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Duloxetine 30mg Cap 30 by Caraco Pharma Exp 1/19

NDC 47335-0382-83 UPC/GTIN No.3-47335-38283-9 Mfg.Part No.38283Caraco Pharm LabsThis Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).Caraco Pharm LabsImage 4 of Duloxetine 30mg Cap 30 by Caraco Pharma Exp 1/19

Duloxetine 30mg Cap 30 by Caraco Pharma Exp 1/19

$57.60$4.99

NDC No. 47335-0382-83 UPC/GTIN No. 3-47335-38283-9 MPN 38283 Only Physician,Pharmacy or Licensed Facility can order this Rx Item No. Rx255529 Duloxetine 30mg Cap 30 by Caraco Pharma Item No. 3255529 NDC No. 47335038283 UPC No. 347335382839 Other Name Duloxetine Hcl,Cymbalta Therapeutic Code 281604 Therapeutic Class Tricyclics & Other Norepineph.-Ru Inhib Item Class Non Controlled Rx. Case Qnty: 24 Therapeutic Code 281604 Tricyclics & Other Norepineph.-Ru Inhib Info Norepinephrine Uptake Inhibit

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DULOXETINE - duloxetine hydrochloride capsule, delayed release
Citron Pharma LLC

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE



Duloxetine delayed-release capsules are indicated for the treatment of:

Major Depressive Disorder [see Clinical Studies (14.1)]
Generalized Anxiety Disorder [see Clinical Studies (14.2)]
Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)]
Chronic Musculoskeletal Pain [see Clinical Studies (14.5)]
2 DOSAGE AND ADMINISTRATION

Swallow duloxetine delayed-release capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.

2.1 Dosage for Treatment of Major Depressive Disorder
Administer duloxetine delayed-release capsules at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.1)].

2.2 Dosage for Treatment of Generalized Anxiety Disorder
Adults - For most patients, initiate duloxetine delayed-release capsules 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)].

Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s duloxetine delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.3 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain
Administer duloxetine delayed-release capsules 60 mg once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies (14.3)]. For patients for whom tolerability is a concern, a lower starting dose may be considered.

Since diabetes is frequently complicated by renal disease, consider a lower starting dose and gradual increase in dose for patients with renal impairment [see Dosage and Administration (2.6), Use in Specific Populations (8.10), and Clinical Pharmacology (12.3)].

2.5 Dosage for Treatment of Chronic Musculoskeletal Pain
Administer duloxetine delayed-release capsules 60 mg once daily. Begin treatment at 30 mg for one week, to allow patients to adjust to the medication before increasing to 60 mg once daily. There is no evidence that higher doses confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.5)].

NDC 47335-0382-83 UPC/GTIN No.3-47335-38283-9 Mfg.Part No.38283
Duloxetine 30mg Cap 30 by Caraco Pharma
NDC 47335-0382-83 UPC/GTIN No.3-47335-38283-9 Mfg.Part No.38283

Caraco Pharm Labs

Caraco Pharm Labs

This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).
DULOXETINE HCL ORAL CAPSU
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

Caraco Pharm Labs
Caraco Pharm Labs

Image 4 of Duloxetine 30mg Cap 30 by Caraco Pharma Exp 1/19