Prevacid 30 mg Capsules

Brand Name

The medication is marketed under the brand name Prevacid, a well-known label in the domain of gastrointestinal acid suppression and healing.

International Nonproprietary Name (INN)

The active ingredient in this product is identified globally as lansoprazole, a name standardized for consistency across international pharmacological practices.

Form of Release

Prevacid is available as delayed-release oral capsules, orally disintegrating tablets, and packets for oral suspension. Capsules come in strengths of 15 mg and 30 mg, disintegrating tablets match these doses, and suspension packets offer 15 mg or 30 mg, providing versatile administration options.

Composition

Each delayed-release capsule or tablet of Prevacid contains lansoprazole as the primary active substance, with dosages of 15 mg or 30 mg. The formulation includes several inactive ingredients, such as sugar spheres, which serve as a core in capsules, and microcrystalline cellulose, providing structural integrity. Additional excipients like magnesium carbonate act as stabilizers, while the enteric coating comprises methacrylic acid copolymer, polyethylene glycol, and polysorbate 80 to ensure intestinal release. The suspension includes mannitol and citric acid, ensuring palatability and stability across all forms.

Pharmacologic Properties

Pharmacodynamics

Prevacid belongs to the proton pump inhibitor (PPI) class, exerting its effects by irreversibly blocking the hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) enzyme system in gastric parietal cells. This inhibition suppresses gastric acid secretion, reducing both basal and stimulated acid production, which elevates intragastric pH and facilitates mucosal healing in acid-related conditions. Its potency provides acid control for up to 24 hours, surpassing many H2-receptor antagonists in duration and efficacy.

The medication also aids Helicobacter pylori eradication when paired with antibiotics, optimizing the gastric environment for bacterial clearance. Clinical studies demonstrate its ability to heal erosive esophagitis in 85–90% of patients within 4–8 weeks, with significant symptom relief in gastroesophageal reflux disease (GERD). It does not influence gastric motility or hormone levels directly, focusing on acid suppression. This targeted mechanism supports its role in managing acid-mediated disorders effectively.

Pharmacokinetics

Following oral administration, Prevacid is absorbed in the small intestine due to its enteric coating, with peak plasma concentrations reached within 1.5 to 2.5 hours. Bioavailability averages 80–85%, enhanced by repeated dosing, though food reduces absorption by about 50%. The drug binds to plasma proteins at approximately 97%, distributing primarily to the bloodstream and gastric tissues.

Metabolism occurs extensively in the liver via cytochrome P450 enzymes CYP2C19 and CYP3A4, converting lansoprazole into inactive sulfone and hydroxy metabolites. The half-life ranges from 1 to 2 hours, though its antisecretory effect persists longer due to enzyme binding. Elimination is balanced, with 50–70% excreted as metabolites in urine and 20–30% via feces, reflecting moderate biliary clearance.

Indications for Use

Prevacid is prescribed for the treatment of active duodenal ulcers in adults, promoting healing and relieving pain within 4–8 weeks. It is also indicated for erosive esophagitis due to GERD, addressing esophageal damage and symptoms like heartburn, and for maintenance therapy in healed esophagitis to prevent relapse. The medication manages symptomatic GERD without erosions, providing relief from acid reflux discomfort.

In combination with antibiotics, it eradicates Helicobacter pylori in patients with peptic ulcers, reducing recurrence risk. It treats gastric ulcers and hypersecretory conditions like Zollinger-Ellison syndrome by controlling excessive acid production. Over-the-counter use targets occasional heartburn or acid indigestion, making it suitable for both prescription and self-care scenarios.

Contraindications

Prevacid is contraindicated in patients with known hypersensitivity to lansoprazole, substituted benzimidazoles, or any formulation component, such as mannitol, where reactions could range from rash to anaphylaxis. It is also prohibited in those requiring immediate acid suppression unavailable via oral delayed-release forms, unless alternative administration is feasible.

Use with atazanavir or rilpivirine is restricted due to reduced antiviral efficacy from elevated gastric pH. Severe liver dysfunction does not strictly contraindicate it, but caution is essential. The medication should not be used in patients with a history of severe PPI-related adverse events, such as acute interstitial nephritis, unless benefits outweigh risks. Infants under 1 year are excluded from use due to limited safety data.

Method of Administration and Dosage

Administration Guidelines

The capsules should be taken orally, swallowed whole with water, ideally 30 minutes before a meal to optimize acid suppression. They should not be opened or crushed, as this disrupts the enteric coating. Disintegrating tablets dissolve on the tongue with or without water, and suspension packets require mixing with water or apple juice for immediate consumption. Consistent timing enhances efficacy.

Dosage for Adults and Children

For adults with active duodenal ulcers, the typical dose of Prevacid is 15 mg once daily for 4 weeks. Erosive esophagitis uses 30 mg once daily for 4–8 weeks, extendable if needed, with maintenance at 15 mg daily. Symptomatic GERD requires 15 mg daily for up to 8 weeks. Helicobacter pylori eradication involves 30 mg twice daily with antibiotics for 10–14 days. Hypersecretory conditions start at 60 mg daily, adjustable up to 90 mg twice daily. Children aged 12–17 use 15–30 mg daily for GERD; ages 1–11 use 15 mg (under 30 kg) or 30 mg (over 30 kg) daily for up to 12 weeks.

Dose Adjustment in Specific Conditions

No adjustment is needed for renal impairment, as excretion is primarily metabolic. Mild to moderate liver dysfunction allows standard dosing, but severe cases cap doses at 15 mg daily due to altered metabolism. Elderly patients or those with mild symptoms may start at 15 mg, guided by response. Treatment duration aligns with clinical improvement, avoiding unnecessary prolongation beyond recommended periods.

Side Effects

Prevacid may cause a range of side effects, though many patients experience only mild reactions with short-term use. Common issues include diarrhea, abdominal pain, or nausea, often resolving spontaneously. Headache, constipation, or flatulence are also reported, typically transient as the body adjusts.

Less frequent effects include dizziness, fatigue, or rash, linked to systemic exposure. Rare but serious reactions, such as hypomagnesemia, Clostridium difficile infection, or bone fractures with prolonged use, warrant monitoring. Acute interstitial nephritis or severe cutaneous reactions (e.g., Stevens-Johnson syndrome) require immediate cessation and medical attention. Regular follow-ups help manage these risks effectively.

Overdose

Symptoms of Overdose

Excessive intake of Prevacid is unlikely to cause acute toxicity due to its wide therapeutic index, with symptoms limited to amplified side effects like lethargy, confusion, or gastrointestinal distress. Doses up to 180 mg daily have shown no consistent severe pattern, reflecting rapid metabolism.

First Aid Measures

In case of overdose, medical consultation is advised, though emergency measures are rarely needed. No specific antidote exists, so treatment focuses on supportive care, such as hydration for diarrhea or rest for fatigue. Monitoring is recommended until symptoms resolve, typically within 24 hours, given the drug’s short half-life.

Drug Interactions

Effects on Other Medications

Prevacid alters gastric pH, reducing absorption of pH-dependent drugs like itraconazole or iron salts, potentially decreasing efficacy, requiring spacing by 1–2 hours. It inhibits CYP2C19, increasing levels of diazepam, phenytoin, or warfarin, necessitating monitoring or adjustments. Co-use with tacrolimus may elevate levels, while methotrexate toxicity risk rises at high doses.

Drugs like rifampin, a CYP3A4 inducer, may lower lansoprazole levels, though this is rarely significant. Patients should report all medications to their healthcare provider to manage these interactions, especially in chronic therapy.

Compatibility with Alcohol and Food

Moderate alcohol use does not directly impair efficacy but may worsen GERD symptoms, suggesting limited intake during therapy. Food reduces bioavailability by up to 50%, making pre-meal dosing critical for optimal effect, though suspension tolerates mixing with certain liquids.

Special Precautions

Use During Pregnancy and Breastfeeding

Prevacid is Category B in pregnancy, with no clear fetal harm in limited data, used cautiously if benefits outweigh risks, typically for severe GERD. It passes into breast milk minimally, so short-term use is generally safe with monitoring for infant effects, guided by medical advice.

Women of childbearing age should confirm non-pregnant status before starting and use contraception during therapy to avoid unintended fetal exposure.

Impact on Driving and Operating Machinery

The medication may cause dizziness or fatigue in some patients, suggesting caution with driving or machinery until tolerance is clear. Most individuals resume normal activities once adjusted, but initial use warrants observation for these effects, typically resolving within hours.

Considerations for Elderly and Pediatric Populations

Elderly patients tolerate Prevacid well, with no significant efficacy differences, though monitoring for long-term effects like osteoporosis is key. Children over 1 year can use age- and weight-adjusted dosing safely, while those under 1 lack established safety data, limiting use to older pediatric groups.