Drug Interactions between Fortabs and hemin

GENERALLY AVOID: Coadministration with drugs that are capable of increasing the activity of delta-aminolevulinic acid synthetase (e.g., estrogens, barbiturates, steroid metabolites, rifampin) may negate the pharmacologic effect of hemin. In the treatment of porphyria, hemin is thought to limit the rate of porphyrin/heme biosynthesis by inhibiting delta-aminolevulinic acid synthetase, thus any induction of this enzyme would be expected to counteract the therapeutic effect of hemin.

MANAGEMENT: Drugs capable of increasing the activity of delta-aminolevulinic acid synthetase should be avoided during hemin therapy.

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GENERALLY AVOID: Theoretically, hemin may potentiate the risk of bleeding in patients treated with agents that affect hemostasis such as anticoagulants, platelet inhibitors, thrombin inhibitors, thrombolytic agents, or agents that commonly cause thrombocytopenia. Hemin has exhibited mild, transient anticoagulant effects during clinical studies. Thrombocytopenia and coagulopathy including prolonged prothrombin time and prolonged partial thromboplastin time have been reported during postmarketing use. The extent and duration of the hypocoagulable state induced by hemin are not known.

MANAGEMENT: The use of hemin with concurrent anticoagulant therapy should be avoided. Caution is advised if hemin is used in combination with other drugs that affect hemostasis such as platelet inhibitors, thrombin inhibitors, thrombolytic agents, or agents that commonly cause thrombocytopenia. Close clinical and laboratory observation for hematologic complications is recommended. Patients should be advised to promptly report any signs of bleeding to their physician, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools.

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One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

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