Chemical formula: C₁₅H₁₈O₃ Molecular mass: 246.302 g/mol PubChem compound: 3965
Loxoprofen sodium patch should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. [The safety of loxoprofen sodium patch in these populations has not been established.]
It has been reported that constriction of the fetal ductus arteriosus is observed when woman in the late stage of pregnancy received other nonsteroidal anti-inflammatory analgesic drugs for external use.
Administration of loxoprofen to nursing mothers should be avoided. If administration of this drug is judged to be essential, nursing should be discontinued. [Preclinical studies have showed that loxoprofen is excreted into milk in rats.]
Loxoprofen sodium patch should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. [The safety of loxoprofen sodium patch in these populations has not been established.]
Some undesirable effects (e.g. dizziness or sleepiness), have been reported. To be safe, should be careful when driving and using machine.
There is no data available on effects on ability to drive and use machines.
(Including reports on adverse reactions the incidence of which cannot be calculated)
Adverse reactions to this drug were reported in 409 (3.03%) of 13,486 patients treated. The major adverse reactions reported were gastrointestinal symptoms (Stomach discomfort, abdominal pain, nausea and/or vomiting, anorexia, etc.: 2.25%); edema (0.59%); rash, urticaria, etc. (0.21%); and sleepiness (0.10%). [At the end of reexamination period1) and at the latest approval of indications 2-7)]
Shock and anaphylactoid symptoms (decreased blood pressure, urticaria, edema of the larynx, dyspnea,etc.) have been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Hemolytic anemia, leukopenia, and thrombocytopenia have been reported with the use of loxoprofen. Patients should be carefully followed by hematological examination, etc. during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Oculomucocutaneous syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome) have been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
and interstitial nephritis
Acute renal failure, nephrotic syndrome and interstitial nephritis have been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately. Loxoprofen should be used with special caution in such patients because hyperkalemia may appear in association with acute renal failure.
Cardiac failure congestive has been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Interstitial pneumonia with manifestations of fever, cough, dyspnea, chest X-ray abnormalities, and eosinophilia have been reported with the use of loxoprofen. If these signs/findings are observed in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies such as corticosteroid medication, should be initiated immediately.
Serious peptic ulceration or gastrointestinal bleeding from the small intestine and/or large intestine, e.g., hematemesis, melena and hematochezia, and consequent shock has been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Gastrointestinal perforation has been reported with the use of loxoprofen. If epigastric pain, abdominal pain, etc. are noted in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Hepatic function disorders, and jaundice: Hepatic function disorders including jaundice, increased serum levels of AST (GOT), ALT (GPT) and ã-GTP, or fulminant hepatitis have been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated.
Acute respiratory disorders such as asthmatic attack have been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately.
Aseptic meningitis including fever, headache, nausea and vomiting, nuchal rigidity, clouding of consciousness, etc. has been reported with the use of loxoprofen. Patients should be carefully monitored during treatment. If any abnormal symptoms occur in a patient being treated with loxoprofen, loxoprofen should be discontinued and appropriate therapies should be initiated immediately. (in particular, the adverse event is likely to occur in the patients with systemic lupus erytgematosus or mixed connective tissue disease).
Aplastic anemia has been reported in association with the use of other nonsteroidal anti-inflammatory-analgesic drugs.
| Adverse Reactions | |||
|---|---|---|---|
| Frequency of Adverse Reactions | |||
| 0.1 to <1.0% | 0.05 to <0.1% | <0.05% | Incidence unknown |
| HypersensitivityNote | |||
| Rash | Pruritus | Urticaria | Fever |
| Gastrointestinal | |||
| Abdominal pain Stomach discomfort Anorexia, Nausea and/or vomiting, Diarrhea | Peptic ulcerNote Constipation Heartburn Stomatitis | Dyspepsia | Thirst Abdominal Distension |
| Cardiovascular | |||
| Palpitations | Blood pressure increased | ||
| Psychone-urologic | |||
| Sleepiness | Headache | Numbness | |
| Hematologic | |||
| Anemia, Leukopenia Eosinophilia | Thrombocytopenia | ||
| Hepatic | |||
| Increased AST (GOT), increased ALT (GPT) | Increased ALP | ||
| Urinary | |||
| Hematuria Proteinuria | |||
| Others | |||
| Edema | Facial-warmth | Chest pain Malaise | |
Note: Discontinue administration.
| 0.5% to <3% | <0.5% | Incidence unknown | |
|---|---|---|---|
| Hypersensitivity | Pruritus, erythema, contact dermatitis, rash | Haemorrhage subcutaneous, skin irritation, pigment precipitation | Blister, swelling |
| Gastrointestinal | Stomach discomfort, upper abdominal pain, diarrhea, loose stools | ||
| Hepatic | Increased AST, increased ALT, increased γ−GTP | ||
| Other | Edema |
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