Pharmacodynamics INDICATION

PARACETAMOL Paracetamol is a centrally acting analgesic and antipyretic with minimal anti-inflammatory Paracetamol (EUZELIA) is useful for reducing fever and for the temporary relief of minor
properties. aches, pains and discomfort associated with the common colds or flu, inoculations or
EUZELIA® vaccinations. It is also valuable in reducing pain following tonsillectomy and
175 mg / 5 mL Syrup Analgesic: Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the adenoidectomy.
central nervous system (specifically cyclooxygenase (COX)-2) and, to a lesser extent,
Analgesic / Antipyretic through a peripheral action by blocking pain impulse generation. The peripheral action RECOMMENDED DOSAGE
may also be due to inhibition of other substances that sensitize pain receptors to Doses of paracetamol for pain and fever in children, given according to age, are:
mechanical or chemical stimulation. Neonates (3 months to 1 year old): ½ - 1 teaspoon
Product Description
Children (1 to 5 years old): 1 - 2 teaspoon
Paracetamol is a red colored syrup. Children (6 to 12 years old): 2 - 4 teaspoon
Antipyretic: Paracetamol acts centrally on the hypothalamic heat-regulating center to
Chemical name: Acetaminofeno; Acetaminophen; N-Acetyl-aminophenol; produce peripheral vasodilation, increasing blood flow through the skin, sweating, and These doses may be given every 6 to 8 hours if necessary up to a maximum of 4 doses in
Asetaminfen; Paracetamolis; Paracetamolum; Parasetamol; 4’-Hydroxyacetanilide; heat loss. Paracetamol reduces fever by inhibiting the formulation and release of 24 hours
N-(4-Hydroxyphenyl) acetamide prostaglandins in the CNS and by inhibiting endogenous pyrogens at the hypothalamic
thermoregulator center. Mode of Administration
Oral
Pharmacokinetics
Absorption: Absorption of paracetamol is rapid and almost complete from the Gl tract. Contraindications
Peak plasma concentrations occur within 0.5 to 2 hours, with slightly faster absorption of Hypersensitivity to paracetamol or any of the other ingredients/ components of the
Molecular formula: C6H9NO2 liquid preparations. With overdose, absorption is complete in 4 hours. product. Paracetamol is also contraindicated to patient with G6PD (phenylketonuria)
Description: Red syrup, cherry flavor. Sparingly soluble in water; freely soluble in deficiency
alcohol; very slightly soluble in dichloromethane. Metabolism/Excretion: The half-life in plasma is 2 hours. Paracetamol is relatively
uniformly distributed throughout most body fluids. The binding of the drug to plasma Precautions
Formulation proteins is variable; variable; only 20% to 50% may be bound at the concentrations
Severe or recurrent pain or high or continued fever may indicate serious illness. If
encountered during acute intoxication. Ninety percent to 100% of the drug is recovered in
Each 5 mL of Paracetamol contains: pain persists for > 5 days or if redness or swelling is present, consult a physician.
the urine within the first day, primarily after hepatic conjugation with glucuronic acid
Acetaminophen / Paracetamol ………………………………..………………… 175 mg ('60%), sulfuric acid ('35%) metabolites also have been detected. Paracetamol is Paracetamol should be given with care to patients with impaired kidney or liver
Sucrose ………………………………….…….………………………..……….... 2.8 g extensively metabolized and excreted in the urine primarily as inactive glucuronate and function. It should also be given with care to patients with alcohol dependence. Care
Sodium citrate ……………………………………..……..…….…..………..…… 10 mg sulfate conjugates (94%). About 4% is metabolized via cytochrome P450 oxidase to a must also be taken into consideration on patients in their late pregnancy because
Citric acid …………………………………….….….……..……..………..……… 5 mg toxic metabolite normally detoxified by preferential conjugation with cellular glutathione the frequent use of paracetamol may be associated with an increased risk of
Sodium chloride …………………………………..………………………….…... 5 mg and excreted in urine as conjugates of cysteine and mercapturic acid. persistent wheezing in the infant, which may persist into childhood. It must also be
Alcohol ……………………………………………….…...………..………...… 0.368 mL used with caution in chronic alcoholics (not to exceed 2p/day)
 Toxic hepatitis also has been associated with long term ingestion of 5-8 p/day for appear relatively well initially and may even continue their normal activities for a day or
Effects on Ability to Drive and Use Machines several weeks or 3-4p/day for a year. Maculopapular rash of urticarial skin two before the onset of liver or kidney failure. Prompt medical attention is of prime
It is unlikely to impair the patient's ability to drive or use machinery reactions, methemoglobinemia, neutropenia, thrombocytopenia, hypoglycemia, and importance to prevent liver toxicity. Delay in seeking medical attention may lead to serious
jaundice may also occur. liver failure and other problems.
Warnings STORAGE CONDITIONS
Do not exceed recommended dosage. Hepatotoxicity and severe hepatic failure Overdose and Treatment Protect from light, moisture, and heat. Preserve in an airtight container at
occurred in I chronic alcoholics following therapeutic doses. Chronic alcoholics Symptoms temperatures not exceeding 30 C. Keep out of reach of children.
should limit paracetamol I intake to <2p/day. If a sensitivity reaction occurs, Overdose of Paracetamol may manifest as follows: Some patients may have no
discontinue use. symptoms during the first 24 hours or may manifest with nonspecific abdominal signs and AVAILABILITY
symptoms such as loss of appetite, nausea and vomiting. Pallor, excessive sweating and Paracetamol is available in 120/5mL, 160mg/5mL, 250mg/5 mL syrup and
Statement on Usage During Pregnancy and Lactation weakness may also be noted. suspension, and 500mg tablet.
Pregnancy Category B. Paracetamol crosses the placenta. It is routinely used
during all stages of pregnancy; when used in therapeutic doses, it appears safe for In the second phase, usually after 24 hours, the above signs and symptoms may resolve For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph
temporarily and may be replaced by right upper abdominal discomfort or pain and a
short-term use. Continuous high daily dosage causes severe anemia in a mother,
feeling of fullness brought about by liver enlargement. Decreased urine output may also Importer, Distributor, and Manufacturer
and the neonate has fatal kidney disease. begin to develop. Liver enzymes (transaminases) and prolongation of prothrombin time Hygieia Manufacturing Laboratory
Use in lactation: Excreted in breast milk. Maternal ingestion of paracetamol in may also be noted around this time. Bonifacio Street, 2600 Baguio City, Philippines
normal therapeutic doses does not appear to present a risk to the nursing infant. If
sensitivity reaction occurs, discontinue use. Around 3 to 5 days after, abdominal signs and symptoms such as nausea, vomiting, loss Date of Revision of Package Insert
of appetite may reappear accompanied by signs of liver failure such as yellowing of the September 9, 2022
Interaction with Other Medicaments skin or jaundice, decreased blood glucose and bleeding tendencies. In some cases, acute
The anticoagulant effect of warfarin and other coumarins may be enhanced by renal failure may also set in as well as disturbances of cardiac rhythm. Abnormalities in Registration Number
prolonged regular daily use of paracetamol with increased risk of bleeding; sensorium or consciousness, confusion and decreased body temperature have also been PLM-013
occasional doses have no significant effect. reported.
Date of First Authorization
Adverse Drug Reactions Patient recovers or may progress to acute and fatal liver failure. September 6, 2022
On acute overdosage (single dose equaling or exceeding 10g or 7.5-10g daily for 1-
2 days), potentially fatal necrosis and possible renal tubular necrosis can occur. Treatment
A doctor or a Poison Control Center should be consulted immediately if a patient has
Toxic hepatitis also has been associated with long term ingestion, and possible
been given more than the recommended dose or if there is any suspicion that this may
renal tubular necrosis can occur.
have been given or ingested. It should be borne in mind that in some cases patients may Manufactured by:
Hygieia Manufacturing Laboratory
Bonifacio Street, 2600 Baguio City, Philippines