Aspirin, carisoprodol, and codeine

Name: Aspirin, carisoprodol, and codeine

What is the most important information I should know about aspirin, carisoprodol, and codeine?

Aspirin may cause stomach or intestinal bleeding, which can be fatal.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use this medicine if you have a bleeding or blood clotting disorder, porphyria, or a history of asthma or severe allergic reaction caused by taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine should not be given to a child younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids. Do not give this medicine to a child or teenager who has a fever.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

How should I take aspirin, carisoprodol, and codeine?

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away aspirin, carisoprodol, and codeine is against the law.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using aspirin, carisoprodol, and codeine.

Store at room temperature away from moisture and heat.

Keep track of your medicine. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medication can be fatal.

Overdose symptoms may include rapid breathing, vomiting, fever, sweating, diarrhea, thirst, extreme weakness or dizziness, headache, vision problems, confusion, ringing in your ears, muffled hearing, pinpoint pupils, fainting, weak or shallow breathing, or breathing that stops.

For Healthcare Professionals

Applies to aspirin / carisoprodol / codeine: oral tablet

Gastrointestinal

Carisoprodol:
Frequency not reported: Nausea, vomiting, epigastric discomfort

Aspirin:
Frequency not reported: Bleeding, perforation, obstruction of stomach, small intestine or large intestine, epigastric discomfort, gastric and duodenal ulcers, gastritis, gastrointestinal erosions, abdominal pain, heartburn, vomiting, nausea, anorexia

Codeine:
Frequency not reported: Nausea, vomiting, constipation[Ref]

Nervous system

Carisoprodol:
Frequency not reported: Sedation, drowsiness, dizziness, ataxia, tremor
Postmarketing reports: Motor vehicle accidents, seizures

Aspirin:
Frequency not reported: Intracranial hemorrhage

Codeine:
Frequency not reported: Sedation, dizziness[Ref]

Other

Tinnitus may be a symptom of high serum salicylate levels.[Ref]

Carisoprodol:
Frequency not reported: Vertigo

Aspirin:
Frequency not reported: Tinnitus[Ref]

Cardiovascular

Carisoprodol:
Frequency not reported: Tachycardia, postural hypotension, facial flushing, syncope

Codeine:
Frequency not reported: Hypotension[Ref]

Dermatologic

Aspirin:
Frequency not reported: Rash pruritus, purpura

Renal

Aspirin:
Frequency not reported: Interstitial nephritis, acute renal failure[Ref]

Hypersensitivity

Aspirin
Frequency not reported: Anaphylaxis, anaphylactoid reactions[Ref]

Hepatic

Aspirin:
Frequency not reported: Elevated liver enzymes[Ref]

General

The most commonly reported adverse reactions may include nausea, dizziness, drowsiness, and gastrointestinal discomfort.[Ref]

Ocular

Codeine:
Frequency not reported: Miosis[Ref]

Psychiatric

Withdrawal symptoms that have been reported following abrupt withdrawal after prolonged use have included: insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis.[Ref]

Frequency not reported: Drug dependence, withdrawal, abuse, misuse, criminal diversion, agitation, irritability, depressive reactions, insomnia[Ref]

Some side effects of aspirin / carisoprodol / codeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Pain

1 to 2 tablets 4 times a day
Maximum daily dose: carisoprodol: 1600 mg; aspirin: 2600 mg; codeine: 128 mg
Duration of therapy: Up to 2 or 3 weeks

Comments:
-Use should be limited to short periods (up to 3 weeks) since acute, painful musculoskeletal conditions are generally of short duration and evidence of effectiveness beyond this time period has not been established.

Use: For the relief of discomfort associated with acute, painful musculoskeletal conditions.

Renal Dose Adjustments

Use with caution

Dialysis

Data not available

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