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Tylenol Infant Drop 100 mg/ml (15 ml)
 

Active ingredient: 
Paracetamol, Acetaminophen, N-Acetyl-P-Aminophenol  
Dosage Form: 
Oral suspension 100 mg/1 mL (grape flavored, alcohol free) x 15 mL
Therapeutic category: 
Analgesic, Miscellaneous
 
      

 


What is the medicine prescribed for? 

 
Adult Formulation:

Use: Labeled Indications
Treatment of mild-to-moderate pain and fever (analgesic/antipyretic)

Use: Dental
Treatment of postoperative pain

Medicines are sometimes prescribed for purposes other than those listed above. Use only for the condition for which it was prescribed. Do not give this medicine to other people even if they have the same symptoms you have, as it may not be right for them.

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How to take medication? 

 

The suitable dosage for each patient should be prescribed by a doctor.

Method of Administration:

Administration: Oral
Doses to be taken up to qid at 4-hr intervals or more between each dose.
May be taken with or without food

Dietary Consideration:

Food: Rate of absorption may be decreased when given with food.

Adult Dosage:
Note: No dose adjustment required if converting between different acetaminophen formulations.

Oral, rectal:
Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day

Dental Usual Dosing
Postoperative pain: Oral, rectal:
Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day
 
Children Dosage:
Note: No dose adjustment required if converting between different acetaminophen formulations.

Oral, rectal:
Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used;

Acetaminophen Dosing (Oral and Rectal Formulations)
• 0-3 months: 40 mg
• 4-11 months: 80 mg
• 1-2 years: 120 mg
• 2-3 years: 160 mg
• 4-5 years: 240 mg
• 6-8 years: 320 mg
• 9-10 years: 400 mg
• 11 years: 480 mg
Note: Higher rectal doses have been studied for use in preoperative pain control in children. However, specific guidelines are not available and dosing may be product dependent. The safety and efficacy of alternating acetaminophen and ibuprofen dosing has not been established.

Dental Usual Dosing
Postoperative pain: Oral, rectal:
Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used

How does it work? 

Amoxicillin:
Although not fully elucidated, believed to inhibit the synthesis of prostaglandins in the central nervous system and work peripherally to block pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center
 
 

Contraindications

 
Hypersensitivity to acetaminophen or any component of the formulation; severe hepatic impairment or severe active liver disease (Ofirmev™)
 
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
 
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
 
 

Important safety information 

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: May cause severe hepatotoxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients. Use with caution in patients with chronic malnutrition.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

Disease-related concerns:

• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.

• G6PD deficiency: Use with caution in patients with known G6PD deficiency; rare reports of hemolysis have occurred.

• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease; use of the intravenous formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease.

• Hypovolemia: Use the intravenous formulation with caution in patients with severe hypovolemia (eg, due to dehydration or blood loss).

• Renal impairment: Use with caution in patients with severe renal impairment; consider dosing adjustments.

Other warnings/precautions:

• Dosage limit: Limit dose to <4 g/day.

• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact healthcare provider if used for fever lasting >3 days or for pain lasting >10 days in adults or >5 days in children.
 

If you miss a dose

 
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at the same time.
 
 

Pregnancy and breastfeeding

 
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
 
Pregnancy considerations
 
Pregnancy Category B
 
Animal reproduction studies have not been conducted with intravenous acetaminophen, therefore, acetaminophen I.V. is classified as pregnancy category C.

Acetaminophen crosses the placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery. An increased risk of teratogenic effects has not been observed following maternal use of acetaminophen during pregnancy. Prenatal constriction of the ductus arteriosus has been noted in case reports following maternal use during the third trimester.
The use of acetaminophen in normal doses during pregnancy is not associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed. Frequent maternal use of acetaminophen during pregnancy may be associated with wheezing and asthma in early childhood. The absorption may be delayed and the bioavailability of acetaminophen may be decreased in some women during pregnancy due to delayed gastric emptying.
 
Breastfeeding considerations
 
Enters breast milk/use caution (AAP rates “compatible”; AAP 2001 update pending)
 
Low concentrations of acetaminophen are excreted into breast milk and can be detected in the urine of nursing infants. Adverse reactions have generally not been observed; however, a rash caused by acetaminophen exposure was reported in one breast-feeding infant.
 
 
 

Possible side effects

 
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
 
Side effects may include:
 
Very common (≥10%) 
Gastrointestinal: Nausea (adults 34%; children ≥5%), vomiting (adults 15%; children ≥5%)
 
Common (1%-10%) 
Cardiovascular: Edema (peripheral), hypervolemia, hypo/hypertension, tachycardia

Central nervous system: Headache (adults 10%; children ≥1%), insomnia (adults 7%; children ≥1%), agitation (children ≥5%), anxiety, fatigue

Dermatologic: Pruritus (children ≥5%), rash

Endocrine & metabolic: Hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia

Gastrointestinal: Constipation (children ≥5%), abdominal pain, diarrhea

Hematologic: Anemia

Hepatic: Transaminases increased

Local: Infusion site pain

Neuromuscular & skeletal: Muscle spasms, pain in extremity, trismus

Ocular: Periorbital edema

Renal: Oliguria (children ≥1%)

Respiratory: Atelectasis (children ≥5%), breath sounds abnormal, dyspnea, hypoxia, pleural effusion, pulmonary edema, stridor, wheezing
 
Serious ADR (<1%) 
postmarketing, and/or case reports: Anaphylaxis (rare), hypersensitivity reactions
 
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
 
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
 
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
 
 

Interaction with other medication 

 
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to ensure that the combination is safe. 
 
Drug
Metabolism/Transport Effects
Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Drug Interactions
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Management: Upon completion/discontinuation of conivaptan, allow at least 7 days before initiating therapy with drugs that are CYP3A4 substrates. Risk D: Consider therapy modification

Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Imatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib. Imatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy

Metyrapone: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Risk D: Consider therapy modification

SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
 
Ethanol/ Nutraceutical/ Herb
Herb/Nutraceutical: St John's wort may decrease acetaminophen levels.
Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
 
Laboratory Test
Urine glucose tests may produce false results while you are taking paracetamol . Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
 

Storage

Suppositories: Store at <27°C (80°F); do not freeze.
 
 

This information is a merely a general guideline and is not a substitute for a consultation with your doctor. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
 
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