Carefully consider the potential benefits and risks of CELEBREX (celecoxib) and other treatment options before deciding to use CELEBREX (celecoxib) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS]Osteoarthritis (OA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of OA [see Clinical Studies]Rheumatoid Arthritis (RA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of RA [see Clinical Studies]Juvenile Rheumatoid Arthritis (JRA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies]Ankylosing Spondylitis (AS)

CELEBREX (celecoxib) is indicated for the relief of signs and symptoms of AS [see Clinical Studies]Acute Pain (AP)

CELEBREX (celecoxib) is indicated for the management of AP in adults [seeClinical Studies]Primary Dysmenorrhea (PD)

CELEBREX (celecoxib) is indicated for the treatment of PD [see Clinical Studies]DOSAGE AND ADMINISTRATIONUse lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.

These doses can be given without regard to timing of meals.

Osteoarthritis

For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis

For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

Juvenile Rheumatoid Arthritis

For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily.

For patients > 25 kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a CELEBREX (celecoxib) capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2-8° C/ 35-45° F).

Ankylosing Spondylitis

For the management of the signs and symptoms of AS, the recommended dose of CELEBREX (celecoxib) is 200 mg daily in single (once per day) or divided (twice per day) doses. If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile. If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

Management of Acute Pain and Treatment of Primary Dysmenorrhea

The recommended dose of CELEBREX (celecoxib) is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Special Populations

Hepatic insufficiencyThe daily recommended dose of CELEBREX (celecoxib) capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX (celecoxib) in patients with severe hepatic impairment is not recommended [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].Poor Metabolizers of CYP2C9 SubstratesPatients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].HOW SUPPLIEDDosage Forms And Strengths

Capsules: 50 mg, 100 mg, 200 mg and 400 mgStorage And Handling

CELEBREX (celecoxib) 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

NDC NUMBER SIZE

0025-1515-01 bottle of 60

CELEBREX (celecoxib) 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:

NDC NUMBER SIZE

0025-1520-31 bottle of 100

0025-1520-51 bottle of 500

0025-1520-34 carton of 100 unit dose

CELEBREX (celecoxib) 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as

NDC NUMBER SIZE

0025-1525-31 bottle of 100

0025-1525-51 bottle of 500

0025-1525-34 carton of 100 unit dose

CELEBREX (celecoxib) 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:

NDC NUMBER SIZE

0025-1530-02 bottle of 60

0025-1530-01 carton of 100 unit dose

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Indications and Usage for CarisoprodolCarisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].

Carisoprodol Dosage and AdministrationThe recommended dose of Carisoprodol tablets is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol tablets use is up to two or three weeks.

Dosage Forms and StrengthsCarisoprodol tablets USP, 350 mg are white, round, debossed MP 58 on one side and blank on the other side.

ContraindicationsCarisoprodol tablets USP are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

Warnings and Precautions

Sedation

Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Carisoprodol tablets USP experienced sedation compared to 6% of patients who received placebo) [see ADVERSE REACTIONS (6.1)] and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. There have been post-marketing reports of motor vehicle accidents associated with the use of Carisoprodol.

Since the sedative effects of Carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

MIACALCIN NASAL USESThis medication is used to treat brittle bone disease (osteoporosis) in women who are at least 5 years past "the change of life" (menopause). Calcitonin works by slowing bone loss to help maintain strong bones and reduce your risk of fractures.How to use Miacalcin nasal

Read the patient and product information sheets if available from your pharmacist before you start using calcitonin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.This medication is for use in the nose as directed, usually one spray in one nostril each day, alternating nostrils daily. It is recommended to use this medication at the lowest effective dosage and for the shortest possible duration to treat your condition. Patients treated long-term with this medication have shown a rare risk of developingcancer. Discuss the benefits and risks of long term treatment with this medication.Remove a new bottle from the refrigerator and allow it to reach room temperature. Follow the instructions on how to prime the pump the first time you use a new bottle. Once the pump is primed, it does not have to be reprimed if the bottle is properly stored in an upright position. Consult your pharmacist if you have any questions.To use the nasal spray, remove the protective cap, keep your head upright and insert the tip into a nostril. Press down firmly on the pump to deliver the medication. Replace the protective cap. Use the other nostril the next day.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.