meclofenamate

Adult Dosing

Mild to moderate pain

50 mg PO q4-6 hrs PRN [Max: 400 mg/day]

Primary dysmenorrhea/idiopathic menorrhagia

100 mg PO tid x6 days; start at the onset of menstrual flow

Rheumatoid arthritis/Osteoarthritis

200-400 mg/day PO divided tid-qid

Pediatric Dosing

Mild to moderate pain

Child >14 yrs: 50 mg PO q4-6 hrs PRN [Max: 400 mg/day]

Primary dysmenorrhea/idiopathic menorrhagia

Child >14 yrs: 100 mg PO tid x6 days; start at the onset of menstrual flow

Rheumatoid arthritis/Osteoarthritis

Child >14 yrs: 200-400 mg/day PO divided tid-qid

[Outline]

Adult Dosing
Pediatric Dosing

Indications ⬆ ⬇

Relief of mild to moderate pain
Treatment of primary dysmenorrhea
Treatment of idiopathic heavy menstrual blood loss
Relief of the signs and symptoms of acute and chronic rheumatoid arthritis and osteoarthritis

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
ASA or NSAID-induced asthma or urticaria
Aspirin triad
Pregnancy 3rd trimester
CABG surgery perioperative use

Black Box Warnings ⬆ ⬇

NSAIDs may increase risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. Risk further increases with duration of use, presence of cardiovascular disease/risk factors for CV disease
Meclofenamate is contraindicated in the treatment of peri-operative pain in the setting of CABG surgery
NSAIDs may increase risk of serious GI events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events occur at any time and without warning symptoms. Elderly patients are at greater risk for serious GI events

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Significant impairment: Closely monitor; use lower daily dosage, amount not defined

Hepatic Dose Adjustment

Hepatic impairment: Dose adjustment not defined, caution advised

Warnings/Precautions ⬆ ⬇

Serious and potentially fatal cardiovascular thrombotic events, MI, and stroke have been reported with the use of therapy. Risk further increases with duration of use, presence of cardiovascular disease/risk factors for CV disease [US Black Box Warning]
Carefully administer therapy in patients with history of serious GI events and other risk factors known to be associated with peptic ulcer disease, such as alcoholism, smoking [US Black Box Warning]
Meclofenamate is contraindicated in the treatment of peri-operative pain in the setting of CABG surgery [US Black Box Warning]
NSAIDs may increase risk of serious GI events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events occur at any time and without warning symptoms. Elderly patients are at greater risk for serious GI events [US Black Box Warning]
Therapy may cause serious gastrointestinal toxicity, such as bleeding, ulceration, and perforation with or without warning symptoms
The risk of serious cardiovascular events & GI bleeding may be increased in patients taking long-term, high-dose NSAIDs; use lowest effective dose to obtain desired results
Monitor serum creatinine at baseline and then periodically if severe renal disease. Monitor BP throughout treatment. Perform CBC and chemistry profile periodically if long term therapy
Do not prescribe therapy for heavy menstrual flow without establishing its idiopathic nature
Events of borderline elevations of one or more liver tests may occur in some patients. Therefore carefully administer in patients with hepatic failure

Cautions: Use cautiously in

Renal impairment
Hepatic impairment
Asthma
Cardiovascular disease
Presence of cardiac risk factors
Hypertension
CHF
Fluid retention
History of PUD/GI bleed
Hematological disorders
Dehydration
Long term use
Diuretic use
Pregnancy

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:NR

Breastfeeding: Safety unknown; other agents may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 3 June 2011). According to manufacturer's data, lactating women should not breastfeed.

Adverse Reactions ⬆ ⬇

CNS: Headache, dizziness
GI: Diarrhea, nausea, vomiting, abdominal pain, pyrosis, flatulence, anorexia, constipation, stomatitis, peptic ulcer
CV: Edema
DERM: Rash, urticaria, pruritus
EENT: Tinnitus

Clinical Pharmacology ⬆ ⬇

Fenamate; inhibits prostaglandin synthesis
Well absorbed from GI tract
Metabolized by liver
Renally excreted primarily (70%); feces (30%)
Half life:

1.3 hrs for meclofenamate
15.3 hrs for metabolite

Brands and Availability ⬆ ⬇

US Trade Name(s)

Only generic available

US Availability

meclofenamate (generic)

CAPS: 50, 100 mg

Canadian Trade Name(s)

Canadian Availability

UK Trade Name(s)

UK Availability

Australian Trade Name(s)

Australian Availability

[Outline]

Classification ⬆ ⬇

Analgesics

Nonsteroidal Anti-inflammatory Agents
Non-Cox-2 Inhibitor NSAIDs

Rheumatologic

Nonsteroidal Anti-inflammatory Agents
Non-Cox-2 Inhibitor NSAIDs

Pill ⬆

Drug Name: Meclofenamate 100 MG Oral Capsule

Ingredient(s): Meclofenamate

Imprint: MYLAN;3000

Color(s): Pink, White

Shape: Capsule

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): colloidal silicon dioxide / fd&c blue # 1 / gelatin / magnesium stearate / microcrystalline cellulose / pregelatinized starch / fd&c red # 3 / sodium lauryl sulfate / titanium dioxide / d&c yellow # 10

Drug Label Author:
Mylan Pharmaceuticals Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Meclofenamate 50 MG Oral Capsule