[Drugs and patient information. Writing of instructions]. / Médicaments et information aux patients. Rédaction des notices.

The main accusation against package inserts is that they are not understood by the patients: the vocabulary used is uncommon and the information is not always relevant. A recent European directive on package inserts for drugs concerning human use specifies the items that must be mentioned. Following this directive and regarding patient interest, a presentation for notices is proposed in which the subject headings are presented as questions and the text is a guide to drug practical use to provide the elements of surveillance. A summarized version added to this detailed notice for the convenience of the patient is also proposed, which should be translated into the language of each European Community's member state.

Tolerability of ramipril in a multicenter study of mild-to-moderate hypertension in general practice.

In this study, the tolerability and safety of ramipril, as monotherapy and in combination with a low dose of furosemide, were assessed in patients with mild-to-moderate hypertension in general practice. After a placebo run-in phase, patients received ramipril as monotherapy in a dose of 2.5 to 5 mg daily for 6 weeks. Nonresponders (diastolic blood pressure greater than 90 mm Hg) entered a double-blind treatment period, and received either 10 mg of ramipril daily, or 5 mg of ramipril in combination with 20 mg of furosemide daily. The tolerability of the study medication was assessed by reported adverse events, and by monitoring blood cell count, electrolytes, serum creatinine, fasting blood glucose, and apolipoproteins AI and B. Of a total of 770 patients who entered the placebo run-in phase, 661 patients were enrolled in the first active treatment period. The most commonly reported adverse events were headache, cough, dizziness, asthenia, cramps, diarrhea, and nausea, but not all of these events were related to ramipril treatment. A total of 38 patients discontinued active treatment due to nonserious adverse events, mainly cough, dizziness, or diarrhea. There appeared to be a relationship between the prevalence of cough and ramipril dosage; however, an increased incidence of cough was also observed during outbreaks of influenza in France. There were no significant changes in laboratory variables during the study.

[Tolerance to Triatec in monotherapy and in combination with Lasilix in a French multicenter study]. / Tolérance du Triatec en monothérapie et en association au Lasilix dans l'étude multicentrique française.

In a multicenter study in general practice, the tolerability and safety of ramipril alone and in combination with a low dose of furosemide were assessed in moderate hypertension. After a placebo run-in period involving 770 patients, 661 were included in the active treatment period and received ramipril alone (2.5-5 mg/day). After 6 weeks, the nonresponders entered in a double-blind period and they received daily ramipril 10 mg or ramipril 5 mg in combination with furosemide 20 mg. In this hypertensive population, the adverse events more commonly reported were headache, cough, dizziness, asthenia, cramps diarrhea and nausea, but not all these events were related to ramipril. There was seemingly a relation between cough prevalence and rampiril dosage; an increased incidence was also observed during the outbreaks of flu-syndrome in our country. 38 patients discontinued the active treatment due to non-serious adverse events, mainly cough, dizziness or diarrhea. No serious adverse drug reaction was observed. Laboratory data (blood cells count, electrolytes, serum creatinine, fasting blood glucose, apolipoproteins AI and B) remained most commonly unaffected. In moderate hypertension in general practice, this study confirms that ramipril is well tolerated, especially with regard to the class effects of the angiotensin converting enzyme inhibitors.

[Prolonged hypocoagulability following the ingestion of anticoagulant raticides]. / Hypocoagulabilité prolongée secondaire à l'ingestion de raticides anticoagulants.

Voluntary ingestion of concentrated anticoagulant rodenticides leads to prolonged hypocoagulability sometimes accompanied by haemorrhage. The authors report 11 cases referred to the Paris Anti-Poisons Centre. The products implicated were chlorophacinone, bromadiolone, and warfarin. The time interval before medical intervention ranged from 90 minutes to 3 weeks. The absence of early clinical signs probably explains the number of late admissions. Haemorrhage of variable severity was observed in 8 cases. The prothrombin time varied with the administered dose of Vitamin K and/or coagulation factors. Three patients were lost to follow-up at days 9, 24 and 68. The other patients were treated for several weeks (27 to 82 days). Massive overdose with these rodenticides justifies stomach washout when the patients are seen early, daily check-ups of coagulability and treatment with Vitamin K at a dosage adapted to the biochemical abnormalities. Severe haemorrhage requires transfusion and the administration of factors of coagulation. The duration of the abnormalities is unpredictable; the prothrombin time should therefore be checked 48 hours after stopping Vitamin K therapy to detect any recurrence.

[Acute poisoning by orphenadrine]. / Intoxication aiguë par l'orphénadrine.

From January 1974 to June 1983, the Paris Poison Control Centre collected 84 cases of overdosage with orphenadrine alone or in combination. Prior papers emphasized fatalities related to orphenadrine poisoning. This retrospective study suggests an underestimated incidence of anticholinergic drugs abuse in our country. The clinical picture of orphenadrine poisoning associates drowsiness, agitation, confusion, delirium and seizures. Anticholinergic symptoms are often noted: mydriasis, sinus tachycardia, dryness of the mouth and urinary retention. No severe cardiac disturbance was found in these patients.