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Each
teaspoonful (5ml) contains
250 mg paracetamol (acetaminophen).
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| Properties: |
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Temporal
contains paracetamol (acetaminophen),
a potent non-narcotic analgesic
and antipyretic agent. Temporal
is specifically valuable for
patients who cannot tolerate
acetylsalicylic acid or non-steroidal
anti-inflammatory drugs.
The antipyretic action of paracetamol
is believed to be exerted by
a direct action on the hypothalamic
heat regulating center to block
the effects of endogenous pyrogen.
This results in an increased
heat dissipation through sweating
and vasodilatation.
The analgesic action of paracetamol
may be related to an elevation
of the pain threshold. This
effect is believed to be due
to inhibition of synthesis or
actions of chemical mediators
that sensitize the pain receptors
to mechanical or chemical stimulation.
Temporal is formulated as a
suspension to achieve complete
freedom, not only from alcohol,
but also from glycols. Its safety
margin is, therefore, higher
than that of soluble paracetamol
liquid preparations.  |
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| Pharmacokinetics: |
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Absorption:
Paracetamol is absorbed rapidly
and completely via the GI tract.
Peak plasma concentrations occur
in ½ to 2 hours.
Distribution:
Paracetamol is 25% protein-bound.
Metabolism:
Approximately 90% to 95% is
metabolized in the liver.
Excretion:
Paracetamol is excreted in urine.
The elimination half-life ranges
from 1 to 4 hours.
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Indications
:
Temporal
is indicated for the relief of
acute and chronic pain including:
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Pain
and fever associated with
influenza, common cold and
other febrile conditions. |
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Headache,
toothache, neuralgia, arthralgia
and myalgia. |
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| Dosage: |
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Temporal
suspension is given by mouth
according to the following recommendations,
or as prescribed by the physician.
Egyptian
MOH Recommendations:
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Less
than 2 years:
1/4 teaspoonful (1.25
ml) per dose. |
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2
to 6 years: Half
teaspoonful (2.5 ml) per
dose. |
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6
to 12 years:
1 teaspoonful (5 ml) per
dose. |
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12
years and older:
1½ teaspoonful
(7.5 ml) per dose. |
The recommended dose may be
given every 4-6 hours as needed
for a maximum of 5 doses per
24 hours.
Worldwide
Oral Dosage Recommendations:
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1.
By Body weight: 10
- 15 mg/kg/dose every
4-6 hours. |
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2.
By Age: |
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| 0-3
months : 40mg /
dose. |
| 4-11
months : 80mg /
dose. |
| 12-24
months: 120mg /
dose. |
| 2-3
years : 160mg /
dose. |
| 4-5
years : 240mg /
dose. |
| 6-8
years : 320mg /
dose. |
| 9-10
years : 400mg /
dose. |
| 11-12
years : 480mg /
dose. |
| Adults
: 325 - 650 mg /
dose. |
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The recommended dose may be
given every 4-6 hours as needed
for a maximum of 5 doses per
24 hours. The maximum adult
dose is 4 grams / 24 hours.
The bottle should be shaken
well before use. |
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| Contraindications: |
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Hypersensitivity
to paracetamol (acetaminophen). |
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| Precautions: |
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Patients with
anemia, hepatic or renal disease,
or viral hepatitis. |
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| Interactions: |
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Antacids may
delay and decrease the absorption
of paracetamol.Concomitant
use of phenothiazines and
paracetamol in large doses
may result in hypothermia. |
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| Adverse
reactions: |
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Skin rash, itching,
nausea, vomiting, abdominal
cramps and cloudy urine may
rarely occur. |
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| How
supplied: |
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Bottle containing
60 ml of 250mg/5ml suspension. |
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