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TEVA-DULOXETINE is a brand name for Duloxetine, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ............................................................................................ 4 WARNINGS AND PRECAUTIONS............................................................................ 5 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
Hepatic Impairment; WARNINGS AND PRECAUTIONS:
Hepatic Impairment; and DOSAGE AND ADMINISTRATION: Dosage for Patient with Hepatic Impairment).
Renal Impairment:
Duloxetine Cmax and AUC values were approximately 2-fold higher in patients with end stage renal disease (ESRD) receiving chronic intermittent hemodialysis, compared with subjects with normal renal function. In contrast, the elimination half-life was similar in both groups.
Studies have not been conducted in patients with a moderate degree of renal dysfunction. Population PK analyses suggest that mild renal dysfunction has no significant effect on duloxetine apparent clearance. TEVA-DULOXETINE is not recommended for patients with end-stage renal disease or severe renal impairment (see CONTRAINDICATIONS; WARNINGS AND PRECAUTIONS: Renal; and DOSAGE AND ADMINISTRATION: Dosage for Patients with Renal Impairment).
Smoking Status:
Duloxetine bioavailability appears to be about 34% lower in smokers than in nonsmokers, although dosage modifications are not routinely recommended.
Clinical Safety Pharmacology Effect on QTc Interval:
A clinical pharmacology study was conducted to assess the safety of duloxetine at the highest tolerable level of exposure of duloxetine and measure QT interval. Of the 117 subjects enrolled, 84 were available for statistical analysis at the maximum dosage of 200 mg BID, and 91 on placebo.
Seventy subjects (approximately 60%) completed the entire protocol. 4 msec. The upper limit of the two-sided 90% confidence intervals was less than 5 msec at each time point, indicating no clinically relevant increase in the QTcF interval.
Similar results were found with the covariance approach and the individual correction method. No individual QTcF exceeded 470 msec on either duloxetine or placebo, and only 2 subjects had a categorical QTcF increase >30 msec at either 160 mg BID or 200 mg BID dosages (n=84), compared with 6 subjects (n=97) at placebo.
Furthermore, no subject had a maximal QTc interval greater than 450 msec based on the average of replicate QTcF and QTcI values on day four of duloxetine 200 mg BID. 0186) with moxifloxacin as compared with placebo. QT interval at doses up to 200 mg BID was not prolonged.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Duloxetine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
STORAGE AND STABILITY Store between 15° and 30°C. TEVA-DULOXETINE Page 50 of 82 DOSAGE FORMS, COMPOSITION AND PACKAGING Availability of Dosage Forms TEVA-DULOXETINE (duloxetine hydrochloride) delayed-release capsules are available in 30 mg and 60 mg strengths.
30 mg: The 30 mg capsule has an opaque grey body and opaque blue cap, and is imprinted with ‘DLX30’. It is available in bottles of 100 capsules and blister cartons of 30 capsules. 60 mg: The 60 mg capsule has an opaque grey body and opaque white cap, and is imprinted with ‘DLX 60’.
It is available in bottles of 90 capsules and blister cartons of 30 capsules. Composition Each capsule contains enteric-coated pellets of duloxetine hydrochloride equivalent to 30 mg or 60 mg of duloxetine that are designed to prevent degradation of the drug in the acidic environment of the stomach.
Nonmedicinal ingredients include black iron oxide, FD&C Blue No. 1 (30 mg only), hydroxypropyl cellulose, hypromellose, hypromellose phthalate, sugar spheres (corn starch, sucrose, sugar syrup), talc, triethyl citrate, and titanium dioxide.
The capsules are printed with edible black ink containing ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. 9 g/mol Structural formula: Physicochemical properties: White to almost white powder.
Solubility:
Sparingly soluble in water, freely soluble in methanol, practically insoluble in hexane. ) was conducted in 48 healthy adult subjects under fasting conditions. TEVA-DULOXETINE Page 52 of 82 Comparative Bioavailability Data for TEVA-DULOXETINE (Duloxetine Hydrochloride) 60 mg Delayed-Release Capsules vs.
), purchased in Canada § Expressed as the median (range) only € Expressed as the arithmetic mean (CV%) only N = 40 Fed Study A randomized, double-blinded, two treatment, two period, two sequence, single oral dose crossover comparative bioavailability study of TEVA-DULOXETINE (Duloxetine Hydrochloride) […]