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Antiepileptics – Question – Answer

| Filed under Antiepileptics

Question. How many double blind studies have been done on the use of antiepileptics for rapid cyclers? If anxiety is a factor, what other drugs should be used with them?

Answer. There are now four main anticonvulsant (anti-epileptic) agents that are either established or being actively investigated as mood stabilizers: valproate (Depakote), carbamazepine (Tegretol), gabapentin (Neurontin) and lamotrigine (Lamictal). Another anticonvulsant, Topiramate (Topamax), is being investigated for this purpose.

Your question involves the conjunction of three factors: a double-blind condition, use of an anticonvulsant and rapid-cycling bipolar patients (i.e., those with four or more major mood swings per year). While I can’t give you a definitive answer as to the number of such studies, my review of the literature suggests that there are fewer than five that meet all three of your criteria. I refer you to papers by Denicoff et al (Journal of Clinical Psychiatry, 1997) and Bowden et al (Journal of the American Medical Association, March 23-30, 1994) for details.

In a recent review of lamotrigine and gabapentin, Dr. Nassir Ghaemi of Massachusetts General Hospital found only a small number of double-blind studies with these agents (International Drug Therapy Newsletter, April and May 1999). In many of the recent studies of lamotrigine and gabapentin, these agents have been used as adjuncts for most patients, rather than as the sole treatment, meaning that judgments about their efficacy must be put in this limited context.

For example, in three non-double blind studies, lamotrigine appeared useful in between 50-75% of rapidly cycling patients, but most of these patients were taking other mood stabilizers or medications. Regarding bipolar patients with concomitant “anxiety,” it is, of course, difficult to distinguish anxiety from agitation in manic patients. In either case, benzodiazepines such as lorazepam or clonazepam are frequently used.

Atypical antipsychotics like olanzapine are also finding a role as adjunctive agents in bipolar illness. Gabapentin appears to have anti-anxiety properties even in patients who are not bipolar, and thus would be a reasonable “add-on” for anxious bipolar patients.

GABA agonists: drugs for epilepsy

| Filed under Antiepileptics

Epilepsy is a chronic neurologic disorder that may result from brain injury, developmental malformation, or a genetic abnormality. It is characterized by recurrent seizures caused by sudden, excessive electrical activity in the brain. Seizures are classified as generalized, in which the electrical discharge occurs throughout the brain, and partial onset, wherein the electrical activity is localized (in simple partial-onset seizures, consciousness is maintained; in complex partial, consciousness is altered). Epilepsy affects up to 1% of the population in industrialized countries, with the highest rates occurring in children and adolescents. Most seizures (60%) are complex partial or secondarily generalized, and 25 to 30% of these seizures are refractory to available therapy. But for every refractory patient, there is another patient who goes into remission on antiepileptic drug (AED) therapy and then, after a seizure-free period, remains in remission when antiepileptic drugs are withdrawn. This shows that epilepsy is not always a lifelong condition.

The most frequently prescribed antiepileptic drugs are phenytoin, carbamazepine, and valproate, although in the past few years a number of new antiepileptic drugs have been approved. These new drugs were developed following major advances in the understanding of neurotransmitters and their receptors, and most enhance the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the brain. Some also inhibit glutamate, the major excitatory neurotransmitter. Blocking glutamate has not been very successful, but augmenting GABA activity has been quite effective.

Gamma-aminobutyric acid is present in an estimated 60 to 70% of all synapses in the brain. It is formed from glutamate by the enzyme glutamic acid decarboxylase. After synaptic release, GABA is taken up into nerve cells or glial cells. In the neuron, gamma-aminobutyric acid either is re-released or is broken down by GABA transaminase into succinic semialdehyde; in the glial cell, it is metabolized, along with glutamate, by glutamine synthetase to form the amino acid glutamine, which is then transported back to the neuron and used to synthesize more glutamate and gamma-aminobutyric acid. When released into the synapse, GABA can bind to two different receptor complexes, designated A and B. GABA-A binds gamma-aminobutyric acid, benzodiazepines, barbiturates, and neurosteroids. When GABA-A is activated, it increases the inward flow of chloride through the nerve cell membrane, which hyperpolarizes the membrane and inhibits neuronal firing. Compounds that increase GABAergic activity via the GABA-A receptor are anticonvulsants, and those that antagonize GABA-A are convulsants.

Neuropharmacologists have discovered several ways to enhance GABA-A receptor activity: direct stimulation, inhibition of gamma-aminobutyric acid metabolism, and reduction of neuronal and/or glial GABA reuptake. Blocking gamma-aminobutyric acid reuptake is an especially fruitful area for drug discovery, because there are at least four different GABA transport mechanisms that mediate gamma-aminobutyric acid reuptake in neurons and glial cells. These transporters show different distributions within the central nervous system (CNS); for example, one is prominent in the substantia nigra, an area that plays a crucial role in the development of seizures.

Antiepileptic Drugs and Their Primary Mechanisms of Action

Drug Name Primary Mechanism
Clobazam Enhances GABA-BZ receptors
Dezinamide Blocks sodium channels
Felbamate Blocks sodium channels
Flunarizine Blocks calcium channels
Fosphenytoin Phenytoin prodrug
Gabapentin Increases GABA synthesis (?)
Oxcarbazepine Tricyclic effects as per carbamazepine (?)
Lamotrigine Decreases glutamate release
Levetiracetam Not yet defined
Midazolam Decreases cGMP (?)
Milacemide Enhances glycine
MK-801 Blocks NMDA-linked channels
Progabide Enhances GABA content
Tiagabine Decreases GABA uptake
Topiramate Blocks sodium channels
Stiripentol Unconfirmed
Vigabatrin Decreases GABA catabolism
Zonisamide Blocks sodium channels
GABA: Gamma-aminobutyric acid;
BZ: Benzodiazepine;
NMDA: N-methyl-D-aspartate;
cGMP: cyclic guanosine monophosphate

One of the most promising gamma-aminobutyric acid (GABA) reuptake inhibitors is tiagabine (Gabitril/Abbott), a novel antiepileptic drug that will probably receive final FDA approval during the first quarter of this year. Developed by researchers at the Danish pharmaceutical company NovoNordisk, tiagabine is a nipecotic acid derivative with an attached lipophilic group that enables the drug to cross the blood-brain barrier. This “rationally” designed drug is a potent, selective, and specific inhibitor of GABA reuptake into presynaptic neurons and glial cells, particularly those in the substantia nigra and associated areas. It binds one of the GABA reuptake transporters and shows no significant affinity for dopamine, norepinephrine, histamine, adenosine, serotonin, glutamate, or acetylcholine sites-either receptors or reuptake transporters.

Tiagabine has shown broad activity against a range of seizure types, including drug- induced, electroshock-induced, light-induced, amygdala-kindled, and audiogenic. It is well tolerated and does not cause withdrawal effects, displace other drugs, or induce hepatic enzymes (although it is a target for enzyme inducers). It is rapidly and completely absorbed, with a half-life of 5 to 8 hours. Because tiagabine is highly effective for partial- onset seizures, it will be approved initially for the adjunctive treatment of partial seizures, with or without secondarily generalized seizures.

Other new antiepileptic drugs on the market or under investigation include valproate (Divalproex/Abbott), topiramate (Topamax/Ortho-McNeil), gabapentin (Neurontin/Warner Lambert), lamotrigine (Lamictal/Glaxo Wellcome), vigabatrin, oxcarbazepine, and levetiracetam. Valproic acid decreases the activity of the enzyme that degrades gamma-aminobutyric acid and increases the activity of the enzyme that generates GABA; topiramate enhances gamma-aminobutyric acid and inhibits glutamate; and gabapentin, which is structurally related to GABA, has a unique (and as yet poorly understood) influence on gamma-aminobutyric acid neurotransmission. Vigabatrin acts through the selective, irreversible inhibition of GABA transaminase, the enzyme responsible for the metabolism of gamma-aminobutyric acid. Oxcarbazepine was developed by modifying the chemical formula of carbamazepine to improve tolerability; it is at least as effective as its parent, but is better tolerated, has fewer drug interaction problems, induces fewer enzymes, and causes less skin allergy. Levetiracetam is an interesting new compound in clinical trial that appears to bind a specific receptor on nerve cell membranes. It shows a broad spectrum of anticonvulsant activity and has been particularly effective for partial seizures. It has a high therapeutic index and does not appear to interact with other antiepileptic drugs.

Lamotrigine is the first antiepileptic drug that was designed specifically to inhibit glutamate and its close cousin, aspartate. It blocks sodium channels and stabilizes the presynaptic neuronal membrane, inhibiting the release of glutamate and aspartate. It has a wide spectrum of antiepileptic activity, including partial-onset and primary generalized tonic-clonic seizures, and is particularly useful for mentally retarded patients. It is very well tolerated and does not alter concentrations of concomitant antiepileptic drugs or induce hepatic enzymes although it is a target for enzyme induction. It interacts with both valproic acid (which approximately doubles the plasma elimination half-life of lamotrigine) and carbamazepine (concomitant lamotrigine/carbamazepine therapy can cause a potentially dangerous cerebellar toxic syndrome).

The understanding of epilepsy has advanced substantially in the past decade, and new antiepileptic drugs with novel mechanisms of action are continually being developed. Monotherapy is the goal-that is, the admInistration of one drug with a mechanism of action specific for the form of epilepsy being treated-but in clinical practice, polytherapy is often used. Using multiple drugs increases the risis of adverse effects and drug interactions, but the new GABAergics have such good safety profiles that “rational polytherapy” is a workable solution to what is often a very complex neurologic problem.

Med Trileptal: Another Choice for Partial Onset Epilepsy

| Filed under Antiepileptics

Brand Name: Trileptal
Active Ingredient: oxcarbazepine
Indication: Treatment of partial epileptic seizures as monotherapy in adults or adjunctive therapy in adults and children as young as age 4
Company Name: Novartis Pharmaceuticals Corporation
Availability: Approved by FDA January 10, 2000

Trileptal: Introduction

More than 2 million people in the US have some form of epilepsy. Seventy percent of them are adults. Although contemporary treatment approaches can provide full or partial control of seizures in about 85% of patients, some 15% of patients do not achieve this control, and many patients are virtually resistant to available drug therapies. Some patients with partial onset seizures – those that originate in one hemisphere of the brain, often without loss of consciousness – resort to surgery to remove the affected area of the brain, ideally without affecting personality or function.

Novartis Pharmaceuticals Corporation recently received FDA approval to market Trileptal (oxcarbazepine), a new drug for both adults and children with partial seizures. The recommended daily doses range from 1200 mg/day as adjunctive therapy and 2400 mg/day as monotherapy in adults (given as two daily doses), and 30-46 mg/kg/day as adjunctive therapy for children ages 4-16.

Trileptal: How It Works

The activity of Trileptal is primarily exerted through its metabolite, monohydroxy metabolite (MHD). The precise mechanism by which Trileptal and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the brain.

Trileptal: Clinical Study Results

The efficacy of Trileptal in adults and children was established in six multicenter randomized double-blind controlled trials. Four of these studies demonstrated Trileptal’s effectiveness as monotherapy. One trial was conducted in 102 adult patients with refractory partial seizures who had been withdrawn from other antiepileptic drugs (AEDs) and received either placebo or Trileptal. Trileptal was given as 1500 mg/day on day 1 and 2400 mg/day thereafter for an additional 9 days. During the 10-day study period, patients who took Trileptal experienced significantly fewer partial seizures than those on placebo.

Similar results in favor of Trileptal were observed in a study of 67 untreated patients with newly diagnosed and recent-onset partial seizures who began treatment with either placebo or 300 mg Trileptal twice daily. Trileptal was titrated to 1200 mg/day (600 mg twice daily) in 6 days, followed by maintenance treatment for 84 days.

A third study substituted Trileptal monotherapy 2400 mg/day for carbamazepine in 143 patients whose seizures were inadequately controlled by carbamazepine at a stable dose of 800 to 1600 mg/day. The Trileptal dose was maintained for 56 days. Patients who were able to tolerate 2400 mg/day of Trileptal during carbamazepine withdrawal were randomized to receive either 300 mg/day or stay on the 2400 mg/day dose. After an observation period of 126 days, patients who received 2400 mg/day of Trileptal experienced significantly fewer seizures than those on the 300 mg/day dose.

Similar results in favor of the 2400 mg/day dose of Trileptal were observed in a fourth monotherapy trial conducted in 87 patients whose seizures were inadequately controlled on 1 or 2 AEDs. Patients were randomized to receive either 2400 mg/day or 300 mg/day Trileptal while eliminating their standard AED regimen over a 6-week period. Seizure frequency was evaluated over an additional 84 days.

Two studies assessed the efficacy of Trileptal as adjunctive therapy for partial seizures in 692 adults and 264 children (3-17 years of age). In both trials, patients were stabilized on optimum dosages of their concomitant AEDs during an 8-week baseline phase. Patients were randomized to receive either placebo or a specific dose of Trileptal in addition to their other AEDs. Adults were followed for 24 weeks while children were observed for 14 weeks. The adults received fixed Trileptal doses of 600, 1200, or 2400 mg/day, while the children received 30-46 mg/kg/day. Trileptal significantly reduced seizure frequency at all doses tested. In the group of adults receiving 2400 mg/day Trileptal, however, more than 65% of the adults discontinued treatment because of adverse events.

Trileptal: What the Patient Should Know

Trileptal may render hormonal contraceptives less effective, so other non-hormonal forms of contraception are recommended in women taking Trileptal (particularly since Trileptal may have the potential to result in birth defects). Caution should be exercised if alcohol is consumed by patients who are taking Trileptal, since an additive sedative effect may result. Trileptal may also result in dizziness or drowsiness, so patients should avoid driving or operating machinery until they have adequately gauged the effects of Trileptal on their ability to perform these tasks.

The most common adverse reactions reported with Trileptal include dizziness, drowsiness, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait. Hyponatremia may develop during Trileptal use. Patients with a known sensitivity to carbamazepine should be aware that 25-30% of them may experience hypersensitivity to Trileptal, and if so, should immediately discontinue using Trileptal. Patients should inform their physicians of other medications they may be taking, since Trileptal may interact with certain drugs (such as felodipine and verapamil).

Drug Keppra: Adjunctive Therapy for Epilepsy

| Filed under Antiepileptics

Brand Name: Keppra
Active Ingredient: levetiracetam
Indication: Adjunctive therapy for patients with partial onset epileptic seizures
Company Name: UCB Pharma, Inc
Availability: Approved for marketing in the US on December 1, 1999

Keppra: Introduction

More than 2 million people in the US have some form of epilepsy. Seventy percent of them are adults. Although contemporary treatment approaches can provide full or partial control of seizures in about 85% of patients, some 15% of patients do not achieve this control, and many patients are virtually resistant to available drug therapies. Some patients with partial onset seizures – those that originate in one hemisphere of the brain, often without loss of consciousness – resort to surgery to remove the affected area of the brain, ideally without affecting personality or function.

Now a new drug manufactured by UCB Pharma, Inc. – Keppra (levetiracetam) – may help patients with partial onset epileptic seizures when administered with other antiepileptic drugs (AEDs). Keppra’s approval within ten months of NDA submission to the FDA makes it the fastest AED approval to date. Keppra has several features that make it a valuable antiseizure medication: Clinicians can initiate treatment with an effective 500 mg daily dose, rather than begin with a subtherapeutic dose and titrate upward. Moreover, Keppra displays a favorable safety profile and does not interact with concomitantly administered AEDs or other drugs (such as oral contraceptives, digoxin, warfarin, and probenecid).

Keppra is approved for use in adults and is available in 250 mg, 500 mg, and 750 mg tablets for oral administration with or without food.

Keppra: How It Works

The exact mechanism by which Keppra exerts its antiepileptic effect is not known and does not appear to derive from any interaction with mechanisms known to be involved in inhibitory and excitatory neurotransmission. In vitro studies show that a stereoselective binding site for Keppra exists exclusively in the synaptic plasma membranes of the central nervous system, but not in peripheral tissues. Both in vitro and in vivo recordings of epileptiform activity from the hippocampus show that Keppra inhibits burst firing without affecting normal neuronal excitability. This finding suggests that Keppra may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity.

Keppra: Clinical Study Results

The efficacy of Keppra was demonstrated in three multicenter, randomized, double-blind, placebo-controlled studies in 904 patients with refractory partial onset seizures with or without secondary generalization. At the time of the study, patients were taking a stable dose of 1 to 2 AEDs and were required to have experienced at least four partial onset seizures during each 4-week period during the 12-week baseline period.

Each of the three studies consisted of the 12-week baseline period followed by an 18-week treatment period. The treatment period included a 6-week titration period followed by a 12-week fixed-dose evaluation period, during which concomitant AED regimens were continued. The primary measure of effectiveness was the percent reduction in weekly partial seizure frequency relative to placebo during the entire 18-week treatment period. Responder rate (the incidence of patients with a seizure reduction of 50% or more) was measured as a secondary outcome.

Study 1 was conducted at 41 sites in the US and compared Keppra 1000 mg/day (97 patients), Keppra 3000 mg/day (101 patients), and placebo (95 patients) given in equally divided doses twice daily. The reduction in weekly seizure frequency was 26.1% in the Keppra 1000 mg group and 30.1% in the Keppra 3000 mg group, a significant reduction compared to placebo. Responder rates were 7.4% for placebo, 37.1% for patients who received 1000 mg Keppra, and 39.6% for the 3000 mg Keppra group – a significant difference.

Study 2 was conducted at 62 centers in Europe and compared Keppra 1000 mg/day (106 patients), Keppra 2000 mg/day (105 patients), and placebo (111 patients) given in equally divided doses twice daily. The reduction in weekly seizure frequency was 17.1% in the Keppra 1000 mg group and 21.4% in the Keppra 2000 mg group, a significant reduction compared to placebo. Responder rates were 6.3% for placebo, 20.8% for patients who received 1000 mg Keppra, and 35.2% for the 3000 mg Keppra group – a significant difference between Keppra and placebo and between the two doses of Keppra.

Study 3 was conducted at 47 centers in Europe and compared Keppra 3000 mg/day (180 patients) and placebo (104 patients). The patients who received Keppra experienced a 23.0% reduction in weekly seizure frequency and achieved a 39.4% responder rate (compared to 14.4% in the placebo group).

Keppra: What the Patient Should Know

Adverse effects associated with Keppra include somnolence and fatigue, dizziness, coordination difficulties (ataxia, abnormal gait, or incoordination), and asthenia. Keppra may also be associated with behavioral symptoms, such as agitation, hostility, anxiety, and depression. These effects occurred primarily during the first four weeks of treatment. Because of associated dizziness and somnolence, patients should be advised to avoid driving or operating heavy machinery until they have gauged the effect of Keppra on their performance. Keppra is also substantially excreted by the kidney, so caution should be taken in administering the proper dose to patients with moderate to severe renal impairment and patients undergoing hemodialysis.

Effexor: Improve Diabetic Neuropathic Pain

| Filed under Antidiabetics

Brand Name: Effexor XR
Active Ingredient: venlafaxine hydrochloride
Indication: Treatment of diabetic neuropathy (investigational)
Company Name: Wyeth-Ayerst
Availability: Approved by the FDA in 1993 for the treatment of depression and anxiety

Effexor: Introduction

The drug Effexor (venlafaxine hydrochloride) was approved by the FDA in 1993 for the treatment of depression and anxiety. An extended-release once-daily dosing preparation, Effexor XR, received marketing clearance in 1997. Now Effexor XR is showing promise for ameliorating the symptoms of another disorder: diabetic neuropathy. The results of the study were reported at the 60th annual meeting of the American Diabetes Association in June 2000.

In doses ranging from 150-225 mg/day, Effexor XR had significantly higher analgesic response rates compared to placebo. The drug is manufactured by Wyeth-Ayerst Laboratories, a division of American Home Products.

Effexor: How It Works

Effexor is a serotonin and norepinephrine reuptake inhibitor. Both serotonin and norepinephrine are involved not only in mediation of mood but also perception of pain.

Effexor: Clinical Study Results

The efficacy, safety, and tolerability of Effexor XR as a treatment for painful diabetic neuropathy were assessed in a double-blind, placebo-controlled, parallel-group multicenter study. A total of 244 patients age 18 or older with type 1 or type 2 diabetes were randomly assigned to receive treatment with Effexor XR 75 mg, 150-225 mg, or placebo for up to 6 weeks. Primary efficacy was measured by patient self-rating assessments of pain intensity and pain relief using a Visual Analog Scale (VAS-PI and VAS-PR). Secondary efficacy was determined by patient self-ratings of pain relief on the Patient Global Rating of Pain Relief scale, and by investigator-rated assessments of pain on the Clinical Global Impressions Severity of Illness (CGI-S) and Clinical Global Impressions Global Improvement (CGI-I) scales.

On both primary outcome measures, Effexor XR 150-225 mg produced significantly greater pain relief at all evaluations compared with placebo. Effexor XR 75 mg produced significant pain relief, compared with placebo, on the VAS-PR scale at weeks 2, 3, and 5. Additionally, by week 6, 56% of patients treated with Effexor XR 150-225 mg experienced significantly lowered pain intensity, compared with 39% treated with Effexor XR 75 mg and 34% given a placebo.

On all secondary measures, similar statistical superiority over placebo was demonstrated for Effexor XR 150-225 mg. Since the presence of major depressive disorder was an exclusion criterion in the study, symptom improvement was attributed to analgesic, rather than an antidepressant, effect.

Effexor: Adverse Events

The most common adverse event associated with Effexor XR was nausea. Other side effects that may occur with use of Effexor XR include insomnia and nervousness, anorexia and weight loss, and sustained hypertension. Because Effexor XR may interact with monoamine oxidase inhibitors, it is recommended that it not be used in combination with these agents, or within at least 14 days of discontinuing treatment with an MAO inhibitor.

Guide to Safe Use of Prescription Drugs: Monitor Your Reactions

| Filed under Manuals Guides

Pay close attention to how your body reacts after taking a medication and contact your doctor, pharmacist or other healthcare professional immediately if you experience any unusual symptoms.

When taking prescription medicines, there are many possible explanations for symptoms, other than a drug reaction. However, if you experience a new symptom and it began after you started taking a new medication, contact your doctor, pharmacist or other healthcare professional immediately. It is important to determine whether the reaction was drug-related and agree on next steps (i.e., should you continue or discontinue the medicine?).

Ask about the signs of overdose, so you can recognize the symptoms either in yourself or a member of the family. In the event of an overdose, you’ll want to know what to do, such as call a poison control center or other emergency number.

Using medicines properly is very important for your health. If you have any questions, contact your doctor, pharmacist, or other healthcare professional before, during, and after taking medicines.

Guide to Safe Use of Prescription Drugs: Follow Prescription Directions

| Filed under Manuals Guides

Take your medicine only as it is prescribed and NEVER exceed the recommended dose unless instructed by your doctor or other healthcare profesisonal.

Always take your medication as instructed by your doctor, pharmacist or other healthcare professional, and never change the way you take it unless one of these healthcare professionals instructs you to do so. A medication will provide little benefit if you skip doses or stop taking it before you should, and could be harmful if you exceed the recommended dose.

Taking your medicine correctly is very important. Some medications need to be taken with meals, others on an empty stomach. Some are taken only as needed (i.e., only when you experience symptoms), others at set times.

Before starting any new medication, make sure to ask your doctor, pharmacist, or other healthcare professional how and when it should be taken. If the directions say to take the medication every three or four hours, ask if that means throughout the night as well as during the day. Should it be taken at the same time every day? Are there certain foods, drinks, other medicines or activities you should avoid while taking the medicine? What happens if you miss a dose?

Also ask if there are any precautions you should follow while taking the drug. For example, some medications may cause drowsiness, so you should not drive a car or operate heavy machinery while taking them. Other drugs may require you to stay away from certain foods or ingredients (e.g., alcohol, caffeine). If you will be traveling, find out if your medication can be used in different climates.

Find out how long it will take before your medicine starts to work and when you should begin to notice an improvement. While taking medications such as drugs that lower your cholesterol or blood pressure, you may need to undergo medical tests to show how the medicine is working. Ask how often you will need to be tested and how and when you can find out the results of these tests.

If you are a caregiver for a child or another person, you may have to remind them to take their medication or administer it to them yourself. If your child goes to school, contact the school nurse to help him/her take medicines on time and safely.

Some products offer aids that can help remind you to take your medicine on time and help you keep track of the doses you take. These aids include calendars, containers with sections for daily doses, and containers that beep when it is time for you to take your medicine. Ask your doctor, pharmacist or other healthcare professional what is available.

If you are unclear about the prescribing directions, ask your healthcare professional to explain them to you until you do understand.

Guide to Safe Use of Prescription Drugs: Ask About Side Effects

| Filed under Manuals Guides

Ask your doctor, pharmacist or other healthcare professional about any side effects associated with the medication and any specific recommendations about how and when to take it.

Virtually any drug will occasionally cause an unwanted reaction. A side effect is a reaction or consequence of medication or therapy that is additional to the desired effect of the medicine. Some side effects are predictable. For example, some antihistamines can cause drowsiness and many cancer therapies can cause hair loss. Side effects are listed in the U.S. Food and Drug Administration (FDA) (This link will take you to a web site to which this Privacy Policy does not apply. You are solely responsible for your interactions with such web sites.) approved labeling for the drug.

Some adverse reactions are unexpected, may be serious, and are unpredictable. Serious adverse reactions are also, in general, rare. The causes of such reactions include medication errors (e.g., overdose), or interactions between different drugs or between drugs and certain foods. Call your doctor, pharmacist, or other healthcare professional immediately if you think you’ve experienced an adverse drug reaction to your medication.

Do not be afraid to ask your doctor, pharmacist or other healthcare professionals any questions or concerns you have about your medications. They can help you anticipate and understand your medicine’s side effects and help you deal with them.

Pharmaceutical companies track adverse events and they must notify the FDA when they learn of side effects. Many pharmaceutical companies offer toll-free numbers you can call if you have questions about your medicine.

Most companies also provide information via web sites on the Internet. The types and amount of information will vary by company.

There are other sources of information you can access to get more information about your medication and possible side effects.

Package Inserts

The Package Insert (also referred to as ‘Labeling,’ ‘Prescribing Information’, or ‘PI’) is prepared by your medicine’s manufacturer for healthcare professionals who prescribe or dispense prescription medicines. PIs ordinarily follow a particular format mandated by the Food and Drug Administration. Your pharmacy should have a current package insert for any drug dispensed. If it does not, ask your pharmacist to get one for you.

Package inserts are not the same as the abbreviated safety information printouts that many pharmacies now offer with your prescription. They may also vary from the labeling information that accompanies most advertisements for prescription medicines (these are called “brief summaries”). The brief summary contains a portion of the full prescribing information. It contains information relating to side effects, warnings, precautions, and contraindications (circumstances under which your medicine should not be used) of the drug, and sometimes is written using more easily understood language.

For several prescription medicines, such as oral contraceptives and other hormone-based products, the FDA requires that manufacturers provide special materials (patient package inserts) written for consumers. The FDA has reviewed these materials. If you receive a prescription for one of these products, the patient package insert should be included. If it is not, ask your doctor, pharmacist or healthcare professional for this information.

Many package inserts can also be found in the Physician’s Desk Reference ® (often referred to as the PDR). For over 50 years, this publication has served as an annual compendium of FDA-approved labeling for many prescription drugs. Keep in mind, however, that the PDR is published only once a year, so any revisions to the package insert occurring in the interim may not appear in the version you are looking at (Note: two supplements to the PDR are published every year). Check at the very end of the package insert or the PDR entry to see when it was last updated. If you’re not sure you have the latest version, ask your doctor, pharmacist, or other healthcare professional, or contact the company.

The PDR ® Family Guide to Prescription Drugs ® is another good resource. In addition to listing each medication under its familiar brand name, as well as its generic name, the publication includes important information about side effects specifically attributed to the drug by the manufacturer. It also provides full information on standard dosage recommendations and provides advice on what to do when you miss a dose of your medication, while alerting you to the warning signs of overdose.

Check your local library or bookstore to see if they have a current version of these books. Both are also available on the Internet.

Other Sources

The Internet offers a number of sources of information about approved drugs.

While you may find a wealth of data on the Net, however, keep in mind that these sites generally do not cover all possible uses, actions, precautions, side effects, or interactions of these medicines, nor are they intended as medical advice for individual problems or for making an evaluation as to the risks and benefits of taking a particular drug. It is still best to discuss this information with your doctor, pharmacist, or other healthcare professional to find out how any medicine applies to you and your particular situation.

Guide to Safe Use of Prescription Drugs: Know Your Medicines

| Filed under Manuals Guides

Tell your doctor and your pharmacist about all medications you are taking (prescription and over-the-counter), before a new prescription is written or dispensed.

You should know the names of all your medications, both prescription and nonprescription (e.g., over-the-counter medicines such as aspirin or cold and allergy remedies, as well as vitamins, herbal remedies, etc.). If you’re seeing more than one doctor make sure to inform each physician of all medications you are taking. It is important your doctors have this information because your new medication may not work well with one or more of those prescription or over-the-counter medicines. Use the Medication Record in this website to list all the prescription drugs and over-the-counter medicines you are currently taking and have taken recently, and make sure to share it with your doctor, pharmacist or other healthcare professional.

To get your list started, ask your pharmacist for a computer printout of all your medications. It’s a good idea to get all your prescriptions filled at the same pharmacy. This way, your pharmacist will have a complete record of all your prescription medicines and can crosscheck for drug interactions. He/she can also check your medication history to see what you have been prescribed for a particular condition in the past. If you have an emergency prescription or mail-order prescription filled elsewhere, bring the bottle/tube to your regular pharmacist the next time you’re in, so it can be entered into your file.

Medication Record

MEDICATIONS YOU TAKE EVERY DAY (complete for each drug)

MEDICATION NAME (Brand and/or generic name) ________________________________

PRESCRIPTION OR NONPRESCRIPTION ________________________________

If Prescription, date it was prescribed and name of prescribing doctor or other healthcare professional
______________________________________________________

DOSAGE (pill size, number of times you take it daily) ________________________________

PURPOSE (why it was prescribed or why you are taking it) ________________________________

HOW TAKEN? (with/without food, time of day) ________________________________

ANY SIDE EFFECTS? (list any side effects you’ve experienced and any action associated with these effects. For example, “stomach upset if not taken with food.”)
______________________________________________________

MEDICATIONS YOU TAKE PERIODICALLY (including medications for allergies, pain, headache, stomach upset, etc.)

MEDICATION NAME (Brand and/or generic name) ________________________________

PRESCRIPTION OR NONPRESCRIPTION ________________________________

If Prescription, date it was prescribed and name of prescribing doctor or other healthcare professional ______________________________________________________

DOSAGE (pill size, number of times you take it daily) ________________________________

PURPOSE (why was it prescribed or why are you taking it) ________________________________

HOW TAKEN? (with/without food, time of day) ________________________________

ANY SIDE EFFECTS? (list any side effects you’ve experienced and any action associated with these effects. For example, “stomach upset if not taken with food.”) ________________________________

MEDICATIONS YOU HAVE TAKEN IN THE PAST (list drugs you’ve taken with success and those you’ve had problems with)

MEDICATION NAME (Brand and/or generic name) ________________________________

PRESCRIPTION OR NONPRESCRIPTION ________________________________

WHEN TAKEN? (month/year) ________________________________

PURPOSE (why was it prescribed or why did you take it) ________________________________

DID IT WORK? ________________________________

LIST ANY SIDE EFFECTS ________________________________

LIST ANY PROBLEMS (include reason and severity of problem. For example, “had allergic reaction”)
______________________________________________________

mEDICATION rECORD

Guide to Safe Use of Prescription Drugs: Know Your Medical History

| Filed under Manuals Guides

Provide your doctor or healthcare professional with a complete medical history.  Be sure to inform him/her of anything unusual about your personal or family health history, or any changes in your diet or lifestyle, before a prescription is written. You know more about you than your doctor possibly can.

A visit to your doctor or other healthcare professional is a two-way learning experience. It’s not only a chance for you to find out how you are doing medically, but it’s also a chance for him/her to get an update on any medical and social changes that could have an impact on your health.

In addition to providing your doctor or other healthcare professional with a list of medicines you are currently taking or have taken recently, be prepared to answer questions about your medical history, including surgeries and immunizations (vaccinations). Make a list of any allergies you have and document your family history (e.g., conditions such as cardiovascular disease, diabetes, kidney disease). If you have previous medical records, have them sent, or if they are in your possession, bring them with you. Tell your doctor or other healthcare professional about changes in your day-to-day life, such as your sleeping and eating patterns (for example, are you on a low-salt, low-sugar, or any other special diet?, are you on a new shift at work?).

All these things can help the healthcare professional determine the best possible prescription for you if one is needed. Also make sure to let them know:

  • Any allergies to specific medications, or if you suspect you have previously experienced an adverse or allergic drug reaction to a particular medicine. If possible, provide the brand name and generic name (also called the chemical or scientific name) of the medicine, the dosage, and any side effects you experienced. This information can be entered into your permanent record.
  • If you are now or soon planning to become pregnant, or if you are currently nursing a baby. Some medications should not be taken by women intending to become pregnant, during pregnancy or while nursing.
  • Any illnesses or problems for which another doctor or healthcare professional is currently treating or has recently treated you.