DRONABINOL capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

DRONABINOL (UNII: 7J8897W37S) (DRONABINOL - UNII:7J8897W37S)

Tersedia dari:

Lannett Company, Inc.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

   Dronabinol capsules are indicated in adults for the treatment of: - anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). - nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules are contraindicated in patients with a history of a hypersensitivity reaction to dronabinol or sesame oil. Reported hypersensitivity reactions to dronabinol capsules include lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing and throat tightness [see Adverse Reactions ( 6.2 )] . Risk Summary Dronabinol capsules, a synthetic cannabinoid, may cause fetal harm. Avoid use of dronabinol capsules in pregnant women. Although there is little published data on the use of synthetic cannabinoids during pregnancy, use of cannabis (e.g., marijuana) during pregnancy has been associated with adverse fetal/neonatal outcomes [see Clinical Considerations ] . Cannabinoids

Ringkasan produk:

Dronabinol capsules, USP are supplied as oval, soft gelatin capsules for oral use as follows: 2.5 mg red oval soft gelatin capsules printed with “2.5” NDC 0527-1450-06 (bottles of 60 capsules). 5 mg brown opaque oval soft gelatin capsules printed with “5” NDC 0527-1451-06 (bottles of 60 capsules). 10 mg orange opaque oval soft gelatin capsules printed with “10” NDC 0527-1452-06 (bottles of 60 capsules). Storage Conditions Dronabinol Capsules, USP should be packaged in a well-closed container and stored in a refrigerator between 2°C to 8°C (36°F to 46°F). Protect from freezing and light.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DRONABINOL- DRONABINOL CAPSULE
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DRONABINOL CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DRONABINOL CAPSULES.
DRONABINOL CAPSULES, FOR ORAL USE, CIII
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Dronabinol is a cannabinoid indicated in adults for the treatment of:
Anorexia associated with weight loss in patients with AIDS. (1)
Nausea and vomiting associated with cancer chemotherapy in patients
who have failed to respond adequately to
conventional antiemetic treatments.(1)
DOSAGE AND ADMINISTRATION
Anorexia Associated with Weight Loss in Adult Patients with AIDS
(2.1):
The recommended adult starting dosage is 2.5 mg orally twice daily,
one hour before lunch and dinner.
See the full prescribing information for dosage titration to manage
adverse reactions and to achieve desired therapeutic
e ffe ct.
Nausea and Vomiting Associated with Chemotherapy in Adult Patients Who
Failed Conventional Antiemetics (2.2):
The recommended starting dosage is 5 mg/m , administered 1 to 3 hours
prior to the administration of chemotherapy,
then every 2 to 4 hours after chemotherapy, for a total of 4 to 6
doses per day. Administer the first dose on an empty
stomach at least 30 minutes prior to eating; subsequent doses can be
taken without regard to meals.
See the full prescribing information for dosage titration to manage
adverse reactions and to achieve desired therapeutic
e ffe ct.
DOSAGE FORMS AND STRENGTHS
Capsules: 2.5 mg, 5 mg, 10 mg (3)
CONTRAINDICATIONS
History of a hypersensitivity reaction to dronabinol or sesame oil (4)
WARNINGS AND PRECAUTIONS
Neuropsychiatric Adverse Reactions: May cause psychiatric and
cognitive effects and impair mental and/or physical
abilities. Avoid use in patients with a psychiatric history. Monitor
for symptoms and avoid concomitant use of drugs
with similar effects. Inform patients not to operate motor vehicles or
other dangerous machine