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THERAPEUTIC INDICATIONS: In acute cases and exacerbations of patients with rheumatoid arthritis, ankylosing spondylitis, osteoarthritis. Relief of pain and inflammation of acute gouty arthritis, acute and subacute bursitis, tendinitis, synovitis.

Pharmacokinetics in Humans: Indomethacin belongs to the group of NSAIDs and has anti-inflammatory and analgesic properties similar to those of major salicylates, as it is a potent inhibitor of cyclooxygenase, which is the enzyme forming prostaglandins involved in the inflammatory process, also inhibits the motility of polymorphonuclear leukocytes.

Indomethacin is rapidly absorbed and almost completely in the gastrointestinal tract after oral administration. The peak plasma concentration is reached within two hours in the fasting subject, but may be delayed when taken after meals or can be reduced by aluminum or magnesium containing antacids. Plasma concentrations are approximately 0.5 ug / ml after prolonged administration. The plasma half-life has been reported in a range of 2.6 to 11.2 hours in adults, is bound to plasma proteins in 90% and also extensively in the tissues. The concentration of indomethacin in the CNS is low, but within 5 hours after administration the concentration in synovial fluid is equal to the plasma.

Indomethacin is metabolized in the liver to glucuronide and desmetilindometacina, desbenzoilindometacina, desmethyl-desbenzoilindometacina and its glucuronide, something of indomethacin undergoes N-dealkylation. Indomethacin and its conjugates undergo enterohepatic circulation. Excretion of indomethacin is primarily in the urine and to a lesser extent in the faeces.

Betamethasone is a glucocorticoid with potent activity, has the general properties of glucocorticoids, 0.75 mg of betamethasone in anti-inflammatory activity equivalent to about 5 mg of prednisolone. It is rapidly absorbed from the gastrointestinal tract and distributed to all body tissues.

Betamethasone binds to plasma proteins in larger quantities to globulin and to a lesser extent to albumin, which means it has high affinity but low capacity for pickup. It has a long half-life of 72 hours with an equivalent dose of 0.75 mg, is metabolized in the liver and kidneys, and excreted in the urine. The effects of betamethasone on sodium and water are lower than with prednisolone or prednisone.

Methocarbamol is a centrally acting muscle relaxant whose mechanism of action is not established but is believed to be due to general depressant effect on the CNS, is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration.

The effects begin around half an hour after administration. Plasma half-life is 1 to 2 hours.

Methocarbamol is used as an adjunct in the symptomatic treatment of painful muscle spasm associated with musculoskeletal disorders. It is metabolized by dealkylation and hydroxylation and excreted primarily in urine as glucuronide and sulfate conjugated metabolites. A small amount is excreted in the feces.

The analgesic effects resulting from the combination of indomethacin, betamethasone and methocarbamol were tested in rats by the method PIFIR and confirmed that the association of these compounds have analgesic activity useful in arthritic conditions as ZOLIDIME showed analgesic efficacy than compounds managed independently, its onset of action was faster with the association with compounds administered independently and with greater duration of analgesia, so reducing the dosage of ZOLIDIME analgesic efficacy is sustained.

CONTRAINDICATIONS: ZOLIDIME is contraindicated in patients with systemic fungal infections or infectious diseases, in patients with diabetes or hypertension, in patients with peptic ulcer disease or kidney failure. In patients with known hypersensitivity to methocarbamol, betamethasone or salicylates, or any other part of the formula.

PRECAUTIONS: May require adjustments in dosage in the process of remission or exacerbation of the disease, depending on the patient's individual response to treatment.

After discontinuation of long-term corticosteroid therapy or high doses, is recommended close observation of the patient up to a year. Prolonged use of corticosteroids can cause posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves.

Normal and high doses of corticosteroids may increase blood pressure, increasing salt and water retention and potassium excretion. Is less likely that these effects occur with other synthetic derivatives such as betamethasone, except when used at high doses.

Dosage should be reduced gradually, the too rapid withdrawal may induce secondary adrenocortical insufficiency, which can be minimized by gradual reduction of dosage.

When administering indomethacin caution should be exercised in patients with peptic ulcer, epigastric pain or dyspepsia, and in patients with clotting problems. Avoid using alcohol and other CNS depressants as methocarbamol has a CNS depressant effect.

Use in Pregnancy and Lactation: For the use of ZOLIDIME during pregnancy and lactation is required to assess the drug's benefits against the potential risks to the mother and embryo or fetus.

The known effects of indomethacin on the human fetus during the third trimester of pregnancy include constriction of the ductus arteriosus before birth, tricuspid regurgitation and pulmonary hypertension, patent ductus arteriosus after birth, platelet dysfunction and bleeding.

Lactation is not recommended in nursing mothers ZOLIDIME. Indomethacin is excreted in breast milk and methocarbamol and betamethasone. Corticosteroids cross the placenta.

Animal studies have shown that corticosteroids increase the incidence of cleft palate, placental insufficiency, spontaneous abortions and intrauterine growth retardation.

ADVERSE REACTIONS: Adverse reactions are the same ZOLIDIME identified for other corticosteroids, and are related to dosage and duration of treatment. Typically, such reactions can be reversed or minimized by reducing the dosage, it is generally preferable to treatment discontinuation. The presence of indomethacin may cause nausea and vomiting, anorexia, epigastric distress, abdominal pain, constipation and diarrhea, asthma and skin rash.

Methocarbamol may cause blurred vision, headache, dizziness, drowsiness. Betamethasone administered for prolonged periods can cause increased blood pressure, weight gain, moon face, hirsutism, acne, hyperglycemia, increased susceptibility to infections, osteoporosis, myopathy, behavioral disorders, cataracts, growth arrest.

DRUG INTERACTIONS AND OTHER GENDER: Concomitant use of phenobarbital, rifampicin, phenytoin or ephedrine may increase the metabolism of corticosteroids decreasing its therapeutic action. Diseases treated concomitantly with a corticosteroid and an estrogen can be observed by increasing the effects of corticosteroid.

We do not recommend the use of other NSAIDs concomitantly with ZOLIDIME or the use of anticoagulants.

The simultaneous use of aspirin may potentiate the side effects.

With the administration of probenecid increases the plasma concentration of indomethacin. The antihypertensive effects of thiazide diuretics may be decreased by the presence of indomethacin, as well as beta-adrenergic blockers and inhibitors of angiotensin converting enzyme. By the presence of methocarbamol, patients should be warned of the combined effects of the use of the product with alcohol and other CNS depressants as well as the use of vehicles and machinery.

CHANGES IN THE LABORATORY TEST RESULTS: Indomethacin may cause increased border of one or more liver function tests.

Methocarbamol may cause color interference in certain screening tests 5-hydroxyindoleacetic acid and vanillylmandelic acid.

Corticosteroids may alter the results of the nitroblue tetrazolium test for bacterial infection and produce false negative results.

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, Impairment of Fertility: In studies in rats, indomethacin did not cause tumorigenic effects and no hyperplastic or neoplastic change throughout the life of them, nor have effects on fertility presented .

The known effects of indomethacin on the human fetus during the third trimester of pregnancy include constriction of the ductus arteriosus before birth, tricuspid regurgitation and pulmonary hypertension, patent ductus arteriosus after birth, platelet dysfunction and bleeding.

Corticosteroid studies done on animals have shown an increased incidence of cleft palate, placental insufficiency, spontaneous abortions and intrauterine growth retardation.

The effect of methocarbamol on fertility have not been made long-term studies in animals to determine whether it is carcinogenic or mutagenic potential.

DOSAGE AND ADMINISTRATION: Oral.

In severe cases of rheumatoid arthritis and other rheumatic disorders is recommended initial daily dose of one capsule every 8 hours for a period of 7 days, the dose should be tapered gradually and by week, by administering a capsule every 12 hours for 7 days, reduce dose back to one capsule every 24 hours for one week and fourth week of treatment to reduce the dosage to leave a maintenance dose of one capsule every other day for a week to be removed while maintaining clinical response with strict control patient without side effects. The dose is variable and can be individualized based on the specific disease, its severity and patient response.

It is recommended that once a favorable response is observed is determined by the appropriate maintenance dose, gradually decreasing the initial dosage in small decrements at appropriate intervals until it is determined the lowest dose able to maintain an adequate clinical response.

REPRESENTATIONS AND MANAGEMENT Overdosage: Overdose may cause nausea, vomiting, severe headache, dizziness, mental confusion, disorientation or lethargy. Treatment is symptomatic and supportive. If ingestion is recent, the stomach should be emptied as soon as possible or gastric lavage.

According to the patient, it may be a need to undergo close observation and medical general care. Administer antacids may be helpful.
Drug Name: Zolidime
Brand comparison: Zolidime
Active ingredient: Dexamethasone /
Salicylamide / phenylbutazone / gel
Dried aluminum hydroxide
Presentation: Tablets
time release tablets: no
Concentration: 0.5/200/100/200 MG
Response time: No
Laboratory: Collins, S. A. de CV
Box of 20 Pills
Manufactured in: Mexico