Trental

Trental

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General

At the first signs of an anaphylactic/anaphylactoid reaction, Trental must be discontinued and a physician must be informed.

Patients with hepatic impairment should be closely monitored during Trental therapy and may require lower doses. Since Trental (pentoxifylline) is extensively metabolized in the liver, the use of this drug is not recommended in patients with severe hepatic impairment of liver function (Child-Pugh class C, score > 9).

Patients with renal impairment (creatinine clearance below 80 mL/min) should be closely monitored during Trental therapy and may require lower doses. Since Trental (pentoxifylline) is eliminated through the kidneys, the use of this drug is not recommended in patients with severe renal impairment (creatinine clearance below 30 mL/min).

Cardiovascular

Low, labile blood pressure

Caution should be exercised when administering Trental (pentoxifylline) to patients with low or labile blood pressure. In such patients any dose increase should be done gradually and careful monitoring is required.

Patients with severe cardiac arrhythmias should be closely monitored during Trental therapy.

Hematologic

The administration of Trental has been associated with bleeding and/or prolonged prothrombin time (see DRUG INTERACTIONS). The risk of bleeding may be increased by combined treatment with anticoagulant agents or use in coagulation disorders. Therefore, in patients with coagulation disorders or being treated with anticoagulant therapy, Trental should be used with caution and only, when in the physician's judgement, the potential benefit outweighs the risk. Careful monitoring is required.

Special Populations

Pregnant Women

Reproduction studies have been performed in rats, mice and rabbits at doses up 23, 2 and 11 times the maximum recommended daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to pentoxifylline. The drug has been shown to cross the bloodplacenta barrier in mice. There is no adequate experience in pregnant women. Therefore, Trental is not recommended for women who are, or may become, pregnant unless the expected benefits for the mothers outweigh the potential risk to the fetus.

Nursing Women

Pentoxifylline and its major metabolites are excreted in human milk, following a 400 mg single oral dose of Trental. The patient should be advised to discontinue nursing or to discontinue taking the drug depending on the importance of the drug to the mother.

Pediatrics

The use of Trental in patients below the age of 18 years is not recommended as safety and effectiveness have not been established in this age group.

Geriatrics

Trental should be used with caution in elderly patients as peak plasma levels of pentoxifylline and its metabolites are moderately higher in this age group. Elderly patients had a slight increase in the incidence of some adverse effects. Careful dose adjustment is therefore recommended.

Last reviewed on RxList: 7/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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