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Alit is a NSAID medicine and contains 2 active elements.

Nimesulide is a component with analgesic, anti-inflammatory and antipyretic activity. This element selectively slows down the activity of COX-2, and at the same time it suppresses the processes of PG binding within the areas where inflammation occurs.

Dicyclomine hydrochloride helps to reduce the spasms of smooth muscles in the gastrointestinal tract.

Indications Alita

It is used to eliminate pain, as well as cramps that have a different nature. [1], [2], [3]

Release form

The release of the drug element is made in tablets - 4 pieces inside the cellular packaging. In a pack - 1 such packaging.

Pharmacodynamics

Nimesulide allows you to slow the release of the enzyme myeloperoxidase, and at the same time inhibits the formation of free oxygen radicals, without affecting the chemotaxis with phagocytosis. The substance also suppresses the formation of tumor necrosis factors and other inflammatory conductors.

Dicyclomine hydrochloride is an antagonist of cholinergic muscarin endings, and in addition it directly affects smooth muscle, probably being an histamine antagonist with bradykinin. Dicyclomine showed an inhibitory effect against several pathogenic bacteria.[4]

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Pharmacokinetics

When ingested, nimesulide is absorbed at a high rate from the gastrointestinal tract. Plasma Cmax values are recorded after 2-3 hours. Protein synthesis of nimesulide is 97.5%. Metabolic processes are realized inside the liver; The main metabolic component is hydroxynimesulide (it has medicinal activity). Approximately 65% of the consumed portion of nimesulide is excreted with urine, and the remainder (35%) is excreted with feces.

After oral administration of dicyclomine, it is absorbed at high speed, reaching Cmax values after 90 minutes. The term half-life is 4-6 hours. Excretion is carried out together with urine (by 79.5%), as well as feces (by 8.4%).[6]

[7]

Dosing and administration

The appointment of Alita is carried out only after a careful assessment of the ratio of possible benefits and existing risks.

It is necessary to take medication orally, after eating, washing it down with plain water. The daily dosage is 1-2 times a day for the first tablet (0.1 g of nimesulide) per day (in the morning and also in the evening). Per day is allowed to consume no more than 0.2 g of nimesulide. Therapy can last no more than 5 days.[12]

Application for children

Nimesulide is approved for use as other analgesics, antipyretic drugs for short-term use (no more than 10 days) in children. The drug is best avoided with known or suspected liver disease; when prescribing nimesulide simultaneously with other hepatotoxic drugs, caution is required.[13]

There is evidence of restriction of the drug in the age of six months. Cases have been published that the administration of dicyclomine hydrochloride to babies was accompanied by severe respiratory symptoms (shortness of breath, respiratory collapse, apnea, and asphyxia), convulsions, fainting, muscle hypotension, coma, and death, but a causal relationship has not been established.[14]

Use Alita during pregnancy

Assign Alit during pregnancy is prohibited. Since nimesulide may adversely affect fertility in women, it cannot be used when planning conception. Like other NSAIDs that inhibit GHG binding, nimesulide can lead to too early closure of the arterial route, the development of oliguria, pulmonary hypertension and low water. There is also the likelihood of uterine atony, bleeding and edema of the peripheral type.[8]

Due to the lack of data on whether nimesulide is excreted in breast milk, the drug is not used for HB. There was one possible case of apnea in a breastfed baby whose mother was taking Dicycloverin.[9]

Contraindications

The main contraindications:

• ulcers affecting the gastrointestinal tract (in the active phase);
• the presence of recurrent ulcers or the presence of bleeding in the area of the gastrointestinal tract (available in history);
• severe hepatic dysfunction (liver failure), as well as a history of hepatotoxic manifestations associated with the use of drugs;
• use together with substances potentially having hepatotoxicity;
• having severe severity of renal dysfunction (CC values are less than 30 ml per minute);
• severe disorders of blood coagulation;
• cerebrovascular or other pathologies in which the appearance of bleeding;
• having a severe form of flow of CH;
• severe intolerance against the active element of the drug or its other components, and in addition to this hypersensitivity associated with other NSAIDs (in history);
• drug or alcohol addiction;
• increased temperature and flu-like conditions;
• existing suspicion of the development of surgical disease in the active phase.

Side effects Alita

Among the adverse symptoms associated with the use of the drug (usually appear during the first 7 days of the drug): [10]

Caused by the influence of nimesulide:

• lesions of the epidermis and subcutaneous tissues: itching, erythema, hyperemia, hyperhidrosis, rashes and dermatitis are often noted. Unity appears puffiness of the face, oral mucosa or tongue, SJS, urticaria, hyperemia of the oral mucosa, PET, polyformal erythema and angioedema;
• digestive problems: symptoms of dyspepsia, including vomiting, bloating, heartburn, constipation, diarrhea, and nausea. In addition, there are pains in the abdominal area or gastritis. Melena, ulcerative perforation or bleeding inside the gastrointestinal tract, and in addition stomatitis and an ulcer in the gastrointestinal tract;
• impaired hepatic function: cholestasis or jaundice, as well as an increase in intrahepatic transaminases. Hepatitis of lightning-like nature can also sometimes occur (sometimes fatal);[11]
• disorders in the work of NA: headaches, encephalopathy, drowsiness and dizziness;
• signs associated with the psyche: nervousness, nightmares and anxiety;
• renal lesions: hematuria, edema, urinary retention and dysuria. There is a single failure of the kidneys, oliguria and tubulo-interstitial nephritis;
• disorders of the blood system: eosinophilia or anemia. Thrombocyto- or pancytopenia, as well as purpura, develops individually;
• immune disorders: anaphylaxis or intolerance symptoms;
• problems with respiratory function: dyspnea. Asthma or BA (especially in people with intolerance to aspirin and other NSAIDs) appears sporadically;
• lesions associated with the activity of the cardiovascular system: increased values of blood pressure or tachycardia. Occasionally, hot flashes, collapse, bleeding and changes in blood pressure are observed;
• others: asthenia, visual disturbance or hypothermia.

Related to dicyclovir activity:

• disorders in the work of the cardiovascular system: palpitations, flushing, tachycardia and loss of consciousness;
• dysfunction of the NA: disorders of sensitivity, dyskinesia, dizziness, drowsiness, loss of consciousness, severe fatigue and headaches, and in addition, nervousness, insomnia, paresthesias, problems with gait stability, systemic weakness and lethargy;
• problems related to the psyche: agitation or confusion, mood lability, hallucinations and speech disorders;
• lesions affecting the subcutaneous layer and epidermis: itching, rash, epidermal dryness, urticaria and other dermatological symptoms;
• signs associated with digestion work: nausea, anorexia, xerostomia, bloating, vomiting, thirst, constipation, taste disorder and pain in the abdomen;
• ODA function disorders: muscle weakness;
• disturbances in the urogenital system: urinary retention or his disorder, as well as impotence;
• problems with visual activity: mydriasis, increased IOP values, visual misting, accommodative paralysis and diplopia;
• lesions of the respiratory organs: asphyxia, hyperemia in the throat, apnea or dyspnea, sneezing and nasal congestion;
• immune disorders: severe allergic manifestations or drug idiosyncrasy, which also includes anaphylaxis;
• endocrine dysfunction: suppression of lactation.

Overdose

A sign of nimesulide poisoning is the potentiation of such disorders as drowsiness, pain in the “under the spoon” area, vomiting, lethargy and nausea (such manifestations are often treatable if supportive actions are taken). In addition, there may be bleeding in the area of the gastrointestinal tract. Occasionally, acute renal failure develops, anaphylactoid symptoms, elevated BP, respiratory depression and coma, hypoglycemia.[15]

With dicycloverine intoxication, a two-step process is observed: first, CNS is excited, with hallucinations, illusions, anxiety, stable mydriasis, hypertension, and tachycardia. After this begins the suppression of the central nervous system, which can reach the coma.

The drug has no antidote. In case of overdose, symptomatic actions and peritoneal dialysis are performed. During the first 4 hours, the victim should be given gastric lavage through a tube, and in addition to this use laxatives and activated charcoal.

Hemodialysis will be ineffective. It is necessary to carefully monitor the liver and kidneys.[16]

Interactions with other drugs

Combination with warfarin and other similar anticoagulants, as well as with aspirin increases the likelihood of bleeding.

The combination of nimesulide with furosemide should be done carefully in people with disorders of the heart and kidneys.

NSAID drugs reduce lithium clearance, which increases its plasma level and its toxic activity. Because of this, with such a combination (nimesulide + lithium), it is necessary to closely monitor the plasma indicators of lithium.

The introduction of nimesulide together with theophylline, ranitidine, digoxin, as well as glibenclamide and antacids did not lead to the development of clinically significant interaction.

Nimesulide slows down the activity of the enzyme СYP 2С9, because of which, when combined with it, an increase in the plasma values of the substances to which this enzyme has an effect can be observed.

It is necessary to use Alit very carefully when it is administered in less than a day / every other day after taking methotrexate - because this increases the serum levels and toxic properties of the latter.

Use together with nimesulide may increase the nephrotoxic activity of cyclosporin.

Dicyclomine is able to potentiate the effect of other anticholinergic agents (among them atropine sulfate), which is why they cannot be combined with Alyt.

Storage conditions

Alit must be kept in a place protected from children, moisture and sunlight. Temperature indicators - no more than 25 ° C.

Shelf life

Alit is allowed to apply within a 36-month term from the date of issue of the pharmaceutical substance.

Analogs

Analogues of the medication are the drugs Nimuspaz, Nanogan with Oxygan, as well as Cygan and Nigan.