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Parkipex 1 Mg 100 Tablets ingredient Pramipexole
Starch 1500, mannitol, microcrystalline cellulose, povidone, talc, magnesium stearate, purified water, ethyl alcohol 96%
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PARKIPEX is indicated for the treatment of signs and symptoms in idiopathic Parkinson's disease. It can be used as monotherapy or in combination with levodopa.
PARKIPEX is indicated for the symptomatic treatment of idiopathic restless leg syndrome.
(All dose information is in salt form on the pramipexole). Adults:
Posology / Application frequency, duration and shape
Tablets should be taken orally and swallowed. Tablets can be opened or packed. The daily dose is divided into three equal parts (3 x). Initial treatment
Dosage should be increased stepwise from an initial dose of 0.375 mg per day, as shown below, and dose increments should be made at intervals of 5-7 days. The dosage should be titrated until the maximum therapeutic effect is achieved, as long as the patient does not have any unacceptable side effects.
If higher doses are required, the daily dose should be increased to 0.75 mg with weekly intervals. The maximum daily dose is 4.5 mg. Maintenance therapy
Daily individual doses should be in the range of 0.375 mg and a maximum of 4.5 mg. In the three main clinical trials, during the dose increase, at the early and later stages of the disease, efficacy was observed when the dose of 1.5 mg per day was started. This observation does not exclude that for some patients, doses higher than 1.5 mg / day may provide additional therapeutic benefits. This applies in particular to persons with advanced disease who are intended to reduce levadopa therapy.
The termination of treatment should be completed by
decreasing the number of steps in a few days. Dosage in patients
receiving concurrent levodopa treatment In patients receiving simultaneous levodopa therapy, it is recommended to reduce the dose of levodopa with PARKIPEX for both dose increase and maintenance treatment periods. This dose reduction may be necessary to avoid excessive dopaminergic stimulation. Restless leg syndrome
Tablets should be taken orally and swallowed. Tablets can be opened or packed.
The recommended starting dose of PARKIPEX is 0.125 mg taken 2-3 hours before bedtime once a day. In patients requiring more symptomatic recovery, the dose may be increased to a maximum of 0.75 mg per day by increasing every 4-7 days.can be
The termination of treatmentterminated
without reducing the dose of PARKIPEX.
Additional information on special populations: Renal failure: Parkinson's disease
Elimination of pramipexole is dependent on renal function. The following dose scheme is recommended when initiating therapy: In
patients with creatinine clearance greater than 50 mL / min, the reduction of the daily dose is not necessary.
In patients with creatinine clearance of 20-50 mL / min, the initial daily dose of PARKYPEX should be administered in two divided doses and should be started twice a day with 0.125 mg (0.25 mg / day). In patients with creatinine clearance below 20 mL / min, daily dose of PARKIPEX should be administered as a single dose daily and should be started at 0.125 mg daily.
If renal function is reduced during maintenance therapy, the dose of PARKIPEX is reduced by the same rate as the decrease in creatinine clearance; eg, if creatinine clearance is reduced by 30%, the daily dose of PARKIPEX is reduced by 30%. The daily doses are given as a single dose per day if the creatinine clearance is between 20-50 mL / min in two divided doses per day and if the creatinine clearance is below 20 mL / min.
restless leg syndrome
Elimination ofPARKIPEX is dependent on renal function and is closely related to creatinine clearance. On the basis of a pharmacokinetic study in patients with renal impairment, reduction of the daily dose in patients with creatinine clearance above 20 mL / min is not necessary. There is no study on the use of PARKIPEX in patients with restless leg syndrome with renal impairment.
Liver failure: Parkinson's disease Since
90% of the absorbed drug is excreted by the kidneys, dose reduction is not considered necessary in patients with liver impairment.
Restless leg syndrome Since
about 90% of the absorbed drug is excreted via the kidneys, dose reduction is not considered necessary in patients with liver impairment.
Pediatric population: The
effectiveness and safety of PARKIPEX in children and adolescents up to the age of 18 years has not been established.
When prescribing PARKIPEX to a patient with renal impairment, a dose reduction is recommended as described in the section on posology and mode of administration.
Hallucinations and confusion are known side effects of dopamine agonists and levodopa treatments in patients with Parkinson's disease. When PARKIPEX was given in combination with levodopa to the advanced Parkinson's disease, hallucinations were more frequent in the early period of Parkinson's disease than monotherapy. In the clinical development program for licensing for restless leg syndrome, hallucinations have been reported in one case. Patients should be warned that hallucinations (mostly visual) may occur.
Patients should be aware of the fact that hallucinations may occur and may adversely affect their ability to drive.
Persons interested in the care and treatment of patients and patients should be aware of the fact that behavioral changes may occur (eg pathological gambling, hypersexuality, increased libido, over-eating). Reduction of the dose or a gradual reduction of the dose should be considered.
In a 2-year carcinogenicity study of albino rats, pathological changes in the retina (degeneration and loss of photoreceptor cells) were observed. Similar changes could not be revealed in retinal assessments of albino mice, pigmented rats, monkeys and mini-pigs. The potential significance of this effect in humans has not been established, but cannot be neglected, due to the possibility of degradation in a universally existent mechanism (ie, disc shift) in vertebrates.
Care should be taken in case of severe cardiovascular disease. Due to the risk of postural hypotension associated with dopaminergic treatment, it is recommended to monitor blood pressure, especially at the beginning of treatment.
Patients should be warned of the potential sedative effects associated with PARKIPEX, including somnolence and hibernation, when performing daily activities. Because somnolence is a frequently encountered undesirable event and can potentially cause serious consequences, patients should not use cars or operate complex machines until they have enough experience on the use of PARKIPEX to measure whether this drug adversely affects their mental and / or motor performance. It should be advised that patients should not use cars, engage in potentially dangerous activities, and consult their physician at any time during the treatment, during periods of daily living (eg speeches, eating, etc.) when there is an increase in the number of somnolence or falling asleep.
Epidemiological studies have shown that patients with Parkinson's have a higher risk of developing melanoma than the general population (about 2 to 6 times higher). It is not clear whether this increased risk depends on Parkinson's disease or other factors such as medications used for the treatment of this disease.
For the reasons described above, it is recommended that patients and healthcare professionals observe the use of pramipexole or other dopaminergic drugs for melanoma.
Parkinson's disease With the
abrupt discontinuation of dopaminergic therapy, symptoms suggestive of a neuroleptic malignant syndrome have been reported.
Increase in Restless Legs Syndrome In the
Report Literature indicate that treatment with dopaminergic drugs in restless leg syndrome may result in increased disease.
As the disease increases, the symptoms start earlier in the evenings (even in the afternoon), and the symptoms are spread to keep the other extremities. PARKIPEX-controlled studies in patients with restless leg syndrome were generally not long enough to properly elucidate the phenomenon of increased disease. After prolonged use of PARKIPEX, the frequency of the increase in the incidence of disease and the appropriate treatment of these events have not been investigated in controlled clinical trials.
Pramipexole is bound to plasma proteins at a very low level (<20%) and a low biotransformation is observed in humans. Therefore, there is no possibility of interaction with other drugs acting on elimination by binding to plasma proteins or by biotransformation.
Drugs that inhibit the active tubular secretion of basic cationic drugs, such as cimetidine, or are eliminated by active renal tubular secretion themselves, can interact with PARKIPEX and lead to a decrease in the clearance of one or both of the two drugs.
In the case of treatment with such drugs (including amantadine), excessive dopamine stimulation such as dyskinesias, agitation or hallucinations should be considered. Dose reduction is necessary when these conditions occur.
Selegiline or levodopa do not affect the pharmacokinetics of pramipexole. The degree of absorption or elimination of levodopa is not altered by the pramipexole. Interactions with anticholinergics and amantadine have not been studied. Pharmacokinetic drug interactions with pramipexole are unlikely because anticholinergics are mainly eliminated by the metabolic route. Amantadine has the possibility of interaction with the kidneys because they are excreted in the same system. While increasing the dose of PARKIPEX in patients with Parkinson's disease, it is recommended to reduce the levodopa dose and to keep the doses of other antiparkinsonian drugs constant.
Caution is advised in the case of patients taking other sedating drugs or alcohol with PARKIPEX and taking medications that raise plasma pramipexole levels (eg cimetidine) together with the possibility of additive effect.
Additional information on special populations
No interaction studies have been conducted.
Pregnancy category: C
Women with childbearing potential / Contraception The
women with childbearing potential should use contraceptive methods that are considered to be medically effective during treatment.
The effects on pregnancy and lactation in humans have not been investigated.
Pramipexole did not show teratogenic effects in rats and rabbits, but showed embryotoxic effects in rats in materno toxic doses.
PARKIPEX should only be used when the potential benefits outweigh the potential risk on the fetus in pregnancy.
It has lactation period
not been studied on whether thePARKIPEX passes into milk in women. The concentration of the drug in milk is higher in rats than in plasma.
In humans, inhibition of lactation is expected because PARKIPEX treatment inhibits prolactin secretion. As a result, PARKIPEX should not be used during breastfeeding.
Reproductive ability / Fertility
ability toPatients should be aware of the fact that hallucinations may occur and that this may adversely affect their ability to drive.
Patients should be warned of the potential sedative effects associated with PARKIPEX, including somnolence and hibernation, when performing daily activities. Because somnolence is a frequently encountered undesirable event and can potentially cause serious consequences, patients should not use cars or operate complex machines until they have enough experience on the use of PARKIPEX to measure whether this drug adversely affects their mental and / or motor performance.
potential clinical effects are listed below by system organ class. Frequencies are defined as follows: very common (> 1/10); common (> 1/100 to <1/10); non-common (> 1/1000 to <1/100); sparse (> 1/10000 to <1/1000); very rare (<1/10000) unknown (unpredictable from available data).
Metabolism and nutritional disorders
Uncommon: Weight gain, overeating
Common: Hallucinations, abnormal dreams, confusion,
Uncommon: Pathological gambling, increased libido, hypersexuality, paranoia
Diseases of the nervous system
Common: dizziness, dyskinesias, delusion, head pain, hyperkinesis, somnolans, insomnia Uncommon: Sudden sleep collapse
Common: Nausea, constipation
Skin and subcutaneous tissue disorders
Uncommon: Itching, rash and other hypersensitivity reactions
General disorders and diseases related to the site of application
There is no massive overdose at the clinic. Expected adverse events will be reactions associated with the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesis, hallucinations, agitation, and hypotension.
A dopamine agonist has no identified antidote for overdose. In the presence of central nervous system stimulation findings, a neuroleptic agent may be indicated. Gastric lavage, intravenous fluids and electrocardiographic monitoring as well as general supportive measures may be necessary for overdose.
Hemodialysis has not been shown to be beneficial.
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