What happens if I overdose Sp Extream?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Sp Extream delayed-release tablets:
Store Sp Extream delayed-release 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 Sp Extream delayed-release tablets out of the reach of children and away from pets.
Overdose of Sp Extream in details
Some reports of overdosage with Sp Extream have been received. A spontaneous report of a suicide involving an overdosage of Sp Extream (560 mg) has been received; however, the death was more reasonably attributed to the unknown doses of chloroquine and zopiclone which were also since 2 other reported cases of Sp Extream overdosage involved similar amounts of Sp Extream (400 mg and 600 mg) with no adverse effects observed. One patient in a flexible dosing study of refractory peptic ulcer disease received a dose of 320 mg daily for 3 months; treatment was well tolerated. Doses of up to 240 mg daily, given IV for 7 days have been administered to healthy subjects and have been well tolerated.
Experience in patients taking very high doses of Sp Extream is limited. Sp Extream is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.
Single oral doses of Sp Extream at 709 mg/kg, 798 mg/kg and 887 mg/kg were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex and tremor.
What should I avoid while taking Sp Extream?
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 Sp Extream and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
Sp Extream warnings
Implications of Symptomatic Response
Symptomatic response to therapy with Sp Extream does not preclude the presence of gastric malignancy.
Hypersensitivity and Severe Skin Reactions
Anaphylaxis and other serious reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN) have been reported with use of intravenous Sp Extream. These may require emergency medical treatment.
Injection Site Reactions
Thrombophlebitis was associated with the administration of intravenous Sp Extream.
Potential for Exacerbation of Zinc Deficiency
Sp Extream contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with Sp Extream I.V. for Injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.
Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including Sp Extream I.V. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Sp Extream I.V. if acute interstitial nephritis develops.
Clostridium difficile associated diarrhea
Published observational studies suggest that PPI therapy like Sp Extream may be associated with an increased risk of Clostridium difficile associated diarrhea, 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.
Bone Fracture
Several published observational studies suggest that proton pump inhibitor (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.
Hepatic Effects
Mild, transient transaminase elevations have been observed in clinical studies. The clinical significance of this finding in a large population of subjects administered intravenous Sp Extream is unknown.
Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and 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.
Interference with Urine Screen for THC
May produce false-positive urine screen for THC (tetrahydrocannabinol)
.
Concomitant use of Sp Extream 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 Sp Extream?
Some medical conditions may interact with Sp Extream suspension. 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, low blood vitamin B12 levels or vitamin B12 deficiency, 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 Sp Extream suspension. 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
- Anticoagulants (eg, warfarin), digoxin, methotrexate, or saquinavir because the risk of their side effects may be increased by Sp Extream suspension
- Ampicillins, atazanavir, bosutinib, clopidogrel, dasatinib, erlotinib, indinavir, iron, itraconazole, ketoconazole, mycophenolate, nelfinavir, nilotinib, posaconazole, rilpivirine, or sorafenib because their effectiveness may be decreased by Sp Extream suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Sp Extream suspension 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.
Sp Extream precautions
Patients suffering from a liver disease. In case of severe hepatic disorder, liver function must be monitored while taking Sp Extream.
If Sp Extream is given for several months or years (long-term use) as required for the treatment of Zollinger-Ellison syndrome and other disorders involving an increased production of gastric acid, the uptake of vitamin B12 by the body may be reduced. This effect occurs in all medicinal products inhibiting gastric acid.
Before taking Sp Extream, it should be established 1st that the patient is not suffering from a malignant gastric or oesophageal disorder, since Sp Extream can mask symptoms of these malignancies, possibly resulting in delay diagnosis. Therefore, patient should inform the physician if they suffer from unintentional weight loss, difficulty swallowing or acid dyspepsia for the 1st time.
Refer to the patient information leaflet enclosed with any antibiotics if used with Sp Extream concomitantly.
If Sp Extream 20 mg is taken to treat complaints eg, heartburn, acid reflux and pain during swallowing as a result of gastric acid reflux to the oesophagus, the physician should be informed if symptoms persist after 4 weeks.
If Sp Extream 20 mg is taken for the prevention of stomach or gastroduodenal ulcers during long-term treatment with certain analgesics (NSAIDs), it should be assessed if the patient is at risk of developing these complications. The physician should be informed if the patient previously suffered from ulcers or gastrointestinal bleeding, or if acetylsalicyclic acid or corticosteroids were taken.
Effects on the Ability to Drive or Operate Machinery: No influence of Sp Extream on the ability to drive and use machines is known.
Use in pregnancy & lactation: Experience in pregnant women is limited. There is no information on the excretion of Sp Extream into human breast milk.
Sp Extream should only be used when the benefit to the mother is greater than the potential risk to the unborn child/baby.
Use in children: To date, there has been no experience with treatment in children.
What happens if I miss a dose of Sp Extream?
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
- DrugBank. "pantoprazole". http://www.drugbank.ca/drugs/DB00213 (accessed September 17, 2018).
- MeSH. "Anti-Ulcer Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- FDA Medication Guides. "Protonix: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.accessdata.fda.gov/drugs... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
