Ibuprofen and Famotidine (Page 3 of 10)

5.14 Hematologic Toxicity

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with ibuprofen and famotidine tablets has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including ibuprofen and famotidine tablets, may increase the risk of bleeding events. Comorbid conditions such as coagulation disorders or concomitant use of warfarin, and other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase the risk. Monitor these patients for signs of bleeding [see Drug Interactions (7)].

5.15 Masking of Inflammation and Fever

The pharmacological activity of ibuprofen and famotidine tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

5.16 Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and chemistry profile periodically [see Warnings and Precautions (5.2, 5.4, 5.7)].

5.17 Concomitant NSAID Use

Ibuprofen and famotidine tablets contain ibuprofen as one of its active ingredients. They should not be used with other ibuprofen-containing products.

The concomitant use of NSAIDs, including aspirin, with ibuprofen and famotidine tablets may increase the risk of adverse reactions [see Adverse Reactions (6), Drug Interactions (7), Clinical Studies (14)].

5.18 Aseptic Meningitis

Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen, which is a component of ibuprofen and famotidine tablets. Although it is probably more likely to occur in patients with systemic lupus erythematosus (SLE) and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen and famotidine tablets, the possibility of its being related to ibuprofen should be considered.

5.19 Ophthalmological Effects

Blurred and/or diminished vision, scotomata, and/or changes in color vision have been reported. If a patient develops such complaints while receiving ibuprofen and famotidine tablets, the drug should be discontinued, and the patient should have an ophthalmologic examination which includes central visual fields and color vision testing.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)]
  • GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2)]
  • Hepatotoxicity [see Warnings and Precautions (5.4)]
  • Hypertension [see Warnings and Precautions (5.5)]
  • Heart Failure and Edema [see Warnings and Precautions (5.6)]
  • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.7)]
  • Anaphylactic Reactions [see Warnings and Precautions (5.8)]
  • Seizures [see Warnings and Precautions (5.9)]
  • Serious Skin Reactions [see Warnings and Precautions (5.11)]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.12)]
  • Fetal Toxicity [see Warnings and Precautions (5.13)]
  • Hematologic Toxicity [see Warnings and Precautions (5.14)]
  • Aseptic Meningitis [see Warnings and Precautions (5.18)]
  • Ophthalmological Effects [see Warnings and Precautions (5.19)]

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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ibuprofen and famotidine tablets was evaluated in 1,022 patients in controlled clinical studies, including 508 patients treated for at least 6 months and 107 patients treated for approximately 1 year. Patients treated with ibuprofen and famotidine tablets ranged in age from 39 to 80 years (median age 55 years), with 67% female, 79% Caucasian, 18% African-American, and 3% other races. Two randomized, active-controlled clinical studies (Study 301 and Study 303) were conducted for the reduction of the risk of development of ibuprofen-associated, upper gastrointestinal ulcers in patients who required use of ibuprofen, which included 1,022 patients on ibuprofen and famotidine tablets and 511 patients on ibuprofen alone. Approximately 15% of patients were on low-dose aspirin. Patients were assigned randomly, in a 2:1 ratio, to treatment with either ibuprofen and famotidine tablets or ibuprofen 800 mg three times a day for 24 consecutive weeks.

Three serious cases of acute renal failure were observed in patients treated with ibuprofen and famotidine tablets in the two controlled clinical trials. All three patients recovered to baseline levels after discontinuation of ibuprofen and famotidine tablets. Additionally, increases in serum creatinine were observed in both treatment arms in the two clinical studies. Many of these patients were taking concomitant diuretics and/or angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers. There were patients with a normal baseline serum creatinine level who developed abnormal values in the controlled trials as presented in Table 1.

Table 1: Shift Table of Serum Creatinine, Normal** to Abnormal*** in Controlled Studies

Study 301

Study 303

Baseline

Post-Baseline*

Ibuprofen and Famotidine Tablets

Ibuprofen

Ibuprofen and Famotidine Tablets

Ibuprofen

N=414

N=207

N=598

N=296

% (n)

% (n)

% (n)

% (n)

Normal**

Abnormal***

4% (17)

2% (4)

2%(15)

4% (12)

* At any point after baseline level

** serum creatinine normal range is 0.5 to 1.4 mg/dL or 44 to 124 micromol/L

*** serum creatinine >1.4 mg/dL

Most Commonly Reported Adverse Reactions

The most common adverse reactions (greater than or equal to 2%), from pooled data from the two controlled studies are presented in Table 2.

Table 2: Incidence of Adverse Reactions in Controlled Studies

Ibuprofen and Famotidine Tablets N=1,022

Ibuprofen N=511

%

%

Blood and lymphatic system disorders

Anemia

2

1

Gastrointestinal disorders

Nausea

6

5

Dyspepsia

5

8

Diarrhea

5

4

Constipation

4

4

Abdominal pain upper

3

3

Gastroesophageal reflux disease

2

3

Vomiting

2

2

Stomach discomfort

2

2

Abdominal pain

2

2

General disorders and administration site conditions

Edema peripheral

2

2

Infections and infestations

Upper respiratory tract infection

4

4

Nasopharyngitis

2

3

Sinusitis

2

3

Bronchitis

2

1

Urinary tract infection

2

2

Influenza

2

2

Musculoskeletal and connective tissue disorders

Arthralgia

1

2

Back pain

2

1

Nervous system disorders

Headache

3

3

Respiratory, thoracic and mediastinal disorders

Cough

2

2

Pharyngolaryngeal pain

2

1

Vascular disorders

Hypertension

3

2

In controlled clinical studies, the discontinuation rate due to adverse events for patients receiving ibuprofen and famotidine tablets and ibuprofen alone were similar. The most common adverse reactions leading to discontinuation from ibuprofen and famotidine tablet therapy were nausea (0.9%) and upper abdominal pain (0.9%).

There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.

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