Universal reference book for medicines
Product name: UNISPAZ ® (UNISPAZ ® )

Active substance: codeine, drotaverine, paracetamol

Type: Spasmoanalgesic

Manufacturer: UNIQUE PHARMACEUTICAL Laboratories (India) promotion of the drug in the Russian Federation DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
The tablets are
brownish-pink in color with dark and light impregnations, oblong, with a risk on one side.

1 tab.

paracetamol 500 mg

drotaverina hydrochloride 40 mg

codeine phosphate 8 mg

Excipients: corn starch, povidone, corn pregelatinized starch, magnesium stearate, purified talc, crospovidone, microcrystalline cellulose, iron oxide, red oxide.

6 pcs.
- blisters from aluminum (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Spasmoanalgesic.
Combined drug, the effect of which is due to its constituent components.
Paracetamol has an analgesic and antipyretic effect mainly by inhibiting the synthesis of prostaglandins in the central nervous system, and, to a lesser extent, by peripheral action, blocking of prostaglandins and other active substances that stimulate pain receptors.

Drotaverine is an isoquinoline derivative, has an antispasmodic effect on smooth muscle due to inhibition of phosphodiesterase 4, an increase in the concentration of cAMP, which inactivating the myosinkinase leads to a relaxation of smooth muscle.
Also drotaverine has a weak inhibitory effect on calmodulin-dependent calcium channels. Regardless of the type of autonomic innervation, drotaverin is effective in spasms of smooth muscles. It acts on smooth muscles, which are in the vascular, gastrointestinal, biliary and urogenital systems (the content of phosphodiesterase 4 in different tissues is different).
Codeine, an antitussive drug of central action that also has an analgesic effect through interaction with opioid receptors involved in the transmission of painful impulses to the central nervous system, potentiates the analgesic effect of paracetamol.

PHARMACOKINETICS

Suction and distribution

After taking the drug inside, paracetamol is quickly absorbed from the digestive tract, distributed in most organs and tissues of the body.

Codeine is rapidly absorbed into the digestive tract, distributed to most organs and tissues, mainly to the parenchymal organs (liver, spleen, kidneys).

Penetrates through the BBB, the placental barrier, excreted in breast milk.

Metabolism and excretion

Paracetamol is metabolized predominantly by conjugation followed by excretion in the urine.
T 1/2 of paracetamol is between 1.25 and 3 hours. About 85% of the dose is excreted within 24 hours.
T 1/2 of codeine - about 2.9 hours. It is excreted mainly with urine.
About 90% of the dose is excreted within 24 hours.
INDICATIONS

Pain syndrome of mild and moderate intensity, due, incl.
and spasms of smooth muscles:
- toothache;

- headache;

- pain in the joints, muscles;

- neuralgia;

- ischialgia;

- algodismenorea;

- renal colic;

- spasms of the ureter and bladder;

- biliary colic;

- intestinal colic;

- spastic constipation;

- other spastic conditions of internal organs.

DOSING MODE

The drug is taken orally.
Single dose - 1-2 tab., If necessary, you can repeat the reception after 8 hours. To achieve a quick effect, the drug should not be taken with food.
At a course of treatment no more than 3 days the maximum daily dose is 6 tab.
With a long course of treatment, the maximum daily dose is 4 tablets / day.
Children aged 6 to12 years, the drug is prescribed in a single dose of 0.5-1 tab.
Repeated use is possible after 10-12 hours, the maximum daily dose is 2 tablets / day.
Older patients with normal liver and kidney function are not required to adjust the dose.

In severe violations of the liver and kidneys, the dose of the drug should be reduced.
At a glomerular filtration rate of less than 10 ml / min, a break between two doses should be more than 12 hours. Only occasional use of the drug is allowed in this category of patients.
The maximum duration of treatment without consulting a doctor is 3 days.

SIDE EFFECT

From the side of the central nervous system: headache, dizziness, drowsiness.

From the cardiovascular system: arterial hypotension, tachycardia, hot flushes.

On the part of the digestive system: nausea, constipation;
rarely when used in high doses - toxic liver damage.
On the part of the hematopoiesis system: agranulocytosis, thrombocytopenia.

Allergic reactions: skin rash;
very rarely - bronchospasm, swelling of the nasal mucosa.
CONTRAINDICATIONS

- severe renal failure;

hepatic failure of severe degree;

- cardiac insufficiency of severe degree;

- AV blockade II and III degree;

- respiratory insufficiency;

- bronchial asthma;

- deficiency of glucose-6-phosphate dehydrogenase;

- chronic alcoholism;

- drug addiction;

- condition after traumatic brain injury;

- intracranial hypertension;

- Blood diseases (thrombocytopenia, leukopenia, agranulocytosis);

- simultaneous use of MAO inhibitors and within 14 days after their cancellation;

- simultaneous use of drugs containing paracetamol;

- Pregnancy;

- lactation period;

- Hypersensitivity to the components of the drug.

With caution apply the drug in patients with constitutional hyperbilirubinemia (Gilbert's syndrome), in elderly patients.

PREGNANCY AND LACTATION

The use of Yunispaz during pregnancy and during lactation is contraindicated.

APPLICATION FOR FUNCTIONS OF THE LIVER

In case of renal insufficiency, the dose should be set individually.

Contraindicated use of the drug for severe renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In case of hepatic insufficiency, the dose should be set individually.

Contraindicated use of the drug for severe hepatic failure.

APPLICATION FOR CHILDREN

Children aged 6 to12 years, the drug is prescribed in a single dose of 0.5-1 tab.
Repeated use is possible after 10-12 hours, the maximum daily dose is 2 tablets / day.
APPLICATION IN ELDERLY PATIENTS

With caution apply the drug in elderly patients.

SPECIAL INSTRUCTIONS

When using the drug, the patient should exclude the use of alcohol.

In case of renal and hepatic insufficiency, the dose should be set individually.

When the drug is used for more than 3 days and / or at high doses, it is necessary to monitor the picture of peripheral blood and the functional state of the liver (number of leukocytes, platelets, creatinine level and activity of liver enzymes in blood plasma).
Clinical symptoms of hepatotoxic effect begin to appear within 48-72 hours after application of the drug in high doses.
Impact on the ability to drive vehicles and manage mechanisms

The question of the possibility of engaging in activities requiring an increased concentration of attention and speed of psychomotor reactions should be addressed after assessing the patient's individual response to the drug.

OVERDOSE

Symptoms: nausea, vomiting, circulatory disorders, respiratory depression, toxic liver damage (up to necrosis).

Treatment: gastric lavage, saline laxatives.
In severe central nervous system damage, ventilation, oxygen supply, and naloxone may be necessary to monitor the condition.
DRUG INTERACTION

Drotaverin reduces the action of levodopa, which makes it possible to increase tremor and rigidity.

When paracetamol is used together with drugs that induce the induction of liver enzymes (salicylamide, barbiturates, antiepileptics, tricyclic antidepressants, rifampicin, alcohol), the concentration of toxic metabolites of paracetamol increases.

When applying paracetamol simultaneously with chloramphenicol, the half-life of the latter increases and its toxicity increases.

Simultaneous use of paracetamol with doxorubicin increases the risk of liver function disorders.

Paracetamol reduces the effect of uricosuric drugs.

Metoclopramide and domperidone increase the absorption of paracetamol, and colestyramine decreases it.
With prolonged use of the drug, the risk of bleeding increases due to the presence of paracetamol.
Codeine increases the effect of hypnotics, analgesics and sedatives.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.

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