Diazolin 100 mg 10s dragee
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The instruction
for medical use
of medicine
Diazolinum
the Trade name
Diazolinum
the International unlicensed
name Mebgidrolin Lekarstvennaya a form
of the Dragee of 50 mg and 100 mg
Structure
One dragee contains
active agent - mebgidrolin – 50 mg, 100 mg,
excipients: sucrose (sugar), starch syrup, povidone (Kollidon 25), sunflower oil
the Description
of the Dragee of color, white or white with a yellowish shade, refined deodorized, talc, wax. In a dragee of color, white or white with slightly creamy or slightly greenish shade.
Pharmacotherapeutic group
Antihistaminic drugs of systemic action others. Mebgidrolin.
The ATX R06AX15 code
the Pharmacological
Pharmacokinetics Therapeutic Effect properties develops 15-30 minutes later after reception, the maximum action is observed in 1-2 hours. Duration of effect can reach 2 days.
It is quickly soaked up from digestive tract, gets into all body tissues. The bioavailability fluctuates within 40-60%. Plasma elimination half-life makes about 4 hours. Drug practically does not get through a blood-brain barrier. It is metabolized in a liver by methylation, induces microsomal enzymes of a liver, it is removed by kidneys.
Pharmacodynamics
Blocker of H1-histamine receptors. Possesses antiallergic action, reduces hypostasis of mucous membranes. Diazolinum weakens action of a histamine on unstriated muscles of bronchial tubes, a uterus and intestines, reduces severity of a lowering of arterial pressure and increase in permeability of vessels. Slightly getting into the central nervous system, unlike antihistaminic drugs of the first generation, has no significant sedative and somnolent effect. Has the slight M-cholinergic and anesthetizing properties.
Indications
- allergic rhinitis, a pollinosis
- urticaria
- a Quincke's edema
- allergodermatoz, followed by a skin itching (eczema, neurodermatitis)
- allergic conjunctivitis
- skin reaction after sting
it is necessary to accept the Route of administration and doses of the Dragee inside, without chewing, in time or right after food.
To adults and children from 12 years appoint 100 mg 1-3 times a day. The maximum doses for adults: single – 300 mg, daily – 600 mg.
Duration of a course of treatment is defined by the nature of a disease and the reached therapeutic effect.
For children aged from 6 up to 10 years – on 50 mg 2-3 times a day, from 10 to 12 years – on 50 mg 2-4 times a day.
Side effects
from digestive tract: renders the irritant action on a mucous membrane of digestive tract which is shown the dispepsichesky phenomena (heartburn, nausea, pain in epigastric area).
From nervous system: dizziness, paresthesias, tremor, increased fatigue, drowsiness, uneasiness (at night), delay of speed of psychomotor reaction.
Other: dryness in a mouth, an urination delay, allergic reactions, a granulocytopenia and an agranulocytosis.
Children have paradoxical reactions: hyperexcitability, irritability, tremor, sleep disorders.
Contraindications
- hypersensitivity
- a prostate hyperplasia
- closed-angle glaucoma
- a peptic ulcer of a stomach and a 12-perstny gut
- inflammatory diseases of digestive tract
- a pylorostenosis
- epilepsy
- disturbances of a warm rhythm
- pregnancy and the period of a lactation
- children's age up to 6 years
- the deficiency of invertase/isomaltase, intolerance of fructose, glyukozo-galaktozny malabsorption (in connection with presence of sucrose as a part of drug)
Medicinal interactions
Strengthens effect of ethanol, sedatives.
Special instructions
With care use drug at patients from a liver and/or renal failure (adjustment of dose and intervals between receptions), at patients with diabetes (in connection with presence of sucrose as a part of drug can be required).
It is ineffective in bronchial asthma and an acute anaphylaxis.
Patients with diabetes should pay attention to the content of sugar as a part of drug. 1 dragee contains 187.680 mg of sucrose for a dragee of 50 mg or 224.715 mg of sucrose for a dragee of 100 mg that corresponds to 0.02 grain units (GU).
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment needs to be careful at control of vehicles and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Overdose
Symptoms: confusion of consciousness, drowsiness, lack of coordination of movements. Further, in process of absorption of the taken drug, symptoms of oppression of functions of the central nervous system (CNS) can amplify up to approach of a coma. The overdose can lead also to promoting effect on central nervous system (it is more often observed at children). Also manifestations of anticholinergic action can develop: dryness in a mouth, expansion of pupils, rushes of blood to an upper half of a trunk, disturbance from digestive tract (nausea, pains in epigastriums, vomiting).
Treatment: drug withdrawal, gastric lavage, intake of activated carbon, if necessary – symptomatic therapy.
The form of release and packing
of the Dragee of 50 mg and 100 mg
On 10 dragees place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children's reach!
3 years 6 months
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
Valenta Pharmatsevtika Open joint stock company, Russian Federation Producer 141101, Shchyolkovo, Moscow Region, Fabrichnaya St., 2
the Owner of the registration certificate
Valenta Pharmatsevtika Open joint stock company,
Russian Federation 141101, Shchyolkovo, Moscow Region, Fabrichnaya St., 2
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Valenta Pharmatsevtika in RK Republic of Kazakhstan, 050009, Almaty, the ave. of Abay, ug. Radostovts St., 151/115, business center Ala Tau, office No. 1102telefon/fax 8 (727) 334-15-52Электронный address: asia@valentapharm.com
for medical use
of medicine
Diazolinum
the Trade name
Diazolinum
the International unlicensed
name Mebgidrolin Lekarstvennaya a form
of the Dragee of 50 mg and 100 mg
Structure
One dragee contains
active agent - mebgidrolin – 50 mg, 100 mg,
excipients: sucrose (sugar), starch syrup, povidone (Kollidon 25), sunflower oil
the Description
of the Dragee of color, white or white with a yellowish shade, refined deodorized, talc, wax. In a dragee of color, white or white with slightly creamy or slightly greenish shade.
Pharmacotherapeutic group
Antihistaminic drugs of systemic action others. Mebgidrolin.
The ATX R06AX15 code
the Pharmacological
Pharmacokinetics Therapeutic Effect properties develops 15-30 minutes later after reception, the maximum action is observed in 1-2 hours. Duration of effect can reach 2 days.
It is quickly soaked up from digestive tract, gets into all body tissues. The bioavailability fluctuates within 40-60%. Plasma elimination half-life makes about 4 hours. Drug practically does not get through a blood-brain barrier. It is metabolized in a liver by methylation, induces microsomal enzymes of a liver, it is removed by kidneys.
Pharmacodynamics
Blocker of H1-histamine receptors. Possesses antiallergic action, reduces hypostasis of mucous membranes. Diazolinum weakens action of a histamine on unstriated muscles of bronchial tubes, a uterus and intestines, reduces severity of a lowering of arterial pressure and increase in permeability of vessels. Slightly getting into the central nervous system, unlike antihistaminic drugs of the first generation, has no significant sedative and somnolent effect. Has the slight M-cholinergic and anesthetizing properties.
Indications
- allergic rhinitis, a pollinosis
- urticaria
- a Quincke's edema
- allergodermatoz, followed by a skin itching (eczema, neurodermatitis)
- allergic conjunctivitis
- skin reaction after sting
it is necessary to accept the Route of administration and doses of the Dragee inside, without chewing, in time or right after food.
To adults and children from 12 years appoint 100 mg 1-3 times a day. The maximum doses for adults: single – 300 mg, daily – 600 mg.
Duration of a course of treatment is defined by the nature of a disease and the reached therapeutic effect.
For children aged from 6 up to 10 years – on 50 mg 2-3 times a day, from 10 to 12 years – on 50 mg 2-4 times a day.
Side effects
from digestive tract: renders the irritant action on a mucous membrane of digestive tract which is shown the dispepsichesky phenomena (heartburn, nausea, pain in epigastric area).
From nervous system: dizziness, paresthesias, tremor, increased fatigue, drowsiness, uneasiness (at night), delay of speed of psychomotor reaction.
Other: dryness in a mouth, an urination delay, allergic reactions, a granulocytopenia and an agranulocytosis.
Children have paradoxical reactions: hyperexcitability, irritability, tremor, sleep disorders.
Contraindications
- hypersensitivity
- a prostate hyperplasia
- closed-angle glaucoma
- a peptic ulcer of a stomach and a 12-perstny gut
- inflammatory diseases of digestive tract
- a pylorostenosis
- epilepsy
- disturbances of a warm rhythm
- pregnancy and the period of a lactation
- children's age up to 6 years
- the deficiency of invertase/isomaltase, intolerance of fructose, glyukozo-galaktozny malabsorption (in connection with presence of sucrose as a part of drug)
Medicinal interactions
Strengthens effect of ethanol, sedatives.
Special instructions
With care use drug at patients from a liver and/or renal failure (adjustment of dose and intervals between receptions), at patients with diabetes (in connection with presence of sucrose as a part of drug can be required).
It is ineffective in bronchial asthma and an acute anaphylaxis.
Patients with diabetes should pay attention to the content of sugar as a part of drug. 1 dragee contains 187.680 mg of sucrose for a dragee of 50 mg or 224.715 mg of sucrose for a dragee of 100 mg that corresponds to 0.02 grain units (GU).
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment needs to be careful at control of vehicles and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Overdose
Symptoms: confusion of consciousness, drowsiness, lack of coordination of movements. Further, in process of absorption of the taken drug, symptoms of oppression of functions of the central nervous system (CNS) can amplify up to approach of a coma. The overdose can lead also to promoting effect on central nervous system (it is more often observed at children). Also manifestations of anticholinergic action can develop: dryness in a mouth, expansion of pupils, rushes of blood to an upper half of a trunk, disturbance from digestive tract (nausea, pains in epigastriums, vomiting).
Treatment: drug withdrawal, gastric lavage, intake of activated carbon, if necessary – symptomatic therapy.
The form of release and packing
of the Dragee of 50 mg and 100 mg
On 10 dragees place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children's reach!
3 years 6 months
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
Valenta Pharmatsevtika Open joint stock company, Russian Federation Producer 141101, Shchyolkovo, Moscow Region, Fabrichnaya St., 2
the Owner of the registration certificate
Valenta Pharmatsevtika Open joint stock company,
Russian Federation 141101, Shchyolkovo, Moscow Region, Fabrichnaya St., 2
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Valenta Pharmatsevtika in RK Republic of Kazakhstan, 050009, Almaty, the ave. of Abay, ug. Radostovts St., 151/115, business center Ala Tau, office No. 1102telefon/fax 8 (727) 334-15-52Электронный address: asia@valentapharm.com
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