Anesthetics, Muscle relaxants / Painkillers and Antispasmodics

Mydocalm 10% / 1 ml 5’s solution for injection in ampoules

Brands: Gedeon Richter (Hungary)

$26.90

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Mydocalm 10% / 1 ml 5's solution for injection in ampoules quantity

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97956762f7be

Brands:: Gedeon Richter (Hungary)

Description

The instruction for medical use

of MIDOKALM® medicine
the Trade name
of Midokalm®

the International unlicensed name
Is not present

the Dosage form
Solution for injections, 1 ml

Structure
of 1 ml of solution contains
active agents: Tolperisonum hydrochloride of 100 mg
of lidocaine hydrochloride of 2.5 mg,
excipients: methylparahydroxybenzoate, diethylene glycol-monoethylether, water for injections

the Description
Transparent, colourless or slightly greenish solution with a specific smell.

Pharmacotherapeutic group
Muscle relaxants. Muscle relaxants of the central action. Other muscle relaxants of the central action.
ATX M03BX code

Pharmacological

Pharmacokinetics Time properties of the maximum concentration (Tcmax) of 0.5-1 h. Bioavailability – about 20% (because of the significant effect of ‘the first passing’ through a liver).
Tolperisonum is metabolized in a liver and kidneys. The pharmacological activity of metabolites is unknown.
Elimination half-life (T1/2) after intravenous administration – about 1.5 hours. It is removed by kidneys in the form of metabolites (99%).

The pharmacodynamics
of Midokalm® is a muscle relaxant of the central action. The action mechanism is completely not found out. As a result of membrane stabilizing and mestnoanesteziruyushchy action complicates carrying out excitement in primary afferent fibers, blocking mono – and polisinaptichesky reflexes of a spinal cord. The secondary mechanism of action probably consists in blockings of release of the transmitter as a result of blockade of receipt of calcium ions in synapses. Reduces readiness for reticulospinal reflexes of a brainstem. In numerous experimental models on animals drug reduces the raised tone and muscle tension, caused by decerebration.
Strengthens peripheric circulation. This effect is not connected with impact of drug on the central nervous system. It can be caused by weak spasmolytic and anti-adrenergic effect of Tolperisonum.

Indications
– a hyper tone and a spasm of cross-striped muscles in organic diseases of the central nervous system (defeat of pyramidal ways, multiple sclerosis, a stroke, a myelipathy, encephalomyelitis)
– a muscle hyper tone and a spasm in musculoskeletal system diseases (spondylosis, a spondylarthrosis, cervical and lumbar syndromes, arthrosis of large joints)
– rehabilitation after orthopedic and traumatologic operations
– obliterating diseases of vessels (obliterating atherosclerosis of vessels, a diabetic angiopatiya, an obliterating thromboangitis, a Raynaud’s disease), the diseases proceeding with a vasospasm of arteries and disturbance of an innervation of vessels (Crocq’s disease, the alternating angioneurotic dysbasia)

the Route of administration and doses
the Adult in oil or in/in slowly.
On 100 mg 2 times a day, intramusculary or on 100 mg once a day intravenously (once), duration of treatment averages 7 days. Duration of treatment is defined by a clinical picture of a disease and the attending physician.
Patients with a renal failure
Data on use for patients with a renal failure are limited. Higher frequency of development of side reactions in this group of patients was observed. Patients with a moderate renal failure need to titrate a dose and to observe carefully. Do not recommend use of Tolperisonum for patients with a heavy renal failure.
Patients with an abnormal liver function
These uses for patients with an abnormal liver function are limited. Higher frequency of development of side reactions in this group of patients was observed. Patients with a moderate abnormal liver function need to titrate a dose and to observe carefully. Do not recommend use of Tolperisonum for patients with a heavy abnormal liver function.

Side effects
Often (& gt, 1/100, & lt, 1/10)
– reddening in the injection site

Infrequently (≥1/1000 to & lt, 1/100)
– a headache, dizziness
– sleep disorders, insomnia or drowsiness
– dryness in a mouth, nausea, feeling of discomfort in a stomach, dyspepsia, diarrhea, anorexia
– muscle weakness, myalgia, extremity pains
– an asthenia, an indisposition, fatigue
– arterial hypotension (at fast in in introduction)

is rare (≥1/10,000 to & lt, 1/1,000)
– tachycardia, heart consciousness, pain in a thorax
– a tachypnea, nasal bleeding, dispnoe
– pain in epigastriums, a constipation, vomiting, a meteorism, thirst
– enuresis, a proteinuria
– face reddening, the increased perspiration, feeling of heat
– irritability, a tremor, hyposensitivity, decrease of the activity, a depression, disturbance of attention
– spasms, a lethargy, mistings of sight, sonitus, vertigo, feeling of intoxication
– allergic dermatitis, a skin itching, rashes, urticaria
– discomfort in extremities
– easy disturbances from a liver
– reaction of hypersensitivity, anaphylactic reaction
– the lowering of arterial pressure, increase in concentration of bilirubin of blood, decrease in number of thrombocytes, increase in number of leukocytes

is Very rare (& lt, 1/10,000)
– bradycardia
– osteosinging
– a polydipsia
– confusion of consciousness
– discomfort in a thorax
– an abnormal liver function, increase in concentration of bilirubin in blood, increase in activity of liver enzymes in blood
– a tromotsitopeniya, a leukocytosis, anemia
– a lymphadenopathy
– increase in content of creatinine in blood
– an acute anaphylaxis

of the Contraindication
– hypersensitivity to active ingredients or to any of drug excipients
– hypersensitivity to an eperizon
– a myasthenia
– children’s and teenage age up to 18 years
– pregnancy the I trimester and the period of a lactation

Medicinal interactions
of the Research of pharmacokinetic interaction of medicines with marker CYP2D6 substrate dextromethorphan showed that simultaneous use of Tolperisonum can increase the level of content in blood of medicines which are metabolized mainly CYP2D6 (tioridazon, tolterodin, venlafaxin, atomoksetin, desipramine, dextromethorphan, metoprolol, nebivalol, Perfenazinum).
Laboratory experiments on microsomes of a liver of the person and human hepatocytes did not show considerable inhibition or induction of other isoenzymes of CYP (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
Increase in influence of Tolperisonum at simultaneous use of CYP2D6 substrates and/or other drugs in connection with a variety of metabolic ways of Tolperisonum is not supposed.
Though Tolperisonum is drug of the central action, sedation its very low. In case of co-administration with other muscle relaxants of the central action, the dose of Tolperisonum should be reduced.
Tolperisonum strengthens effect of niflumovy acid therefore at simultaneous use it is necessary to consider the possibility of a dose decline of niflumovy acid or other NPVS.

Special instructions
Before parenteral use of Midokalma® it is necessary to be convinced of absence at the patient of hypersensitivity to lidocaine. In case of the known hypersensitivity to lidocaine it is necessary to observe the increased care during use of Tolperisonum because of possible cross-reactions.
Female patients with reactions of hypersensitivity to other drugs or allergic reactions in the anamnesis are subject to higher risk.
Patients should recommend to be attentive concerning any symptoms of hypersensitivity.
Allergic reactions varied from easy skin reactions before heavy system reactions, including an acute anaphylaxis. Symptoms of allergic reaction: erythema, rash, small tortoiseshell, itching, Quincke’s disease, tachycardia, hypotension and asthma.
If symptoms developed, it is necessary to stop immediately prescribing of Tolperisonum and to see immediately a doctor. It is not necessary to appoint repeatedly Tolperisonum after a hypersensitivity episode to Tolperisonum.
Pregnancy and the period of a lactation
according to preclinical trials Tolperisonum does not possess
teratogenic action. In a type of lack of clinical trials
the prescribing of the drug Midokalm® during pregnancy, especially in the first
trimester, is possible only if the expected advantage unambiguously
exceeds risk of harming a fruit.
Use of Tolperisonum during a lactation is contraindicated
due to the lack of the relevant data on penetration of Tolperisonum into breast
milk.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
during treatment needs to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Overdose
Symptoms: ataxy, tonic spasms, dispnoe, apnoea.
Treatment: there is no special antidote, symptomatic and maintenance therapy.

A form of release and packing
On 1 ml of drug in ampoules glass brown color with a point for a break of white color.
On 5 ampoules place in plastic blister strip packaging.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a box of cardboard.

To Store storage conditions at a temperature from 8 of 0C up to 12 0C, in the place protected from light
to Store out of children’s reach!

3 years
not to use a period of storage after the expiry date specified on packing.

Prescription status
According to the prescription

the Name and the country

of JSC Gideon Richter manufacturing organization 1103 Budapest, Djemrei St., 19-21, Hungary

the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products:
Representative office of JSC Gideon Richter in RK
E-mail: info@richter.kz
Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23

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