The instruction for use
of medicine for experts
PAPAZOLUM
(Papazolum)
the Trade name
Papazolum Papazolum
the International unlicensed name
Is not present
the Dosage form
of the Tablet Structure One Tablet contains
active agents: Dibazolum of 0.03 g, papaverine hydrochloride of 0.03 g,
excipients: potato starch, talc, calcium stearate.
The description
of the Tablet of color, white or white with a grayish shade, slightly marble, ploskotsilindrichesky, with a facet
Pharmacotherapeutic group
Other peripheral vasodilators.
The Pharmacological
Pharmacokinetics Later properties of intake the papaverine and Dibazolum are quickly absorbed by C04AX in digestive tract. The bioavailability is a papaverine is 29-57%, bioavailability of Dibazolum about 60%. Therapeutic effective concentration of drug in plasma correspond to the maintenance of a papaverine of 0.2-2.0 mkg/ml, Dibazolum of 0.5-2.0 mkg/ml. Linking with proteins of blood plasma makes for a papaverine 90%, for Dibazolum about 70%.
Papazolum components easily pass through gistogematichesky barriers, including through gematoplatsentarny and hematoencephalic barriers. In tissue of a liver and fatty tissue the cumulation of a papaverine, Dibazolum is observed – practically does not kumulirut. The papaverine is exposed to biotransformation in a liver. The period of semi-elimination (T½) of a papaverine is 0.5-2.0 h. It is removed in the form of the phenolic metabolites conjugated with glucuronic acid with urine, insignificant quantities of a papaverine (less than 0.5%) are removed in not changed look. The biotransformations given relatively and eliminations of Dibazolum at the person are absent.
The pharmacodynamics
Papazolum has hypotensive, spasmolytic, immunopromoting effect.
The mechanism of hypotensive and spasmolytic action is connected with ability of a papaverine and Dibazolum to block activity (FDE IV) phosphodiesterase IV. Blockade of enzyme leads to the termination of hydrolysis of cyclo-adenosinemonophosphate (tsAMF) and increase in its concentration in smooth muscle cells of vessels, internals. tsAMF limits receipt of calcium ions in a muscle cell and inactivates a kinase of light chains of myosin – sokratitelny protein which provides reduction of a muscle.
Papazolum reduces a tone and relaxes unstriated muscles of internals (digestive tract, airways, an urinogenital system) and vessels. Papazolum expands mainly arterial vessels and promotes increase in a blood-groove, including cerebral. Hypotensive effect of Papazolum moderate lasting 2-3 h. At prolonged use (especially) causes decrease in warm emission and deterioration in indicators of electric activity of a myocardium (ECG) in older persons.
Dibazolum which is a part of Papazolum has the stimulating impact on functions of a spinal cord, facilitating synoptic cholinergic transfer. The similar effect is observed from peripheral nervous trunks (cranial nerves, neuroplexes of extremities).
Immunopromoting effect of Papazolum is connected with Dibazolum which blocks FDE IV in immune cells that leads to ratio shift tsAMF/tsGMF (tsiklo-guanizinmonofosfat) in cells towards prevalence TSGMF. tsGMF stimulates proliferation of mature sensibilized T - and V-lymphocytes, secretion by them of monokin and other factors of mutual regulation, activation of final effector function of immune cells.
Indications
- prevention and stopping of spasms of unstriated muscles of internals in an urolithiasis, cholecystitis, a spastic colitis, a pylorospasm
- arterial hypertension (labial) (as a part of combination therapy)
- mono and polyneurites of traumatic and toxic origin, the residual phenomena of the postponed poliomyelitis, paralysis of a facial nerve.
The route of administration and doses
Apply inside on an empty stomach. The adult appoint 1-2 tablets 3-4 times a day. Course of treatment no more than 8-14 days. At persons 70 years an initial single dose no more than ½ tablets are more senior.
To children aged from 5 up to 12 years appoint in a dose ¼-½ tablets 2-3 times a day.
Side effects
- nausea, constipations
- drowsiness, the increased perspiration
- increase in level of transaminases, an eosinophilia
- hypotension, AV blockade, ventricular premature ventricular contraction
- allergic reactions
- increase of heart failure.
Contraindications
- children's age up to 5 years
- respiratory depression or coma
- AV blockade
- hypersensitivity to a papaverine and Dibazolum
- glaucoma
- age are more senior than 75 years
- a liver and renal failure
- insufficiency of function of adrenal glands
- a cranial brain injury
- a prostate hyperplasia
- a convulsive syndrome or epileptic seizures in the anamnesis.
Medicinal interactions
At simultaneous use Papazolum exponentiates effect of alcohol, weakens hypotensive effect Methyldopums.
At simultaneous use with phentolamine, a clonidine, reserpine and diuretics strengthening of their hypotensive action is observed. Does not affect hypotensive effect of β-adrenoblockers, but prevents the increase in peripheric resistance of vessels mediated by β-adrenoblockers.
At combined use with ascorbic acid strengthening of the immunostimulating effect of Papazolum is observed.
At the smoking persons the metabolism of Papazolum is accelerated, and its pharmacological effects decrease.
Milk reduces absorption of components of Papazolum in digestive tract.
The special
instructions Pregnancy and a lactation
At pregnancy and in the period of a lactation safety and efficiency of use of Papazolum are not established.
Use in pediatrics
Use of a papaverine of a hydrochloride for children up to 5 years of life is not recommended in connection with high risk of development of a hyperthermia, electric instability of a myocardium.
Use in gerontology
It is necessary to be careful and use short rates of Papazolum at treatment of persons 70 years, in connection with a possibility of decrease at them are more senior than warm emission and deterioration in indicators of the ECG.
Influence on ability to driving of motor transport and control of mechanisms
is not established.
Overdose
Symptoms: emergence of feeling of inflows of heat, diaforez (perspiration), diplopia, weakness, drowsiness, nausea, dizziness, hypotension, headache.
Treatment: specific antidote does not exist. Drug withdrawal, gastric lavage, prescribing of activated carbon and performing symptomatic therapy.
A form of release and packing
On 6 tablets in planimetric bezjyacheykovy packing. Planimetric bezjyacheykovy packings together with iinstruktion on use place in group packing.
To Store storage conditions in the place protected from light, at a temperature of 5-30 wasps.
To store out of children's reach!
Not to apply an expiration date of 5 years after expiry date!
Prescription status
Without prescription
Producer RUP Borisovsky Plant of Medications,
Republic of Belarus. Minsk Region, Borisov, Chapayev St., 64/27
of medicine for experts
PAPAZOLUM
(Papazolum)
the Trade name
Papazolum Papazolum
the International unlicensed name
Is not present
the Dosage form
of the Tablet Structure One Tablet contains
active agents: Dibazolum of 0.03 g, papaverine hydrochloride of 0.03 g,
excipients: potato starch, talc, calcium stearate.
The description
of the Tablet of color, white or white with a grayish shade, slightly marble, ploskotsilindrichesky, with a facet
Pharmacotherapeutic group
Other peripheral vasodilators.
The Pharmacological
Pharmacokinetics Later properties of intake the papaverine and Dibazolum are quickly absorbed by C04AX in digestive tract. The bioavailability is a papaverine is 29-57%, bioavailability of Dibazolum about 60%. Therapeutic effective concentration of drug in plasma correspond to the maintenance of a papaverine of 0.2-2.0 mkg/ml, Dibazolum of 0.5-2.0 mkg/ml. Linking with proteins of blood plasma makes for a papaverine 90%, for Dibazolum about 70%.
Papazolum components easily pass through gistogematichesky barriers, including through gematoplatsentarny and hematoencephalic barriers. In tissue of a liver and fatty tissue the cumulation of a papaverine, Dibazolum is observed – practically does not kumulirut. The papaverine is exposed to biotransformation in a liver. The period of semi-elimination (T½) of a papaverine is 0.5-2.0 h. It is removed in the form of the phenolic metabolites conjugated with glucuronic acid with urine, insignificant quantities of a papaverine (less than 0.5%) are removed in not changed look. The biotransformations given relatively and eliminations of Dibazolum at the person are absent.
The pharmacodynamics
Papazolum has hypotensive, spasmolytic, immunopromoting effect.
The mechanism of hypotensive and spasmolytic action is connected with ability of a papaverine and Dibazolum to block activity (FDE IV) phosphodiesterase IV. Blockade of enzyme leads to the termination of hydrolysis of cyclo-adenosinemonophosphate (tsAMF) and increase in its concentration in smooth muscle cells of vessels, internals. tsAMF limits receipt of calcium ions in a muscle cell and inactivates a kinase of light chains of myosin – sokratitelny protein which provides reduction of a muscle.
Papazolum reduces a tone and relaxes unstriated muscles of internals (digestive tract, airways, an urinogenital system) and vessels. Papazolum expands mainly arterial vessels and promotes increase in a blood-groove, including cerebral. Hypotensive effect of Papazolum moderate lasting 2-3 h. At prolonged use (especially) causes decrease in warm emission and deterioration in indicators of electric activity of a myocardium (ECG) in older persons.
Dibazolum which is a part of Papazolum has the stimulating impact on functions of a spinal cord, facilitating synoptic cholinergic transfer. The similar effect is observed from peripheral nervous trunks (cranial nerves, neuroplexes of extremities).
Immunopromoting effect of Papazolum is connected with Dibazolum which blocks FDE IV in immune cells that leads to ratio shift tsAMF/tsGMF (tsiklo-guanizinmonofosfat) in cells towards prevalence TSGMF. tsGMF stimulates proliferation of mature sensibilized T - and V-lymphocytes, secretion by them of monokin and other factors of mutual regulation, activation of final effector function of immune cells.
Indications
- prevention and stopping of spasms of unstriated muscles of internals in an urolithiasis, cholecystitis, a spastic colitis, a pylorospasm
- arterial hypertension (labial) (as a part of combination therapy)
- mono and polyneurites of traumatic and toxic origin, the residual phenomena of the postponed poliomyelitis, paralysis of a facial nerve.
The route of administration and doses
Apply inside on an empty stomach. The adult appoint 1-2 tablets 3-4 times a day. Course of treatment no more than 8-14 days. At persons 70 years an initial single dose no more than ½ tablets are more senior.
To children aged from 5 up to 12 years appoint in a dose ¼-½ tablets 2-3 times a day.
Side effects
- nausea, constipations
- drowsiness, the increased perspiration
- increase in level of transaminases, an eosinophilia
- hypotension, AV blockade, ventricular premature ventricular contraction
- allergic reactions
- increase of heart failure.
Contraindications
- children's age up to 5 years
- respiratory depression or coma
- AV blockade
- hypersensitivity to a papaverine and Dibazolum
- glaucoma
- age are more senior than 75 years
- a liver and renal failure
- insufficiency of function of adrenal glands
- a cranial brain injury
- a prostate hyperplasia
- a convulsive syndrome or epileptic seizures in the anamnesis.
Medicinal interactions
At simultaneous use Papazolum exponentiates effect of alcohol, weakens hypotensive effect Methyldopums.
At simultaneous use with phentolamine, a clonidine, reserpine and diuretics strengthening of their hypotensive action is observed. Does not affect hypotensive effect of β-adrenoblockers, but prevents the increase in peripheric resistance of vessels mediated by β-adrenoblockers.
At combined use with ascorbic acid strengthening of the immunostimulating effect of Papazolum is observed.
At the smoking persons the metabolism of Papazolum is accelerated, and its pharmacological effects decrease.
Milk reduces absorption of components of Papazolum in digestive tract.
The special
instructions Pregnancy and a lactation
At pregnancy and in the period of a lactation safety and efficiency of use of Papazolum are not established.
Use in pediatrics
Use of a papaverine of a hydrochloride for children up to 5 years of life is not recommended in connection with high risk of development of a hyperthermia, electric instability of a myocardium.
Use in gerontology
It is necessary to be careful and use short rates of Papazolum at treatment of persons 70 years, in connection with a possibility of decrease at them are more senior than warm emission and deterioration in indicators of the ECG.
Influence on ability to driving of motor transport and control of mechanisms
is not established.
Overdose
Symptoms: emergence of feeling of inflows of heat, diaforez (perspiration), diplopia, weakness, drowsiness, nausea, dizziness, hypotension, headache.
Treatment: specific antidote does not exist. Drug withdrawal, gastric lavage, prescribing of activated carbon and performing symptomatic therapy.
A form of release and packing
On 6 tablets in planimetric bezjyacheykovy packing. Planimetric bezjyacheykovy packings together with iinstruktion on use place in group packing.
To Store storage conditions in the place protected from light, at a temperature of 5-30 wasps.
To store out of children's reach!
Not to apply an expiration date of 5 years after expiry date!
Prescription status
Without prescription
Producer RUP Borisovsky Plant of Medications,
Republic of Belarus. Minsk Region, Borisov, Chapayev St., 64/27
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