United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 100 mg - tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use: tramadol hydrochloride extended-release tablets are contraindicated for: all children younger than 12 years of age [see warnings and precautions (5.4) ] post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4) ] . tramadol hydrochloride extended-release tablets are also contraindicated in patients with: significant respiratory depression [see warnings and precautions (5.3) ] acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.12) ] known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.15) ] hypersensitivity to tramadol (e.g., anaphylaxis

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use: because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): tramadol hydrochloride tablets are contraindicated for: tramadol hydrochloride tablets are also contraindicated in patients with: prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.

United States - English - NLM (National Library of Medicine)

virtus pharmaceuticals llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: tramadol hydrochloride tablets are contraindicated for: tramadol hydrochloride tablets are also contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. available data with tramadol hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - tramadol hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - tramadol hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - tramadol hydrochloride -

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - tramadol hydrochloride, quantity: 200 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; magnesium stearate; calcium hydrogen phosphate dihydrate; hyprolose - indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. not indicated for use in chronic non-cancer pain other than in exceptional circumstances. not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - tramadol hydrochloride, quantity: 150 mg - tablet, modified release - excipient ingredients: calcium hydrogen phosphate dihydrate; hyprolose; colloidal anhydrous silica; magnesium stearate - indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. not indicated for use in chronic non-cancer pain other than in exceptional circumstances. not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - tramadol hydrochloride, quantity: 100 mg - tablet, modified release - excipient ingredients: colloidal anhydrous silica; magnesium stearate; hyprolose; calcium hydrogen phosphate dihydrate - indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. not indicated for use in chronic non-cancer pain other than in exceptional circumstances. not indicated as an as-needed (prn) analgesia.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - tramadol hydrochloride, quantity: 200 mg - tablet, modified release - excipient ingredients: hypromellose; hydrogenated castor oil; maize starch; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; povidone; magnesium stearate; sodium starch glycollate; colour - tramadol sandoz sr is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long term treatment. tramadol sandoz sr is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. tramadol sandoz sr is not indicated as an as-needed (prn) analgesia.