Peptazole Uses

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

What is Peptazole?

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

Peptazole is used to treat and prevent stomach and intestinal ulcers, erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome.

Over-the-counter Peptazole is used to treat frequent heartburn that happens 2 or more days per week.

Peptazole is not for immediate relief of heartburn symptoms.

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

Peptazole indications

Short-Term Treatment of Active Duodenal Ulcer

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Peptazole/amoxicillin/clarithromycin

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: Peptazole/amoxicillin

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Please refer to the full prescribing information for amoxicillin.

Maintenance of Healed Duodenal Ulcers

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

Short-Term Treatment of Active Benign Gastric Ulcer

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

Healing of NSAID-Associated Gastric Ulcer

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

Risk Reduction of NSAID-Associated Gastric Ulcer

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Peptazole delayed-release capsules or Peptazole delayed-release orally disintegrating tablets for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of Peptazole delayed-release capsules or Peptazole delayed-release orally disintegrating tablets may be considered.

Maintenance of Healing of Erosive Esophagitis (EE)

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

How should I use Peptazole?

Use Peptazole powder packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Peptazole powder packet by mouth on an empty stomach before eating.
• Place 2 tablespoons (30 mL) of water in a small cup. Do NOT use other liquids or foods. Empty the contents of the packet into the cup, stir well, and drink at once. Do not store the mixture for use at a later time. If any of the mixture remains in the cup, refill with water, stir, and drink at once.
• You may take antacids while you are using Peptazole powder packet if you are directed to do so by your doctor.
• If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Peptazole powder packet.
• If you also take sucralfate, take Peptazole powder packet at least 30 minutes before taking sucralfate.
• Do not take Peptazole powder packet through an enteral tube (eg, g-tube, ng-tube). If you must take your medicines through an enteral tube, discuss your dosing options with your doctor.
• Continue to take Peptazole powder packet even if you feel well. Do not miss any doses.
• If you miss a dose of Peptazole powder packet, 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 Peptazole powder packet.

Uses of Peptazole in details

Peptazole is used to treat acid-related throat problems (erosive esophagitis). It works by blocking acid production in the stomach. This medication is known as a proton pump inhibitor (PPI). Decreasing excess stomach acid can help relieve symptoms such as heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent serious acid damage to your digestive system (e.g., ulcers, cancer of the esophagus).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent and treat bleeding from stomach/intestinal ulcers.

How to use Peptazole intravenous

This medication is given by injection into a vein over 30 minutes as directed by your doctor, usually once daily.

When you are able to take medicines by mouth, your doctor will switch your treatment to an oral form of this drug.

If needed, antacids may be taken along with this medication.

The dosage and length of treatment is based on your medical condition and response to therapy.

If you are giving this medication to yourself 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.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Continue to use this medication for the prescribed length of treatment even if you are feeling better.

Inform 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.

Peptazole description

Each capsule contains Lansoprazole 30 mg.

Peptazole is a proton pump inhibitor with actions and uses similar to those of omeprazole. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphatase, the proton pump of the gastric pariental cells.

Peptazole dosage

Peptazole I.V. (Peptazole for injection) for Injection admixtures should be administered intravenously using the in-line filter provided. The filter must be used to remove precipitate that may form when the reconstituted drug product is mixed with I.V. solutions. Studies have shown that filtration does not alter the amount of Peptazole that is available for administration. Read the following instructions carefully.

There are two methods for preparing Peptazole I.V. (Peptazole for injection) for Injection:

1. Reconstitution in Vial and Preparation of Admixture.

OR

2. Direct reconstitution with Baxter's MINI-BAG Plus Container.

1. Reconstitution in Vial and Preparation of Admixture

There are two steps for preparing Peptazole I.V. (Peptazole for injection) for Injection.

STEP ONE - Reconstitution in Vial

- First Peptazole I.V. (Peptazole for injection) MUST be reconstituted with Sterile Water for Injection, USP.

- Inject 5 mL of ONLY Sterile Water for Injection, USP into a 30 mg vial of Peptazole I.V. for Injection. The resulting solution will contain Peptazole 6 mg/mL (30 mg/5 mL).

- Failure to reconstitute with Sterile Water may result in formation of precipitation/particulates.

- Mix gently until the powder is dissolved.

The pH of this reconstituted solution is approximately 11. The reconstituted solution can be held for 1 hour when stored at 25

Peptazole interactions

See also:
What other drugs will affect Peptazole?

Peptazole is metabolized through the cytochrome P isozymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. When Peptazole 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 Peptazole 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 Peptazole. However, there have been reports of increased International Normalized Ratio (INR) and prothrombin time in patients receiving proton pump inhibitors, including Peptazole, 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.

Peptazole causes a profound and long-lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that Peptazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters, iron salts, digoxin).

Peptazole side effects

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

Clinical

Worldwide, over 10,000 patients have been treated with Peptazole in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, Peptazole treatment has been well-tolerated in both short-term and long-term trials.

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.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Peptazole-treated patients and occurred at a greater rate in Peptazole-treated patients than placebo-treated patients in Table 1.

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of Peptazole, but higher in the patients who received 60 mg of Peptazole (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Peptazole for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Peptazole, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or Peptazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with Peptazole included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received Peptazole in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System – angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System – diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System – anemia, hemolysis, lymphadenopathy

Metabolic and Nutritional Disorders – avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System – arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System – asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages – acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System – abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing Experience

Additional adverse experiences have been reported since Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets have been marketed. The majority of these cases are foreign-sourced and a relationship to Peptazole delayed-release capsules and Peptazole delayed-release orally disintegrating tablets have not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole – anaphylactic/anaphylactoid reactions; Digestive System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses - speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with Peptazole plus amoxicillin and clarithromycin, and Peptazole plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Peptazole, amoxicillin, or clarithromycin.

Triple Therapy: Peptazole/amoxicillin/clarithromycin

The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Peptazole/amoxicillin

The most frequently reported adverse reactions for patients who received Peptazole three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with Peptazole three times daily plus amoxicillin three times daily dual therapy than with Peptazole alone.

For information on adverse reactions with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Laboratory Values

The following changes in laboratory parameters in patients who received Peptazole were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased/abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and Peptazole, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received Peptazole reported jaundice at any time during the study.

In clinical trials using combination therapy with Peptazole plus amoxicillin and clarithromycin, and Peptazole plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For information on laboratory value changes with amoxicillin or clarithromycin, refer to their full prescribing information, ADVERSE REACTIONS sections.

Peptazole contraindications

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

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.

Ask a doctor or pharmacist if it is safe for you to take Peptazole if you have liver disease, or low levels of magnesium in your blood.

Peptazole is not for immediate relief of heartburn symptoms.

Some conditions are treated with a combination of Peptazole and antibiotics. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also take sucralfate (Carafate), avoid taking it at the same time you take Peptazole. Sucralfate can make it harder for your body to absorb Peptazole. Wait at least 30 minutes after taking Peptazole before you take sucralfate.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Peptazole 24HR should be taken only once every 24 hours for 14 days. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.

Allow at least 4 months to pass before you start another 14-day treatment with Peptazole 24HR. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.

Active ingredient matches for Peptazole:

Lansoprazole in Oman, South Korea.

Pantoprazole in South Korea.

References

1. 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).
2. PubChem. "pantoprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. PubChem. "lansoprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology