Soma Compound

DRUG DESCRIPTION

Soma Compound (carisoprodol and aspirin tablets, USP) is 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, white and orange, 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:

Carisoprodol Structural Formula Illustration

Aspirin: Chemically, aspirin (acetylsalicyclic 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 Soma Compound (carisoprodol and aspirin) drug product are croscarmellose sodium, FD&C Red #40, FD&C Yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, starch, and stearic acid.

What are the possible side effects of aspirin and carisoprodol (Soma Compound)?

If you experience any of the following serious side effects, stop taking aspirin and carisoprodol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • paralysis (loss of feeling) or extreme weakness;
  • vision loss;
  • agitation or tremor;
  • red, black, or bloody stools; or
  • bloody vomit.

Other, less serious side...

Read All Potential Side Effects and See Pictures of Soma Compound

What are the precautions when taking carisoprodol and aspirin (Soma Compound)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to carisoprodol, codeine, or aspirin; or to related medications such as meprobamate, tybamate, other narcotics such as hydrocodone, NSAIDs such as ibuprofen or naproxen, or other salicylates such as salsalate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding/blood clotting problems, certain...

Read All Potential Precautions of Soma Compound


Soma Compound Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, stomach upset, headache, or flushing may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, hearing problems, difficult/painful swallowing, difficult urination, fast heartbeat, change in the amount/color of urine, easy bleeding/bruising.

Sometimes carisoprodol may cause a very rare but serious reaction that occurs within minutes or hours of the first dose of this medication. Stop taking this medication and seek immediate medical attention if any of these symptoms occur: unable to move arms/legs, shaky/unsteady movement, loss of balance, joint pain, mental/mood changes (e.g., agitation, confusion, unexplained mood swings), vision problems (e.g., blurred vision, double vision, loss of vision), extreme weakness.

The aspirin in this product may rarely cause very serious (possibly fatal) bleeding in the stomach/intestines. Seek immediate medical attention if you notice any of these rare but very serious side effects: severe stomach/abdominal pain, black/bloody/tarry stools, vomit that looks like coffee grounds, unexplained weight loss.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to carisoprodol, codeine, or aspirin; or to related medications such as meprobamate, tybamate, other narcotics such as hydrocodone, NSAIDs such as ibuprofen or naproxen, or other salicylates such as salsalate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding/blood clotting problems, certain genetic blood disorder (porphyria), severe breathing problems, serious stomach/intestinal problems (e.g., ulcers, bleeding, blockage), intoxication with alcohol or medications that depress the nervous system or your breathing (CNS/respiratory depressants such as tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problem (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), personal/family history of regular use/abuse of drugs/alcohol, gallbladder disease, gout, growths in the nose (nasal polyps), heart problems (e.g., fast/irregular heartbeat, heart failure), high blood pressure, kidney disease, liver disease, lung diseases (e.g., asthma, chronic obstructive pulmonary disease), mental/mood disorders (e.g., toxic psychosis), disease of the pancreas (e.g., pancreatitis), a certain spinal problem (kyphoscoliosis), other stomach problems (e.g., acid-reflux disease, heartburn), difficulty urinating (e.g., due to enlarged prostate or urethral narrowing), underactive thyroid (hypothyroidism).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To avoid dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, dizziness, drowsiness, and stomach/intestinal bleeding.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Soma Compound Patient Information Including Side Effects

Brand Names: Soma Compound

Generic Name: aspirin and carisoprodol (Pronunciation: AS pir in/ kar eye soe PROE dole)

  • What is aspirin and carisoprodol (Soma Compound)?
  • What are the possible side effects of aspirin and carisoprodol (Soma Compound)?
  • What is the most important information I should know about aspirin and carisoprodol (Soma Compound)?
  • What should I discuss with my healthcare provider before taking aspirin and carisoprodol (Soma Compound)?
  • How should I take aspirin and carisoprodol (Soma Compound)?
  • What happens if I miss a dose (Soma Compound)?
  • What happens if I overdose (Soma Compound)?
  • What should I avoid while taking aspirin and carisoprodol (Soma Compound)?
  • What other drugs will affect aspirin and carisoprodol (Soma Compound)?
  • Where can I get more information?

What is aspirin and carisoprodol (Soma Compound)?

Aspirin is in a class of drugs called salicylates. Aspirin works by reducing substances in the body that cause pain and inflammation. It is used to reduce pain, inflammation, and fever.

Carisoprodol is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to the brain.

The combination of aspirin and carisoprodol is used, along with rest and physical therapy, to treat injuries and other painful muscular conditions.

Aspirin and carisoprodol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of aspirin and carisoprodol (Soma Compound)?

If you experience any of the following serious side effects, stop taking aspirin and carisoprodol and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • paralysis (loss of feeling) or extreme weakness;
  • vision loss;
  • agitation or tremor;
  • red, black, or bloody stools; or
  • bloody vomit.

Other, less serious side effects may be more likely to occur. Continue to take aspirin and carisoprodol and talk to your doctor if you experience

  • drowsiness or dizziness;
  • headache;
  • depression;
  • blurred vision;
  • insomnia;
  • hiccups;
  • faint ringing in the ears; or
  • nausea or diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about aspirin and carisoprodol (Soma Compound)?

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin and carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking aspirin and carisoprodol. Also, in combination with aspirin, alcohol can be damaging to the stomach.

Watch for bloody, black, or tarry stools or bloody vomit. This could indicate damage to the stomach.

Do not take more of this medication than is prescribed. If the pain is not being adequately treated, talk to your doctor.

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