Butex

Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Butex (Butalbital (Butex) and Acetaminophen (Butex)) tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because Butalbital (Butex) is habit-forming and potentially abusable.

Acetaminophen (Butex) is a pain reliever and fever reducer.

Butalbital (Butex) is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

The combination of Butex is used to treat tension headaches. This medicine is not for treating headaches that come and go.

Butex may also be used for purposes not listed in this medication guide.

Butalbital (Butex) and Acetaminophen (Butex), 50 mg/ 325 mg tablets: One or two tablets every four hours as needed. Do not exceed not exceed 6 tablets per day.

Butex (Butalbital (Butex) and Acetaminophen (Butex), 25 mg/ 325 mg) tablets: Two tablets every four hours. Total daily dosage should not exceed 12 tablets.

Extended and repeated use of these products is not recommended because of the potential for physical dependence.

How supplied

Butalbital (Butex) and Acetaminophen (Butex), 50 mg/ 325 mg: White, capsule shaped tablet debossed "LL 721" on one side and plain on the other, in bottles of 100 tablets (NDC 68047-721-01).

Butex (Butalbital (Butex) and Acetaminophen (Butex), 25 mg/ 325 mg): White, capsule shaped tablet debossed "LL 722" on one side and plain on the other, in bottles of 100 tablets (NDC 68047-722-01).

Storage

Protect from light and moisture. Store Butex (Butalbital (Butex) and Acetaminophen (Butex)) tablets at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).

Dispense in a tight, light-resistant container with a child-resistant closure.

Distributed by: Larken Laboratories, Inc. Canton, MS 39046. Revised: Aug 2015

See also:
What is the most important information I should know about Butex?

Butex should not be administered to patients who have previously exhibited hypersensitivity to it.

Use Butex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Butex by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Butex is usually taken as needed. If you forget to take a dose of Butex and you still have pain, take it when you remember as directed by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Butex.

This combination medication is used to treat tension headaches. Acetaminophen (Butex) helps to decrease the pain from the headache. Butalbital (Butex) is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How to use Butex

Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor. Do not take more than 300 milligrams of Butalbital (Butex) in a 24-hour period.

The dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Inform your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

See also:
What other drugs will affect Butex?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: darunavir, sodium oxybate, anti-seizure drugs (e.g., carbamazepine, phenytoin), drugs affecting liver enzymes that remove this medication from your body (such as disulfiram, valproic acid, MAO inhibitors including isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), isoniazid, methoxyflurane, phenothiazines (e.g., chlorpromazine).

This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include "blood thinners" (e.g., warfarin), corticosteroids such as prednisone, estrogen, felodipine, quinidine, certain beta blockers such as metoprolol, theophylline, doxycycline.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain laboratory tests (including urine 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

See also:
What are the possible side effects of Butex?

Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.

Infrequently Observed: All adverse events tabulated below are classified as infrequent.

Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of Butalbital (Butex).

Autonomic Nervous System: dry mouth, hyperhidrosis.

Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.

Cardiovascular: tachycardia.

Musculoskeletal: leg pain, muscle fatigue.

Genitourinary: diuresis.

Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.

Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.

The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.

Acetaminophen (Butex): allergic reactions, rash, thrombocytopenia, agranulocytosis.

Drug Abuse And Dependence

Abuse and Dependence

Butalbital (Butex): Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.