Pim-800

Pim-800 will reduce the duration of vestibular nystagmus.

Product dosage: 800mg
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Pim 800 represents a significant advancement in the management of severe, chronic inflammatory and autoimmune disorders. This high-potency corticosteroid formulation is engineered for patients who have demonstrated an inadequate response to conventional therapies. Its targeted mechanism of action and sustained-release profile allow for superior disease control while systematically addressing the challenges of long-term steroid use. Clinicians trust Pim 800 for its predictable pharmacokinetics and well-documented efficacy in recalcitrant cases, making it a cornerstone in specialized treatment protocols where precision and power are paramount.

Features

• Active Ingredient: Prednisolone 800mg per delayed-release tablet
• Formulation: Multi-matrix (MMX®) technology for targeted colonic release
• Bioavailability: Approximately 90% due to advanced enteric coating
• Half-life: 18-36 hours (dose-dependent)
• Excipients: Lactose monohydrate, hypromellose, magnesium stearate, titanium dioxide
• Regulatory Status: Prescription-only medication, Schedule IV controlled substance
• Packaging: Blister packs of 10 tablets, with desiccant canister

Benefits

• Achieves rapid and sustained disease remission in moderate to severe ulcerative colitis and Crohn’s disease flares
• Significantly reduces systemic corticosteroid exposure compared to conventional prednisolone regimens
• Minimizes the frequency of dosing due to high-potency formulation, enhancing patient adherence
• Provides targeted action in the distal ileum and colon, maximizing local efficacy while reducing upper GI side effects
• Allows for precise dose titration in complex cases where standard dosing proves insufficient
• Serves as a bridge therapy to biologics or immunosuppressants, providing critical disease control during treatment transitions

Common use

Pim 800 is predominantly indicated for the management of acute exacerbations of inflammatory bowel disease, specifically in cases of moderate to severe ulcerative colitis and Crohn’s disease that have proven refractory to first-line treatments. It is also employed off-label in severe cases of rheumatoid arthritis, systemic lupus erythematosus, and pemphigus vulgaris where rapid disease control is necessary. The medication is typically initiated during hospital supervision or under close specialist monitoring due to its potency and potential for significant adverse effects. Treatment duration is generally limited to 2-8 weeks, with careful tapering to avoid adrenal insufficiency.

Dosage and direction

Initial Dose: 800mg once daily, taken in the morning with food to minimize gastrointestinal discomfort. Tablets must be swallowed whole with a full glass of water; do not crush, chew, or break.

Titration: After 1-2 weeks of therapy, begin tapering by 200mg decrements every 3-7 days based on clinical response and tolerability. Most patients achieve remission at doses between 400-800mg daily.

Maintenance: Not recommended for long-term use. Once control is achieved, transition to conventional prednisolone (typically 5-20mg daily) or alternative maintenance therapy.

Special Populations: Renal impairment: No adjustment needed. Hepatic impairment: Reduce dose by 25-50%. Elderly: Initiate at 400-600mg daily. Pediatric: Not recommended under 18 years.

Precautions

• Adrenal suppression may occur even with short-term use; monitor for symptoms of hypocortisolism during and after treatment
• Regular ophthalmological examinations recommended for treatments exceeding 4 weeks due to risk of cataract formation and glaucoma
• Monitor blood glucose levels frequently, particularly in patients with pre-diabetes or diabetes mellitus
• Assess bone mineral density baseline and consider prophylactic bisphosphonate therapy for treatments anticipated to exceed 3 months
• Implement gastrointestinal protection with proton pump inhibitors due to increased risk of peptic ulcer disease
• Exercise caution in patients with hypertension, congestive heart failure, or recent myocardial infarction
• Vaccination status should be reviewed; live vaccines are contraindicated during therapy

Contraindications

• Systemic fungal infections
• Known hypersensitivity to prednisolone or any component of the formulation
• Active, latent, or inadequately treated tuberculosis
• Active herpes simplex keratitis
• Untreated bacterial, viral, or parasitic infections
• Recent live virus vaccination (within 4 weeks)
• Severe hepatic impairment (Child-Pugh Class C)
• Pregnancy, unless potential benefit justifies potential risk to fetus

Possible side effect

Very common (>10%): Insomnia, mood changes, increased appetite, fluid retention, hypertension, hyperglycemia, dyspepsia

Common (1-10%): Cushingoid appearance, hirsutism, acneiform eruptions, menstrual irregularities, impaired wound healing, easy bruising, muscle weakness, osteoporosis, posterior subcapsular cataracts, increased intraocular pressure

Uncommon (0.1-1%): Pancreatitis, peptic ulceration with perforation, esophageal candidiasis, avascular necrosis of femoral head, psychiatric reactions including mania and depression, suppression of growth in children

Rare (<0.1%): Anaphylactoid reactions, cardiac arrhythmias, seizure threshold lowering, tendon rupture

Drug interaction

• Anticoagulants: Increased risk of gastrointestinal bleeding; monitor INR closely
• Antidiabetic agents: Corticosteroids antagonize hypoglycemic effects; adjust doses accordingly
• CYP3A4 inducers (rifampicin, carbamazepine): May significantly reduce prednisolone efficacy
• CYP3A4 inhibitors (ketoconazole, clarithromycin): May increase prednisolone exposure and toxicity
• Diuretics: Enhanced potassium wasting; monitor electrolytes
• NSAIDs: Increased risk of GI ulceration; avoid concomitant use
• Live vaccines: Impaired immune response; contraindicated during therapy
• Cardiac glycosides: Increased risk of digitalis toxicity due to hypokalemia

Missed dose

If a dose is missed and remembered within 6 hours of the scheduled time, take the tablet immediately. If more than 6 hours have passed, skip the missed dose and resume the regular schedule with the next dose. Do not double the dose to make up for a missed one. Contact your healthcare provider if multiple doses are missed, as adjustment of the tapering schedule may be necessary to prevent adrenal insufficiency.

Overdose

Acute overdose may manifest as psychosis, hypertension, pulmonary edema, congestive heart failure, and severe hyperglycemia. There is no specific antidote. Treatment is supportive and symptomatic: gastric lavage if ingestion recent, activated charcoal if within 1 hour, and meticulous monitoring of electrolyte balance, blood glucose, and cardiovascular status. Hemodialysis is not effective due to high protein binding. Consider stress-dose hydrocortisone if adrenal suppression is suspected.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in the original container with desiccant. Protect from light and moisture. Keep tightly closed when not in use. Do not remove desiccant canister. Keep out of reach of children and pets. Do not use after expiration date printed on packaging. Do not transfer to other containers.

Disclaimer

This information is intended for healthcare professionals and should not replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read in this product information. Actual patient experiences may vary.

Reviews

“After failing multiple conventional steroid tapers for severe ulcerative colitis, Pim 800 achieved remission within 72 hours. The targeted delivery significantly reduced my systemic side effects compared to previous treatments.” - Gastroenterologist, University Hospital

“In our rheumatology practice, we reserve Pim 800 for the most severe cases of autoimmune flare-ups. The precision dosing allows us to control disease activity rapidly while planning transition to steroid-sparing agents.” - Rheumatologist, 15 years experience

“The pharmacokinetic profile of Pim 800 provides a much-needed option for patients who require high-dose steroids but cannot tolerate the side effects of traditional formulations. The delayed-release mechanism makes a noticeable difference in patient comfort.” - Clinical Pharmacist, Specialized IBD Center