Acetaminophen Infant Uses

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What is Acetaminophen Infant?

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

Acetaminophen Infant 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 Infant may cause unwanted effects when taken in large doses, including liver damage.

Acetaminophen Infant is available only with your doctor's prescription.

Acetaminophen Infant indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, Acetaminophen Infant or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Acetaminophen Infant Injection is indicated for

How should I use Acetaminophen Infant?

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

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

Uses of Acetaminophen Infant in details

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 few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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 Infant 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 Infant available. Read the dosing instructions carefully for each product because the amount of Acetaminophen Infant may be different between products. Do not take more Acetaminophen Infant than recommended.

If you are giving Acetaminophen Infant 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.

Acetaminophen Infant description

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Acetaminophen Infant (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.

Acetaminophen Infant dosage

General Dosing Information

Acetaminophen Infant Injection 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 Infant and Acetaminophen Infant Injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of Acetaminophen Infant is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing Acetaminophen Infant. Exceeding the maximum mg/kg daily dose of Acetaminophen Infant as described in Tables 1 to 3 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 Infant from all routes and from all sources 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 Infant Injection is 1,000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Acetaminophen Infant Injection of 1,000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Acetaminophen Infant of 4,000 mg per day (includes all routes of administration and all Acetaminophen Infant-containing products including combination products).

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

Table 1. Dosing for Adults and Adolescents
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Acetaminophen Infant (by all routes)

Adults and adolescents (13 years and older) weighing

≥ 50 kg

650 mg

1,000 mg

1,000 mg

4,000 mg in 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 in

24 hours

(up to 3,750 mg)

Recommended

Dosage: Children

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

Table 2. Dosing for Children
Age group

Dose given every 4 hours

Dose given every 6 hours

Maximum single dose

Maximum total daily dose of Acetaminophen Infant (by all routes)

Children 2 to 12 years of age

12.5 mg/kg

15 mg/kg

15 mg/kg

(up to 750 mg)

75 mg/kg in

24 hours

(up to 3,750 mg)

Recommended Dosage for Treatment of Fever in Neonates and Infants

Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of Acetaminophen Infant is 12.5 mg/kg every 6 hours, to a maximum daily dose of Acetaminophen Infant of 50 mg/kg per day, with a minimum dosing interval of 6 hours.

Infants 29 days to 2 years of age: the recommended dosage of Acetaminophen Infant is 15 mg/kg every 6 hours, to a maximum daily dose of Acetaminophen Infant of 60 mg/kg per day, with a minimum dosing interval of 6 hours.

Table 3. Dosing for Treatment of Fever in Neonates and Infants
Age group

Dose given every 6 hours

Maximum total daily dose of Acetaminophen Infant (by all routes)

Neonates (birth to 28 days)

12.5 mg/kg

50 mg/kg

Infants (29 days to 2 years)

15 mg/kg

60 mg/kg

Instructions for

Intravenous Administration

For adult and adolescent patients weighing ≥ 50 kg requiring 1,000 mg doses of Acetaminophen Infant Injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen Infant Injection may be administered without further dilution. Examine the container 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 Infant Injection for intravenous infusion. Do not add other medications to the Acetaminophen Infant Injection vial or infusion device.

For doses less than 1,000 mg, the appropriate dose must be withdrawn from the container 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 Infant Injection container 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 container of Acetaminophen Infant Injection is not intended for use in patients weighing less than 50 kg. Acetaminophen Infant Injection is supplied in a single-dose container 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 Infant Injection infusion is the primary infusion.

Once the container seal has been penetrated, or the contents transferred to another container, administer the dose of Acetaminophen Infant Injection within 6 hours.

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

Acetaminophen Infant interactions

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What other drugs will affect Acetaminophen Infant?

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Acetaminophen Infant is metabolized (eliminated by conversion to other chemicals) by the liver. Therefore drugs that increase the action of liver enzymes that metabolize Acetaminophen Infant [for example, carbamazepine (Tegretol), isoniazid (INH, Nydrazid, Laniazid), rifampin (Rifamate, Rifadin, Rimactane)] reduce the levels of Acetaminophen Infant and may decrease the action of Acetaminophen Infant. Doses of Acetaminophen Infant greater than the recommended doses are toxic to the liver and may result in severe liver damage. The potential for Acetaminophen Infant 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 Infant by decreasing its absorption into the body from the intestine. Therefore, Acetaminophen Infant should be administered 3 to 4 hours after cholestyramine or one hour before cholestyramine.

Acetaminophen Infant 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 Infant should be avoided during warfarin therapy

Acetaminophen Infant side effects

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What are the possible side effects of Acetaminophen Infant?

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.

Adult Population

A total of 1,020 adult patients have received Acetaminophen Infant in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with Acetaminophen Infant 1,000 mg every 6 hours. A total of 13.1% (n=134) received Acetaminophen Infant 650 mg every 4 hours.

All adverse reactions that occurred in adult patients treated with either Acetaminophen Infant or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 4. The most common adverse events in adult patients treated with Acetaminophen Infant (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.

Table 4. Treatment-Emergent Adverse Reactions Occurring in ≥ 3% of Acetaminophen Infant-treated Adult Patients and at a Greater Frequency than Placebo in Placebo-Controlled, Repeated Dose Studies
* Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of Acetaminophen Infant may mask fever.
System Organ Class – Preferred Term

Acetaminophen Infant (N=402)

n (%)

Placebo (N=379)

n (%)

Gastrointestinal Disorders

Nausea

Vomiting

138 (34)

62 (15)

119 (31)

42 (11)

General Disorders and Administration Site Conditions

Pyrexia*

22 (5)

52 (14)

Nervous System Disorders

Headache

39 (10)

33 (9)

Psychiatric Disorders

Insomnia

30 (7)

21 (5)

Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Infant in Adults

The following additional treatment-emergent adverse reactions were reported by adult subjects treated with Acetaminophen Infant in all clinical trials (n=1,020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).

Blood and lymphatic system disorders: anemia

General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral

Investigations: aspartate aminotransferase increased, breath sounds abnormal

Metabolism and nutrition disorders: hypokalemia

Musculoskeletal and connective tissue disorders: muscle spasms, trismus

Psychiatric disorders: anxiety

Respiratory, thoracic and mediastinal disorders: dyspnea

Vascular disorders: hypertension, hypotension

Pediatric Population

A total of 483 pediatric patients (72 neonates, 167 infants, 171 children, and 73 adolescents) have received Acetaminophen Infant in active-controlled (n=250) and open-label clinical trials (n=225), including 43.9% (n=212) who received 5 or more doses and 31.2% (n=153) who received more than 10 doses. Pediatric patients received Acetaminophen Infant doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.

The most common adverse events (incidence ≥ 5%) in pediatric patients treated with Acetaminophen Infant were nausea, vomiting, constipation, and pruritus.

Other Adverse Reactions Observed During Clinical Studies of Acetaminophen Infant in Pediatrics

The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with Acetaminophen Infant (n=483) that occurred with an incidence of at least 1%.

Blood and lymphatic system disorders: anemia

Gastrointestinal disorders: diarrhea

General disorders and administration site conditions: pyrexia, injection site pain

Metabolism and nutrition disorders: hypokalemia, hypomagnesemia, hypoalbuminemia, hypophosphatemia

Musculoskeletal and connective tissue disorders: muscle spasm

Nervous system disorders: headache

Psychiatric disorders: agitation

Renal and urinary disorders: oliguria

Respiratory, thoracic and mediastinal disorders: atelectasis, pleural effusion, pulmonary edema, stridor, wheezing

Vascular disorders: hypotension, hypertension

Acetaminophen Infant contraindications

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What is the most important information I should know about Acetaminophen Infant?

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

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

Know the amount of Acetaminophen Infant 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 Infant.

Avoid drinking alcohol. It may increase your risk of liver damage while taking Acetaminophen Infant.

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 Infant (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much Acetaminophen Infant which can lead to a fatal overdose. Check the label to see if a medicine contains ACETAMINOPHEN or APAP.



Active ingredient matches for Acetaminophen Infant:

Acetaminophen


List of Acetaminophen Infant substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Acetaminophen 325 mg
Tablet; Oral; Acetaminophen 500 mg
Liquid; Oral; Acetaminophen 160 mg / 5 ml
Liquid; Oral; Acetaminophen 80 mg / ml
Tablets; Oral; Acetaminophen 325 mg
Tablets; Oral; Acetaminophen 500 mg
Acetaminophene tablet 325 mg (Pharmalab Inc. (Canada))
Tablet; Oral; Acetaminophen 325 mg
Tablet; Oral; Acetaminophen 500 mg
Tablets; Oral; Acetaminophen 325 mg
Tablets; Oral; Acetaminophen 500 mg
Tablet; Oral; Acetaminophen 160 mg
Tablets; Oral; Acetaminophen 160 mg
Tablet; Oral; Acetaminophen 160 mg
Tablet; Oral; Acetaminophen 80 mg
Tablets; Oral; Acetaminophen 160 mg
Tablets; Oral; Acetaminophen 80 mg
Tablet; Oral; Acetaminophen 160 mg
Tablets, Chewable; Oral; Acetaminophen 160 mg
Tablets; Oral; Acetaminophen 160 mg
Tablet; Oral; Acetaminophen 160 mg
Tablet; Oral; Acetaminophen 80 mg
Tablets, Chewable; Oral; Acetaminophen 80 mg
Tablets; Oral; Acetaminophen 160 mg
Tablets; Oral; Acetaminophen 80 mg
Tablet; Oral; Acetaminophen 80 mg
Tablets; Oral; Acetaminophen 80 mg
Tablet; Oral; Acetaminophen 325 mg
Tablets; Oral; Acetaminophen 325 mg
Acetaphen 300 mg/2 mL x 10 tube
Acetaphen 325 mg x 10 Blister x 10 Tablet
Acetaphen 325 mg x 1 Bottle 100 Tablet
Acetaphen 325 mg x 1 Bottle 500 Tablet
Acetaphen 500 mg x 10 Blister x 10 Tablet
Acetaphen 500 mg x 100 Tablet
Acetaphen 500 mg x 500 Tablet
Acetaphen 160 mg/5 mL x 1 Bottle 30 mL
Acetaphen 160 mg/5 mL x 1 Bottle 60 mL
Acetaphen 500 500 mg x 10 Blister x 10 Tablet
Acetaphen 500 500 mg x 100 Tablet
Acetaphen 500 500 mg x 500 Tablet

References

  1. DailyMed. "ACETAMINOPHEN; ASPIRIN; CAFFEINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "acetaminophen". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "acetaminophen". http://www.drugbank.ca/drugs/DB00316 (accessed September 17, 2018).

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