Lagaflex

Acetaminophen (Lagaflex)® (Acetaminophen (Lagaflex)) injection is indicated for

• the management of mild to moderate pain
• the management of moderate to severe pain with adjunctive opioid analgesics
• the reduction of fever.

Carisoprodol (Lagaflex) tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Carisoprodol (Lagaflex) tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration ( 2) ].

Acetaminophen (Lagaflex) injection is used together with other medicines (eg, narcotic pain relievers) to relieve moderate to severe pain.

Acetaminophen (Lagaflex) is used to relieve mild to moderate pain and reduce fever in patients. It does not become habit-forming when taken for a long time. Acetaminophen (Lagaflex) may cause unwanted effects when taken in large doses, including liver damage.

Acetaminophen (Lagaflex) is available only with your doctor's prescription.

Carisoprodol (Lagaflex) 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 (Lagaflex) does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol (Lagaflex) is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles.

Carisoprodol (Lagaflex) is available only with your doctor's prescription.

General Dosing Information

Acetaminophen (Lagaflex) may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral Acetaminophen (Lagaflex) and Acetaminophen (Lagaflex) dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen (Lagaflex) is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen (Lagaflex). Exceeding the maximum mg/kg daily dose of Acetaminophen (Lagaflex) as described in Tables 1 and 2 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of Acetaminophen (Lagaflex) from all routes and from all credits does not exceed the maximum recommended dose.

Recommended

Dosage: Adults and Adolescents

Adults and adolescents weighing 50 kg and over: the recommended dosage of Acetaminophen (Lagaflex) is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen (Lagaflex) of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Lagaflex) of 4000 mg per day (includes all routes of administration and all Acetaminophen (Lagaflex)-containing products including combination products).

Adults and adolescents weighing under 50 kg: the recommended dosage of Acetaminophen (Lagaflex) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Lagaflex) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Lagaflex) of 75 mg/kg per day (includes all routes of administration and all Acetaminophen (Lagaflex)-containing products including combination products).

Table 1: Dosing for Adults and Adolescents

Recommended

Dosage: Children

Children 2 to 12 years of age: the recommended dosage of Acetaminophen (Lagaflex) is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Acetaminophen (Lagaflex) of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen (Lagaflex) of 75 mg/kg per day.

Table 2: Dosing for Children

Instructions For

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of Acetaminophen (Lagaflex), administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen (Lagaflex) may be administered without further dilution. Examine the vial contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15-minutes. Use aseptic technique when preparing Acetaminophen (Lagaflex) for intravenous infusion. Do not add other medications to the Acetaminophen (Lagaflex) vial or infusion device.

For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed Acetaminophen (Lagaflex) vial and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL vial of Acetaminophen (Lagaflex) is not intended for use in patients weighing less than 50 kg. Acetaminophen (Lagaflex) is a single-use vial and the unused portion must be discarded.

Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.

Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the Acetaminophen (Lagaflex) infusion is the primary infusion.

Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose of Acetaminophen (Lagaflex) within 6 hours.

Do not add other medications to the Acetaminophen (Lagaflex) solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with Acetaminophen (Lagaflex), therefore do not administer simultaneously.

How supplied

Dosage Forms And Strengths

Acetaminophen (Lagaflex) is a sterile, clear, colorless, non pyrogenic, preservative free, isotonic formulation of Acetaminophen (Lagaflex) intended for intravenous infusion. Each 100 mL glass vial contains 1000 mg Acetaminophen (Lagaflex) (10 mg/mL).

Storage And Handling

NDC 43825-102-01 - Acetaminophen (Lagaflex)® (Acetaminophen (Lagaflex)) Injection is supplied in a 100 mL glass vial containing 1000 mg Acetaminophen (Lagaflex) (10 mg/mL) in cartons of 24 vials.

Acetaminophen (Lagaflex) should be stored at 20°C to 25°C (68°F to 77°F).

For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.

Manufactured for: Mallinckrodt Hospital Products Inc., Hazelwood, MO 63042 USA. Revised: Dec 2014

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet,

Oral:

Carisoprodol (Lagaflex): 250 mg, 350 mg

Generic: 250 mg, 350 mg

Dosing: Adult

Musculoskeletal conditions:

Oral: 250 to 350 mg 3 times daily and at bedtime for a maximum recommended duration of 2 to 3 weeks.

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

Dosing: Geriatric

Avoid use (Beers Criteria [AGS 2019]).

Dosing: Pediatric

Musculoskeletal conditions: Adolescents ≥16 years:

Oral: 250 to 350 mg 3 times daily and at bedtime (ie, 4 daily doses); maximum daily dose: 1,400 mg/day; maximum duration of therapy: 3 weeks

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

See also:
What is the most important information I should know about Acetaminophen (Lagaflex)?

There are many brands and forms of Acetaminophen (Lagaflex) available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An overdose of Acetaminophen (Lagaflex) can damage your liver or cause death.

Know the amount of Acetaminophen (Lagaflex) in the specific product you are taking.

Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take Acetaminophen (Lagaflex).

Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen (Lagaflex).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (Lagaflex) (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen (Lagaflex) which can lead to a fatal overdose. Check the label to see if a medicine contains Acetaminophen (Lagaflex) or APAP.

See also:
What is the most important information I should know about Carisoprodol (Lagaflex)?

This medication may be habit-forming and should be used only by the person it was prescribed for. Carisoprodol (Lagaflex) should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms when you stop using Carisoprodol (Lagaflex) after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Carisoprodol (Lagaflex) can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase drowsiness and dizziness caused by Carisoprodol (Lagaflex).

Use Acetaminophen (Lagaflex) injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Acetaminophen (Lagaflex) injection is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Acetaminophen (Lagaflex) injection at home, a health care provider will teach you how to use it. Be sure you understand how to use Acetaminophen (Lagaflex) injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not mix other medicines (especially chlorpromazine or diazepam) in the same container or IV line as Acetaminophen (Lagaflex) injection. Contact your health care provider if you have any questions about how to give Acetaminophen (Lagaflex) injection with other medicines.
• Do not use Acetaminophen (Lagaflex) injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Acetaminophen (Lagaflex) injection within 6 hours after opening.
• If you miss a dose of Acetaminophen (Lagaflex) injection and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen (Lagaflex) injection.

Use Carisoprodol (Lagaflex) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Carisoprodol (Lagaflex) by mouth with or without food.
• If you miss a dose of Carisoprodol (Lagaflex) and you are taking it regularly, take it as soon as possible. If it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Carisoprodol (Lagaflex).

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Acetaminophen (Lagaflex) Extra Strength

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of Acetaminophen (Lagaflex) available. Read the dosing instructions carefully for each product because the amount of Acetaminophen (Lagaflex) may be different between products. Do not take more Acetaminophen (Lagaflex) than recommended.

If you are giving Acetaminophen (Lagaflex) to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

Carisoprodol (Lagaflex) is used short-term to treat muscle pain and discomfort. It is usually used along with rest, physical therapy, and other treatments. It works by helping to relax the muscles.

How to use Carisoprodol (Lagaflex)

Take this medication by mouth with or without food as directed by your doctor, usually 4 times a day.

The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

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 stomach cramps, trouble sleeping, headache, nausea) 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.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your condition persists after 2 to 3 weeks or if it worsens.

See also:
What other drugs will affect Acetaminophen (Lagaflex)?

Acetaminophen (Lagaflex) is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen (Lagaflex) [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen (Lagaflex) and may decrease the action of Acetaminophen (Lagaflex). Doses of Acetaminophen (Lagaflex) greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen (Lagaflex) to harm the liver is increased when it is combined with alcohol or drugs that also harm the liver.

Cholestyramine (Questran) reduces the effect of Acetaminophen (Lagaflex) by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen (Lagaflex) should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Acetaminophen (Lagaflex) doses greater than 2275 mg per day may increase the blood thinning effect of warfarin (Coumadin) by an unknown mechanism. Therefore, prolonged administration or large doses of Acetaminophen (Lagaflex) should be avoided during warfarin therapy

See also:
What other drugs will affect Carisoprodol (Lagaflex)?

CNS Depressants

The sedative effects of Carisoprodol (Lagaflex) and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of Carisoprodol (Lagaflex) and meprobamate, a metabolite of Carisoprodol (Lagaflex), is not recommended.

CYP2C19 Inhibitors and Inducers

Carisoprodol (Lagaflex) is metabolized in the liver by CYP2C19 to form meprobamate. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with Carisoprodol (Lagaflex) could result in increased exposure of Carisoprodol (Lagaflex) and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John's Wort, with Carisoprodol (Lagaflex) could result in decreased exposure of Carisoprodol (Lagaflex) and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of Carisoprodol (Lagaflex) is unknown.

Drug Abuse And Dependence

Controlled Substance

Carisoprodol (Lagaflex) contains Carisoprodol (Lagaflex), a Schedule IV controlled substance. Carisoprodol (Lagaflex) has been subject to abuse, misuse, and criminal diversion for nontherapeutic use.

Abuse

Abuse of Carisoprodol (Lagaflex) poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders. Patients at high risk of Carisoprodol (Lagaflex) abuse may include those with prolonged use of Carisoprodol (Lagaflex), with a history of drug abuse, or those who use Carisoprodol (Lagaflex) in combination with other abused drugs.

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence).

Dependence

Tolerance is when a patient's reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of Carisoprodol (Lagaflex). Reported withdrawal symptoms with Carisoprodol (Lagaflex) include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of Carisoprodol (Lagaflex) or those taking the drug for a prolonged time to not abruptly stop Carisoprodol (Lagaflex).

See also:
What are the possible side effects of Acetaminophen (Lagaflex)?

Applies to Acetaminophen (Lagaflex): capsule, capsule liquid filled, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, tablet chewable, tablet disintegrating, tablet effervescent, tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, Acetaminophen (Lagaflex) (the active ingredient contained in Acetaminophen (Lagaflex)) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking Acetaminophen (Lagaflex):

Rare

• Bloody or black, tarry stools
• bloody or cloudy urine
• fever with or without chills (not present before treatment and not caused by the condition being treated)
• pain in the lower back and/or side (severe and/or sharp)
• pinpoint red spots on the skin
• skin rash, hives, or itching
• sore throat (not present before treatment and not caused by the condition being treated)
• sores, ulcers, or white spots on the lips or in the mouth
• sudden decrease in the amount of urine
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking Acetaminophen (Lagaflex):

Symptoms of overdose

• Diarrhea
• increased sweating
• loss of appetite
• nausea or vomiting
• stomach cramps or pain
• swelling, pain, or tenderness in the upper abdomen or stomach area

See also:
What are the possible side effects of Carisoprodol (Lagaflex)?

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain. In these studies, patients were treated with 250 mg of Carisoprodol (Lagaflex), 350 mg of Carisoprodol (Lagaflex), or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of Carisoprodol (Lagaflex), and 350 mg of Carisoprodol (Lagaflex), respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of Carisoprodol (Lagaflex), and 350 mg of Carisoprodol (Lagaflex), respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with Carisoprodol (Lagaflex) in the two trials described above.

Table 1: Patients with Adverse Reactions in Controlled Studies

Post-marketing Experience

The following events have been reported during postapproval use of Carisoprodol (Lagaflex). 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.

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

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia

Acetaminophen (Lagaflex) (with the Optizorb formulation) also contains the following excipients: Pregelatinized maize starch, calcium carbonate, alginic acid, crospovidone, povidone, magnesium stearate, colloidal anhydrous silica, parahydroxybenzoates (sodium methyl, ethyl and propyl), OPADRY YS-1-7003 white, carnauba wax, purified water.

It contains no sugar, lactose or gluten.

A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Carisoprodol (Lagaflex) has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of anxiety disorders, and also for the short-term management of insomnia but has largely been superseded by the benzodiazepines. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) Carisoprodol (Lagaflex) is a controlled substance in the U.S.