CAMBIA Powder for oral solution (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Assertio Therapeutics, Inc.

Λέξεις κλειδιά

13913-011

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BOXED WARNING SECTION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular ...

1. Indications and Usage

1.1 Acute Treatment of Migraine CAMBIA (Diclofenac Potassium for Oral Solution) is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). 1.2 Important ...

2. Dosage and Administration

2.1 Acute Treatment of Migraine Administer one packet (50 mg) of CAMBIA for the acute treatment of migraine. Empty the contents of one packet into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 ...

3. Dosage Forms and Strengths

CAMBIA is available in individual packets each designed to deliver a 50 mg dose when mixed in water.

4. Contraindications

CAMBIA is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to diclofenac [see Warnings and Precautions (5.7, 5.8)]. CAMBIA is ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years' duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.1)] Gastrointestinal effects ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

7. Drug Interactions

7.1 Aspirin When administered with aspirin, diclofenac potassiums protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration ...

8.1. Pregnancy

Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Starting at 30 weeks gestation, CAMBIA, and other NSAIDS, should be avoided by pregnant women as premature closure ...

8.2. Labor and Delivery

The effects of CAMBIA on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence ...

8.3. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from CAMBIA, a decision ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Clinical studies of CAMBIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients are at increased risk for ...

8.6. Hepatic Impairment

Because hepatic metabolism accounts for almost 100% of diclofenac elimination, patients with hepatic impairment should be considered for treatment with CAMBIA only if the benefits outweigh the risks. There ...

8.7. Renal Impairment

No information is available from controlled clinical studies regarding the use of CAMBIA in patients with advanced renal disease. Therefore, treatment with CAMBIA is not recommended in patients with advanced ...

10. Overdosage

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding ...

11. Description

CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. ...

12.1. Mechanism of Action

CAMBIA is a non-steroidal anti-inflammatory drug (NSAID). The mechanism of action of CAMBIA, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. ...

12.3. Pharmacokinetics

Absorption Diclofenac is 100% absorbed after oral administration compared to intravenous administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (less than the recommended human dose [RHD] of 50 mg/day on a body surface area [mg/m²] basis) have revealed no significant ...

14. Clinical Studies

The efficacy of CAMBIA in the acute treatment of migraine headache was demonstrated in two randomized, double-blind, placebo-controlled trials. Patients enrolled in these two trials were predominantly ...

16.1. How Supplied

CAMBIA 50 mg (Diclofenac Potassium for Oral Solution) is supplied as one or more sets of three perforated co-joined individual dose packets. Each individual packet is designed to deliver a dose of 50 mg ...

16.2. Storage and Handling

Store at 25°C (77°F). Excursions permitted from 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]

17. Patient Counseling Information

Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using CAMBIA [see Medication ...