A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Meclofenamate Indications, Dosage, Storage, Stability - Meclofenamate
Meclofenamate Indications, Dosage, Storage, Stability - Meclofenamate
INDICATIONS
Meclofenamate sodium
is indicated for the relief
of mild to moderate pain.
Meclofenamate sodium
is also indicated for the treatment
of primary dysmenorrhea and for the treatment
of idiopathic heavy
menstrual blood loss (see CLINICAL
PHARMACOLOGY and PRECAUTIONS
sections).
Meclofenamate sodium
is also indicated for relief
of the signs and symptoms of acute
and chronic rheumatoid
arthritis and osteoarthritis.
As with all nonsteroidal
anti-inflammatory
drugs, selection of
meclofenamate sodium requires a careful assessment
of the benefit/risk ratio
(see WARNINGS, PRECAUTIONS
and ADVERSE REACTIONS
sections).
Meclofenamate sodium
is not recommended in children because adequate studies to demonstrate
safety and efficacy
have not been carried out.
DOSAGE AND ADMINISTRATION
Usual Dosage
For Mild To Moderate Pain, the recommended dose
is 50 mg every 4 to 6 hours.
Doses of 100 mg may be needed
in some patients for optimal pain relief (see CLINICAL
PHARMACOLOGY section). However, the daily dose
should not exceed 400 mg
(see ADVERSE REACTIONS section).
For excessive menstrual blood
loss and primary
dysmenorrhea, the recommended dose
of meclofenamate sodium
is 100 mg three times a day,
for up to six days, starting at the onset of menstrual flow.
For rheumatoid
arthritis and osteoarthritis,
including acute exacerbations
of chronic disease,
the dosage is 200 to
400 mg per
day, administered in three or four equal doses.
Therapy should be initiated at the lower dosage,
then increased as necessary to improve clinical
response. The dosage
should be individually adjusted for each patient,
depending on the severity of the symptoms and the clinical response.
The daily dosage should
not exceed 400 mg per
day. The smallest dosage of meclofenamate sodium
that yields clinical
control should be employed.
Although improvement may be seen in some patients in a few days,
two to three weeks of treatment
may be required to obtain the optimum
therapeutic benefit. After a satisfactory response
has been achieved, the dosage
should be adjusted as required. A lower dosage
may suffice for long-term administration.
If gastrointestinal
complaints occur (see WARNINGS
and PRECAUTIONS), meclofenamate
sodium may be administered with meals or with milk
(see CLINICAL PHARMACOLOGY
for a description of food
effects). If intolerance occurs, the dosage
may need to be reduced.
Therapy should be terminated if any severe adverse reactions occur.
HOW SUPPLIED
Meclofenamate sodium
capsules, USP are available containing either 50 mg or 100 mg
of meclofenamic acid as
the sodium salt.
The 50 mg capsules are coral (cap) and coral (body) and
are marked with MYLAN on both body
and cap. They are available as follows:
NDC 0378-2150-01 bottles of 100 capsules
NDC 0378-2150-05 bottles of 500 capsules
The 100 mg capsules are coral (cap) and white
(body) and are marked with MYLAN on both body
and cap. They are available as follows:
NDC 0378-3000-01 bottles of 100 capsules
NDC 0378-3000-05 bottles of 500 capsules
STORE AT CONTROLLED ROOM TEMPERATURE 15°-30° C( 59°-86°
F).
PROTECT FROM LIGHT AND MOISTURE.
Dispense in a tight, light-resistant container
as defined in the USP using a child-resistant closure.
CAUTION: Federal law prohibits
dispensing without prescription.
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