Provigil Uses

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What is Provigil?

Provigil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Provigil does not cure these conditions and will only work as long as you continue to take it.

Provigil is available only with your doctor's prescription.

Provigil indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Provigil tablets, USP are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD).

Limitations of Use

In OSA, Provigil tablets, USP 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 and during treatment with Provigil tablets, USP for excessive sleepiness.

How should I use Provigil?

Use Provigil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Provigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Provigil refilled.
  • Provigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Provigil refilled.
  • Take Provigil by mouth with or without food.
  • Take Provigil in the morning unless otherwise directed by your doctor.
  • If you miss a dose of Provigil, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Provigil.

Uses of Provigil in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Provigil is used to treat excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea (problems in breathing while asleep) and chronic shift work.

Provigil description

Provigil is a stimulant drug marketed as a 'wakefulness promoting agent' and is one of the stimulants used in the treatment of narcolepsy. Narcolepsy is caused by dysfunction of a family of wakefulness-promoting and sleep-suppressing peptides, the orexins, whose neurons are activated by Provigil. The prexin neuron activation is associated with psychoactivation and euphoria. The exact mechanism of action is unclear, although in vitro studies have shown it to inhibit the reuptake of dopamine by binding to the dopamine reuptake pump, and lead to an increase in extracellular dopamine. Provigil activates glutamatergic circuits while inhibiting GABA.

Provigil dosage

Dosage in Narcolepsy and Obstructive Sleep Apnea (OSA)

The recommended dosage of Provigil tablets for patients with narcolepsy or OSA is 200 mg taken orally once a day as a single dose in the morning.

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/day dose.

Dosage in Shift Work Disorder (SWD)

The recommended dosage of Provigil tablets for patients with SWD is 200 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modifications in Patients with Severe Hepatic Impairment

In patients with severe hepatic impairment, the dosage of Provigil tablets should be reduced to one-half of that recommended for patients with normal hepatic function.

Use in Geriatric Patients

Consideration should be given to the use of lower doses and close monitoring in geriatric patients.

Provigil interactions

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Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: medications for high blood pressure (e.g., beta blockers such as atenolol/metoprolol, clonidine, guanabenz, methyldopa, prazosin), "blood thinners" (e.g., warfarin), street drugs (e.g., methamphetamine, MDMA-"ecstasy"), drugs that affect liver enzymes that remove Provigil from the body (e.g., azole antifungals such as itraconazole/ketoconazole, rifamycins such as rifabutin/rifampin, anti-seizure medications such as carbamazepine/phenobarbital).

Provigil can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs may include certain antidepressants (e.g. TCAs such as clomipramine/desipramine, SSRIs such as fluoxetine, fluvoxamine), cyclosporine, diazepam, phenytoin, propranolol, theophylline, triazolam.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with Provigil. In some cases a serious (possibly fatal) drug interaction may occur.

This medication may decrease the effectiveness of hormonal birth control (e.g., pills, patch, ring). This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication and for 1 month after stopping this medication. Consult your doctor or pharmacist for details.

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients (e.g., pseudoephedrine, ephedra/ma huang) that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.

Avoid drinking large amounts of beverages containing caffeine (e.g., coffee, tea, cola). Caffeine can increase the side effects of this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Provigil side effects

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The following serious adverse reactions are described elsewhere in the labeling:

  • Serious Rash, including Stevens-Johnson Syndrome
  • Angioedema and Anaphylaxis Reactions
  • Multi-organ Hypersensitivity Reactions
  • Persistent Sleepiness
  • Psychiatric Symptoms
  • Effects on Ability to Drive and Use Machinery
  • Cardiovascular Events

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Provigil tablets have been evaluated for safety in over 3,500 patients, of whom more than 2,000 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

Most Common Adverse Reactions

In placebo-controlled clinical trials, the most common adverse reactions (≥ 5%) associated with the use of Provigil tablets more frequently than placebo-treated patients were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. The adverse reaction profile was similar across these studies.

Table 1 presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in Provigil tablets-treated patients than in placebo-treated patients in the placebo-controlled clinical trials.

Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials* in Narcolepsy, OSA, and SWD

* Adverse Reactions that occurred in ≥1% of Provigil tablets-treated patients (either 200, 300, or 400mg once daily) and greater incidence than placebo

Dose-Dependent Adverse Reactions

In the placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of Provigil tablets and placebo, the following adverse reactions were dose related: headache and anxiety.

Adverse Reactions Resulting in Discontinuation of Treatment

In placebo-controlled clinical trials, 74 of the 934 patients (8%) who received Provigil tablets discontinued due to an adverse reaction compared to 3% of patients that received placebo. The most frequent reasons for discontinuation that occurred at a higher rate for Provigil tablets than placebo patients were headache (2%), nausea, anxiety, dizziness, insomnia, chest pain, and nervousness (each <1%).

Laboratory Abnormalities

Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of Provigil tablets, but not placebo. Few patients, however, had GGT or AP elevations outside of the normal range. Shifts to higher, but not clinically significantly abnormal, GGT and AP values appeared to increase with time in the population treated with Provigil tablets in the placebo- controlled clinical trials. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Provigil tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic: agranulocytosis

Psychiatric disorders: psychomotor hyperactivity

Provigil contraindications

Provigil tablets are contraindicated in patients with known hypersensitivity to Provigil or arModafinil or its inactive ingredients.

Active ingredient matches for Provigil:

Modafinil in Belgium, Ireland, Israel, Italy, Malta, South Africa, South Korea, Taiwan, United Kingdom, United States.

Chorionic gonadotrophin in India.

Human Chorionic Gonadotropin

Human chorionic gonadotrophin in India.


Unit description / dosage (Manufacturer)Price, USD
Tablet; Oral; Modafinil 100 mg
Tablet; Oral; Modafinil 200 mg
Provigil 1000 IU AMP / 1$ 3.13
Provigil 2000 IU AMP / 1$ 4.68
Provigil 5000 IU AMP / 1$ 6.78
Provigil 10000 IU AMP / 11$ 9.13
Provigil 200 mg x 100's
1000 IU x 1's$ 3.13
2000 IU x 1's$ 4.68
5000 IU x 1's$ 6.78
10000 IU x 1's$ 9.13
PROVIGIL 5000IU INJECTION 1 vial / 1 ML injection each (Maneesh Pharmaceuticals Ltd)$ 8.03
Provigil tablet 200 mg/1 (Unit Dose Services (US))
Provigil tablet 100 mg/1 (Rebel Distributors Corp (US))

List of Provigil substitutes (brand and generic names):

Provake 200mg Tablet (Ranbaxy (Solus))$ 0.30
PROVIGIL HP 5000IU INJECTION 1 vial / 1 injection each (Maneesh Pharmaceuticals Ltd)$ 3.57
Provigil-HP 2000 IU AMP / 1 (Svizera)$ 4.76
Provigil-HP 5000 IU AMP / 1 (Svizera)$ 8.33
Provigil-HP 10000 IU AMP / 1 (Svizera)$ 13.49
2000 IU x 1's (Svizera)$ 4.76
5000 IU x 1's (Svizera)$ 8.33
10000 IU x 1's (Svizera)$ 13.49
PUBERGEN Injection / 10000 i.u. / 1 units (Uni Sankyo)$ 8.92
PUBERGEN Injection / 5000 i.u. / 1 units (Uni Sankyo)$ 6.00
PUBERGEN Injection / 2000 i.u. / 1 units (Uni Sankyo)$ 4.29
PUBERGEN Injection / 1000 i.u. / 1 units (Uni Sankyo)$ 3.02
1000 IU x 1's (Uni Sankyo)$ 3.03
2000 IU x 1's (Uni Sankyo)$ 4.24
5000 IU x 1's (Uni Sankyo)$ 6.00
10000 IU x 1's (Uni Sankyo)$ 8.70
Pubergen 1000 IU AMP / 1 (Uni Sankyo)$ 3.03
Pubergen 2000 IU AMP / 1 (Uni Sankyo)$ 4.24
Pubergen 5000 IU AMP / 1 (Uni Sankyo)$ 6.00
Pubergen 10000 IU AMP / 1 (Uni Sankyo)$ 8.70
PUBERGEN 10000IU INJECTION 1 vial / 1 injection each (Uni Sankyo)$ 11.05
PUBERGEN 1000IU INJECTION 1 vial / 1 ML injection each (Uni Sankyo)$ 3.86
PUBERGEN 2000IU INJECTION 1 vial / 1 ML injection each (Uni Sankyo)$ 5.37
PUBERGEN 5000IU INJECTION 1 vial / 1 ML injection each (Uni Sankyo)$ 9.21
Pubergen 10000IU Injection (Uni Sankyo)$ 11.05
Pubergen 1000IU Injection (Uni Sankyo)$ 3.86
Pubergen 2000IU Injection (Uni Sankyo)$ 5.37
Pubergen 5000IU Injection (Uni Sankyo)$ 6.31
PUBERGEN AQUA 5000 IU INJECTION 1 vial / 1 ML injection each (Sanzyme Ltd)$ 9.21
Pubergen Aqua 5000IU Injection (Sanzyme Ltd)$ 9.21
PUBERGEN HP 2000IU INJECTION 1 vial / 1 injection each (Sanzyme Ltd)$ 4.01
PUBERGEN HP 5000IU INJECTION 1 vial / 1 injection each (Sanzyme Ltd)$ 9.35
Pubergen HP 5000IU Injection (Sanzyme Ltd)$ 9.35
PUBERGEN JO 7500IU INJECTION 1 vial / 1 ML injection each (Sanzyme Ltd)$ 9.57
PUBERGEN NANO 500IU INJECTION 1 vial / 1 ML injection each (Sanzyme Ltd)$ 3.43
Pubergen-HP 2000 IU AMP / 1 (Uni Sankyo)$ 8.70
2000 IU x 1's (Uni Sankyo)$ 8.70
Tablet; Oral; Modafinil 200 mg (Drugtech)
ROGON-HP inj 5000 IU x 1's (Rowez)$ 6.19
SIFASI 5000IU INJECTION 1 vial / 1 ML injection each (Serum Institute)$ 6.11
SIFASI inj 2000 IU x 1's (Serum Institute)$ 5.76
SIFASI inj 5000 IU x 1's (Serum Institute)$ 7.86

References

  1. DailyMed. "MODAFINIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailymed/se... (accessed September 18, 2017).
  2. PubChem. "modafinil". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).

Reviews

The results of a survey conducted on ndrugs.com for Provigil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Provigil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported useful

Was the Provigil drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful1
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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