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Archive for the ‘Central Nervous System Agents’


11/08, 2008

Citalopram Hydrobromide - An Antidepressant Drug

Type of Drug:

Antidepressant; mood-elevating agent.

How the Drug Works:

Citalopram blocks the uptake of a chemical found in the brain (serotonin) which increases the activity of this chemical, resulting in improved mood.

Uses:

To treat depression.

Pregnancy: Adequate studies have not been done in pregnant women. Use only if clearly needed and potential benefits outweigh the possible hazards to the fetus.

Breastfeeding: Citalopram appears in breast milk. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the risks to the infant of citalopram exposure (eg, excessive drowsiness, decreased feeding, weight loss) and the importance of the drug to the mother. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children have not been established.

Elderly: Older individuals may be more sensitive to the effects of citalopram than younger individuals. The recommended dose for most elderly patients is 20 mg/day with titration to 40 mg/day only for nonresponding patients.

Drug Interactions:

Tell your doctor if you are taking or are planning to take any over-the­counter or prescription medications while taking citalopram. 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 with citalopram: alcohol

  • Carbamazepine (eg, Tegretol)
  • Cimetidine (eg, Tagamet)
  • CNS drugs (eg, antidepressants)
  • Imipramine (eg, Tofranil)
  • Lithium (eg, Lithobid)

Side Effects:

Every drug is capable of producing side effects. Many citalopram 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; dry mouth; vomiting; diarrhea; indigestion; stomach pain; gas; increased salivation; appetite changes.

Nervous System: Dizziness; sleeplessness; drowsiness; agitation; tremor; fatigue; weakness; anxiety; impaired concentration; amnesia; apathy; worsening of depression; suicide attempt; confusion; headache.

Circulatory System: Decreased heart rate; fast heartbeat; postural (standing) low blood pressure; low blood pressure.

Respiratory System: Upper respiratory tract infection; runny nose; sinus infection; coughing.

Urinary and Reproductive Tract: Painful menstruation; absence of menstruation; excessive urination; ejaculation disorder; decreased sex drive; impotence.

Other: Rash; itching; increased sweating; fever; abnormal skin sensations (eg, burning, prickling, tingling); joint or muscle pain; yawning; weight changes; taste pereception changes.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not stop taking or change the dose unless directed by your doctor.
  • Usual adult starting dose is 20 mg/day as a single dose. If necessary, dose may be increased to 40 mg/day after at least 1 week.
  • Take once daily, in the morning or evening, with or without food.
  • For most elderly patients and patients with liver disease, 20 mg/day is the recommended dose, with titration to 40 mg/day only for non responding patients.
  • If a dose is missed, inhale it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless directed by your doctor. If more than one dose is missed or if it is necessary to establish a new dosage schedule, con­tact your doctor or pharmacist.
  • Contact your doctor if you experience suicidal thoughts, sexual problems, appetite loss, nausea, vomiting, weight gain, restlessness, irritability, confusion, or excessive urination.
  • Citalopram should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. At least 14 days should be allowed after stopping citalopram before starting an MAOI.
  • May cause drowsiness or dizziness. Use caution while driving or per­forming other tasks requiring alertness, coordination, or physical dexterity.
  • Avoid alcohol while taking citalopram.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or are breastfeeding.
  • Improvement in depression may be noticed in 1 to 4 weeks. Continue to take citalopram as directed even though your depression has improved.
  • Contact your doctor if adverse reactions persist and become bother­some.
  • Store at controlled room temperature (59° to 86 F).

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10/11, 2008

Uses of 5-Aminosacylic Acid (5-ASA) Agents

How The Drug Works

The exact mechanism of action of the 5-aminosalicyclic acid (5-ASA) agents is unknown. They appear to work topically, reducing inflammation of the colon by preventing the production of substances involved in the inflammatory process.

Uses

Balsalazide Disodium: To treat mild to moderate active ulcerative colitis (inflammation of the colon or rectum).

Mesalamine: To treat mild to moderate inflammation of the colon or rectum (eg, ulcerative colitis) and to reduce chances of reoccurance (delayed-release tablets).

To treat active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis (rectal suppositories and suspension).

Olsalazine Sodium: To reduce the chances that ulcerative colitis will reoccur in patients who cannot take sulfasalazine.

Intolerance: Mesalamine can cause an intolerance syndrome characterized by cramping, acute stomach pain, bloody diarrhea, fever, head­ache, and rash. Prompt withdrawal is required. Consult your doctor.

Worsening of Symptoms: Worsening of symptoms of colitis (thought to have been caused by mesalamine or sulfasalazine) has occurred.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits to the mother outweigh the possible hazards to the fetus.

Breastfeeding: Oral mesalamine appears in breast milk. It is not known if rectal mesalamine, balsalazide, or olsalazine appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children have not been established.

Sulfites: Some of these products contain sulfite preservatives that 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 with 5-ASA. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. Thiopurines (eg, mercaptopurine) and anticoagulants (eg, warfarin) interact with olsalazine.

Side Effects

Every drug is capable of producing side effects. Many 5-ASA 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: Diarrhea; constipation; frequent stools; indigestion; heart­burn; bloating; gas; stomach pain or cramps; nausea; vomiting; belching; worsening of colitis; appetitie loss; rectal bleeding; mouth inflammation.

Nervous System: Dizziness; headache; tiredness; weakness; disorientation; sleeplessness; fatigue; drowsiness; depression; vertigo (feeling of whirling motion); Lightheadedness.

Other: Sweating; chills; hair loss; fever; flu-like symptoms; cough; muscle pain, cramps, or tension; general pain; painful urination; fever; leg, back, chest, joint, or rectal pain; hemorrhoids; sore throat; edema (fluid retention); general body discomfort; dry mouth; sore throat; congestion; runny nose; sinus inflammation; upper respiratory infection; painful menstruation; eye inflammation; hives; rash; itching; acne; increased bowel swelling; urinary tract infection.


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12/24, 2007

Lamotrigine - Guidelines for Using Lamotrigine

Type of Drug:

Anticonvulsant; antiepileptic.

How the Lamotrigine Product Works:

It is not known exactly how lamotrigine works. It is believed that lamotrigine prevents or reduces the number of seizures by acting on stabilizing the brain to control the activity of nerve impulses.

Uses of The Lamotrigine:

As an additional therapy in the treatment of partial seizures in patients older than 16 years of age with epilepsy.

Unlabeled Uses: Occasionally, doctors may prescribe lamotrigine to adults with generalized clonic-tonic seizures.

Precautions:

Rash may occur during treatment with this medicine and may be a symptom of a serious allergic reaction. If a rash should develop, discontinue lamotrigine if the drug is suspected and contact your doctor immediately. The incidence of severe, potentially life-threatening rash in pediatric patients is very much higher than that reported in adults using lamotrigine. Specifically, reports from clinical trials suggest that as many as 1 in 50 to 1 in 100 pediatric patients develop a potentially life-threatening rash. Thus, lamotrigine is not approved for use in patients below the age of 16.

Pregnancy: Adequate studies have not been done in pregnant women or animal studies may have shown a risk to the fetus. Use only if clearly needed and potential benefits outweigh the possible hazards to the fetus.

Breastfeeding: Lamotrigine appears in breast milk. Breastfeeding while taking lamotrigine is not recommended. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children younger than 16 years of age have not been established.

Lab Tests: Lab tests to monitor the amount of lamotrigine and other seizure drugs in the blood may be needed. Since it is possible that lamotrigine may collect in the tissues of the eyes, testing may be necessary if visual impairment occurs.

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 lamotrigine. 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 with lamotrigine:

  • Carbamazepine (eg, Tegretol)
  • Phenobarbital (eg, solfoton)
  • Phenytoin (eg, dilantin)
  • Valroic acid (eg, depakene)

Side Effects:

Every drug is capable of producing side effects. Many lamotrigine 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:

Circulatory System: Hot flashes; pounding in the chest (palpitations); chest pain.

Digestive Tract: Stomachache; nausea; vomiting; diarrhea; indigestion; constipation; dry mouth; loss of appetite; tooth disorder.

Nervous System: Dizziness; incoordination; drowsiness; sleeplessness; tremor; depression; anxiety; nervousness; hostility; convulsions; worsened seizures; irritability; speech disorder; memory loss; confusion; thinking abnormality; unstable emotions; mind racing; rapid eye movement; concentration disturbance; feeling of whirling motion.

Respiratory System: Sore throat; increased cough; difficulty breathing; congestion.

Urinary and Reproductive Tract: Painful menstruation; inflammation of the vagina; absence of menstrual bleeding;

Skin: Rash; itching; hair loss; acne. Senses: Double vision; blurred vision.

Other: Headache; flu syndrome; fever; neck, joint or back pain; general body discomfort; chills; weakness; abnormal vision; ear pain; ringing in the ears; muscle spasm; accidental injury; infection; weight gain.

Guidelines for Use:

  • Use exactly as prescribed.
  • May be taken without regard to food.
  • For long-term therapy, take in two equally divided doses.
  • If a rash should develop, it could be a sign of a serious medical condition. Contact your doctor immediately. Also report any fever or gland swelling.
  • Notify your doctor if seizures become worse.
  • If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearly time for the next dose, do not double the dose 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 and drowsiness. Avoid driving or performing other tasks requiring alertness or coordination until effects are known, then use caution.
  • Do not discontinue medication or change the dose without first consulting with your doctor. Seizures could increase. Unless safety concerns require a faster withdrawal, the dose of lamotrigine should be tapered over 2 weeks.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant during therapy, or if you are breastfeeding or intend to breastfeed an infant.
  • Lab tests may be required to monitor therapy. Be sure to keep appointments.
  • Store in a dry place at room temperature; protect from light.

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12/18, 2007

Zonisamide - How Zonisamide Works?

Type of Drug:

Anticonvulsant; sulfonamide used to treat a certain type of seizure disorder.

How the Zonisamide Product Works:

Zonisamide works in the brain to prevent seizures. Its mechanism of action is not fully understood.

Uses of The Zonisamide:

For adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Precautions:

Do not use in the following situations:

  • Allergy to the drug or any of its ingredients
  • Allergy to sulfonamides

Use with caution in the following situations:

  • Kidney disease
  • Liver disease

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits out­weigh the possible hazards to the fetus.

Breastfeeding: It is not known whether zonisamide is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from zonisamide, decide whether to discontinue breastfeeding or the drug, taking into account the importance of the drug to the mother. Consult your doctor before you begin breastfeeding.

Children: Safety and efficacy in patients younger than 16 years of age have not been established. Zonisamide is not approved for pediatric use.

Elderly: Older patients may be more sensitive to the effects of zonisamide. Lower starting doses should be considered.

Lab Tests: Lab tests may be required during treatment. Tests include blood counts and kidney and liver function tests.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over-the-counter or prescription medications or dietary supplements with this drug. Drug may need may need to be modified or a different drug prescribe.

Side Effects:

Every drug is capable of producing side effects. Many patients 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: Stomach pain; appetite loss; constipation; diarrhea; indigestion; nausea; vomiting.

Nervous System: Agitation or irritability; anxiety; incoordination; confusion; depression; difficulty concentrating; difficulty with memory; dizziness; fatigue; headache; sleeplessness; mental slowing; nervousness; continual rapid eye movement; tremor; convulsion; abnormal walking; weakness; unusual thoughts (schizophrenic behavior); drowsiness; tiredness; speech problems.

Respiratory System: Sore throat; cough; runny nose.

Skin: Itching; rash; abnormal skin sensations (eg, burning, prickling, tingling).

Other: Dry mouth; unusual bruising; flu symptoms; weight loss; vision problems; ringing in ear; kidney stones; taste sensation changes.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not stop taking or change the dose, unless instructed by your doctor. Abrupt stopping of zonisamide in patients with epilepsy may increase seizure frequency.
  • May be taken with or without food.
  • Capsules should be swallowed whole.
  • Contact your doctor immediately if you experience decreased sweating with or without fever, sore throat, oral ulcers, easy bruising, rash, or worsening seizures.
  • Contact your doctor if you experience sudden back pain, stomach pain, or blood in the urine. These could be signs of a kidney stone.
  • If dose is missed, take as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose to catch up, unless instructed 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.
  • Drink at least 6 to 8 glasses of fluid per day while taking this drug to decrease the risk of kidney stones.
  • Inform your doctor if you are pregnant, become pregnant, plan on becoming pregnant, or are breastfeeding.
  • Women of child-bearing potential taking zonisamide should use effective contraception.
  • May cause drowsiness, dizziness, or blurred vision. Use caution when driving or performing other tasks requiring alertness, coordination, or physical dexterity until tolerance is determined.
  • Store at room temperature (59° to 86°F). Protect from moisture And light.

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12/11, 2007

Clonazepam Information - Side Effects

Type of Drug:

Benzodiazepine. Anticonvulsant; drug used to treat epilepsy (seizures) and panic disorder.

How the Drug Works:

The actual mechanism of clonazepam’s action is unknown. However, it is believed that clonazepam prevents or reduces the number of seizures and controls panic attacks by acting on the central nervous system to control the activity of nerve impulses.

Uses:

To control Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures either alone or in combination with other anticonvulsant drugs.

To treat absence (petit mal) seizures when succinimides have failed.

To treat panic disorder with or without agoraphobia (fear of crowds, public places, open areas).

Precatuions:

Multiple seizure type: When used in patients in whom several different types of seizure disorders coexist, c10nazepam may increase the frequency or precipitate the onset of generalized tonic-clonic (grand mal) seizures. This may require the addition of other anticonvulsant’s or an increase in dosage.

Chronic respiratory disease: Clonazepam may produce respiratory depression and an increase in salivation. In some patients, increased salivation can cause difficulty breathing. Because of these possibilities, use c10nazepam with caution in patients with chronic respiratory disease.

Withdrawal syndrome: Withdrawal symptoms (eg, convulsions, psychosis, hallucinations, behavioral disorder, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuation of c1onazepam. Severity is related to the degree of dependence and length of time used. The more severe withdrawal symptoms occurred in patients who received excessive doses over an extended period of time. After extended therapy, avoid abrupt discontinuation and follow a gradual dos­age tapering schedule.

Drug dependence: Addiction prone individuals (eg, alcoholics, drug addicts) must be closely supervised during clonazepam therapy. Dependence has occurred in such patients.

Pregnancy: Reports suggest an association between use of anticonvulsant drugs by women with epilepsy and an increased number of birth defects in children born to these women. Other factors (eg, genetics or the epileptic condition) may also contribute to the higher incidence of birth defects. Most mothers receiving anticonvulsant medication deliver normal infants. Do not discontinue anticonvulsant drugs used to prevent major seizures. This could result in the occurrence of seizures, oxygen deficiency in body tissues, and an increased risk to both the mother and the unborn child. In cases where seizures do not pose a serious threat, your doctor may recommend discontinuation of anticonvulsants prior to and during pregnancy. It is not known whether even minor seizures constitute some risk to the developing embryo or fetus. In addition, children born to mothers taking benzodiazepines late in pregnancy may exhibit side effects (eg, flaccid muscles, breathing or feeding difficulties) or withdrawal symptoms. Use this medicine during pregnancy only when benefits to the mother outweigh risks to the fetus.

Breastfeeding: Do not breastfeed while receiving clonazepam.

Children: Children being treated for seizure disorder may be more sensitive to the effects of this drug. Consult your doctor. Safety and effectiveness for use in children younger than 18 years of age with panic disorder have not been established.

Lab tests: Lab Testmay be required during treatment with c1onazepam. Tests may include blood counts and liver function tests.

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 with clonazepam. 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 with c1onazepam:

  • Alcohol antidepressants (eg, fluvoxamine)
  • Cimetidine (eg, tagamet)
  • Contraceptives, oral (eg, orthonovum)
  • Rifamycins (eg, rifampin)
  • Valproic acid (eg, depakene)

Consider all drug interactions reported for benzodiazepines, in the Antianxiety Agents-Benzodiazepines monograph in this chapter when using this drug.

Side Effects:

Every drug is capable .of producing side effects. Many clonazepam 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: Constipation; diarrhea; nausea; appetite changes.

Nervous System: Drowsiness; incoordination; behavior problems; headache; confusion; depression; memory loss; hysteria; bizarre behavior; mood changes; behavior changes; sleeplessness; tremor; dizziness; vertigo (feeling of whirling motion); partial paralysis; reduced intellectual ability; suicidal thoughts; nightmares; abnormal involuntary body movements; coma; hallUCinations.

Respiratory System: Difficult breathing; chest congestion; “runny” nose; coughing; sore throat.

Skin: Rash; excessive growth or loss of hair.

Eyes or Ocular: Blurred vision; double vision; “glassy-eyed” appearance; unusual eye movements.

Other: Fever; fatigue; loss of voice; increased salivation or dry mouth; coated tongue; changes in urination; fluid retention; difficulty speaking; sore gums; swollen lymph nodes; weight changes; increased or decreased sex drive; incontinence of urine or feces; muscle pain or weakness; dehydration; menstruation problems; sexual problems; general deterioration; pounding in the chest; slurred speech.

Guidelines for Use:

  • Dosage will be individualized.
  • Do not discontinue use or change the dose without first checking with your doctor. If you stop taking this drug suddenly, the frequency of your seizures could increase or you could experience withdrawal symptoms.
  • Take with food if stomach upset occurs.
  • 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 to catch up, unless advised to do so by your doctor. If several doses are missed or it is necessary to establish a new dosage schedule, contact your doctor or pharmacist. Use exactly as prescribed.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or if you are breastfeeding.
  • May cause drowsiness, dizziness, or blurred vision. Use caution when driving or performing other tasks requiring alertness, coordination, or physical dexterity.
  • Using this drug with alcohol or other central nervous system depressants (eg, pain relievers, sedatives) may cause added drowsiness.
  • If the drug does not seem to be working as well after taking it for a few weeks, check with your doctor. A dosage adjustment may be needed.
  • Carry Medic Alert identification indicating that you are using this drug and have epilepsy.
  • Lab tests may be required to monitor therapy. Be sure to keep appointments.
  • Store at room temperature (59° to 86°F).

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12/05, 2007

Benzisoxazole-Derivatives - Guidelines for Using

Type of Drug:

Atypical antipsychotic.

How the Drug Works:

The exact mechanism of action, like other drugs used to treat schizophrenia, is not known. Benzisoxazole drugs may work by antagonizing dopamine type 2 and Sheraton type 2 receptors in the brain.

Uses:

For treatment of schizophrenia.

Precautions:

Tardive dyskinesia: Involuntary and uncontrollable movements may develop in patients treated with antipsychotic drugs. Occurrence is highest in the elderly, especially women. However, it is impossible to predict which patients are likely to develop the syndrome. The risk of developing these involuntary movements and the likelihood they will become permanent are increased with long-term use and with high doses. However, it is possible to develop these symptoms after short­term treatment at low doses. The syndrome is characterized by rhythmical, involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs. Fine worm-like movement of the tongue may be an early sign of the

syndrome . If the medication is stopped at this time, the may not develop further. There is no known treatment for established case of tardive dyskinesia, although the syndrome may stop, partially or cell politely, if the drug is withdrawn. Antipsychotic treatment, however, my suppress or partially suppress the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process; The effect that symptomatic suppression has upon the long-term scour of the syndrome is unknown.

Neuroleptic Malignant Syndrome (NMS) Is a potentially fatal syndrome associated with antipsychotic drugs. Symptoms include fever, muscle rigidity, altered mental abilities, irregular pulse and blood pressure, Increased heart rate, sweating, and irregular heart rhythm.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits weigh the possible hazards to the fetus.

Breastfeeding: It is not known if benisoxazole derivatives appear in brest milk. It is recommended that women not breastfeed while receiving these drug.

Children: The safety and effectiveness in patients younger than 18 years of age have not been established.

Elderly: Dose modifications (eg, lower starting dose) of dispersion may be necessary. Ziprasidone injection has not been evaluated in patients 65 years of age and older.

Lab Tests: Lab tests may be required to monitor ziprasidone therapy. Tests include serum potassium and magnesium levels.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over­the-counter or prescription medications or dietary supplements with these drugs. 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 with these drugs:

  • Antihypertensive agents (eg, hydrochlorothiazide)
  • Carbamazepine (eg, Tegretol)
  • Centrally acting drugs (eg, guanfacine, tramadol)
  • Clozapine (eg, Clozaril)
  • Dopamine agonists (eg, pramipexole)
  • Drugs that prolong the OT interval (eg, chlorpromazine, quinidine, sparfloxacin)
  • Fluoxetine (eg, Prozac)
  • Ketoconazole (eg, Nizoral)

Side Effects:

Every drug is capable of producing side effects. Many patients 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; constipation; indigestion; diarrhea; dry mouth; vomiting; stomach pain; increased or decreased saliva; toothache; appetite loss.

Respiratory System: Upper respiratory infection; cough; rhinitis; sinus infection; sore throat; difficulty breathing; runny nose.

Nervous System: Sleepiness; dizziness; inability to sit still; muscle tension; headache; anxiety; agitation; increased dream activity; abnormal tongue, face, jaw, or mouth movements; involuntary arm and leg movements; tremor; shuffling; rigidity.

Circulatory System: Increased or decreased heart rate; postural hypotension (light-headedness when rising quickly from sitting or lying position); increased blood pressure.

Skin: Rash; skin irritation; dry skin; sensitivity to light.

Other: Weakness; muscle pain; joint pain; fainting; dizziness; erectile dysfunction; weight gain; decreased sexual desire; abnormal vision.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not stop taking or change the dose unless instructed by your doctor.
  • Swallow the ziprasidone capsules whole; take with food.
  • It is best to take ziprasidone at the same time each day.
  • It may take a few weeks for this medicine to start working. Continue taking the medication, even when you feel better.
  • Avoid alcohol while taking this medicine.
  • Use caution in hot weather; be careful not to become dehydrated.
  • Notify your doctor immediately if you experience fever, perspiration, muscle rigidity, involuntary movements, abnormal heart rate or rhythm, or fainting.
  • May cause drowsiness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.
  • This medicine may cause dizziness, light-headedness, or fainting, especially when rising or standing. If these symptoms occur, sit or lie down. Contact your doctor if they continue.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or if you are breastfeeding.
  • Lab tests may be required to monitor therapy. Be sure to keep appointments.
  • Store at controlled room temperature (59° to 86°F). Protect from light and moisture.

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12/02, 2007

Cholinesterase Inhibitors - Drug Interactions, Side Effects and Precautions of Use

Type of Drug:

Reversible cholinesterase inhibitor used in managing mild to moderate Alzheimer disease-associated dementia.

How the Drug Works:

The exact mechanism is unknown. Cholinesterase inhibitors act by enhancing cholinergic function. Deterioration or loss of cholinergic neurons may be a primary cause of cognitive dysfunction associated with Alzheimer disease. Cholinesterase inhibitors may enhance cholinergic transmission in this setting. If this mechanism of action is correct, the effect of cholinesterase inhibitors may lessen as the disease advances and fewer cholinergic neurons remain functionally intact. There is no evidence that cholinesterase inhibitors alter the course of the underlying dementing process.

Uses:

To treat mild to moderate dementia of the Alzheimer type.

Precautions:

Do not use in the following situations:

  • Allergy to acridine derivatives (tacrine only)
  • Allergy to carbamate derivatives (rivastigmine only)
  • Allergy to a cholinesterase inhibitor or any of its ingredients
  • Allergy to piperidine derivatives (donepezil only)
  • Treatment-associated jaundice from previous treatments (tacrine only)

Nicotine: Nicotine use increases the elimination of tacrine from the body.

Gender: Tacrine and galantamine are eliminated from the body more slowly in women.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits to the mother outweigh possible hazards to the fetus.

Breastfeeding: It is not known if cholinesterase inhibitors are excreted in breast milk. Contact your doctor before you begin breastfeeding.

Children: Safety and effectiveness in children have not been established.

Elderly: Rivastigmine and galantamine are eliminated from the body more slowly in the elderly.

Lab Tests: Lab tests will be required to monitor therapy with tacrine. Tests include liver function tests every other week from at least week 4 to week 16, after which monitoring may be decreased to every 3 months, and blood counts.

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 with a cholinesterase inhibitor. Doses of one or both drug may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with cholinesterase inhibitors:

  • Anticholinergics (eg, atropine, scopolamine)
  • Cholinergic agonists (eg, bethanechol)
  • Cholinesterase inhibitors (eg, neostigmine)
  • Cimetidine (eg, Tagamet)
  • Food (rivastigmine only)
  • Ketoconazole (eg, Nizoral)
  • NSAIDs (eg, ibuprofen)

Side Effects:

Every drug is capable of producing side effects. Many cholinesterase inhibitor 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; appetite loss; stomach bleeding; black tarry stools; loss of bowel control; bloating; gas; belching; indigestion; stomach pain; weight loss; constipation.

Nervous System: Sleeplessness; fatigue; drowsiness; headache; pain; difficulty moving; dizziness; fainting; depression; abnormal dreams; abnormal thinking; hallucinations; tremors; irritability; numbness or tingling in hands or feet; abnormal skin sensations (eg, burning, prickling, tingling); aggression; feeling of whirling motion; clumsiness; twitching; restless­ness; nervousness; anxiety; paranoia; convulsions; weakness; confusion; hostility; difficulty speaking.

Circulatory System: Chest pain; abnormal heartbeat; heart pounding; blood pressure changes; flushing; hot flashes.

Skin: Itching; hives; rash; excessive sweating; unusual bruising or bleeding.

Respiratory System: Difficulty breathing; sore throat; nasal congestion; sinus problems; runny nose; coughing; upper respiratory infection; pulmonary congestion.

Urinary and Reproductive Tract: Loss of bladder control; frequent urination; excessive urination at night; urinary tract infection; blood in the urine.

Other: Flu-like syndrome; chills; fever; general body discomfort; muscle cramps; muscle or joint pain; muscle tension; back pain; swelling in hands or feet; anemia; dehydration; eye irritation; blurred vision; elevated transaminase; accidental trauma; abnormal gait; ringing in the ears; nosebleed.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Oonepezil- Take in the evening just before bedtime with or without food.
  • Galantamine - Take during morning and evening meal if possible. Fellow recommended dosage and administration. If therapy is interrupted for several days or longer, restart treatment at the lowest dose. Nausea may be reduced by administering with food, antiemetic medication, or ensuring adequate fluid intake.
  • Tacrine - Take between meals if possible; however, it may be taken with meals to avoid stomach upset. The effect of tacrine is thought to depend upon its administration at regular intervals.
  • Rivastigmine capsules- Take with food in divided doses in the morning or evening.
  • Rivastigmine solution - Remove the oral dosing syringe provided in its protective case and, using the provided syringe, withdraw the pre­scribed amount of rivastigmine. Each dose may be swallowed from the syringe or first mixed with a small glass of water, cold fruit juice, or soda. Stir the mixture before drinking.
  • 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 to catch up, unless advised 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.
  • Tacrine - Do not stop taking this medicine suddenly or change the dos­age unless instructed to do so by your doctor. Abrupt discontinuation or large reduction in the total daily dose of tacrine may cause a decline in mental function and behavioral disturbances. Unsupervised increases in the dose of tacrine may also have serious consequences.
  • Inform your doctor if you are pregnant, become pregnant, planning to become pregnant, or are breastfeeding before beginning therapy.
  • Report any new or worsening side effects to your doctor.
  • May cause dizziness or blurred vision. Use caution while driving or per­forming other tasks requiring alertness, coordination, or physical dexterity.
  • Rivastigmine - There is a high incidence of nausea and vomiting associated with the use of the drug, along with the possibility of anorexia and weight loss. Monitor for these adverse events and inform your doctor if they occur.
  • Tacrine - Contact you doctor if you experience side effects that occur soon after taking a dose (eg, nausea, vomiting, loose stools) or develop side effects that are delayed (eg, rash, yellowing of the skin, changes in stool color).
  • Lab tests will be required to monitor therapy. Be sure to keep appointments.
  • Store capsules and tablets at controlled room temperature (59 to 86 F) away from moisture. Store rivastigmine solution below 77 F in an upright position. Protect from freezing.

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11/20, 2007

How Phenylbutylpiperadine Derivatives Works?

Type of Drug:

Typical (conventional) antipsychotics.

How the Drug Works:

The mechanism of action is not well defined, but thought to be related to central dopamine receptor antagonist activity.

Uses:

Haloperidol is used in the management of manifestations of serious psychotic disorders, including schizophrenia.

Pimozide and haloperidol may be used to suppress motor and phonic tics in patients with Turreted disorder who have failed to respond to standard treatment.

Unlabeled Uses: Bipolar disorder; management of patients with demetiarelated psychotic symptoms.

Tardive dyskinesia: Involuntary and uncontrollable movements may develop in patients treated with antipsychotic drugs. Occurrence is highest in the elderly, especially women. However, it is impossible to predict which patients are likely to develop the syndrome. The risk of developing these involuntary movements and the likelihood they will become permanent are increased with long-term use and with high doses. However, it is possible to develop these symptoms after short­term treatment at low doses. The syndrome is character rhythmcal, involuntary movements of tongue, face, mouth, of jaw (eg,protrusion of tongue, puffing of Cheeks, plucking of mouth chewing movement sometimes accompanied by involuntary movements of the arms and ages. Fine worm-like movement of the tongue may be an early sign of the syndrome. If the medication is stopped at this time, the syndrome may not develop further. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may stop, partially or completely, if the drug is withdrawn. Anti psychotic treatment, however, may suppress or partially suppress the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Neuroleptic Malignant Syndrome (NMS) Is a potentially fatal syndrome associated with antipsychotic drugs. Symptoms include fever, muscle rigidity, altered mental abilities, irregular pulse and blood pressure, increased heart rate, sweating, and irregular heart rhythm.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits out- weigh the possible hazards to the fetus.

Breastfeeding: It is not known if these drugs appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness of help have not been established. Safety and effectiveness of pimozide in children younger than 12 years of age have not been established.

Elderly: A lower starting dose is recommended for elderly patients.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over the-counter or prescription medications or dietary supplements with these drugs. 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 with these drugs:

  • Alcohol amphetamines (eg, dextroamphetamine) (pimozide only)
  • Antiarrhythmic agents (eg, quinidine) (pimozide only)
  • Azole antifungals (eg, fluconazole) (pimozide only)
  • Blood pressure-lowering medicines (eg, clonidine)
  • Carbamazepine (eg, Tegretol)
  • Clozapine (eg, Clozaril)
  • Dopamine (eg, Intropin)
  • Fluoxetine (eg, Prozac)
  • Levodopa (eg, Larodopa)
  • Macrolide antibiotics (eg, clarithromycin) (pimozide only)
  • Methylphenidate (eg, Ritalin) (pimozide only)
  • Nefazodone (Serzone) (pimozide only)

Side Effects:

Every drug is capable of producing side effects. Many patients 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: Constipation; dry mouth; diarrhea; nausea; indigestion; vomiting; stomach pain; decreased or increased saliva; toothache; appetite changes.

Nervous System: Tremor; restlessness; headache; dizziness; sleepless­ness; agitation; anxiety; drowsiness; aggressive reaction; increased sleep duration; increased dream activity; nervousness; depression; excitement.

Respiratory System: Upper respiratory infection; sinus irritation; congested or runny nose; coughing; sore throat; difficulty breathing.

Urinary and Reproductive Tract: Frequent urination; heavy menstrual bleeding; difficulty with orgasm; vaginal dryness; difficulty with erection; decreased sexual desire; impotence; lactation; breast enlargement.

Skin: Rash; dry skin; excessively oily skin; dark spots on the skin; sensitivity to sunlight; hair loss.

Other: Fast heartbeat; back, chest, or joint pain; muscle stiffness or rigidity; difficult or abnormal movement; clumsiness; difficulty walking; involuntary muscle contractions; fatigue; dizziness or light-headedness upon rising or standing; visual changes; weight gain; fever; sweating.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not stop taking or change the dose, unless instructed by your doctor.
  • Can be taken with or without food. Take with food if stomach upset occurs. Avoid grapefruit juice while taking pimozide.
  • Generally, low starting doses are used and then the dose is increased to achieve the best effects.
  • Contact your doctor immediately if you experience skin rash, sexual days function, difficulty breathing, involuntary muscle movements, muscle rigidity, fever, irregular or fast heartbeat, or profuse sweating.
  • May cause dizziness, light-headedness, or fainting when rising or standing, particularly during initial use. Get up slowly and avoid sudden changes in posture.
  • May cause drowsiness. Use caution while driving or performing other tasks requiring alertness, coordination, and physical dexterity.
  • Avoid alcohol while you are taking this medicine.
  • May cause sensitivity to sunlight. Avoid prolonged exposure to the sun or other forms of ultraviolet (UV) light (eg, tanning beds). Use sunscreens and wear protective clothing.
  • Consult your doctor or pharmacist before taking prescription or OTC drugs or dietary supplements with phenylbutylpiperadine derivatives.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or are breastfeeding.
  • Store tablets at controlled room temperature (59 to 86°F) in a tightly closed container and protect from light. Store oral solution at controlled room temperature (59 to 86°F) and protect from light. Do not freeze.

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09/17, 2007

5-HT Receptor Antagonists Information Drug - Precautions and Side Effects

Type of Drug:

Antinauseants; antiemetics; drugs used to prevent nausea and vomiting.

How the Drug Works:

Dolasetron, granisetron, and ondansetron are selective serotonin 5-HT 3 receptor antagonists that block serotonin stimulation to prevent nausea and vomiting.

Uses:

Oral doseforms - To prevent nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemstherapy.

Oral dolasetron and ondansetron - To prevent postoperative nausea and vomiting.

Oral granisetron and ondansetron - To prevent nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction, or daily fractions the abdomen.

Intravenous (IV; into a vein) dolasetron - To prevent and treat postoperative nausea or vomiting.

Unlabeled Uses: Dolasetron has been used to treat radiotherapy-induced nausea and vomiting. Granisetron has been used for acute nausea and vomiting following surgery. Ondansetron has been used in the treatment of nausea and vomiting associated with acetaminophen poisoning, acute levodopa-induced psychosis, and prostacyclin therapy; to reduce bulimic episodes in patients with bulimia nervosa; to treat patients with social anxiety disorder; and as treatment of spinal or epidural morphine-induced pruritis.

Precautions:

Benzyl alcohol: Some of these products contain benzyl alcohol, which has been associated with a fatal “gasping syndrome” in premature infants. Consult your doctor or pharmacist.

Phenylketonuria: Ondansetron orally-disintegrating tablets contain phenylalanine. Consult your doctor or pharmacist.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits to the mother outweigh the possible hazards to the fetus.

Breastfeeding: Ondansetron appears in breast milk. It is not known if other 5-HT 3 receptor antagonists appear in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness for use of dolasetron and the injection form of granisetron in children younger than 2 years of age have not been established. Safety and effectiveness for use of the oral form of granisetron in children of any age have not been established. Safety and effectiveness for use of ondansetron in children 3 years of age and younger have not been established.

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 supplolnol1ls while taking a 5-HT 3 receptor antagonist. Doses of one or both drugs may need to be modified or a different drug may need to be prescribrd. Rifamycins (eg, rifampin) interact with ondansetron

Side Effects:

Every drug is capable of producing side effects. Many 5-HT 3 receptor antagonist 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: Diarrhea; nausea; constipation; stomach pain; appetite loss; taste disorder; indigestion; dry mouth.

Nervous System: Headache; drowsiness; weakness; agitation; fatigue; anxiety; stimulation; sleeplessness; dizziness; flushing; shivers; chills; vertigo (feeling of whirling motion); agitation.

Other: Changes in blood pressure; fever; heart rhythm changes; hair loss; abnormal blood counts; muscle, joint, chest, or bone pain; general body discomfort; injection site reaction; cold sensation; rash; tremor; itching; urinary retention; tingling or prickling sensation; deficient oxygenation of the blood.

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not change the dose or stop taking, unless advised by your doctor.
  • Ondansetron orally-disintegrating tablets - Remove the tablets from the package just before taking. Peel backing off blister and remove tab­let gently. Place tablet on the tongue and swallow with saliva. Tablets disintegrate rapidly on the tongue and do not require water for dissolution or swallowing.
  • Contact your doctor immediately if you experience rash, itching, short­ness of breath, abnormal heart rhythm, dizziness, fainting, low blood pressure, hives, facial swelling, or difficulty breathing.
  • Dolasetron injection can be mixed in apple or apple-grape juice and given orally. The mixed product may be kept up to 2 hours at room temperature (59 to 86°F).
  • Store at controlled room temperature (68 to 77°F). Protect from light. Do not freeze injection vials.


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08/14, 2007

Amphetamines - Guidelines for Using Amphetamines

Type of Drug:

Central nervous system stimulants: “Bennies,” “dexies,” “speed”, or “crystal.”

How the Drug Works:

These synthetic drugs are a stronger form of the natural body stimulant adrenaline. They work by altering natural chemicals (neurotransmitters) in the brain and can affect other body systems (eg, circulatory system) in high doses.

Uses:

Indicated as an integral part of a total treatment program of attention deficit disorder with hyperactivity that includes other remedial measures (psychological, educational, social) for a stabilizing effect in children 3 to 16 years of age with a behavioral syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity, emotional 13 ability, and impulsivity.

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

Methamphetamine only: For short term (eg, a few weeks) use in a weight reduction program based on caloric restriction, for patients who have failed alternative therapy (eg, repeated diets, group programs, other drugs).

Unlabeled Uses: Dextroamphetamine has been used to treat cocaine dependence and autism.

Precautions:

Use with caution in the following situations: High blood pressure Turreted syndrome

Abuse: Amphetamines have a high potential for abuse. Use in weight reduction programs only when alternative therapy (diets, group programs, other drugs) has been ineffective. Use for prolonged periods may lead to drug dependence.

Attention deficit disorders: Drug treatment is not indicated in all cases. The decision to use amphetamines depends on the chronicity and severity of the child’s symptoms and appropriateness for his/her age. When symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

Chronic intoxication: Severe skin rash, marked sleeplessness, irritability, hyperactivity, personality changes, disorganization of thoughts, poor concentration, hallucinations, and compulsive behavior often occur. The most severe side effect of chronic intoxication is psychosis, often indistinguishable from paranoid schizophrenia.

Diabetes: Insulin requirements may be altered with the use of amphetamines and diet restriction.

Do not use: Do not use to combat fatigue or to replace rest.

Drug dependence: Tolerance, extreme dependence and severe social disability have occurred with amphetamine abuse. Patients may gradually increase the dosage to many times that recommended. Abrupt discontinuation following a long period of using high doses results in extreme fatigue, mental depression, and changes in sleep habits.

Pregnancy: Adequate studies have not been done in pregnant women, or animal studies may have shown a risk to the fetus. Birth defects have been reported with amphetamine use in pregnancy. Usually If clearly needed and potential benefits outweigh the possible hazardsto the fetus. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight may experience symptoms of amphetamine withdrawal demonstrated by restlessness including agitation and weakness.

Breastfeeding: Amphetamines appear in breast milk. Discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Consult your doctor before you begin breastfeeding.

Children: Long-term effects in children have not been well established.

Amphetamines are not recommended in children younger than 3 years of age. Do not use methamphetamine as a weight loss medication in children younger than 12 years of age. Extended-release amphetamine mixture capsules are indicated for children 6 years of age and older. Effects of extended-release amphetamine mixture capsules in children 3 to 5 years of age have not been studied. In psychotic children, amphetamines may worsen symptoms of behavior disturbance and thought disorder. Amphetamines may precipitate or worsen Tourette syndrome. Monitor growth during treatment. Chronic administration may be associated with growth inhibition.

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

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any overthe-counter or prescription medications or dietary supplements while taking this medicine. 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 with amphetamines:

  • Antihypertensives (eg, methyldopa)
  • Furazolidone (Furoxone)
  • Guanethidine (lsmelin)
  • MAOls (eg, phenelzine)
  • Phenothiazines (eg, chlorpromazine)
  • Selective serotonin reuptake inhibitors (eg, fluoxetine)
  • Urinary acidifiers (eg, ammonium chloride)
  • Urinary alkalinizers (eg, acetazolamide)

Side Effects:

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

Digestive Tract: Diarrhea; constipation; appetite loss; dry mouth; unpleasant taste sensation; indigestion; nausea; vomiting.

Nervous System: Dizziness; sleeplessness; depression; irritability; restlessn; nervousness; headache; tremor; exacerbation of motor and phOnic tics and Tourette syndrome; exaggerated sense of well-being; overvaluation; difficulty moving; unpleasant feelings; weakness; drowsiness between doses or after stopping medicine.

Circulatory System : pounding in the chest (palpitation); rapid or irregular heartbeat; high blood presser.

Other: Impotence; changes in sex drive; hives; weight loss; suppression of growth in children (long-term use).

Guidelines for Use:

  • Dosage is individualized. Take exactly as prescribed.
  • Do not change the dose or stop taking, unless directed by your doctor.
  • Do not take more frequently than prescribed. These drugs can be addicting.
  • Do not chew or crush sustained- or extended-release products.
  • Extended-release amphetamine mixture capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. The sprinkled applesauce should then be consumed immediately; it should not be stored. Take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided.
  • May cause insomnia. Avoid taking these medications late in the day.
  • This medicine may cause dizziness. Use caution while driving or performing other tasks requiring alertness, coordination, or physical dexterity.
  • May cause nervousness, restlessness, sleeplessness, dizziness, appetite loss, dry mouth, and digestive tract disturbances. Contact your doctor if these become troublesome.
  • If a dose is missed, take it as soon as possible. If several hours have passed or it is nearing time for the next dose, do not double the dose 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.
  • Do not take any prescription or OTC medications or dietary supplements, unless directed by your doctor.
  • Inform your doctor if you are pregnant, become pregnant, are planning to become pregnant, or if you are breastfeeding.
  • Use of many of these drugs to improve athletic skills, mental alertness, or to stay awake is dangerous and illegal. Never share drugs with others.
  • Attention deficit disorder in children - Your doctor may occasionally interrupt drug therapy to determine if there is a recurrence of symptoms.
  • Weight control - Appropriate lifestyle changes (eg, diet and exercise) should be made while on therapy in order to avoid continued use of the drug.
  • Store at room temperature (59° to 86°F) in a tight, light-resistant container.

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