What happens if I overdose Tersen?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.
Proper storage of Tersen orally disintegrating tablets:
Store Tersen orally disintegrating tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tersen orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Tersen in details
Clinical Features: Experience with Tersen overdosage is limited.
Treatment: There is no specific antidote for Tersen. Treatment is essentially symptomatic and supportive.
To Decrease Absorption: Any unabsorbed material should be removed from the gastrointestinal tract.
To Enhance Elimination: Hemodyalisis does not remove an appreciable fraction of the total quantity of Tersen or its metabolites.
What should I avoid while taking Tersen?
This medication can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Tersen and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
If you also take sucralfate (Carafate), avoid taking it at the same time you take Tersen. Sucralfate can make it harder for your body to absorb Tersen. Wait at least 30 minutes after taking Tersen before you take sucralfate.
Tersen warnings
Gastric Malignancy
Symptomatic response to therapy with Tersen does not preclude the presence of gastric malignancy.
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including Tersen. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Tersen if acute interstitial nephritis develops.
Cyanocobalamin (vitamin B12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Clostridium difficile Associated Diarrhea
Published observational studies suggest that proton pump inhibitor (PPI) therapy like Tersen may be associated with an increased risk of Clostridium difficile associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Tersen, refer to WARNINGS and PRECAUTIONS sections of those package inserts.
Bone Fracture
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Concomitant Use of Tersen with Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
What should I discuss with my healthcare provider before taking Tersen?
Some medical conditions may interact with Tersen powder packet. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)
Some MEDICINES MAY INTERACT with Tersen powder packet. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased
- Clarithromycin or voriconazole because they may increase the risk of Tersen powder packet's side effects
- Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Tersen powder packet
- Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Tersen powder packet
This may not be a complete list of all interactions that may occur. Ask your health care provider if Tersen powder packet may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Tersen precautions
General
Symptomatic response to therapy with Tersen does not preclude the presence of gastric malignancy.
Treatment with Tersen I.V. for Injection should be discontinued as soon as the patient is able to resume treatment with Tersen oral formulations.
Drug Interactions
Tersen is metabolized through the cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes. Studies have shown that Tersen does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, or clarithromycin in healthy subjects. These compounds are metabolized through various cytochrome P450 isozymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. When Tersen was administered concomitantly with theophylline (CYP1A2, CYP3A), a minor increase (10%) in the clearance of theophylline was seen. Because of the small magnitude and the direction of the effect on theophylline clearance, this interaction is unlikely to be of clinical concern. Nonetheless, individual patients may require additional titration of their theophylline dosage when Tersen is started or stopped to ensure clinically effective blood levels.
In a study of healthy subjects neither the pharmacokinetics of warfarin enantiomers nor prothrombin time were affected following single or multiple 60 mg doses of Tersen. However, there have been reports of increased International Normalized Ratio (INR) and prothrombin time in patients receiving proton pump inhibitors, including Tersen, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
Tersen causes a profound and long-lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that Tersen may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters, iron salts, digoxin).
Carcinogenesis, Mutagenesis, Impairment of Fertility
In two 24-month carcinogenicity studies, Sprague-Dawley rats were treated orally with doses of 5 to 150 mg/kg/day-about 1 to 40 times the exposure on a body surface (mg/m2) basis of a 50-kg person of average height [1.46 m2 body surface area (BSA)] given the recommended human dose of 30 mg/day (22.2 mg/m2). Tersen produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, Tersen produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat. Testicular interstitial cell adenoma occurred in 1 of 30 rats treated with 50 mg/kg/day (13 times the recommended human dose based on BSA) in a 1-year toxicity study.
In a 24-month carcinogenicity study, CD-1 mice were treated orally with doses of 15 to 600 mg/kg/day, 2 to 80 times the recommended human dose based on BSA. Tersen produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Tersen treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA).
Tersen was not genotoxic in the Ames test, the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test. It was positive in in vitro human lymphocyte chromosomal aberration assays.
Tersen at intravenous doses of up to 30 mg/kg/day (approximately 8 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance in male and female rats.
Pregnancy
Teratogenic EffectsPregnancy Category B
Teratology studies have been conducted in rats and rabbits using intravenous Tersen doses of up to 30 mg/kg/day (approximately 8 times in rats and 16 times in rabbits of the recommended human dose based on BSA). Treatment with Tersen did not result in any impairment of fertility or harm to the fetus.
However, there are no adequate and well-controlled studies in pregnant women using the intravenous route. Because animal reproduction studies are not always predicative of human response, Tersen I.V. for Injection should be used during pregnancy only if clearly needed.
Nursing Mothers
Tersen or its metabolites are excreted in the milk of rats. It is not known whether Tersen is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from Tersen, and because of the potential for tumorigenicity shown for Tersen in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue Tersen I.V. for Injection, taking into account the importance of Tersen I.V. for Injection to the mother.
Pediatric Use
The safety and effectiveness of Tersen I.V. for Injection have not been established for pediatric patients. For further information, please see the Tersen package insert for the oral formulations.
Use in Women
Among intravenous Tersen treated subjects, similar percentages of adverse events were reported in males and females.
Over 4,000 women were treated with oral Tersen. Ulcer healing rates in females were similar to those in males. The incidence rates of adverse events in females were also similar to those seen in males.
Use in Geriatric Patients
Data in elderly patients administered intravenous Tersen is limited; however, with oral Tersen, ulcer healing rates in elderly patients are similar to those in a younger age group. The incidence rates of Tersen-associated adverse events and laboratory test abnormalities are similar to those seen in younger patients. For geriatric patients, dosage and administration of Tersen need not be altered for a particular indication.
What happens if I miss a dose of Tersen?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "LANSOPRAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "lansoprazole". http://www.drugbank.ca/drugs/DB00448 (accessed September 17, 2018).
- MeSH. "Proton Pump Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
