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

redpharm drug inc. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - propoxyphene napsylate 100 mg - propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. propoxyphene napsylate and acetaminophen tablets are a schedule iv narcotic under the u.s. controlled substances act. propoxyphene napsylate and acetaminophen tablets can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene napsylate and aceta

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

rebel distributors corp. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - propoxyphene napsylate 100 mg - propoxyphene napsylate and acetaminophen tablets are indicated for the relief of mild to moderate pain. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. propoxyphene napsylate and acetaminophen tablets are a schedule iv narcotic under the u.s. controlled substances act. propoxyphene napsylate and acetaminophen tablets can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene napsylate and aceta

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

keltman pharmaceuticals inc. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - propoxyphene napsylate 100 mg - propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. propoxyphene napsylate and acetaminophen is a schedule iv narcotic under the u.s. controlled substances act. propoxyphene napsylate and acetaminophen can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene napsylate and acetaminophen should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-c

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

altura pharmaceuticals, inc. - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - propoxyphene napsylate 100 mg - propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. propoxyphene napsylate and acetaminophen tablets are contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. propoxyphene napsylate and acetaminophen tablets are contraindicated in any patient who has or is suspected of having paralytic ileus. propoxyphene napsylate and acetaminophen is a schedule iv narcotic under the u.s. controlled substances act. propoxyphene napsylate and acetaminophen can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene napsylate and acetaminophen should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-c

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

heritage pharmaceuticals inc - propoxyphene hydrochloride (unii: cb2tl9ps0t) (propoxyphene - unii:s2f83w92tk) - propoxyphene hydrochloride 65 mg - propoxyphene hydrochloride capsule is a schedule iv narcotic under the u.s. controlled substances act. propoxyphene hydrochloride capsule can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. propoxyphene hydrochloride capsule should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications. since propoxyphene hydrochloride capsule is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. addiction to opioids prescribed for pain management has not been estimated. however, requests for opioids from opioid-addicted patients occur. as such, physicians should take appropriate care in prescribing propoxyphene hydrochloride capsule. opioid analgesics may cause psychological and physical dependence. physical dependence results in withdrawal symptoms in patients who abruptly discontinue the d

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

glenmark pharmaceuticals inc., usa - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)]. twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or atypic

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

acetris health, llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)]. raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)]. the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)]. twenty-seven percent of  the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (

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

dr.reddy’s laboratories inc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participan

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

sciegen pharmaceuticals inc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies ( 14.1, 14.2)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies ( 14.3)] . raloxifene hydrochloride tablets, usp is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies ( 14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies ( 14.4)] . twenty-seven percent of the participant

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

camber pharmaceuticals inc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women [see clinical studies (14.1)]. raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (vte), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see warnings and precautions (5.1)]. raloxifene hydrochloride tablets are contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see use in specific populations (8.1, 8.3)]. raloxifene hydrochloride tablets may cause fetal harm when administered to a pregnant woman. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. in rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ), and hydrocephal