Tapendol - Tablet Tapentadol - 50mg 1 Tablet(s) / Tablet Opsonin Pharma Limited Introduction: Tapendol is a medicine used to treat moderate to severe acute pain in adults. It is used to treat many conditions such as headache, fever, period pain, toothache, and colds. It effectively alleviates pain when other treatments fail to relieve your pain. Tapendol may be prescribed alone or in combination with another medicine. You should take it regularly as advised by your doctor. It can be taken with or without food. Your doctor may change the dose and time between doses according to your pain level and your needs. Do not take more or use it for longer than recommended... Uses of Tapendol: Moderate to severe pain Side effects of Tapendol: NauseaSleepinessVomitingDizziness How to use Tapendol: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Tapendol may be taken with or without food, but it is better to take it at a fixed time. How Tapendol works: Tapendol decreases the perception of pain by blocking the transmission of pain signals to the brain. What if you forget to take Tapendol?: If you miss a dose of Tapendol, skip it and continue with your normal schedule. Do not double the dose. Indication: Acute Moderate-to-Severe Pain, Musculoskeletal pain, Diabetic Peripheral Neuropathy Administration: May be taken with or without food. Adult Dose: Oral Moderate to severe acute pain Adult: Initially, 50 mg, 75 mg or 100 mg 4-6 hrly, depending on pain intensity. On day 1, a 2nd dose may be given 1 hr after the initial dose if pain relief is inadequate; subsequent dose may be given 4-6 hrly, adjust according to response. Max: 700 mg on day 1, 600 mg daily on subsequent days. Elderly: Initiate dosage at lower end of range Hepatic impairment Mild: Dosage adjustment not required Moderate: 50 mg q8hr initially; dosing frequency not to exceed 3 times daily; Severe: Not recommended Child Dose: Safety and efficacy not established Renal Dose: Renal impairment CrCl >30 mL/min : Dosage adjustment not required CrCl <30 mL/min: Not recommended Contraindication: Significant resp depression (in unmonitored settings or absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, known or suspected paralytic ileus; acute intoxication w/ alcohol, hypnotics, centrally acting analgesics or psychotropic active substances. Concurrent or recent (w/in 2 wk) therapy w/ MAOIs. Mode of Action: Mu-opioid agonist; inhibits ascending pain pathways, thus altering response to pain; produces analgesia, respiratory depression, and sedation; also inhibits reuptake of norepinephrine, which also affects ascending pain pathways. 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 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. Side Effect: >10% Nausea (30%),Dizziness (24%),Vomiting (18%),Somnolence (15%) 1-10% (selected) Constipation (8%),Pruritus (5%),Xerostomia (4%),Fatigue (3%),Hyperhidrosis (3%),Anorexia (2%),Dyspepsia (2%),Insomnia (2%) Interaction: Potential severe adverse effects w/ MAOIs. CNS-active drugs; other serotonergic agents (including triptans, SSRIs, other SNRIs, lithium, sibutramine, fentanyl & its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine or St. John's wort), drugs which impair serotonin (eg linezolid & methylene blue) or serotonin precursors (eg tryptophan supplements). Increased risk of QTc prolongation &/or ventricular arrhythmias w/ some antipsychotics & antibiotics. Decreased AUC & Cmax of indinavir. Increased AUC & Cmax of haloperidol. Increased plasma conc w/ ketoconazole. Increased plasma conc & reduced BP-lowering effect of metoprolol. Increased AUC of risperidone. Reduced metabolism w/ CYP2D6 inhibitors. Increased venlafaxine levels w/ CYP3A4...