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PERMAX

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Overview

What is PERMAX?

Permax (Pergolide Tablets, USP) is an ergot derivative dopamine receptor agonist at both D and D receptor sites. Pergolide mesylate is chemically designated as 8β-[(Methylthio)methyl]-6-propylergoline monomethanesulfonate; the structural formula is as follows:

The empirical formula is CHNS∙CHOS, representing a molecular weight of 410.60.

Permax is provided for oral administration in tablets containing 0.05 mg (0.159 µmol), 0.25 mg (0.795 µmol), or 1 mg (3.18 µmol) pergolide as the base. The tablets also contain croscarmellose sodium, iron oxide, lactose, magnesium stearate, and povidone. The 0.05 mg tablet also contains L-methionine, and the 0.25 mg tablet also contains FD&C Blue No. 2.



What does PERMAX look like?



What are the available doses of PERMAX?

Sorry No records found.

What should I talk to my health care provider before I take PERMAX?

Sorry No records found

How should I use PERMAX?

Permax is indicated as adjunctive treatment to levodopa/carbidopa in the management of the signs and symptoms of Parkinson's disease.

Evidence to support the efficacy of pergolide as an antiparkinsonian adjunct was obtained in a multicenter study enrolling 376 patients with mild to moderate Parkinson's disease who were intolerant to -dopa/carbidopa as manifested by moderate to severe dyskinesia and/or on-off phenomena. On average, the patients evaluated had been on -dopa/carbidopa for 3.9 years (range, 2 days to 16.8 years). The administration of pergolide permitted a 5% to 30% reduction in the daily dose of -dopa. On average, these patients treated with pergolide maintained an equivalent or better clinical status than they exhibited at baseline.

Administration of Permax should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.

Permax is usually administered in divided doses 3 times per day. During dosage titration, the dosage of concurrent dopa/carbidopa may be cautiously decreased.

In clinical studies, the mean therapeutic daily dosage of Permax was 3 mg/day. The average concurrent daily dosage of dopa/carbidopa (expressed as dopa) was approximately 650 mg/day. The efficacy of Permax at doses above 5 mg/day has not been systematically evaluated.  Doses of pergolide above 5 mg/day are not recommended ().


What interacts with PERMAX?

Pergolide is contraindicated in patients who are hypersensitive to this drug or other ergot derivatives.



What are the warnings of PERMAX?

Array

Somnolence is a common occurrence in patients receiving Permax. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with Permax, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Permax such as concomitant sedating medications or the presence of sleep disorders. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., conversations, eating, etc.), Permax should ordinarily be discontinued. If a decision is made to continue Permax, patients should be advised to not drive and to avoid other potentially dangerous activities.

While dose reduction may reduce the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Fatalities

In particular, a case-by-case review of the clinical course of the patients who died failed to disclose any unique set of signs, symptoms, or laboratory results that would suggest that treatment with pergolide caused their deaths. Sixty-eight percent (68%) of the patients who died were 65 years of age or older. No death (other than a suicide) occurred within the first month of treatment; most of the patients who died had been on pergolide for years. A relative frequency of the causes of death by organ system are: Pulmonary failure/Pneumonia, 35%; Cardiovascular, 30%; Cancer, 11%; Unknown, 8.4%; Infection, 3.5%; Extrapyramidal syndrome, 3.5%; Stroke, 2.1%; Dysphagia, 2.1%; Injury, 1.4%; Suicide, 1.4%; Dehydration, 0.7%; Glomerulonephritis, 0.7%.


What are the precautions of PERMAX?

General

Caution should be exercised when administering pergolide to patients prone to cardiac dysrhythmias.

In a study comparing pergolide and placebo, patients taking pergolide were found to have significantly more episodes of atrial premature contractions (APCs) and sinus tachycardia.

The use of pergolide in patients on -dopa may cause and/or exacerbate preexisting states of confusion and hallucinations () and preexisting dyskinesia. Also, the abrupt discontinuation of pergolide in patients receiving it chronically as an adjunct to -dopa may precipitate the onset of hallucinations and confusion; these may occur within a span of several days. Discontinuation of pergolide should be undertaken gradually whenever possible, even if the patient is to remain on -dopa.

A symptom complex resembling the neuroleptic malignant syndrome (NMS) (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy, including pergolide.

Raynaud’s Phenomenon

Pergolide can rarely cause Raynaud’s phenomenon.

Information for Patients

Because pergolide may cause somnolence and the possibility of falling asleep during activities of daily living, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that pergolide therapy does not affect them adversely. Patients should be advised that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Due to the possible additive sedative effects, caution should also be used when patients are taking other CNS depressants in combination with pergolide.

Patients and their families should be informed of the common adverse consequences of the use of pergolide () and the risk of hypotension ().

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

Patients should be advised to notify their physician if they are breast feeding an infant.

As with other dopamine agonists, compulsive self-rewarding behavior (e.g., pathologic gambling) and libido increase have been reported in patients receiving pergolide therapy.

Laboratory Tests

No specific laboratory tests are deemed essential for the management of patients on Permax. Periodic routine evaluation of all patients, however, is appropriate.

Drug Interactions

Dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthines) or metoclopramide, ordinarily should not be administered concurrently with Permax (a dopamine agonist); these agents may diminish the effectiveness of Permax.

Because pergolide is approximately 90% bound to plasma proteins, caution should be exercised if pergolide is coadministered with other drugs known to affect protein binding.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 2-year carcinogenicity study was conducted in mice using dietary levels of pergolide equivalent to oral doses of 0.6, 3.7, and 36.4 mg/kg/day in males and 0.6, 4.4, and 40.8 mg/kg/day in females. A 2-year study in rats was conducted using dietary levels equivalent to oral doses of 0.04, 0.18, and 0.88 mg/kg/day in males and 0.05, 0.28, and 1.42 mg/kg/day in females. The highest doses tested in the mice and rats were approximately 340 and 12 times the maximum human oral dose administered in controlled clinical trials (6 mg/day equivalent to 0.12 mg/kg/day).

A low incidence of uterine neoplasms occurred in both rats and mice. Endometrial adenomas and carcinomas were observed in rats. Endometrial sarcomas were observed in mice. The occurrence of these neoplasms is probably attributable to the high estrogen/progesterone ratio that would occur in rodents as a result of the prolactin-inhibiting action of pergolide. The endocrine mechanisms believed to be involved in the rodents are not present in humans. However, even though there is no known correlation between uterine malignancies occurring in pergolide-treated rodents and human risk, there are no human data to substantiate this conclusion.

Pergolide was evaluated for mutagenic potential in a battery of tests that included an Ames bacterial mutation assay, a DNA repair assay in cultured rat hepatocytes, an in vitro mammalian cell gene mutation assay in cultured L5178Y cells, and a determination of chromosome alteration in bone marrow cells of Chinese hamsters. A weak mutagenic response was noted in the mammalian cell gene mutation assay only after metabolic activation with rat liver microsomes. No mutagenic effects were obtained in the 2 other in vitro assays and in the in vivo assay. The relevance of these findings in humans is unknown.

A fertility study in male and female mice showed that fertility was maintained at 0.6 and 1.7 mg/kg/day but decreased at 5.6 mg/kg/day. Prolactin has been reported to be involved in stimulating and maintaining progesterone levels required for implantation in mice and, therefore, the impaired fertility at the high dose may have occurred because of depressed prolactin levels.

Usage in Pregnancy − Pregnancy Category B

Reproduction studies were conducted in mice at doses of 5, 16, and 45 mg/kg/day and in rabbits at doses of 2, 6, and 16 mg/kg/day. The highest doses tested in mice and rabbits were 375 and 133 times the 6 mg/day maximum human dose administered in controlled clinical trials. In these studies, there was no evidence of harm to the fetus due to pergolide.

There are, however, no adequate and well-controlled studies in pregnant women. Among women who received pergolide for endocrine disorders in premarketing studies, there were 33 pregnancies that resulted in healthy babies and 6 pregnancies that resulted in congenital abnormalities (3 major, 3 minor); a causal relationship has not been established. Because human data are limited and because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. The pharmacologic action of pergolide suggests that it may interfere with lactation. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions to pergolide in nursing infants, 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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of the total number of subjects in clinical studies of pergolide, 78 were 65 and over. There were no apparent differences in efficacy between these subjects and younger subjects. There was an increased incidence of confusion, somnolence, and peripheral edema in patients 65 and over. 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. 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.


What are the side effects of PERMAX?

Commonly Observed

Associated With Discontinuation of Treatment

Fatalities —

see

Incidence in Controlled Clinical Trials

l

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.

Events Observed During the Premarketing Evaluation of Permax

The following enumeration by organ system describes events in terms of their relative frequency of reporting in the data base. Events of major clinical importance are also described in the Warnings and Precautions sections.

The following definitions of frequency are used: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole

Frequent:

Infrequent:

Rare:

Cardiovascular System

Frequent:

Infrequent:

Rare:

Digestive System

Frequent:

Infrequent:

Rare:

Endocrine System

Infrequent:

Rare:

Hemic and Lymphatic System

Frequent:

Infrequent:

Rare:

Metabolic and Nutritional System

Frequent:

Infrequent:

Rare:

Musculoskeletal System

Frequent:

Infrequent:

Rare:

Nervous System

Frequent:

Infrequent:

Rare:

Respiratory System

Frequent:

Infrequent:

Rare:

Skin and Appendages System

Frequent:

Infrequent:

Rare:

Special Senses System

Frequent:

Infrequent:

Rare:

Urogenital System

Frequent:

Infrequent:

Rare:

Postintroduction Reports

Incidence of Treatment-Emergent Adverse Experiences in the Placebo-Controlled Clinical Trial
PergolidePlacebo
Body system/Adverse Event*N=189N=187
Body as a Whole
Pain7.02.1
Abdominal pain5.82.1
Injury, accident5.87.0
Headache5.36.4
Asthenia4.24.8
Chest pain3.72.1
Flu syndrome3.22.1
Neck pain2.71.6
Back pain1.62.1
Surgical procedure1.6
Chills1.10
Face edema1.10
Infection1.10
Cardiovascular
Postural hypotension9.07.0
Vasodilatation3.2
Palpitation2.1
Hypotension2.1
Syncope2.11.1
Hypertension1.61.1
Arrhythmia1.1
Myocardial infarction1.1
Digestive
Nausea24.312.8
Constipation10.65.9
Diarrhea6.42.7
Dyspepsia6.42.1
Anorexia4.82.7
Dry mouth3.7
Vomitting2.71.6
Hemic and Lymphatic
Anemia1.1
Metabolic and Nutritional
Peripheral edema7.44.3
Edema1.60
Weight gain1.60
Musuloskeletal
Arthralgia1.62.1
Bursitis1.6
Myalgia1.1
Twitching1.10
Nervous System
Dyskinesia62.424.6
Dizziness19.113.9
Hallucinations13.83.2
Dystonia11.68.0
Confusion11.19.6
Somnolence10.13.7
Insomnia7.93.2
Anxiety6.44.3
Tremor4.27.5
Depression3.25.4
Abnormal dreams2.74.3
Personality disorder2.1
Psychosis2.10
Abnormal gait1.61.6
Akathisia1.60
Extrapyramidal syndrome1.61.1
Incoordination1.6
Paresthesia1.63.2
Akinesia1.11.1
Hypertonia1.10
Neuralgia1.1
Speech disorder1.11.6
Respiratory system
Rhinitis12.25.4
Dyspnea4.81.1
Epistaxis1.6
Hiccup1.10
Skin and Appendages
Rash3.22.1
Sweating2.12.7
Special Senses
Abnormal vision5.85.4
Diplopia2.10
Taste perversion1.60
Eye disorder1.10
Urogenital System
Urinary frequency2.76.4
Urinary tract infection2.73.7
Hematuria1.1



What should I look out for while using PERMAX?

Pergolide is contraindicated in patients who are hypersensitive to this drug or other ergot derivatives.

Cardiac Valvulopathy and Fibrotic Complications

(SEE

).

Falling Asleep During Activities of Daily Living

Patients treated with Permax have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on Permax, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as 1 year after the initiation of treatment.

Somnolence is a common occurrence in patients receiving Permax. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with Permax, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Permax such as concomitant sedating medications or the presence of sleep disorders. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., conversations, eating, etc.), Permax should ordinarily be discontinued. If a decision is made to continue Permax, patients should be advised to not drive and to avoid other potentially dangerous activities.

While dose reduction may reduce the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Symptomatic Hypotension

l

l

see

Hallucinosis

l

l

Fatalities

In particular, a case-by-case review of the clinical course of the patients who died failed to disclose any unique set of signs, symptoms, or laboratory results that would suggest that treatment with pergolide caused their deaths. Sixty-eight percent (68%) of the patients who died were 65 years of age or older. No death (other than a suicide) occurred within the first month of treatment; most of the patients who died had been on pergolide for years. A relative frequency of the causes of death by organ system are: Pulmonary failure/Pneumonia, 35%; Cardiovascular, 30%; Cancer, 11%; Unknown, 8.4%; Infection, 3.5%; Extrapyramidal syndrome, 3.5%; Stroke, 2.1%; Dysphagia, 2.1%; Injury, 1.4%; Suicide, 1.4%; Dehydration, 0.7%; Glomerulonephritis, 0.7%.


What might happen if I take too much PERMAX?

There is no clinical experience with massive overdosage. The largest overdose involved a young hospitalized adult patient who was not being treated with pergolide but who intentionally took 60 mg of the drug. He experienced vomiting, hypotension, and agitation. Another patient receiving a daily dosage of 7 mg of pergolide unintentionally took 19 mg/day for 3 days, after which his vital signs were normal but he experienced severe hallucinations. Within 36 hours of resumption of the prescribed dosage level, the hallucinations stopped. One patient unintentionally took 14 mg/day for 23 days instead of her prescribed 1.4 mg/day dosage. She experienced severe involuntary movements and tingling in her arms and legs. Another patient who inadvertently received 7 mg instead of the prescribed 0.7 mg experienced palpitations, hypotension, and ventricular extrasystoles. The highest total daily dose (prescribed for several patients with refractory Parkinson's disease) has exceeded 30 mg.

Symptoms

Treatment

Physicians’ Desk Reference

Management of overdosage may require supportive measures to maintain arterial blood pressure. Cardiac function should be monitored; an antiarrhythmic agent may be necessary. If signs of CNS stimulation are present, a phenothiazine or other butyrophenone neuroleptic agent may be indicated; the efficacy of such drugs in reversing the effects of overdose has not been assessed.

Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal.

There is no experience with dialysis or hemoperfusion, and these procedures are unlikely to be of benefit.


How should I store and handle PERMAX?

Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Store at controlled room temperature 20° to 25°C (68° to 77°F)Rx onlyManufactured by:Yung Shin Pharmaceutical Industrial Co., Ltd.Tachia, TaichungTaiwan, ROCRevision: April 2007Tablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USATablets (modified rectangle shape, scored):0.05 mg, ivory, debossed with A 024, in bottles of 30 (UC5336) — NDC 0187-0839-010.25 mg, green, debossed with A 025, in bottles of 100 (UC5337) — NDC 0187-0840-021 mg, pink, debossed with A 026, in bottles of 100 (UC5338) — NDC 0187-0841-02Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].PERMAX is a registered trademark of Eli Lilly and Company, and licensed in the US to Valeant Pharmaceuticals International.Literature revised August 18, 2004Manufactured for:Valeant Pharmaceuticals International3300 Hyland Ave.Costa Mesa, CA 92626 U.S.A.Part Number 3083900EX00PRINTED IN USA


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Pergolide is a potent dopamine receptor agonist. Pergolide is 10 to 1000 times more potent than bromocriptine on a milligram per milligram basis in various in vitro and in vivo test systems. Pergolide inhibits the secretion of prolactin in humans; it causes a transient rise in serum concentrations of growth hormone and a decrease in serum concentrations of luteinizing hormone. In Parkinson's disease, pergolide is believed to exert its therapeutic effect by directly stimulating postsynaptic dopamine receptors in the nigrostriatal system.

Non-Clinical Toxicology
Pergolide is contraindicated in patients who are hypersensitive to this drug or other ergot derivatives.

Cardiac Valvulopathy and Fibrotic Complications

(SEE

).

Falling Asleep During Activities of Daily Living

Patients treated with Permax have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles which sometimes resulted in accidents. Although many of these patients reported somnolence while on Permax, some perceived that they had no warning signs such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events had been reported as late as 1 year after the initiation of treatment.

Somnolence is a common occurrence in patients receiving Permax. Many clinical experts believe that falling asleep while engaged in activities of daily living always occurs in a setting of preexisting somnolence, although patients may not give such a history. For this reason, prescribers should continually reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.

Before initiating treatment with Permax, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with Permax such as concomitant sedating medications or the presence of sleep disorders. If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require participation (e.g., conversations, eating, etc.), Permax should ordinarily be discontinued. If a decision is made to continue Permax, patients should be advised to not drive and to avoid other potentially dangerous activities.

While dose reduction may reduce the degree of somnolence, there is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.

Symptomatic Hypotension

l

l

see

Hallucinosis

l

l

Fatalities

In particular, a case-by-case review of the clinical course of the patients who died failed to disclose any unique set of signs, symptoms, or laboratory results that would suggest that treatment with pergolide caused their deaths. Sixty-eight percent (68%) of the patients who died were 65 years of age or older. No death (other than a suicide) occurred within the first month of treatment; most of the patients who died had been on pergolide for years. A relative frequency of the causes of death by organ system are: Pulmonary failure/Pneumonia, 35%; Cardiovascular, 30%; Cancer, 11%; Unknown, 8.4%; Infection, 3.5%; Extrapyramidal syndrome, 3.5%; Stroke, 2.1%; Dysphagia, 2.1%; Injury, 1.4%; Suicide, 1.4%; Dehydration, 0.7%; Glomerulonephritis, 0.7%.

Dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthines) or metoclopramide, ordinarily should not be administered concurrently with Permax (a dopamine agonist); these agents may diminish the effectiveness of Permax.

Because pergolide is approximately 90% bound to plasma proteins, caution should be exercised if pergolide is coadministered with other drugs known to affect protein binding.

Caution should be exercised when administering pergolide to patients prone to cardiac dysrhythmias.

In a study comparing pergolide and placebo, patients taking pergolide were found to have significantly more episodes of atrial premature contractions (APCs) and sinus tachycardia.

The use of pergolide in patients on -dopa may cause and/or exacerbate preexisting states of confusion and hallucinations () and preexisting dyskinesia. Also, the abrupt discontinuation of pergolide in patients receiving it chronically as an adjunct to -dopa may precipitate the onset of hallucinations and confusion; these may occur within a span of several days. Discontinuation of pergolide should be undertaken gradually whenever possible, even if the patient is to remain on -dopa.

A symptom complex resembling the neuroleptic malignant syndrome (NMS) (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy, including pergolide.

Raynaud’s Phenomenon

Pergolide can rarely cause Raynaud’s phenomenon.

Commonly Observed

Associated With Discontinuation of Treatment

Fatalities —

see

Incidence in Controlled Clinical Trials

l

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.

Events Observed During the Premarketing Evaluation of Permax

The following enumeration by organ system describes events in terms of their relative frequency of reporting in the data base. Events of major clinical importance are also described in the Warnings and Precautions sections.

The following definitions of frequency are used: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a Whole

Frequent:

Infrequent:

Rare:

Cardiovascular System

Frequent:

Infrequent:

Rare:

Digestive System

Frequent:

Infrequent:

Rare:

Endocrine System

Infrequent:

Rare:

Hemic and Lymphatic System

Frequent:

Infrequent:

Rare:

Metabolic and Nutritional System

Frequent:

Infrequent:

Rare:

Musculoskeletal System

Frequent:

Infrequent:

Rare:

Nervous System

Frequent:

Infrequent:

Rare:

Respiratory System

Frequent:

Infrequent:

Rare:

Skin and Appendages System

Frequent:

Infrequent:

Rare:

Special Senses System

Frequent:

Infrequent:

Rare:

Urogenital System

Frequent:

Infrequent:

Rare:

Postintroduction Reports

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).