Unispaz

The drug Unispaz has an international name in accordance with the active substances in its composition - Drotaverine + Codeine + Paracetamol. The combined analgesic substance was developed by the pharmacological company "Unique Pharmaceutical Laboratories" (India), is an over-the-counter drug.

The drug Unispaz relieves pain syndromes of low and moderate severity, including spastic conditions and spasms of smooth muscles lining internal organs. The combination of an analgesic and an antispasmodic has made the drug an indispensable assistant for monthly recurring symptoms of dysmenorrhea (pain during menstruation). Drotaverine with paracetamol, contained in the drug, are also used for fever during a cold or flu, characterized by chills, temperature and pale skin.

Indications Unispaz

The medicine Unispaz relieves mild and moderate pain syndromes in children after 6 years of age, as well as in adulthood. The antispasmodic analgesic is prescribed for headache attacks:

• predominantly of a tense nature (a consequence of a stressful situation) of an acute or chronic type;
• for problems with blood vessels;
• resulting from fatigue or excessive overwork.

Pharmacological effectiveness of the drug Unispaz - suppresses spasms, is a powerful analgesic, has an antipyretic effect. These characteristics determine the scope of application of the drug. Indications for the use of Unispaz apply to the following types of pain:

• dental ( toothache );
• muscular and joint;
• menstrual ( primary dysmenorrhea );
• due to various types of colic ( renal, biliary, intestinal);
• neuralgic and sciatic;
• as a result of spasm of the bladder or ureter;
• for spastic problems (colitis, constipation, tenesmus).

Release form

The oblong tablets of Unispaz have a brownish-pinkish tint and a one-sided score line, and also contain color inclusions.

Release form - blisters of 6 tablets or packages of two blisters, with 12 tablets respectively. Each unit of the tablet preparation includes:

• paracetamol – 500 mg;
• drotaverine hydrochloride – 40 mg;
• codeine phosphate – 8 mg.

Additional components include magnesium stearate, purified talc, corn starch and pregelatinized corn starch, povidone and crospovidone, microcrystalline cellulose, and dye E172 (iron oxide red).

Pharmacodynamics

Pharmacologically, Unispaz belongs to the group of myotropic antispasmodic substances and anilides in combinations.

The pharmacodynamics of Unispaz is based on the characteristics of the substances that make up the drug:

• paracetamol – reduces fever, relieves pain by inhibiting the synthesis of prostaglandins in the central nervous system. It also has a peripheral effect by inhibiting the activity of prostaglandins and other components responsible for stimulating pain receptors;
• codeine is an antitussive component with a central effect, is an analgesic as a result of its effect on opioid receptors (involved in the delivery of pain impulses to the central nervous system). Enhances the effectiveness of paracetamol;
• drotaverine is a vasodilator, antispasmodic, myotropic, hypotensive substance of the isoquinoline series. It is especially effective (due to the prolongation of the dilating effect) in spasms of smooth muscles of internal organs and vessels. The properties of the drug are due to a decrease in the penetration of active calcium into the cells of smooth muscle structures as a result of inhibition of phosphodiesterase and accumulation of cyclic adenosine monophosphate inside the cells.

Pharmacokinetics

Pharmacokinetics of Unispaz by constituent components:

• bioavailability of drotaverine when taken orally is about 100%, the substance is maximally and quickly absorbed by the digestive system with subsequent uniform distribution in tissues, including smooth muscle cells. Half-absorption is observed after 12 minutes, and excretion occurs through the kidneys. The component does not affect the central and practically does not affect the autonomic nervous system;
• rapid absorption of paracetamol occurs mainly in the small intestine. The substance penetrates well into tissues and liquid media, excluding fat cells and cerebrospinal fluid. It is excreted in the urine;
• rapid absorption of codeine in the digestive system promotes active distribution in the tissue of the spleen, liver and kidneys. Biotransformation of the pharmacological agent occurs in the liver, excretion is carried out by the kidneys. The drug disrupts the placental and hematoencephalic (between the bloodstream and nervous tissue) barriers, and also accumulates in breast milk.

Dosing and administration

The drug Unispaz is used orally, with a sufficient amount of water, at least an hour after a meal (swallowing a tablet during or immediately after a meal delays its effect).

Method of administration and dosage according to the patient's age:

• Children aged 6-12 years – one-time dose of ½ tablet, repeated administration is recommended only after 10 hours. The maximum daily dosage is 2 tablets;
• adolescents and adults - 1-2 tablets once, the next dose of the drug no earlier than 8 hours later. The maximum permissible dose is 6 pieces per day for short-term treatment (up to 3 days) and 4 pieces if longer therapy is required;
• in old age with severe liver or kidney dysfunction, the dosage is selected individually.

It should be noted that independent use of the drug is permitted for three days; further use of the drug requires medical consultation.

[ 2 ]

Use Unispaz during pregnancy

The use of Unispaz during pregnancy and breastfeeding is strictly prohibited.

Contraindications

Contraindications for the use of Unispaz:

• individual intolerance to one of the components of the antispasmodic analgesic;
• diagnosis of bronchial asthma or acute respiratory failure;
• atrioventricular blocks of the first and second degrees;
• chronic forms of cardiac, renal, and hepatic failure;
• chronic alcohol dependence;
• addiction to drugs;
• blood clotting problems;
• history of recent traumatic brain injury;
• detection of intracranial hypertension;
• It is prohibited to use Unispaz in parallel with monoamine oxidase inhibitors, as well as for two weeks after stopping their use;
• not prescribed together with paracetamol;
• against the background of glucose-6-phosphate dehydrogenase deficiency;
• patients under 6 years of age;
• during pregnancy and breastfeeding.

Maximum caution is exercised in treating elderly people and those suffering from Gilbert's syndrome (benign hyperbilirubinemia - a hereditary gene defect associated with the process of bilirubin metabolism) with antispasmodic analgesics.

Side effects Unispaz

In general, the antispasmodic analgesic Unispaz is well tolerated. Sometimes the following side effects of Unispaz are detected:

• in relation to the central nervous system - lethargy, constant drowsiness, dizziness or headache;
• circulatory system – thrombocytopenia, agranulocytosis;
• digestive system – nausea, bowel disturbances, quite rare – toxic liver damage (in case of severe overdose);
• cardiovascular disorders – tachycardia, hypotension, anemia, hot flashes;
• manifestations of allergies - skin rashes, itching, rare negative consequences are spasms in the bronchi and swelling of the nasal mucosa.

In order to prevent negative consequences, it is necessary to carefully study the instructions-insert or consult a specialist. Rules that reduce the risk of side effects:

• take Unispaz separately from food;
• maintain precise dosage;
• During the period of taking the antispasmodic analgesic, alcoholic beverages are prohibited;
• in case of mild renal/hepatic insufficiency, the appropriateness of therapy with the drug is assessed by a physician;
• When using Unispaz for more than three days, constantly check the amount of liver enzymes and monitor the blood composition, this way you can prevent hematological changes.

[ 1 ]

Overdose

Overdose of the antispasmodic analgesic Unispaz is characterized by such primary symptoms as: paleness of the skin, nausea, vomiting, anorexia, excessive sweating, deterioration of the general condition. Toxic damage to the liver (including necrosis), as well as respiratory dysfunction are possible.

If such signs are detected, seek immediate medical attention. Saline laxatives and gastric lavage are used to stabilize the patient. Monitoring the condition in severe conditions characterized by damage to the central nervous system involves the use of artificial ventilation of the lung, additional saturation of cells with oxygen, and the administration of naloxone.

Interactions with other drugs

Paracetamol, which is one of the medicinal components of Unispaz, is incompatible with alcoholic beverages, salicylamide, tricyclic antidepressants, substances for the treatment of epilepsy, barbiturates, rifampicin, as they contribute to an increase in the level of toxic metabolism of paracetamol. Parallel therapy with paracetamol and chloramphenicol activates the toxic effect with an increase in the period of elimination of the latter drug. Liver dysfunction is a consequence of the use of paracetamol with doxorubicin. Oral anticoagulants against the background of therapy with the spasmoanalgesic Unispaz often provoke bleeding.

Drotaverine taken simultaneously with levodopa reduces its antiparkinsonian effect, resulting in a sharp increase in muscle tone (rigidity) and increased tremor (muscle shaking).

There are also negative interactions of Unispaz with other drugs that have hypnotic, anesthetic, anxiolytic properties, including tricyclic antidepressants and antipsychotic substances. The listed drugs significantly increase the suppression of the central nervous system by codeine phosphate.

[ 3 ], [ 4 ]

Storage conditions

The presence of a place in the house inaccessible to children and protected from sunlight, with a temperature not exceeding 30º C - these are the main conditions for storing Unispaz while maintaining the integrity of the blister.

Shelf life

Unispaz has a shelf life of three years from the date of manufacture in undamaged pharmaceutical packaging.