Butalbital, Aspirin, Caffeine, and Codeine Phosphate

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Overview

What is Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Butalbital, aspirin, caffeine, and codeine phosphate capsules, USP are supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:

Aspirin (benzoic acid, 2-(acetyloxy)-) is a nonsteroidal anti-inflammatory drug.. It has the following structural formula:

Caffeine (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula:

Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate) is an opioid agonist. It has the following structural formula:

Inactive Ingredients:

What does Butalbital, Aspirin, Caffeine, and Codeine Phosphate look like?

What are the available doses of Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Capsules: Butalbital, 50 mg, Aspirin, 325 mg, Caffeine, 40 mg, Codeine Phosphate, 30 mg

Purple cap with a yellow body. Body is imprinted with "312" in black.

What should I talk to my health care provider before I take Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

How should I use Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Butalbital, aspirin, caffeine, and codeine phosphate capsules is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate.

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals

Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse .

What interacts with Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Sorry No Records found

What are the warnings of Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

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What are the precautions of Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Sorry No Records found

What are the side effects of Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Sorry No records found

What should I look out for while using Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Butalbital, aspirin, caffeine, and codeine phosphate capsules is contraindicated for:

Butalbital, aspirin, caffeine, and codeine phosphate capsules is also contraindicated in patients with:

What might happen if I take too much Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

How should I store and handle Butalbital, Aspirin, Caffeine, and Codeine Phosphate?

Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Butalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black.NDC 68308-312-10Bottles of 100 capsulesButalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black.NDC 68308-312-10Bottles of 100 capsulesButalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black.NDC 68308-312-10Bottles of 100 capsulesButalbital, aspirin, caffeine, and codeine phosphate capsules Each capsule has a yellow body and a purple cap. The yellow body is imprinted with "312" in black.NDC 68308-312-10Bottles of 100 capsules

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Butalbital, a barbiturate, is a GABA receptor agonist and may inhibit excitatory AMPA receptors.

Aspirin is a nonsteroidal anti-inflammatory drug and a non-selective irreversible inhibitor of cyclooxygenases.

Caffeine is a methylxanthine and CNS stimulant. The exact mechanism with respect to the indication is not clear; however, the effects of caffeine may be due to antagonism of adenosine receptors.

Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

Non-Clinical Toxicology

Butalbital, aspirin, caffeine, and codeine phosphate capsules is contraindicated for:

Butalbital, aspirin, caffeine, and codeine phosphate capsules is also contraindicated in patients with:

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Butalbital, aspirin, caffeine, and codeine phosphate capsules contains codeine. Codeine in combination with butalbital, aspirin, and caffeine is a Schedule III controlled substance. As butalbital, aspirin, caffeine, and codeine phosphate capsules contains butalbital and codeine, it exposes users to the risks of addiction, abuse, and misuse

Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed butalbital, aspirin, caffeine, and codeine phosphate capsules. Addiction can occur at recommended dosages and if the drug is misused or abused.

Assess each patient's risk for addiction, abuse, or misuse prior to prescribing butalbital, aspirin, caffeine, and codeine phosphate capsules, and monitor all patients receiving butalbital, aspirin, caffeine, and codeine phosphate capsules for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as butalbital, aspirin, caffeine, and codeine phosphate capsules, but use in such patients necessitates intensive counseling about the risks and proper use of butalbital, aspirin, caffeine, and codeine phosphate capsules along with intensive monitoring for signs of addiction, abuse, and misuse.

Opioids and barbiturates are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing butalbital, aspirin, caffeine, and codeine phosphate capsules. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug . Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

The following serious adverse reactions are described, or described in greater detail, in other sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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