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Aprepitant (Aprepitant)

Trade Name : Aprepitant

Sandoz Inc

CAPSULE

Strength 40 mg/1

APREPITANT Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 3A4 Inducers [MoA]

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Product information is meant for

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Disclaimer

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 Aprepitant (Aprepitant) which is also known as Aprepitant and Manufactured by Sandoz Inc. It is available in strength of 40 mg/1 per ml. Read more

Aprepitant (Aprepitant) 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

Validated Cold Chain Shipment

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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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

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.

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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  • No data
  • Aprepitant is a substance P/neurokinin 1 (NK) receptor antagonist, indicated:
  • Limitations of Use ()
  • Recommended Dosage for PONV
  • 2.4
  • Aprepitant Capsules, USP
  • Aprepitant Capsules, USP: 40 mg; 80 mg; 125 mg ()
  • Aprepitant is contraindicated in patients:
  • No data
  • CYP3A4 Interactions:
  • Warfarin (a CYP2C9 substrate):
  • Hormonal Contraceptives:
  • Most common adverse reactions are ():
  • Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
  • PONV
  • See Full Prescribing Information for a list of clinically significant drug interactions. (, , , , , )
  • Pediatric use information is approved for Merck Sharp & Dohme Corp.u2019s EMEND (aprepitant) capsules. However, due to Merck Sharp & Dohme Corpu2019s marketing exclusivity rights, this drug product is not labeled with that information.
  • No data
  • No specific information is available on the treatment of overdosage.
  • Drowsiness and headache were reported in one patient who ingested 1440 mg of aprepitant (approximately 11 times the maximum recommended single dose).
  • In the event of overdose, aprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, drug-induced emesis may not be effective in cases of aprepitant overdosage.
  • Aprepitant is not removed by hemodialysis.
  • Aprepitant capsules, USP contain the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK) receptor antagonist, an antiemetic agent, chemically described as 5-[[(2,3)-2-[(1)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-1,2-dihydro-3-1,2,4-triazol-3-one.
  • Its molecular formula is CHFNO, and its structural formula is:
  • Aprepitant is a white to off-white crystalline solid, with a molecular weight of 534.43. It is practically insoluble in water. Aprepitant is sparingly soluble in ethanol and isopropyl acetate and slightly soluble in acetonitrile.
  • Each aprepitant capsule, USP for oral administration contains either 40 mg, 80 mg or 125 mg of aprepitant and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate and sucrose.
  • The aprepitant capsule shell for 40 mg and 80 mg consists of gelatin and titanium dioxide.
  • The aprepitant capsule shell for 125 mg consists of FD&C Blue # 1, gelatin and titanium dioxide.
  • The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac.
  • Dissolution Test 2 is used.
  • No data
  • Carcinogenesis
  • Carcinogenicity studies were conducted in Sprague-Dawley rats and in CD-1 mice for 2 years. In the rat carcinogenicity studies, animals were treated with oral doses ranging from 0.05 to 1000 mg/kg twice daily. The highest dose produced a systemic exposure to aprepitant (AUC) of 0.7 to 1.6 times the adult human exposure at the 125-mg/80-mg/80-mg aprepitant regimen. Treatment with aprepitant at doses of 5 to 1000 mg/kg twice daily caused an increase in the incidences of thyroid follicular cell adenomas and carcinomas in male rats. In female rats, it produced hepatocellular adenomas at 5 to 1000 mg/kg twice daily and hepatocellular carcinomas and thyroid follicular cell adenomas at 125 to 1000 mg/kg twice daily. In the mouse carcinogenicity studies, the animals were treated with oral doses ranging from 2.5 to 2000 mg/kg/day. The highest dose produced a systemic exposure of about 2.8 to 3.6 times the adult human exposure at the 125-mg/80-mg/80-mg aprepitant regimen. Treatment with aprepitant produced skin fibrosarcomas at 125 and 500 mg/kg/day doses in male mice.
  • Mutagenesis
  • Aprepitant was not genotoxic in the Ames test, the human lymphoblastoid cell (TK6) mutagenesis test, the rat hepatocyte DNA strand break test, the Chinese hamster ovary (CHO) cell chromosome aberration test and the mouse micronucleus test.
  • Impairment of Fertility
  • Aprepitant did not affect the fertility or general reproductive performance of male or female rats at doses up to the maximum feasible dose of 1000 mg/kg twice daily (providing exposure in male rats lower than the exposure at the recommended adult human dose and exposure in female rats at about 1.6 times the adult human exposure at the 125-mg/80-mg/80-mg aprepitant regimen).
  • No data
  • Aprepitant capsules, USP 40 mg, are hard gelatin capsules with opaque white cap and opaque white body containing white to off white colored pellets. The cap is imprinted with u2018SZu2019 and the body is imprinted with u2018525u2019 in black ink
  • Aprepitant capsules, USP 80 mg, are hard gelatin capsules with opaque white cap and clear transparent body containing white to off white colored pellets. The cap is imprinted with u2018SZu2019 and the body is imprinted with u2018528u2019 in black ink.
  • Aprepitant capsules, USP 125 mg, are hard gelatin capsules with opaque light blue cap and opaque white body containing white to off white colored pellets. The cap is imprinted with u2018SZu2019 and the body is imprinted with u2018529u2019 in black ink.
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-Approved patient labeling (Patient Information).
  • Arrayn- Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions, including anaphylaxis, have been reported in patients taking aprepitant. Advise patients to stop taking aprepitant and seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, or difficulty in breathing or swallowing.
  • Arrayn- Drug Interactions
  • Advise patients to discuss all medications they are taking, including other prescription, nonu2011prescription medication or herbal products .
  • Warfarin
  • Instruct patients on chronic warfarin therapy to follow instructions from their healthcare provider regarding blood draws to monitor their INR during the 2-week period, particularly at 7 to 10 days, following initiation of the 3-day regimen of aprepitant with each chemotherapy cycle, or following administration of a single 40-mg dose of aprepitant for the prevention of postoperative nausea and vomiting.
  • Hormonal Contraceptives
  • Advise patients that administration of aprepitant may reduce the efficacy of hormonal contraceptives. Instruct patients to use effective alternative or back-up methods of contraception (such as condoms and spermicides) during treatment with aprepitant and for 1 month following the last dose of aprepitant .
  • The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
  • Finished Drug Product Manufactured by
  • Lek Pharmaceuticals d.d.,
  • SI-1526 Ljubljana, Slovenia for
  • Sandoz Inc., Princeton, NJ 08540
  • Product of India
  • Rev.: June 2017
  • Aprepitant Capsules
  • (a-PRE-pi-tant)
  • Read this Patient Information before you start taking aprepitant and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
  • What are aprepitant capsules?
  • Aprepitant is not used to treat nausea and vomiting that you already have. Aprepitant should not be used continuously for a long time (chronic use).
  • Who should not take aprepitant capsules?
  • Do not take aprepitant capsules if you:
  • Aprepitant capsules may affect the way other medicines work, and other medicines may affect how aprepitant works causing serious side effects.
  • Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of aprepitant capsules. For more information ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088.
  • Keep aprepitant capsules and all medicines out of the reach of children.
  • General information about the safe and effective use of aprepitant capsules
  • Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use aprepitant capsules for a condition for which it was not prescribed. Do not give aprepitant capsules to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about aprepitant capsules that is written for health professionals. For more information about aprepitant capsules call Sandoz Inc., at 1-800-525-8747.
  • What are the ingredients in aprepitant capsules?
  • Active ingredient
  • Inactive ingredients
  • The capsule shell for 40 mg and 80 mg contains gelatin and titanium dioxide. The capsule shell for 125 mg contains FD&C Blue # 1, gelatin and titanium dioxide. The capsule is printed with edible black pharmaceutical ink. The printing ink contains black iron oxide, propylene glycol and shellac.
  • Pediatric use information is approved for Merck Sharp & Dohme Corp.u2019s EMEND (aprepitant) capsules. However, due to Merck Sharp & Dohme Corpu2019s marketing exclusivity rights, this drug product is not labeled with that information.
  • The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.
  • Finished Drug Product Manufactured by
  • Lek Pharmaceuticals d.d.,
  • Sl-1526 Ljubljana, Slovenia for
  • Sandoz Inc., Princeton, NJ 08540
  • Product of India
  • Rev.: June 2017
  • NDC
  • Aprepitant Capsules, USP
  • 40 mg
  • Rx only
  • 5 Capsules
  • WARNING: Do not use if blisters are torn, broken or missing.
  • This unit-dose package is not child-resistant.
  • (For institutional use only)
  • SANDOZ
  • NDC
  • Aprepitant Capsules, USP
  • 80 mg
  • Rx only
  • 6 Capsules
  • WARNING: Do not use if blisters are torn, broken or missing.
  • This unit-dose package is not child-resistant.
  • (For institutional use only)
  • SANDOZ
  • NDC
  • Aprepitant Capsules, USP
  • 125 mg
  • Rx only
  • 6 Capsules
  • WARNING: Do not use if blisters are torn, broken or missing.
  • This unit-dose package is not child-resistant.
  • (For institutional use only)
  • SANDOZ
  • NDC
  • Aprepitant Capsules, USP
  • 125 mg
  • and
  • Aprepitant Capsules, USP
  • 80 mg
  • Rx only
  • 3 Capsules
  • One 125 mg capsule contains 125 mg aprepitant
  • Two 80 mg capsules each containing 80 mg aprepitant
  • SANDOZ

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