DRONABINOL capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Rhodes Pharmaceuticals L.P.

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

DRONABINOL CAPSULES, USP 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: 2.5 mg oblong opaque cream capsules (Identified as RP 867) NDC 42858-867-06 (Bottle of 60 capsules). 5 mg oblong opaque brown capsules (Identified as RP 868) NDC 42858-868-06 (Bottle of 60 capsules). 10 mg oblong opaque orange capsules (Identified as RP 869) NDC 42858-869-06 (Bottle of 60 capsules). Storage Conditions Dronabinol Capsules, USP should be packaged in a well-closed container and stored in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

DRONABINOL- DRONABINOL CAPSULE
RHODES PHARMACEUTICALS L.P.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DRONABINOL CAPSULES,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DRONABINOL CAPSULES,
USP.
DRONABINOL CAPSULES, USP FOR ORAL USE, CIII
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Dronabinol capsules are 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 effect.
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 effect.
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