Calmirex solution 100mg/ml + 2.5mg/ml 1ml #10

Calmirex instruction

You can buy Calmirex here

Release form, composition and packaging

The solution for injections the introduction of a transparent, colorless or slightly greenish, with a specific smell.
1 amp
tolperisone hydrochloride (calculated on the dry matter) 100 mg
lidocaine hydrochloride (in terms of dry substance) 2.5 mg
Excipients: methyl parahydroxybenzoate - 0.6 mg, diethylene glycol monoethyl ether - 0.3 ml, concentrated hydrochloric acid - to pH 3.0-4.5, water d / and - to 1 ml.

pharmachologic effect

Tolperisone hydrochloride is a centrally acting muscle relaxant. It has a membrane stabilizing, local anesthetic effect, inhibits the conduction of nerve impulses in primary afferent fibers and motor neurons, which leads to the blocking of spinal mono-and polysynaptic reflexes. It probably mediates the blocking of the release of mediators by inhibiting the entry of calcium ions into synapses. Inhibits conduction of excitation along the reticulospinal pathway in the brainstem. Regardless of the effect on the central nervous system increases peripheral blood flow. The weak spasmolytic and antiadrenergic effect of tolperisone may play a role in the development of this effect.
Lidocaine hydrochloride has a local anesthetic effect and does not have a systemic effect when dispensing according to the instructions.

Pharmacokinetics

Tolperisone hydrochloride

Tolperisone is extensively metabolized in the liver and kidneys. Excreted in urine almost exclusively (> 99%) in the form of metabolites. Pharmacological activity of metabolites is unknown. T1 / 2 after the on / in the introduction - about 1.5 h.

Lidocaine hydrochloride

Absorption is complete (the rate of absorption depends on the site of administration and dose). The time to reach Cmax in plasma with i / m administration is 30-45 minutes. Plasma protein binding is 50-80%.
Quickly distributed in tissues and organs. Gets through the BBB and placental barrier, penetrates into breast milk (40% concentration in the mother's plasma). Metabolized in the liver (90-95%) with the participation of microsomal enzymes by dealkylation of the amino group and breaking the amide bond with the formation of active metabolites. Excreted in the bile (part of the dose undergoes reabsorption in the gastrointestinal tract) and the kidneys (up to 10% unchanged).

Indications for Calmirex

- hypertonus and spasm of striated muscles arising due to organic diseases of the central nervous system (including damage to the pyramidal tract, multiple sclerosis, stroke, myelopathy, encephalomyelitis), musculoskeletal system (including spondylosis, spondylarthrosis, cervical and lumbar syndrome; arthrosis of large joints);
- rehabilitation treatment after orthopedic and traumatological operations.
In the complex therapy:
- with obliterating vascular diseases (obliterating atherosclerosis, diabetic angiopathy, thromboangiitis obliterans, Raynaud’s disease, diffuse scleroderma);
- in case of diseases arising on the basis of vascular innervation disorder (acrocyanosis, intermittent angioedema).

Contraindications for Calmirex

- severe myasthenia gravis;
- pregnancy;
- lactation period;
- children's and teenage age up to 18 years;
- Hypersensitivity to the components of Calmirex, including to lidocaine.
With caution should use Calmirex for renal and hepatic insufficiency (dose adjustment is not required).

Dosage

For adults, Calmirex is prescribed daily i / m in 100 mg 2 times / day or in / in 100 mg 1 time / day.

Side effects of Calmirex

The frequency of side effects: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥1 / 10 000 to <1/1000), very rarely (<1/10 000), the frequency is unknown (cannot be estimated from the available data).
From the hematopoietic system: very rarely - anemia, lymphadenopathy.
On the part of the immune system: rarely - hypersensitivity reactions, anaphylactic reactions; very rarely - anaphylactic shock.
Metabolism and nutrition: infrequently - anorexia; very rarely - polydipsia.
Mental Disorders: Infrequently - insomnia, sleep disorders; rarely - loss of activity, depression.
On the part of the nervous system: infrequently - headache, dizziness, drowsiness; rarely - attention deficit disorder, tremor, convulsions, loss of sensitivity, sensitivity disorders, lethargy.
On the part of the organ of vision: rarely - disorders of visual perception.
On the part of the organ of hearing and labyrinth disorders: rarely - ringing in the ears, vertigo.
Since the cardiovascular system: infrequently - arterial hypotension; rarely - angina, tachycardia, palpitations; very rarely - bradycardia, flushing.
On the part of the respiratory system: rarely - shortness of breath, nasal bleeding, rapid breathing.
On the part of the digestive system: infrequently - gastrointestinal discomfort, diarrhea, dry mouth, dyspepsia, nausea; rarely - epigastric pain, constipation, flatulence, vomiting, abnormal liver function.
On the part of the skin and subcutaneous tissues: rarely - allergic dermatitis, sweating, pruritus, urticaria, skin rash.
From the musculoskeletal system: infrequently - muscular weakness, myalgia, pain in the extremities; rarely, limb discomfort; very rarely, osteopenia.
From the urinary system: rarely - enuresis, proteinuria.
General disorders and disorders at the injection site: often - redness of the injection site; infrequently - asthenia (weakness), malaise, fatigue; seldom - feeling of intoxication, feeling of heat, irritability, thirst; very rarely - a feeling of discomfort in the chest.
Laboratory and instrumental data: rarely - decrease in blood pressure, increase in bilirubin concentration, impaired liver function tests, decrease in platelet count, increase in the number of leukocytes; very rarely - increased creatinine.

Overdose

Symptoms: ataxia, tonic and clonic convulsions, dyspnea, respiratory arrest.
Treatment: symptomatic and maintenance therapy is recommended. There is no specific antidote.

Drug interaction

There is no data on the interaction with drugs, limiting the use of Calmirex.
Although tolperisone has an effect on the central nervous system, Calmirex does not cause a sedative effect, therefore it can be used in combination with sedatives, hypnotics and drugs containing ethanol.
Does not enhance the effect of ethanol on the central nervous system.
Enhances the effect of NSAIDs, so with simultaneous use may require a decrease in the dose of the latter.

special instructions

Influence on ability to drive vehicles and mechanisms
Care must be taken when driving motor vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.

Pregnancy and lactation

Calmirex is contraindicated during pregnancy and lactation.

Use in childhood

Use of Calmirex in children and adolescents up to 18 years of age is contraindicated.

In case of impaired renal function

With caution should use Calmirex for renal failure (dose adjustment is not required).

With abnormal liver function

With caution should use Calmirex for liver failure (dose adjustment is not required).

Pharmacy sales terms

To buy Calmirex the prescription is not required.

Terms and conditions of storage

Calmirex should be stored out of the reach of children, protected from light at a temperature of 8 ° C to 15 ° C. Shelf life - 2 years.