Cloppelin Tablets (Clophelin tablets)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceClonidineClonidine
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  • Clophelin
    drops d / eye 
    MOSCOW ENDOCRINE FACTORY, FSUE     Russia
  • Clofelin injection for 0.01%
    solution in / in 
    ORGANICS, JSC     Russia
  • Cloppelin Tablets
    pills inwards 
    MOSCOW ENDOCRINE FACTORY, FSUE     Russia
    • Dosage form: & nbsp

    pills

    Composition:

    Active substance:

    clonidine hydrochloride (clonidine) - 0.15 mg.

    Excipients:

    potato starch - 13.79 mg, povidone (polyvinylpyrrolidone low molecular weight medical 12600 ± 2700) - 1.20 mg, lactose monohydrate (sugar milk) -133.36 mg, magnesium stearate-1.50 mg.

    Description:

    Tablets are white, round, flat-cylindrical with a facet and a risk.

    Pharmacotherapeutic group:Hypotensive central agent
    ATX: & nbsp
  • Clonidine
    • Pharmacodynamics:

    A central-action hypotensive drug, penetrating the blood-brain barrier, stimulates postsynaptic alpha2-adrenoceptors of the vasomotor center of the medulla oblongata and reduces the flow of sympathetic impulse to the vessels and the heart at the presynaptic level. Reduces the overall peripheral vascular resistance and the minute volume of blood, reduces the heart rate. Increases renal blood flow; increasing the tone of the vessels of the brain, reduces cerebral blood flow; has a pronounced sedative effect.The beginning of antihypertensive action - after 30-60 minutes after ingestion maximum effect - in 2-4 hours. The duration of the therapeutic effect is 6-12 hours.

    Pharmacokinetics:

    Absorption after oral administration is rapid. Biodegrade with long-term use - about 65%. The maximum concentration in the blood plasma after ingestion is 1, 5-2.5 hours. Connection with blood plasma proteins - 20-40%. Easily and quickly penetrates the blood-brain barrier, the placenta and into breast milk.

    Metabolised by the liver (about 50% of the absorbed drug).

    It is excreted by the kidneys (40-60%) and through the intestine (20%).

    The half-life of the drug is 12-16 hours, with a violation of the kidneys - up to 41 hours.

    Indications:

    Arterial hypertension (including renovascular).

    Contraindications:

    Hypersensitivity to the components of the drug, atrioventricular blockade of II and III degree, pronounced sinus bradycardia, weakness syndrome of the sinus node, arterial hypotension, simultaneous use of tricyclic antidepressants, and ethanol, pregnancy, lactation, age under 18 years (efficacy and safety not established) , lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Carefully:
    Ischemic heart disease (especially recent myocardial infarction), severe chronic heart failure, cardiogenic shock, intracardiac conduction disorders, obliterating arterial diseases; expressed atherosclerotic changes in cerebral vessels, depression (including in the anamnesis), cerebrovascular diseases, polyneuropathy, constipation, diabetes mellitus, hepatic insufficiency, chronic renal failure.
    Pregnancy and lactation:

    RThe results of clinical studies of clonidine in beremaMr.are limited. Application during pregnancy is contraindicated. Clonidine penetrates into breast milk, so when Mr.The need for preparation During lactation,toratify goreMr.th feeding.

    Dosing and Administration:

    The drug is effective in very small doses. Doses should be selected strictly individually.

    Clopheline is taken during or after a meal, without chewing, with a small amount of liquid. Usually, treatment starts with small doses (0.075 mg 2-3 times a day). If the antihypertensive effect is insufficient, a single dose is gradually increased every 1-2 days by 0.0375 mg to 0.15 mg.

    In elderly patients, especially with the manifestation of cerebral vascular sclerosis, hypersensitivity to the drug is possible. Therefore, they start treatment with a dose of 0.0375 mg.

    Daily doses are usually 0.3-0.45 mg, sometimes 1.2-1.5 mg.

    The maximum single dose is 0.3 mg; the maximum daily dose is 2.4 mg.

    Side effects:

    Frequency: very often - more than 1/10, often - more than 1/100 and less than 1/10, infrequently - more than 1/1000 and less than 1/100, rarely - more than 1/10000 and less than 1/1000, very rarely - less than 1/10000, including single messages.

    From the central nervous system: very often - dizziness, drowsiness, increased fatigue, slowing the speed of mental and motor reactions; often - headache, nervousness, depression, sleep disturbance; infrequently - paresthesia, rarely - asthenia, impaired perception, hallucinations, bright or "nightmarish" dreams; frequency is unknown - confusion.

    From the sense organs: rarely - reduced tearing; frequency is unknown - the detriment of accommodation.

    From the side of the cardiovascular system: in rare cases at the beginning of treatment, a paradoxical increase in blood pressure (short-term) is possible; very often - orthostatic hypotension, infrequently - sinus bradycardia,Raynaud's syndrome; rarely - atrioventricular block; frequency unknown - bradyarrhythmia.

    From the respiratory system: rarely - dryness of the nasal mucosa.

    From the digestive system: very often - dryness of the oral mucosa; often - constipation, decreased appetite, nausea, pain in the salivary glands, decreased gastric secretion, vomiting; rarely pseudo-obstruction of the large intestine; frequency is unknown-hepatitis.

    From the skin: infrequently - skin itching, rash (including urticaria); rarely, alopecia.

    From the side of the reproductive system: often - erectile dysfunction; frequency is unknown - decreased libido; rarely gynecomastia.

    From the laboratory indicators: rarely - hyperglycemia; frequency unknown - change in functional liver samples.

    Other: the frequency is unknown - the phenomenon of Raynaud, the delay of sodium and water, manifested by swelling of the feet and ankles, infrequent - nasal congestion; with a sudden abolition - the syndrome of "cancellation", "hemiton crisis."

    If the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: pronounced bradycardia, slowing of atrioventricular conduction, syndrome of early repolarization, sedation, respiratory depression (up to apnea), depression of consciousness (up to coma); change in blood pressure - from a pronounced decrease to a significant increase, collapse; weakness, vomiting, decreased or absent reflexes, pallor of the skin, hypothermia, arrhythmia, miosis, weak pupillary response to light.

    Treatment: reception of activated carbon, gastric lavage in case of an overdose; symptomatic therapy (with bradycardia-atropine, with an increase in blood pressure-vasodilators, with a decrease - vasopressors, with respiratory depression, coma and pronounced lowering of blood pressure - naloxone); regular monitoring of heart rate, blood pressure (within 48 hours), electrocardiograms, blood glucose concentrations, body temperature. Hemodialysis is ineffective.

    Interaction:

    Strengthens the effect of drugs that depress the central nervous system, and ethanol.

    The effect is enhanced by other vasodilators, antihypertensive drugs,diuretics and blockers of H1-histamine receptors; weaken - tricyclic antidepressants, anorexigenic drugs (with the exception of fenfluramine - strengthens), nonsteroidal anti-inflammatory drugs, non-selective alpha-blockers (including phentolamine, tolazoline - due to the blockade of alpha2adrenoreceptors) and adrenomimetics.

    Beta-adrenoblockers, blockers of "slow" calcium channels and / or cardiac glycosides increase the risk of bradycardia and atrioventricular blockade.

    Special instructions:

    The course of treatment depends on the results obtained, the duration of treatment is determined by the doctor. Stopping the drug should be done gradually (reduce doses) for 7-10 days to avoid the development of hypertensive crisis - "withdrawal syndrome" (anxiety, palpitation, a sharp rise in blood pressure, nervousness, tremor, headache, nausea, especially in patients, taking more than 0.9 mg per day). With the development of the syndrome, they immediately return to taking the drug and in the future it is gradually canceled, replacing it with other antihypertensive drugs.To prevent the syndrome, the drug should not be prescribed to patients who do not have the conditions for its regular admission.

    With simultaneous use with beta-blockers and the need to cancel both drugs, first gradually the beta-blockers are abolished, then clonidine.

    Special care should be taken in patients with depression or cerebrovascular disease, A sharp drop in blood pressure can cause changes in mental status.

    Patients with diabetes may require an increase in the dose of hypoglycemic drugs.

    Not effective with pheochromocytoma.

    During treatment, clonidine is prohibited from drinking alcohol. Patients using contact lenses should remember that the drug reduces the production of tear fluid.

    If the kidney or liver is impaired, blood pressure should be monitored more closely.

    Effect on the ability to drive transp. cf. and fur:It should be taken into account that the drug reduces mental and physical reactions in different types of operator activity.Treatment of patients, whose work requires a quick mental and physical reaction (driving and other potentially dangerous activities requiring increased concentration and speed of psychomotor reactions) is only permissible in a hospital or outpatient setting with exemption from work.
    Form release / dosage:

    Tablets of 0.15 mg.

    Packaging:
    10 tablets per contour cell pack. 1, 2 or 5 contour cells; Packaging together with the instructions for use are placed in a pack of cardboard.
    Storage conditions:

    In accordance with the rules for storage of potent substances.

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 of the year. Not use after expiration term validity, the on packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001148
    Date of registration:29.08.2011 / 13.02.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia
    Manufacturer: & nbsp
    Representation: & nbspMOSCOW ENDOCRINE FACTORY FGUP MOSCOW ENDOCRINE FACTORY FGUP Russia
    Information update date: & nbsp30.01.2018
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