Dafal
Dafapyridine Chinese Description
Complete pre-determined information indications and usage AMPYRA (dalfampridine) is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This can be demonstrated by an increase in walking speed [see Clinical Studies (14)]. Dosage and Administration The maximum recommended dose of AMPHRA is 10 mg tablets twice daily, with or without, and should not be exceeded. The dose should be approximately 12 hours apart. If the dose is missed, the patient should not take double or extra doses. No additional benefit was demonstrated at doses greater than 10 mg twice due to adverse effects, daily and adverse reactions and interruptions were more common at higher doses. Tablets should only be used as a whole; do not split, smash, chew or dissolve. AMPYRA is contraindicated in patients with moderate or severe renal insufficiency [see contraindications (4)]. The risk of seizures in patients with mild renal insufficiency (CrCl 51-80 mL / min) is unclear, but AMPYRA plasma exposure in these patients may be close to the 15 mg dose twice daily, which may increase the risk of seizures; Estimated CrCl should be known before starting treatment with AMPYRA [see Warnings and Precautions, Kidney Injury (5.2) and Clinical Pharmacology, Special Population (12.4)]. [For complete "Instructions for Use", please refer to FDA-approved patient information] Dosage Form and Strength AMMYRA is 10 mg in strength and is a thin film coating, white to off-white, biconvex, elliptical, non-notched flat Side, one side of the depression, "A10". Contraindications The use of AMMYRA is prohibited under the following conditions: Moderate or severe renal impairment warnings and precautions in epileptic seizures 5.1 Seizures AMMYRA is contraindicated in patients with a history of epilepsy [see contraindications (4)]. The incidence of seizures increased by 20 mg twice daily in a control clinical study with dalfampridine for 9-14 weeks in patients with MS. A seizure (0.4%) was observed in the placebo group and a dose of 10 mg twice daily (0.25%), no seizures occurred twice at 15 mg twice daily, and 2 seizures were observed twice at 20 mg twice daily (3.5 %). In the open-label extension trial of MS patients, the incidence of seizures (1.7 / 100PY) during 15 mg of dalfampridine twice daily was 4 times higher than that of 10 mg twice daily (0.4 / 100 PY). AMPYRA has not been evaluated in patients with a history of seizures or EEG epileptiform activity because these patients were excluded from clinical trials. The risk of seizures in patients with EEG epileptiform activity is unclear and may be much higher than the risk of seizures observed in the AMMYRA clinical study. For patients with seizures during treatment, AMMYRA should be discontinued and not restarted. 5.2 Renal impairment AMPYRA is eliminated by the kidney as an unaltered drug [see Clinical Pharmacology, Special Population (12.4)]. Because patients with renal insufficiency require less than 10 mg per day and no intensity less than 10 mg, AMMYRA is contraindicated in patients with moderate to severe renal insufficiency [creatinine clearance (CrCl) ≤ 50 mL/min] [see contraindications] Symptoms] (4)]. The risk of seizures in patients with mild renal insufficiency (CrCl 51-80 mL / min) is unclear, but the plasma levels of diaminopiperidine in these patients may be close to twice daily doses of 15 mg, which may be Increased risk of seizures [see Warnings and Precautions, Seizures (5.1)]. If you don't know, you should estimate CrCl before starting treatment with AMPYRA. CrCl can be estimated using the following equation (female multiplied by 0.85): 5.3 Simultaneous treatment with other forms of 4-aminopyridine AMMYRA should not be taken with other forms of 4-aminopyridine (4-AP, pyridinium) because of the active ingredient Are the same. Patients should discontinue treatment with AMPYRA with any product containing 4-aminopyridine prior to initiation to reduce the likelihood of dose-related adverse effects. 5.4 Urinary tract infection compared with placebo (8%), receiving AMMYRA 10 Read more...