Modafinil (Modafinil)

Trade Name : modafinil

Aphena Pharma Solutions - Tennessee, LLC

TABLET

Strength 200 mg/1

MODAFINIL Central Nervous System Stimulation [PE],Increased Sympathetic Activity [PE],Sympathomimetic-like Agent [EPC]

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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 Modafinil (Modafinil) which is also known as modafinil and Manufactured by Aphena Pharma Solutions - Tennessee, LLC. It is available in strength of 200 mg/1 per ml. Read more

Modafinil (Modafinil) 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

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About GNH

No data

Modafinil is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is CHNOS and the molecular weight is 273.35.
The chemical structure is:
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. Modafinil tablets contain 100u00a0mg or 200u00a0mg of modafinil and theu00a0following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.

The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents like amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of sympathomimetic amines.
Modafinil has weak to negligible interactions with receptors for norepinephrine, serotonin, dopamine, GABA, adenosine, histamine-3, melatonin, and benzodiazepines. Modafinil also does not inhibit the activities of MAO-B or phosphodiesterases II-V.
Modafinil-induced wakefulness can be attenuated by the u03b1-adrenergic receptor antagonist prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to u03b1-adrenergic agonists, such as the rat vas deferens preparation.
Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals. In genetically engineered mice lacking the dopamine transporter (DAT), modafinil lacked wake-promoting activity, suggesting that this activity was DAT-dependent. However, the wake-promoting effects of modafinil, unlike those of amphetamine, were not antagonized by the dopamine receptor antagonist haloperidol in rats. In addition, alpha-methyl-p-tyrosine, a dopamine synthesis inhibitor, blocks the action of amphetamine, but does not block locomotor activity induced by modafinil.
In the cat, equal wakefulness-promoting doses of methylphenidate and amphetamine increased neuronal activation throughout the brain. Modafinil at an equivalent wakefulness-promoting dose selectively and prominently increased neuronal activation in more discrete regions of the brain. The relationship of this finding in cats to the effects of modafinil in humans is unknown.
In addition to its wake-promoting effects and ability to increase locomotor activity in animals, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking, and feelings typical of other CNS stimulants in humans. Modafinil has reinforcing properties, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. Modafinil was also partially discriminated as stimulant-like.
The optical enantiomers of modafinil have similar pharmacological actions in animals. Two major metabolites of modafinil, modafinil acid and modafinil sulfone, do not appear to contribute to the CNS-activating properties of modafinil.

The effectiveness of modafinil in reducing excessive sleepiness has been established in the following sleep disorders: narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD).

Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder.
In OSA, modafinil is indicated as an adjunct to standard treatment(s) 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 modafinil. If modafinil is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.
The effectiveness of modafinil in long-term use (greater than 9 weeks in Narcolepsy clinical trials and 12 weeks in OSA and SWD clinical trials) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe modafinil for an extended time in patients with Narcolepsy, OSA, or SWD should periodically reevaluate long-term usefulness for the individual patient.

Modafinil is contraindicated in patients with known hypersensitivity to modafinil, armodafinil or its inactive ingredients.

No data

No data

Modafinil has been evaluated for safety in over 3500 patients, of whom more than 2000 patients with excessive sleepiness associated with primary disorders of sleep and wakefulness were given at least one dose of modafinil. In clinical trials, modafinil has been found to be generally well tolerated and most adverse experiences were mild to moderate.
The most commonly observed adverse events (u22655%) associated with the use of modafinil more frequently than placebo-treated patients in the placebo-controlled clinical studies in primary disorders of sleep and wakefulness were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse event profile was similar across these studies.
In the placebo-controlled clinical trials, 74 of the 934 patients (8%) who received modafinil discontinued due to an adverse experience compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for modafinil than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain and nervousness (each <1%). In a Canadian clinical trial, a 35 year old obese narcoleptic male with a prior history of syncopal episodes experienced a 9-second episode of asystole after 27 days of modafinil treatment (300 mg/day in divided doses).

No data

No data

The recommended dose of modafinil is 200 mg given once a day.
For patients with narcolepsy and OSA, modafinil should be taken as a single dose in the morning.
For patients with SWD, modafinil should be taken approximately 1 hour prior to the start of their work shift.
Doses up to 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 200 mg dose (See and ).
General Considerations
Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine (See ).
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, phenytoin (also via CYP2C9) or S-mephenytoin may have prolonged elimination upon coadministration with modafinil and may require dosage reduction and monitoring for toxicity.
In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function (See and ).
There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See and ).
In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population (See and).

100 mg
NDC 55253-801-30 - Bottles of 30
NDC 55253-801-90 - Bottles of 90
200 mg
NDC 55253-802-30 - Bottles of 30
NDC 55253-802-90 - Bottles of 90
Store at 20 to 25 C (68 to 77 F).

Manufactured In Canada By:
Patheon Inc.
Mississauga, Ontario, Canada L5N 7K9
Manufactured For:
Cephalon, Inc.
Frazer, PA 19355
February 2012
MODT-001
PROVIGIL is a trademark of Cephalon, Inc. or its affiliates.
Iss. 2/2012

Modafinil Tablets C-IV
Read the Medication Guide that comes with modafinil tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your condition or treatment.
What is the most important information I should know about modafinil tablets?
Modafinil tablets may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening.
Stop taking modafinil tablets and call your doctor right away or get emergency help if you have any of these symptoms:
If you have a severe rash with modafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
Modafinil tablets are not approved for use in children for any medical condition.
It is not known if modafinil tablets are safe or if they work in children under the age of 17.
What are modafinil tablets?
Modafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
Modafinil tablets will not cure these sleep disorders. Modafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Modafinil tablets do not take the place of getting enough sleep. Follow your doctoru2019s advice about good sleep habits and using other treatments.
Who should not take modafinil tablets?
Do not take modafinil tablets if you:
What should I tell my doctor before taking modafinil tablets?
Tell your doctor about all of your medical conditions including, if you:
Tell your doctor about all the medicines you take
Especially, tell your doctor if you use or take:
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take modafinil tablets and other medicines together. Do not start any new medicines with modafinil tablets unless your doctor has told you it is okay.
How should I take modafinil tablets?
Symptoms of an overdose of modafinil tablets may include:
What should I avoid while taking modafinil tablets?
What are possible side effects of modafinil tablets?
Modafinil tablets may cause serious side effects.
Common side effects that can happen in anyone who takes modafinil tablets include:
Modafinil tablets is not approved for use in children for any medical condition. In studies of modafinil tablets in children with narcolepsy, side effects included:
Tell your doctor if you get any side effect that bothers you or that does not go away while taking modafinil tablets.
These are not all the side effects of modafinil tablets. For more information, ask your doctor or pharmacist.
Some effects of modafinil tablets on the brain are the same as other medicines called u201cstimulantsu201d. These effects may lead to abuse or dependence on modafinil tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store modafinil tablets?
General information about modafinil tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use modafinil tablets for a condition for which it was not prescribed. Do not give modafinil tablets to other people, even if they have the same symptoms you have. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about modafinil tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about modafinil tablets that is written for health professionals. For more information, call 1-800-896-5855.
What are the ingredients in modafinil tablets?
Active Ingredient:
Inactive Ingredients:
Manufactured In Canada By:
Patheon Inc.
Mississauga, Ontario, Canada L5N 7K9
Manufactured For:
Cephalon, Inc.
Frazer, PA 19355
February 2012
MODMGT-001
This Medication Guide has been approved by the U.S. Food and Drug Administration.
PROVIGIL and NUVIGIL are trademarks of Cephalon, Inc. or its affiliates.
Iss. 2/2012

Please reference the section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Store between 20u00b0-25u00b0C (68u00b0-77u00b0F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:n n Cookeville, TN 38506n 20121219JH

NDC 43353-925 - 200mg - Rx Onlyn n

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Modafinil (Modafinil)

Trade Name : modafinil

TABLET

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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Modafinil (Modafinil)

Trade Name : modafinil

TABLET

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?

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