Ranitidine precautions

List of precautions
Transaminase Elevations Activation of Mania/Hypomania Seizure Use in Patients with Concomitant Illness Nursing Mothers Pediatric Use Geriatric Use

Transaminase Elevations
Clinically significant ALT (SGPT) elevations (≥ 3 times the upper limit of the normal range) were observed in 2.0% (8/424) of patients exposed to Ranitidine in a pool of short-term US controlled trials, compared to 0.3% (1/328) of placebo patients and 2.0% (3/181) of amitriptyline patients. Most of these patients with ALT increases did not develop signs or symptoms associated with compromised liver function. While some patients were discontinued for the ALT increases, in other cases, the enzyme levels returned to normal despite continued Ranitidine treatment. Ranitidine should be used with caution in patients with impaired hepatic function. Return to top

Activation of Mania/Hypomania
Mania/hypomania occurred in approximately 0.2% (3/1299 patients) of Ranitidine-treated patients in US studies. Although the incidence of mania/hypomania was very low during treatment with mirtazapine, it should be used carefully in patients with a history of mania/hypomania. Return to top

Seizure
In premarketing clinical trials only one seizure was reported among the 2796 US and non-US patients treated with Ranitidine. However, no controlled studies have been carried out in patients with a history of seizures. Therefore, care should be exercised when mirtazapine is used in these patients. Return to top

Use in Patients with Concomitant Illness
Clinical experience with Ranitidine in patients with concomitant systemic illness is limited. Accordingly, care is advisable in prescribing mirtazapine for patients with diseases or conditions that affect metabolism or hemodynamic responses. Ranitidine has not been systematically evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or other significant heart disease. Ranitidine was associated with significant orthostatic hypotension in early clinical pharmacology trials with normal volunteers. Orthostatic hypotension was infrequently observed in clinical trials with depressed patients. Ranitidine should be used with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (history of myocardial infarction, angina, or ischemic stroke) and conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medication) Return to top

Nursing Mothers
It is not known whether mirtazapine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ranitidine (mirtazapine) Tablets are administered to nursing women. Return to top

Pediatric Use
Safety and effectiveness in children have not been established. Return to top

Geriatric Use
Approximately 190 elderly individuals (≥ 65 years of age) participated in clinical studies with Ranitidine. This drug is known to be substantially excreted by the kidney (75%), and the risk of decreased clearance of this drug is greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. Sedating drugs may cause confusion and over-sedation in the elderly. No unusual adverse age-related phenomena were identified in this group. Pharmacokinetic studies revealed a decreased clearance in the elderly. Caution is indicated in administering Ranitidine to elderly patients. Return to top