Unispaz N tabs #12

Unispaz N instruction

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Composition

The composition of tablets Unispaz N as active components include: paracetamol, drotaverina hydrochloride and codeine phosphate.
As additional substances in the preparation there are: povidone, purified talc, corn starch, pregelatinized corn starch, crospovidone, magnesium stearate, MCC, dye.
Also produced is Unispaz N, which does not contain codeine.

Form of issue

Unispaz is produced in the form of tablets having a pink-brown color. In tablets there are impregnations, light and dark. The form of the tablets is oblong, on the one hand risk. The blister contains 6 tablets, 2 such blisters are put into the box.

pharmachologic effect

Unispaz is a spasmoanalgic. This is a combined drug, the effect of which is determined by the active substances that make up its composition.
The agent acts as an analgesic, antispasmodic, antipyretic preparation.
Paracetamol provides antipyretic and analgesic effect, which is due to inhibition of PG synthesis in the central nervous system, as well as peripheral action (to a lesser extent).
Drotaverin is a derivative of isoquinoline, it acts as an antispasmodic against smooth muscle. This occurs by inhibiting phosphodiesterase 4, also under the influence of the substance, the concentration of cAMP increases, which leads to the inactivation of myosinkinase. As a consequence, smooth muscles relax. Drotaverin also has a weak inhibitory effect on calmodulin-dependent calcium channels. This substance affects the smooth muscles in the digestive tract, as well as in the vascular, urogenital, biliary systems.
Codeine acts as an analgesic by interacting with opioid receptors that participate in the transmission of painful impulses to the nervous system. Codeine increases the analgesic effect of paracetamol, there is also a central antitussive effect.

Pharmacokinetics and pharmacodynamics

After the drug has been taken orally, there is a rapid absorption of paracetamol from the gastrointestinal tract, then it is actively distributed in organs and tissues.
Codeine is also actively absorbed from the digestive system, then the substance is distributed in tissues and organs, and mainly it enters the spleen, liver, kidneys. Its penetration through the BBB, placenta, codeine is indicated in breast milk.
Metabolism of paracetamol occurs mainly through conjugation with excretion in the urine. Half-life is from 1.25 to 3 hours. Removal of approximately 85% of the dose occurs within 24 hours.
The half-life of codeine is approximately 2.9 hours. It is also mainly excreted through the kidneys. The elimination of approximately 90% of the dose occurs over a period of 24 hours.

Indications for use

Application of the medicine Unispaz N is indicated for such diseases and conditions:
    weak and moderate pain, including those associated with spasms of smooth muscles:
    headache and toothache;
    pain in muscles and joints;
    ischialgia;
    neuralgia;
    renal, biliary, intestinal colic;
    algodismenorea;
    spasms of the bladder, ureter;
    spastic constipation;
    other conditions spastic internal organs.

Contraindications

Unispaz is not assigned in the following cases:
    strong sensitivity to the components of the remedy;
    hepatic, renal, respiratory, cardiac insufficiency, severe;
    bronchial asthma;
    AV blockade of the second and third degree;
    alcoholism in chronic form;
    deficiency of glucose-6-phosphate dehydrogenase;
    drug dependence;
    recently suffered craniocerebral trauma;
    intracranial hypertension;
    blood diseases - leukopenia, agranulocytosis, thrombocytopenia;
    pregnancy and feeding;
    the simultaneous use of MAO inhibitors, and the drug should not be administered within two weeks after the withdrawal of these drugs;
    simultaneous use of drugs that contain paracetamol.
Caution Unispaz is prescribed for elderly people, as well as for patients diagnosed with constitutional hyperbilirubinemia.

Side effects

When receiving the following side effects may develop:
    nervous system: dizziness, headaches, drowsiness;
    cardiovascular system: tachycardia, arterial hypotension, periodic hot flashes;
    the digestive system: constipation, nausea, in rare cases - toxic liver damage (under the condition of using large doses of the drug);
    hematopoiesis system: thrombocytopenia, agranulocytosis;
    allergic manifestations: rash on the skin, in rare cases - bronchospasm, swelling of the nasal mucosa.

Unispaz, instructions for use (Method and dosage)

The drug should be taken orally, at a time you should drink 1-2 tablets, if necessary, you can repeat taking the tablets in 8 hours. If the tablets are taken separately from food intake, the effect will be more rapid.
If the course of therapy lasts no more than three days, then the allowable dose per day is 6 tablets. With more prolonged treatment, you can drink no more than 4 Unispaz N tablets per day.
When treating children from 6 to 12 years, the single dose is 0.5-1 tablets. Repeat reception can be no earlier than 10-12 hours. In a day, patients of this age can drink no more than 2 tablets.
Elderly people with a healthy liver and kidney dose should not be adjusted. If severe violations of the kidneys and liver are noted, the dosage is reduced. In this case, you can apply Unispaz N only sporadically. Take the product without consulting a specialist can be no more than three days.

Overdose

If an overdose occurs, the patient may develop vomiting, nausea, respiratory depression, circulatory disorders, liver damage toxic (in severe cases, necrosis is possible). In case of an overdose it is necessary to take saline laxatives, to carry out lavage of the stomach. Sometimes, with severe damage to the nervous system, oxygen supply, ventilation, and Naloxone administration may be necessary.

Interaction

With the simultaneous use of Levodopa, the effect of this drug is reduced by the action of drotaverin. As a consequence, tremor and stiffness may increase.
If paracetamol is used simultaneously with barbiturates, salicylamide, tricyclic antidepressants, antiepileptic drugs, rifampicin, ethanol, the concentration of toxic metabolites of paracetamol increases in the body.
If paracetamol is used with chloramphenicol, the toxicity of this drug and the half-life of the drug will increase.
With the simultaneous use of doxorubicin and paracetamol, the risk of liver dysfunction increases.
With simultaneous use, the effect of uricosuric medicines is reduced.
Absorption of paracetamol is enhanced by the simultaneous administration of Domperidone and Metoclopramide.
When taking concomitantly with Kolestyramin, paracetamol absorption decreases.
In view of the presence of paracetamol in the composition of the drug with prolonged treatment, the Unispaz N drug increases the likelihood of bleeding.
With simultaneous reception with codeine, the effect of analgesic, hypnotics, sedatives is increasing.

Storage conditions

Keep away from children, the temperature of storage should not be above 30 degrees.

Shelf life

The storage period is 3 years. Can not be applied after the expiration of this period.

special instructions

During the treatment period, you should not take alcohol.
The dosage is set individually, if the patient is diagnosed with hepatic or renal insufficiency.
If the treatment lasts more than three days, or the patient takes Unispaz N in high doses, you need to monitor the peripheral blood, the liver. Attention should be paid to the platelet count, white blood cell count, creatinine level, as well as the activity of liver enzymes in plasma. It is important to consider that the symptoms of hepatotoxic action can develop 2-3 days after taking large doses of the drug.
When driving vehicles and working with precise mechanisms, one must consider the probability of an individual reaction of the organism to the components of the medicine.

Children

It is possible to use children from 6 years old, while carefully following the indicated dosage.

In pregnancy

Unispaz can not be used to treat pregnant women and nursing mothers. If you need to take Unispaz N, breastfeeding should be stopped.

Reviews about Unispaz

In reviews of these tablets, patients write about their effectiveness in dental and headaches, muscle spasms, etc. Side effects are reported rarely, but such opinions also occur.