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Sotret

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Sotret

Sotret

OVERDOSE

The oral LD50 of isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin is greater than 4000 mg/kg in rats and mice ( > 600 times the recommended clinical dose of 1.0 mg/ kg/day after normalization of the rat dose for total body surface area and > 300 times the recommended clinical dose of 1.0 mg/ kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area). In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.

Isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin causes serious birth defects at any dosage (see Boxed CONTRAINDICATIONS AND WARNINGS). Female patients of childbearing potential who present with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the boxed CONTRAINDICATIONS AND WARNINGS. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in PRECAUTIONS. Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose. All patients with isotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) inoin overdose should not donate blood for at least 1 month.

CONTRAINDICATIONS

Pregnancy: Category X.

See Boxed CONTRAINDICATIONS AND WARNINGS.

Allergic Reactions

Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) is contraindicated in patients who are hypersensitive to this medication or to any of its components. Sotret (isotret (isotret (isotretinoin capsules) inoin capsules) inoin capsules) should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule (see PRECAUTIONS: Hypersensitivity).

Last reviewed on RxList: 9/27/2010
This monograph has been modified to include the generic and brand name in many instances.

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