Protofix Side effects

• Side effects of Protofix in details
• Protofix contraindications
• Protofix reviews

What are the possible side effects of Protofix?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• sudden pain or trouble moving your hip, wrist, or back;

• bruising or swelling where intravenous Protofix was injected;

• kidney problems--urinating less than usual, blood in your urine, swelling, rapid weight gain;

• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking Protofix long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use Protofix for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• headache, dizziness;

• stomach pain, gas, nausea, vomiting, diarrhea;

• joint pain; or

• fever, rash, or cold symptoms (most common in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Protofix in details

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)

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

• Protofix suspension may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Protofix suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do NOT change your dose, stop taking Protofix suspension, or take Protofix suspension for longer than prescribed without checking with your doctor.
• Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.
• Protofix suspension may increase the risk of a serious form of diarrhea. Contact your doctor right away if stomach pain or cramps, severe or persistent diarrhea, or bloody or watery stools occur. Discuss any questions or concerns with your doctor.
• Protofix suspension may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Protofix suspension in high doses or for longer than a year, or if you are older than 50 years old. Contact your doctor if you have any questions about this information.
• Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Protofix suspension for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).
• Long-term treatment (eg, longer than 3 years) with medicines like this one has rarely caused low vitamin B12 levels. Discuss any questions or concerns with your doctor.
• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Protofix suspension.
• Protofix suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Protofix suspension.
• Protofix suspension should be used with caution in Asian patients; the risk of side effects may be increased in these patients.
• Use Protofix suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Protofix suspension while you are pregnant. Protofix suspension is found in breast milk. Do not breast-feed while taking Protofix suspension.

Protofix contraindications

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.

References

1. 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).
2. European Chemicals Agency - ECHA. "2-{[(3,4-dimethoxy-2-pyridinyl)methyl]-sulfinyl}-5-methyl-1H-1,3-benzimidazole;5-difluoromethoxy-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "PANTOPRAZOLE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology