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Ambenyl (Generic Codeine)

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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 tumour, 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 laboured 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.

While receiving codeine therapy, taking certain drugs may raise your chance of developing breathing issues or other severe, life-threatening respiratory issues, drowsiness, or coma. Inform your physician if you are now taking or intend to take any of the following drugs: a few antifungal drugs, such ketoconazole; some antibiotics, like erythromycin (Erytab, Erythrocin); benzodiazepines, like alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); Medication for mental illness or nausea; other pain medications; muscle relaxants; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; or tranquillizers; and carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); certain HIV medications, such as indinavir (Crixivan), Your doctor will closely monitor you and may need to adjust the dosage of your drugs. If you take codeine together with any of these drugs and experience any of the following symptoms, contact your doctor right away or seek emergency medical attention: unusual dizziness, lightheadedness, extreme drowsiness, slowed or laboured breathing, or unresponsiveness. Make sure your carer or family members are aware of any symptoms that might be dangerous so they can contact a doctor or emergency services on your behalf if you are unable to get help on your own.

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, diarrhoea, or failure to gain weight.

Do not share your medication with anybody else. Children especially may be harmed or killed by codeine while taking your medication.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start taking codeine and at each time your prescription is renewed. 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.

Why is this medication prescribed?

To treat mild to severe pain, codeine is utilised. 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 product that contains both codeine and another drug, 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 without consulting your doctor if you have been taking it for several weeks or longer. Your dose could be gradually reduced by your doctor. Codeine withdrawal symptoms include agitation, teary eyes, widened pupils (black circles in the centre of the eyes), irritability, anxiety, runny nose, trouble falling or staying asleep, yawning, sweating, rapid breathing, rapid heartbeat, chills, hair standing on end on your arms, nausea, loss of appetite, vomiting, diarrhoea, stomach cramps, muscle aches, and 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 an allergy to codeine, any other medications, or any of the substances in the codeine product you intend to use, let your doctor and pharmacist know right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Any of the following monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine, should be disclosed to your doctor or pharmacist (Parnate). 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 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: medication for anxiety or seizures; bupropion (Aplenzin, Wellbutrin, Zyban); cyclobenzaprine (Amrix); diuretics (‘water pills’); lithium (Lithobid); medications for allergies, colds, or coughs; Almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig) are migraine treatments. Mirtazapine (Remeron) and 5HT3-serotonin blockers include alose (Kytril), fluoxetine (Prozac, Sarafem, in Symbyax), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors such citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline, Tramadol (Conzip), trazodone (Oleptro), and tricyclic antidepressants (‘mood elevators’) like amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine are (Surmontil). Tell your doctor about all of the medications you are taking, even any not on this list, as many other drugs may also interact with codeine. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Any herbal treatments you are taking, especially tryptophan and St. John’s wort, should be disclosed to your doctor.
  • Inform your doctor if you have paralytic ileus, a blockage or constriction of your stomach or intestines, or any of the disorders listed in the IMPORTANT WARNING section (condition in which digested food does not move through the intestines). You could be advised by your doctor not to use codeine.
  • If you drink or have recently undergone stomach or urinary tract surgery, 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 know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking codeine.
  • Inform your doctor if you are nursing a child. While taking codeine, breastfeeding is not advised. Codeine can result in irregular or noisy breathing, shallow breathing, disorientation, unusual tiredness, difficulties nursing, or limpness in breastfed newborns.
  • Inform the surgeon or dentist that you are taking codeine if you are having surgery, including dental surgery.
    You should be aware that this medicine may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
    You should be aware that if you get out of a laying position too rapidly while taking codeine, you could have dizziness, lightheadedness, and fainting. When you initially start taking codeine, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • It’s important to be aware that codeine might cause constipation. To treat or prevent constipation, discuss with your doctor modifying your diet and taking additional drugs.

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, codeine is consumed as needed. Take the missing dose as soon as you remember it if your doctor has instructed you to take codeine on a regular basis. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

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:

  • Migraine
  • 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:

  • Hallucinations (seeing or hearing objects or voices that aren’t there), agitation, sweating excessively, confusion, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, appetite loss, exhaustion, or lightheadedness
  • Failure to achieve or maintain erection
  • Abnormal menstruation
  • Reduced sexual arousal
  • Shallow or noisy breathing
  • Breathing or swallowing challenges
  • Alterations in heartbeat
  • Rash
  • Itching
  • Hives
  • Vision changes
  • 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 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. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

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.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

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 Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

You should consult your doctor about keeping naloxone, a life-saving drug, on hand while taking codeine (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:

  • Having trouble breathing
  • Shallow or sluggish breathing
  • Excessive somnolence or drowsiness
  • Unable to wake up or speak
  • Muscle tone loss
  • Tempest-like skin
  • Fainting
  • Dizziness
  • Sluggish heartbeat

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how your body reacts to codeine, your doctor will request specific lab tests.

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