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Centradol 75 Tablet

Centradol 75 Tablet, Tapentadol, Prescriptions
Centradol 75 Tablet
Tk17
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Description

Tapentadol is a centrally-acting synthetic analgesic. Although its exact mechanism of action is unknown, analgesic efficacy is thought to be due to µ opioid agonist activity and the inhibition of norepinephrine reuptake.

Indications

Tapentadol is an opioid analgesic indicated for the management of moderate to severe acute pain in adults.

Dosage & Administration

Individualize dosing according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.Initiate Tapentadol at a dose of 50 mg, 75 mg, or 100 mg every 4 to 6 hours with or without food depending upon pain intensity. On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first 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 first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended.

Side Effects

The most common (≥10%) adverse reactions were nausea, vomiting, dizziness and somnolence.

Precautions

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 µ-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with Tapentadol may exhibit additive CNS depression.

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 benefit justifies the potential risk to the fetus. Neonates whose mothers have been taking Tapentadol should be monitored for respiratory depression.

Drug Interaction

Tapentadol is mainly metabolized by glucuronidation. The following substances have been included in a set of interaction studies without any clinically significant finding: Acetaminophen, Acetylsalicylic acid, Naproxen and Probenecid. The pharmacokinetics of Tapentadol were not affected when gastric pH or gastrointestinal motility were increased by Omeprazole and Metoclopramide, respectively.

Over Dose

Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes pulmonary edema, bradycardia, hypotension and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.

Storage

Store in a cool and dry place. Keep away from light and moisture and out of reach of children.

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