How much acetaminophen is in Fioricet. What are the dosing recommendations for Fioricet. What are the potential side effects and precautions associated with Fioricet use. How does Fioricet compare to other similar medications.

Composition of Fioricet: Breaking Down the Active Ingredients

Fioricet is a combination medication used primarily for the treatment of tension headaches. To understand its composition, let’s break down the active ingredients:

• Butalbital: 50 mg
• Acetaminophen: 300 mg or 325 mg (depending on the formulation)
• Caffeine: 40 mg

The acetaminophen content in Fioricet can vary slightly depending on the specific formulation. Most commonly, Fioricet contains either 300 mg or 325 mg of acetaminophen per dose. This variation is important to note when calculating daily acetaminophen intake.

Why is the acetaminophen content important?

The acetaminophen content in Fioricet is crucial to monitor due to the potential risk of hepatotoxicity associated with excessive acetaminophen use. The maximum recommended daily dose of acetaminophen is 4000 mg for adults. Exceeding this limit can lead to severe liver damage, potentially requiring liver transplantation or even resulting in death.

Dosage Recommendations for Fioricet in Adults

The recommended dosage for Fioricet in adults varies based on the formulation:

• For capsules or tablets containing 300 mg or 325 mg of acetaminophen: 1-2 capsules/tablets every 4 hours as needed, not exceeding 6 capsules/tablets per day.
• For oral liquid formulation (325 mg acetaminophen per 15 mL): 15-30 mL every 4 hours as needed, not exceeding 90 mL per day.

It’s crucial to adhere to these dosage guidelines to minimize the risk of side effects and potential acetaminophen overdose.

What factors influence Fioricet dosage?

Several factors can affect the appropriate Fioricet dosage for an individual:

1. Age: Elderly patients may require lower doses due to decreased metabolism and increased sensitivity to the drug’s effects.
2. Liver function: Patients with liver impairment may need dose adjustments to prevent further liver damage.
3. Kidney function: Renal impairment can affect drug clearance, necessitating dosage modifications.
4. Concurrent medications: Interactions with other drugs may require dose adjustments.
5. Individual response: Some patients may achieve adequate pain relief with lower doses.

Pediatric Use of Fioricet: Safety Considerations

Fioricet is generally not recommended for use in children under 12 years of age. For adolescents 12 years and older, the dosage recommendations are similar to those for adults. However, it’s essential to consider the following:

• The safety and efficacy of Fioricet in pediatric patients have not been well-established.
• Children may be more susceptible to the side effects of barbiturates like butalbital.
• The risk of acetaminophen toxicity may be higher in pediatric patients due to their smaller body size.

Parents and healthcare providers should carefully weigh the potential benefits and risks before considering Fioricet use in adolescents.

Potential Side Effects and Adverse Reactions of Fioricet

While Fioricet can be effective for tension headaches, it’s important to be aware of potential side effects:

• Drowsiness and dizziness
• Nausea and vomiting
• Abdominal pain
• Shortness of breath
• Anxiety or restlessness
• Dry mouth
• Lightheadedness

More serious adverse reactions can include:

• Liver toxicity (due to acetaminophen)
• Respiratory depression (particularly with high doses or in combination with other CNS depressants)
• Allergic reactions (including skin rashes)
• Physical dependence and withdrawal symptoms (associated with butalbital)

How can patients minimize the risk of side effects?

To reduce the likelihood of experiencing adverse effects, patients should:

1. Adhere strictly to prescribed dosages
2. Avoid alcohol consumption while taking Fioricet
3. Inform their healthcare provider of all other medications they are taking
4. Be aware of the signs of acetaminophen overdose and seek immediate medical attention if suspected
5. Use Fioricet for the shortest duration necessary to control symptoms

Drug Interactions: What to Watch Out for When Taking Fioricet

Fioricet can interact with various medications, potentially altering its effectiveness or increasing the risk of side effects. Some notable interactions include:

• Other CNS depressants (e.g., opioids, benzodiazepines, alcohol): Can enhance sedative effects and increase the risk of respiratory depression
• Monoamine oxidase inhibitors (MAOIs): Can potentiate the effects of butalbital and increase the risk of hypertensive crisis
• Warfarin: Butalbital may affect warfarin metabolism, potentially altering anticoagulant effects
• CYP3A4 inducers or inhibitors: May affect the metabolism of butalbital

Patients should always disclose their full medication list, including over-the-counter drugs and supplements, to their healthcare provider before starting Fioricet.

What are the risks of combining Fioricet with alcohol?

Combining Fioricet with alcohol can be particularly dangerous due to:

1. Increased risk of acetaminophen-induced liver damage
2. Enhanced CNS depression, leading to severe drowsiness and impaired coordination
3. Potential for respiratory depression, especially at higher doses
4. Increased risk of developing physical dependence on butalbital

Patients should be strongly advised to avoid alcohol consumption while taking Fioricet.

Precautions and Warnings: Essential Information for Fioricet Users

Several important precautions should be considered when using Fioricet:

• Hepatotoxicity risk: Due to the acetaminophen content, patients should be cautious about total daily acetaminophen intake from all sources.
• Dependence potential: Butalbital can lead to physical dependence with prolonged use.
• Pregnancy and breastfeeding: Fioricet should be used with caution in pregnant or breastfeeding women due to potential risks to the fetus or infant.
• Elderly patients: May be more sensitive to the effects of Fioricet and require lower doses.
• Patients with liver or kidney impairment: May require dosage adjustments or alternative treatments.

How should patients safely discontinue Fioricet use?

If a patient needs to stop taking Fioricet, especially after prolonged use, it’s important to follow these guidelines:

1. Consult with a healthcare provider before discontinuing the medication
2. Gradually taper the dose under medical supervision to minimize withdrawal symptoms
3. Be aware of potential withdrawal symptoms, such as anxiety, tremors, and seizures
4. Consider alternative pain management strategies during the tapering process
5. Seek immediate medical attention if severe withdrawal symptoms occur

Alternatives to Fioricet: Exploring Other Treatment Options

While Fioricet can be effective for tension headaches, there are several alternative treatments that patients and healthcare providers may consider:

• Non-opioid analgesics: Such as ibuprofen or naproxen
• Triptans: For migraine headaches
• Muscle relaxants: For tension-type headaches
• Preventive medications: Such as beta-blockers or anticonvulsants for chronic headaches
• Non-pharmacological approaches: Including stress management, acupuncture, or biofeedback

The choice of alternative treatment depends on the specific type of headache, individual patient factors, and the potential risks and benefits of each option.

How do these alternatives compare to Fioricet in terms of efficacy and safety?

Comparing alternative treatments to Fioricet involves considering several factors:

1. Efficacy: Some alternatives may be equally or more effective for certain types of headaches
2. Safety profile: Many alternatives have a lower risk of dependence and hepatotoxicity
3. Side effect profile: Different treatments may have varying side effects that need to be considered
4. Long-term use: Some alternatives may be more suitable for long-term management of chronic headaches
5. Individual response: Patient-specific factors can influence the effectiveness of different treatments

Patients should work closely with their healthcare providers to determine the most appropriate treatment option based on their individual needs and medical history.

Monitoring and Follow-up: Ensuring Safe and Effective Fioricet Use

Regular monitoring is crucial for patients taking Fioricet to ensure safe and effective use. Healthcare providers should consider the following aspects:

• Liver function tests: Periodic monitoring to assess potential hepatotoxicity
• Headache frequency and severity: To evaluate treatment efficacy
• Signs of dependence or tolerance: Watching for increased dosage needs or withdrawal symptoms
• Medication reconciliation: Regularly reviewing all medications to prevent potential interactions
• Side effect assessment: Monitoring for adverse reactions and adjusting treatment as needed

Patients should be educated about the importance of follow-up appointments and reporting any concerning symptoms or changes in their condition.

What signs should prompt immediate medical attention?

Patients taking Fioricet should be aware of certain warning signs that require immediate medical attention:

1. Signs of liver problems: Yellowing of skin or eyes, dark urine, pale stools, abdominal pain
2. Allergic reactions: Rash, itching, swelling, severe dizziness, difficulty breathing
3. Severe drowsiness or confusion
4. Unusual bleeding or bruising
5. Severe or persistent headache unrelieved by the medication

Prompt medical evaluation in these cases can help prevent serious complications and ensure appropriate management of potential adverse effects.

Acetaminophen / Butalbital / Caffeine Dosage Guide + Max Dose, Adjustments

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Medically reviewed by Drugs.com. Last updated on Jan 21, 2022.

Applies to the following strengths: 325 mg-50 mg-40 mg; 300 mg-50 mg-40 mg; 500 mg-50 mg-40 mg; 325 mg-50 mg-40 mg/15 mL; 750 mg-50 mg-40 mg

Usual Adult Dose for:

• Headache

Usual Pediatric Dose for:

• Headache

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Headache

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache

12 years or older:

Butalbital 50 mg/acetaminophen 300 mg/caffeine 40 mg: 1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine 40 mg: 1 or 2 capsules or tablets orally every 4 hours as needed not to exceed 6 capsules or tablets per day

Butalbital 50 mg/acetaminophen 325 mg/caffeine per 15 mL oral liquid: 15 to 30 mL orally every 4 hours as needed not to exceed 90 mL per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be cautious generally starting at the low end of the dosing range.

The drug should not be abruptly discontinued in the physically dependent person.

Precautions

US BOXED WARNING: Hepatotoxicity

• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with acetaminophen use at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally as needed
• Do not exceed 6 capsules/tablets per day or 90 mL of oral liquid per day; do not exceed 4000 mg of acetaminophen per day; when calculating daily acetaminophen doses, be sure to include all acetaminophen-containing products and all routes of administration.
• Oral liquid is 7.368% alcohol.

Storage requirements: Protect from light and moisture

General:

• Butalbital use is associated with a high rate of physical dependence; extended use is not recommended.
• Acetaminophen induced hepatotoxicity is mostly preventable by ensuring maximum daily doses are not exceeded; use of more than 1 acetaminophen-containing product at a time should be discouraged as the use of multiple acetaminophen-containing products increases the risk of excess acetaminophen doses.
• Serious skin reaction may occur; discontinue therapy at first appearance of skin rash or any other sign of hypersensitivity.

Monitoring:

• Monitor for potential abuse
• Monitor for respiratory depression, especially with concomitant CNS depressant use
• Monitor for nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in upper right part of the stomach, yellow of the skin or eyes, and/or flu-like symptoms as this may be an indication of acetaminophen overdose.
• Monitor for skin reactions

Patient advice:

• Patients should be advised that this drug has the potential to cause physical and psychological dependence, and tolerance; patients should be instructed to take this drug as prescribed, in the amounts prescribed, and no more frequently than prescribed.
• Patients should be advised that severe liver damage may occur if more than the recommended amount of acetaminophen is taken; if they suspect they may have taken too much acetaminophen or if they experience nausea, vomiting, loss of appetite, or yellowing of the skin or eyes they should seek medical help promptly.
• Patients should be discouraged from using multiple acetaminophen-containing products concurrently; patients should be instructed to check with their healthcare provider or pharmacist if they have questions on what products contain acetaminophen.
• Patients should be advised to avoid alcohol use while taking this drug.
• Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

More about acetaminophen / butalbital / caffeine

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• Drug class: analgesic combinations
• En español

Patient resources

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• Butalbital, acetaminophen, and caffeine (Advanced Reading)
• Butalbital, Acetaminophen, and Caffeine Capsules and Tablets
• Butalbital, Acetaminophen, and Caffeine Solution

Other brands

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Professional resources

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Acetaminophen / Butalbital Dosage Guide + Max Dose, Adjustments

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Medically reviewed by Drugs. com. Last updated on Aug 17, 2022.

Applies to the following strengths: 325 mg-50 mg; 650 mg-50 mg; 300 mg-50 mg; 325 mg-25 mg

Usual Adult Dose for:

• Headache

Usual Pediatric Dose for:

• Headache

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Headache

Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Usual Pediatric Dose for Headache

12 years or older:
Butalbital 50 mg/acetaminophen 300 or 325 mg:
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day

Butalbital 25 mg/acetaminophen 325 mg:
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Comments:

• Due to high rate of physical dependence, the extended use of this drug is not recommended.
• The safety and efficacy of treating multiple recurrent headaches with this product is not known.

Uses: For the relief of the symptom complex of tension (or muscle contraction) headache.

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be cautious generally starting at the low end of the dosing range.

The drug should not be abruptly discontinued in the physically dependent person.

Precautions

US BOXED WARNING: Hepatotoxicity

• Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with acetaminophen use at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally as needed; do not exceed recommended doses
• Do not exceed 4000 mg of acetaminophen per day; when calculating daily acetaminophen doses, be sure to include the amount in this product as well as all acetaminophen-containing products and all routes of administration.

Storage requirements: Protect from light and moisture

General:

• Butalbital use is associated with a high rate of physical dependence; extended use is not recommended.
• Acetaminophen induced hepatotoxicity is mostly preventable by ensuring maximum daily acetaminophen doses are not exceeded; use of more than 1 acetaminophen-containing product at one time should be discouraged.
• Serious skin reaction may occur; discontinue therapy at first appearance of skin rash or any other sign of hypersensitivity.

Monitoring:

• Monitor for potential abuse
• Monitor for respiratory depression, especially with concomitant CNS depressant use
• Monitor for nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in upper right part of the stomach, yellow of the skin or eyes, and/or flu-like symptoms as this may be an indication of acetaminophen overdose.
• Monitor for skin reactions

Patient advice:

• Patients should be advised that this drug has the potential to cause physical and psychological dependence, and tolerance; patients should be instructed to take this drug as prescribed, in the amounts prescribed, and no more frequently than prescribed.
• Patients should be advised that severe liver damage may occur if more than the recommended amount of acetaminophen is taken; if they suspect they may have taken too much acetaminophen or if they experience nausea, vomiting, loss of appetite, or yellowing of the skin or eyes they should seek medical help promptly.
• Patients should be discouraged from using multiple acetaminophen-containing products concurrently; patients should be instructed to check with their healthcare provider or pharmacist if they have questions on what products contain acetaminophen.
• Patients should be advised to avoid alcohol use while taking this drug.
• Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

More about acetaminophen / butalbital

• Check interactions
• Compare alternatives
• Pricing & coupons
• Reviews (18)
• Drug images
• Side effects
• Patient tips
• During pregnancy
• Drug class: analgesic combinations
• En español

Patient resources

• Drug Information
• Butalbital and acetaminophen (Advanced Reading)
• Butalbital and Acetaminophen

Other brands

Bupap, Allzital, Cephadyn, Marten-Tab, . .. +2 more

Professional resources

• Prescribing Information

Related treatment guides

• Headache

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Acetaminophen (paracetamol)

Paracetamol/acetaminophen is an anilide medicine used for mild to moderate pain, fever and colds.

Synonyms Russian

N-(4-Hydroxyphenyl)acetamide, C ₈ H ₉ NO _2, ifimol.

English synonyms

Paracetamol, Acetaminophen, Ifimol.

Test method

High performance liquid chromatography with tandem mass spectrometry.

Units

µg/mL (micrograms per milliliter).

What biomaterial can be used for research?

Venous blood.

How to properly prepare for an examination?

• Children under 1 year of age do not eat for 30-40 minutes before the test.
• Do not eat for 2-3 hours before the study, you can drink clean still water.
• Do not smoke for 30 minutes before the test.

Study background

Paracetamol/acetaminophen is one of the most popular and most commonly used pain and fever reducers worldwide. It serves as the drug of choice for patients who are contraindicated in non-steroidal anti-inflammatory drugs (NSAIDs), in people with bronchial asthma, peptic ulcer, hemophilia, among children, pregnant and lactating women. Paracetamol is well tolerated and causes few gastrointestinal side effects with the correct dosage regimen, however, the number of reported cases of paracetamol-induced liver damage is steadily increasing every year worldwide.

Paracetamol is an antipyretic analgesic, that is, a drug with analgesic, antipyretic and weak anti-inflammatory action. The mechanism of action is associated with the inhibition of prostaglandin synthesis, the predominant effect on the thermoregulatory center in the hypothalamus by reducing its excitability. Paracetamol therapy is effective, well tolerated by most patients, and safe when used at therapeutic doses. However, the use of paracetamol, even at therapeutic doses in underweight individuals who abuse alcohol, or when taken with other drugs, can cause serious liver damage. In addition, paracetamol is “hidden” in other drugs under different names. Long-term use of high doses of paracetamol is associated with the risk of adverse reactions such as hypertension, myocardial infarction or renal failure. In addition, the side effects of paracetamol include agranulocytosis, thrombocytopenia, anemia, renal colic, aseptic pyuria, interstitial glomerulonephritis, allergic reactions in the form of skin rashes. Symptoms of an overdose of the drug include pallor, nausea, vomiting and pain in the abdominal region, after 12-48 hours damage to the kidneys and liver may begin with the development of liver failure (encephalopathy, coma, death), cardiac arrhythmias and pancreatitis.

The use of paracetamol in children requires special care and the choice of an adequate dosage (depending on age), which differs significantly from the standard adult.

What is research used for?

• Detection of the toxic level of the drug.
• Monitoring of the concentration of paracetamol in the blood.
• Evaluation of drug interactions.

When is the test ordered?

• If an overdose of the drug is suspected.
• With the development of side effects of paracetamol.

What do the results mean?

Reference values: 10 – 20 µg/ml.

The results of the study are evaluated by the attending physician, taking into account the dose of paracetamol, its regimen, the patient’s age, comorbidities and individual drug tolerance.

After a single dose of 500 mg, the maximum plasma concentration is reached after 10-60 minutes and is about 6 mcg / ml, then gradually decreases and after 6 hours is 11-12 mcg / ml.

What can influence the result?

• Metoclopramide increases the rate of absorption of acetaminophen.
• Colestyramine reduces the rate of absorption of acetaminophen.

Important notes

• Paracetamol increases the risk of hemorrhagic complications.
• Concomitant use of paracetamol and alcoholic beverages increases the risk of liver damage and acute pancreatitis.
• Hypnotic drugs increase the side effects of paracetamol, can lead to liver damage even with non-toxic doses of paracetamol, so liver function should be monitored.
• Long-term co-administration of paracetamol and NSAIDs increases the risk of developing nephropathy and end-stage renal disease.
• Paracetamol increases the effect of indirect anticoagulants, so INR should be monitored.
• Taking paracetamol increases the chance of liver damage from hepatotoxic drugs.

Who orders the examination?

Therapist, hepatologist, nephrologist, rheumatologist, toxicologist.

Literature

• Jóźwiak-BebenistaM, NowakJZ. Paracetamol: mechanism of action, applications and safety concern. Acta Pol Pharm. 2014 Jan-Feb;71(1):11-23. PMID: 24779190.
• https://www.rlsnet.ru/mnn_index_id_500.htm.
• https://www.vidal.ru/drugs/molecule/800.

Acetaminophen CODEINE JALINOUS – instructions for use, dosage, composition, analogues, side effects / Pillintrip

Page reviewed by pharmacist Kovalenko Svetlana Olegovna ateFioricet With CodeineTheracodeine-300Tylenol With Codeine (Acetaminophen,Codeine Phosphate)Acetaminophen And Codeine PhosphateAcetaminophen With CodeineAcetaminophen CODEINE JALINOUSAcetaminophen/Codeine phosphateAdco-DolAferinBetapynCodral Cold & FluDymadon CoMyprodolPacecoPropainPynstop Ratio-lenoltec No 1, No 2, No 3

Name of the medicine

Description The name of the medicine Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more…

Paracetamol codeine JALINOUS

Therapeutic indications

Description Therapeutic indications Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more. ..

A prescription is a term used to refer to a list of conditions, symptoms, or diseases for which a drug is prescribed or used by a patient. For example, CODEINE acetaminophen or paracetamol is used by a patient for a fever, or a doctor prescribes it for a headache or body aches. Now fever, headache and body aches are signs of paracetamol. The patient should be aware of the indications for drugs used in common conditions, because they can be taken without a prescription from a pharmacy.

Acetaminophen CODEINE JALINOUS® (Acetaminophen CODEINE JALINOUS) injection is indicated for

• treatment of mild to moderate pain
• treatment of moderate to severe pain with ancillary opioid analgesics
• fever reduction.

Paracetamol codeine JALINUS injection is used with other medicines (eg narcotic pain relievers) to relieve moderate to severe pain.

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

Acetaminophen CODEINE JALINOUS is only available with your doctor’s prescription.

Dosage and Administration

Description Dosage and Administration Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more…

General Dosing Information

Acetaminophen CODEINE JALINOUS may be given as a single or repeated dose to treat acute pain or fever. No dose adjustment is required when switching from oral Acetaminophen CODEINE to oral Acetaminophen CODEINE in adults and adolescents weighing 50 kg or more. The calculated maximum daily dose of CODEINE JALINOUS acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing CODEINE acetaminophen. Exceeding the maximum daily dose of CODEINE acetaminophen in mg/kg, as described in Tables 1 and 2, may result in liver damage, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of CODEINE JALINOUS acetaminophen from all routes and from all credits does not exceed the maximum recommended dose of

Recommended

Dosage: Adults and adolescents

Adults and adolescents weighing 50 kg or older: The recommended dose of CODEINE JALINOUS acetaminophen is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum of CODEINE JALINOUS Acetaminophen 1000 mg, minimum dosing interval of 4 hours, and CODEINE JALINOUS Acetaminophen 4000 mg daily maximum daily dose (includes all routes of administration and all products containing CODEINE JALINOUS Acetaminophen, including combination products).

Adults and adolescents weighing less than 50 kg: The recommended dose of CODEINE JALINOUS Acetaminophen is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of CODEINE JALINOUS Acetaminophen of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetami nophene CODEINE JALINOUS is 75 mg/kg per day (includes all routes of administration and all products containing Acetaminophen CODEINE JALINOUS, including combination products).

Table 1: Dosage for adults and adolescents

Age group	Dose every 4 hours	Dose every 6 hours	Maximum single dose	Maximum total daily dose of acetaminophen CODEINE JALINOSE (all routes)
Adults and adolescents (13 years and older) weighing ≥ 50 kg	650 mg	1000 mg	1000 mg	4000 mg over 24 hours
Adults and adolescents (13 years and older) weighing < 50 kg	12. 5 mg/kg	15 mg/kg	15 mg/kg (up to 750 mg)	75 mg/kg for 24 hours (up to 3750 mg)

Recommended

Dose: Children

up to 12 years: The recommended dose of CODEINE Acetaminophen is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of CODEINE Acetaminophen of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of CODEINE acetaminophen of 75 mg/kg per day.

Table 2: Dosage for children

Instructions for

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring a 1000 mg dose of CODEINE JALINOUS acetaminophen, administer the dose by injecting a ventilated intravenous set through the septum of the vial 100 ml. Acetaminophen CODEINE YALINOS can be administered without further dilution. Before preparing a dose or administration, examine the contents of the vial. DO NOT USE if particulate matter or discoloration is observed. Inject the contents of the vial intravenously over 15 minutes. Use of an antiseptic in the preparation of JALINOUS Codeine Paracetamol for intravenous infusion. Do not add other medicines to the codeine acetaminophen vial or infusion device

For doses less than 1000 mg, the appropriate dose must be removed from the vial and placed in a separate container prior to administration. Using aseptic technique, remove the appropriate dose (650 mg or by weight) from the intact acetaminophen-CODEINE sealed vial and place the measured dose in a separate, empty, sterile container (e.g., glass vial, plastic IV container, or syringe) for IV infusion to avoid inadvertent delivery and administration of the entire volume of the commercially available container. The entire 100 ml vial of JALINOUS CODEINE Acetaminophen is not intended for use in patients weighing less than 50 kg. Acetaminophen CODEINE JALINOUS is a single use vial and the unused portion should be discarded.

Place pediatric small volume doses up to 60 ml into a syringe and inject over 15 minutes using a syringe pump.

Monitor the end of the infusion to prevent the possibility of an air embolism, especially when an acetaminophen-CODEINE infusion is the primary infusion.

After the vacuum seal of the glass vial has been broken or the contents transferred to another container, administer a dose of CODEINE JALINOS acetaminophen over 6 hours.

Do not add other drugs to the acetaminophen and CODEINE solution. Diazepam and chlorpromazine hydrochloride are not physically compatible with CODEINE acetaminophen and should therefore not be given concomitantly.

How Delivered

Dosage Forms & Strengths

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

Storage & Handling

NDC 43825-102-01 – Acetaminophen CODEINE JALINOUS® (Acetaminophen CODEINE JALINOUS) for injection is supplied in a 100 ml glass vial containing 1000 mg A cetaminophen CODEINE JALINOUS (10 mg/ml) in cardboard boxes of 24 vials.

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

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: December 2014

Contraindications

Description Contraindications Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
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What is the most important information I should know about Codeine Jalinus Acetaminophen?

There are many brands and forms of CODEINE JALINOUS acetaminophen available and not all brands are listed in this leaflet.

Do not take more of this medicine than recommended. An overdose of CODEINE acetaminophen can damage your liver or cause death.

Know the amount of acetaminophen-CODEINE JALINOUS in the particular product you are taking.

Do not take this medicine without your doctor’s advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic drinks per day. You may not be able to take Acetaminophen CODEINE JALINUS.

Avoid alcohol. This may increase the risk of liver damage when taking CODEINE JALINO acetaminophen.

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

Talk to your doctor or pharmacist before taking any other cold, allergy, pain or sleep medicines. JALINOUS codeine, acetaminophen (sometimes abbreviated as APAP) is found in many drug combinations. Taking certain foods together can cause you to get too much CODEINE acetaminophen, which can lead to a fatal overdose. Check the label to see if the medicine contains ACETAMINOPHENE or APAP.

Special warnings and precautions

Description Special warnings and precautions Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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Use CODEINE acetaminophen injection as directed by your doctor. Check the medication label for exact dosage instructions.

• Acetaminophen – CODEINE is usually given as an injection at a doctor’s office, hospital or clinic. If you will be using CODEINE acetaminophen at home, your doctor will teach you how to use it. Make sure you understand how to use Codeine Injection Acetaminophen. Follow the procedures you are taught when you use your dose. If you have any questions, please contact your doctor.
• Do not mix other medicines (especially chlorpromazine or diazepam) in the same container or IV line as CODEINE acetaminophen. Talk to your doctor if you have any questions about taking CODEINE Acetaminophen Injection with other medicines.
• Do not use CODEINE Acetaminophen for Injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Acetaminophen CODEINE Injection within 6 hours of opening.
• If you miss a dose of Acetaminophen-CODEINE Injection and are using it regularly, use it as soon as possible. If several hours have passed or the next dose is approaching, do not double the dose to make up for lost time unless advised by your healthcare professional. Do not use 2 doses at once.

Ask your doctor any questions you may have about how to use CODEINE Acetaminophen Injection.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after a few days, some drugs need to be continued for an extended period to get the benefit from it.

This drug is used to treat mild to moderate pain (from headache, menstrual periods, toothache, back pain, osteoarthritis, or cold/flu) and to reduce fever.

How to use Acetaminophen CODEINE JALINOUS Extra Strength

Take this product by mouth as directed. Follow all directions on the product packaging. If you are unsure of any information, ask your doctor or pharmacist.

There are many brands and forms of JALINOUS acetaminophen-CODEINE. Read the dosing instructions for each product carefully because the amount of CODEINE JALINOUS acetaminophen may vary between products. Do not take more acetaminophen-CODEINE than recommended.

If you are giving acetaminophen-CODEINE to a child, be sure to use a product intended for children. Use your child’s weight to find the correct dose on the product packaging. If you do not know your child’s weight, you can use his age.

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

For quick-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. This can release all of the medicine at once, increasing the risk of side effects. Also, do not split tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or divided tablet without crushing or chewing.

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

Pain medications work best when used at the first sign of pain. If you wait until the symptoms get worse, the medicine may not work.

Do not take this fever medicine 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 your child has a sore throat (especially with a high fever, headache, or nausea/vomiting), call a doctor right away.

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, seek medical attention immediately.

Interaction with other drugs

Description Interaction with other drugs Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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What other drugs will affect Acetaminophen CODEINE YALINOSIS?

Acetaminophen CODEINE JALINOSIS is metabolized (excreted into other chemicals) by the liver. Therefore, drugs that enhance the action of liver enzymes that are metabolized by paracetamol codeine JALINOUS [eg, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampicin (Rifamate, Rifadin, Rimactane)] reduce the levels of paracetamol and codeine JALINOUS may reduce the effects of paracetamol codeine JALINOUS. Doses of CODEINE JALINOUS acetaminophen in excess of the recommended doses are toxic to the liver and can lead to severe liver damage. The likelihood that codeine acetaminophen can harm the liver increases when it is combined with alcohol or drugs that also harm the liver.

Cholestyramine (Questran) reduces the effect of acetaminophen on CODEINE by reducing its absorption into the body from the intestines. Therefore, acetaminophen CODEINE YALINOS should be administered 3-4 hours after cholestyramine or one hour before cholestyramine.

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

Side effects

Description Side effects Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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What are the possible side effects of acetaminophen and CODEINE?

Applies to JALINOUS Acetaminophen CODEINE: capsule, liquid-filled capsule, elixir, liquid, powder, powder for solution, solution, suppository, suspension, syrup, tablet, chewable tablet, disintegrating tablet, effervescent tablet, extended release tablet

9000 2 Other dosage forms:

• intravenous solution

In addition to its intended effects, CODEINE JALINOUS Acetaminophen (the active ingredient found in CODEINE JALINOUS Acetaminophen) may cause some unwanted effects. While not all of these side effects may occur, if they do occur, they may require medical attention.

Talk to your doctor right away if you experience any of the following side effects while taking codeine acetaminophen:

Rare

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

Seek immediate medical attention Seek emergency care if any of the following overdose symptoms occur while taking CODEINE acetaminophen:

Overdose symptoms

• Diarrhea0045 increased sweating
• loss of appetite
• nausea or vomiting
• abdominal cramps or pain
• swelling, pain or soreness in the upper abdomen or abdomen

Overdose

90 002 Description Overdose Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
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Composition

Description Composition Acetaminophen CODEINE JALINOUS is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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