Aldornet* (methyldopa, MSD Std.) Methyldopa is contraindicated in active hepatic diseases and hypersensitivity. It is important to recognize that a positive Coombs test may occur. Hemolytic anemia and liver disorders have been reported with methyldopa therapy. INDICATIONS: Arterial hypertension. May be employed in conjunction with a diuretic and/or other antihypertensive drugs in patients with hypertension of various severity, or as the initial agent in patients for whom treatment should not be started with a diuretic. DOSAGE SUMMARY: ADULTS: Start usually with 250 mg two or three times daily during the first 48 hours; thereafter adjust at intervals of not less than two days according to the patient's response. Maximal daily dosage is 3.0 g of methyldopa. Smaller doses may be needed in presence of impaired renal function, or in older patients with an increased sensitivity or advanced arteriosclerotic vascular disease. Tolerance may occur occasionally between the second and third month after initiating therapy. Effectiveness can frequently be restored by increasing the dose or adding a thiazide. CONTRAINDICATIONS: Active hepatic disease such as acute hepatitis and active cirrhosis; if previous methyldopa therapy has been associated with liver disorders or hemolytic anemia (see WARNINGS); hypersensitivity. WARNINGS: It is important to recognize that a positive Coombs test, hemolytic anemia, and liver disorders may occur with methyldopa therapy. The rare occurrences of hemolytic anemia or liver disorders could lead to potentially fatal complications unless properly recognized and managed. Read this section carefully to understand these reactions. With prolonged methyldopa therapy, 10% to 20% of patients develop a positive direct Coombs test, usually between 6 and 12 months of therapy. Lowest incidence is at daily dosage of 1 g or less. This on rare occasions may be associated with hemolytic anemia, which could lead to potentially fatal complications. One cannot predict which patients with a itive direct Coombs test may develop hemolytic anemia. Prior exist. or development of a positive direct (.mbs test is not in itself a contraindication to use of methyldopa. If a positive Coombs test develops during methyldopa therapy, determine whether hemolytic anemia exists and whether the positive Coombs test may be a problem. For example, in addition to a positive direct Coombs test there is less often a positive indirect Coombs test which may interfere with cross matching of blood. At the start of meth Idopa therapy, it is desirable to do a blood count (hematocrit, hemoglobin, or red cell count) for a baseline or to estallish whether there is anemia. Periodic blood counts should be done during therapy to detect hemolytic anemia. it may be useful to do a direct Ooombs test before therapy and at 6 and 12 months after the start of therapy. if Coombs-positive hemolytic anemia occurs, the cause may be methyldopa and the drug should be discontinued. Usually the anemia remits promptly. If not, corticosteroids may be given and other causes of anemia should be consideredif hemolytic anemia occurs,the drug should not be reinstituted.When methyldopa causesCoombs positivity alone or with hemolytic anemia,the red cell is usually coated with gamma globulin of the lgG (gamma G) class only. The positive Coombs test may not revert to normal until weeks to months after methyldopa is stopped. Should the need for transfusion arise in a patient receiving methyldopa, both a direct and an indirect Coombs test should be performed on his blood. In the absence of hemolytic anemia, usually only the direct Coombs test will be positive. A positive direct Coombs test alone will not interfere with typing or cross matching. If the indirect Coombs test is also positive, problems may arise in the major cross match and the assistance of a hematologist or transfusion expert will be needed. Occasionally fever has occurred within the first three weeks of therapy, sometimes with eosinophilia or abnormalities in one or more liver function tests. Jaundice, with or without fever, may occur, with onset usually within first 2 or 3 months of therapy. In some patients the findings are consistent with those of cholestasis. Rare cases of fatal hepatic necrosis have been reported. These hepatic changes may represent hypersensitivity reactions; periodic determination of hepatic function should be done particularly during the first 6 to 12 weeks of therapy or whenever unexplained fever occurs. Discontinue If fever, abnormalities in liver function tests, or jaundice occur. If related to methyldopa, reversion to normal has been characteristic when drug was discontinued. Do not reinstitute methyldopa in such patients and use with caution in those with history of previous liver disease or dysfunction. Reversible leukopenia with primary effect on granulocytes has been seen rarely. Rare cases of granulocytopenia have been reported. Granulocyte and leukocyte counts returned promptly to normal on discontinuance of drug. Reversible thrombocytopenia has occurred rarely. Methyldopa may potentiate action of other antihypertensive drugs. Follow patients carefully to detect side reactions or unusual manifestations of drug idiosyncrasy. Use in Pregnancy: Use of any drug in women who are or may become pregnant requires that anticipated benefits be weighed against possible risks; possibility of fetal injury cannot be excluded. PRECAUTIONS: Use cautiously if there is a history of liver disease or dysfunction (see WARNINGS). Methyldopa may interfere with measurement of: uric acid by the phosphotungstate method, creatinine by the alkaline picrate method, and SGOT by colorimetric method. Fluorescence in urine samples at same wave lengths as catecholamines may be reported as urinary catecholamines. This will interfere with the diagnosis of pheochromocytoma. It is important to recognize this phenomenon before a patient with possible pheochromocytoma is subjected to surgery. Methyldopa is not recommended for treatment of patients with pheochromocytoma. Rarely, urine may darken when exposed to air after voiding. Stop methyldopa if involuntary choreoathetotic movements occur in patients with severe bilateral cerebrovascular disease. Patients with impaired renal function may respond to smaller doses. Syncope in older patients may be related to increased sensitivity and advanced arteriosclerotic vascular disease; this may be avoided by lower doses. Patients may require reduced doses of anesthetics. Hypotension occurring during anesthesia usually can be controlled by vasopressors. Dialysis removes methyldopa and hypertension may recur. ADVERSE REACTIONS: Central Nervous System: sedation, headache, asthenia, or weakness, usually early and transient. Dizziness, lightheadedness, symptoms of cerebrovascular insufficiency, paresthesias, parkinsonism, Bell's palsy, decreased mental acuity, involuntary choreoathetotic movements; psychic disturbances including nightmares and reversible mild psychoses or depression; toxic encephalopathy. Cardiovascular: Bradycardia, aggravation of angina pectoris; orthostatic hypotension (decrease daily dosage); edema (and weight gain) usually relieved by use of a diuretic; discontinue methyldopa if edema progresses or signs of heart failure appear. Gastrointestinal: Nausea, vomiting, distention, constipation, flatus, diarrhea, mild dryness of mouth, sore or "black" tongue, pancreatitis, sialadenitis. Hepatic: Abnormal liver function tests, jaundice, liver disorders. Hematologic: Positive Ooombs test, hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia. Allergic: Drug-related fever, myocarditis. Other: Nasal stuffiness, rise in BUN, breast enlargement, gynecomastia, lactation, impotence, decreased libido, dermatologic reactions including eczema and lichenoid eruptions, mild arthralgia, myalgia. FULL PRESCRIBING INFORMATION AVAILABLE ON REQUEST HOW SUPPLIED: Tablets ALDOMET* are yellow, film-coated, biconvex shaped tablets, supplied as follows: Ca 8737-each tablet containing 125 mg of methyldopa, market MSD 135 on one side, supplied in bottles of 100 and 1000. Ca 3290-each tablet containing 250mg of methyldopa, marked MSD 401 on one side, supplied in bottles of 100 and 1000. Ca 8733-each tablet containing 500mg of methyl. marked MSD 516 on one side, supplied in bottles of 100 and 250. Also available: Ca 3293-Injection AL.MET* Ester hydrochloride, a clear colourless solution containing 250mg methyldopate hydrochloride per 5 ml, supplied in 5 ml ampoules. 1. Onesti, G.L.: When hypertension is complicated, Drug Therapy 566-78, June 1975. MERCK *Trademark

SHARP

ADM-8-476-JA

& DOH ME CANADA LIMITED POINTE CLAIRE, QUEBEC

screening over clinical examination confer on the patient or on the delivery of medical services any form of benefit whatever? If the answer is no, forget the subject; if yes, proceed to question 4. 4. Is mass screening affordable? This, I suspect, is the main bone of contention. The current price in Ontario of $25 to $30 every 2 years or so is a relatively trivial amount for each woman at risk to pay for either the benefit of the procedure (if she has disease) or peace of mind (if she has not). Clearly then, on a per capita basis, it is affordable. A health ministry bureaucrat, of course, may consider that this amount paid every 2 years and multiplied by the number of women at risk is a horrendously expensive price to pay for a mere humanitarian gain. I suggest that the bureaucrat's approach to health care delivery is irrational, irrelevant and inhuman, and that the per capita cost is a more valid way to consider such issues than the mad mathematics of the paramedical bureaucracy. T.J. MUCKLE, MD, FRCP[C] Director of laboratories Chedoke hospitals Hamilton, Ont.

Reference 1. SCOTT R: U.S. women over 50 still to have cancer screening. Med Post 13: 1, 52; 1977

Prune-belly syndrome To the editor: Many interesting and unusual medical cases occur in the developing third world that, for various reasons, are never reported in medical literature. In Africa some families live far from medical centres or are unable to pay for medical care, so they usually seek local traditional treatment. Many patients present late to a medical centre when they are suffering from complications which obscure the underlying problem. Most hospitals in Africa, except those in university centres or in large cities, lack the sophisticated laboratory diagnostic facilities required to investigate obscure cases. Zaire (population, approximately 23 000 000) has only one university medical school which is situated in Kinshasa. The prune-belly syndrome or triad is characterized by absence or deficiency of the abdominal musculature, cryptorchidism and urinary tract abnormalities such as megaloureter, cystic renal dysplasia, urethral obstruction, megacystis or urachal diverticulum.1 Persons with an anatomic urethral obstruction, such as posterior urethral valves, meatal stenosis or urethral atresia, generally have a poor prognosis and have been said to have the lethal variant of the syndrome.2 Other clinical features may be present, namely, flar-

CMA JOURNAL/JANUARY 21, 1978/VOL. 118 121

The modifier of digestive behaviour Indications: Sub-acute gastntis, chronic gastritis, gasWIG sequelee of surgical procedures such as vagotomy and pyloroplasty. Under these conditions, when gastnc emptying is delayed, Maxeran may relieve such symptoms as nausea, vomiting, epigastric distress, bloating, etc. Small bowel intubation: Maxeran may facilitate and accelerate small bowel intubation. Side-effects: Drowsiness and, more rarely, insomnia, fatigue, headaches, dizziness and bowel disturbances have been reported. Parkinsonism and other extra-pyramidal syndromes have been reported infrequently. An increase in the frequency and severity of seizures has been reported in conjunction with the administration of Maxeran to epileptic patients. Precautions: Drugs with atropine-like action should not be used simultaneously with Maxeran since they have a tendency to antagonize effect of this drug on gastrointestinal motility. Maxeran should not be used in conjunction with potent ganglioplegic or neuroleptic drugs since potentiation of effects might occur. Maxeran should not be used in patients with epilepsy and extrapyramidal syndromes, unless its expected benefits outweigh the risk of aggravating these symptoms. In view of the risk of extrapyramidal manifestations, metoclopramide should not be used in children unless a clear indication has been established. The recommended dosage of Maxeran should not be exceeded since a further increase in dosage will not produce a corresponding increase in the clinical response. The dosage recommended br children should not be exceeded. Contraindications: Maxeran should not be administered to patients in combination with MAO inhibitors, Incyclic antidepressants, sympathomimetics and foods with high tyramine content, since safety of such an association has not yet been established. As a safety measure, a twoweek period should elapse between using Maxeran and administration of any of these drugs. The safety of use of Maxeran in pregnancy has not been established. Therefore Maxeran should not be used in pregnant women, unless in the opinion of the physician the expected benefits to the patient outweigh the potential risks to the fetus.

ing of the lower ribs, flattening of the diaphragm, talipes equinovarus and anomalies of the gastrointestinal tract, particularly malrotation. The syndrome is seen almost exclusively in boys. A definite pattern of inheritance is not known, although an X-linked recessive inheritance has been proposed. As the child gets older and as the subcutaneous tissue increases the abdomen is more appropriately described as "potbelly".3 We report a case of prune-belly syndrome in a boy from Zaire. An 8-year-old boy was referred by the physician in charge of a factory dispensary because of abdominal distension that had been present since infancy. He had previously been treated for malaria, ascariasis and schistosomiasis, but he had had no complaints referable to the bowel or urinary tract. In African children with borderline malnutrition and intestinal parasites, a pot-belly is not unusual, but the patient was noted to have a very weak abdominal wall and cryptorchidism, and therefore was admitted to hospital for further investigation. He was a slight boy with an obviously distended abdomen (Fig. 1), but he was in no distress. There was slight flaring of the lower costal margin. Loops of in. testine could be seen easily; no abnormal masses were palpable although there was unusual fullness in the umbilical region. He was unable to sit up from a supine position without turning on his side and using his arms, because of the weak

Dosage and administration:

For delayed gastric emptying Adults Tablets: 1/2 to 1 tablet (5 - 10 mg) three or Liquid: Injectable:

Children: Liquid:

Availability:

R.I. HILLIARD, MD, FRCP[C] Institut m6dical 6vangelique Kimpese, Zaire

Each white scored compressed tablet contains 10 mg of Metoclopramide hydrochloride. Bottles of 50 & 500 tablets.

Liquid:

Each ml contains 1 mg of Metoclopramide hydrochloride. Available in bottles of 110 ml and 450 ml. Each 2 ml ampoule contains 10 mg of Metoclopramide hydrochloride in a clear colourless solution. Keep away from light and heat. Available in boxes of 5 and 50 ampoules. Product monograph available upon

Injectable:

References

minutes before intubation. Other routes (oral or tM.) may be used but with a greater period of latency. (5 to 14 years): 2.5to5ml (2.5 -5mg)

Tablets:

1. VAUGHAN VC, MCKAY RJ (eds): Nelson Textbook of Pediatrics, 10th Cd, Philadelphia, Saunders, 1975, p 1247 2. ROGERS LW, OsTRow PT: The prune belly syndrome. Report of 20 cases and description of a lethal variant. J Pediatr 83: 786, 1973 3. BARNETT HL: Pediatrics, 15th ed, New York, Appleton, 1972, p 1559 4. DAVEY WW: Companion to Surgery in Africa, Baltimore, Williams & Wilkins, 1968, p 75

Acute lindane poisoning

request

.©c.3c.o©

PHARMACEUTIQUES LTEE PHARMACEUTICALS LTD Laval, Que. Canada.

At present there is no evidence of an anatomic urethral obstruction, and the boy is progressing well although he is short (121 cm) for his age. Chronic infestation with S. hematobium usually results in a fibrous contracture of the bladder with reduced capacity and, later, reflux and hydronephrosis.4 This child displays the features of prunebelly syndrome and he will be referred to a urologist in Kinshasa for further management. I gratefully acknowledge the assistance of Citoyen Mandiangu Mbongi, administrator, the staff and Miss Audrey Kimber, roentgenography technician.

four times a day before meals. 5 - 10 ml (5 - 10 mg) three or tour times a day before meals. When parenteral administration is required, 1 ampoule (10 mgl IM. or IV. (slowly) to be repeated 2 or 3 times a day if necessary. (5 to 14 years): 2.5 to 5 ml 12.5-5 mg) three times a day before meals.

For small bowel intubation: Adults: One ampoule (10 mg) IV. - 15 Children:

abdominal muscles. He had bilateral cryptorchidism. Hemoglobin value was 11.6 g/dL, leukocyte count 6.75 X 109/L with a normal differential and serum creatinine value 0.9 mg/dL. The urine had a specific gravity of 1.020 and contained protein (1 +). erythrocytes (2 to 3 per high-power field) and ScI.istosoma hematobium ova. Stools contained no ova or parasites. (After treatment with niridazole [Ambilharj ova were absent from subsequent urine samples.) An intravenous pyelogram showed no function on the right side, and a dilated renal pelvis and megaloureter on the left; the bladder was not visualized, probably because the dye was diluted by the large amount of residual urine in the grossly distended bladder. After the boy had urinated, a cystogram was performed which showed reflux into the dilated right ureter and a grossly distended bladder. During this procedure 500 mL of contrast medium was introduced and caused no discomfort to the boy; subsequently 2 L of urine was drained. He continues to pass urine in small amounts and the bladder is never completely emptied.

FIG. 1-Characteristic abdominal distension of the prune belly syndrome.

To the editor: I read with interest the report by Drs. Z.M. Munk and A. Nantel on acute poisoning with the insecticide lindane (Can Med Assoc J 117: 1050, 1977). The report and the front cover suggest that such poisoning is unusual and perhaps of little interest to the average physician. However, for human use, lindane (gamma benzene hexachloride [GBH]) is sold as Kwellada and GBH lotion for the treatment of scabies and pedi-

CMA JOURNAL/JANUARY 21, 1978/VOL. 118 123

Prune-belly syndrome.

Aldornet* (methyldopa, MSD Std.) Methyldopa is contraindicated in active hepatic diseases and hypersensitivity. It is important to recognize that a po...
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