Motrin (Ibuprofen) - Indications and Dosage

INDICATIONS AND USAGE

In Children   MOTRIN is indicated:

• For reduction of fever in patients aged 6 months and older.
• For relief of mild to moderate pain in patients aged 6 months and older.
• For relief of signs and symptoms of juvenile arthritis.

In Adults   MOTRIN is indicated:

• For relief of mild to moderate pain.
• For treatment of primary dysmenorrhea.
• For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.

Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjuction with aspirin, the combination cannot be recommended (see PRECAUTIONS -- Drug Interactions).

DOSAGE AND ADMINISTRATION

CHILDREN

Fever reduction:   For reduction of fever in children, 6 months to 12 years of age, the dosage should be adjusted on the basis of the initial temperature level (see CLINICAL PHARMACOLOGY). The recommended dose is 5 mg/kg if the baseline temperature is less than 102.5°F, or 10 mg/kg if the baseline temperature is 102.5°F or greater. The duration of fever reduction is generally 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg.

Analgesia:   For relief of mild to moderate pain in children, 6 months to 12 years of age, the recommended dosage is 10 mg/kg, every 6 to 8 hours. The recommended maximum daily dose is 40 mg/kg. Doses should be given so as not to disturb the child's sleep pattern. Taking fluids after chewing MOTRIN Chewable Tablets may help to promote absorption of the drug (see CLINICAL PHARMACOLOGY --Pharmacokinetics, and "Individualization of Dosage" in this section).

Juvenile Arthritis:   The recommended dose is 30 to 40 mg/kg/day divided into three to four doses (see Individualization of Dosage). Patients with milder disease may be adequately treated with 20 mg/kg/day.

ADULTS

Analgesia:   400 mg every 4 to 6 hours as necessary for the relief of mild to moderate pain in adults. In controlled analgesic clincial trials, doses of MOTRIN greater than 400 mg were no more effective than the 400 mg dose.

Primary Dysmenorrhea:   For the treatment of primary dysmenorrhea, beginning with the earliest onset of such pain, MOTRIN should be given in a dose of 400 mg every 4 hours, as necessary, for the relief of pain.

Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:   Suggested dosage: 1200-3200 mg daily (300 mg q.i.d or 400 mg, 600 mg or 800 mg t.i.d. or q.i.d). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clincial benefits to offset potential increased risk.

Individualization of Dosage The dose of MOTRIN should be tailored to each patient, and may be lowered or raised from the suggested doses depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.

One fever study showed that, after the initial dose of MOTRIN, subsequent doses may be lowered and still provide adequate fever control.

In a situation when low fever would require the MOTRIN 5 mg/kg dose in a child with pain, the dose that will effectively treat the predominant symptom should be chosen.

In chronic conditions, a therapeutic response to MOTRIN therapy is sometimes seen in a few days to a week, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

In patients with juvenile arthritis, doses above 50 mg/kg/day are not recommended because they have not been studied and doses exceeding the upper recommended dose of 40 mg/kg/day may increase the risk of causing serious adverse events. The therapeutic response may require from a few days to several weeks to be achieved. Once a clincial effect is obtained, the dosage should be lowered to the smallest dose of MOTRIN needed to maintain adequate control of symptoms.

In general, patients with rheumatoid arthritis seem to require higher doses than do patients with osteoarthritis. The smallest dose of MOTRIN that yields acceptable control should be employed.

HOW SUPPLIED

MOTRIN® (ibuprofen) Suspension 100 mg/5 mL

Orange-colored, berry-flavored suspension

-Bottles of 120 mL--NDC 0045-0448-04

-Bottles of 480 mL--NDC 0045-0448-16

Shake well before using. Store at controlled room temperature [15° to 30°C (59° to 86°F)]

MOTRIN® (ibuprofen) Oral Drops, 40mg/mL

(intended for pediatric use only)

Pink-colored, berry flavored suspension

-Bottles of 15 ml--NDC 0045-0446-15

Shake well before using. Store at controlled room temperature [15° to 30°C (59° to 86°F)].

MOTRIN® (ibuprofen) Chewable Tablets, 50 mg

Round, orange-colored, citrus-tasting, scored tablet, debossed "MOTRIN 50"

-Bottles of 100 Chewable Tablets--NDC 0045-0361-10

Store at controlled room temperature [15° to 30°C (59° to 86°F)]

MOTRIN® (ibuprofen) Chewable Tablets, 100 mg

Round, orange-colored, citrus-tasting, scored tablet, debossed "MOTRIN 100"

-Bottles of 100 Chewable Tablets--NDC 0045-0431-10

Store at controlled room temperature [15° to 30°C (59° to 86°F)]

MOTRIN® (ibuprofen) Caplets, 100 mg

White-colored, scored capsule-shaped tablet, imprinted "M 100"

-Bottles of 100 Caplets--NDC 0045-0445-10

Store at controlled room temperature [15° to 30°C (59° to 86°F)]

Caution:   Federal Law prohibits dispensing without prescription.

MCNEIL CONSUMER & SPECIALTY PHARMACEUTICALS

DIVISION OF McNEIL-PPC, INC.

FORT WASHINGTON, PA 19034-USA

JUNE 1995