Tradonal may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tradonal in the following countries:
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Pratin may be available in the countries listed below.
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Dostinex Tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8β-yl)-carbonyl]-1-[3-(dimethylamino) propyl]-3-ethylurea. Its empirical formula is C26H37N5O2, and its molecular weight is 451.62. The structural formula is as follows:
Cabergoline is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.
Dostinex Tablets, for oral administration, contain 0.5 mg of cabergoline. Inactive ingredients consist of leucine, USP, and lactose, NF.
The secretion of prolactin by the anterior pituitary is mainly under hypothalamic inhibitory control, likely exerted through release of dopamine by tuberoinfundibular neurons. Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. Results of in vitro studies demonstrate that cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that cabergoline has low affinity for dopamine D1, α1- and α2-adrenergic, and 5-HT1- and 5-HT2-serotonin receptors.
The prolactin-lowering efficacy of Dostinex was demonstrated in hyperprolactinemic women in two randomized, double-blind, comparative studies, one with placebo and the other with bromocriptine. In the placebo-controlled study (placebo n=20; cabergoline n=168), Dostinex produced a dose-related decrease in serum prolactin levels with prolactin normalized after 4 weeks of treatment in 29%, 76%, 74% and 95% of the patients receiving 0.125, 0.5, 0.75, and 1.0 mg twice weekly respectively.
In the 8-week, double-blind period of the comparative trial with bromocriptine (cabergoline n=223; bromocriptine n=236 in the intent-to-treat analysis), prolactin was normalized in 77% of the patients treated with Dostinex at 0.5 mg twice weekly compared with 59% of those treated with bromocriptine at 2.5 mg twice daily. Restoration of menses occurred in 77% of the women treated with Dostinex, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea, this symptom disappeared in 73% of those treated with Dostinex compared with 56% of those treated with bromocriptine.
Following single oral doses of 0.5 mg to 1.5 mg given to 12 healthy adult volunteers, mean peak plasma levels of 30 to 70 picograms (pg)/mL of cabergoline were observed within 2 to 3 hours. Over the 0.5-to-7 mg dose range, cabergoline plasma levels appeared to be dose-proportional in 12 healthy adult volunteers and nine adult parkinsonian patients. A repeat-dose study in 12 healthy volunteers suggests that steady-state levels following a once-weekly dosing schedule are expected to be twofold to threefold higher than after a single dose. The absolute bioavailability of cabergoline is unknown. A significant fraction of the administered dose undergoes a first-pass effect. The elimination half-life of cabergoline estimated from urinary data of 12 healthy subjects ranged between 63 to 69 hours. The prolonged prolactin-lowering effect of cabergoline may be related to its slow elimination and long half-life.
In animals, based on total radioactivity, cabergoline (and/or its metabolites) has shown extensive tissue distribution. Radioactivity in the pituitary exceeded that in plasma by >100-fold and was eliminated with a half-life of approximately 60 hours. This finding is consistent with the long-lasting prolactin-lowering effect of the drug. Whole body autoradiography studies in pregnant rats showed no fetal uptake but high levels in the uterine wall. Significant radioactivity (parent plus metabolites) detected in the milk of lactating rats suggests a potential for exposure to nursing infants. The drug is extensively distributed throughout the body. Cabergoline is moderately bound (40% to 42%) to human plasma proteins in a concentration-independent manner. Concomitant dosing of highly protein-bound drugs is unlikely to affect its disposition.
In both animals and humans, cabergoline is extensively metabolized, predominately via hydrolysis of the acylurea bond or the urea moiety. Cytochrome P-450 mediated metabolism appears to be minimal. Cabergoline does not cause enzyme induction and/or inhibition in the rat. Hydrolysis of the acylurea or urea moiety abolishes the prolactin-lowering effect of cabergoline, and major metabolites identified thus far do not contribute to the therapeutic effect.
After oral dosing of radioactive cabergoline to five healthy volunteers, approximately 22% and 60% of the dose was excreted within 20 days in the urine and feces, respectively. Less than 4% of the dose was excreted unchanged in the urine. Nonrenal and renal clearances for cabergoline are about 3.2 L/min and 0.08 L/min, respectively. Urinary excretion in hyperprolactinemic patients was similar.
The pharmacokinetics of cabergoline were not altered in 12 patients with moderate-to-severe renal insufficiency as assessed by creatinine clearance.
In 12 patients with mild-to-moderate hepatic dysfunction (Child-Pugh score ≤10), no effect on mean cabergoline Cmax or area under the plasma concentration curve (AUC) was observed. However, patients with severe insufficiency (Child-Pugh score >10) show a substantial increase in the mean cabergoline Cmax and AUC, and thus necessitate caution.
Effect of age on the pharmacokinetics of cabergoline has not been studied.
In 12 healthy adult volunteers, food did not alter cabergoline kinetics.
Dose response with inhibition of plasma prolactin, onset of maximal effect, and duration of effect has been documented following single cabergoline doses to healthy volunteers (0.05 to 1.5 mg) and hyperprolactinemic patients (0.3 to 1 mg). In volunteers, prolactin inhibition was evident at doses >0.2 mg, while doses ≥0.5 mg caused maximal suppression in most subjects. Higher doses produce prolactin suppression in a greater proportion of subjects and with an earlier onset and longer duration of action. In 12 healthy volunteers, 0.5, 1, and 1.5 mg doses resulted in complete prolactin inhibition, with a maximum effect within 3 hours in 92% to 100% of subjects after the 1 and 1.5 mg doses compared with 50% of subjects after the 0.5 mg dose.
In hyperprolactinemic patients (N=51), the maximal prolactin decrease after a 0.6 mg single dose of cabergoline was comparable to 2.5 mg bromocriptine; however, the duration of effect was markedly longer (14 days vs. 24 hours). The time to maximal effect was shorter for bromocriptine than cabergoline (6 hours vs. 48 hours).
In 72 healthy volunteers, single or multiple doses (up to 2 mg) of cabergoline resulted in selective inhibition of prolactin with no apparent effect on other anterior pituitary hormones (GH, FSH, LH, ACTH, and TSH) or cortisol.
Dostinex Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.
Dostinex Tablets are contraindicated in patients with
Post marketing cases of cardiac valvulopathy have been reported in patients receiving Dostinex. These cases have generally occurred during long-term administration of high doses of Dostinex (>2mg/day) used for the treatment of Parkinson's disease. Rare cases have been reported associated with short-term treatment (<6 months) or in patients receiving lower doses for the treatment of hyperprolactinemia.
Physicians should use the lowest effective dose of Dostinex for the treatment of hyperprolactinemia and should periodically reassess the need for continuing therapy with Dostinex. In addition, patients receiving long term treatment with Dostinex should undergo periodic reassessment of their cardiac status, and echocardiography should be considered. Any patient who develops signs or symptoms of cardiac disease, including dyspnea, edema, congestive heart failure, or a new cardiac murmur, while being treated with Dostinex should be evaluated for possible valvulopathy.
Dostinex should be used with caution in patients who have hemodynamically significant valvular disease or have been exposed to other medications associated with valvulopathy.
Dopamine agonists in general should not be used in patients with pregnancy-induced hypertension, for example, preeclampsia eclampsia, and post partum hypertension, unless the potential benefit is judged to outweigh the possible risk.
Initial doses higher than 1.0 mg may produce orthostatic hypotension. Care should be exercised when administering Dostinex with other medications known to lower blood pressure.
Dostinex is not indicated for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this purpose, has been associated with cases of hypertension, stroke, and seizures.
Since cabergoline is extensively metabolized by the liver, caution should be used, and careful monitoring exercised, when administering Dostinex to patients with hepatic impairment.
As with other ergot derivatives, pleural effusion or pulmonary fibrosis have been reported following long-term administration of cabergoline. Some reports were in patients previously treated with ergotinic dopamine agonists. Dostinex should not be used in patients with a history of, or current signs and or clinical symptoms of, respiratory or cardiac disorders linked to fibrotic tissue.
Following diagnosis of pleural effusion or pulmonary fibrosis, the discontinuance of cabergoline has been reported to result in improvement of signs and symptoms.
Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis. Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values. Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder.
Pathological gambling, increased libido, and hypersexuality have been reported in patients treated with dopamine agonists including cabergoline. This has been generally reversible upon reduction of the dose or treatment discontinuation (See Post-marketing Surveillance data).
Patients should be instructed to notify their physician if they suspect they are pregnant, become pregnant, or intend to become pregnant during therapy. A pregnancy test should be done if there is any suspicion of pregnancy and continuation of treatment should be discussed with their physician.
Patients should notify their physician if they develop shortness of breath, persistent cough, difficulty with breathing when lying down, or swelling in their extremities.
Dostinex should not be administered concurrently with D2-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
Carcinogenicity studies were conducted in mice and rats with cabergoline given by gavage at doses up to 0.98 mg/kg/day and 0.32 mg/kg/day, respectively. These doses are 7 times and 4 times the maximum recommended human dose calculated on a body surface area basis using total mg/m2/week in rodents and mg/m2/week for a 50 kg human.
There was a slight increase in the incidence of cervical and uterine leiomyomas and uterine leiomyosarcomas in mice. In rats, there was a slight increase in malignant tumors of the cervix and uterus and interstitial cell adenomas. The occurrence of tumors in female rodents may be related to the prolonged suppression of prolactin secretion because prolactin is needed in rodents for the maintenance of the corpus luteum. In the absence of prolactin, the estrogen/progesterone ratio is increased, thereby increasing the risk for uterine tumors. In male rodents, the decrease in serum prolactin levels was associated with an increase in serum luteinizing hormone, which is thought to be a compensatory effect to maintain testicular steroid synthesis. Since these hormonal mechanisms are thought to be species-specific, the relevance of these tumors to humans is not known.
The mutagenic potential of cabergoline was evaluated and found to be negative in a battery of in vitro tests. These tests included the bacterial mutation (Ames) test with Salmonella typhimurium, the gene mutation assay with Schizosaccharomyces pombe P1 and V79 Chinese hamster cells, DNA damage and repair in Saccharomyces cerevisiae D4, and chromosomal aberrations in human lymphocytes. Cabergoline was also negative in the bone marrow micronucleus test in the mouse.
In female rats, a daily dose of 0.003 mg/kg for 2 weeks prior to mating and throughout the mating period inhibited conception. This dose represents approximately 1/28 the maximum recommended human dose calculated on a body surface area basis using total mg/m2/week in rats and mg/m2/week for a 50 kg human.
Reproduction studies have been performed with cabergoline in mice, rats, and rabbits administered by gavage.
(Multiples of the maximum recommended human dose in this section are calculated on a body surface area basis using total mg/m2/week for animals and mg/m2/week for a 50 kg human.)
There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis.
A dose of 0.012 mg/kg/day (approximately 1/7 the maximum recommended human dose) during the period of organogenesis in rats caused an increase in post-implantation embryofetal losses. These losses could be due to the prolactin inhibitory properties of cabergoline in rats. At daily doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) during the period of organogenesis in the rabbit, cabergoline caused maternotoxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) during the period of organogenesis in the rabbit caused an increased occurrence of various malformations. However, in another study in rabbits, no treatment-related malformations or embryofetotoxicity were observed at doses up to 8 mg/kg/day (approximately 300 times the maximum recommended human dose).
In rats, doses higher than 0.003 mg/kg/day (approximately 1/28 the maximum recommended human dose) from 6 days before parturition and throughout the lactation period inhibited growth and caused death of offspring due to decreased milk secretion.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cabergoline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use of Dostinex for the inhibition or suppression of physiologic lactation is not recommended (see PRECAUTIONS section).
The prolactin-lowering action of cabergoline suggests that it will interfere with lactation. Due to this interference with lactation, Dostinex should not be given to women postpartum who are breastfeeding or who are planning to breastfeed.
Safety and effectiveness of Dostinex in pediatric patients have not been established.
Clinical studies of Dostinex did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The safety of Dostinex Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.
In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1.0 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.
| Adverse Event* | Cabergoline (n=168) 0.125 to 1 mg two times a week | Placebo (n=20) |
|---|---|---|
| Number (percent) | ||
| ||
| Gastrointestinal | ||
| Nausea | 45 (27) | 4 (20) |
| Constipation | 16 (10) | 0 |
| Abdominal pain | 9 (5) | 1 (5) |
| Dyspepsia | 4 (2) | 0 |
| Vomiting | 4 (2) | 0 |
| Central and Peripheral Nervous System | ||
| Headache | 43 (26) | 5 (25) |
| Dizziness | 25 (15) | 1 (5) |
| Paresthesia | 2 (1) | 0 |
| Vertigo | 2 (1) | 0 |
| Body As a Whole | ||
| Asthenia | 15 (9) | 2 (10) |
| Fatigue | 12 (7) | 0 |
| Hot flashes | 2 (1) | 1 (5) |
| Psychiatric | ||
| Somnolence | 9 (5) | 1 (5) |
| Depression | 5 (3) | 1 (5) |
| Nervousness | 4 (2) | 0 |
| Autonomic Nervous System | ||
| Postural hypotension | 6 (4) | 0 |
| Reproductive – Female | ||
| Breast pain | 2 (1) | 0 |
| Dysmenorrhea | 2 (1) | 0 |
| Vision | ||
| Abnormal vision | 2 (1) | 0 |
In the 8-week, double-blind period of the comparative trial with bromocriptine, Dostinex (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from Dostinex were headache, nausea and vomiting (3, 2 and 2 patients respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.
| Adverse Event* | Cabergoline (n=221) | Bromocriptine (n=231) |
|---|---|---|
| Number (percent) | ||
| ||
| Gastrointestinal | ||
| Nausea | 63 (29) | 100 (43) |
| Constipation | 15 (7) | 21 (9) |
| Abdominal pain | 12 (5) | 19 (8) |
| Dyspepsia | 11 (5) | 16 (7) |
| Vomiting | 9 (4) | 16 (7) |
| Dry mouth | 5 (2) | 2 (1) |
| Diarrhea | 4 (2) | 7 (3) |
| Flatulence | 4 (2) | 3 (1) |
| Throat irritation | 2 (1) | 0 |
| Toothache | 2 (1) | 0 |
| Central and Peripheral Nervous System | ||
| Headache | 58 (26) | 62 (27) |
| Dizziness | 38 (17) | 42 (18) |
| Vertigo | 9 (4) | 10 (4) |
| Paresthesia | 5 (2) | 6 (3) |
| Body As a Whole | ||
| Asthenia | 13 (6) | 15 (6) |
| Fatigue | 10 (5) | 18 (8) |
| Syncope | 3 (1) | 3 (1) |
| Influenza-like symptoms | 2 (1) | 0 |
| Malaise | 2 (1) | 0 |
| Periorbital edema | 2 (1) | 2 (1) |
| Peripheral edema | 2 (1) | 1 |
| Psychiatric | ||
| Depression | 7 (3) | 5 (2) |
| Somnolence | 5 (2) | 5 (2) |
| Anorexia | 3 (1) | 3 (1) |
| Anxiety | 3 (1) | 3 (1) |
| Insomnia | 3 (1) | 2 (1) |
| Impaired concentration | 2 (1) | 1 |
| Nervousness | 2 (1) | 5 (2) |
| Cardiovascular | ||
| Hot flashes | 6 (3) | 3 (1) |
| Hypotension | 3 (1) | 4 (2) |
| Dependent edema | 2 (1) | 1 |
| Palpitation | 2 (1) | 5 (2) |
| Reproductive – Female | ||
| Breast pain | 5 (2) | 8 (3) |
| Dysmenorrhea | 2 (1) | 1 |
| Skin and Appendages | ||
| Acne | 3 (1) | 0 |
| Pruritus | 2 (1) | 1 |
| Musculoskeletal | ||
| Pain | 4 (2) | 6 (3) |
| Arthralgia | 2 (1) | 0 |
| Respiratory | ||
| Rhinitis | 2 (1) | 9 (4) |
| Vision | ||
| Abnormal vision | 2 (1) | 2 (1) |
Other adverse events that were reported at an incidence of <1.0% in the overall clinical studies follow.
Body As a Whole: facial edema, influenza-like symptoms, malaise
Cardiovascular System: hypotension, syncope, palpitations
Digestive System: dry mouth, flatulence, diarrhea, anorexia
Metabolic and Nutritional System: weight loss, weight gain
Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety
Respiratory System: nasal stuffiness, epistaxis
Skin and Appendages: acne, pruritus
Special Senses: abnormal vision
Urogenital System: dysmenorrhea, increased libido
The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson's disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson's disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.
The following events have been reported in association with cabergoline: valvulopathy and fibrosis, (See WARNINGS, Valvulopathy and PRECAUTIONS, Fibrosis).
Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (See PRECAUTIONS, Psychiatric). In addition, during post-marketing surveillance, cases of alopecia, aggression and psychotic disorder have been reported in patients taking Dostinex. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.
Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.
The recommended dosage of Dostinex Tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.
Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered. Patients receiving long term treatment with Dostinex should undergo periodic assessment of their cardiac status and echocardiography should be considered.
After a normal serum prolactin level has been maintained for 6 months, Dostinex may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with Dostinex should be reinstituted. The durability of efficacy beyond 24 months of therapy with Dostinex has not been established.
Dostinex Tablets are white, scored, capsule-shaped tablets containing 0.5 mg cabergoline. Each tablet is scored on one side and has the letter P and the letter U on either side of the breakline. The other side of the tablet is engraved with the number 700.
Dostinex is available as follows:
Bottles of 8 tablets NDC 0013-7001-12
Store at controlled room temperature 20°to 25°C (68°to 77°F) [see USP].
Rx only
LAB-0030-8.0
December 2007
| Dostinex cabergoline tablet | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
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In the US, Leukine (sargramostim systemic) is a member of the drug class colony stimulating factors and is used to treat Aplastic Anemia, Bone Marrow Transplantation, Bone Marrow Transplantation - Failure or Engraftment Delay, Bone Marrow Transplantation - Myeloid Reconstruction and Neutropenia Associated with Chemotherapy.
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Buscon may be available in the countries listed below.
Scopolamine is reported as an ingredient of Buscon in the following countries:
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Calcitonin is reported as an ingredient of Brosidon in the following countries:
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Panthenol (BAN) is known as Dexpanthenol in the US.
Calcium Pantothenate is reported as an ingredient of Panthenol in the following countries:
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Glossary
| BAN | British Approved Name |
Methoblastin may be available in the countries listed below.
Methotrexate is reported as an ingredient of Methoblastin in the following countries:
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Streptomycin Sulphate (BANM) is known as Streptomycin in the US.
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| BANM | British Approved Name (Modified) |
Eritromicina Estearato Induquimica may be available in the countries listed below.
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In the US, Raltegravir (raltegravir systemic) is a member of the drug class integrase strand transfer inhibitor and is used to treat HIV Infection.
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Rec.INN
J05AX08
0518048-05-0
C20-H21-F-N6-O5
444
Antiviral agent, treatment of HIV infection
N-[(4-Fluorophenyl)methyl]-5-hydroxy-1-methyl-2-[2-(5-methyl-1,3,4-oxadiazole-2-carboxamido)propan-2-yl]-6-oxo-1,6-dihydropyrimidine-4-carboxamide (WHO)
4-Pyrimidinecarboxamide, N-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-
5-Hydroxy-1-methyl-2-{1-methyl-1-[(5-methyl[1,3,4]oxadiazol-2-carbonyl)amino]ethyl}-6-oxo-1,6-dihydropyrimidin-4-carbonsäure-4-fluorbenzylamid (IUPAC)
N-(2-(4-(4-Fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide
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Glossary
| BAN | British Approved Name |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Neurosedine may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Neurosedine in the following countries:
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Danamet may be available in the countries listed below.
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Generic Name: dextromethorphan (Oral route)
dex-troe-meth-OR-fan
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antitussive
Dextromethorphan is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.
Dextromethorphan relieves cough by acting directly on the cough center in the brain.
This medicine is available without a prescription.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
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.
Although there is no specific information comparing use of dextromethorphan in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children 4 years of age and older than it does in adults.
Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of dextromethorphan in the elderly with use in other age groups.
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.
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 dextromethorphan. It may not be specific to Babee Cof Syrup. Please read with care.
Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.
Use this medicine only as directed by your doctor or the directions on the label. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.
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.
If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.
Dissolve lozenges in the mouth with caution, to lessen the risk of choking.
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 as soon as possible 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: Babee Cof side effects (in more detail)
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Insulin Novomix may be available in the countries listed below.
Insulin Aspart is reported as an ingredient of Insulin Novomix in the following countries:
International Drug Name Search
Definition of Nephrolithiasis: Nephrolithiasis is a condition in which one or more stones are present in the pelvis or calyces of the kidney or in the ureter. (See also cystinuria.)
The following drugs and medications are in some way related to, or used in the treatment of Nephrolithiasis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Micromedex Care Notes:
Medical Encyclopedia:
Harvard Health Guide:
Fexofénadine Winthrop may be available in the countries listed below.
Fexofenadine hydrochloride (a derivative of Fexofenadine) is reported as an ingredient of Fexofénadine Winthrop in the following countries:
International Drug Name Search
Velacin may be available in the countries listed below.
Doxycycline is reported as an ingredient of Velacin in the following countries:
International Drug Name Search
Nifestad may be available in the countries listed below.
Nifedipine is reported as an ingredient of Nifestad in the following countries:
International Drug Name Search
Rec.INN
0141388-76-3
C19-H21-Cl-F-N3-O3
393
Chemotherapeutic
Antibacterial: Gyrase inhibitor
(+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4oxo-1,4-dihydroquinoline-3-carboxylic acid
7-[(3R)-3-aminoazepan-1-yl]-8-chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid (WHO)
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Each Dallergy PE Caplet (capsule shaped caplet) contains:
Chlorpheniramine Maleate . . . . . . . . . . . 8 mg
Methscopolamine Nitrate . . . . . . . . . . . 2.5 mg
Phenylephrine Hydrochloride . . . . . . . . 20 mg
in a specially prepared base to provide a prolonged therapeutic effect.
Chlorpheniramine Maleate is an antihistamine having the chemical name 2-pyridinepropanamine, γ-(4 chlorophenyl)- N,N-dimethyl, (Z)-2- butenedioate (1:1), having the following structural formula:
C16H19ClN2 • C4H4O4 M.W. 390.86
Methscopolamine Nitrate is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo [3.3.1.02,4]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)- 9, 9- dimethyl-, nitrate, [7(S)-(1α, 2β, 4β, 5α, 7β)]-, having the following structural formula:
C18H24NO4• NO3 M.W. 380.4
Phenylephrine Hydrochloride is a decongestant having the chemical name Benzenemethanol, 3-hydroxy-α- [(methylamino)methyl]-, hydrochloride (R)-, having the following structural formula:
C9H13NO2 • HCl M.W. 203.67[/IC]
Dallergy PE Caplets contain ingredients of the following therapeutic classes: antihistamine, antisecretory agent, and nasal decongestant.
Inactive ingredients include: calcium phosphate, magnesium stearate, methylcellulose, povidone, and stearic acid.
Chlorpheniramine Maleate is an alkylamine type antihistamine. This group of antihistamines is among the most active histamine antagonists and is generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but a significant proportion of patients do experience this effect.
Methscopolamine Nitrate is a quaternary ammonium derivative of scopolamine, which possesses the peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory effects on the respiratory system.
Phenylephrine Hydrochloride is a sympathomimetic amine which acts predominantly on alpha receptors and has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal CNS stimulation.
This product is indicated for the relief of upper respiratory symptoms due to seasonal and perennial allergic and non-allergic rhinitis, such as: nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever.
Dallergy PE Caplets are contraindicated in patients with hypersensitivity to any of the ingredients. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, patients on monoamine oxidase inhibitor (MAOI) therapy, patients with narrow angle glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.
Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or sleeplessness may occur. Do not exceed recommended dosage.
Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol.
Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly.
MAOIs and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other CNS depressants may have an additive effect.
Pregnancy Category C: Animal reproduction studies have not been conducted with Dallergy PE Caplets. It is also not known whether Dallergy PE Caplets can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Dallergy PE Caplets 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 Dallergy PE Caplets are administered to a nursing mother.
Safety and effectiveness in pediatric patients under 6 years of age have not been established. Use of antihistamines is not recommended in newborn or premature infants because this age group has an increased susceptibility to anticholinergic side effects, such as CNS excitation, and an increased tendency toward convulsion. In infants and children, overdosage may cause hallucinations, convulsions, and death. A paradoxical reaction characterized by hyperexcitability may occur in older children taking antihistamines. Use is not recommended for children under six (6) years of age. Infants and young children are especially susceptible to the toxic effects of anticholinergics. Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to anticholinergics has been reported in these patients, and dosage adjustments are often required.
When anticholinergics are given to children where the environmental temperature is high, there is a risk of a rapid increase in body temperature because of the suppression of sweat gland activity. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics. Appropriate studies with phenylephrine have not been performed in the pediatric population; however, no pediatric- specific problems have been documented to date.
Confusion, hallucinations, seizures, and CNS depression may be more likely to occur in geriatric patients taking sympathomimetic amines. Geriatric patients also may be more sensitive to the effects, especially the vasopressor effects, of sympathomimetic amines. Confusion, dizziness, sedation, hypotension, hyperexcitability, and anticholinergic side effects, such as dryness of mouth and urinary retention (especially in males), may be more likely to occur in geriatric patients taking antihistamines. Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function.
Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children).
In all cases of suspected overdose, immediately call your regional poison control center, and/or contact a physician immediately. The stomach should be emptied promptly by lavage or by induction of emesis with Syrup of Ipecac. The installation of activated charcoal into the stomach also should be considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine type drugs should be used.
Dallergy PE Caplets: Adults and children 12 years of age and older: 1 caplet every 12 hours, not to exceed 2 caplets a day. Children 6 to under 12 years: As prescribed by a physician.
Not recommended for children under 6 years of age.
Caplets should not be crushed or chewed prior to swallowing.
Dallergy PE Caplets are white, capsule shaped caplets with “LAS 154” debossed on one side. The opposite side is plain. Available in bottles of 100 caplets (NDC 68134-154-01).
Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F). See USP Controlled Room Temperature.
Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Rx Only
Manufactured for:
Palmetto Pharmaceuticals, Inc.
Greenville, SC 29615
500396 Rev. 04/2010
Figure 1 Container Label
| DALLERGY PE chlorpheniramine maleate / methscopolamine nitrate / phenylephrine hcl tablet, extended release | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 07/08/2010 | ||
| Labeler - Palmetto Pharmaceuticals, Inc. (963291864) |
| Registrant - Palmetto Pharmaceuticals, Inc. (963291864) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sovereign Pharmaceuticals, LLC | 623168267 | MANUFACTURE | |
