Vivax

Each capsule contains Lansoprazole 30 mg.

Vivax is a proton pump inhibitor with actions and uses similar to those of omeprazole. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase, the proton pump of the gastric pariental cells.

Short-Term Treatment of Active Duodenal Ulcer

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Vivax/amoxicillin/clarithromycin

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: Vivax/amoxicillin

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Please refer to the full prescribing information for amoxicillin.

Maintenance of Healed Duodenal Ulcers

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

Short-Term Treatment of Active Benign Gastric Ulcer

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

Healing of NSAID-Associated Gastric Ulcer

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

Risk Reduction of NSAID-Associated Gastric Ulcer

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Vivax delayed-release capsules or Vivax delayed-release orally disintegrating tablets for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of Vivax delayed-release capsules or Vivax delayed-release orally disintegrating tablets may be considered.

Maintenance of Healing of Erosive Esophagitis (EE)

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Vivax is a proton pump inhibitor. Vivax decreases the amount of acid produced in the stomach.

Vivax is used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

Over-the-counter Vivax is used to treat frequent heartburn that happens 2 or more days per week.

Vivax is not for immediate relief of heartburn symptoms.

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

Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below. Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets should be taken before eating. Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets.

Recommended Dose

Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment.

Important Administration Information

Administration Options

Vivax Delayed-Release Capsules -

Oral Administration

• Vivax delayed-release capsules should be swallowed whole.
• Alternatively, for patients who have difficulty swallowing capsules, Vivax delayed-release capsules can be opened and administered as follows:
  • Open capsule.
  • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  • Swallow immediately.
• Vivax delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
  • Open capsule.
  • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
  • Mix briefly.
  • Swallow immediately.
  • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

​Vivax Delayed-Release Capsules - Nasogastric Tube (≥16 French) Administration

• For patients who have a nasogastric tube in place, Vivax delayed-release capsules can be administered as follows:
  • Open capsule.
  • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
  • Inject through the nasogastric tube into the stomach.
  • Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

​Vivax Delayed-Release

Orally Disintegrating Tablets

• Vivax delayed-release orally disintegrating tablets should not be broken or cut.
• Vivax delayed-release orally disintegrating tablets should not be chewed.
  • Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
  • The tablet typically disintegrates in less than 1 minute.
  • Alternatively, for children or other patients who have difficulty swallowing tablets, Vivax delayed-release orally disintegrating tablets can be delivered in two different ways.

Vivax Delayed-Release

Orally Disintegrating Tablets –

Oral Syringe

• For administration via oral syringe, Vivax delayed-release orally disintegrating tablets can be administered as follows:
  • Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
  • Shake gently to allow for a quick dispersal.
  • After the tablet has dispersed, administer the contents within 15 minutes.
  • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.

​Vivax Delayed-Release

Orally Disintegrating Tablets – Nasogastric Tube (≥ 8 French) Administration

• For administration via a nasogastric tube, Vivax delayed-release orally disintegrating tablets can be administered as follows:
  • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
  • Shake gently to allow for a quick dispersal.
  • After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
  • Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.

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

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.

Ask a doctor or pharmacist if it is safe for you to take Vivax if you have liver disease, or low levels of magnesium in your blood.

Vivax is not for immediate relief of heartburn symptoms.

Some conditions are treated with a combination of Vivax and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also take sucralfate (Carafate), avoid taking it at the same time you take Vivax. Sucralfate can make it harder for your body to absorb Vivax. Wait at least 30 minutes after taking Vivax before you take sucralfate.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Vivax 24HR should be taken only once every 24 hours for 14 days. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.

Allow at least 4 months to pass before you start another 14-day treatment with Vivax 24HR. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.

Use Vivax delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Vivax delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Vivax delayed-release capsules refilled.
• Take Vivax delayed-release capsules by mouth on an empty stomach before eating.
• Swallow Vivax delayed-release capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. Do NOT mix Vivax delayed-release capsules with other foods.
• You may also open the capsule and sprinkle the contents into 2 oz (60 mL) apple juice, orange juice, or tomato juice. Mix briefly, then swallow at once. Do not chew or crush the granules. Do not store the mixture for use at a later time. After you take your dose, rinse the glass with at least 4 oz (120 mL) of juice and swallow to be sure you have received all of the medicine. Do NOT mix Vivax delayed-release capsules with other liquids.
• If the patient is taking Vivax delayed-release capsules through a nasogastric (NG) tube, follow the instructions for use in the extra patient leaflet.
• You may take antacids while you are using Vivax delayed-release capsules if you are directed to do so by your doctor.
• If you also take sucralfate, take Vivax delayed-release capsules at least 30 minutes before taking sucralfate.
• Continue to take Vivax delayed-release capsules even if you feel well. Do not miss any doses.
• If you miss a dose of Vivax delayed-release capsules, 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 Vivax delayed-release capsules.

Vivax is used to treat acid-related throat problems (erosive esophagitis). It works by blocking acid production in the stomach. This medication is known as a proton pump inhibitor (PPI). Decreasing excess stomach acid can help relieve symptoms such as heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent and treat bleeding from stomach/intestinal ulcers.

How to use Vivax intravenous

This medication is given by injection into a vein over 30 minutes as directed by your doctor, usually once daily.

When you are able to take medicines by mouth, your doctor will switch your treatment to an oral form of this drug.

If needed, antacids may be taken along with this medication.

The dosage and length of treatment is based on your medical condition and response to therapy.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. 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.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Continue to use this medication for the prescribed length of treatment even if you are feeling better.

Inform your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should use this medication.

See also:
What other drugs will affect Vivax?

Drugs With pH-Dependent Absorption

Due to its effects on gastric acid secretion, Vivax can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. As with other drugs that decrease the intragastric acidity, the absorption of drugs such as ampicillin esters, ketoconazole, atazanavir, nelfinavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with Vivax.

Vivax is likely to substantially decrease the systemic concentrations of HIV protease inhibitors, such as atazanavir and nelfinavir, which are dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir or nelfinavir and the development of HIV resistance. Therefore, Vivax should not be co-administered with atazanavir or nelfinavir.

Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PPIs and MMF. Use Vivax with caution in transplant patients receiving MMF.

Warfarin

In a study of healthy subjects, co-administration of single or multiple 60 mg doses of Vivax and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Tacrolimus

Concomitant administration of Vivax and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Theophylline

A minor increase (10%) in the clearance of theophylline was observed following the administration of Vivax concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when Vivax is started or stopped to ensure clinically effective blood levels.

Clopidogrel

Concomitant administration of Vivax and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Vivax.

Methotrexate

Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of high dose methotrexate with PPIs have been conducted.

In a study of rheumatoid arthritis patients receiving low-dose methotrexate, Vivax and naproxen, no effect on pharmacokinetics of methotrexate was observed.

Combination Therapy With Clarithromycin

Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions. Because of these drug interactions, clarithromycin is contraindicated for co-administration with certain drugs.

For information about drug interactions of antibacterial agents (amoxicillin and clarithromycin) indicated in combination with Vivax, refer to the DRUG INTERACTIONS section of their package inserts.

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

Clinical

Worldwide, over 10,000 patients have been treated with Vivax in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, Vivax treatment has been well-tolerated in both short-term and long-term trials.

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 clinical practice.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Vivax-treated patients and occurred at a greater rate in Vivax-treated patients than placebo-treated patients in Table 1.

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of Vivax, but higher in the patients who received 60 mg of Vivax (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Vivax for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Vivax, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or Vivax and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with Vivax included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received Vivax in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System – diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy

Metabolic and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing Experience

Additional adverse experiences have been reported since Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets have been marketed. The majority of these cases are foreign-sourced and a relationship to Vivax delayed-release capsules and Vivax delayed-release orally disintegrating tablets have not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole – anaphylactic/anaphylactoid reactions; Digestive System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses - speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with Vivax plus amoxicillin and clarithromycin, and Vivax plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Vivax, amoxicillin, or clarithromycin.

Triple Therapy: Vivax/amoxicillin/clarithromycin

The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Vivax/amoxicillin

The most frequently reported adverse reactions for patients who received Vivax three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with Vivax three times daily plus amoxicillin three times daily dual therapy than with Vivax alone.

For information on adverse reactions with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Laboratory Values

The following changes in laboratory parameters in patients who received Vivax were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and Vivax, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received Vivax reported jaundice at any time during the study.

In clinical trials using combination therapy with Vivax plus amoxicillin and clarithromycin, and Vivax plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For information on laboratory value changes with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.