PARACETAMOL

Palmol
550 mg tablets
ANALGESIG/ANTIPYRETIC
Formulation:
Each tablet contains:
Paracetamol .......................................5
50mg
Description:
White tablet with no flavouring.
Pharmacology:
Inhibits prostaglandins in CNS but
lacks anti-inflammatory effects in
periphery; reduces fever through
direct action on hypothalamic heatregulating center.
Pharmacokinetics/ Dynamics:
Absorption: Rapid and complete from
the GI tract. Tmax is 0.5 to 2 hr; 4 hr
after overdosage.
Distribution: Distributed throughout
most body fluids. Binding to plasma
proteins is variable.
Metabolism: Primarily metabolized
by hepatic conjugation (94%), and
about 4% is metabolized by CYP450
oxidase to toxic metabolite
Excretion: T1/2 is about 2hr. 90% to
100% is recovered in the urine within
the first day, primarily as inactive
metabolites. 2% is excreted as
unchanged drug.
Indication:

To relief mild to moderate pain;

treatment of fever.
Contraindication:
Paracetamol is contraindicated in
patients with hypersensitivity to
paracetamol.
Precaution:
Pregnancy : Category B
Lactation: Excreted in breast milk
Hepatic function impairment: Chronic
alcoholics should not exceed 2g/day.
Persistent pain or fever: May indicate
serious illness. Consult health care
provider.
Paracetamol should be given with care
to patients with impaired kidney and
or liver function. It is recommended
that large dose
should be avoided in patients with
hepatic impairment.
Adverse Reactions:
HEMA: Hemolytic anemia;
neutropenia; leukopenia;
pancytopenia; thrombocytopenia.
HEPA: Jaundice
Others: Hypoglycemia; allergic skin
eruptions or fever.
Dosage and Route of
administration:
Oral
Adults: PO 325 to 650 mg when
needed, every 4 to 6 hours or 1g 3 to
4 times a day.
Children: PO 10 to 15 mg/kg dose
when needed every 4 hours to 6
hours; do not exceed 5 doses/24hr.
Administer with water 30 min before
or 2 hrs after meals.

Overdosage: Signs and Symptoms

Nausea, vomiting, abdominal pain,
diarrhea, anorexia, malaise,
diaphoresis, confusion, low BP, cardiac
arrhythmias, jaundice, acute renal
failure, liver failure.
Information for the patients:
Consult health care provider for use in
children less than 3yr and not to
continue taking drug more than 5 days
unless advised by health care
provider. Adults should not continue to
take the drug more than 10 days for
pain or 3 days for fever.
Availability:
Tablet: 325 mg
Forte Tablet: 500 mg
Oral Drops: 100 mg/ml
Caplet: 500 mg
XR Tablets: 650 mg
Storage Condition:
STORE TABLETS AND CAPSULES AT
ROOM TEMPERATURE IN TIGHTLY
CLOSED CONTAINERS.
Date of Latest Revision:
MARCH 30, 2016
Imported & Distributed by:
Paramount Pharmaceuticals

Mac Arthur Highway, corner OG road, San

Fernando, Pampanga
Manufactured by: Paramount
Manufacturing

Henes Road,
Disputanta, VA