INDICATION
PentadolTM tablet is indicated for the relief of moderate to severe acute pain in
patients 18 years of age or older.
DOSAGE AND ADMINISTRATION
As with many centrally-acting analgesic medications, the dosing regimen should be
individualized according to the severity of pain being treated, the previous experience
with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity.
On the rst day of dosing, the second dose may be administered as soon as one hour
after the rst dose, if adequate pain relief is not attained with the rst dose.
Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be
adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the rst day of therapy and 600 mg on subsequent
days have not been studied and are not recommended.
CONTRAINDICATION
This drug is contraindicated in patients with impaired Pulmonary Function, It is also
contraindicated in patients with acute or severe bronchial asthma or hypercapnia in
unmonitored settings or the absence of resuscitative equipment. This drug is contraindicated
in any patient who has or is suspected of having paralytic ileus.
PRECAUTION
Tapentadol should be administered with caution to patients with conditions
accompanied by hypoxia, hypercapnia respiratory problems such as: asthma, chronic
obstructive pulmonary disease etc. Besides this in case of patient with sleep apnea
syndrome, myxedema, kyphoscoliosis, central nervous system (CNS) depression
should have to be cautious prior administration of Tapentadol. Patients receiving
other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other
tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol)
concomitantly with Tapentadol may exhibit additive CNS depression.
PEDIATRIC & GERIATRIC USE
The safety and eectiveness of Tapentadol in pediatric patients less than 18 years of
age have not been established.
In general, recommended dosing for elderly patients with normal renal and hepatic
function is the same as for younger adult patients with normal renal and hepatic
function. consideration should be given to starting elderly patients with the lower
range of recommended doses.
Use in Renal Disease
In patients with severe renal impairment, the safety and eectiveness of Tapentadol
has not been established.
Use in Hepatic Disease
Tapentadol should be used with caution in patients with moderate hepatic
impairment. Tapentadol has not been studied in patients with severe hepatic
impairment.
ADVERSE REACTIONS
The following treatment-emergent adverse events may happen:
heart rate increased, heart rate decreased, visual disturbance, abdominal discomfort,
impaired gastric emptying, irritability, edema, drug withdrawal
syndrome,hypersensitivity, involuntary muscle contractions, sensation of heaviness,
hypoesthesia, paresthesia, disturbance in attention, sedation, dysarthria, memory
impairment, ataxia, presyncope, syncope, coordination abnormal, seizure, urticaria,
blood pressure decreased etc.
USE IN PREGNANCY & LACTATION
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant
women. This preparation should be used during pregnancy only if the potential
benet justies the potential risk to the fetus.
Neonates whose mothers have been taking Tapentadol should be monitored for
respiratory depression.
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Pentadol 50mg 1pcs
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