Depromel may be available in the countries listed below.
Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Depromel in the following countries:
International Drug Name Search
Treating and suppressing acute attacks of certain strains of malaria and a certain type of parasitic infection (extraintestinal amebiasis). It may also be used for other conditions as determined by your doctor.
Chloroquine is an aminoquinoline. It is thought to kill sensitive malaria parasites by stopping normal metabolism inside the parasite.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Chloroquine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Chloroquine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Chloroquine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Chloroquine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Chloroquine.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Appetite loss; diarrhea; mild headache; nausea; stomach cramps; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bizarre behavior; change in the color of the skin or the inside of mouth; difficulty seeing or reading (words, letters, or parts of objects missing when reading); dizziness; fever or sore throat; hair loss; hearing loss; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; sensitivity to sunlight; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent nausea or stomach pain); unusual bleeding or bruising; unusual weakness; vision problems (eg, blurred vision, trouble focusing); weight loss.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Chloroquine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; drowsiness; excessive excitability; fainting; headache; irregular heartbeat; loss of consciousness; mood changes; seizures; severe drowsiness or dizziness; slow, shallow breathing.
Store Chloroquine in a tightly closed container at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Chloroquine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Chloroquine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Alendronato may be available in the countries listed below.
Alendronic Acid is reported as an ingredient of Alendronato in the following countries:
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendronato in the following countries:
International Drug Name Search
Bieskadog may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Bieskadog in the following countries:
Sulfaguanidine is reported as an ingredient of Bieskadog in the following countries:
International Drug Name Search
Generic Name: carbamazepine (Oral route)
kar-ba-MAZ-e-peen
Serious and sometimes fatal dermatologic reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported, especially in patients with the inherited allelic variant HLA-B*1502. Genetically at-risk patients should be screened prior to receiving carbamazepine. Carbamazepine should not be started in patients who test positive for the allele. Aplastic anemia and agranulocytosis have also been reported. Complete pretreatment hematological testing should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anticonvulsant
Chemical Class: Dibenzazepine Carboxamide
Carbamazepine is used to control certain types of seizures in the treatment of epilepsy. It is also used to relieve pain due to trigeminal neuralgia (tic douloureux). It should not be used for other more common aches or pains. This medicine can also be used in the treatment of bipolar disorder (manic-depressive illness).
Carbamazepine may also be used for other conditions as determined by your doctor.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, carbamazepine is used in certain patients with the following medical conditions:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of carbamazepine extended-release capsules to treat bipolar disease in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of carbamazepine to treat epilepsy in children.
Although appropriate studies on the relationship of age to the effects of carbamazepine have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of carbamazepine in the elderly. However, elderly patients are more likely to have confusion or agitation, which may require caution in patients receiving carbamazepine.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain carbamazepine. It may not be specific to Carbatrol. Please read with care.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand before taking this medicine.
Carbamazepine suspension and tablets should be taken with meals to lessen the chance of stomach upset (nausea and vomiting).
Carbamazepine extended-release capsules do not need to be taken with meals unless they upset your stomach. The contents of the extended-release capsules may be sprinkled over a teaspoonful of applesauce or other similar food. The capsule or its contents should not be crushed or chewed.
The extended-release tablets must be swallowed whole and should not be crushed or chewed. Do not take extended-release tablets that are damaged or have chips or cracks.
Grapefruit and grapefruit juice may increase the effects of carbamazepine by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.
If you are taking this medicine for pain relief:
If you are taking Tegretol® oral suspension:
Tegretol® tablets works differently than Tegretol® oral suspension, even at the same dose (number of milligrams). Do not switch from the tablets to the oral suspension unless your doctor tells you to.
Tegretol® may be used alone or together with other seizure medicines. Ask your doctor first before taking any other seizure medicine together with Tegretol®.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check the progress of you or your child at regular visits. Your doctor may want to have certain tests done to see if you are receiving the right amount of medicine or if certain side effects may be occurring without your knowing it. Also, the amount of medicine you or your child are taking may have to be changed often.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
Birth control pills containing estrogen may not work properly if you take them while you are taking carbamazepine. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking carbamazepine. If you have any questions about this, check with your doctor. .
Do not take carbamazepine with or within 14 days of taking a drug with monoamine oxidase (MAO) inhibitors (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Also, do not take nefazodone (Serzone®) and other medicines (prescription, over-the-counter [OTC] or herbal products) unless they have been discussed with your doctor.
Carbamazepine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.
Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.
Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
Carbamazepine may cause serious allergic reactions affecting multiple body organs (e.g., liver or kidney). Check with your doctor right away if you or your child have the following symptoms: fever, dark urine, headache, rash, stomach pain, unusual tiredness, or yellow eyes or skin.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you or your child are using this medicine.
This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally, especially when they are starting treatment or increasing the dose. It may also cause blurred or double vision, weakness, or loss of muscle control in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well-coordinated or able to see well.
Some people who take carbamazepine may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
If you have a severe reaction from the sun, check with your doctor.
For diabetic patients:
Before having any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some pregnancy tests and the metyrapone test may be affected by this medicine.
Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking carbamazepine together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects and cause other unwanted effects.
Your doctor may want you to carry a medical identification card or bracelet stating that you are taking this medicine.
Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent worsening of seizures.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Carbatrol side effects (in more detail)
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Generic Name: Captopril
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
CAS Number: 62571-86-2
May cause fetal and neonatal morbidity and mortality if used during pregnancy.401 402 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
If pregnancy is detected, discontinue captopril as soon as possible.115 402
Sulfhydryl ACE inhibitor.1 3 4 5
Management of hypertension (alone or in combination with other classes of antihypertensive agents).100 115 215 259 316 317
One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.382
Can be used as monotherapy for initial management of uncomplicated hypertension;115 however, thiazide diuretics are preferred by JNC 7.382
Stabilization or improvement of effective renal blood flow and glomerular filtration rate and reduction of proteinuria in hypertensive115 141 142 143 174 187 188 189 281 323 or normotensive115 162 patients with moderately impaired renal function,141 143 174 323 moderate to severe renal disease,141 323 or diabetic nephropathy.141 142 143 187 188 189 268 334
Management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.115 210 246 247 248 249 250 252 253 254 256 257 292 304 319 320 321 333 377
Treatment of clinically stable patients with left ventricular dysfunction (ejection fraction ≤40%) to improve survival following MI and to reduce the incidence of overt heart failure and subsequent hospitalizations for CHF.115 319 321 374
Administer orally 1 hour before meals to maximize absorption.115
Dosage has been reduced in proportion to body weight; titrate carefully.115 Some experts recommend an initial dosage of 0.9–1.5 mg/kg daily (given as 0.3–0.5 mg/kg 3 times daily).398 Increase dosage as necessary to a maximum of 6 mg/kg daily.398
Initially, 25 mg 2 or 3 times daily.115 316 382 If BP is not adequately controlled after 1–2 weeks, increase dosage to 50 mg 2 or 3 times daily.115
Lower initial dosages (e.g., 6.25 mg twice daily to 12.5 mg 3 times daily) may be effective in some patients, particularly those already receiving a diuretic.a (See Hypotension under Cautions.)
Usual dosage: Manufacturers recommend 25–150 mg 2 or 3 times daily (usually not necessary to exceed 450 mg daily).115 316 JNC 7 recommends 25–100 mg daily given in 2 divided doses; JNC 7 recommends adding another drug, if needed, rather than continuing to increase dosage.382
If combination therapy is initiated with captopril/hydrochlorothiazide fixed-combination preparation, captopril 25 mg and hydrochlorothiazide 15 mg daily initially;102 259 adjust dosage (generally at 6-week intervals) by administering each drug separately or by advancing the fixed-combination preparation.102 259
25 mg 2 or 3 times daily, initiated promptly under close supervision with frequent monitoring of BP.115 May continue previous diuretic therapy, but discontinue other hypotensive agents.115 May increase dosage at intervals of ≤24 hours under continuous supervision until optimum BP response is attained or 450 mg daily is given.115 Adjunctive therapy with other hypotensive agents may be necessary.a
Acute therapy (e.g., 12.5–25 mg, repeated once or twice if necessary at intervals of 30–60 minutes or longer) has been effective231 232 236 259 in adults with hypertensive urgencies†231 232 259 and emergencies†.233 234 235 236 237 238 259 310
25 mg 3 times daily.115 262
Manufacturers recommend initial dosage of 25 mg 3 times daily;115 in patients with normal or low BP who may be volume- and/or salt-depleted, initial dosage of 6.25 or 12.5 mg 3 times daily.115 Increase dosage gradually to 50 mg 3 times daily; delay further dosage increases for ≥2 weeks to assess response.115
Some clinicians recommend initial dosage of 6.25 or 12.5 mg 3 times daily, with gradual titration over several weeks to 50 mg 3 times daily, regardless of BP, salt/volume status, or concomitant diuretic therapy.321 333 377 Generally titrate dosage to prespecified target (i.e., ≥150 mg daily) or highest tolerated dosage rather than according to response.333 377
Manufacturers recommend initiation of therapy ≥3 days post-MI with single dose of 6.25 mg, followed by 12.5 mg 3 times daily.115 Increase dosage over next several days to 25 mg 3 times daily and then over next several weeks (as tolerated) to 50 mg 3 times daily.115
Some clinicians recommend initiation of therapy <24 hours post-MI with initial dose of 6.25 mg, followed by 12.5 mg 2 hours later, 25 mg 10–12 hours later, and then 50 mg twice daily as tolerated.319 Recommended maintenance dosage: 50 mg 3 times daily.115
Maximum 6 mg/kg daily.398
Maximum 450 mg daily.115
Dosage of captopril/hydrochlorothiazide fixed-combination generally should not exceed captopril 150 mg and hydrochlorothiazide 50 mg daily.102
Maximum dosage recommended by manufacturer and some experts is 450 mg daily.115 333 Other experts suggest maximum dosage of 50 mg 3 times daily.377
Manufacturers recommend initial dosage of <75 mg daily; increase dosage in small increments at 1- to 2-week intervals.115 After desired therapeutic effect has been attained, slowly reduce dosage to minimum effective level.115
Patients with Clcr 10–50 mL/minute: 75% of usual captopril dosage or administration of usual dose every 12–18 hours suggested by some clinicians.211
Clcr <10 mL/minute: 50% of usual dosage or administration of usual dose every 24 hours suggested by some clinicians.211
Patients undergoing hemodialysis may require supplemental dose after dialysis.211
Fixed-combination captopril/hydrochlorothiazide tablets usually are not recommended for patients with severe renal impairment.102
Usual adult dosages generally have been used; dosages of 6.25–12.5 mg 1–4 times daily used occasionally.175
Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.115 116 148 153 (See Dosage: CHF, under Dosage and Administration.)
Known hypersensitivity (e.g. history of angioedema) to captopril or another ACE inhibitor.115 147 325 326 333
Possible neutropenia or agranulocytosis; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma).115
Use with caution and only after careful risk/benefit assessment in patients with collagen vascular disease or those taking drugs known to affect leukocytes or immune response.115
If used in patients with renal impairment, determine complete and differential leukocyte counts prior to initiation of therapy, at about 2-week intervals for the first 3 months of therapy, and periodically thereafter.115 Discontinue therapy if confirmed neutrophil count is <1000/mm3.115
Proteinuria possible, particularly in patients with prior renal disease and/or those receiving relatively high dosages (>150 mg daily).115 Usually occurs by the 8th month of treatment1 3 46 and subsides or clears within 6 months whether or not therapy is continued;115 however, may persist in some patients.a
Possible excessive hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis, patients with severe CHF).1 5 17 23 25 31 66 85 115 116 148 154 156
Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.115
Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).115
To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.a (See Special Populations under Dosage and Administration.) Discontinue other antihypertensive therapy, if possible, 1 week before initiating captopril, except in patients with severe hypertension.115 a Withholding diuretic therapy and/or increasing sodium intake approximately 3–7 days prior to initiation of captopril may minimize potential for severe hypotension.115 116 148 153
Initiate therapy in patients with CHF under close medical supervision; monitor closely for first 2 weeks following initiation of captopril or any increase in captopril or diuretic dosage.115
Possible fetal and neonatal morbidity and mortality when used during pregnancy.102 115 239 240 241 402 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.402
Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.401 402
Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.402 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.239
Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.102 115 370
If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.115
Anaphylactoid reactions and/or angioedema possible; if associated with laryngeal edema, may be fatal.115 333 Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.115 Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.115
Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption115 275 276 277 or following initiation of hemodialysis that utilized high-flux membrane.102 115 242 243 244
Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.102 155 278
Not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitors.a
Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment, sodium depletion, or hypovolemia; patients with renovascular hypertension, particularly those with bilateral renal-artery stenosis or those with renal-artery stenosis in a solitary kidney;5 86 115 117 122 123 124 207 208 209 333 372 or patients with chronic or severe hypertension in whom the glomerular filtration rate may decrease transiently.1 115
Possible increases in BUN and Scr in patients with CHF;115 206 333 rapidity of onset and magnitude may depend in part on degree of sodium depletion.148 156 206 372
Closely monitor renal function following initiation of therapy in such patients.86 87 115 117 122 123 124 333 372 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.115 156 206 207 209
Possible hyperkalemia,5 7 38 69 70 85 115 122 125 126 162 163 164 177 especially in patients with impaired renal function, CHF, or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).38 85 115 125 126 148 162 163 164 333 372 (See Interactions.)
Monitor serum potassium concentration carefully in these patients.126 162 163
Persistent and nonproductive cough; resolves after drug discontinuance.102 115 333
Possible risk of decreased coronary perfusion in patients with aortic stenosis when treated with captopril.a 115
When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.102
Category C (1st trimester); Category D (2nd and 3rd trimesters).115 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)
Distributed into milk.115 Discontinue nursing or the drug.115
Safety and efficacy not established; however, captopril has been used in children.115 Manufacturer states that captopril should be used only when other measures for controlling BP have not been effective.115
Possible excessive, prolonged, and unpredictable decreases in BP and associated complications (e.g., oliguria, seizures) in infants.115
Systemic exposure to captopril may be increased.115 (See Special Populations under Pharmacokinetics.) Initial dosage adjustment recommended in patients with severe renal impairment.115 (See Renal Impairment under Dosage and Administration.)
Deterioration of renal function may occur.115 211 Possible increased risk of neutropenia/agranulocytosis,115 proteinuria,115 and hyperkalemia.115 (See Warnings and General Precautions under Cautions.)
Use of captopril/hydrochlorothiazide fixed combination usually is not recommended in patients with severe renal impairment.102
BP reduction may be smaller in black patients compared with nonblack patients;115 139 177 178 179 180 181 351 however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.179 193 194 217 218 219 316 Use in combination with a diuretic.179 193 194 217 218 219 316
Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.102 115 325 326 327 351 379 380
Rash, pruritus, cough, dysgeusia, proteinuria, tachycardia, chest pain, palpitations.115
Drug | Interaction | Comments |
|---|---|---|
Adrenergic neuron blocking agents (guanethidine) | Possible increased hypotensive effect115 | Use with caution115 |
Antacids | Decreased rate and extent of captopril absorption197 201 | Clinical importance is uncertain197 201 |
Antidiabetic agents, oral | Possible hypoglycemia in diabetic patients101 | Consider risk of hypoglycemia if used concomitantly101 |
Allopurinol | Pharmacokinetic interaction unlikely115 | |
β-adrenergic blocking agents | Increased (but less than additive) hypotensive effect115 | |
Cimetidine | Neuropathy reporteda | Further documentation of interaction necessarya |
Digoxin | Possible increased serum digoxin concentrations in patients with CHF198 199 200 | Monitor serum digoxin concentration;198 200 reduction of digoxin dosage not required upon initiation of captopril198 |
Diuretics | Possible additive hypotensive effectsa Pharmacokinetic interaction with furosemide unlikely115 | Adjust dosage carefullya (see Dosage under Dosage and Administration) |
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene) | Possible hyperkalemia, especially in patients with renal impairment162 329 331 335 | Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;85 115 125 126 148 162 163 164 discontinue or reduce dosage of potassium-sparing diuretic as necessary85 126 148 162 163 |
Insulin | Possible hypoglycemia in diabetic patients101 | Consider risk of hypoglycemia101 |
Lithium | Possible increased serum lithium concentrations, particularly in patients receiving concomitant diuretic therapy115 | Use with caution; monitor serum lithium concentrations frequently115 |
NSAIAs | Possible decreased antihypertensive response to captopril;283 284 285 286 287 288 289 290 333 364 potential for acute reduction of renal function;285 291 possible attenuation of hemodynamic actions of ACE inhibitors in patients with CHF333 364 | Monitor BP carefully and be alert for evidence of impaired renal function;285 if interaction is suspected, discontinue NSAIA or modify captopril dosage or use another hypotensive agent285 286 |
Potassium supplements or potassium-containing salt substitutes | Possible hyperkalemia, especially in patients with renal impairment162 | Use cautiously and only if hypokalemia is documented; monitor serum potassium carefully;85 115 125 126 148 162 163 164 discontinue or reduce dosage of potassium supplement as necessary85 126 148 162 163 |
Probenecid | Possible increased blood concentrations of captopril and its metabolites203 204 205 213 | |
Test for urine acetone | Possible false-positive results with sodium nitroprusside reagent54 115 | |
Vasodilating agents (e.g., hydralazine, nitrates, prazosin) | Possible increased hypotensive effect115 | If possible, discontinue vasodilating agent before starting captopril; if vasodilating agent is resumed during captopril therapy, administer with caution and possibly at a lower dosage115 |
Rapidly absorbed following oral administration in fasting individuals,19 20 84 115 with peak blood concentration attained in 1 hour.19 Approximately 60–75% of an oral dose is absorbed.19 20 84 115
Hypotensive effect may be apparent within 15 minutes5 6 16 23 and usually is maximal in 1–2 hours after a single oral dose.1 3 10 15 16 17 21 24 29 Several weeks of therapy may be required before full effect on BP is achieved.1 3 5 16 21 28
Duration of action generally is 2–6 hours but appears to increase with increasing doses.a
Food may decrease absorption of captopril by up to 25–40%;1 3 115 191 195 196 197 202 effect may not be clinically important.191 192 195
Appears to be rapidly distributed into most body tissues, except CNS.1 5
Crosses the placenta and is distributed into milk.115
25–30%1 3 22 (mainly albumin).3
About half the absorbed dose is rapidly metabolized.3 5 19 Captopril and its metabolites may undergo reversible interconversions.3
Excreted in urine (95%) as unchanged drug (40–50%) and metabolites.3 19 20 22 115
<2 hours.115
Elimination half-life is about 20–40 hours in patients with Clcr <20 mL/minute 3 and up to 6.5 days in anuric patients.5 22
Tight containers at ≤30°C.115
Tight containers at ≤30°C.102
Suppresses the renin-angiotensin-aldosterone system.1
Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.115 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.115
Importance of reporting signs of infection (e.g., sore throat, fever).115
Risk of hypotension.115 Importance of informing clinicians promptly if lightheadedness or fainting occurs.115
Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.115
Importance of not discontinuing or interrupting therapy unless instructed by a clinician.115
Risks of use during pregnancy.115 401 402 (See Boxed Warning.)
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium) as well as any concomitant illnesses.115
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.115
Importance of taking 1 hour before meals.115
Importance of advising patients of other important precautionary information.115 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 12.5 mg* | Capoten (scored) | Par |
25 mg* | Capoten (scored) | Par | ||
50 mg* | Capoten (scored) | Par | ||
100 mg* | Capoten (scored) | Par |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 25 mg Captopril and Hydrochlorothiazide 15 mg* | Capozide (scored) | Par |
Captopril and Hydrochlorothiazide Tablets | Endo, Mylan, Sandoz, Teva | |||
25 mg Captopril and Hydrochlorothiazide 25 mg* | Capozide (scored) | Par | ||
Captopril and Hydrochlorothiazide Tablets | Endo, Mylan, Sandoz, Teva | |||
50 mg Captopril and Hydrochlorothiazide 15 mg* | Capozide (scored) | Par | ||
Captopril and Hydrochlorothiazide Tablets | Endo, Mylan, Sandoz, Teva | |||
50 mg Captopril and Hydrochlorothiazide 25 mg* | Capozide (scored) | Par | ||
Captopril and Hydrochlorothiazide Tablets | Endo, Mylan, Sandoz, Teva |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Capozide 50-25MG Tablets (PAR): 30/$95.99 or 90/$269.98
Captopril 100MG Tablets (WEST-WARD): 90/$19.99 or 180/$29.97
Captopril 12.5MG Tablets (WEST-WARD): 100/$12.99 or 200/$18.98
Captopril 25MG Tablets (TEVA PHARMACEUTICALS USA): 90/$13.99 or 180/$26.99
Captopril 50MG Tablets (WEST-WARD): 100/$16.99 or 200/$22.97
Captopril-Hydrochlorothiazide 25-15MG Tablets (MYLAN): 90/$47.99 or 270/$114.97
Captopril-Hydrochlorothiazide 25-25MG Tablets (MYLAN): 90/$44.99 or 270/$125.99
Captopril-Hydrochlorothiazide 50-15MG Tablets (TEVA PHARMACEUTICALS USA): 60/$53.99 or 180/$154.98
Captopril-Hydrochlorothiazide 50-25MG Tablets (MYLAN): 60/$53.99 or 180/$154.99
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. ER Squibb & Sons, Inc. Capoten prescribing information. Princeton, NJ; 1981 Mar.
3. ER Squibb & Sons, Inc. Capoten (captopril) monograph. Princeton, NJ; 1981 Apr.
4. Atkinson AB, Robertson JIS. Captopril in the treatment of clinical hypertension and cardiac failure. Lancet. 1979; 2:836-9. [IDIS 102581] [PubMed 90928]
5. Heel RC, Brogden RN, Speight TM et al. Captopril: a preliminary review of its pharmacological properties and therapeutic efficacy. Drugs. 1980; 20:409-52. [IDIS 134943] [PubMed 7009133]
6. Ferguson RK, Turini GA, Brunner HR et al. A specific orally active inhibitor of angiotensin-converting enzyme in man. Lancet. 1977; 1:775-8. [IDIS 78256] [PubMed 66571]
7. Gavras H, Brunner HR, Turini GA et al. Antihypertensive effect of the oral angiotensin converting-enzyme inhibitor SQ 14225 in man. N Engl J Med. 1978; 298:991-5. [IDIS 80115] [PubMed 205788]
8. Larochelle P, Genest J, Kuchel O et al. Effect of captopril (SQ 14225) on blood pressure, plasma renin activity and angiotensin I converting enzyme activity. Can Med Assoc J. 1979; 121:309-16. [IDIS 100999] [PubMed 223756]
9. Swartz S, Williams GH, Hollenberg NK et al. Increase in prostaglandins during converting enzyme inhibition. Clin Sci. 1980; 59(Suppl):133-5S.
10. Brunner HR, Gavras H, Waeber B et al. Oral angiotensin-converting enzyme inhibitor in long-term treatment of hypertensive patients. Ann Intern Med. 1979; 90:19-23. [IDIS 96700] [PubMed 217289]
11. Johnston CI, Millar JA, McGrath BP et al. Long-term effects of captopril (SQ 14225) on blood-pressure and hormone levels in essential hypertension. Lancet. 1979; 2:493-6. [IDIS 103099] [PubMed 90216]
12. McCaa CS, Langford HG, Cushman WC et al. Response of arterial blood pressure, plasma renin activity and aldosterone concentration to long-term administration of captopril to patients with severe, treatment-resistant malignant hypertension. Clin Sci. 1979; 57(Suppl):371-3S.
13. Fagard R, Amery A, Reybrouck T et al. Acute and chronic systemic and pulmonary hemodynamic effects of angiotensin converting enzyme inhibition with captopril in hypertensive patients. Am J Cardiol. 1980; 46:295-300. [IDIS 122485] [PubMed 6250392]
14. Maruyama A, Ogihara T, Naka T et al. Long-term effects of captopril in hypertension. Clin Pharmacol Ther. 1980; 28:316-23. [IDIS 123828] [PubMed 6996895]
15. Mimran A, Brunner HR, Turini GA et al. Effect of captopril on renal vascular tone in patients with essential hypertension. Clin Sci. 1979; 57(Suppl):421-3S. [IDIS 109948] [PubMed 519950]
16. Case DB, Atlas SA, Laragh JH et al. Clinical experience with blockade of the renin-angiotensin-aldosterone system by an oral converting-enzyme inhibitor (SQ 14,225, captopril) in hypertensive patients. Prog Cardiovasc Dis. 1978; 21:195-206. [PubMed 214819]
17. Morganti A, Pickering TG, Lopez-Ovejero JA et al. Endocrine and cardiovascular influences of converting enzyme inhibition with SQ 14225 in hypertensive patients in the supine position and during head-up tilt before and after sodium depletion. J Clin Endocrinol Metab. 1980; 50:748-54. [IDIS 124889] [PubMed 6245101]
19. Kripalani KJ, McKinstry DN, Singhvi SM et al. Disposition of captopril in normal subjects. Clin Pharmacol Ther. 1980; 27:636-41. [IDIS 113124] [PubMed 6989546]
20. McKinstry DN, Kripalani KJ, Migdalof BH et al. The effect of repeated administration of captopril (CP) on its disposition in hypertensive patients. Clin Pharmacol Ther. 1980; 27:270-1.
21. Case DB, Atlas SA, Laragh JH et al. Use of
