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Ceta Plus (Generic Hydrocodone Combination Products)

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Products containing hydrocodone may lead to addiction. As recommended, take your hydrocodone combo medication. Never exceed your doctor’s recommended dosage, frequency, or method of administration. Talk to your healthcare practitioner about your pain management options, treatment duration, and goals while taking hydrocodone combo medications. Inform your doctor if you or any family members currently or in the past have used excessive amounts of alcohol, street drugs, abused prescription medications, experienced an overdose, or have depression or another mental condition. If you currently have or have ever had any of these conditions, you are more likely to overuse a hydrocodone combo product. If you believe you may have an opioid addiction, speak with your healthcare physician right away and ask for advice. You can also contact the SAMHSA National Helpline by calling 1-800-662-HELP.

When taking hydrocodone for the first 24 to 72 hours of treatment or if the dose is raised, breathing issues that are serious or life-threatening can occur. The course of your treatment will be closely monitored by your doctor. Describe to your doctor any asthma or delayed breathing you may have now or in the past. A hydrocodone combo product is probably not something you should take, according to your doctor. Furthermore let your physician know if you now or previously had a lung condition like chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, a head injury, a brain tumour, or any other condition that raises the pressure inside of your head. Being an older adult or being weak or undernourished as a result of a sickness may increase your risk of developing respiratory issues. Immediately call your doctor or seek emergency medical attention if you encounter any of the following symptoms: shortness of breath, delayed breathing, or prolonged breath pauses.

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); benzodiazepines like alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion); erythromycin (Erytab, Erythrocin); drugs for nausea or mental illness, phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate), muscle relaxants, sedatives, sleeping pills, or tranquillizers, as well as other painkillers. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms after taking a hydrocodone combination product with any of these drugs: unusual dizziness, lightheadedness, excessive sleepiness, slowed or trouble breathing, or unresponsiveness. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

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 renew your prescription, your doctor or pharmacist will give you the manufacturer’s patient information page (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. 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 pharmacist 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.

If you will be using hydrocodone combination solution, syrup, or extended-release suspension, do not use a household teaspoon to measure your dose. Household teaspoons are not accurate measuring devices, and you may receive too much medication or not enough medication if you measure your dose with a household teaspoon. Instead, use a properly marked measuring device such as a dropper, medicine spoon, or oral syringe. Ask your doctor or pharmacist if you need help getting or using a measuring device.

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 available for some hydrocodone combination medicines, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist 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 pharmacist 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 ingredients, consult your pharmacist or look in the patient’s information provided by the manufacturer.
  • Inform your doctor and pharmacist 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 (included in numerous cough medicines, including Nuedexta), cyclobenzaprine (Amrix); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); medications for irritable bowel disease, motion sickness, Parkinson’s disease; 5HT3 serotonin blockers such palonosetron (Aloxi), ondansetron (Zofran, Zuplenz), alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), or ondansetron; fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors. Tricyclic antidepressants (also known as “mood elevators”) include amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine. Serotonin and norepinephrine reuptake inhibitors include des (Surmontil). Also let your physician or pharmacist 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.
  • Inform your doctor if you have or have ever had paralytic ileus or any of the disorders listed in the IMPORTANT WARNING section (condition in which digested food does not move through the intestines). Your physician might advise against ingesting a hydrocodone combo product.
  • Inform your physician if you currently or in the past 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 this medicine may lower both male and female fertility. The dangers of using a hydrocodone combo product should be discussed with your doctor.
  • Inform the surgeon or dentist that you are taking a hydrocodone combination product if you are having surgery, including dental surgery.
  • The use of hydrocodone combination drugs may cause drowsiness, therefore be aware of this. Prior to understanding how this drug affects you, avoid using machinery or driving 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?

Typically, this drug is given as needed. Take the missing dose as soon as you remember it if your doctor has instructed you to regularly take a hydrocodone combination product. Afterwards, wait at least 4 hours or at least 12 hours before taking your next dose of tablets, syrup, capsules, or solution, or of extended-release capsules or extended-release solution, respectively. Skip the missed dose and carry on with your regular dosing plan if it is almost time for your next dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Products that combine hydrocodone may have negative side effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Constipation
  • Drowsiness
  • Lightheadedness
  • Unclear thinking
  • Anxiety
  • Unusually joyful or unhappy mood
  • Throat is dry
  • Difficulty urinating
  • Rash
  • Itching
  • Reduction in pupil size (black circles in the centre of the eyes)

Certain adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

  • 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 pharmacist 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 pharmacist. For the directions, speak to your pharmacist 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.

Overdose signs could 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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