Protolan30 mg

Protolan is a proton pump inhibitor (PPI) approved for the following uses:

Established / FDA-approved uses

• Gastroesophageal reflux disease (GERD): short-term treatment of symptomatic GERD and healing/maintenance of erosive esophagitis.
• Duodenal ulcer: short-term treatment and maintenance of healed duodenal ulcer.
• Gastric ulcer: short-term treatment of active benign gastric ulcer.
• NSAID-associated gastric ulcer: treatment, and risk reduction in patients who require continued NSAID use.
• Pathological hypersecretory conditions (including Zollinger-Ellison syndrome).

Uses requiring combination therapy

• Helicobacter pylori eradication: Protolan is used together with two antibiotics (commonly amoxicillin and clarithromycin) as part of triple therapy to eradicate H. pylori and reduce the risk of duodenal ulcer recurrence. Protolan alone does not eradicate the infection.

Pediatric use

• GERD and erosive esophagitis in children 1 year and older, for short-term treatment, per approved age/weight-based dosing.

Each capsule/tablet contains Lansoprazole as the active ingredient, available in delayed-release (enteric-coated) formulations, typically as 15 mg and 30 mg capsules or orally disintegrating tablets. Formulation and available strengths may vary by manufacturer; check the product label for exact composition and excipients.

Protolan is a substituted benzimidazole proton pump inhibitor that suppresses gastric acid secretion. It is prescribed for acid-related disorders of the upper gastrointestinal tract, including GERD, peptic ulcer disease, and as part of combination regimens for H. pylori eradication. Protolan is formulated as a delayed-release preparation because it is acid-labile and is broken down rapidly in an acidic environment.

Protolan belongs to the Proton Pump Inhibitor (PPI) class of anti-secretory, acid-suppressing drugs used in the management of acid-peptic disorders.

Lansoprazole is a prodrug that accumulates in the acidic secretory canaliculi of gastric parietal cells, where it is converted to an active sulfenamide form. This active form binds covalently to cysteine residues on the H+/K+-ATPase (the "proton pump") on the luminal surface of the parietal cell membrane, irreversibly inhibiting the final step of gastric acid secretion.

Because the inhibition is irreversible, acid suppression persists until new proton pumps are synthesized, giving Lansoprazole a duration of action longer than its plasma half-life. Lansoprazole is well absorbed after oral administration, extensively metabolized in the liver primarily by CYP2C19 and, to a lesser extent, CYP3A4, and eliminated mainly via the bile and, to a lesser extent, the kidneys.

Take Protolan before a meal, preferably in the morning. Swallow the delayed-release capsule whole with water; do not crush or chew. If unable to swallow capsules, the capsule may be opened and its granules sprinkled on a small amount of soft food (such as applesauce) or mixed with an appropriate liquid, and taken immediately without chewing, following product-specific instructions. Orally disintegrating tablet formulations, where available, dissolve on the tongue and can be taken with or without water.

Protolan raises gastric pH, which can affect the absorption of certain co-administered drugs, and it is partly metabolized by CYP2C19, which can affect drugs sharing that pathway. Clinically significant interactions include:

• Rilpivirine-containing HIV medicines: Protolan significantly reduces rilpivirine absorption and antiviral effect; concomitant use is contraindicated (see Contraindications).
• Azole antifungals (e.g. ketoconazole, itraconazole, posaconazole) and certain other pH-dependent drugs (e.g. erlotinib, atazanavir): reduced absorption and efficacy due to increased gastric pH; avoid combination or use alternative acid-independent formulations where possible.
• Methotrexate (especially high-dose): Protolan may increase and prolong serum methotrexate levels, raising the risk of methotrexate toxicity; temporary withdrawal of Protolan may be considered under physician guidance during high-dose methotrexate therapy.
• Clopidogrel: Protolan has a comparatively weaker CYP2C19-inhibiting effect than omeprazole, but a theoretical reduction in clopidogrel's antiplatelet effect cannot be excluded; use together only if clearly needed, with physician oversight.
• Warfarin: concurrent use has been associated with changes in INR/prothrombin time; monitor coagulation status if used together.
• Tacrolimus: Protolan may increase tacrolimus blood levels, particularly in patients who are CYP2C19 poor metabolizers or post-transplant; monitor tacrolimus levels.
• Digoxin: increased gastric pH may modestly increase digoxin absorption; monitor for digoxin toxicity, especially in the elderly.
• Sucralfate: delays and reduces absorption of Protolan; take Protolan at least 30 minutes before sucralfate.

Most patients tolerate Protolan well. Reported adverse effects include:

Common

• Headache
• Diarrhea
• Nausea, abdominal pain
• Constipation

Less common / serious (see Precautions and Warnings for details)

• Clostridioides difficile-associated diarrhea
• Bone fracture with long-term/high-dose use
• Hypomagnesemia with prolonged use
• Vitamin B12 deficiency with prolonged use
• Acute interstitial nephritis
• Cutaneous or systemic lupus erythematosus (new onset or exacerbation)
• Rare hepatic dysfunction and severe skin reactions (e.g. Stevens-Johnson syndrome) — seek medical attention immediately if these occur

Pregnancy: Available human data have not shown a clear increased risk of major birth defects with Protolan use in pregnancy, but data remain limited. Protolan should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus; consult a physician before use.

Lactation: Protolan is excreted into breast milk. Because the effects on a nursing infant are not fully established, Protolan should be used during breastfeeding only after consulting a physician, weighing the benefits of treatment against potential risk to the infant.

The following precautions apply to Protolan:

• Bone fracture: long-term use (especially high dose or use beyond one year) may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. Use the lowest effective dose for the shortest duration appropriate to the condition.
• Hypomagnesemia: prolonged Protolan use (generally beyond one year), and especially concurrent use with diuretics or digoxin, has been associated with low serum magnesium, which may present as tremor, seizure, arrhythmia, or tetany. Consider monitoring magnesium levels with long-term therapy.
• Vitamin B12 deficiency: prolonged acid suppression (generally over 3 years) may reduce absorption of dietary vitamin B12; monitor in long-term users.
• Clostridioides difficile-associated diarrhea: PPI therapy including Protolan may increase risk; consider this diagnosis in patients with persistent diarrhea that does not improve.
• Rebound acid hypersecretion: stopping Protolan abruptly after prolonged use may cause a temporary increase in acid-related symptoms; consider tapering under physician guidance.
• Fundic gland polyps: risk increases with long-term use, particularly beyond one year; use the lowest effective dose for the shortest duration needed.
• Masking of malignancy: symptomatic response to Protolan does not preclude the presence of gastric malignancy; evaluate as clinically indicated, especially in patients with alarm symptoms (weight loss, GI bleeding, dysphagia) or in older adults with new or worsening symptoms.
• Antibiotic stewardship (when used for H. pylori eradication): when Protolan is prescribed together with antibiotics for H. pylori eradication, take the complete combination regimen exactly as prescribed by your physician; do not stop, extend, skip doses, or share the antibiotics with others without medical advice, as incomplete courses can lead to treatment failure and antibiotic resistance.

See Pregnancy and Lactation, and Side Effects, for additional related information.

Reported experience with Protolan overdose is limited and no specific antidote is known. In case of suspected overdose, seek immediate medical attention or contact a poison control center/emergency services. Management is supportive and symptomatic, guided by a physician; do not attempt specific home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: no overall dosage adjustment is generally required based on age alone, though elderly patients may be at greater risk of the long-term risks described under Precautions and Warnings (fracture, hypomagnesemia, B12 deficiency); use the lowest effective dose.

Renal impairment: no dosage adjustment is generally required, as Protolan is primarily eliminated by hepatic metabolism.

Hepatic impairment: in severe hepatic impairment, dose reduction and closer monitoring should be considered; consult a physician for individualized dosing. See Dosage and Administration.

Pediatric: approved for GERD/erosive esophagitis in children 1 year and older using age/weight-based dosing (see Dosage and Administration); safety and efficacy for other indications in children have not been established.

Duration of Protolan therapy depends on indication: typically 4 weeks for duodenal ulcer, up to 8 weeks for GERD/erosive esophagitis/gastric ulcer, 10-14 days as part of H. pylori triple therapy, and longer-term/maintenance dosing for erosive esophagitis maintenance or hypersecretory conditions under physician supervision. Do not continue therapy beyond the period advised by your physician without re-evaluation, given the risks of long-term use described under Precautions and Warnings.

Lansoprazole belongs to the Proton Pump Inhibitor (PPI) class, within the broader category of antisecretory / anti-ulcer agents.

Lansoprazole irreversibly inhibits the gastric H+/K+-ATPase (proton pump) in parietal cells, blocking the final common step of gastric acid secretion regardless of the stimulus (histamine, gastrin, or acetylcholine), resulting in profound and sustained suppression of gastric acid output.

B

Protolan is approved for short-term treatment of GERD and erosive esophagitis in children 1 year of age and older, using weight-based dosing (15 mg once daily for children ≤30 kg, 30 mg once daily for children >30 kg, ages 1-11 years, for up to 12 weeks; 30 mg once daily for ages 12-17 years, for up to 8 weeks). Safety and efficacy of Protolan have not been established for other indications or in children under 1 year of age. Use in children should be under close physician supervision.