COMPOSITION

Each ml contains 30 mg of ketorolac tromethamine.

THERAPEUTIC INDICATIONS

For a short-term therapy of an acute pain of moderate to severe intensity of a different origin.

CONTRAINDICATIONS

- Erosive and ulcerative affections of GIT in the phase of exacerbation;
- Hypersensitization to the drug;
- Nasal polyps, bronchial asthma, urticaria, angioedema in past history;
- Moderate and severe renal insufficiency, a risk of the development of renal insufficiency dye to a liquid loss or dehydration;
- A combined intake with other non-steroidal anti-inflammatory agent, and also a co-administration with pentoxifylline;
- Directly preoperational period in probable significant surgery. Also the drug is contraindicated because of an increased risk of bleeding;
- Disorder of blood coagulation, a condition with a high risk of bleeding or incomplete hemostasis;
- Pregnancy, labor.

ADVERSE EFFECTS

As with other NSAIDs, dyspeptic manifestations are the most frequent adverse effects of Medrolgin. Effects from CVS, rarely: bradycardia, variation of blood pressure, tachycardia. Possible: allergic reactions.

DOSAGE AND ADMINISTRATION

The recommended dose for adults under 65 is 30 mg IV or IM every 6 h. For patients older 65 years, patients with renal insufficiency and a body weight less than 50 kg the recommended dose is 15 mg IV or IM every 6 h.
An analgesic effect appears in 30 min, the maximum anesthesia comes in 1-2 h following injection. The duration of anesthesia is 4-6 h. The therapeutical period should not exceed 5 days.

DRUG INTERACTIONS

The therapeutical concentrations of digoxin, warfarin, acetaminophen, phenitoin, tolbutamid, ibuprofen, naproxen and piroxicam does not influence on Medrolgin protein binding. Numerous studies have shown that the co-administration of NSAIDs with anticoagulants increases the risk of adverse effects from GIT. Prothrombin time should be under the constant control in all patients treated with peroral anticoagulants together with Medrolgin. The co-administration of NSAIDs with glycocorticoids increases the risk of adverse effects from GIT. Medrolgin attenuates furosemide diuretic action by about 20% in normovolemic patients therefore patients with cardiac decompensation require special attention. The co-administration of methotrexate and some NSAIDs reduces methotrexate clearance and thus elevating its toxicity. The combined administration of ATP-inhibitors and NSAIDs may increases the risk of renal impairment, especially in patients with a significant loss of liquid. Medrolgin application decreases the necessity in opioid analgesics for a pain relief.

PRECAUTIONS

The introduction into spinal marrow is contraindicated as the drug contains alcohol.
Medrolgin is recommended with cautious in patients with renal and hepatic impairment. Prescribe Medrolgin for patients with erosive and ulcerative affections of GIT and GIT bleeding in past history with cautious. It is not recommended during lactation.
The safety and efficacy in children has been not established. Therefore its application in children under 16 is not recommended.
Use the drug in the post-operative period in that cases when very close hemostasis is required with cautious.

MANUFACTURED FORM

A package contains 10 ampoules with solution for injections, 1 ml.