ibuprofen/famotidine (Rx)

Brand and Other Names:Duexis
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

ibuprofen/famotidine

tablet

  • 800mg/26.6mg

Rheumatoid Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Osteoarthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Safety and efficacy not established

Rheumatoid Arthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

Osteoarthritis

Indicated for relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper GI ulcers

1 tablet PO q8hr

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Interactions

Interaction Checker

and ibuprofen/famotidine

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            Adverse Effects

            1-10%

            Nausea (6%)

            Dyspepsia (5%)

            Diarrhea (5%)

            Constipation (4%)

            Headache (3%)

            Hypertension (3%)

            Upper abdominal pain (3%)

            Gastroesophageal reflux (2%)

            Vomiting (2%)

            Stomach discomfort (2%)

            Anemia (2%)

            Peripheral edema (2%)

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Contains ibuprofen; may increase the risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal; risk may increase with duration of use
            • Patients with CV disease or risk factors may be at greater risk
            • Contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs, including ibuprofen, increase the risk of serious GI adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
            • Reactions can occur at any time without warning symptoms
            • Elderly patients are at greater risk

            Contraindications

            Hypersensitivity

            Pre-existing asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs

            Use during the perioperative period in the setting of CABG surgery

            Starting at 30 weeks gestation, NSAIDs should not be used by pregnant women as premature closure of the ductus arteriosus in the fetus may occur

            Cautions

            Hypertension can occur with NSAID treatment; monitor blood pressure

            Fluid retention and edema can occur with NSAID treatment; use with caution in patients with fluid retention or heart failure

            Antiplatelet effect; active and clinically significant bleeding from any source can occur; discontinue if active bleeding occurs

            Long-term NSAID administration can result in renal papillary necrosis and other renal injury; caution in patients at risk (eg elderly, existing renal impairment, heart failure, liver impairment, coadministration with diuretics or ACE inhibitors)

            Anaphylaxis may occur; especially in asthmatic patients experiencing rhinitis and bronchospasm; discontinue immediately if an anaphylactoid reaction occurs

            Serious/fatal skin reactions may occur and include exfoliative dermatitis, Stevens-Johnson Syndrome, and toxic epidermal necrolysis; discontinue if rash or other signs of local skin reaction occur

            Hepatic injury ranging from transaminase elevations to liver failure can occur; discontinue immediately if abnormal liver tests persist or worsen, if clinical signs and symptoms of liver disease develop, or if systemic manifestations occur

            Drug reaction with eosinophilia and systemic symptoms

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
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            Pregnancy & Lactation

            Pregnancy

            Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

            Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy

            Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus

            Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment

            There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of the drug combination

            Ibuprofen

            • Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
            • In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
            • In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss
            • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses

            Famotidine

            • Limited published data do not report an increased risk of congenital malformations or other adverse pregnancy effects with use of H2-receptor antagonists during pregnancy; however, these data are insufficient to adequately determine a drug-associated risk
            • Reproductive studies with famotidine have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day (approximately 243 and 122 times the recommended human dose, respectively, based on body surface area) and in both species at intravenous (IV) doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine
            • Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
            • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible
            • If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice

            Labor or Delivery

            • There are no studies on the effects of drug combination during labor or delivery; in animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

            Lactation

            No studies conducted with use of drug combination in lactating women; limited data from published literature report famotidine is present in human milk in low amounts

            Published literature also reports the presence of ibuprofen in human milk in low amounts; no information is available on effects of famotidine or ibuprofen on milk production or on a breastfed infant

            Famotidine is present in milk of lactating rats; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug combination or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Ibuprofen: NSAID; elicits analgesic and antipyretic effects by prostaglandin synthetase inhibition

            Famotidine: H2-receptor antagonist; inhibits gastric acid secretion, thereby lowering gastric pH

            Pharmacokinetics

            Protein Bound: extensive (ibuprofen); 15-20% (famotidine)

            Excretion

            Half-life: 2 hr (ibuprofen); 4 hr (famotidine)

            Renal clearance: 250-450 mL/min (famotidine)

            Urine: Ibuprofen metabolite (45-79%); free or conjugated drug (1-14%); famotidine (65-70% with 30% as unchanged)

            Absorption

            • Peak Plasma Time: 1.9 hr (ibuprofen); 2 hr (famotidine); food delays peak time
            • Peak Plasma Concentration: 45 mcg/mL (ibuprofen); 61 ng/mL (famotidine)
            • AUC: Food reduces AUC by 11-15%
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.