Xinlitan Allisartan Isoproxil Tablets

1. Indications and Usage
Hypertension: Indicated for the treatment of mild to moderate primary hypertension.
2. Dosage and Administration
Recommended Dose: The recommended dosage for adults is 240 mg once daily.
Administration: Administration should be performed without food. Food decreases the absorption of this drug, so it should not be taken during meals.
Dose Adjustment: The dosage may be adjusted based on blood pressure response, but specific maximum dose limits should be determined by clinical evaluation.
3. Mechanism of Action
Prodrug Metabolism: After oral administration, Allisartan Isoproxil is rapidly metabolized by esterases widely present in the gastrointestinal tract into its active metabolite, EXP-3174.
AT1 Receptor Antagonism: EXP-3174 selectively binds to the angiotensin II type 1 (AT1) receptor, blocking the physiological effects of angiotensin II and causing vasodilation.
Metabolic Advantage: This prodrug mechanism does not require hepatic cytochrome P450 metabolism, reducing the likelihood of pharmacokinetic drug interactions.
4. Safety and Warnings
Pregnancy and Lactation: Drugs acting directly on the renin-angiotensin system can cause injury and death to the developing fetus. The drug is contraindicated during the second and third trimesters of pregnancy and during lactation.
Renal Impairment: Renal blood flow and glomerular filtration rate may be affected in patients with renal artery stenosis or renal impairment.
Hyperkalemia: Monitoring of serum potassium is recommended, especially when used with other agents that can increase potassium levels.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include headache, dizziness, flushing, fatigue, and gastrointestinal disturbances.
Clinical Research: Clinical trials have demonstrated that Allisartan Isoproxil effectively lowers blood pressure in patients with mild to moderate hypertension and generally shows a favorable safety profile.
6. Drug Interactions
Lithium: Concomitant use with lithium may cause reversible increases in serum lithium levels and toxicity; serum lithium levels must be monitored.
Potassium-Sparing Diuretics and Potassium Supplements: Concomitant use may lead to hyperkalemia.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAIDs may weaken the antihypertensive effect of Allisartan Isoproxil.
Ephedra: Medications containing ephedra may reduce the efficacy of this antihypertensive drug.
7. Pharmaceutical Information
Composition: The active ingredient is Allisartan Isoproxil.
Appearance: The tablets are film-coated.
Storage: The drug should be sealed and stored in a dry place.