Ranitidina Prediluida Grifols may be available in the countries listed below.
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In some countries, this medicine may only be approved for veterinary use.
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| BANM | British Approved Name (Modified) |
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[ bu'fen-əl ]
(sodium phenylbutyrate)
Rx Only
Buphenyl® (sodium phenylbutyrate) Tablets for oral administration and Buphenyl® (sodium phenylbutyrate) Powder for oral, nasogastric, or gastrostomy tube administration contain sodium phenylbutyrate. Sodium phenylbutyrate is an off-white crystalline substance which is soluble in water and has a strong salty taste. Sodium phenylbutyrate also is freely soluble in methanol and practically insoluble in acetone and diethyl ether. It is known chemically as 4-phenylbutyric acid, sodium salt with a molecular weight of 186 and the molecular formula C10H11O2Na.
Chemical Structure:
Each tablet of Buphenyl contains 500 mg of sodium phenylbutyrate and the inactive ingredients microcrystalline cellulose NF, magnesium stearate NF, and colloidal silicon dioxide NF.
Each gram of Buphenyl Powder contains 0.94 grams of sodium phenylbutyrate and the inactive ingredients calcium stearate NF, and colloidal silicon dioxide NF.
Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to phenylacetate. Phenylacetate is a metabolically-active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine. Phenylacetylglutamine then is excreted by the kidneys. On a molar basis, it is comparable to urea (each containing two moles of nitrogen). Therefore, phenylacetylglutamine provides an alternate vehicle for waste nitrogen excretion.
Pharmacokinetic studies have not been conducted in the primary patient population (neonates, infants, and children), but pharmacokinetic data were obtained from normal adult subjects.
Peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate tablet with a Cmax of 218 µg/mL under fasting conditions; peak plasma levels of phenylbutyrate occur within 1 hour after a single dose of 5 grams of sodium phenylbutyrate powder with a Cmax of 195 µg/mL under fasting conditions. The effect of food on phenylbutyrate's absorption is unknown.
The overall disposition of sodium phenylbutyrate and its metabolites has not been characterized fully. However, the drug is known to be metabolized to phenylacetate and subsequently to phenylacetylglutamine. Following oral administration of 5 grams (tablets), measurable plasma levels of phenylbutyrate and phenylacetate were detected 15 and 30 minutes after dosing, respectively, and phenylacetylglutamine was detected shortly thereafter. The pharmacokinetic parameters for phenylbutyrate for Cmax (µg/mL), Tmax (hours), and elimination half-life (hours) were 218, 1.35, and 0.77, respectively, and for phenylacetate were 48.5, 3.74, and 1.15, respectively.
Following oral administration of 5 grams of the powder, measurable plasma levels of phenylbutyrate and phenylacetate were detected 15 and 30 minutes after dosing, respectively, and phenylacetylglutamine was detected shortly thereafter. The pharmacokinetic parameters for phenylbutyrate for Cmax (µg/mL), Tmax (hours), and elimination half-life (hours) were 195, 1.00, and 0.76, respectively, and for phenylacetate were 45.3, 3.55, and 1.29, respectively.
The major sites for metabolism of sodium phenylbutyrate are the liver and kidney.
A majority of the administered compound (approximately 80 – 100%) was excreted by the kidneys within 24 hours as the conjugation product, phenylacetylglutamine. For each gram of sodium phenylbutyrate administered, it is estimated that between 0.12 – 0.15 grams of phenylacetylglutamine nitrogen are produced.
In patients with urea cycle disorders, Buphenyl® decreased elevated plasma ammonia glutamine levels. It increases waste nitrogen excretion in the form of phenylacetylglutamine.
Gender
Significant gender differences were found in the pharmacokinetics of phenylbutyrate and phenylacetate, but not for phenylacetylglutamine. The pharmacokinetic parameters (AUC and Cmax), for both plasma phenylbutyrate and phenylacetate were about 30 to 50 percent greater in females than in males.
Hepatic insufficiency
In patients who did not have urea cycle disorders but had impaired hepatic function, the metabolism and excretion of sodium phenylbutyrate were not affected. However, this information was obtained from unvalidated, uncontrolled case studies.
Buphenyl® is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy. It is important that the diagnosis be made early and treatment initiated immediately to improve survival. Any episode of acute hyperammonemia should be treated as a life-threatening emergency.
Buphenyl must be combined with dietary protein restriction and, in some cases, essential amino acid supplementation. (See Nutritional Supplementation subsection of the DOSAGE AND ADMINISTRATION section.)
Previously, neonatal-onset disease was almost universally fatal within the first year of life, even when treated with peritoneal dialysis and essential amino acids or their nitrogen-free analogs. However, with hemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate, and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth but within the first month of life is almost 80%. Most deaths have occurred during an episode of acute hyperammonemic encephalopathy. Patients with neonatal-onset disease have a high incidence of mental retardation. Those who had IQ tests administered had an incidence of mental retardation as follows: ornithine transcarbamylase deficiency, 100% (14/14 patients tested); argininosuccinic acid synthetase deficiency, 88% (15/17 patients tested); and carbamylphosphate synthetase deficiency, 57% (4/7 patients tested). Retardation was severe in the majority of the retarded patients.
In patients diagnosed during gestation and treated prior to any episode of hyperammonemic encephalopathy, survival is 100%, but even in these patients, most subsequently demonstrate cognitive impairment or other neurologic deficits.
In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recover from hyperammonemic encephalopathy and are then treated chronically with sodium phenylbutyrate and dietary protein restriction, the survival rate is 98%. The two deaths in this group of patients occurred during episodes of hyperammonemic encephalopathy. However, compliance with the therapeutic regimen has not been adequately documented to allow evaluation of the potential for Buphenyl and dietary protein restriction to prevent mental deterioration and recurrence of hyperammonemic encephalopathy if carefully adhered to. The majority of these patients tested (30/46 or 65%) have IQ's in the average to low average/borderline mentally retarded range. Reversal of pre-existing neurologic impairment is not likely to occur with treatment and neurologic deterioration may continue in some patients.
Even on therapy, acute hyperammonemic encephalopathy recurred in the majority of patients for whom the drug is indicated.
Buphenyl may be required life-long unless orthotopic liver transplantation is elected.
(See CLINICAL PHARMACOLOGY, Pharmacodynamics subsection for the biochemical effects of Buphenyl).
Buphenyl® should not be used to manage acute hyperammonemia, which is a medical emergency.
Each Buphenyl® Tablet contains 62 mg of sodium (9.2% w/w) (corresponding to 124 mg of sodium per gram of sodium phenylbutyrate [12.4% w/w]) and Buphenyl Powder contains 11.7 grams of sodium per 100 grams of powder, corresponding to 125 mg of sodium per gram of sodium phenylbutyrate (12.4% w/w). Buphenyl should be used with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states in which there is sodium retention with edema.
Because Buphenyl is metabolized in the liver and kidney, and phenylacetylglutamine is primarily excreted by the kidney, use caution when administering the drug to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. Probenecid is known to inhibit the renal transport of many organic compounds, including hippuric acid, and may affect renal excretion of the conjugated product of Buphenyl as well as its metabolite.
Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels.
Buphenyl® should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation.
There have been published reports of hyperammonemia being induced by haloperidol and by valproic acid.
When given subcutaneously to rat pups, 190–474 mg/kg phenylacetate caused decreased proliferation and increased loss of neurons, and it reduced CNS myelin. Cerebral synapse maturation was retarded, and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth. Prenatal exposure of rat pups to phenylacetate produced lesions in layer 5 of the cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number.
The full text of the separate insert of information for patients is reprinted at the end of the labeling.
Plasma levels of ammonia, arginine, branched-chain amino acids, and serum proteins should be maintained within normal limits, and plasma glutamine should be maintained at levels less than 1,000 µmol/L. Serum drug levels of phenylbutyrate and its metabolites, phenylacetate and phenylacetylglutamine, should be monitored periodically.
Carcinogenicity, mutagenicity, and fertility studies of sodium phenylbutyrate have not been conducted.
Pregnancy Category C.
Animal reproduction studies have not been conducted with Buphenyl®. It is also not known whether Buphenyl can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Buphenyl should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Buphenyl® is administered to a nursing woman.
The use of tablets for neonates, infants and children to the weight of 20 kg is not recommended. (See Dosage and Administration.)
The assessment of clinical adverse events came from 206 patients treated with sodium phenylbutyrate. Adverse events (both clinical and laboratory) were not collected systematically in these patients, but were obtained from patient-visit reports by the 65 co-investigators. Causality of adverse effects is sometimes difficult to determine in this patient population because they may result from either the underlying disease, the patient's restricted diet, intercurrent illness, or Buphenyl®. Furthermore, the rates may be under-estimated because they were reported primarily by parent or guardian and not the patient.
In female patients, the most common clinical adverse event reported was amenorrhea/menstrual dysfunction (irregular menstrual cycles), which occurred in 23% of the menstruating patients.
Decreased appetite occurred in 4% of all patients. Body odor (probably caused by the metabolite, phenylacetate) and bad taste or taste aversion were each reported in 3% of patients.
Other adverse events reported in 2% or fewer patients were:
Gastrointestinal: abdominal pain, gastritis, nausea and vomiting; constipation, rectal bleeding, peptic ulcer disease, and pancreatitis each occurred in one patient.
Hematologic: aplastic anemia and ecchymoses each occurred in one patient.
Cardiovascular: arrhythmia and edema each occurred in one patient.
Renal: renal tubular acidosis
Psychiatric: depression
Skin: rash
Miscellaneous: headache, syncope, and weight gain
Neurotoxicity was reported in cancer patients receiving intravenous phenylacetate, 250–300 mg/kg/day for 14 days, repeated at 4-week intervals. Manifestations were predominately somnolence, fatigue, and lightheadedness; with less frequent headache, dysgeusia, hypoacusis, disorientation, impaired memory, and exacerbation of a pre-existing neuropathy. These adverse events were mainly mild in severity. The acute onset and reversibility when the phenylacetate infusion was discontinued suggest a drug effect.
In patients with urea cycle disorders, the frequency of laboratory adverse events by body system were:
Metabolic: acidosis (14%), alkalosis and hyperchloremia (each 7%), hypophosphatemia (6%), hyperuricemia and hyperphosphatemia (each 2%), and hypernatremia and hypokalemia (each 1%).
Nutritional: hypoalbuminemia (11%) and decreased total protein (3%).
Hepatic: increased alkaline phosphatase (6%), increased liver transaminases (4%), and hyperbilirubinemia (1%).
Hematologic: anemia (9%), leukopenia and leukocytosis (each 4%), thrombocytopenia (3%), and thrombocytosis (1%).
The clinician is advised to routinely perform urinalysis, blood chemistry profiles, and hematologic tests.
No adverse experiences have been reported involving overdoses of sodium phenylbutyrate in patients with urea cycle disorders.
In the event of an overdose, discontinue the drug and institute supportive measures.
Hemodialysis or peritoneal dialysis may be beneficial.
For oral use only.
The use of Buphenyl® Tablets is indicated for children weighing more than 20 kg and for adults.
The usual total daily dose of Buphenyl Tablets and Powder for patients with urea cycle disorders is 450 – 600 mg/kg/day in patients weighing less than 20 kg, or 9.9 – 13.0 g/m2/day in larger patients. The tablets and powder are to be taken in equally divided amounts with each meal or feeding (i.e., three to six times per day).
Buphenyl® Powder is indicated for oral use (via mouth, gastrostomy, or nasogastric tube) only. The powder is to be mixed with food (solid or liquid) for immediate use; however, when dissolved in water, Buphenyl Powder has been shown to be stable for up to one week at room temperature or refrigerated. Sodium phenylbutyrate is very soluble in water (5 grams per 10 mL). When Buphenyl Powder is added to a liquid, only sodium phenylbutyrate will dissolve, the excipients will not. The effect of food on sodium phenylbutyrate has not been determined.
Each level teaspoon (enclosed) dispenses 3.2 grams of powder and 3.0 grams of sodium phenylbutyrate. Each level tablespoon (enclosed) dispenses 9.1 grams of powder and 8.6 grams of sodium phenylbutyrate.
Shake lightly before use.
The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.
To promote growth and development, plasma levels of ammonia, arginine, branched-chain amino acids, and serum protein should be maintained within normal limits while plasma glutamine is maintained at levels less than 1,000 µmol/L. Minimum daily protein intake for a patient of a particular age should be taken from, for example, "Recommended Dietary Allowances", 10th ed., Food and Nutrition Board, National Academy of Sciences, 1989. The allocation of dietary nitrogen into natural protein and essential amino acids is a function of age, residual urea-cycle enzyme activity, and the dose of sodium phenylbutyrate.
At the recommended dose of sodium phenylbutyrate, it is suggested that infants with neonatal-onset CPS and OTC deficiencies initially receive a daily dietary protein intake limited to approximately 1.6 g/kg/day for the first 4 months of life. If tolerated, the daily protein intake may be increased to 1.9 g/kg/day during this period. Protein tolerance will decrease as the growth rate decreases, requiring a reduction in dietary nitrogen intake. From 4 months to 1 year of age, it is recommended that the infant receive at least 1.4 g/kg/day, but 1.7 g/kg/day is advisable. From 1 to 3 years of age, the protein intake should not be less than 1.2 g/kg/day; 1.4 g/kg/day is advisable during this period. For neonatal-onset patients with carbamylphosphate synthetase deficiency or ornithine transcarbamylase deficiency who are at least 6 months of age, it is recommended that the daily protein intake be equally divided between natural protein and supplemental essential amino acids.
Patients with argininosuccinic acid synthetase deficiency and those with late-onset disease (partial deficiencies, including females heterozygous for ornithine transcarbamylase), initially may receive a diet containing the age-determined minimal daily natural protein allowance. The protein intake may be increased as tolerated and determined by plasma glutamine and other amino acid levels. However, many patients with partial deficiencies avoid dietary protein.
Citrulline supplementation is required and recommended for patients diagnosed with neonatal-onset deficiency of carbamylphosphate synthetase or ornithine transcarbamylase; citrulline daily intake is recommended at 0.17 g/kg/day or 3.8 g/m2/day.
The free-base form of arginine may be used instead of citrulline in patients with milder forms of carbamylphosphate synthetase and ornithine transcarbamylase deficiency (daily intake is recommended at 0.17 g/kg/day or 3.8 g/m2/day).
Arginine supplementation is needed for patients diagnosed with deficiency of argininosuccinic acid synthetase; arginine (free base) daily intake is recommended at 0.4 – 0.7 g/kg/day or 8.8 – 15.4 g/m2/day.
If caloric supplementation is indicated, a protein-free product is recommended. Caloric intake should be based upon the "Recommended Dietary Allowances", 10th ed., Food and Nutrition Board, National Research Council, National Academy of Sciences, 1989.
Buphenyl® Tablets are available in 250 cc bottles which contain 250 sodium phenylbutyrate tablets (NDC 62592-496-03). The bottles are equipped with child-resistant caps. Each tablet is off-white, oval, and embossed with "UCY 500". Each tablet contains 500 mg of sodium phenylbutyrate. STORE AT ROOM TEMPERATURE 15°C – 30°C (59°F – 86°F). AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED.
Buphenyl® Powder is available in 500 cc bottles, which hold 266 grams of powder, containing 250 grams of sodium phenylbutyrate (NDC 62592-188-64). The bottles are equipped with child-resistant caps. Measurers are provided. Each level teaspoon (enclosed) dispenses 3.2 grams of powder and 3.0 grams of sodium phenylbutyrate. Each level tablespoon (enclosed) dispenses 9.1 grams of powder and 8.6 grams of sodium phenylbutyrate. STORE AT ROOM TEMPERATURE 15°C – 30°C (59°F – 86°F). AFTER OPENING, KEEP BOTTLE TIGHTLY CLOSED.
All marks are the property of their respective owners.
Manufactured for: Ucyclyd Pharma, Inc., Scottsdale, AZ 85256
NDC 62592-496-03 bottle contains 250 tablets of 500 mg.
NDC 62592-188-64 bottle containing 250 g of sodium phenylbutyrate powder.
Prescribing Information as of April 2009.
08170038
What is the most important information I should know about Buphenyl®?
Buphenyl® is prescribed along with changes in diet for long-term treatment of urea cycle disorders. Buphenyl can only be obtained with a prescription from your doctor.
Buphenyl must be taken exactly as the doctor prescribes; do not increase or decrease the dose of this medication without the doctor's approval.
What are urea cycle disorders?
Urea cycle disorders include a group of diseases, each having a specific liver enzyme deficiency. Because they are inherited, other family members may be affected. These disorders vary in severity and may be first detected at various ages, from newborn infants to adults. They lead to increased amounts of ammonia in the blood, which may cause disturbed brain function and severe brain damage. Typical signs of the disease are decreased mental awareness, vomiting, combativeness, slurred speech, unstable gait, and unconsciousness. The diagnosis of urea cycle disorders requires special laboratory tests. These typical signs of the disease may recur after the diagnosis is made if the condition is not under control. If they do, the doctor should be notified immediately because this is a medical emergency. An infection can cause the condition to go out of control. Therefore, if a fever develops, the doctor should be seen immediately.
A patient or carrier of these disorders should wear a Medic Alert tag stating the diagnosis. In the event that the patient has a sudden, rapid accumulation of ammonia in the blood, and, therefore, in the brain, leading to unconsciousness, the doctor will be alerted to treat the disease properly.
Periodically, depending upon the severity of a particular patient's urea cycle disorder, it will be necessary to perform blood tests. These include plasma ammonia, plasma amino acid levels, and other more routine blood tests to evaluate nutritional status.
What is Buphenyl®?
Buphenyl® is a drug that helps to prevent ammonia from accumulating in the blood. Buphenyl aids the body in eliminating substances that produce ammonia. However, despite drug treatment, blood ammonia levels may become elevated periodically and there may be episodes of altered brain function in association with these ammonia elevations. Patients who have disease onset as newborns have a high incidence of mental retardation. Medical attention should be obtained as soon as signs appear (see above under "What are urea cycle disorders?"). Buphenyl may be used as life-long therapy or as a temporary measure until liver transplantation is performed.
What diet should I or my child follow?
In addition to taking Buphenyl®, it is equally important that a prescribed diet be followed. Because there is great variability in the severity of urea cycle disorders, each patient's diet should be custom designed by a physician and a nutritionist. Because the diet is so important, it is recommended that the prescribed diet be discussed with a nutritionist who is familiar with urea cycle disorders.
Who should not take Buphenyl®?
Buphenyl® is prescribed only for patients with urea cycle disorders. It is not to be used for any other reason. Keep the medication in a safe place where children cannot reach it.
What other medical conditions may also be present that could increase the risk of taking Buphenyl®?
Heart failure or decreased kidney function may lead to retention of the sodium content of Buphenyl® with potentially serious consequences such as worsening heart failure, high blood pressure, and swelling. If these medical conditions are present, the doctor will determine if your child should take Buphenyl.
How should I or my child take Buphenyl®?
The dose of Buphenyl® prescribed for adults and children is based upon the patient's weight or size. It is very important that the full amount prescribed for any 24-hour period be taken. If a dose is missed it should be administered as soon as possible that same day. The total daily dose should be administered in equally divided amounts with meals.
What medications should I or my child avoid or be cautious of taking while on Buphenyl®?
Patients with urea cycle disorders usually should not take Depakene® (valproic acid), a drug sometimes prescribed for seizure disorders, or Haldol® (haloperidol), a drug used to treat certain types of psychiatric or neurologic disorders. Both of these drugs have been reported to increase blood ammonia levels. Steroids may break down body protein, thereby increasing blood ammonia levels. The doctor should be consulted before administering medications containing steroids.
What medications may affect the way the body breaks down the drug?
Probenecid, a medication used to treat gout, may affect the way the kidneys excrete Buphenyl® (consult the doctor for details).
What are the most common side effects of Buphenyl®?
The most common side effect reported in premenopausal women taking Buphenyl® was absent or irregular menstrual periods. Decreased appetite was reported in 4% of all people treated. Body odor and bad taste were each reported in 3% of all patients treated.
A breakdown product of Buphenyl has been associated mainly with sleepiness and light-headedness. Because these symptoms may also be due to the urea cycle going out of control, a doctor should see the patient immediately if these symptoms occur, so the cause can be determined. Blood tests should be performed periodically for adverse effects and for levels of medication and its breakdown products.
How should Buphenyl® be stored?
Buphenyl® should be stored in a tightly closed bottle at room temperature.
This leaflet provides a brief summary of the information available on Buphenyl®. The information here is incomplete and is not designed to take the place of your doctor's instructions. For more complete information, consult your physician or call or write Ucyclyd Pharma, Inc. at 7720 N. Dobson Road, Scottsdale, AZ 85256. (888) 829-2593.
Ucyclyd
Pharma®
NDC 62592-496-03
Buphenyl®
(sodium phenylbutyrate)
500 mg
Tablets
250 Tablets
Pharmacist: Dispense in this
unit-of-use Child Resistant container
with enclosed patient leaflet.
Rx Only
Ucyclyd
Pharma®
NDC 62592-188-64
Buphenyl®
(sodium phenylbutyrate)
Powder
250 Grams
Rx Only
| Buphenyl sodium phenylbutyrate tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020572 | 05/13/1996 | |
| Buphenyl sodium phenylbutyrate powder | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020573 | 04/30/1996 | |
| Labeler - Ucyclyd Pharma Inc. (150393221) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Lyne Laboratories, Inc. | 053510459 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pharmaceuticals International, Inc. (PII) | 878265586 | MANUFACTURE | |
Rec.INN
C02DB01
0000484-23-1
C8-H10-N6
190
Vasodilator, peripheric
Antihypertensive agent
1,4-Phthalazinedione, 2,3-dihydro-, dihydrazone
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Diacare may be available in the countries listed below.
Cyproterone 17α-acetate (a derivative of Cyproterone) is reported as an ingredient of Diacare in the following countries:
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Genabil may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
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Sodium fluoride acts systemically and topically by increasing tooth resistance to cavities and acid dissolution, by promoting remineralization.
ReNaf Fluoride Chewable Tablets 1.0 mg, 0.5 mg, 0.25 mg are to be used as a dental caries preventive in children. Ingestion of fluoridated drinking water (1 ppm F-) during the period of tooth development results in a significant decrease in the incidence of dental caries. ReNaf Fluoride Chewable Tablets were developed to provide systemic fluoride for use as a once daily supplement in children from 6 months to age 3 years and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F-.
ReNaf Fluoride Chewable Tablets 1.0 mg are contraindicated when the fluoride content of drinking water is 0.3 ppm F- or more and should not be administered to children under age 6 years. ReNaf Fluoride Chewable Tablets 0.5 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children underage 6 when the fluoride content of drinking water is 0.3 ppm F- or more or to children under age 3 years. ReNaf Fluoride Chewable Tablets 0.25 mg are contraindicated when the fluoride content of drinking water is more than 0.6 ppm F- and should not be administered to children under age 3 years when the fluoride content of drinking water is 0.3 ppm F- or more. Do not administer any strength of ReNaf Fluoride Chewable Tablets to children under age 6 months. ReNaf Fluoride Chewable Tablets are not indicated for use in adults.
Prolonged daily ingestion of quantities greater than the recommended amount may result in various degrees of dental fluorosis in children under age 6 years, especially if the water fluoridation exceeds 0.6 ppm. Read directions carefully before using. Keep out of reach of infants and children.
General: Use in children below the age of 6 months is not recommended by current American Dental Association and American Academy of Pediatrics guidelines.
Drug Interactions: Do not eat or drink dairy products within one hour of fluoride administration. Using fluoride along with dairy foods is not recommended due to formation of calcium fluoride which is poorly absorbed.
Carcinogenesis, Mutagenesis, Impairment of Fertility: In animals,studies evaluating the carcinogenic potential of fluoride at greater levels than the recommended daily dose of ReNaf Fluoride Chewable Tablets are inconclusive. Fluoride ion is not mutagenic in standard bacterial systems. In vivo data are conflicting. Potential adverse reproductive effects of fluoride exposure in humans has not been adequately evaluated.
Pregnancy: Teratogenic Effects: Pregnancy Category B. It has been shown that fluoride crosses the placenta of rats, but only 0.01% of the amount administered is incorporated in fetal tissue. Animal studies (rats, mice, rabbits) have shown that fluoride is not a teratogen. Epidemiological studies conducted in areas with high levels of naturally fluoridated water showed no increase in birth defects. Consult your physician before taking this product.
Nursing Mothers: It is not known if fluoride is excreted in human milk. However, many drugs are excreted in human milk and caution should be exercised when ReNaf Fluoride Chewable Tablets are administered to nursing women. Consult your physician before taking this product.
Pediatric Use: The use of ReNaf Fluoride Chewable Tablets as a caries preventive in pediatric age groups 6 months to 16 years is supported by evidence from adequate and well controlled studies on fluoride supplementation from birth through adolescence.
Geriatric Use: ReNaf Fluoride Chewable Tablets are not indicated for use in geriatric patients.
Allergic reactions (rash, hives, itching) have rarely been reported. This is not a complete list of all the possible reactions that may occur.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
If you suspect an overdosage contact your physician and/or your local Poison Control Center immediately. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting and diarrhea may occur soon or within 30 minutes of ingestion and are accompanied by salivation, hematemesis and epigastric cramping abdominal pain. This is not a complete list of all the symptoms that may occur with overdosage.
Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.
ReNaf Fluoride Chewable Tablets 1.0 mg are round, pink, cherry flavored tablets in a 120-count bottle, NDC# 68032-384-12 and a 1000-count bottle, NDC# 68032-384-00.
ReNaf Fluoride Chewable Tablets 0.5 mg are round, white, grape flavored tablets in a 120-count bottle, NDC# 68032-383-12 and a 1000-count bottle, NDC# 68032-383-00.
ReNaf Fluoride Chewable Tablets 0.25 mg are round, cream colored, vanilla-flavored tablets in a 120-count bottle, NDC# 68032-382-12.
Store at Controlled Room Temperature, 20-25°C (68-77°F).
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| unapproved drug other | 02/27/2009 | 12/31/2010 | |
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| unapproved drug other | 02/27/2009 | 12/31/2010 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |
fe-LOE-di-peen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Cardiovascular Agent
Pharmacologic Class: Calcium Channel Blocker
Chemical Class: Dihydropyridine
Felodipine is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Felodipine is a calcium channel blocker. It works by affecting the movement of calcium into the cells of the heart and blood vessels. Felodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart, which reduces the workload.
felodipine is available only 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 felodipine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to felodipine 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 felodipine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of felodipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving felodipine.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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 felodipine, 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 felodipine 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 felodipine 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 felodipine 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 felodipine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of felodipine. Make sure you tell your doctor if you have any other medical problems, especially:
In addition to the use of felodipine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
Remember that felodipine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You might have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.
Swallow the extended-release tablet whole. Do not crush, break, or chew it.
You may take felodipine without food or with a light meal.
The dose of felodipine 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 felodipine. 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 felodipine, 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 your progress at regular visits to make sure felodipine is working properly and to check for unwanted effects.
Low blood pressure (hypotension) may occur while taking felodipine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.
felodipine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet; tingling of the hands or feet; or unusual weight gain or weight loss.
Redness, swelling, or bleeding of the gums may occur while taking felodipine. Brushing and flossing your teeth carefully and regularly, and massaging your gums may help prevent this. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any redness, swelling, or bleeding of your gums.
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: felodipine side effects (in more detail)
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Definition of Hemoglobinopathy: Hemoglobinopathy is a group of rare, inherited disorders involving abnormal structure of the hemoglobin molecule. These disorders include hemoglobin C disease , hemoglobin S-C disease, sickle cell anemia, and various types of thalassemia.
Micromedex Care Notes:
Medical Encyclopedia:
A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.
Narcotic analgesics are drugs that relieve pain, can cause numbness and induce a state of unconsciousness.
They work by binding to opioid receptors, which are present in the central and peripheral nervous system. There are three types of opioid receptors, which are all G-protein linked and either facilitate opening of potassium channels (causing hyperpolarization) or inhibit calcium channel opening (so inhibits release of excitatory neurotransmitters such as substance P). Overall, narcotic analgesics reduce neuronal excitability in the pain carrying pathway.
Morphine and its analogues, and some synthetic derivatives are classed as narcotics analgesics. Narcotic analgesics are used to relieve acute and chronic, severe pain. Some narcotics are more potent than others. They also have the tendency to cause tolerance and dependence.
Medical conditions associated with narcotic analgesics:
