Centradol 50

Tapentadol 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. Tapentadol 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 by your doctor. Some common side effects of this medicine includes nausea, sleepiness, vomiting, dizziness, headache, and constipation. If any of these side effects bother you or do not go away, you should let your doctor know. Your doctor may help with ways to reduce or prevent these symptoms by prescribing you an alternative medicine or by adjusting the dose. The medicine may not be suitable for everybody. Before taking it, let your doctor know if you have any problems with your heart, kidneys, and liver. You should avoid consumption of alcohol while on this medication. Let your doctor know about all the other medicines you are taking because they may affect, or be affected by this medicine. Pregnant and breastfeeding mothers should consult their doctors before using this medicine as it can cause harmful effects to the developing baby. Tapentadol decreases the perception of pain by blocking the transmission of pain signals to the brain.

• Moderate to severe pain

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.

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

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. Tapentadol may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Tapentadol, skip it and continue with your normal schedule. Do not double the dose.

Common: • Nausea • Sleepiness • Vomiting • Dizziness

[UNSAFE] Tapentadol may cause side effects which could affect your ability to drive. If you feel drowsy, dizzy, have blurred vision or a slow reaction time while taking Tapentadol, then do not drive. Tapentadol is a strong painkiller which is used in the treatment of moderate to severe pain when other treatments do not treat your pain well enough or you cannot tolerate them. The addiction / habit-forming potential of Tapentadol is very high. Take exactly as prescribed by your doctor. Use caution while driving or doing anything that requires concentration as Tapentadol can cause dizziness and sleepiness. While taking this medication, avoid alcohol in all forms including beer, wine, aftershave lotions, mouthwash, vinegar, certain desserts, colognes, and liquid medications. Inform your doctor if you have asthma, liver, kidney or pancreatic disease, or are severely constipated.

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.

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 inhibitors.

[UNSAFE] It is unsafe to consume alcohol with Tapentadol.

[CONSULT YOUR DOCTOR] Tapentadol may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.

[CONSULT YOUR DOCTOR] Tapentadol is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

[CAUTION] Tapentadol should be used with caution in patients with kidney disease. Dose adjustment of Tapentadol may be needed. Please consult your doctor. [CAUTION] Tapentadol should be used with caution in patients with severe liver disease. Dose adjustment of Tapentadol may be needed. Please consult your doctor. Use of Tapentadol is not recommended in patients with severe kidney disease.

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