Midol Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ibuprofen

Indications/Uses

Relief of minor aches & pains associated w/ menstrual cycle eg, headache, muscular aches, back aches & menstrual cramps.

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Dosage/Direction for Use

Adult & childn >12 yr 1 tab every 4-6 hr. If pain persists, 2 tab. Max: 6 tab/24 hr. Max duration of treatment: 10 days.

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Overdosage

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Administration

Should be taken with food: Take w/ food or milk if stomach upset occurs.

Contraindications

Hypersensitivity to ibuprofen, aspirin or other NSAIDs. Bronchospasm, angioedema, nasal polyps or allergic-type reactions after taking aspirin or other NSAIDs. Concomitant therapy w/ aspirin, other NSAIDs, lithium or MTX. Stomach ulcers, bleeding or stomach problems. Before or after surgery. History of stroke, heart attack, uncontrolled high BP or CHF. Kidney disease. Signs & symptoms of liver abnormality (eg, jaundice). Pregnancy & lactation.

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Special Precautions

May cause severe allergic reaction, especially in patients allergic to aspirin. Risk of severe stomach bleeding. Risk of heart attack or stroke may increase if used more than directed or for longer than directed. Discontinue use in case of allergic reaction; signs of stomach bleeding; pain getting worse or lasting >10 days; fever getting worse or lasting >3 days; redness & swelling in the painful area; any new symptoms appearance. Patients w/ problems or serious side effects from taking pain relievers or fever reducers; any serious condition; stomach bleeding; history of stomach problems eg, heartburn, upset stomach or stomach pain; liver or kidney problems; heart problems, previous stroke or risk factors (eg, HTN, high cholesterol, DM, or if patient is a smoker); asthma; SLE or other autoimmune diseases; elderly ≥60 yr. Concomitant use w/ other medicines. Do not give to childn <12 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, drowsiness, malaise, lightheadedness, nervousness, headache, fatigue, mood swings, paresthesia, hallucinations & dream abnormalities; stomach ulceration &/or bleeding, indigestion, heartburn, nausea, vomiting, anorexia, diarrhea, constipation, mouth ulcers, flatulence, bloating & abdominal pain; blood in the urine, kidney damage/failure; abnormal LFTs, jaundice, inflammation of the liver, liver failure; blood does not clot properly, anemia & low WBC count; fluid retention, increased BP, low BP, CVA, palpitations; tinnitus, decreased hearing, amblyopia, conjunctivitis, optic neuritis, diplopia & cataracts; rashes, symptoms of serious allergies (eg, SJS, Lyell's syndrome, erythema multiforme) which includes multiple skin lesions, itch, fever, joint pains; allergic reaction.

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Drug Interactions

Decreased blood conc w/ aspirin. Increased risk of stomach & intestinal bleeding w/ phenylbutazone, indomethacin, salicylates & other NSAIDs (eg, mefenamic acid, naproxen, diclofenac, ketoprofen); anticoagulants (eg, warfarin, dicumarol) or thrombolytics (eg, streptokinase); corticosteroids (eg, prednisone, prednisolone), SSRIs (eg, citalopram, escitalopram, sertraline); Ginkgo biloba. Acute reduction in kidney function & BP response to ACE inhibitors (eg, captopril, enalapril, ramipril, imidapril, fosinopril, lisinopril). May reduce the effect of mifepristone (do not use 8-12 days after mifepristone); diuretics (eg, furosemide & thiazide). Risk of MTX & lithium toxicity. Increased plasma conc of cardiac glycosides (eg, digitalis). May enhance effect of phenytoin. Increased risk of nephrotoxicity w/ ciclosporin or tacrolimus.

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Storage

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Description

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Action

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MIMS Class

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

ATC Classification

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

Regulatory Classification

Non-Rx

Presentation/Packing

Form

Midol tab 200 mg

Packing/Price

100's (P18/tab);200's (P18/tab)

Midol

ibuprofen

Manufacturer:

A. Menarini

Distributor:

Zuellig