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MOTRIN Tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

MOTRIN.

Summary product information

Route of Administration Oral Dosage Form / Strength Clinically Relevant Nonmedicinal Ingredients Oral Tablet/200 mg None<br />For a complete listing see Dosage Forms, Composition and Packaging section. ...

Indications and clinical use

MOTRIN (ibuprofen) is indicated for fast and effective relief of: headache pain (including mild to moderate migraine and tension headache) menstrual pain toothache (dental pain) pain from inflammation ...

Contraindications

The following are contraindications to the use of MOTRIN: Patients who are hypersensitive to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or to any ingredient in the formulation. For ...

Warnings and precautions

Patients with heart disease and high blood pressure should not take this drug unless directed by a physician. Caution in patients with heart failure, hypertension or other conditions predisposing to fluid ...

Adverse reactions

Clinical Trial & Post-Market Adverse Drug Reactions The most common adverse reactions encountered with nonsteroidal anti-inflammatory drugs are gastrointestinal, of which gastric or duodenal ulcer, with ...

Drug interactions

Serious Drug Interactions Use with acetylsalicylic acid (ASA) or other NSAIDs, including ibuprofen, may result in possible additive adverse side effects. Use with acetaminophen, may increase the risk of ...

Dosage and administration

Dosing Considerations Do not take for pain for more than 5 consecutive days or fever for more than 3 days unless directed by a physician. If your condition deteriorates or new symptoms occur (such as the ...

Overdosage

For management of a suspected drug overdose, contact your regional Poison Control Centre. Clinical Features A clear pattern of clinical features associated with accidental or intentional overdose of ibuprofen ...

Action and clinical pharmacology

Mechanism of Action Ibuprofen is a member of the class of agents commonly known as non-steroidal anti- inflammatory drugs (NSAID). Like all NSAIDs, ibuprofen is an analgesic, antipyretic, and anti- inflammatory ...

Storage and stability

Tablets: Store at 15 to 30°C (59 to 86°F).

Special handling instructions

Not applicable.

Dosage forms, composition and packaging

MOTRIN 200 mg is available as white, sweet-coated biconvex tablets, with Motrin IB printed in black ink, in bottles of 24, 90 and 150. MOTRIN 200 mg contains ibuprofen 200 mg and the following non-medicinal ...

Pharmaceutical information

Drug Substance <u>Proper name:</u> Ibuprofen. <u>Chemical name:</u> Ibuprofen is described chemically as 2 - (p-isobutylphenyl) propionic acid. <u>Molecular formula and molecular mass:</u> 206.28. <u> ...

Detailed pharmacology

Animal Studies Pharmacodynamics While the mechanism of action of ibuprofen is not definitely known, the generally accepted mechanism is the inhibition of prostaglandin synthesis. Inhibition of prostaglandin ...

Clinical trials

The efficacy of ibuprofen as an analgesic and antipyretic has been demonstrated by a variety of clinical studies and pain models. Dental Pain In adults, the effects of a drug on post-surgical dental extraction ...

Microbiology

Not applicable.

Toxicology

Toxicity studies have been conducted using a variety of species, including: mice, rats, rabbits, guinea pigs and beagle dogs. Acute Toxicity Studies Single-dose acute toxicity studies indicate that ibuprofen ...

Marketing authorization holder

McNeil Consumer Healthcare, Division of Johnson & Johnson Inc., 88 McNabb Street, Markham, Canada, L3R 5L2

Submission control number

237424

Date of approval

Last Approved: February 26, 2015

Date of revision

June 18, 2020

References

1. Arthritis Advisory Committee. Transcript of proceedings. Review of ibuprofen for non-prescription sale. Food and Drug Administration, Department of Health and Human Services, Bethesda. August 18, 1983. ...

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