of the following medications, let your doctor know right away: some antifungal drugs, such as voriconazole (Vfend), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, and flurazepam are examples of benzodiazepines, erythromycin (Erytab, Erythrocin); lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); drugs for mental illness or nausea; certain HIV medications, such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); rifampin (Rifadin, Rimactane, in Rifamate), phenytoin (Dilantin, Phenytek), other painkillers, muscle relaxants, sedatives, sleeping aids, or tranquillizers. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. If you take any of these drugs along with a hydrocodone combination product and experience any of the following symptoms, contact your doctor right away or seek emergency medical attention: unusual dizziness, lightheadedness, extreme drowsiness, slowed or trouble breathing, or unresponsiveness. Make sure your carer or family members are aware of any symptoms that could be significant so they can contact an emergency room or a doctor if you are unable to do so on your own.

You have a higher risk of developing these severe, potentially fatal side effects while receiving treatment with a hydrocodone combination product if you consume alcohol, use alcohol-containing prescription or over-the-counter drugs, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

Do not share your medication with anybody else. Some individuals who take your drug, particularly children, may suffer injury or even pass away from hydrocodone.

If you are pregnant or want to become pregnant, let your doctor know. Regular use of a hydrocodone combo medication during pregnancy may put your unborn child in danger of experiencing life-threatening withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.

When you start therapy with a hydrocodone combination medication and each time you refill your prescription, your doctor or chemist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The dangers of using a hydrocodone combo product should be discussed with your doctor.

Why is this medication prescribed?

There are products that combine hydrocodone with additional substances, and they are prescribed for various purposes. To treat moderate to severe pain, several hydrocodone combination medications are used. To treat coughs, other hydrocodone combination medications are employed. In addition to being an antitussive, hydrocodone belongs to the group of drugs known as opiate (narcotic) analgesics. By altering how the brain and nerve system react to pain, hydrocodone reduces pain. By reducing activity in the area of the brain that triggers coughing, hydrocodone reduces coughing.

Although you will combine hydrocodone with at least one additional drug, this monograph exclusively covers hydrocodone. Make careful to read the contents list for the hydrocodone product you are using. If you have any inquiries, speak with your physician or pharmacist.

How should this medicine be used?

Products containing a mixture of hydrocodone are available as tablets, capsules, syrup, solutions (clear liquids), extended-release (long-acting) capsules, and extended-release (long-acting) suspensions (liquids). Typically, every 4 to 6 hours, depending on necessity, the tablet, capsule, syrup, and solution are consumed. It is typical to take the extended-release capsule or suspension every 12 hours as needed. If you regularly take hydrocodone, try to take it at roughly the same time each day. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following.

Do not break, chew, or crush the extended-release capsules; instead, swallow them whole.

Before each usage, thoroughly shake the extended-release suspension to evenly distribute the medication. The extended-release suspension should not be used with other drugs or fluids, such as water.

Never use a regular teaspoon to measure your dose of a hydrocodone combination solution, syrup, or extended-release suspension. You risk receiving too much or too little medication if you estimate your dose with a household teaspoon because they are not precise measuring tools. Use a dropper, medicine spoon, or oral syringe instead as long as it is appropriately marked. If you need assistance getting or using a measuring device, consult your doctor or chemist.

If your symptoms are not being managed by the hydrocodone combo medicine you are taking, contact your doctor. Don’t alter your prescription dosage on your own. If you take more medication or take it more frequently than recommended by your doctor, you could experience a deadly overdose.

Do not discontinue taking a hydrocodone combination product if you have been using it for many weeks or longer without first consulting your doctor. A hydrocodone combo medicine may cause withdrawal symptoms if you stop using it abruptly. Your dose will likely be gradually reduced by your doctor.

For a copy of the manufacturer’s information for the patient, which is provided for some hydrocodone combination medicines, ask your chemist or doctor.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking a hydrocodone combination product,

  • Inform your doctor and chemist if you have any allergies to hydrocodone, the other medication in the hydrocodone combination product you are taking, any other medications, any of the ingredients in the hydrocodone combination product, other opiate (narcotic) medications like morphine or codeine, or any other medications. For a list of the chemicals, consult your chemist or look in the patient’s information provided by the manufacturer.
  • Inform your doctor and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: antipsychotics, antihistamines, and antidepressants (medications for mental illness) ipratropium (Atrovent), lithium (Lithobid), dextromethorphan (present with several cough medicines, including Nuedexta), cyclobenzaprine (Amrix), and drugs for irritable bowel syndrome, motion sickness, Parkinson’s disease, seizures, ulcers, or urinary issues; medications for migraine headaches include sumatriptan (Imitrex, in Treximet), eletriptan (Relpax), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig); 5HT3 serotonin blockers like alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); mirtazapine (Remeron); selective serotonin-reuptake inhibitors such fluoxetine (Prozac, Sarafem, in Symbyax), citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake blockers such milnacipran (Savella), desvenlafaxine (Effexor), duloxetine (Cymbalta), and desvenlafaxine (Khedezla); drugs like tramadol, trazodone (Oleptro), and tricyclic antidepressants (sometimes known as “mood elevators”) like amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), and doxepin (Silenor), nortriptyline (Pamelor), protriptyline (Vivactil), imipramine (Tofranil), and trimipramine (Surmontil). Also let your physician or chemist know if you are taking or have recently stopped taking any of the following monoamine oxidase (MAO) inhibitors: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Be important to inform your doctor about all of the medications you are taking, even any that do not appear on this list, as many other drugs may also interact with hydrocodone combination products. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
  • If you have or have ever experienced paralytic ileus or any of the disorders listed in the IMPORTANT WARNING section, let your doctor know (condition in which digested food does not move through the intestines). A hydrocodone combo product might not be recommended by your doctor.
  • Inform your physician if you experience or have ever experienced urinary incontinence, seizures, thyroid, intestinal, liver, pancreatic, gallbladder, or renal problems.
  • If you are breastfeeding, let your doctor know.
  • You should be aware that both men and women who use this medicine may have decreased fertility. Discuss the dangers of using a hydrocodone combo product with your doctor.
  • Inform your surgeon or dentist if you are taking a hydrocodone combination product before any type of surgery, including dental surgery.
  • You need to be aware that hydrocodone combo drugs can cause drowsiness. Before you know how this prescription affects you, do not operate machinery or drive a car.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Usually, this drug is consumed as required. Take the missing dose as soon as you remember it if your doctor has prescribed you a hydrocodone combo medication on a regular basis. Then wait at least 4 hours or 12 hours before taking your next dose of tablets, syrup, capsules, or solution. If you are using extended-release capsules or an extended-release solution, wait at least 24 hours before taking your next dose. Skip the missed dose if your next dose is soon due and carry on with your regular dosing plan. Never take two doses at once to make up for missing ones.

What side effects can this medication cause?

Products containing both hydrocodone and other ingredients may have negative effects. If any of these symptoms are severe or do not go away, consult your doctor right once:

  • Constipation
  • Drowsiness
  • Lightheadedness
  • Unclear thinking
  • Anxiety
  • Abnormally happy or melancholy feelings
  • Throat is dry
  • Having trouble urinating
  • Rash
  • Itching
  • Reduction in pupil size (black circles in the centre of the eyes)

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you have any of these symptoms:

  • Sluggish or erratic breathing
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Chest constriction

Products that combine hydrocodone may result in additional negative effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). Any medication that has expired or is no longer needed must be disposed of right away via a medicine take-back programme. If you do not have a take-back programme nearby or that you can quickly access, flush any obsolete or no longer required hydrocodone combo products down the toilet to prevent others from taking them. See your chemist for advice on how to properly dispose of your medications.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should speak with your doctor about keeping naloxone on hand while taking a hydrocodone combo medicine (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. If you live with young children or someone who has abused prescription or illicit drugs, your doctor could also advise you to get naloxone. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or chemist. For the directions, speak to your chemist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Symptoms of overdose may include the following:

  • Expanded or narrowed pupils
  • Breathing that is irregular, shallow, or nonexistent
  • Having trouble breathing
  • Slow or irregular heartbeat
  • Clammy, cold, or bluish skin
  • Extreme drowsiness
  • Not able to speak or awaken
  • Seizures

What other information should I know?

Keep all of your appointments with your physician and the lab. In order to monitor your body’s reaction to a hydrocodone combo medication, your doctor will need specific lab tests.

Inform your doctor and the lab staff that you are taking hydrocodone prior to any laboratory test (particularly one that uses methylene blue).

This medication cannot be renewed. Call your doctor if you experience pain or a cough after taking your prescription.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

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