Aldomet
Please Note: This brand name drug is no longer available in the US.ALDOMET®
(METHYLDOPA) TABLETS
DRUG DESCRIPTION
ALDOMET* (Methyldopa) is an antihypertensive drug.
Methyldopa, the L-isomer of alpha-methyldopa, is levo-3-(3,4-dihydroxyphenyl)-2-methylalanine. Its empirical formula is C10H13NO4, with a molecular weight of 211.22, and its structural formula is:
Methyldopa is a white to yellowish white, odorless fine powder, and is soluble in water.
ALDOMET is supplied as tablets, for oral use, in three strengths: 125 mg, 250 mg, or 500 mg of methyldopa per tablet. Inactive ingredients in the tablets are: calcium disodium edetate, cellulose, citric acid, colloidal silicon dioxide, D&C Yellow 10, ethylcellulose, guar gum, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, propylene glycol, talc, and titanium dioxide.
*Registered trademark of MERCK & CO., Inc., COPYRIGHT © MERCK & CO., Inc., 1985 All rights reserved
Last updated on RxList: 1/31/2005
DOSAGE AND ADMINISTRATION
ADULTS
Initiation of Therapy
The usual starting dosage of ALDOMET is 250 mg two or three times a day in the first 48 hours. The daily dosage then may be increased or decreased, preferably at intervals of not less than two days, until an adequate response is achieved. To minimize the sedation, start dosage increases in the evening. By adjustment of dosage, morning hypotension may be prevented without sacrificing control of afternoon blood pressure.
When methyldopa is given to patients on other antihypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When ALDOMET is given with antihypertensives other than thiazides, the initial dosage of ALDOMET should be limited to 500 mg daily in divided doses; when ALDOMET is added to a thiazide, the dosage of thiazide need not be changed.
The usual daily dosage of ALDOMET is 500 mg to 2 g in two to four doses. Although occasional patients have responded to higher doses, the maximum recommended daily dosage is 3 g. Once an effective dosage range is attained, a smooth blood pressure response occurs in most patients in 12 to 24 hours. Since methyldopa has a relatively short duration of action, withdrawal is followed by return of hypertension usually within 48 hours. This is not complicated by an overshoot of blood pressure.
Occasionally tolerance may occur, usually between the second and third month of therapy. Adding a diuretic or increasing the dosage of methyldopa frequently will restore effective control of blood pressure. A thiazide may be added at any time during methyldopa therapy and is recommended if therapy has not been started with a thiazide or if effective control of blood pressure cannot be maintained on 2 g of methyldopa daily.
Methyldopa is largely excreted by the kidney and patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to an increased sensitivity and advanced arteriosclerotic vascular disease. This may be avoided by lower doses.
PEDIATRIC PATIENTS
Initial dosage is based on 10 mg/kg of body weight daily in two to four doses. The daily dosage then is increased or decreased until an adequate response is achieved. The maximum dosage is 65 mg/kg or 3 g daily, whichever is less. (See PRECAUTIONS, Pediatric Use.)
HOW SUPPLIED
No. 3341 — Tablets ALDOMET, 125 mg, are yellow, film coated, round tablets, coded MSD 135 on one side and ALDOMET on the other. They are supplied as follows:
NDC 0006-0135-68 bottles of 100.
No. 3290 — Tablets ALDOMET, 250 mg, are yellow, film coated, round tablets, coded MSD 401 on one side and ALDOMET on the other. They are supplied as follows:
NDC 0006-0401-68 bottles of 100
(6505-00-890-1856, 250 mg 100's)
NDC 0006-0401-82 bottles of 1000
(6505-00-931-6646, 250 mg 1000's).
No. 3292 — Tablets ALDOMET, 500 mg, are yellow, film coated, round tablets, coded MSD 516 on one side and ALDOMET on the other. They are supplied as follows:
NDC 0006-0516-68 bottles of 100
(6505-01-003-4119, 500 mg 100's)
NDC 0006-0516-74 bottles of 500
(6505-01-199-8339, 500 mg 500's).
Storage
Store Tablets ALDOMET in a well-closed container at controlled room temperature [15-30°C (59-86°F)].
Issued July 1998 Printed in USA
Last updated on RxList: 1/31/2005
SIDE EFFECTS
Sedation, usually transient, may occur during the initial period of therapy or whenever the dose is increased. Headache, asthenia, or weakness may be noted as early and transient symptoms. However, significant adverse effects due to ALDOMET have been infrequent and this agent usually is well tolerated.
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.
Cardiovascular: Aggravation of angina pectoris, congestive heart failure, prolonged carotid sinus hypersensitivity, orthostatic hypotension (decrease daily dosage), edema or weight gain, bradycardia.
Digestive: Pancreatitis, colitis, vomiting, diarrhea, sialadenitis, sore or "black" tongue, nausea, constipation, distension, flatus, dryness of mouth.
Endocrine: Hyperprolactinemia.
Hematologic: Bone marrow depression, leukopenia, granulocytopenia, thrombocytopenia, hemolytic anemia; positive tests for antinuclear antibody, LE cells, and rheumatoid factor, positive Coombs test.
Hepatic: Liver disorders including hepatitis, jaundice, abnormal liver function tests (see WARNINGS).
Hypersensitivity: Myocarditis, pericarditis, vasculitis, lupus-like syndrome, drug-related fever, eosinophilia.
Nervous System/Psychiatric: Parkinsonism, Bell's palsy, decreased mental acuity, involuntary choreoathetotic movements, symptoms of cerebrovascular insufficiency, psychic disturbances including nightmares and reversible mild psychoses or depression, headache, sedation, asthenia or weakness, dizziness, lightheadedness, paresthesias.
Musculoskeletal: Arthralgia, with or without joint swelling; myalgia.
Respiratory: Nasal stuffiness.
Skin: Toxic epidermal necrolysis, rash.
Urogenital: Amenorrhea, breast enlargement, gynecomastia, lactation, impotence, decreased libido.
DRUG INTERACTIONS
When methyldopa is used with other antihypertensive drugs, potentiation of antihypertensive effect may occur. Patients should be followed carefully to detect side reactions or unusual manifestations of drug idiosyncrasy.
Patients may require reduced doses of anesthetics when on methyldopa. If hypotension does occur during anesthesia, it usually can be controlled by vasopressors. The adrenergic receptors remain sensitive during treatment with methyldopa.
When methyldopa and lithium are given concomitantly the patient should be carefully monitored for symptoms of lithium toxicity. Read the circular for lithium preparations.
Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate. This may adversely affect blood pressure control in patients treated with methyldopa. Coadministration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended.
Monoamine oxidase (MAO) inhibitors: See CONTRAINDICATIONS.
Drug/Laboratory Test Interactions
Methyldopa may interfere with measurement of: urinary uric acid by the phosphotungstate method, serum creatinine by the alkaline picrate method, and SGOT by colorimetric methods. Interference with spectrophotometric methods for SGOT analysis has not been reported.
Since methyldopa causes fluorescence in urine samples at the same wave lengths as catecholamines, falsely high levels of urinary catecholamines may be reported. This will interfere with the diagnosis of pheochromocytoma. It is important to recognize this phenomenon before a patient with a possible pheochromocytoma is subjected to surgery. Methyldopa does not interfere with measurement of VMA (vanillylmandelic acid), a test for pheochromocytoma, by those methods which convert VMA to vanillin. Methyldopa is not recommended for the treatment of patients with pheochromocytoma. Rarely, when urine is exposed to air after voiding, it may darken because of breakdown of methyldopa or its metabolites.
Last updated on RxList: 1/31/2005
WARNINGS
It is important to recognize that a positive Coombs test, hemolytic anemia, and liver disorders may occur with methyldopa therapy. The rare occurrences of hemolytic anemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed. Read this section carefully to understand these reactions.
With prolonged methyldopa therapy, 10 to 20 percent of patients develop a positive direct Coombs test which usually occurs between 6 and 12 months of methyldopa therapy. Lowest incidence is at daily dosage of 1 g or less. This on rare occasions may be associated with hemolytic anemia, which could lead to potentially fatal complications. One cannot predict which patients with a positive direct Coombs test may develop hemolytic anemia.
Prior existence or development of a positive direct Coombs test is not in itself a contraindication to use of methyldopa. If a positive Coombs test develops during methyldopa therapy, the physician should determine whether hemolytic anemia exists and whether the positive Coombs test may be a problem. For example, in addition to a positive direct Coombs test there is less often a positive indirect Coombs test which may interfere with cross matching of blood.
Before treatment is started, it is desirable to do a blood count (hematocrit, hemoglobin, or red cell count) for a baseline or to establish whether there is anemia. Periodic blood counts should be done during therapy to detect hemolytic anemia. It may be useful to do a direct Coombs test before therapy and at 6 and 12 months after the start of therapy.
If Coombs-positive hemolytic anemia occurs, the cause may be methyldopa and the drug should be discontinued. Usually the anemia remits promptly. If not, corticosteroids may be given and other causes of anemia should be considered. If the hemolytic anemia is related to methyldopa, the drug should not be reinstituted.
When methyldopa causes Coombs positivity alone or with hemolytic anemia, the red cell is usually coated with gamma globulin of the IgG (gamma G) class only. The positive Coombs test may not revert to normal until weeks to months after methyldopa is stopped.
Should the need for transfusion arise in a patient receiving methyldopa, both a direct and an indirect Coombs test should be performed. In the absence of hemolytic anemia, usually only the direct Coombs test will be positive. A positive direct Coombs test alone will not interfere with typing or cross matching. If the indirect Coombs test is also positive, problems may arise in the major cross match and the assistance of a hematologist or transfusion expert will be needed.
Occasionally, fever has occurred within the first 3 weeks of methyldopa therapy, associated in some cases with eosinophilia or abnormalities in one or more liver function tests, such as serum alkaline phosphatase, serum transaminases (SGOT, SGPT), bilirubin, and prothrombin time. Jaundice, with or without fever, may occur with onset usually within the first 2 to 3 months of therapy. In some patients the findings are consistent with those of cholestasis. In others the findings are consistent with hepatitis and hepatocellular injury.
Rarely, fatal hepatic necrosis has been reported after use of methyldopa. These hepatic changes may represent hypersensitivity reactions. Periodic determinations of hepatic function should be done particularly during the first 6 to 12 weeks of therapy or whenever an unexplained fever occurs. If fever, abnormalities in liver function tests, or jaundice appear, stop therapy with methyldopa. If caused by methyldopa, the temperature and abnormalities in liver function characteristically have reverted to normal when the drug was discontinued. Methyldopa should not be reinstituted in such patients.
Rarely, a reversible reduction of the white blood cell count with a primary effect on the granulocytes has been seen. The granulocyte count returned promptly to normal on discontinuance of the drug. Rare cases of granulocytopenia have been reported. In each instance, upon stopping the drug, the white cell count returned to normal. Reversible thrombocytopenia has occurred rarely.
PRECAUTIONS
General
Methyldopa should be used with caution in patients with a history of previous liver disease or dysfunction (see WARNINGS).
Some patients taking methyldopa experience clinical edema or weight gain which may be controlled by use of a diuretic. Methyldopa should not be continued if edema progresses or signs of heart failure appear.
Hypertension has recurred occasionally after dialysis in patients given methyldopa because the drug is removed by this procedure.
Rarely involuntary choreoathetotic movements have been observed during therapy with methyldopa in patients with severe bilateral cerebrovascular disease. Should these movements occur, stop therapy.
Laboratory Tests
Blood count, Coombs test, and liver function tests are recommended before initiating therapy and at periodic intervals (see WARNINGS).
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of a tumorigenic effect was seen when methyldopa was given for two years to mice at doses up to 1800 mg/kg/day or to rats at doses up to 240 mg/kg/day (30 and 4 times the maximum recommended human dose in mice and rats, respectively, when compared on the basis of body weight; 2.5 and 0.6 times the maximum recommended human dose in mice and rats, respectively, when compared on the basis of body surface area; calculations assume a patient weight of 50 kg).
Methyldopa was not mutagenic in the Ames Test and did not increase chromosomal aberration or sister chromatid exchanges in Chinese hamster ovary cells. These in vitro studies were carried out both with and without exogenous metabolic activation.
Fertility was unaffected when methyldopa was given to male and female rats at 100 mg/kg/day (1.7 times the maximum daily human dose when compared on the basis of body weight; 0.2 times the maximum daily human dose when compared on the basis of body surface area). Methyldopa decreased sperm count, sperm motility, the number of late spermatids and the male fertility index when given to male rats at 200 and 400 mg/kg/day (3.3 and 6.7 times the maximum daily human dose when compared on the basis of body weight; 0.5 and 1 times the maximum daily human dose when compared on the basis of body surface area).
Pregnancy Category B. Reproduction studies performed with methyldopa at oral doses up to 1000 mg/kg in mice, 200 mg/kg in rabbits and 100 mg/kg in rats revealed no evidence of harm to the fetus. These doses are 16.6 times, 3.3 times and 1.7 times, respectively, the maximum daily human dose when compared on the basis of body weight; 1.4 times, 1.1 times and 0.2 times, respectively, when compared on the basis of body surface area; calculations assume a patient weight of 50 kg. There are, however, no adequate and well-controlled studies in pregnant women in the first trimester of pregnancy. Because animal reproduction studies are not always predictive of human response, ALDOMET should be used during pregnancy only if clearly needed.
Published reports of the use of methyldopa during all trimesters indicate that if this drug is used during pregnancy the possibility of fetal harm appears remote. In five studies, three of which were controlled, involving 332 pregnant hypertensive women, treatment with ALDOMET was associated with an improved fetal outcome. The majority of these women were in the third trimester when methyldopa therapy was begun.
In one study, women who had begun methyldopa treatment between weeks 16 and 20 of pregnancy gave birth to infants whose average head circumference was reduced by a small amount (34.2 ± 1.7 cm vs. 34.6 ± 1.3 cm [mean ± 1 S.D.]). Long-term follow up of 195 (97.5%) of the children born to methyldopa-treated pregnant women (including those who began treatment between weeks 16 and 20) failed to uncover any significant adverse effect on the children. At four years of age, the developmental delay commonly seen in children born to hypertensive mothers was less evident in those whose mothers were treated with methyldopa during pregnancy than those whose mothers were untreated. The children of the treated group scored consistently higher than the children of the untreated group on five major indices of intellectual and motor development. At age seven and one-half developmental scores and intelligence indices showed no significant differences in children of treated or untreated hypertensive women.
Nursing Mothers
Methyldopa appears in breast milk. Therefore, caution should be exercised when methyldopa is given to a nursing woman.
Pediatric Use
There are no well-controlled clinical trials in pediatric patients. Information on dosing in pediatric patients is supported by evidence from published literature regarding the treatment of hypertension in pediatric patients. (See DOSAGE AND ADMINISTRATION.)
Last updated on RxList: 1/31/2005
OVERDOSE
Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, lightheadedness, constipation, distention, flatus, diarrhea, nausea, vomiting).
In the event of overdosage, symptomatic and supportive measures should be employed. When ingestion is recent, gastric lavage or emesis may reduce absorption. When ingestion has been earlier, infusions may be helpful to promote urinary excretion. Otherwise, management includes special attention to cardiac rate and output, blood volume, electrolyte balance, paralytic ileus, urinary function and cerebral activity.
Sympathomimetic drugs [e.g., levarterenol, epinephrine, ARAMINE* (Metaraminol Bitartrate)] may be indicated. Methyldopa is dialyzable.
The oral LD50 of methyldopa is greater than 1.5 g/kg in both the mouse and the rat.
CONTRAINDICATIONS
ALDOMET is contraindicated in patients:
— with active hepatic disease, such as acute hepatitis and active cirrhosis
— with liver disorders previously associated with methyldopa therapy (see WARNINGS) † with hypersensitivity to any component of these products.
— on therapy with monoamine oxidase (MAO) inhibitors.
Last updated on RxList: 1/31/2005
CLINICAL PHARMACOLOGY
ALDOMET is an aromatic-amino-acid decarboxylase inhibitor in animals and in man. Although the mechanism of action has yet to be conclusively demonstrated, the antihypertensive effect of methyldopa probably is due to its metabolism to alpha-methylnorepinephrine, which then lowers arterial pressure by stimulation of central inhibitory alpha-adrenergic receptors, false neurotransmission, and/or reduction of plasma renin activity. Methyldopa has been shown to cause a net reduction in the tissue concentration of serotonin, dopamine, norepinephrine, and epinephrine.
Only methyldopa, the L-isomer of alpha-methyldopa, has the ability to inhibit dopa decarboxylase and to deplete animal tissues of norepinephrine. In man the antihypertensive activity appears to be due solely to the L-isomer. About twice the dose of the racemate (DL-alpha-methyldopa) is required for equal antihypertensive effect.
Methyldopa has no direct effect on cardiac function and usually does not reduce glomerular filtration rate, renal blood flow, or filtration fraction. Cardiac output usually is maintained without cardiac acceleration. In some patients the heart rate is slowed.
Normal or elevated plasma renin activity may decrease in the course of methyldopa therapy.
ALDOMET reduces both supine and standing blood pressure. Methyldopa usually produces highly effective lowering of the supine pressure with infrequent symptomatic postural hypotension. Exercise hypotension and diurnal blood pressure variations rarely occur.
Pharmacokinetics and Metabolism
The maximum decrease in blood pressure occurs four to six hours after oral dosage. Once an effective dosage level is attained, a smooth blood pressure response occurs in most patients in 12 to 24 hours. After withdrawal, blood pressure usually returns to pretreatment levels within 24-48 hours.
Methyldopa is extensively metabolized. The known urinary metabolites are: a-methyldopa mono-0-sulfate; 3-0-methyl-a-methyldopa; 3,4-dihydroxyphenylacetone; a-methyldopamine; 3-0-methyl-a-methyldopamine and their conjugates.
Approximately 70% of the drug which is absorbed is excreted in the urine as methyldopa and its mono-0-sulfate conjugate. The renal clearance is about 130 mL/min in normal subjects and is diminished in renal insufficiency. The plasma half-life of methyldopa is 105 minutes. After oral doses, excretion is essentially complete in 36 hours.
Methyldopa crosses the placental barrier, appears in cord blood, and appears in breast milk.
Last updated on RxList: 1/31/2005
PATIENT INFORMATION
Last updated on RxList: 1/31/2005
Consumer
IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
METHYLDOPA - ORAL
(meth-ill-DOPE-uh)
COMMON BRAND NAME(S): Aldomet
USES: This medication is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Methyldopa blocks certain natural chemicals (e.g., epinephrine, norepinephrine) that can raise your blood pressure.
HOW TO USE: Take this medication by mouth with or without food, usually 2 to 4 times daily or as directed by your doctor. The dosage is based on your medical condition and response to therapy.
Usually this medication is started at a low dose and increased slowly to the best dose for you. It may take several weeks for your doctor to determine the best dosage for controlling your blood pressure.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.
It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased. Your doctor may adjust the dose of this medication when you start or stop using other blood pressure medications.
To avoid injury related to dizziness or fainting, take your first dose at bedtime. Also, anytime the dosage of this drug is changed, take your first new dose at bedtime.
Learn how to monitor your blood pressure while taking this medication. This will help you and your doctor make sure the medication is working well.
When this medication is used for an extended time, it may not work as well, and you may need a higher dose or a different medication. Talk with your doctor if this medication stops working well (e.g., your blood pressure readings increase).
SIDE EFFECTS: Dizziness, drowsiness, headache, nasal congestion, and weakness may occur, especially when you start this medication and when your dose is increased. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
In rare cases, this medication may increase your level of a certain natural substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop these symptoms, tell your doctor immediately.
Tell your doctor immediately if any of these rare but very serious side effects occur: swelling of ankles/feet, unexpected or rapid weight gain, unusual bruising or bleeding, involuntary movements, joint/muscle aches, mental/mood changes (e.g., confusion, depression), signs of infection (e.g., fever, persistent sore throat).
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, slow/fast/irregular heartbeat.
This drug may infrequently cause serious (rarely fatal) liver disease. If you notice any of the following unlikely but very serious side effects, tell your doctor immediately: persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking methyldopa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease (e.g., hepatitis or cirrhosis), a history of liver disease caused by medications.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low red blood cell count (e.g., hemolytic anemia), certain genetic conditions (glucose-6-phosphate dehydrogenase deficiency), heart failure, kidney disease, liver disease, stroke/transient ischemic attack, pheochromocytoma, Parkinson's disease.
This drug may make you dizzy or drowsy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Before having surgery, tell your doctor or dentist that you are using this medication.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to its effects, especially dizziness, difficulty concentrating, and memory problems.
Tell your doctor if you are pregnant before using this medication.
This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before, during and after taking methyldopa. In some cases a serious, possibly fatal drug interaction may occur. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting methyldopa.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: entacapone, levodopa, lithium, iron products, other blood pressure medications (e.g., beta blockers such as propranolol, calcium channel blockers such as nifedipine, ACE inhibitors such as lisinopril, diuretics such as furosemide).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).
Check the labels on all your medicines (e.g., allergy, cough and cold products, diet aids) because they may contain ingredients that could cause drowsiness, dizziness, or an increase in your heart rate or blood pressure. Ask your pharmacist about the safe use of those products.
Caffeine may increase your blood pressure. Caffeine can be found in nonprescription diet medications, soft drinks, coffee and tea. Limit caffeine intake.
This medication may interfere with certain laboratory tests (e.g., matching blood), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (e.g., blood count, Coombs test, liver function tests) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
Lifestyle changes such as starting an exercise program, stopping smoking, limiting alcohol, and making diet changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call Medic Alert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
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