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Armodafinil (Armodafinil)

Trade Name : Armodafinil

Mylan Pharmaceuticals Inc.

TABLET

Strength 50 mg/1

ARMODAFINIL

Delivery Process

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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 Armodafinil (Armodafinil) which is also known as Armodafinil and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 50 mg/1 per ml. Read more

Armodafinil (Armodafinil) 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
  • Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
  • Arrayn- Limitations of Use
  • In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.
  • Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). ()
  • Limitations of Use
  • In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
  • The recommended dosage of armodafinil tablets for each indication is as follows:
  • 2.3n- 12.3
  • 2.4n- 12.3
  • Armodafinil Tablets are available containing 50 mg, 150 mg or 250 mg of armodafinil.
  • Tablets: 50 mg, 150 mg, and 250 mg. ()
  • Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or their inactive ingredients .
  • Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil. ()
  • No data
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • Most common adverse reactions (u2265 5%): headache, nausea, dizziness, and insomnia. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Arrayn- u00a0[see ]
  • The effectiveness of steroidal contraceptives may be reduced when used with armodafinil tablets and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with armodafinil tablets and for one month after discontinuation of armodafinil tablet treatment.
  • Blood levels of cyclosporine may be reduced when used with armodafinil tablets. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with armodafinil tablets.
  • Arrayn- Effects of Armodafinil Tablets on CYP2C19 Substrates:
  • Arrayn- [see ]
  • Arrayn- Monoamine Oxidase (MAO) Inhibitors:
  • Pregnancy: based on animal data, may cause fetal harm. ()
  • No data
  • Fatal overdoses involving modafinil alone or involving armodafinil tablets or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying armodafinil tablet or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.
  • No specific antidote exists for the toxic effects of an armodafinil tablet overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.
  • Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is CHNOS and the molecular weight is 273.35.
  • The chemical structure is:
  • Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol.
  • Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone.
  • No data
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling ().
  • Serious Dermatologic Reactions:n n- [see ]
  • DRESS/Multi-organ Hypersensitivity:n- [see ]
  • Angioedema and Anaphylactic Reactions:n- [see ]
  • Wakefulness:n
  • Continuing Previously Prescribed Treatments:
  • Psychiatric Symptoms:u00a0
  • Females of Reproductive Potential:
  • Concomitant Medication:u00a0
  • Alcohol:u00a0
  • This Medication Guide has been approved by the U.S. Food and Drug Administration
  • Manufactured for:n n Morgantown, WVu00a026505u00a0U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • 75065951
  • Revised: 9/2018MX:ARDFL:R7
  • NDC 0378-3431-93
  • Armodafiniln- Tablets CIVn- 50 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only u00a0u00a0u00a0u00a0u00a030 Tablets
  • Each tablet contains:Armodafinil u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a050 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX3431H1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-3432-93
  • Armodafiniln- Tablets CIVn- 150 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only u00a0u00a0u00a0u00a0u00a030 Tablets
  • Each tablet contains:Armodafinil u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0150 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX3432H1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-3433-93
  • Armodafiniln- Tablets CIVn- 250 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only u00a0u00a0u00a0u00a0u00a030 Tablets
  • Each tablet contains:Armodafinil u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0250 mg
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX3433H1
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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