Jevity

Jevity Injection (Jevity injection) Premixed, supplied as a premixed solution in plastic containers (PL 2501 Plastic), and Jevity Injection (Jevity injection), supplied as a concentrated solution for intravenous injection, are intended for intravenous use only. Jevity Injection (Jevity injection) Premixed and Jevity Injection (Jevity injection) are indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:

1. Short term treatment of active duodenal ulcer. Most adult patients heal within 4 weeks; there is rarely reason to use Jevity at full dosage for longer than 6 to 8 weeks. Studies have not assessed the safety of Jevity in uncomplicated active duodenal ulcer for periods of more than eight weeks.
2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. Controlled studies in adults have not extended beyond one year.
3. Short term treatment of active benign gastric ulcer. Most adult patients heal within 6 weeks. Studies have not assessed the safety or efficacy of Jevity in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.
4. Short term treatment of gastroesophageal reflux disease (GERD). Jevity is indicated for short term treatment of patients with symptoms of GERD.

   Jevity is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy.

5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).

Jevity (Jevity) a histamine-2 blockers. Jevity works by decreasing the amount of acid the stomach produces.

Jevity is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Jevity also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Jevity may also be used for purposes not listed in this medication guide.

In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Jevity Injection (Jevity injection) Premixed or Jevity Injection (Jevity injection) may be administered until oral therapy can be instituted.

The recommended dosage for Jevity Injection (Jevity injection) Premixed and Jevity Injection (Jevity injection) in adult patients is 20 mg intravenously q 12 h.

The doses and regimen for parenteral administration in patients with GERD have not been established.

Dosage for Pediatric Patients < 1 year of age Gastroesophageal Reflux Disease (GERD)

The studies described in PRECAUTIONS, Pediatric Patients < 1 year of age suggest the following starting doses in pediatric patients < 1 year of age: Gastroesophageal Reflux Disease (GERD) - 0.5 mg/kg/dose of Jevity oral suspension for the treatment of GERD for up to 8 weeks once daily in patients < 3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to < 1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous Jevity in pediatric patients < 1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest that the starting dose in pediatric patients 1-16 years of age is 0.25 mg/kg intravenously (injected over a period of not less than two minutes or as a 15-minute infusion) q 12 h up to 40 mg/day.

While published uncontrolled clinical studies suggest effectiveness of Jevity in the treatment of peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or gastric pH determination and endoscopy. Published uncontrolled studies in pediatric patients 1-16 years of age have demonstrated gastric acid suppression with doses up to 0.5 mg/kg intravenously q 12 h.

Dosage Adjustments for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half-life of Jevity is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of Jevity Injection (Jevity injection) Premixed or Jevity Injection (Jevity injection) may be reduced to half the dose, or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

Based on the comparison of pharmacokinetic parameters for Jevity in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of Jevity in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult intravenous dose is 20 mg q 12 h. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. In some patients, a higher starting dose may be required.

Oral doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Jevity Injection (Jevity injection) Premixed

Jevity Injection (Jevity injection) Premixed, supplied in Galaxy§ containers (PL 2501 Plastic), is a 50 mL iso-osmotic solution premixed with 0.9% sodium chloride for administration as an infusion over a 15-30 minute period. This premixed solution is for intravenous use only using sterile equipment.

Directions for Use of Galaxy® Containers

Check the container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for administration:

1. Suspend container from eyelet support.
2. Remove plastic protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions accompanying set. To prepare Jevity intravenous solutions, aseptically dilute 2 mL of Jevity Injection (solution containing 10 mg/mL) with 0.9% Sodium Chloride Injection or other compatible intravenous solution ) to a total volume of either 5 mL or 10 mL and inject over a period of not less than 2 minutes.

To prepare Jevity intravenous infusion solutions, aseptically dilute 2 mL of Jevity Injection (Jevity injection) with 100 mL of 5% dextrose or other compatible solution ), and infuse over a 15-30 minute period.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Stability

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Jevity Injection (Jevity injection) Premixed

Jevity Injection (Jevity injection) Premixed, as supplied premixed in 0.9% sodium chloride in Galaxy® containers (PL 2501 Plastic), is stable through the labeled expiration date when stored under the recommended conditions.

Jevity Injection (Jevity injection)

When added to or diluted with most commonly used intravenous solutions, e.g., Water for Injection, 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, or Lactated Ringer's Injection, diluted Jevity Injection (Jevity injection) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature - see HOW SUPPLIED, Storage.

When added to or diluted with Sodium Bicarbonate Injection, 5%, Jevity Injection (Jevity injection) at a concentration of 0.2 mg/mL (the recommended concentration of Jevity intravenous infusion solutions) is physically and chemically stable (i.e., maintains at least 90% of initial potency) for 7 days at room temperature - see HOW SUPPLIED, Storage. However, a precipitate may form at higher concentrations of Jevity Injection ( > 0.2 mg/mL) in Sodium Bicarbonate Injection, 5%.

How supplied

FOR INTRAVENOUS USE ONLY

No. 3537 - Jevity Injection (Jevity injection) Premixed 20 mg per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with Sodium Chloride, and is supplied as follows:

NDC 0006-3537-50, 50 mL single dose Galaxy® containers (PL 2501 Plastic).

No. 3539 - Jevity Injection (Jevity injection) 10 mg per 1 mL, is a non-preserved, clear, colorless solution and is supplied as follows:

NDC 0006-3539-04, 10 x 2 mL single dose vials.

No. 3541 - Jevity Injection (Jevity injection) 10 mg per 1 mL, is a clear, colorless solution and is supplied as follows:

NDC 0006-3541-14, 4 mL vials

NDC 0006-3541-20, 20 mL vials

NDC 0006-3541-49, 10 x 20 mL vials.

Storage

Store Jevity Injection (Jevity injection) Premixed in Galaxy® containers (PL 2501 Plastic) at room temperature (25°C, 77°F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35°C (95°F) does not adversely affect the product.

Store Jevity Injection (Jevity injection) at 2-8°C (36-46°F). If solution freezes, bring to room temperature; allow sufficient time to solubilize all the components.

Although diluted Jevity Injection (Jevity injection) has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution. Therefore, it is recommended that if not used immediately after preparation, diluted solutions of Jevity Injection (Jevity injection) should be refrigerated and used within 48 hours.

Jevity (Jevity) Injection Premixed is manufactured for: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA, By: BAXTER HEALTHCARE CORPORATION., Deerfield, Illinois 60015 USA. Jevity (Jevity) Injection is manufactured by: MERCK & CO., INC/Whitehouse Station, NJ 08889, USA. Issued October 2006. FDA rev date: 11/5/2007

See also:
What is the most important information I should know about Jevity?

You should not use this medication if you are allergic to Jevity or similar medications such as ranitidine (Zantac), cimetidine (Tagamet), or nizatidine (Axid).

Before taking Jevity, tell your doctor if you have kidney or liver disease, a history of Long QT syndrome, stomach cancer or other problems, or asthma, COPD, or other breathing problems.

Avoid taking cimetidine (Tagamet), ranitidine (Zantac), or nizatidine (Axid) while you are taking Jevity, unless your doctor has told you to.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Jevity may be only part of a complete program of treatment that also includes changes in diet or lifestyle habits. Follow your doctor's instructions very closely.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Use Jevity solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Jevity solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Jevity solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Jevity solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Jevity solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• If you take atazanavir, erlotinib, itraconazole, ketoconazole, or rilpivirine, ask your doctor or pharmacist how to take it with Jevity solution.
• Ask your doctor before taking antacids or other acid reducers with Jevity solution.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Jevity solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Jevity solution.

Jevity is used to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed. This medication is also used to treat certain stomach and throat (esophagus) problems (such as erosive esophagitis, gastroesophageal reflux disease-GERD, Zollinger-Ellison syndrome). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as cough that doesn't go away, stomach pain, heartburn, and difficulty swallowing. Jevity belongs to a class of drugs known as H2 blockers.

This form of Jevity is given by vein and is used to treat these conditions for a short time when you cannot take the medication by mouth. Your doctor should switch you to taking this medication by mouth when possible.

How to use Jevity (PF) intravenous

This medication is injected into a vein as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment. In children, dosage may also be based on body weight.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before injecting each dose, clean the injection site with rubbing alcohol. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Jevity?

In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.

In an application of Jevity with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.

Jevity in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of ascorbic acid in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

See also:
What are the possible side effects of Jevity?

The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which Jevity Tablets were compared to placebo, the incidence of adverse experiences in the group which received Jevity Tablets, 40 mg at bedtime, was similar to that in the placebo group.

The following adverse reactions have been reported to occur in more than 1% of patients on therapy with Jevity in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).

The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with Jevity has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:

Body as a Whole: fever, asthenia, fatigue

Cardiovascular: arrhythmia, AV block, palpitation

Gastrointestinal: cholestatic jaundice, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth

Hematologic: rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia

Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection

Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia

Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence. Convulsions, in patients with impaired renal function, have been reported very rarely.

Respiratory: bronchospasm, interstitial pneumonia

Skin: toxic epidermal necrolysis/Stevens Johnson syndrome (very rare), alopecia, acne, pruritus, dry skin, flushing

Special Senses: tinnitus, taste disorder

Other: rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo.

The adverse reactions reported for Jevity Tablets may also occur with Jevity for

Oral Suspension, Jevity Injection (Jevity injection) Premixed or Jevity Injection (Jevity injection). In addition, transient irritation at the injection site has been observed with Jevity Injection (Jevity injection).

Pediatric Patients

In a clinical study in 35 pediatric patients < 1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on Jevity that resolved when the medication was discontinued.

A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Jevity is considered an antioxidant.