DESCRIPTION
id: 31dd8572-984f-1416-e054-00144ff8d46c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Diclofenac sodium and misoprostol delayed-release tablets are a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E
1 analog. Diclofenac sodium and misoprostol delayed-release tablets are white circular, biconvex tablets containing 200 mcg misoprostol with off white circular enteric coated inlay tablet containing either 50 or 75 mg of diclofenac sodium and approximately 11.5 mm in diameter.
Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are:
C
14H
10Cl
2NO
2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt.
Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are:
C
22H
38O
5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate.
Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone (polyvidone) K-30; sodium starch glycolate; starch (corn); talc; triethyl citrate.
INDICATIONS AND USAGE
id: 31dd8572-9859-1416-e054-00144ff8d46c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See
WARNINGS, Gastrointestinal Effects – Risk of Ulceration, Bleeding and Perforation
for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications.
CONTRAINDICATIONS
id: 31dd8572-985a-1416-e054-00144ff8d46c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
See boxed
CONTRAINDICATIONS AND WARNINGS
related to misoprostol.
Diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women.
Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. Diclofenac sodium and misoprostol delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac sodium have been reported in such patients (see
WARNINGS- Anaphylactic Reactions
, and
PRECAUTIONS-Preexisting Asthma
).
Diclofenac sodium and misoprostol delayed-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see boxed
CONTRAINDICATIONS AND WARNINGS
).
WARNINGS
id: 31dd8572-985b-1416-e054-00144ff8d46c
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
Regarding misoprostol:
See boxed
CONTRAINDICATIONS AND WARNINGS.
Regarding diclofenac:
See boxed
CONTRAINDICATIONS AND WARNINGS
OVERDOSAGE
id: 31dd8572-988e-1416-e054-00144ff8d46c
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
The toxic dose of diclofenac sodium and misoprostol delayed-release tablets has not been determined. However, signs of overdosage from the components of the product have been described.
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS
id: 31dd8572-9891-1416-e054-00144ff8d46c
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5
Symptoms of overdosage with diclofenac sodium and misoprostol delayed-release tablets should be treated with supportive therapy. In case of acute overdosage, gastric lavage is recommended. Induced diuresis may be beneficial because diclofenac sodium and misoprostol metabolites are excreted in the urine. The effect of dialysis or hemoperfusion on the elimination of diclofenac sodium (99% protein bound) and misoprostol acid remains unproven. The use of oral activated charcoal may help to reduce the absorption of diclofenac sodium and misoprostol.
DOSAGE AND ADMINISTRATION
id: 31dd8572-9892-1416-e054-00144ff8d46c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
After observing the response to initial therapy with diclofenac sodium and misoprostol delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis and osteoarthritis the recommended dose is given below.
Diclofenac sodium and misoprostol delayed-release tablets are administered as diclofenac sodium and misoprostol delayed-release tablets 50/0.2 mg (50 mg diclofenac sodium/200 mcg misoprostol) or as diclofenac sodium and misoprostol delayed-release tablets 75/0.2 mg (75 mg diclofenac sodium/200 mcg misoprostol).
Note: See
SPECIAL DOSING CONSIDERATIONS
section, below.
HOW SUPPLIED
id: 31dd8572-9896-1416-e054-00144ff8d46c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Diclofenac sodium and misoprostol delayed-release tablets (diclofenac sodium/misoprostol) are supplied as a film-coated tablet in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength is a white circular, biconvex tablets with off white circular enteric coated inlay tablets on one side and debossed “DM2” on other side. The 75 mg/200 mcg dosage strength is a white circular, biconvex tablets with off white circular enteric coated inlay tablets on one side and debossed “DM1” on other side.
The dosage strengths are supplied in:
| Strength
|
|
NDC Number
|
|
Size
|
| 50/200
|
|
42367-110-06
|
|
bottle of 60
|
|
|
42367-110-09
|
|
bottle of 90
|
|
|
|
|
|
|
|
|
|
|
|
| 75/200
|
|
42367-111-06
|
|
bottle of 60
|
Store at or below 25°C (77°F), in a dry area.
Rx only
Manufactured by: Cipla Ltd., India
For: Eagle Pharmaceuticals, Inc.
Woodcliff Lake, NJ 07677 USA
Revised April 2013
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
PATIENT INFORMATION LEAFLET
id: 31dd8572-9897-1416-e054-00144ff8d46c
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0
Read this leaflet before taking diclofenac sodium and misoprostol delayed-release tablets (diclofenac sodium 50 or 75 mg/misoprostol 200 mcg) and each time your prescription is renewed, because the leaflet may be changed.
Diclofenac sodium and misoprostol delayed-release tablets are being prescribed by your doctor for treatment of your arthritis symptoms while at the same time providing protection from the development of stomach and intestinal ulcers due to the arthritis medication. Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac, an arthritis medication. Diclofenac sodium and misoprostol delayed-release tablets also contain misoprostol to decrease the chance of getting stomach and intestinal ulcers that sometimes develop with NSAID medications. Serious side effects are still possible, however, and you should report to your doctor any signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain or swelling. If signs of liver toxicity occur (nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, and “flu-like” symptoms), you should stop therapy and seek immediate medical attention.
If signs of an anaphylactic reaction occur (e.g., difficulty breathing, swelling of the face or throat), you should stop therapy and seek immediate medical attention (see
WARNINGS
).
Do not take diclofenac sodium and misoprostol delayed-release tablets if you are pregnant (see boxed
CONTRAINDICATIONS AND WARNINGS
). Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac sodium and misoprostol. Misoprostol can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.
If you become pregnant during therapy with diclofenac sodium and misoprostol delayed-release tablets, stop taking diclofenac sodium and misoprostol delayed-release tablets and contact your doctor immediately. Remember that even if you are using a means of birth control, it is still possible to become pregnant. Should this occur, stop taking diclofenac sodium and misoprostol delayed-release tablets and consult your doctor immediately.
Diclofenac sodium and misoprostol delayed-release tablets are not recommended for nursing mothers.
Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, may cause an increased risk of heart attack, or stroke, which can lead to death. This risk may increase with duration of use. If you have heart disease or risk factors for heart disease, you may be at greater risk (see boxed
CONTRAINDICATIONS AND WARNINGS
). Diclofenac sodium and misoprostol delayed-release tablets should never be used for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see boxed
CONTRAINDICATIONS AND WARNINGS
). Although serious CV events can occur without warning symptoms, ask for medical advice when observing signs and symptoms of chest pain, shortness of breath, weakness, or slurring of speech (see boxed
CONTRAINDICATIONS AND WARNINGS
).
Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, may cause GI discomfort and, rarely, serious GI effects such as ulcers and bleeding, which may result in hospitalization and even death.
Diclofenac sodium and misoprostol delayed-release tablets may cause diarrhea, abdominal pain, upset stomach and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week with continued treatment. You can minimize possible diarrhea by making sure you take diclofenac sodium and misoprostol delayed-release tablets with meals and by avoiding the use of antacids containing magnesium (if needed, use one containing aluminum or calcium instead). Diclofenac sodium and misoprostol delayed-release tablets should be swallowed whole, and not chewed, crushed or dissolved.
Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take diclofenac sodium and misoprostol delayed-release tablets. If you have prolonged difficulty (more than 7 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.
Diclofenac sodium and misoprostol delayed-release tablets may also cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can lead to death. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see boxed
CONTRAINDICATIONS AND WARNINGS
). This risk may increase with duration of use.
Although serious GI tract ulcerations and bleeding can occur without warning symptoms, ask for medical advice when observing signs and symptoms of ulceration and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis.
(See boxed
CONTRAINDICATIONS AND WARNINGS
.)
Diclofenac sodium and misoprostol delayed-release tablets, like other NSAIDs, may cause serious skin side effects, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis, which may result in hospitalization and even death.
Although serious skin reactions may occur without warning, ask for medical advice when observing signs or symptoms, such as skin rash and blisters, fever, or other signs of hypersensitivity such as itching. Stop the drug immediately at the first appearance of skin rash or any other signs of hypersensitivity and contact your physician as soon as possible.
Take diclofenac sodium and misoprostol delayed-release tablets only according to the directions given by your doctor. Changes in dose should be made only with your doctor’s approval.
Do not give diclofenac sodium and misoprostol delayed-release tablets to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and could be dangerous for another person, especially a woman who may be, or could become, pregnant.
This information sheet does not cover all possible side effects of diclofenac sodium and misoprostol delayed-release tablets. See your doctor if you have questions.
Keep out of reach of children.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Principal Display Panel – 75 mg Bottle Label
id: 31de16ed-521e-4b7e-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Blenheim Pharmacal, Inc.
NDC 10544-955-14
14 Tablets Rx Only
Diclofenac Sodium
and Misoprostol
Delayed-Release Tablets
75 mg/0.2 mg
