Central nervous system (brain) stimulant; analeptic.



How the Drug Works

Caffeine stimulates the brain. It also stimulates the heart, dilates (widens) blood vessels in the body, constricts (narrows) blood vessels in the brain, increases acid secretion in the stomach, and acts as a mild or weak diuretic (water pill).

How modafinil works to stimulate the brain is not completely known. It may act by altering natural chemicals (neurotransmitters) in the brain that affect alertness.

Uses

Caffeine: As an aid in staying awake and restoring mental alertness. As an adjuvant (added to) in various pain medications (eg, aspirin, acetaminophen) to increase pain relieving effects.

Madafinil: To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

Unlabeled Uses: Topical treatment with caffeine in a hydrophilic base or hydrocortisone has been used to treat skin rash, hives, redness, scaling, oozing, and itching. In combination with ephedrine, caffeine causes a modest weight loss in obese individuals when energy intake is restricted over an extended period. Caffeine enhances the migrainetreating effects of ergotamine. Caffeine has been used to treat excited or comatose alcoholic patients. Caffeine has eased postprandial (after meal) hypotension in a small number of patients, although its use is strongly discouraged by most doctors.

Precautions

Diabetic patients: Caffeine may cause blood sugar levels to increase in diabetic patients. Monitor blood sugar more closely until effects have been determined.

Pregnancy: There are no adequate and well-controlled studies of modafinil in pregnant women. Use only if clearly needed and the potential benefits to the mother outweigh the possible hazards to the fetus. Pregnant patients should minimize their intake of caffeine and caffeine-containing beverages.

Breastfeeding: Caffeine appears in breast milk. It is not known if modafinil appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Use of caffeine in children younger than 12 years of age is not recommended. Safety and effectiveness of modafinil in patients younger than 16 years of age have not been established.

Elderly: Safety and effectiveness of modafinil in patients older than 65 years of age have not been established. Consider reduced dosages in elderly patients.

Lab Tests: Lab tests may be required to monitor modafinil therapy. Tests may include blood pressure monitoring.

Tartrazine: Some of these products may contain the dye tartrazine (FD&C Yellow No.5), which can cause allergic reactions in certain individuals. Check package label when available or consult your doctor or pharmacist.

Drug Interactions

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements while taking analeptics. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact analeptics:

Allopurinol (eg, Zyloprim)

Aspirin cimetidine (eg, Tagamet)

Clozapine (eg, Clozaril)

Contraceptives, oral (eg, Ortho Novum)

Contraceptives, oral (eg, Ortho-Novum)

Cyclosporine (eg, Neoral)

Diazepam (eg, Valium)

Disulfiram (eg, Antabuse)

MAOls (eg, phenelzine)

Fluoroquinolones methylphenidate (eg, Metadate)

Phenytoin (eg, Dilantin)

SSRls (eg, fluoxetine)

Mexiletine (Mexitil)

Side Effects

Every drug is capable of producing side effects. Many analeptic users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy and individual susceptibility. Possible side effects include:

Digestive Tract: Nausea; vomiting; diarrhea; stomach pain; dry mouth; appetite loss; mouth ulcer; gum inflammation; thirst.

Nervous System: Sleeplessness; restlessness; excitement; nervousness; ringing in the ears; muscle tremor; headache; light-headedness; dizziness; depression; anxiety; muscle weakness; abnormal skin sensations; involuntary movements; confusion; muscle tension; amnesia; emotional instability; stumbling.

Circulatory System: Increased heart rate; palpitations (pounding in the chest); changes in blood pressure. Skin: Hives; herpes simplex; dry skin.

Other: Abnormal vision; high blood sugar; fainting; abnormal liver function; abnormal urine; urinary retention; abnormal ejaculation; runny nose; sore throat; lung disorder; difficulty breathing; asthma; nosebleed; lazy eye; abnormal blood counts; chest or neck pain; chills; fever; rigid neck; joint disorder.

Guidelines for Use

Dosage is individualized. Take exactly as prescribed.

Do not change the dose or stop taking, unless directed by your doctor.

If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose in order to catch up, unless advised to do so by your doctor. If more than one dose is missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist.

May cause dizziness, changes in judgment, or abnormal vision. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.

Stop taking and notify your doctor immediately if you experience an increased or abnormal heart rate, dizziness, or palpitations.

Notify your doctor if fatigue or drowsiness persists or recurs, or if you experience rash, hives or other allergic reactions.

Limit use of caffeine-containing medications, foods, or beverages while taking caffeine tablets or capsules. Too much caffeine may cause nervousness, irritability, sleeplessness, and rapid heart rate.

Avoid alcohol while taking modafinil.

Effectiveness of hormonal contraceptives (eg, inject able or implant able birth control, birth control pills) may be reduced by modafinil during treatment and for one month after stopping treatment. Additional or alternative methods of contraception (eg, condoms) should be used.

Inform your doctor if you are pregnant, are planning to become pregnant, become pregnant, or are breastfeeding.

Caffeine is not intended for use as a substitute for normal sleep.

Do not take any other prescription or OTC medications or dietary supplements, unless directed by your doctor.

Store caffeine products at room temperature (59 to 86F). Store modafinil at 68 to 77F.