Rekvip Modatab - instructions for use, analogs, reviews and release forms (2 mg, 4 mg and 8 mg tablets) of the drug for the treatment of Parkinson's disease in adults, children and pregnancy. Composition and alcohol

In this article, you can read the instructions for using the drug Rekvip Modabit. Presented are reviews of visitors to the site - consumers of this medication, as well as the opinions of the doctors of specialists on the use of Requital Modababa in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Rekvip Modababa in the presence of existing structural analogues. Use for the treatment of Parkinson's disease in adults, children, as well as in pregnancy and lactation. Composition and interaction of the drug with alcohol.

Rekvip Modabitab - an anti-Parkinsonian drug, a highly selective non -ergoline agonist of dopamine D2 and D3 receptors, which has a peripheral and central effect. The drug does not affect the collapsing presynaptic dopaminergic neurons of black matter and acts directly as a synthetic neurotransmitter. Thus, ropinirole (the active substance of the drug Rekvip Modatab) reduces the degree of hypodynamia, rigidity and tremor, which are symptoms of parkinsonism.

Ropinirole compensates for dopamine deficiency in systems of black matter and the striatum by stimulating dopamine receptors in the striatum. It enhances the effects of levodopa, including monitoring the incidence of the on / off phenomenon and the effect of "end-of-dose" associated with prolonged therapy with levodopa drugs, and allows to reduce the daily dose of levodopa.

Ropinirole has an effect on the hypothalamus and pituitary levels, inhibiting the secretion of prolactin.

Composition

Ropinirole + auxiliary substances.

Pharmacokinetics

The pharmacokinetics of ropinirole is similar in healthy people, patients with Parkinson's disease and patients with restless legs syndrome and varies depending on the dosage form.After oral administration, the bioavailability of ropinirole is low and is approximately 50%. Binding to blood plasma proteins is low (10-40%). Ropinirole is mainly metabolized by the isoenzyme CYP1A2. The metabolite of ropinirole is mainly excreted by the kidneys. There is no difference in the excretion of ropinirole after a single dose inward or with regular use.

Indications

• Parkinson's disease, namely monotherapy of early stages of the disease in patients requiring dopaminergic therapy to delay the appointment of drugs of levodopa;
• as part of combination therapy in patients receiving levodopa preparations to improve the effectiveness of levodopa, including monitoring the fluctuations in the therapeutic action of levodopa (the phenomenon of "on-off") and the effect of "end-of-dose" on the background of chronic therapy with levodopa, and also in order to reduce the daily dose levodopa.

Forms of release

Tablets 2 mg, 4 mg and 8 mg.

Instructions for use and dosing regimen

The drug is administered orally once a day at the same time, regardless of the meal. Tablets take whole, not liquid, not breaking.

Individual selection of the dose is recommended in accordance with the efficacy and tolerability of the drug.

It is recommended that the dose be reduced in the event that the patient experiences drowsiness at any stage of dose selection. When developing other unwanted reactions, it is necessary to reduce the dose of the drug followed by a gradual increase in the dose.

It should be borne in mind the need for titration dose when passing a dose (one or more).

Monotherapy

The recommended initial dose of Rekvip Modabat is 2 mg once a day for one week. Subsequently, the dose is increased by 2 mg at intervals of not less than 1 week to 8 mg per day. If, after choosing a dose, the therapeutic effect is not sufficiently pronounced or unstable, you can continue increasing the daily dose of the drug by 4 mg at intervals of 1-2 weeks (until the desired therapeutic effect is achieved). The dose can be changed depending on the therapeutic effect and increased to a maximum dose of 24 mg once a day.

Combination Therapy

When using Rekvip Modabut in doses used in monotherapy, in combination with levodopa preparations, the dose of levodopa can be gradually reduced (depending on the clinical effect).In clinical trials in patients simultaneously receiving requetip modabab in sustained-release tablets, the dose of levodopa was gradually reduced by approximately 30%. Patients with a progressive form of the disease who are taking Rekvip Modabab in combination with levodopa preparations may experience dyskinesia during the titration of ropinirole. Reducing the dose of levodopa medications can lead to a decrease in this symptomatology.

Abolition of therapy

Rekvip Modabab (as well as other dopaminergic drugs) should be canceled, gradually reducing the daily dose for at least 1 week. If treatment was interrupted for 1 day or more, then when resumption of therapy should consider the need for titration dose.

Despite the possible reduction in clearance of the drug in patients aged 65 years and older, titration of the dose of ropinirole in this category of patients is carried out as usual.

In patients with impaired renal function of mild and moderate severity (creatinine clearance 30-50 ml per minute) the clearance of ropinirole does not change, correction of the dose of ropinirole is not required.

For patients with a terminal stage of renal failure who are on hemodialysis, the recommended initial dose of ropinirole is 2 mg 1 time per day.The subsequent dose increase should be based on an assessment of tolerability and efficacy. The maximum daily dose in patients on chronic hemodialysis is 18 mg. The introduction of maintenance doses after hemodialysis is not required.

Side effect

Clinical Trials Data:

• hallucinations;
• drowsiness;
• dizziness;
• hypotension (lowering blood pressure);
• Orthostatic hypotension (a violation of the ability of the body to maintain a normal level of blood pressure in the vertical position);
• nausea, vomiting;
• abdominal pain, indigestion (disruption of normal stomach activity, difficult and painful digestion);
• constipation;
• peripheral edema;
• dyskinesia (impaired coordination of movements) may develop in patients with a progressive form of the disease who are taking Rekvip Modabut in combination with levodopa preparations, during the titration period.

Post-registration data:

• hypersensitivity reactions, including hives, angioedema, rash, itching;
• psychotic reactions (excluding hallucinations), including delusions, paranoia, delirium;
• a syndrome of impulsive drives (the desire for arson, the desire for murder, as well as the pathological attraction to picking up trash ("Plyushkin's symptom"), etc.);
• increased libido (sexual desire), including hypersexuality;
• pathological attraction to gambling;
• irresistible attraction to shopping;
• binge eating;
• aggression;
• severe drowsiness, episodes of sudden falling asleep;
• orthostatic hypotension;
• hypotension.

Contraindications

• acute psychosis;
• impaired liver function;
• severe impairment of kidney function (QC less than 30 ml per minute), which does not undergo regular hemodialysis;
• rare hereditary diseases: lactose intolerance, lactase deficiency, impaired absorption of glucose or galactose;
• pregnancy;
• lactation (breastfeeding);
• children and adolescents under 18;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Contraindicated the use of Requital Modababa during pregnancy and lactation.

Use in children

Contraindicated in children and adolescents under the age of 18 years.

Application in elderly patients

Despite the possible reduction in clearance of the drug in patients aged 65 years and older, titration of the dose of ropinirole in this category of patients is carried out as usual.

special instructions

Patients should be warned about the possible development of drowsiness or episodes of sudden falling asleep, sometimes not preceded by drowsiness. In the case of such reactions, consideration should be given to the possibility of reversing therapy.

It is recommended to monitor blood pressure (BP) because of the possibility of developing orthostatic hypotension.

Patients receiving dopaminergic drugs, including ropinirole, reported a syndrome of impulsive drives, including compulsive behavior, including pathological attraction to gambling, hypersexuality, an irresistible attraction to shopping, overeating. Attraction disorders, as a rule, are reversible after dose reduction or drug withdrawal. In some cases, with the use of the Rekvip Modabut drug, other risk factors may be compulsive behavior in the history or the combined use of several dopaminergic drugs.

Paradoxical worsening of restless legs syndrome was noted with ropinirole therapy (earlier onset, increased intensity of manifestation, or progression of symptoms involving previously unaffected limbs), or ricochet syndrome in the early morning hours (relapse of symptoms in the early morning hours). When these symptoms appear, it is necessary to revise the tactics of treatment with ropinirole, specify the dose up to the possible withdrawal of the drug.

The drug Rekvap Modabut is available in the form of long-acting tablets coated with a film coat, with the property of releasing the active substance within 24 hours. In the case of rapid passage of the drug through the gastrointestinal tract (GIT), there is a risk of incomplete release of the drug and the transition of its residue in the stool.

Impact on the ability to drive vehicles and manage mechanisms

Patients should be advised of possible adverse reactions during ropinirole therapy.

Patients should be informed that there are very rare cases of episodes of sudden falling asleep without any previous or obvious signs of daytime sleepiness and cases of dizziness (sometimes expressed).If the patient develops daytime drowsiness or episodes of falling asleep during the day, requiring active intervention, the patient should be warned about the need to abandon driving and avoid other activities requiring high concentration and speed of psychomotor reactions.

Drug Interactions

Typical antipsychotics and other central action dopamine antagonists, such as Sulpiride or metoclopramide, can reduce the effectiveness of ropinirole (simultaneous administration should be avoided).

There was no pharmacokinetic interaction between ropinirole and levodopa or domperidone, which would require correction of the doses of these drugs.

Rekvip Modabut does not interact with other drugs that are often used to treat Parkinson's disease.

In patients with Parkinson's disease, who simultaneously took digoxin, there was no interaction of Digoxin with ropinirole, which would require correction of doses.

Ropinirole is mainly metabolized by the isoenzyme CYP1A2. In patients receiving ropinirole, its dose should be adjusted for the appointment and discontinuation of drugs,inhibiting isoenzyme CYP1A2, for example, ciprofloxacin, enoxacin or fluvoxamine.

A pharmacokinetic study of the drug interaction in patients with Parkinson's disease between ropinirole and theophylline, which is the substrate of the CYP1A2 isoenzyme, showed that the pharmacokinetics of the drugs do not change. With the simultaneous use of ropinirole with other substrates of the CYP1A2 isoenzyme, the pharmacokinetics of ropinirole does not change.

An increase in the plasma concentration of ropinirole was observed in patients receiving estrogens in high doses. In patients receiving hormone replacement therapy before starting treatment with ropinirole, ropinirole treatment can be started according to the usual scheme. However, in the event of discontinuation of hormone replacement therapy or its initiation during therapy with ropinirole, dose adjustment may be required.

There is no information on the possible interaction of ropinirole and ethanol (alcohol). As with other central drugs, patients should be warned about the need to refrain from drinking alcohol (ethanol) during treatment with ropinirole.

It is known that nicotine induces the isoenzyme CYP1A2, so in case the patient starts or stops smoking during ropinirole treatment, it may be necessary to adjust its dose.

Analogues of the medicinal product

Structural analogs for the active substance:

• Rolprin;
• Cindranol.

Analogues of the Rekvip Modabab preparation for the pharmacological group (antiparkinsonian agents):

• Azilect;
• Bromocriptine;
• Bromergon;
• Duellin;
• Zimox;
• Izik;
• Cognitive;
• Creeded;
• Levodopa;
• Levodopa + Benserazide;
• Madopar;
• Midantan;
• Mipexol;
• Mirapex;
• On whom;
• Niar;
• Newpro;
• Decrying;
• Parcón;
• Parlodel;
• Permax;
• Piribedil;
• PC-Merz;
• Pramipexole;
• Pronoran;
• Razagiline mesylate;
• Rolprin;
• Segan;
• Selegiline;
• Cindranol;
• Sinemet;
• Stalevo;
• Striaton;
• Tasmar;
• Tremonorm;
• Eldepril.

Review of the neurologist's doctor

The medicinal preparation of Rekvip Modatab I appoint to patients with Parkinson's disease quite often. The daily dose is always selected individually for each patient, depending on how he responds to therapy. The average daily dose usually varies from 4 mg to 8 mg per day, but sometimes it has to be increased to 20-22 mg per day.Always warn patients about the possible development of adverse reactions during treatment. In my practice on Rekvip Modabut therapy, both with monotherapy and when combined with levodopa preparations, patients complain of the following undesirable effects: drowsiness, constipation, hallucinations (rarely), pressure decrease.

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