Panlor-SS (Oral)

Acetaminophen, caffeine, and dihydrocodeine combination is used to relieve moderate to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. However, acetaminophen may cause other unwanted effects when taken in large doses, including liver damage. Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Dihydrocodeine is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

When dihydrocodeine is used for a long time or in large doses, it may become habit-forming, leading to mental or physical dependence. However, people who have ongoing pain should not let the fear of dependence prevent them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually reducing the dose over time before stopping treatment completely.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress while you are taking this medicine, especially in the first 24 to 72 hours of treatment. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

Do not use this medicine if you are currently using or have used an MAO inhibitor (MAOI) like isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] in the past 14 days.

This medicine will increase the effects of alcohol and other central nervous system (CNS) depressants (medicines that can cause drowsiness or make you less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for attention deficit and hyperactivity disorder, seizure medications or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Additionally, drinking 3 or more alcoholic beverages while taking acetaminophen may increase the risk of liver damage. Do not drink alcoholic beverages. Check with your doctor before taking any of these medicines while you are on this medicine.

This medicine may be habit-forming. If you feel the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Signs of an overdose include: dark urine, difficulty or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Codeine is converted to morphine in the body. Some people convert codeine to morphine more rapidly than others. These individuals are known as "ultra-rapid metabolizers of codeine." Contact your doctor right away if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine," which means there could be too much morphine in your body, leading to more side effects than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery to remove tonsils or adenoids.
• Children 12 to 18 years of age who have a high risk for breathing problems (e.g., obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby, causing very serious side effects.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking codeine or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor, hospital emergency room, or local emergency services (e.g., "call 9-1-1") right away if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you feel dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Using narcotics for a long time can cause severe constipation. To help prevent this, your doctor may suggest taking laxatives, drinking plenty of fluids, or increasing the amount of fiber in your diet. Be sure to follow the directions carefully, as ongoing constipation can lead to more serious issues.

Do not change your dose or suddenly stop using this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as convulsions (seizures), hallucinations, stomach or muscle cramps, tremors, or unusual behavior.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Inform your doctor immediately if you think you are pregnant or plan to become pregnant while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be signs of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause reduced fertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the chances of taking the medicine must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Trezix™ in the pediatric population. It should not be used in children 12 years of age or younger. Safety and efficacy have not been established.

Trezix™ should not be used to ease pain following surgery removal of tonsils or adenoids in any children. Severe breathing issues and deaths have been reported in some children who received codeine following tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen, caffeine, and dihydrocodeine combination in the elderly. However, elderly patients are more likely to have age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving acetaminophen, caffeine, and dihydrocodeine combination in order to avoid potentially severe adverse effects.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medicine should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medicines is not advised. Your clinician may decide not to treat you with this drug or change some of the other drugs you take.

• Nalmefene
• Naltrexone
• Riociguat
• Safinamide
• Samidorphan
• Viloxazine

Using this medication with any of the following medications is normally not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Abiraterone Acetate
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bupropion
• Buspirone
• Butabarbital
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Capmatinib
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Givosiran
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iobenguane I 131
• Iproniazid
• Isocarboxazid
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Naratriptan
• Nefazodone
• Nelfinavir
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Peginterferon Alfa-2b
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sildenafil
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

• Acenocoumarol
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Phenytoin
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following is typically not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Problems

The presence of other medical problems may affect the use of this medication. Make sure you inform your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland issue) or
• Alcohol abuse, or history of or
• Brain tumor, history of or
• Breathing or lung issues (eg, COPD, sleep apnea, respiratory depression) or
• Cor pulmonale (severe heart condition) or
• Depression, history of or
• Drug dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Head injuries, history of or
• Hypothyroidism (an underactive thyroid) or
• Increased pressure in the head or
• Mental health problems, history of or
• Obesity (overweight) or
• Issues with passing urine or
• Weakened physical condition—Use with caution. May raise risk for more serious side effects.

• Hypotension (low blood pressure) or
• Pancreatitis (inflammation of the pancreas) or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

• Lung breathing problems (eg, asthma, respiratory depression), serious or
• Stomach or bowel blockage (such as paralytic ileus)—Should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bleeding gums
• blood in the urine or stools
• bloody, black, or tarry stools
• chest pain
• chills
• clay colored stools
• cough
• dark urine
• decreased appetite
• dizziness
• drowsiness
• fever
• headache
• high fever
• itching or skin rash
• lightheadedness
• loss of appetite
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain or tenderness
• swelling of the feet or lower legs
• swollen glands
• unexplained or unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Rare

• Agitation
• confusion
• decreased urine output
• difficulty with swallowing
• fast heartbeat
• hives
• hostility
• irritability
• loss of consciousness
• muscle twitching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seeing, hearing, or feeling things that are not there
• seizures
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest
• unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• Cold sweats
• darkening of the skin
• decrease in the frequency of urination
• decrease in the urine volume
• difficult or troubled breathing
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• fainting
• irregular, fast or slow, or shallow breathing
• overactive reflexes
• pale or blue lips, fingernails, or skin
• poor coordination
• shivering
• talking or acting with excitement you cannot control
• trembling or shaking

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Difficulty having a bowel movement
• relaxed and calm feeling
• sleepiness

Incidence not known

• Constricted, pinpoint, or small pupils (black part of the eye)
• diarrhea
• dry mouth
• gas in the stomach
• heartburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Panlor-DC
• Panlor-SS
• Trezix
• Zerlor

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Methylxanthine

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Also, large amounts of acetaminophen may cause liver damage.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):For moderate to severe pain: Adults—2 capsules every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 capsules per day. Children 12 years of age and older—Use and dose must be determined by your doctor. Children younger than 12 years of age—Should not be used in these patients.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDAsafe disposal of medicines website:www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm.