Gani-Tuss NR (Generic Codeine)
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WARNING
Codeine could lead to habit formation. Administer codeine precisely as prescribed. Do not take it in larger amounts, more frequently, or otherwise differently than prescribed by your doctor. Discuss your pain management objectives, course of treatment, and additional pain management options with your healthcare professional while taking codeine. 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 currently have or have ever had any of these conditions, you are more likely to abuse codeine. 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.
Breathing issues brought on by codeine can be significant or even fatal, especially in the first 24 to 72 hours of treatment and whenever the amount is raised. 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 codeine. Additionally, let your physician know if you now have 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 tumor, or any other condition that raises the pressure inside of your skull. 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 codeine were reported to have serious and perhaps fatal breathing issues, including fatalities and slow or labored breathing. Children under the age of 18 should never be given codeine to alleviate pain or a cough. Consult your kid’s doctor about other therapies if your child is currently on a codeine-containing cough and cold medication.
You run a higher chance of developing breathing issues or other severe, life-threatening respiratory issues, drowsiness, or coma if you take certain drugs while receiving codeine therapy. Inform your physician if you are now taking or intend to take any of the following drugs: certain antifungal drugs, including ketoconazole; certain antibiotics such erythromycin (Erytab, Erythrocin); benzodiazepines including carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril), alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); drugs for mental illness or nausea; certain HIV medications, such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); other painkillers, muscle relaxants, rifampin (Rifadin, Rimactane, in Rifamate), phenytoin (Dilantin, Phenytek), sedatives, sleeping medicines, or tranquilizers. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away or go to an emergency room if you take codeine with any of these drugs and experience any of the following symptoms: Unusual lightheadedness, drowsiness, breathing that is sluggish or difficult, or inability to respond. If you are unable to seek treatment on your own, make sure your caregiver or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.
You run a higher chance of developing these severe, sometimes fatal side effects if you consume alcohol or other illegal substances while taking codeine. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.
If you are pregnant or want to become pregnant, let your doctor know. Codeine use during pregnancy increases the risk of your unborn child developing potentially fatal 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, diarrhea, or failure to gain weight.
Never let someone else take your medication. Children, especially, who take your prescription with codeine risk injury or even death.
When you start receiving codeine therapy and each time you refill your prescription, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website or the manufacturer’s website.
Why is this medication prescribed?
To treat mild to severe pain, codeine is utilized. It is also employed to lessen coughing, typically in conjunction with other drugs. While codeine will aid in symptom relief, it won’t address their underlying causes or hasten the healing process. In addition to being an antitussive, codeine is a member of the opiate (narcotic) analgesic drug class. The way the brain and nervous system react to pain is altered when codeine is used to relieve pain. Codeine serves to lessen coughing by reducing activity in the area of the brain that triggers coughing.
Additionally, codeine can be found as a constituent in many cough and cold treatments as well as in products that combine it with acetaminophen, aspirin, carisoprodol, and promethazine (such as Capital and Codeine and Tylenol with Codeine). Only information about the usage of codeine is covered in this monograph. If you are taking a medicine that contains both codeine and another substance, make sure to read the contents list and contact your doctor or pharmacist for more details.
How should this medicine be used?
Codeine is available as a tablet, a capsule, and a solution (liquid) for oral administration (alone or in combination with other drugs). As needed, it is typically taken every 4 to 6 hours. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer codeine precisely as prescribed.
Do not discontinue taking codeine if you have been doing it for several weeks or longer without first consulting your doctor. Your dosage may progressively be reduced by your doctor. If you suddenly stop taking codeine, you might experience withdrawal symptoms like agitation, widened pupils (black circles in the center of the eyes), teary eyes, irritability, anxiety, runny nose, difficulty falling or staying asleep, yawning, sweating, rapid breathing, rapid heartbeat, chills, hair standing on end on your arms, nausea, loss of appetite, vomiting, diarrhea, stomach cramps, muscle aches, or backaches.
Before each usage, thoroughly shake the mixture to combine the medication. Don’t measure your dose with a regular spoon. Use a spoon made specifically for measuring medication, the measuring cup that came with the medicine, or both.
Other uses for this medicine
Ask your doctor or pharmacist for more details if you’re interested in using this drug for any other conditions.
What special precautions should I follow?
Before taking codeine,
- If you have any allergies, including to codeine, other drugs, or any of the substances in the codeine product you intend to use, let your doctor and pharmacist know right once. For a list of the ingredients, ask your doctor or pharmacist.
- Inform your physician or pharmacist if you are currently taking any of the following monoamine oxidase (MAO) inhibitors: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate), or if you have recently stopped taking any of them. If you are now taking any of these drugs or have recently taken them, your doctor will likely advise against taking codeine.
- Inform your doctor and pharmacist about any vitamins, nutritional supplements, herbal items, and prescription and over-the-counter medicines you are now taking or intend to take. Any of the following should be mentioned: Bupropion (Wellbutrin, Zyban, Aplenzin); Cyclobenzaprine (Amrix); medication for anxiety or seizures; diuretics (‘water pills’); lithium (Lithobid); drugs for allergies, colds, or coughs; almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig) are among the migraine treatments; alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); the antidepressant 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 (Khedezla, Pristiq), and venlafaxine (Effexor); trazadone (Oleptro), tramadol (Conzip), and tricyclic antidepressants (often known as “mood elevators”) such amitriptyline, clomipramine (Anafranil), nortriptyline (Pamelor), doxepin (Silenor), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil) are some examples of the drugs in this class. Codeine may also interact with many other drugs, so be sure to let your doctor know about all the drugs you’re taking, even if they don’t appear on this list. 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 suffer from any of the disorders listed in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (a condition where the intestines do not move the digested food). Your doctor might advise against taking codeine.
- If you drink or have just had surgery on your urinary or abdominal tract, let your doctor know. If you have or have ever had seizures, mental illness, prostatic hypertrophy (enlargement of a male reproductive gland), urinary issues, low blood pressure, Addison’s disease (condition in which the body does not produce enough of certain natural substances), thyroid, pancreatic, intestinal, gallbladder, liver, or kidney disease, be sure to let your doctor know as well.
- You should be aware that both men and women who use this medicine may have decreased fertility. Discuss the dangers of taking codeine with your doctor.
- If you are breastfeeding, let your doctor know. While using codeine, you shouldn’t breastfeed. Codeine can result in shallow breathing, noisy breathing, disorientation, excessive drowsiness, nursing difficulties, or limpness in breastfed newborns.
- Inform your doctor or dentist that you are taking codeine if you are having surgery, including dental surgery.
- You should be aware that this drug may cause you to feel sleepy. Until you know how this drug affects you, do not operate machinery or drive a car.
- You should be aware that if you stand up too rapidly from a supine position while taking codeine, you could have dizziness, lightheadedness, and fainting. When you initially begin using codeine, this happens more frequently. Get out of bed carefully, resting your feet on the floor for a few minutes before rising up, to avoid this issue.
- You should be aware that codeine may cause constipation. Consult your doctor about modifying your diet and using additional drugs to treat or prevent constipation.
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?
As needed, codeine is typically taken. Take the missed dose of codeine as soon as you remember it if your doctor has prescribed it to you on a regular basis. Skip the missed dose and carry on with your regular dosing plan, nevertheless, if it is almost time for the subsequent dose. Never take two doses at once to make up for missing ones.
What side effects can this medication cause?
Possible negative consequences of codeine. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Headache
- Abdominal pain
- Having trouble urinating
Some adverse effects can be very harmful. Call your doctor right away, stop taking codeine, and get emergency medical assistance if you notice any of the symptoms below or those in the IMPORTANT WARNINGS section:
- 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 diarrhea
- Nausea, vomiting, weight loss, anorexia, or lightheadedness
- Failure to achieve or maintain erection
- Irregular periods of time
- Less sexual arousal
- Loud or irregular breathing
- Breathing or swallowing challenges
- Alterations in heartbeat
- Rash
- Itching
- Hives
- Alterations to vision
- Seizures
Other negative effects of codeine are possible. If you have any strange side effects while taking this medicine, contact your doctor right once.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.
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 at room temperature and out of the bathroom and other places with excessive heat and moisture.
As 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.http://www.upandaway.org
To make sure that pets, kids, and other people cannot take leftover pharmaceuticals, they should be disposed of in a specific manner. You shouldn’t flush this medication down the toilet, though. The best option to get rid of your medication is instead through a medication take-back program. To find out about take-back initiatives in your neighborhood, speak with your pharmacist or get in touch with your city’s waste/recycling department. If you do not have access to a take-back program, you can find more information at the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p).
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. 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 handy while taking codeine (for example, at home or the 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:
- Having trouble breathing
- Weak or sluggish breathing
- Extreme tiredness or drowsiness
- Not able to speak or awaken
- Decline in muscular tone
- Clammy, frigid skin
- Fainting
- Dizziness
- Sluggish heartbeat
What other information should I know?
Maintain all scheduled times with your physician and the lab. To assess your body’s reaction to codeine, your doctor may prescribe specific lab tests.
Inform the lab staff and your doctor that you are taking codeine before undergoing any laboratory test (particularly ones that use methylene blue).
It is against the law to sell or give away this drug because doing so could result in death or harm to others. It’s possible that your prescription won’t be refilled. Any queries you may have regarding medication refills should be directed to your pharmacist.
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.
Brand names
- Tuzistra XR® (as a combination product containing Chlorpheniramine, Codeine)