Coleb-Duriles may be available in the countries listed below.
Isosorbide Mononitrate is reported as an ingredient of Coleb-Duriles in the following countries:
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Decatylen Neo may be available in the countries listed below.
Cinchocaine hydrochloride (a derivative of Cinchocaine) is reported as an ingredient of Decatylen Neo in the following countries:
Dequalinium Chloride is reported as an ingredient of Decatylen Neo in the following countries:
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Evicap may be available in the countries listed below.
Tocopherol, α- is reported as an ingredient of Evicap in the following countries:
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Evicap in the following countries:
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Cobatensin may be available in the countries listed below.
Nitrendipine is reported as an ingredient of Cobatensin in the following countries:
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Prexor may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Prexor in the following countries:
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Loperax may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Loperax in the following countries:
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Generic Name: benzocaine (Oral route, Oromucosal route)
BEN-zoe-kane
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Anesthetic, Local
Chemical Class: Amino Ester
Benzocaine lozenges are used to relieve pain and irritation caused by sore throat, sore mouth, or canker sores.
This medicine is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.
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.
No information is available on the relationship of age to the effects of benzocaine lozenges in the pediatric population. Safety and efficacy have not been established in children below 5 years of age.
No information is available on the relationship of age to the effects of benzocaine in geriatric patients.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with 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 benzocaine. It may not be specific to Trocaine. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects.
This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present.
Do not use this medicine for more than 2 days without checking first with your doctor.
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.
If your condition does not improve within 7 days, or if it becomes worse, check with your doctor.
Call your doctor right away if you start to have a severe sore throat or sore throat that occurs with a high fever, headache, nausea, or vomiting. These maybe signs of an infection.
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:
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: Trocaine side effects (in more detail)
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Codicaps Kindersaft Neo may be available in the countries listed below.
Codeine monohydrate (a derivative of Codeine) is reported as an ingredient of Codicaps Kindersaft Neo in the following countries:
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Cefotaxima Farma-APS may be available in the countries listed below.
Cefotaxime is reported as an ingredient of Cefotaxima Farma-APS in the following countries:
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E-Moxclav may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of E-Moxclav in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of E-Moxclav in the following countries:
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Rx Only
Pyril DM Suspension is an antihistamine/ nasal decongestant/antitussive combination for oral administration as a suspension. Each 5 mL (one teaspoonful) of the grape-flavored, purple-colored suspension for oral administration contains:
| Phenylephrine HCl | 5 mg |
| Pyrilamine Maleate | 16 mg |
| Dextromethorphan HBr | 15 mg |
Inactive ingredients: Citric acid, FD&C Blue No. 1, FD&C Red No. 40, glycerin, grape flavor, magnesium aluminum silicate, methylparaben, purified water, sucralose, monoammonium glycyrrhizinate, sodium benzoate, sodium citrate dihydrate, sucrose, xanthan gum and galloquinate.
Pyril DM Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine and the antitussive effect of dextromethorphan.
Phenylephrine is a decongestant which is a potent postsynaptic α-receptor agonist with little effect on β receptors of the heart. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels.
Phenylephrine has a mild central stimulant effect.
Pyrilamine is an antihistamine, H1 receptor blocking agent belonging to the ethylenediamine class of antihistamines. H1-blocking drugs inhibit the actions of histamine on smooth muscle, capillary permeability, and can both stimulate and depress the central nervous system.
Pyrilamine also possesses anticholinergic and sedative properties.
Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. The drug acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity.
Pyril DM Suspension is indicated for the symptomatic relief of coryza, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.
Pyril DM Suspension is contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.
Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds).
Pyril DM Suspension should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS-DRUG INTERACTIONS").
This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines shoud be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck.
Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients, and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma. Dextromethorphan should be used with caution in sedated patients, and in patients confined to the supine position.
Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether a prescription drug contains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.
MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following coadministration of MAO inhibitors and dextromethorphan. Thus, concomitant administration of Pyril DM Suspension and MAO inhibitors should be avoided (see " CONTRAINDICATIONS").
No long-term animal studies have been performed with Pyril DM Suspension.
Animal reproduction studies have not been conducted with Pyril DM Suspension. It is also not known whether Pyril DM Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pyril DM Suspension should be given to a pregnant woman only if clearly needed.
Administration of phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Pyril DM Suspension should not be administered to a nursing mother.
The most common effects associated with antihistamines have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include:
Dermatologic - urticaria, drug rash, photosensitivity, pruritus.
Cardiovascular - hypotension, hypertension, cardiac arrhythmias, palpitations.
Central Nervous System (CNS) - disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.
Genitourinary - urinary frequency, difficult urination.
Gastrointestinal - epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory - tightness of chest and wheezing, shortness of breath.
Hematologic - hemolytic anemia, thrombocytopenia, agranulocytosis.
May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Dextromethorphan may produce central excitement and mental confusion. Very high doses of dextromethorphan may produce respiratory depression.
Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.
Administer the recommended dose every 8 hours. Adults and Children over 12 years of age – 5 to 10 mL (1 to 2 teaspoonfuls); 6 to 12 years of age – 5 mL (1 teaspoonful); 2 to 6 years of age – 2.5 mL (1/2 teaspoonful); Under 2 years of age – Consult a physician.
NOTE: The maleate salt of pyrilamine, the hydrochloride salt of phenylephrine, and the hydrobromide salt of dextromethorphan are provided in a suspension by means of a patented manufacturing process.
Pyril DM Suspension: is available in a grape-flavored, purple-colored suspension.
NDC No.: 44183-210-16 – 16 fl. oz. bottles.
Store at controlled room temperature, 20°-25°C (68°-77°F).
Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.
Patent Protected
Rx Only
Manufactured for:
Macoven Pharmaceuticals, LLC
Magnolia, TX 77354
Int 3/09
547-60416-2
MACOVEN
PHARMACEUTICALS, LLC
NDC 44183-210-16
PYRIL DM
Each 5 mL (one teaspoonful)
for oral administration contains:
| Pyrilamine Maleate | 16 mg |
| Phenylephrine HCl | 5 mg |
| Dextromethorphan HBr | 15 mg |
SUSPENSION
Rx only
16 fl. oz. (473mL)
| PYRIL DM phenylephrine hydrochloride, pyrilamine maleate, and dextromethorphan hydrobromide suspension | ||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 01/04/2010 | ||
| Labeler - Macoven Pharmaceuticals (832591965) |
Lansoprazol Ciclum may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lansoprazol Ciclum in the following countries:
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Ketozol-Mepha may be available in the countries listed below.
Ketoconazole is reported as an ingredient of Ketozol-Mepha in the following countries:
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Hevizos may be available in the countries listed below.
Epervudine is reported as an ingredient of Hevizos in the following countries:
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Methyldopa USP is an antihypertensive drug.
Methyldopa USP is the L-isomer of alpha-Methyldopa. Its chemical name is levo-3-(3,4-dihydroxyphenyl)- 2-methylalanine sesquihydrate. Its structural formula is:
C 10H13NO4 • 1 1/2 H2O M.W. 238.24
Methyldopa USP is a white to yellowish white, odorless fine powder and is sparingly soluble in water.
Each tablet, for oral administration, contains 250 mg or 500 mg of Methyldopa USP. Potency is calculated in the anhydrous basis. Inactive ingredients: citric acid, colloidal silicon dioxide, edetate disodium, ethylcellulose, hypromellose, magnesium stearate, methylcellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 250 mg tablet contains calcium sulfate, hydroxypropyl cellulose, and talc, and the 500 mg tablet contains polysorbate 80.
Methyldopa 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.
Methyldopa 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.
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: α-Methyldopa mono-0- sulfate; 3-0-methyl-α-Methyldopa; 3,4,-dihydroxyphenylacetone; α-Methyldopamine; 3-0-methyl-α-Methyldopamine and their conjugates.
Approximately 70 percent 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.
Hypertension.
Methyldopa 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 this product.
- on therapy with monoamine oxidase (MAO) inhibitors.
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 or 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.
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.
Blood count, Coombs tests and liver function tests are recommended before initiating therapy and at periodic intervals (see WARNINGS).
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.
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.
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, Methyldopa 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 Methyldopa 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 7 and one-half developmental scores and intelligence indices showed no significant differences in children of treated or untreated hypertensive women.
Methyldopa appears in breast milk. Therefore, caution should be exercised when Methyldopa is given to a nursing woman.
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).
Of the total number of subjects (1685) in clinical studies of Methyldopa, 223 patients were 65 years of age and over while 33 patients were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out (see DOSAGE AND ADMINISTRATION).
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
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 Methyldopa 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, distention, 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, light-headedness, paresthesias.
Metabolic: Rise in BUN.
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.
Acute overdosage may produce acute hypotension with other responses attributable to brain and gastrointestinal malfunction (excessive sedation, weakness, bradycardia, dizziness, light-headedness, 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, 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.
The usual starting dosage of Methyldopa tablet 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 anti-hypertensives, the dose of these agents may need to be adjusted to effect a smooth transition. When Methyldopa is given with anti-hypertensives other than thiazides, the initial dosage of Methyldopa should be limited to 500 mg daily in divided doses; when Methyldopa is added to a thiazide, the dosage of thiazide need not be changed.
The usual daily dosage of Methyldopa 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 (see PRECAUTIONS, Geriatric Use).
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).
Methyldopa Tablets USP are available as white to off-white, round, convex, unscored, film-coated tablets, debossed “N11” on one side, and plain on the other side, containing 250 mg of Methyldopa USP, packaged in bottles of 100 and 1000 tablets. Methyldopa Tablets USP are available as white to off-white, round, convex, unscored, film-coated tablets, debossed “N77” on one side, and plain on the other side, containing 500 mg of Methyldopa USP, packaged in bottles of 100 and 500 tablets.
PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Iss. 12/2008
Manufactured In India By:
EMCURE PHARMACEUTICALS LTD.
Hinjwadi, Pune, India
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
NDC 0093-2931-01
Methyldopa
Tablets USP
250 mg
Rx only
100 TABLETS
TEVA
NDC 0093-2932-01
Methyldopa
Tablets USP
500 mg
Rx only
100 TABLETS
TEVA
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA070098 | 10/05/2010 | |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA070343 | 10/05/2010 | |
| Labeler - TEVA Pharmaceuticals USA Inc (118234421) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Emcure Pharmaceuticals Ltd. | 916921919 | MANUFACTURE | |
Codein Slovakofarma may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Codein Slovakofarma in the following countries:
International Drug Name Search
Generic Name: hydrocortisone (Topical application route)
hye-droe-KOR-ti-sone
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Corticosteroid, Weak
Pharmacologic Class: Adrenal Glucocorticoid
Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).
This medicine is available both over-the-counter (OTC) and with your doctor's prescription.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.
No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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. Discuss with your healthcare professional the use of your medicine with 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 hydrocortisone. It may not be specific to Nutracort. Please read with care.
It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.
This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.
This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.
To use:
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, apply 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.
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 your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.
Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.
Do not use cosmetics or other skin care products on the treated areas.
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:
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: Nutracort side effects (in more detail)
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Losartan/Hydrochlorothiazide Qualimed may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Losartan/Hydrochlorothiazide Qualimed in the following countries:
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan/Hydrochlorothiazide Qualimed in the following countries:
International Drug Name Search
Cocaine Hydrochloride (BANM) is known as Cocaine in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
Capto-CT may be available in the countries listed below.
Captopril is reported as an ingredient of Capto-CT in the following countries:
International Drug Name Search
Domerajin may be available in the countries listed below.
Flucytosine is reported as an ingredient of Domerajin in the following countries:
International Drug Name Search
