Carisoprodol and aspirin

Carisoprodol and aspirin combination is used to relax certain muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions. However, carisoprodol and aspirin does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles. Aspirin is an antiinflammatory agent that is often used for pain and fever.

carisoprodol and aspirin is available only with your doctor's prescription. .

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 carisoprodol and aspirin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to carisoprodol and aspirin 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of carisoprodol and aspirin combination in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of Soma® Compound in geriatric patients. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of carisoprodol and aspirin combination in geriatric patients. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution in patients receiving carisoprodol and aspirin combination.

Pregnancy

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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 doctor may want to change the dose, or other precautions may be necessary. When you are taking carisoprodol and aspirin, 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 carisoprodol and aspirin 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.

• Defibrotide
• Dichlorphenamide
• Influenza Virus Vaccine, Live
• Ketorolac

Using carisoprodol and aspirin 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.

• Acarbose
• Aceclofenac
• Acemetacin
• Alfentanil
• Alipogene Tiparvovec
• Alprazolam
• Alteplase, Recombinant
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Anisindione
• Apixaban
• Aprobarbital
• Argatroban
• Bendroflumethiazide
• Benzthiazide
• Betrixaban
• Bivalirudin
• Bromazepam
• Bromfenac
• Bufexamac
• Bumetanide
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carisoprodol
• Celecoxib
• Chloral Hydrate
• Chlordiazepoxide
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Chlorzoxazone
• Choline Salicylate
• Cilostazol
• Citalopram
• Clobazam
• Clomipramine
• Clonazepam
• Clonixin
• Clopamide
• Clopidogrel
• Clorazepate
• Codeine
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Danaparoid
• Dantrolene
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Diazepam
• Diazoxide
• Dibenzepin
• Diclofenac
• Dicumarol
• Diflunisal
• Digoxin
• Dihydrocodeine
• Dipyrone
• Dothiepin
• Doxepin
• Doxylamine
• Droxicam
• Duloxetine
• Edoxaban
• Eplerenone
• Eptifibatide
• Escitalopram
• Eslicarbazepine Acetate
• Estazolam
• Ethacrynic Acid
• Ethchlorvynol
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Feverfew
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Glimepiride
• Glipizide
• Glyburide
• Gossypol
• Halazepam
• Heparin
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Ibuprofen
• Imipramine
• Indapamide
• Indomethacin
• Ketazolam
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorazepam
• Lormetazepam
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Medazepam
• Mefenamic Acid
• Melitracen
• Meloxicam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Metformin
• Methadone
• Methocarbamol
• Methohexital
• Methotrexate
• Methyclothiazide
• Metolazone
• Midazolam
• Milnacipran
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Naproxen
• Nateglinide
• Nefazodone
• Nepafenac
• Nicorandil
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nitrazepam
• Nortriptyline
• Opipramol
• Oxaprozin
• Oxazepam
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Parecoxib
• Paroxetine
• Pemetrexed
• Pentazocine
• Pentobarbital
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Periciazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piracetam
• Piroxicam
• Polythiazide
• Pralatrexate
• Pranoprofen
• Prasugrel
• Prazepam
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quazepam
• Remifentanil
• Repaglinide
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Secobarbital
• Sertraline
• Sodium Oxybate
• Sodium Salicylate
• Spironolactone
• Sufentanil
• Sulindac
• Tacrolimus
• Tapentadol
• Temazepam
• Tenoxicam
• Thiopental
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tiotropium
• Tirofiban
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Tramadol
• Treprostinil
• Triamterene
• Triazolam
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Varicella Virus Vaccine
• Venlafaxine
• Vilazodone
• Vortioxetine
• Warfarin
• Xipamide
• Zolpidem

Using carisoprodol and aspirin 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
• Atenolol
• Betamethasone
• Betaxolol
• Bisoprolol
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cortisone
• Delapril
• Dexamethasone
• Enalaprilat
• Enalapril Maleate
• Esmolol
• Imidapril
• Labetalol
• Levobunolol
• Lisinopril
• Methylprednisolone
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nitroglycerin
• Oxprenolol
• Paramethasone
• Penbutolol
• Pindolol
• Practolol
• Prednisolone
• Prednisone
• Probenecid
• Propranolol
• Sotalol
• Streptokinase
• Tamarind
• Temocapril
• Tenecteplase
• Timolol
• Triamcinolone
• Valproic Acid

Interactions with Food/Tobacco/Alcohol

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 carisoprodol and aspirin 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 carisoprodol and aspirin, 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 carisoprodol and aspirin. Make sure you tell your doctor if you have any other medical problems, especially:

• Aspirin-induced asthma, history of or
• Bleeding disorders, history of or
• Porphyria (an enzyme problem), history of or
• Stomach or bowel problems (e.g., blockage, perforation), history of—Should not be used in patients with these conditions.

• Drug abuse or dependence, or history of—Use with caution. Dependence on carisoprodol may develop.

• Gastritis (inflammation of the stomach) or
• Seizures, history of or
• Stomach ulcers, history of—Use with caution. May make these conditions worse.

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

It is very important that your doctor check your progress at regular visits to make sure carisoprodol and aspirin is working properly and to check for unwanted effects. .

carisoprodol and aspirin may cause some people to become dizzy, drowsy, or less alert than they are normally. Avoid driving, using machines, or do anything else that could be dangerous if you are not alert.

carisoprodol and aspirin will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking carisoprodol and aspirin.

Do not stop using carisoprodol and aspirin suddenly without first asking your doctor. You may need to slowly decrease your dose before stopping it completely.

carisoprodol and aspirin may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a blood thinner or nonsteroidal anti-inflammatory medicine [NSAIDs]).

carisoprodol and aspirin may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using carisoprodol and aspirin during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

If your condition does not improve or become worse, check with your doctor. Do not use carisoprodol and aspirin for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor has told you to.

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.

Carisoprodol and Aspirin tablets, USP are a fixed-dose combination product containing the following two products:

• 200 mg of carisoprodol, a centrally-acting muscle relaxant
• 325 mg of aspirin, an analgesic with antipyretic and anti-inflammatory properties

It is available as a two-layered, Red and White, round tablet for oral administration.

Carisoprodol: Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3 propanediol dicarbamate and its molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula of carisoprodol is:

Aspirin: Chemically, aspirin (acetylsalicylic acid) is 2-(acetyloxy-, benzoic acid and its molecular formula is C9H8O4, with a molecular weight of 180.16. The structural formula of aspirin is:

Other ingredients in the Carisoprodol and Aspirin Tablets, drug product are Corn starch, FD&C Red # 40 Aluminum Lake, Hydroxypropyl Cellulose, Lactose Anhydrous, Microcrystalline Cellulose, Magnesium Stearate, Pregelatinized Starch, Sodium Starch Glycolate and Sodium Lauryl Sulfate.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The following adverse reactions which have occurred with the administration of the individual products alone may also occur with the use of Carisoprodol and Aspirin tablets. The following events have been reported during post-approval individual use of Carisoprodol and Aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Carisoprodol: The following events have been reported during post-approval use of carisoprodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing (see OVERDOSAGE).

Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures (see OVERDOSAGE).

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia.

Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including abdominal pain, anorexia, nausea, vomiting, gastritis, and occult bleeding (see WARNINGS, Serious Gastrointestinal Adverse Reactions and PRECAUTIONS, Gastrointestinal Adverse Reactions). Other adverse reactions associated with the use of aspirin include elevated liver enzymes, rash, pruritus, purpura, intracranial hemorrhage, interstitial nephritis, acute renal failure, and tinnitus. Tinnitus may be a symptom of high serum salicylate levels (see OVERDOSAGE).

Carisoprodol and Aspirin Tablets, USP 200mg/325mg are red and white, round unscored convex, two layered tablets debossed on red layer with “CL” over “023” and plain on the white layer. The tablets are available in:

Bottles of 100 NDC 52682-023-01.
Bottles of 500 NDC 52682-023-03.

Storage: Store at controlled room temperature 20° - 25°C (68° - 77°F). Protect from moisture.
Dispense in a tight container.
To report SUSPECTED ADVERSE REACTIONS, FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:
Ingenus Pharmaceuticals NJ, LLC
Fairfield, NJ 07004 USA

5507

• Skeletal Muscle Relaxant

Musculoskeletal conditions: Oral: 1 to 2 tablets 4 times a day for a maximum recommended duration of 2 to 3 weeks (maximum: 8 tablets/24 hours)

Discontinuation in patients on long-term therapy: Although this combination product should only be used for short periods (2 to 3 weeks), in patients with a history of long term use or high doses, carisoprodol should be tapered off slowly (eg, over 14 days) to avoid withdrawal symptoms such as anxiety, insomnia, or irritability (Eleid 2010).

Children ≥16 years: Refer to adult dosing.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, lack of appetite, headache, nausea, vomiting, or heartburn. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling); signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes); severe dizziness; passing out; tinnitus; severe loss of strength and energy; seizures; severe constipation; severe abdominal pain (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.