This drug (1g) contains 10 mg of diclofenac sodium listed in the Pharmacopoeia of Japan.
Excipients/Inactive Ingredients: This product contains octa-acetylated sucrose, ethanol, glycerin, hydroxypropyl cellulose, polyoxyethylene polyoxypropylene cetylether, ℓ-menthol, and sodium edetate hydrate, as additives.
Percutaneous analgesic anti-inflammatory drugs.
For relief of pain and inflammation of the following diseases or symptoms: Arthritis deformans, scapulohumeral periarthritis, tendonitis/tenosynovitis, peritendonitis, humeral epicondylitis (such as tennis elbow), muscle pain (myofascial low back pain, etc.), a swelling and pains after external injury.
Apply an appropriate amount of this product to the affected area three times a day.
Diclofenac Sodium Lotion 1% W/W is contraindicated in the following patients: Patients having a history of hypersensitivity to the ingredient of this drug; Patients with aspirin-induced asthma (asthma attack induced by a nonsteroidal analgesic anti-inflammatory drug etc.) or patients having a history of aspirin asthma [serious asthmatic attack may be induced]; The third trimester of pregnancy [risk of premature closure of the ductus arteriosus and prolonged parturition].
Careful administration: Diclofenac Sodium Lotion should be administered with care to the following patients: Patients with bronchial asthma: Bronchial asthma patients also include aspirin-induced asthma patients, and serious asthmatic attack may be induced in such patients.
Important precautions: Note that treatment with analgesic anti-inflammatory drugs is not causal treatment but symptomatic treatment.
This drug may make skin infectious diseases inapparent. When this drug is used for inflammation with infection, proper antibacterial agent or antifungal agent should be coadministered, and this drug should be administered carefully with sufficient observation.
When this drug is used for chronic diseases (arthritis deformans etc.), therapy other than medicament therapy should be also considered. In addition, conditions of patients should be sufficiently observed while paying attention to the manifestation of adverse reactions.
Precautions concerning use: Application Area: This product should not be used on eyes and mucous membranes.
This product should be used carefully on areas where the epidermis is damaged because use for such an area may cause temporary smarting or tingling pain.
Application Method: This product should not be used by occlusive dressing technique (ODT) because it may cause adverse reactions in the same way as systemic administration (oral agent, suppository).
Use in Children: The safety of this product in children has not been established [insufficient clinical data].
This product is contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition.
Caution is recommended in prescribing this product during the first and second trimesters of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure. This product should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus.
Published studies and postmarketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
In after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if this product treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow up.
This product has not been undergone investigations such as drug use investigation, etc. to determine the incidence of adverse reactions.
Clinically significant adverse reactions (Incidence unknown): Shock and anaphylaxis:
Since shock or anaphylaxis (urticaria, angioedema, dyspnea, etc.) may occur, observation should be sufficiently performed. If abnormalities are observed, treatment with this product should be discontinued and appropriate measures should be taken.
Since cutaneous symptoms such as redness, erythema, rash, itching, and pains may occur in the area to which this product is applied, the symptoms may progress to swelling, edema, blister/erosion, etc., and the symptoms may be further extended systemically, resulting in serious conditions. In such cases, treatment with this product should be discontinued and appropriate measures should be taken, if abnormalities are observed.
Other adverse reactions:
See Table 1.
Click on icon to see table/diagram/image
Precautions for coadministration:
This drug should be administered with care in coadministration with the following drugs. (See Table 2.)
Click on icon to see table/diagram/image
Precautions for handling: Tighten cap firmly after use and store this product.
Keep this product away from flames when storing it.
This product may soften or melt synthetic resin; so care should be taken during use.
Storage at room temperature (below 25°C) (airtight container).
M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Diclofenac Sodium 1% w/w Lotion Main Life
50 g x 1's