Ambit film-coated tablets 10 mg, pack of 10 pcs.

• active ingredient: ketorolac trometamol;
• 1 tablet contains ketorolac trometamol 10 mg;
• excipients: microcrystalline cellulose; lactose monohydrate; magnesium stearate;
• film coating: hypromellose, titanium dioxide (E 171), macrogol.

• hypersensitivity to ketorolac or other NSAIDs or to other components of the drug;
• hypersensitivity reactions, such as bronchial asthma, rhinitis, angioedema or urticaria in history, caused by the use of acetylsalicylic acid or other NSAIDs (due to the possibility of severe anaphylactic reactions);
• gastrointestinal bleeding or perforation, active or in history, associated with taking NSAIDs;
• active recurrent peptic ulcer/gastrointestinal bleeding (two or more episodes) in the acute stage or in history;
• do not use as an analgesic before and during surgery and after manipulations on coronary vessels due to inhibition of platelet aggregation, which may cause bleeding;
• suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, including blood clotting disorders and a high risk of bleeding, as well as in the postoperative period, if there is a high risk of bleeding or incomplete hemostasis;
• complete or partial nasal polyps syndrome, angioedema or bronchospasm;
• concomitant treatment with other non-steroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase inhibitors), acetylsalicylic acid, warfarin, oxpentoxifylline, probenecid or lithium salts, anticoagulants, including low-dose heparin (2500–5000 units every 12 hours);
• violation of hematopoiesis of unknown etiology;
• severe heart failure;
• history of bronchial asthma;
• hepatic or moderate to severe renal failure (serum creatinine level more than 160 μmol/l);
• risk of kidney failure due to fluid depletion;
• hypovolemia, dehydration;
• the drug is contraindicated during pregnancy, labor and delivery, and during breastfeeding;
• Do not use in children and adolescents under 16 years of age.

On the part of the digestive tract: peptic ulcer, perforation or gastrointestinal bleeding, sometimes fatal (especially in the elderly), nausea, dry mouth, dyspepsia, gastrointestinal pain, abdominal discomfort, spasm or burning in the epigastric region, vomiting with blood, gastritis, esophagitis, diarrhea, belching, constipation, flatulence, feeling of fullness of the stomach, melena, rectal bleeding, stomatitis, ulcerative stomatitis, vomiting, hemorrhages, perforation, pancreatitis, exacerbation of colitis and Crohn’s disease.

From the blood and lymphatic system: purpura, thrombocytopenia, neutropenia, agranulocytosis, aplastic and hemolytic anemia, eosinophilia.

Immune system (hypersensitivity): Hypersensitivity reactions, including non-specific allergic reactions and anaphylactoid reactions such as anaphylaxis, respiratory tract reactivity including asthma, worsening of asthma, bronchospasm, laryngeal edema or dyspnea, and various skin disorders including rashes of various types, pruritus, urticaria, flushing, purpura, angioedema, hypotension and, in rare cases, exfoliative and bullous dermatitis (including epidermal necrolysis and erythema multiforme), have been reported.

Such reactions may occur in patients with or without known hypersensitivity to ketorolac or other NSAIDs. They may also occur in individuals with a history of angioedema, bronchospastic reactivity (e.g. asthma and nasal polyps). Anaphylactic reactions may be fatal.

It is advisable to take the tablets during or after meals.

Adverse reactions can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms.

The total duration of treatment (parenteral administration followed by oral administration) should not exceed 5 days.

The usual recommended dose is 10 mg every 4 or 6 hours. It is not recommended to administer more than 40 mg per day.

Patients should be switched to oral administration as early as possible.

Use during pregnancy or breastfeeding

The safety of ketorolac during human pregnancy has not been established. Approximately 10% of ketorolac crosses the placenta.

Ketorolac passes into breast milk in small amounts, so Ambit® is contraindicated during breastfeeding.

Children

Do not use in children under 16 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

Some patients may experience drowsiness, dizziness, vertigo, insomnia, fatigue, visual disturbances, headache, or depression when taking ketorolac. If patients experience these or similar effects, they should not drive or operate machinery.

Symptoms: headache, nausea, vomiting, epigastric pain, peptic ulcers, erosive gastritis, gastrointestinal bleeding; hyperventilation, hypertension, rarely – diarrhea, disorientation, agitation, coma, drowsiness, dizziness, tinnitus, loss of consciousness, convulsions. In cases of severe poisoning, acute renal failure and liver damage are possible.

Treatment: gastric lavage, administration of activated charcoal. Adequate diuresis should be ensured. Renal and hepatic function should be closely monitored. Patients should be observed for at least 4 hours after ingestion of a potentially toxic amount. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be prescribed depending on the clinical condition of the patient. Treatment is symptomatic. There is no specific antidote. Dialysis does not remove ketorolac from the circulation.

Does not require any special storage conditions. Keep out of the reach of children.