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Aspirin, caffeine, and dihydrocodeine (Oral route)

Pronunciation:

AS-pir-in, KAF-een, dye-hye-droe-KOE-deen bye-TAR-trate

Brand Names:

  • Synalgos-DC

Dosage Forms:

  • Capsule

Warnings:

Oral route(Capsule)

Respiratory depression and death have been reported in children following tonsillectomy or adenoidectomy. These children had evidence of being ultra-rapid metabolizers due to a CYP2D6 polymorphism .

Classifications:

Therapeutic—

Opioid/Salicylate, Aspirin Combination

Pharmacologic—

NSAID

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

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

Aspirin is used to relieve pain and reduce fever in patients. Aspirin is a salicylate medicine and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.

Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Dihydrocodeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts 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, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.

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

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aspirin, caffeine, and dihydrocodeine combination in the pediatric population. Safety and efficacy have not been established.

Synalgos®-DC should not be used to relieve pain after surgery removal of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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 doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, 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 medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Influenza Virus Vaccine, Live
  • Ketorolac
  • Naltrexone
  • Riociguat

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

  • Abciximab
  • Acenocoumarol
  • Adenosine
  • Alipogene Tiparvovec
  • Alteplase, Recombinant
  • Anagrelide
  • Anisindione
  • Apixaban
  • Ardeparin
  • Argatroban
  • Beta Glucan
  • Bivalirudin
  • Buprenorphine
  • Butorphanol
  • Carbinoxamine
  • Certoparin
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Clovoxamine
  • Clozapine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Desirudin
  • Desvenlafaxine
  • Dezocine
  • Dicumarol
  • Dipyridamole
  • Dipyrone
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Femoxetine
  • Fentanyl
  • Feverfew
  • Flesinoxan
  • Fluoxetine
  • Fluvoxamine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrocodone
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Meadowsweet
  • Meclizine
  • Meptazinol
  • Methadone
  • Methotrexate
  • Milnacipran
  • Morphine
  • Morphine Sulfate Liposome
  • Nadroparin
  • Nalbuphine
  • Naproxen
  • Nefazodone
  • Oxycodone
  • Oxymorphone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentazocine
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Pixantrone
  • Pralatrexate
  • Prasugrel
  • Protein C
  • Regadenoson
  • Reteplase, Recombinant
  • Reviparin
  • Rivaroxaban
  • Sertraline
  • Sibutramine
  • Sildenafil
  • Suvorexant
  • Tacrolimus
  • Tapentadol
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Treprostinil
  • Varicella Virus Vaccine
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Warfarin
  • Zimeldine

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

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Anagrelide
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betamethasone
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cortisone
  • Cyclopenthiazide
  • Deflazacort
  • Delapril
  • Dexamethasone
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Ibuprofen
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Methylprednisolone
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Nitroglycerin
  • Olmesartan Medoxomil
  • Oxprenolol
  • Paramethasone
  • Penbutolol
  • Pentopril
  • Perampanel
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Prednisolone
  • Prednisone
  • Probenecid
  • Propranolol
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Sotalol
  • Spirapril
  • Spironolactone
  • Streptokinase
  • Talinolol
  • Tamarind
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tenecteplase
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamcinolone
  • Triamterene
  • Trichlormethiazide
  • Valproic Acid
  • Valsartan
  • Verapamil
  • Xipamide
  • Zofenopril

Other interactions—

Certain medicines 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 medicines 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 medicine with any of the following is usually not recommended, 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.

  • 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.

  • Ethanol

Other medical problems—

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

  • Alcohol abuse, or history of or
  • Breathing problems (eg, sleep apnea, respiratory depression) or
  • Drug dependence, especially with narcotics, or history of or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Blood clotting problems or
  • Peptic ulcer disease, active or history of—Use with caution. May make these conditions worse.
  • Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with this condition.

Proper Use of This Medicine:

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).

This medicine is taken only when needed, so there are no special instructions for a missed dose.

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 moderately severe pain:
      • Adults—Two capsules every 4 hours as needed.
      • Children—Use and dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

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

This medicine may make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect.

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

For nursing mothers taking this medicine:

  • Talk to your doctor if you have any questions about taking codeine or about 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 more than 4 hours at a time.
  • Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately 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.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult 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.

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common
Lightheadedness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Confusion
difficult or troubled breathing
extreme sleepiness
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
shortness of breath

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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Difficulty having a bowel movement (stool)
dizziness
drowsiness
itching skin
nausea
relaxed and calm
sleepiness
vomiting

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.


Last Updated: 11/4/2014

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