Medrolgin (Ketorolac)
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.
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