What is Sp Extream?
Sp Extream is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Sp Extream is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Sp Extream is usually given for up to 8 weeks at a time while your esophagus heals.
Sp Extream is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.
Sp Extream is not for immediate relief of heartburn.
Sp Extream may also be used for purposes not listed in this medication guide.
Sp Extream indications
Sp Extream For Delayed-Release
Oral Suspension and Sp Extream Delayed-Release Tablets are indicated for:
Short-Term Treatment Of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)
Sp Extream is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Sp Extream may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
Maintenance Of Healing Of Erosive Esophagitis
Sp Extream is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Sp Extream is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
How should I use Sp Extream?
Use Sp Extream suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sp Extream suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Sp Extream suspension refilled.
- Take Sp Extream suspension by mouth on an empty stomach about 30 minutes before a meal.
- Do not crush or chew Sp Extream suspension.
- Do not divide the contents of the packet to make a smaller dose.
- Only mix Sp Extream suspension with applesauce or apple juice. Do not mix with water or other liquids or foods.
- If you are mixing Sp Extream suspension with applesauce, sprinkle the contents of the packet onto 1 teaspoonful of applesauce. Swallow within 10 minutes after mixing. Take sips of water to make sure the granules are washed down into the stomach.
- If you are mixing Sp Extream suspension with apple juice, empty the contents of the packet into a small cup containing 5 mL (1 teaspoonful) apple juice. Stir for 5 seconds and then swallow immediately. To be sure you receive all the medicine, rinse the container once or twice with apple juice and swallow immediately.
- If the patient is taking Sp Extream suspension through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the extra patient leaflet.
- You may take antacids while you are using Sp Extream suspension if you are directed to do so by your doctor.
- Continue to take Sp Extream suspension even if you feel well. Do not miss any doses.
- If you miss a dose of Sp Extream suspension, 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 Sp Extream suspension.
Uses of Sp Extream in details
Sp Extream is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Sp Extream belongs to a class of drugs known as proton pump inhibitors (PPIs).
The injection form of this drug is used for a short time when you cannot take the medication by mouth. When possible, your doctor should switch you to the form that is taken by mouth.
How to use Sp Extream intravenous
This medication is given by injection into a vein as directed by your doctor. The dosage and length of treatment are based on your medical condition and response to treatment.
If you are using this medication 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.
Tell 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.
Sp Extream description
Each 20-mg tablet contains Pantoprazole sodium sesquihydrate 22.6 mg equivalent to Sp Extream 20 mg.
Sp Extream also contains the following excipients: Crospovidone, yellow iron oxide E172, hypromellose 2910, methylacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium carbonate, titanium dioxide E171, triethyl citrate; mannitol (approximately 0.0036 BU), povidone K90, calcium stearate, povidone K25, propylene glycol, sodium lauryl sulfate; printing ink (for tablets only); microcrystalline cellulose, povidone, sodium dodecyl sulfate.
Sp Extream dosage
Sp Extream Dosage
Generic name: Sp Extream SODIUM 40mg in 10mL
Dosage form: injection, powder, for solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.
Parenteral routes of administration other than intravenous are not recommended.
Sp Extream I.V. for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of Sp Extream I.V. for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, Sp Extream I.V. for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.
Midazolam HCl has been shown to be incompatible with Y-site administration of Sp Extream I.V. for Injection. Sp Extream I.V. for Injection may not be compatible with products containing zinc. When Sp Extream I.V. for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
Recommended Dosage
The recommended adult dose is 40 mg Sp Extream given once daily by intravenous infusion for 7 to 10 days.
Treatment with Sp Extream® I.V. (Sp Extream sodium) for Injection should be discontinued as soon as the patient is able to receive treatment with Sp Extream Delayed-Release Tablets or
Oral Suspension.
Administration and Preparation Instructions
Data on the safe and effective dosing for conditions other than those described such as life-threatening upper gastrointestinal bleeds, are not available. Sp Extream I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.
Fifteen Minute Infusion
Sp Extream I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted (admixed) with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Sp Extream I.V. for Injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two Minute Infusion
Sp Extream I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. Sp Extream I.V. for Injection should be administered intravenously over a period of at least 2 minutes.
Pathological Hypersecretion Including Zollinger-Ellison Syndrome
Recommended Dosage
The dosage of Sp Extream I.V. for Injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dosage is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied. Transition from oral to intravenous and from intravenous to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with Zollinger-Ellison Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.
Administration and Preparation Instructions
Fifteen Minute Infusion
Each vial of Sp Extream I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Sp Extream I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Two minute Infusion
Sp Extream I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.
More about Sp Extream (Sp Extream)
- Side Effects
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- Dosage Information
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- Drug Interactions
- Support Group
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- En Espanol
- 51 Reviews - Add your own review/rating
- Generic Availability
Consumer resources
- Sp Extream
- Sp Extream delayed-release tablets
- Sp Extream suspension
- Sp Extream (Advanced Reading)
- Sp Extream
Intravenous (Advanced Reading)
Professional resources
- Sp Extream (AHFS Monograph)
- Sp Extream (FDA)
Other formulations
- Sp Extream IV
Related treatment guides
- GERD
- Barrett's Esophagus
- Erosive Esophagitis
- Zollinger-Ellison Syndrome
- Duodenal Ulcer
- More (4) »
Sp Extream interactions
See also:
What other drugs will affect Sp Extream?
Sp Extream is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isozymes, and subsequently undergoes Phase II conjugation.
Based on studies evaluating possible interactions of Sp Extream with other drugs, no dosage adjustment is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole, or amoxicillin. Clinically relevant interactions of Sp Extream with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with Sp Extream, adjustment of the dosage of Sp Extream or of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids. There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including Sp Extream, 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 should be monitored for increases in INR and prothrombin time.
Because of profound and long lasting inhibition of gastric acid secretion, Sp Extream may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg, ketoconazole, ampicillin esters, and iron salts).
Laboratory Tests
There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including Sp Extream. An alternative confirmatory method should be considered to verify positive results.
Sp Extream side effects
See also:
What are the possible side effects of Sp Extream?
The adverse reaction profiles for Sp Extream (Sp Extream sodium) For Delayed-Release
Oral Suspension and Sp Extream (Sp Extream sodium) Delayed-Release Tablets are similar.
Clinical Trial Experience
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.
Adults
Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral Sp Extream (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another proton pump inhibitor, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 3.
Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2%
| Sp Extream (n=1473) % | Comparators (n=345) % | Placebo (n=82) % | |
| Headache | 12.2 | 12.8 | 8.5 |
| Diarrhea | 8.8 | 9.6 | 4.9 |
| Nausea | 7.0 | 5.2 | 9.8 |
| Abdominal pain | 6.2 | 4.1 | 6.1 |
| Vomiting | 4.3 | 3.5 | 2.4 |
| Flatulence | 3.9 | 2.9 | 3.7 |
| Dizziness | 3.0 | 2.9 | 1.2 |
| Arthralgia | 2.8 | 1.4 | 1.2 |
Additional adverse reactions that were reported for Sp Extream in clinical trials with a frequency of ≤ 2% are listed below by body system:
Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema
Gastrointestinal: constipation, dry mouth, hepatitis
Hematologic: leukopenia, thrombocytopenia
Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated
Musculoskeletal: myalgia
Nervous: depression, vertigo
Skin and Appendages: urticaria, rash, pruritus
Special Senses: blurred vision
Pediatric Patients
Safety of Sp Extream in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to Sp Extream are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported ( > 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
For safety information in patients less than 1 year of age see Use in Specific Populations.
Additional adverse reactions that were reported for Sp Extream in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system:
Body as a Whole: allergic reaction, facial edema
Gastrointestinal: constipation, flatulence, nausea
Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase)
Musculoskeletal: arthralgia, myalgia
Nervous: dizziness, vertigo
Skin and Appendages: urticaria
The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.
Zollinger-Ellison Syndrome
In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking Sp Extream 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Sp Extream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions are listed below by body system:
General Disorders and Administration Conditions: asthenia, fatigue, malaise
Hematologic: pancytopenia, agranulocytosis
Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure
Immune System Disorders: anaphylaxis (including anaphylactic shock)
Infections and Infestations: Clostridium difficile associated diarrhea
Investigations: weight changes
Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia
Musculoskeletal Disorders: rhabdomyolysis, bone fracture
Nervous: ageusia, dysgeusia
Psychiatric Disorders: hallucination, confusion, insomnia, somnolence
Renal and Urinary Disorders: interstitial nephritis
Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal), and angioedema (Quincke's edema)
Sp Extream contraindications
See also:
What is the most important information I should know about Sp Extream?
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.
You should not use this medication if you are allergic to Sp Extream or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox).
Sp Extream is not for immediate relief of heartburn symptoms.
Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.
Sp Extream should not be taken together with atazanavir (Reyataz) or nelfinavir (Viracept). Tell your doctor if you are taking either of these medications to treat HIV or AIDS.
Some conditions must be treated long-term with Sp Extream. The chronic use of Sp Extream has caused stomach cancer in animal studies, but it is not known if this medication would have the same effects in humans. Talk with your doctor about your specific risk of developing stomach cancer.
Long-term treatment with Sp Extream may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term Sp Extream treatment and you have concerns about vitamin B-12 deficiency.
Active ingredient matches for Sp Extream:
Pantoprazole in Vietnam.
List of Sp Extream substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Sozol (Australia) | |
| SPAND | |
| SPAND 40MG TABLET 1 strip / 10 tablets each (Times Drugs & Pharmaceuticals Pvt Ltd) | $ 0.92 |
| Spenta (India) | |
| Spenta 40 mg Injection (Iscon Lifesciences) | $ 0.72 |
| SPENTA tab 40 mg x 10's (Iscon Lifesciences) | $ 0.66 |
| Stamic (Georgia) | |
| STEDPAN (India) | |
| 40 mg x 10's (Aareen Healthcare) | $ 0.59 |
| Stedpan 40 mg Tablet (Aareen Healthcare) | $ 0.06 |
| Stedpan 40mg TAB / 10 (Aareen Healthcare) | $ 0.59 |
| STEDPAN tab 40 mg x 10's (Aareen Healthcare) | $ 0.59 |
| Stedpan 40mg TAB / 10 (Aareen Healthcare) | $ 0.59 |
| STELPAN (India) | |
| 40 mg x 100's (Stellar Bio Labs) | $ 5.42 |
| 40 mg x 1's (Stellar Bio Labs) | $ 0.70 |
| Stelpan 40 mg Tablet (Stellar Bio Labs) | $ 0.05 |
| Stelpan 40mg TAB / 100 (Stellar Bio Labs) | $ 5.42 |
| Stelpan 40mg INJ / 1 (Stellar Bio Labs) | $ 0.70 |
| STELPAN tab 40 mg x 10's (Stellar Bio Labs) | $ 0.54 |
| Stelpan 40mg TAB / 100 (Stellar Bio Labs) | $ 5.42 |
| Stelpan 40mg INJ / 1 (Stellar Bio Labs) | $ 0.70 |
| Stomafor (Portugal) | |
| Stripole (Thailand) | |
| Stripole inj 40 mg 1's (Gufic Stridden) | |
| Sumipral (Peru) | |
| Sunpraz (Russian Federation) | |
| Tablet, Enteric Coated; Oral; Pantoprazole Sodium Sesquihydrate 40 mg (Sun) | |
| Supacid (Mexico) | |
| Injectable; Subcutaneous; Pantoprazole Sodium 40 mg | |
| Super OM (Greece) | |
| Suppi (Philippines) | |
| Supracam (Argentina) | |
| Supracid (Czech Republic) | |
| Tablet, Film-Coated; Oral; Hydrochlorothiazide; Spironolactone (Medreich Saimirra Ltd) | |
| Supracid Alginic acid 200 mg, Magnesiumhydroxide 250 mg, Aluminiumhydroxide 250 mg, Simethicone125 mg, Magnesium trisilicate250 mg/15 mL. SUSP / 200ml (Medreich Saimirra Ltd) | $ 0.67 |
| 200ml (Medreich Saimirra Ltd) | $ 0.67 |
| Supracid 200 ml Suspension (Medreich Saimirra Ltd) | $ 0.05 |
| SUPRACID oral susp 200ml (Medreich Saimirra Ltd) | $ 0.67 |
| Surmera (Bulgaria) | |
| Suvacid Heartburn (Australia) | |
| Suvacid Heartburn Relief (Australia) | |
| SWISSPAN | |
| SWISSPAN 40 MG TABLET 1 strip / 10 tablets each (Ronyd Healthcare Pvt Ltd) | $ 0.60 |
| Swisspan 40mg Tablet (Ronyd Healthcare Pvt Ltd) | $ 0.06 |
| SYMTOP (India) | |
| 40 mg x 100's (Symbiosis Pharmaceuticals Pvt Ltd) | $ 6.02 |
| Symtop 40 mg Tablet (Symbiosis Pharmaceuticals Pvt Ltd) | $ 0.06 |
| Symtop 40mg TAB / 100 (Symbiosis Pharmaceuticals Pvt Ltd) | $ 6.02 |
| SYMTOP 40MG TABLET 1 strip / 10 tablets each (Symbiosis Pharmaceuticals Pvt Ltd) | $ 0.49 |
| SYMTOP tab 40 mg x 10's (Symbiosis Pharmaceuticals Pvt Ltd) | $ 0.60 |
| Symtop 40mg TAB / 100 (Symbiosis Pharmaceuticals Pvt Ltd) | $ 6.02 |
See 3968 substitutes for Sp Extream | |
References
- PubChem. "pantoprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "pantoprazole". http://www.drugbank.ca/drugs/DB00213 (accessed September 17, 2018).
- DTP/NCI. "pantoprazole: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Sp Extream are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Sp Extream. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology
