• Protofix indications
• Uses of Protofix in details
• Protofix description
• Protofix dosage
• Protofix interactions
• Protofix side effects
• Protofix contraindications

What is Protofix?

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

Protofix 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. Protofix is usually given for up to 8 weeks at a time while your esophagus heals.

Protofix is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.

Protofix is not for immediate relief of heartburn.

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

Protofix indications

Protofix For Delayed-Release

Oral Suspension and Protofix Delayed-Release Tablets are indicated for:

Short-Term Treatment Of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)

Protofix 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 Protofix may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

Maintenance Of Healing Of Erosive Esophagitis

Protofix 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

Protofix is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

How should I use Protofix?

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

• Protofix suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Protofix suspension refilled.
• Take Protofix suspension by mouth on an empty stomach about 30 minutes before a meal.
• Do not crush or chew Protofix suspension.
• Do not divide the contents of the packet to make a smaller dose.
• Only mix Protofix suspension with applesauce or apple juice. Do not mix with water or other liquids or foods.
• If you are mixing Protofix 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 Protofix 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 Protofix 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 Protofix suspension if you are directed to do so by your doctor.
• Continue to take Protofix suspension even if you feel well. Do not miss any doses.
• If you miss a dose of Protofix 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 Protofix suspension.

Uses of Protofix in details

Protofix 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. Protofix 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 Protofix 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.

Protofix description

Each 20-mg tablet contains Pantoprazole sodium sesquihydrate 22.6 mg equivalent to Protofix 20 mg.

Protofix 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.

Protofix dosage

Protofix Dosage

Generic name: Protofix 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.

Protofix 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 Protofix 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, Protofix 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 Protofix I.V. for Injection. Protofix I.V. for Injection may not be compatible with products containing zinc. When Protofix 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 Protofix given once daily by intravenous infusion for 7 to 10 days.

Treatment with Protofix® I.V. (Protofix sodium) for Injection should be discontinued as soon as the patient is able to receive treatment with Protofix 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. Protofix 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

Protofix 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.

Protofix 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

Protofix 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. Protofix 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 Protofix 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 Protofix 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.

Protofix 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

Protofix 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 Protofix (Protofix)

• Side Effects
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• Dosage Information
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Consumer resources

• Protofix
• Protofix delayed-release tablets
• Protofix suspension
• Protofix (Advanced Reading)
• Protofix

  Intravenous (Advanced Reading)

Professional resources

• Protofix (AHFS Monograph)
• Protofix (FDA)

Other formulations

• Protofix IV

Related treatment guides

• GERD
• Barrett's Esophagus
• Erosive Esophagitis
• Zollinger-Ellison Syndrome
• Duodenal Ulcer
• More (4) »

Protofix interactions

See also:
What other drugs will affect Protofix?

Protofix 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 Protofix 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 Protofix with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with Protofix, adjustment of the dosage of Protofix 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 Protofix, 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, Protofix 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 Protofix. An alternative confirmatory method should be considered to verify positive results.

Protofix side effects

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

The adverse reaction profiles for Protofix (Protofix sodium) For Delayed-Release

Oral Suspension and Protofix (Protofix 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 Protofix (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%

Additional adverse reactions that were reported for Protofix 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 Protofix 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 Protofix 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 Protofix 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 Protofix 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 Protofix. 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)

Protofix contraindications

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

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 Protofix or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox).

Protofix 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.

Protofix 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 Protofix. The chronic use of Protofix 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 Protofix 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 Protofix treatment and you have concerns about vitamin B-12 deficiency.

Active ingredient matches for Protofix:

Pantoprazole in Egypt.

References

1. PubChem. "pantoprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
2. DrugBank. "pantoprazole". http://www.drugbank.ca/drugs/DB00213 (accessed September 17, 2018).
3. 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology