Dronabinol (Marinol)

Trade Name : Marinol

AbbVie Inc.

CAPSULE

Strength 2.5 mg/1

DRONABINOL Cannabinoid [EPC],Cannabinoids [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Dronabinol (Marinol) which is also known as Marinol and Manufactured by AbbVie Inc.. It is available in strength of 2.5 mg/1 per ml. Read more

Dronabinol (Marinol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

MARINOL is indicated in adults for the treatment of:
MARINOL is a cannabinoid indicated in adults for the treatment of:

Anorexia associated with weight loss in patients with AIDS. ()
Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. ()

Anorexia Associated with Weight Loss in Adult Patients with AIDS ():
Nausea and Vomiting Associated with Chemotherapy in Adult Patients Who Failed Conventional Antiemetics ():

MARINOL is supplied as round, soft gelatin capsules for oral use as follows:

Capsules: 2.5u00a0mg, 5u00a0mg, 10u00a0mg ()

MARINOL is 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 .

History of a hypersensitivity reaction to dronabinol or sesame oil ()

No data

Neuropsychiatric Adverse Reactions
Hemodynamic Instability
Seizures and Seizure-like Activity
Multiple Substance Abuse
Paradoxical Nausea, Vomiting, or Abdominal Pain

p138287291476464004
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Most common adverse reactions (u22653%) are: abdominal pain, dizziness, euphoria, nausea, paranoid reaction, somnolence, thinking abnormal and vomiting. ()

No data

Inhibitors and inducers of CYP2C9 and CYP3A4
Highly protein-bound drugs

No data

Pregnancy
Lactation
Geriatric Use

No data

Signs and symptoms of dronabinol overdosage include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened conjunctiva, dry mouth, tachycardia, memory impairment, depersonalization, mood alteration, urinary retention, reduced bowel motility, decreased motor coordination, lethargy, slurred speech, and postural hypotension. Patients may also experience panic reactions if they have a prior history of nervousness or anxiety, and seizures may occur in patients with existing seizure disorders.
It is not known if dronabinol can be removed by dialysis in cases of overdose.
If over-exposure of MARINOL occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas:
CHO (molecular weight = 314.46)
Dronabinol, the active ingredient in MARINOL (dronabinol capsules, USP), is synthetic delta-9-tetrahydrocannabinol (delta-9-THC).
Dronabinol is a light yellow resinous oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble in water and is formulated in sesame oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.
Each MARINOL capsule strength is formulated with the following inactive ingredients: 2.5 mg capsule contains gelatin, glycerin, sesame oil, and titanium dioxide; 5 mg capsule contains iron oxide red and iron oxide black, gelatin, glycerin, sesame oil, and titanium dioxide; 10 mg capsule contains iron oxide red and iron oxide yellow, gelatin, glycerin, sesame oil, and titanium dioxide.

No data

In 2-year carcinogenicity studies, there was no evidence of carcinogenicity in rats at doses up to 50 mg/kg/day dronabinol (approximately 20 times the MRHD in AIDS patients on a body surface area basis) or in mice at doses up to 500u00a0mg/kg/day (approximately 100 times the MRHD in AIDS patients on a body surface area basis).
Dronabinol was not genotoxic in the Ames tests, the chromosomal aberration test in Chinese hamster ovary cells, and the mouse micronucleus test. However, dronabinol produced a weak positive response in a sister chromatid exchange test in Chinese hamster ovary cells.
In a long-term study (77 days) in rats, oral administration of dronabinol at doses of 30 to 150 mg/m, equivalent to 2 to 10 times the MRHD of 15 mg/m/day in AIDS patients or 0.3 to 1.5 times the MRHD of 90 mg/m/day in cancer patients, reduced ventral prostate, seminal vesicle and epididymal weights and caused a decrease in seminal fluid volume. Decreases in spermatogenesis, number of developing germ cells, and number of Leydig cells in the testis were also observed. However, sperm count, mating success, and testosterone levels were not affected. The significance of these animal findings in humans is not known.

The effectiveness of MARINOL has been established based on studies for the treatment of anorexia associated with weight loss in patients with AIDS and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
The appetite stimulant effect of MARINOL in the treatment of AIDS-related anorexia associated with weight loss was studied in a randomized, double-blind, placebo-controlled study involving 139 patients. The initial dosage of MARINOL in all patients was 5 mg/day, administered in doses of 2.5 mg one hour before lunch and one hour before dinner. In pilot studies, early morning administration of MARINOL appeared to have been associated with an increased frequency of adverse experiences, as compared to dosing later in the day. The effect of MARINOL on appetite, weight, mood, and nausea was measured at scheduled intervals during the six-week treatment period. Side effects (feeling high, dizziness, confusion, somnolence) occurred in 13 of 72 patients (18%) at this dosage level and the dosage was reduced to 2.5 mg/day, administered as a single dose at supper or bedtime.
Of the 112 patients that completed at least 2 visits in the randomized, double-blind, placebo-controlled study, 99 patients had appetite data at 4-weeks (50 received MARINOL and 49 received placebo) and 91 patients had appetite data at 6-weeks (46 received MARINOL and 45 received placebo). A statistically significant difference between MARINOL and placebo was seen in appetite as measured by the visual analog scale at weeks 4 and 6 (see figure). Trends toward improved body weight and mood, and decreases in nausea were also seen.
After completing the 6-week study, patients were allowed to continue treatment with MARINOL in an open-label study, in which there was a sustained improvement in appetite.

MARINOL (dronabinol capsules, USP)
2.5 mg white capsules (Identified UM).NDC 0051-0021-21 (Bottle of 60 capsules).
5 mg dark brown capsules (Identified UM).NDC 0051-0022-21 (Bottle of 60 capsules).
10 mg orange capsules (Identified UM).NDC 0051-0023-21 (Bottle of 60 capsules).
Storage Conditions
MARINOL capsules should be packaged in a well-closed container and stored in a cool environment between 8u00b0 and 15u00b0C (46u00b0 and 59u00b0F) and alternatively could be stored in a refrigerator. Protect from freezing.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Neuropsychiatric Adverse Reactionsn- [see Warnings and Precautions ()]
Hemodynamic Instability
Advise patients, especially those with cardiac disorders, to report to their healthcare provider if they experience any signs or symptoms of hemodynamic instability, including hypotension, hypertension, syncope or tachycardia, especially after initiating or increasing the dosage of MARINOL .
Seizures
Advise patients to discontinue MARINOL and contact a healthcare provider immediately if they experience a seizure .
Multiple Substance Abuse
Inform patients with a history of substance abuse or dependence, including marijuana or alcohol, that they may be more likely to abuse MARINOL. Advise patients to report to their healthcare provider if they develop abuse behaviors or conditions .
Paradoxical Nausea, Vomiting, or Abdominal Pain
Advise patients to report worsening nausea, vomiting or abdominal pain to their healthcare provider .
Pregnancy
Advise pregnant women of the potential risk to a fetus and to avoid use of MARINOL during pregnancy .
Lactation
Manufactured by: Patheon Softgels Inc. High Point, NC 27265
Manufactured for:AbbVie Inc. North Chicago, IL 60064, U.S.A.
1248A00 08/17-(R5) August, 2017

This Patient Information has been approved by the U.S. Food and u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: August, 2017Drug Administration.
1248A99 08/17-(R4)

NDC 0051-0021-21
60 Capsules
2.5 mg CIII
MARINOL (dronabinol capsules, USP)
Each capsule contains: Dronabinol 2.5 mg
Rx only abbvie
NDC 0051-0022-21
60 Capsules
5 mg CIII
MARINOL (dronabinol capsules, USP)
Each capsule contains: Dronabinol 5 mg
Rx only abbvie
NDC 0051-0023-21
60 Capsules
10 mg CIII
MARINOL (dronabinol capsules, USP)
Each capsule contains: Dronabinol 10 mg
Rx only abbvie

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Dronabinol (Marinol)

Trade Name : Marinol

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Dronabinol (Marinol)

Trade Name : Marinol

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

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QUICK LINKS

CONTACT US

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