PREVIDOLRX PLUS ANALGESIC PAK- diclofenac sodium kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

GenPak Solutions, LLC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Delayed-release Tablets, are indicated: • For relief of the signs and symptoms of osteoarthritis • For relief of the signs and symptoms of rheumatoid arthritis • For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac Sodium Delayed-release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac Sodium 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 NSAIDs have been reported in such patients (see WARNINGS, ANAPHYLACTOID REACTIONS, a

Product summary:

Diclofenac Sodium Delayed-release Tablets, USP, for oral administration, are available as: 75 mg - round, Light brown, enteric-coated tablets, P 75 imprinted on one side in black ink and plain on the reverse side, are supplied as: Bottles of 60, NDC 16571-201-06 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PREVIDOLRX PLUS ANALGESIC PAK- DICLOFENAC SODIUM
GENPAK SOLUTIONS, LLC
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PREVIDOLRX PLUS ANALGESIC PAK - 095
PREVIDOLRX PLUS ANALGESIC PAK
GENPAK SOLUTIONS LLC
PREVIDOLRX PLUS ANALGESIC PAK (PART 1 OF 2) DESCRIPTION: DICLOFENAC
SODIUM
DELAYED-RELEASE TABLETS USP-75MG
RX ONLY
Cardiovascular Risk
NASAIDs may cause an increase risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of
use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be a
greater risk. (see WARNINGS)
Diclofenac sodium delayed-release tablets is contraindicated for the
treatment of
perioperative pain in the setting of coronary artery bypass graft
(CABG) surgery (see
WARNINGS)
Gastrointestinal Risk
NSAIDs cause an increase risk of serious gastrointestional adverse
events including
inflammation, bleeding, ulceration, and perforation of the stomach or
intestines, which can be
fatal. These events can occur at any time during use and without
warning symptoms. Elderly
patients are at a greater risk for serious gastrointestinal events.
(see WARNINGS.)
DESCRIPTION DICLOFENAC SODIUM
Diclofenac Sodium Delayed-release Tablets are a benzene-acetic acid
derivative. The chemical name
is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt.
The molecular weight is
318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the
following structural formula:
The inactive ingredients in Diclofenac Sodium Delayed-release Tablets
include: lactose (monohydrate),
microcrystalline cellulose, croscarmellose sodium, povidone, talc,
magnesium stearate, methacrylic
acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide,
hypromellose, polyethylene
glycol, iron oxide red, iron oxide yellow) and purified water.
PHARMACODYNAMICS
PHARMACOKINETICS
DIS TRIBUTION
METABOLIS M
EXCRETION
DRUG INTERACTIONS
PHARMACODYNAMICS
Diclofenac Sodium Delayed-release Tablets are a non-steroidal
anti-inflammatory drug (NSAID) that
exhibits ant