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Basic Drug Info
Drug Name:Renese-R
Manufacturer:Pfizer Labs
Other Info:Rx onlyDistributed by:Pfizer LabsDivision of Pfizer, Inc, NY, NY 1001769-1200-00-3September 1995



Clinical Trials:


Indications and Usage
Hypertension (see box warning).
Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Contraindications

A.

Related to polythiazideAdvanced renal or hepatic failure.

Hypersensitivity to this or other sulfonamide derivatives.B.

Related to reserpineDemonstrated hypersensitivity.Patients with a history of mental depression.Demonstrated peptic ulcer or ulcerative colitis.
Liver Failure -- Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTIC DEHYDROGENASE; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Peptic Ulcer -- Ulcer that occurs in the regions of the GASTROINTESTINAL TRACT which come into contact with GASTRIC JUICE containing PEPSIN and GASTRIC ACID. It occurs when there are defects in the MUCOSA barrier. The common forms of peptic ulcers are associated with HELICOBACTER PYLORI and the consumption of nonsteroidal anti-inflammatory drugs (NSAIDS).

Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Warnings

Serum electrolyte determinations are especially indicated for patients with severe derangement of metabolic processes, e.g., surgery, vomiting, or parenteral fluid therapy.

Electrolyte imbalance may be caused by certain diseases such as cirrhosis, or it may result from drug therapy, such as therapy with corticosteroids.

Patients with cirrhosis who are continually receiving RENESE-R should be observed carefully for the development of hepatic precoma or coma.

Indications of impending hepatic failure are tremor, confusion, drowsiness, and hepatic fetor.Thiazides may precipitate kidney failure and uremia in patients with pre-existing renal pathology and impaired renal function.Available information tends to implicate all oral dosage forms of potassium salts ingested in solid form with or without thiazides in the etiology of nonspecific, small bowel lesions consisting of ulceration with or without stenosis, causing obstruction, hemorrhage and perforation, and frequently requiring surgery.

Deaths due to these complications have been reported.

All oral dosage forms of potassium salts ingested in solid form should be used only when adequate dietary supplementation is not practical, and should be discontinued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur.

RENESE-R does not itself contain enteric-coated potassium.Electroshock therapy should not be given within one week of cessation of reserpine.Reserpine may cause mental depression.

Recognition of depression may be difficult because this condition may often be disguised by somatic complaints (Masked Depression).

The drug should be discontinued at first signs of depression such as despondency, early morning insomnia, loss of appetite, impotence, or self-deprecation.

Drug-induced depression may persist for several months after drug withdrawal and may be severe enough to result in suicide.

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