break day [5.0%:<1.0% Blood and lymphatic system disorders: anemia, thrombocytopenia Cardiac disorders : bradycardia Eye disorders: blurred vision, visual disturbance Gastrointestinal disorders : abdominal discomfort, abdominal distension, abdominal tenderness, change in bowel habit, constipation aggravated, diverticulitis, diverticulum, dyspepsia aggravated, dysphagia, fecal impaction, gastric irritation, gastritis, gastrointestinal hemorrhage, gastrointestinal irritation, gastro-esophageal reflux disease, lower abdominal pain, pancreatitis aggravated, rectal hemorrhage, rectal prolapse, retching General disorders : asthenia, malaise Hepatobiliary disorders: biliary tract disorder, cholelithiasis Immune system disorders: hypersensitivity Investigations : alanine aminotransferase decreased, alanine aminotransferase increased, aspartate aminotransferase decreased, aspartate aminotransferase increased, blood amylase increased, blood creatinine increased, blood in stool, blood potassium abnormal, blood pressure increased gamma glutamyltransferase increased Metabolism and nutrition disorders : appetite decreased, dehydration Nervous system disorders : ataxia, disturbance in attention, dysarthria, gait abnormal, headache aggravated, mental impairment, sedation, seizure, sleep apnea syndrome, syncope, tremor Psychiatric disorders : abnormal behavior, agitation, anxiety, confusion, depression, emotional disturbance, euphoric mood, indifference, irritability, libido decreased, nervousness, sleep disorder Renal and urinary disorders : difficulty in micturition, urinary hesitation, urinary retention Reproductive system and breast disorders : erectile dysfunction, sexual dysfunction Respiratory, thoracic and mediastinal disorders : dyspnea Skin and subcutaneous tissue disorders : allergic dermatitis, cold sweat, dermatitis, night sweats, pallor, generalized pruritus, urticaria Vascular disorders : flushing, hypertension, hypotension, orthostatic hypotension Overdosage Acute overdosage with tramadol can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension and death. Death due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, or injecting the crushed tablets. The risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol and other CNS depressants, including other opioids. In the treatment of tramadol overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. While naloxone will reverse some (but not all) symptoms caused by overdosage with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 7% of the administered dose in a 4-hour dialysis period. Dosage and Administration Ryzolt extended-release tablets should be taken once a day. The tablets should be swallowed whole with liquid and not split, chewed, dissolved or crushed. Ryzolt tablets produce a continuous release of active ingredient over 24 hours: a repeat dosage within 24 hours is not recommended. Patients Not Currently on Tramadol Immediate-Release Products: Treatment with Ryzolt should be initiated at a dose of 100 mg/day. Daily doses should be titrated by 100 mg/day increments every 2-3 days (i.e., start 200 mg/day on day 3 or 4 of therapy) to achieve a balance between adequate pain control and tolerability for the individual patient. For patients requiring the 300 mg daily dose, titration should take at least 4 days (i.e. 300 mg/day on day 5). The usual daily dose is 200 or 300 mg. The daily dose and titration should be individualized for each patient. Therapy should be continued with the lowest effective dose. Ryzolt should not be administered at a dose exceeding 300 mg per day. Clinical experience suggests that signs and symptoms of withdrawal may be reduced by tapering medication when discontinuing tramadol therapy. Patients Currently on Tramadol Immediate-Release Products: For patients maintained on tramadol immediate release (IR) products, the 24-hour tramadol IR dose should be calculated and the patient should be initiated on a total daily dose of Ryzolt rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Ryzolt , some patients maintained on tramadol IR products may not be able to convert to Ryzolt . Ryzolt should not be administered at a dose exceeding 300 mg per day. Do not use Ryzolt with other tramadol products. ( see WARNINGS ). Individualization of Dose Good pain management practice dictates that analgesic dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol products in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability. Renal and Hepatic Disease Ryzolt should not be used in patients with: Creatinine clearance less than 30 mL/min, Hepatic impairment. (see PRECAUTIONS, Use in Renal and Hepatic Disease ). Geriatric patients (65 years of age and older) In general, dose selection for patients over 65 years of age who may have decreased hepatic or renal function, or other concomitant diseases, should be initiated cautiously, usually starting at the low end of the dosing range. Ryzolt should be administered with greater caution at the lowest effective dose in patients over 75 years, due to the potential for greater frequency of adverse events in this population. How Supplied Ryzolt (tramadol hydrochloride extended-release tablets) are supplied in a number of packages and dose strengths: 100-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 100" in black ink on the other side. Bottle of 30 tablets NDC 59011-334-30 Bottle of 90 tablets NDC 59011-334-90 200-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 200" in black ink on the other side Bottle of 30 tablets NDC 59011-335-30 Bottle of 90 tablets NDC 59011-335-90 300-mg, white, beveled edge, round biconvex tablets, plain on one side and printed "PP 300" in black ink on the other side Bottle of 30 tablets NDC 59011-336-30 Bottle of 90 tablets NDC 59011-336-90 Store at 25 C (77 F); excursions permitted between 15-30 C (59 86 F). Dispense in a tight, light-resistant container. Warning: keep out of reach of children. Healthcare professionals can telephone Purdue Pharma s Medical Services Department (1-888-726-7535) for information on this product. Revised 09/2011 301397-0C Manufactured by: Confab Laboratories Inc Saint-Hubert, Quebec, Canada J3Y 3X3 Distributed by: Purdue Pharma L.P. Stamford, CT 06901-3431 Licensed from Labopharm Europe Limited U.S. Patent 6,607,748; 7,988,998 Ryzolt is a trademark of Purdue Pharma L.P. Ryzolt (tramadol hydrochloride) 100 mg Tablets 30 tablets (NDC 59011-334-30) Ryzolt (tramadol hydrochloride) 200 mg Tablets 30 tablets (NDC 59011-335-30) Ryzolt (tramadol hydrochloride) 300 mg Tablets 30 tablets (NDC 59011-336-30) Ryzolt tramadol hydrochloride tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-334 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 100 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE POVIDONES SODIUM LAURYL SULFATE XANTHAN GUM Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code PP;100 Contains Packaging # Item Code Package Description 1 NDC:59011-334-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2 NDC:59011-334-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 3 NDC:59011-334-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021745 12/15/2008 09/30/2013 Ryzolt tramadol hydrochloride tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-335 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 200 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE POVIDONES SODIUM LAURYL SULFATE XANTHAN GUM Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code PP;200 Contains Packaging # Item Code Package Description 1 NDC:59011-335-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2 NDC:59011-335-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 3 NDC:59011-335-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021745 12/15/2008 09/30/2013 Ryzolt tramadol hydrochloride tablet, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59011-336 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 300 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE POVIDONES SODIUM LAURYL SULFATE XANTHAN GUM Product Characteristics Color WHITE Score no score Shape ROUND Size 13mm Flavor Imprint Code PP;300 Contains Packaging # Item Code Package Description 1 NDC:59011-336-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE 2 NDC:59011-336-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE 3 NDC:59011-336-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021745 12/15/2008 09/30/2013 Labeler - Purdue Pharma LP (932323652) Registrant - Purdue Pharma LP (932323652) Establishment Name Address ID/FEI Operations Confab Laboratoires Inc 241754217 MANUFACTURE(59011-335, 59011-336, 59011-334) Revised: 01/2013 Purdue Pharma LP Next Interactions Print this page Add to My Med List More about Ryzolt (tramadol) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group 11 Reviews Add your own review/rating Drug class: narcotic analgesics Consumer resources Ryzolt Ryzolt (Advanced Reading) Professional resources Tramadol Hydrochloride (AHFS Monograph) Tramadol Tablets (FDA) Other brands: Ultram , Ultram ER , ConZip , Ultram ODT , Rybix ODT Related treatment guides Back Pain Chronic Pain Pain> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out 4 CSA Schedule Some potential for abuse Approval History Drug history at FDA Drug Class Narcotic analgesics Related Drugs narcotic analgesics tramadol , hydrocodone , oxycodone , morphine , fentanyl , Ultram Back Pain tramadol , naproxen , Cymbalta , aspirin , ibuprofen , Norco , duloxetine , More... Chronic Pain tramadol , oxycodone , Cymbalta , duloxetine , Percocet , morphine , fentanyl , More... Pain tramadol , acetaminophen , Tylenol , naproxen , oxycodone , aspirin , ibuprofen , More... Ryzolt Rating 11 User Reviews 6.2 /10 11 User Reviews 6.2 Rate it! Ryzolt Images Ryzolt tramadol hydrochloride extended-release 100 mg (PP 100 ) View all images} } guidelines
46 Ryzolt the reality
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