Pronunciation:

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

Brand Names:

• Synalgos-DC

Dosage Forms:

• Capsule

Warnings:

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:

Dihydrocodeine, aspirin, and caffeine combination is used to relieve moderate to moderately severe pain. Dihydrocodeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Aspirin is used to relieve pain and reduce fever in patients. Aspirin belongs to the group of medicines known as salicylates 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.

When dihydrocodeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep 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 lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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 dihydrocodeine, aspirin, and caffeine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dihydrocodeine, aspirin, and caffeine 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 dihydrocodeine, aspirin, and caffeine 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
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Anagrelide
• Anisindione
• Apixaban
• Ardeparin
• Argatroban
• Beta Glucan
• Bivalirudin
• Buprenorphine
• Butorphanol
• Carbinoxamine
• Certoparin
• Cilostazol
• Citalopram
• Clopidogrel
• Clopidogrel Hydrogen Sulfate
• 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
• Methotrexate
• Milnacipran
• Nadroparin
• Nalbuphine
• Naproxen
• Nefazodone
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentazocine
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Pixantrone
• Pralatrexate
• Prasugrel
• Protein C
• Reteplase, Recombinant
• Reviparin
• Rivaroxaban
• Sertraline
• Sibutramine
• Sildenafil
• 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
• Levobetaxolol
• 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
• Drug dependence, especially with narcotics, or history of—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.

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).

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.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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.

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, drowsy, or lightheaded. 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.

Check with your doctor right away if you have the following symptoms while using this medicine: acid or sour stomach; bloody or black, tarry stools; heartburn; nausea; vomiting; stomach pain; or vomiting of blood or material that looks like coffee grounds.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with 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 abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

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:

Incidence not known

Abdominal pain, cramping, or tenderness

bleeding gums

blood in the urine or stools

bloody, black, or tarry stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

constipation

convulsions

coughing or vomiting blood

dark-colored urine

heartburn

hives or itching

increased menstrual flow or vaginal bleeding

indigestion

large, flat, blue or purplish patches in the skin

nausea or vomiting

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red or purple spots on the skin

prolonged bleeding from cuts

red or black, tarry stools or dark urine

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of material that looks like coffee grounds, severe and continuing

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

lightheadedness

nausea

relaxed and calm feeling

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.